Continuous spinal anaesthesia versus single dosing. A comparative study.

PubMed

De Andrés, J A; Febré, E; Bellver, J; Bolinches, R

1995-03-01

Continuous and single dose spinal anaesthesia were compared in a prospective randomized fashion in 108 patients undergoing orthopaedic surgery. Continuous spinal anaesthesia was via a 20 gauge polyamide multiperforated catheter introduced through an 18 gauge Tuohy needle. Single-dose spinal anaesthesia was performed with a 24 guage x 103 mm Sprotte spinal needle. The mean local anaesthetic dose for the continuous technique was 38.4 (SD 16.5) mg as hyperbaric lignocaine 5%, and for the single-dose spinal anaesthesia 10.8 (SD 2.2) mg as hyperbaric bupivacaine 0.5%. Segmental levels reached with the initial dose did not differ significantly between the two groups. Mean time required to perform continuous spinal anaesthesia was 6.7 (SD 3.9) min, which was longer than for single dose 4.9 (SD 2.8) min (P < 0.05). The onset time and efficacy of anaesthesia, and the duration of the operation were similar in the two groups. Analgesia was inadequate in six patients who received continuous spinal anaesthesia (11%) and one patient who received single dose (2%) (P = 0.18). Hypotension was more frequent in those receiving single doses (P < 0.05). Caudal rotation of the outlet needle orifice to advance the catheter correlated with inadequate analgesia (P < 0.01, r = 0.38). There were no significant differences in the incidence of post-operative complications.

Comparison between oral antibiotics and probiotics as bowel preparation for elective colon cancer surgery to prevent infection: prospective randomized trial.

PubMed

Sadahiro, Sotaro; Suzuki, Toshiyuki; Tanaka, Akira; Okada, Kazutake; Kamata, Hiroko; Ozaki, Toru; Koga, Yasuhiro

2014-03-01

We have already reported that, for patients undergoing elective colon cancer operations, perioperative infection can be prevented by a single intravenous dose of an antibiotic given immediately beforehand if mechanical bowel preparation and the administration of oral antibiotics are implemented. Synbiotics has been reported to reduce the rate of infection in patients after pancreatic cancer operations. The effectiveness of oral antibiotics and probiotics in preventing postoperative infection in elective colon cancer procedures was examined in a randomized controlled trial. Three hundred ten patients with colon cancer randomly were assigned to one of three groups. All patients underwent mechanical bowel preparation and received a single intravenous dose of flomoxef immediately before operation. Probiotics were administered in Group A; oral antibiotics were administered in Group B; and neither probiotics nor oral antibiotics were administered in Group C. Stool samples were collected 9 and 2 days before and 7 and 14 days after the procedure. Clostridium difficile toxin and the number of bacteria in the intestine were determined. The rates of incisional surgical-site infection were 18.0%, 6.1%, and 17.9% in Groups A, B, and C, and the rates of leakage were 12.0%, 1.0%, and 7.4% in Groups A, B, and C, respectively, indicating that both rates were lesser in Group B than in Groups A and C (P = .014 and P = .004, respectively). The detection rates of C. difficile toxin were not changed among the three groups. We recommend oral antibiotics, rather than probiotics, as bowel preparation for elective colon cancer procedures to prevent surgical-site infections. Copyright © 2014 Mosby, Inc. All rights reserved.

Single-port Colectomy VS Multi-port Laparoscopic Colectomy. Systematic Review and Meta-analysis of More Than 2800 Procedures.

PubMed

Luján, Juan Antonio; Soriano, María Teresa; Abrisqueta, Jesús; Pérez, Domingo; Parrilla, Pascual

2015-05-01

Multiport laparoscopic surgery in colon pathology has been demonstrated as a safe and effective technique. Interest in reducing aggressiveness has led to other procedures being described, such as SILS. The aim of this meta-analysis is to evaluate feasibility and security of SILS technique in colonic surgery. A meta-analysis of twenty 7 observational studies and one prospective randomized trial has been conducted by the use of random-effects models. A total amount of 2870 procedures was analyzed: 1119 SILS and 1751 MLC. We did not find statistically significant differences between SILS and MLC in age (WMD 0.28 [-1.13, 1.68]; P=.70), BMI (WMD -0.63 [-1.34, 0.08]; P=.08), ASA score (WMD -0.02 [-0.08, 0.04]; P=.51), length of incision (WMD -1.90 [-3.95, 0.14]; P=.07), operating time (WMD -2.69 (-18.33, 12.95]; P=.74), complications (OR=0.89 [0.69, 1.15]; P=.37), conversion to laparotomy (OR=0.59 [0.33, 1.04]; P=.07), mortality (OR=0.91 [0.36, 2.34]; P=.85) or number of lymph nodes harvested (WMD 0.13 [-2.52, 2.78]; P=.92). The blood loss was significantly lower in the SILS group (WMD -42.68 [-76.79, -8.57]; P=.01) and the length of hospital stay was also significantly lower in the SILS group (WMD -0.73 [-1.18, -0.28]; P=.001). Single-port laparoscopic colectomy is a safe and effective technique with additional subtle benefits compared to multiport laparoscopic colectomy. However, further prospective randomized studies are needed before single-port colectomy can be considered an alternative to multiport laparoscopic surgery of the colon. Copyright © 2014 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

Long-term Clinical Outcomes of Cervical Disc Arthroplasty: A Prospective, Randomized, Controlled Trial.

PubMed

Sasso, Willa R; Smucker, Joseph D; Sasso, Maria P; Sasso, Rick C

2017-02-15

Prospective, randomized, single-center, clinical trial. To prospectively examine the 7- and 10-year outcomes of cervical arthroplasty to anterior cervical discectomy and fusion (ACDF). Degeneration of the cervical discs causing radiculopathy is a frequent source of surgical intervention, commonly treated with ACDF. Positive clinical outcomes are associated with arthrodesis techniques, yet there remains a long-term concern for adjacent segment change. Cervical disc arthroplasty has been designed to mitigate some of the challenges associated with arthrodesis whereas providing for a similar positive neurological outcome. As data has been collected from numerous prospective US FDA IDE trials, longer term outcomes regarding adjacent segment change may be examined. As part of an FDA IDE trial, a single center collected prospective outcomes data on 47 patients randomized in a 1:1 ratio to ACDF or arthroplasty. Success of both surgical interventions remained high at the 10-year interval. Both arthrodesis and arthroplasty demonstrated statistically significant improvements in neck disability index, visual analog scale neck and arm pain scores at all intervals including 7- and 10-year periods. Arthroplasty demonstrated an advantage in comparison to arthrodesis as measured by final 10-year NDI score (8 vs. 16, P = 0.0485). Patients requiring reoperation were higher in number in the arthrodesis cohort (32%) in comparison with arthroplasty (9%) (P = 0.055). At 7 and 10 years, cervical arthroplasty compares favorably with ACDF as defined by standard outcomes scores in a highly selected population with radiculopathy. 1.

Transverse vs torsional ultrasound: prospective randomized contralaterally controlled study comparing two phacoemulsification-system handpieces.

PubMed

Assil, Kerry K; Harris, Lindsay; Cecka, Jeannie

2015-01-01

To compare surgical efficiency and multiple early clinical outcome variables in eyes undergoing phacoemulsification using either transversal or torsional ultrasound systems. Assil Eye Institute, Beverly Hills, CA, USA. Prospective, randomized, clinician-masked, contralaterally controlled single-center evaluation. Patients seeking cataract removal in both eyes with implantation of multifocal intraocular lenses were randomly assigned to one of two treatment rooms for phacoemulsification with either a transverse ultrasound system or torsional handpiece system. The contralateral eye was treated at a later date with the alternate device. A total of 54 eyes of 27 patients having similar degrees of cataract, astigmatism, and visual potential were included. All operative data were collected for analysis, and patients were followed for 3 months after surgery. Similar visual acuity was reported at all postoperative visits between the two groups. Mean phacoemulsification time and total power required were both significantly lower with the transverse system than with the torsional technique (P<0.05 for both). Similarly, mean total balanced salt solution used was significantly less with the transverse system vs torsional (P<0.05). Postoperative safety demonstrated significantly lower endothelial cell loss at 1 day and 1 month (P<0.05) with transverse vs torsional. Macular swelling was less at 1 week, 1 month, and 3 months with transverse vs torsional, although the difference did not achieve significance (P=0.1) at any single time point. Clinically detectable corneal edema was reported less frequently at all postoperative time points with the transverse system. The transverse ultrasound system was found to be possibly associated with less balanced salt-solution use, less phacoemulsification time, and less power required than the torsional phaco system. Postoperative data suggested that improved phaco efficiency may translate to a better overall safety profile for the patient.

A Prospective Randomized Comparison Between Laparoscopic Ureterolithotomy and Semirigid Ureteroscopy for Upper Ureteral Stones >2 cm: A Single-Center Experience.

PubMed

Kumar, Anup; Vasudeva, Pawan; Nanda, Biswajit; Kumar, Niraj; Jha, Sanjeev Kumar; Singh, Harbinder

2015-11-01

The optimal management method of upper ureteral stones >2 cm is still a challenge. We performed a prospective randomized comparison between laparoscopic ureterolithotomy (LU) and ureteroscopic lithotripsy for upper ureteral calculus >2 cm to evaluate safety and efficacy of both procedures. Between January 2010 and May 2012, 110 patients with a single radiopaque upper ureteral calculus >2 cm were included in the present study. Randomization was done in two groups-group A: LU was performed and group B: Ureteroscopy (URS) was performed using a 6/7.5F semirigid ureteroscope (Richard Wolf) with holmium laser intracorporeal lithotripsy. Statistical analysis was performed regarding demographic profile, success, retreatment, auxiliary procedure rates, and also complications. Out of the total 110 patients, 54 patients were enrolled in group A and 56 patients were enrolled in group B. Mean stone size was 2.3±0.2 cm in group A versus 2.2±0.1 cm in group B (p=0.52). The overall 3-month stone-free rate was (50/50) 100% for group A versus (38/50) 76% for group B (p=0.02). The retreatment rate was significantly greater in group B than group A (8% vs. 0%, respectively; (p=0.01). Auxiliary procedure rate was higher in group B than in group A (26% vs. 0% respectively; p=0.001). The complication rate was 12% in group A versus 26% in group B (p=0.001). For upper ureteral stones of size greater than 2 cm, LU has a greater stone clearance rate, comparable operating time, lesser need for auxiliary procedure, and complication rate as compared to URS.

A randomized, prospective study of laparoendoscopic single-site plus one-port versus mini laparoscopic technique for live donor nephrectomy.

PubMed

Lee, Kyu Won; Choi, Sae Woong; Park, Yong Hyun; Bae, Woong Jin; Choi, Yong Sun; Ha, U-Syn; Hong, Sung-Hoo; Lee, Ji Youl; Kim, Sae Woong; Cho, Hyuk Jin

2018-04-01

To compare the clinical outcomes of laparoendoscopic single-site plus one-port donor nephrectomy (LESSOP-DN) and mini laparoscopic donor nephrectomy (MLDN). A prospective randomized controlled trial was conducted from December 2014 to February 2016 in donors scheduled for left donor nephrectomy. Donor and recipient demographics and clinical outcomes including pain scores and questionnaires (BIQ: body image questionnaire, SF-36, patient-reported overall convalescence) were also compared. A total of 121 eligible donors were recruited, of which 99 donors who were scheduled to undergo an operation on their left side were randomized into LESSOP-DN (n = 50) and MLDN (n = 49) groups. There were no significant demographic differences between the two groups. The renal extraction time in the LESS-DN group was shorter than that in the MLDN group (75.89 ± 13.01 vs. 87.31 ± 11.38 min, p < 0.001). Other perioperative parameters and complication rates were comparable between the two groups. The LESSOP-DN group had a smaller incision length than the MLDN group (4.89 ± 0.68 vs. 6.21 ± 1.11 cm, p < 0.001), but cosmetic scores and body image scores were similar in the two groups (p = 0.905, 0.217). Donor quality of life (SF-36) and recovery and satisfaction data were comparable between the two groups. Delayed graft function (DGF) occurred in one recipient undergoing MLDN procedure (2.1%) and progressed to graft failure. There were no differences in cosmetic satisfaction between groups despite the smaller incision size of LESSOP-DN. Safety parameters and subjective measures of postoperative morbidity were similar between the two groups.

Timing of operation for poor-grade aneurysmal subarachnoid hemorrhage: study protocol for a randomized controlled trial

PubMed Central

2013-01-01

Background Subarachnoid hemorrhage is a common and dangerous disease with an unfavorable prognosis. Patients with poor-grade subarachnoid hemorrhage (Hunt & Hess Grades 4–5) are unconscious on admission. Because of the high mortality and disability rate associated with poor-grade subarachnoid hemorrhage, it is often treated conservatively. Timing of surgery for poor-grade aneurysmal subarachnoid hemorrhage is still controversial, therefore this study aims to identify the optimal time to operate on patients admitted in poor clinical condition. Methods/design Ninety-nine patients meeting the inclusion criteria were randomly assigned into three treatment groups. The early surgery group received operation within 3 days after onset of subarachnoid hemorrhage (day of SAH = day 1); the intermediate surgery group received operation from days 4 to 7, and surgery was performed on the late surgery group after day 7. Follow-up was performed 1, 3, and 6 months after aneurysm clipping. Primary indicators of outcome included the Extended Glasgow Outcome Scale and the Modified Rankin Scale, while secondary indicators of outcome were assessed using the Barthel Index and mortality. Discussion This is the first prospective, single-center, observer-blinded, randomized controlled trial to elucidate optimal timing for surgery in poor-grade subarachnoid hemorrhage patients. The results of this study will be used to direct decisions of surgical intervention in poor-grade subarachnoid hemorrhage, thus improving clinical outcomes for patients. Trial registration Chinese Clinical Trial Registry: ChiCTR-TRC-12002917 PMID:23957458

Laparoscopic transumbilical gastrojejunostomy: an advanced anastomotic procedure performed through a single site.

PubMed

Nguyen, Ninh T; Slone, Johnathan; Reavis, Kevin M; Woolridge, James; Smith, Brian R; Chang, Ken

2009-04-01

Single-site laparoscopic surgery and natural orifice transumbilical surgery (NOTUS) have become exciting areas of surgical development. However, most reported case series consist of basic laparoscopic procedures, such as cholecystectomy and appendectomy. In this paper, we present the case of an advanced laparoscopic operation-construction of a gastrointestinal anastomosis-that was performed through ports placed entirely within the umbilicus. In this paper, we describe a 61-year-old male with a history of advanced pancreatic carcinoma who was referred with a gastric outlet obstruction. A laparoscopic gastrojejunostomy bypass, using a linear stapler with suture closure of the enterotomy, was performed through three abdominal trocars placed entirely within the umbilicus. Some potential advantages of NOTUS palliative gastrojejunostomy include reduced postoperative pain and the lack of visible abdominal scars. The operation was completed uneventfully in 40 minutes. The patient recovered without complications and was discharged on postoperative day 2. At 1-month follow-up, the patient had improved oral intake without any further vomiting symptoms. This case report documents the feasibility of an advanced anastomotic gastrojejunostomy procedure which can be performed through a single site. However, benefits of this approach, compared to conventional laparoscopic procedures, will require a prospective randomized clinical trial.

Clamp-Crushing versus stapler hepatectomy for transection of the parenchyma in elective hepatic resection (CRUNSH) - A randomized controlled trial (NCT01049607)

PubMed Central

2011-01-01

Background Hepatic resection is still associated with significant morbidity. Although the period of parenchymal transection presents a crucial step during the operation, uncertainty persists regarding the optimal technique of transection. It was the aim of the present randomized controlled trial to evaluate the efficacy and safety of hepatic resection using the technique of stapler hepatectomy compared to the simple clamp-crushing technique. Methods/Design The CRUNSH Trial is a prospective randomized controlled single-center trial with a two-group parallel design. Patients scheduled for elective hepatic resection without extrahepatic resection at the Department of General-, Visceral- and Transplantation Surgery, University of Heidelberg are enrolled into the trial and randomized intraoperatively to hepatic resection by the clamp-crushing technique and stapler hepatectomy, respectively. The primary endpoint is total intraoperative blood loss. A set of general and surgical variables are documented as secondary endpoints. Patients and outcome-assessors are blinded for the treatment intervention. Discussion The CRUNSH Trial is the first randomized controlled trial to evaluate efficacy and safety of stapler hepatectomy compared to the clamp-crushing technique for parenchymal transection during elective hepatic resection. Trial Registration ClinicalTrials.gov: NCT01049607 PMID:21888669

Prospective randomized controlled trial comparing standard analgesia with combined intra-operative cystic plate and port-site local anesthesia for post-operative pain management in elective laparoscopic cholecystectomy.

PubMed

Protic, Mladjan; Veljkovic, Radovan; Bilchik, Anton J; Popovic, Ana; Kresoja, Milana; Nissan, Aviram; Avital, Itzhak; Stojadinovic, Alexander

2017-02-01

Various mechanisms, including somatic and visceral nociceptive stimulation, have been suggested as a cause for pain after laparoscopic cholecystectomy (LC). We therefore conducted a prospective randomized controlled trial (PRCT) to evaluate whether somatovisceral pain blockade reduces pain after LC. Analgesic efficacy of multimodal analgesia is superior to standard analgesia for patients undergoing elective LC for symptomatic cholelithiasis. Specifically, topical cystic plate and port-site injection with 0.25 % bupivacaine significantly reduces pain after LC. This study was designed as single-blinded PRCT. This study was conducted in an academic medical center. Between February and May 2010 we randomly assigned 63 patients with symptomatic cholelithiasis in a 1:1 ratio to non-opioid/opioid analgesic combinations (Control Group, n = 32) and non-opioid/opioid analgesic combinations plus topical 0.25 % bupivacaine onto the cystic plate and local 0.25 % bupivacaine port-site injection, post-LC (Study Group, n = 31). Primary endpoint was patient-reported pain 1, 4, 6, 12, 24 h and 1 week post-LC using the Visual Analog Scale (VAS 0-10). Study groups were comparable clinicopathologically. There were no adverse events. A statistically significant reduction in mean pain score was apparent in Study Group patients in comparison with Control Group (mean VAS 4.83 ± 2.33 vs. 6.80 ± 1.87; p < 0.001) at all early (1-6 h) post-operative time points following LC. This PRCT shows significantly improved pain control with somatovisceral pain blockade over non-opioid/opioid analgesic combinations following LC for symptomatic cholelithiasis. For centers not utilizing adjunctive local anesthetic for LC, this topical use of bupivacaine may improve patient comfort during recovery. This trial was registered on www.ClinicalTrials.gov NCT# 01972620.

Training With Curved Laparoscopic Instruments in Single-Port Setting Improves Performance Using Straight Instruments: A Prospective Randomized Simulation Study.

PubMed

Lukovich, Peter; Sionov, Valery Ben; Kakucs, Timea

2016-01-01

Lately single-port surgery is becoming a widespread procedure, but it is more difficult than conventional laparoscopy owing to the lack of triangulation. Although, these operations are also possible with standard laparoscopic instruments, curved instruments are being developed. The aims of the study were to identify the effect of training on a box trainer in single-port setting on the quality of acquired skills, and transferred with the straight and curved instruments for the basic laparoscopic tasks, and highlight the importance of a special laparoscopic training curriculum. A prospective study on a box trainer in single-port setting was conducted using 2 groups. Each group performed 2 tasks on the box trainer in single-port setting. Group-S used conventional straight laparoscopic instruments, and Group-C used curved laparoscopic instruments. Learning curves were obtained by daily measurements recorded in 7-day sessions. On the last day, the 2 groups changed instruments between each other. 1st Department of Surgery, Semmelweis University of Medicine from Budapest, Hungary, a university teaching hospital. In all, 20 fifth-year medical students were randomized into 2 groups. None of them had any laparoscopic or endoscopic experience. Participation was voluntary. Although Group-S performed all tasks significantly faster than Group-C on the first day, the difference proved to be nonsignificant on the last day. All participants achieved significantly shorter task completion time on the last day than on the first day, regardless of the instrument they used. Group-S showed improvement of 63.5%, and Group-C 69.0% improvement by the end of the session. After swapping the instruments, Group-S reached significantly higher task completion time with curved instruments, whereas Group-C showed further progression of 8.9% with straight instruments. Training with curved instruments in a single-port setting allows for a better acquisition of skills in a shorter period. For this reason, there is a need for proficiency-based conventional, but also for a single-port, laparoscopic training curriculum in general surgery residency education. Copyright © 2015 Association of Program Directors in Surgery. Published by Elsevier Inc. All rights reserved.

Enhanced recovery after elective coronary revascularization surgery with minimal versus conventional extracorporeal circulation: a prospective randomized study.

PubMed

Anastasiadis, Kyriakos; Asteriou, Christos; Antonitsis, Polychronis; Argiriadou, Helena; Grosomanidis, Vassilios; Kyparissa, Magdalena; Deliopoulos, Apostolos; Konstantinou, Dimitrios; Tossios, Paschalis

2013-10-01

A minimal extracorporeal circulation (MECC) circuit integrates the advances in cardiopulmonary bypass (CPB) technology into a single circuit and is associated with improved short-term outcome. The aim of this study was to prospectively evaluate MECC compared with conventional CPB in facilitating fast-track recovery after elective coronary revascularization procedures. Prospective randomized study. All patients scheduled for elective coronary artery surgery were evaluated, excluding those considered particularly high risk for fast-track failure. The fast-track protocol included careful preoperative patient selection, a fast-track anesthetic technique based on minimal administration of fentanyl, surgery at normothermia, early postoperative extubation in the cardiac recovery unit, and admission to the cardiothoracic ward within the first 24 hours postoperatively. One hundred twenty patients were assigned randomly into 2 groups (60 in each group). Group A included patients who were operated on using the MECC circuit, whereas patients in Group B underwent surgery on conventional CPB. Incidence of fast-track recovery was significantly higher in patients undergoing MECC (25% v 6.7%, p = 0.006). MECC also was recognized as a strong independent predictor of early recovery, with an odds ratio of 3.8 (p = 0.011). Duration of mechanical ventilation and cardiac recovery unit stay were significantly lower in patients undergoing MECC together with the need for blood transfusion, duration of inotropic support, need for an intra-aortic balloon pump, and development of postoperative atrial fibrillation and renal failure. MECC promotes successful early recovery after elective coronary revascularization procedures, even in a nondedicated cardiac intensive care unit setting. Copyright © 2013 Elsevier Inc. All rights reserved.

Short-term intravenous antimicrobial prophylaxis for elective rectal cancer surgery: results of a prospective randomized non-inferiority trial.

PubMed

Ishibashi, Keiichiro; Ishida, Hideyuki; Kuwabara, Kouki; Ohsawa, Tomonori; Okada, Norimichi; Yokoyama, Masaru; Kumamoto, Kensuke

2014-04-01

To investigate the non-inferiority of postoperative single-dose intravenous antimicrobial prophylaxis to multiple-dose intravenous antimicrobial prophylaxis in terms of the incidence of surgical site infections (SSIs) in patients undergoing elective rectal cancer surgery by a prospective randomized study. Patients undergoing elective surgery for rectal cancer were randomized to receive a single intravenous injection of flomoxef (group 1) or five additional doses (group 2) of flomoxef after the surgery. All the patients had received preoperative oral antibiotic prophylaxis (kanamycin and erythromycin) after mechanical cleansing within 24 h prior to surgery, and had received intravenous flomoxef during surgery. A total of 279 patients (including 139 patients in group 1 and 140 in group 2) were enrolled in the study. The incidence of SSIs was 13.7% in group 1 and 13.6% in group 2 (difference [95% confidence interval]: -0.2% [-0.9 to 0.7%]). The incidence of SSIs was not significantly different in patients undergoing elective rectal surgery who were treated using a single dose of postoperative antibiotics compared to those treated using multiple-dose antibiotics when preoperative mechanical and chemical bowel preparations were employed.

Comparing Single Versus Double Screw-Rod Anterior Instrumentation for Treating Thoracolumbar Burst Fractures with Incomplete Neurological Deficit: A Prospective, Randomized Controlled Trial.

PubMed

Yu, Yu; Wang, Juan; Shao, Gaohai; Wang, Qunbo; Li, Bo

2016-05-19

BACKGROUND Following a thoracolumbar burst fracture (TCBF), anterior screw-rods apply pressure upon the graft site. However, there is limited evidence comparing single screw-rod anterior instrumentation (SSRAI) to double screw-rod anterior instrumentation (DSRAI) for TCBFs. Our objective was to compare SSRAI versus DSRAI for TCBFs with incomplete neurological deficit. MATERIAL AND METHODS A total of 51 participants with T11-L2 TCBFs (AO classification: A3) were randomly assigned to receive SSRAI or DSRAI. Key preoperative, perioperative, and postoperative data were collected. Statistical analysis was conducted to determine the independent factors associated with inferior clinical outcomes, as well as the comparative efficacy of SSRAI and DSRAI. RESULTS There were no significant differences in the key demographic and clinical characteristics between the two groups (all p>0.05). Smoking status was significantly associated with inferior three-month and six-month Denis pain scores (Wald statistic=4.246, p=0.039). Both SSRAI and DSRAI were significantly effective in improving three-month and six-month postoperative degree of kyphosis, three-month and six-month postoperative ASIA impairment scale scores, three-month and six-month postoperative Denis pain score, and three-month and six-month postoperative Denis work score (all p<0.001). Although there were no significant differences between DSRAI and SSRAI with respect to all outcomes (all p>0.05), DSRAI displayed significantly longer operating times, as well as significantly larger operative blood losses (both p<0.001). CONCLUSIONS SSRAI may be preferable over DSRAI for TCBFs with incomplete neurological deficit due to its lower operating time and amount of operative blood loss.

Fibrin Sealants in Dura Sealing: A Systematic Literature Review

PubMed Central

2016-01-01

Background Fibrin sealants are widely used in neurosurgery to seal the suture line, provide watertight closure, and prevent cerebrospinal fluid leaks. The aim of this systematic review is to summarize the current efficacy and safety literature of fibrin sealants in dura sealing and the prevention/treatment of cerebrospinal fluid leaks. Methods A comprehensive electronic literature search was run in the following databases: Cochrane Database of Systematic Reviews, Cochrane Central Resister of Controlled Trials, clinicaltrials.gov, MEDLINE/PubMed, and EMBASE. Titles and abstracts of potential articles of interest were reviewed independently by 3 of the authors. Results A total of 1006 database records and additional records were identified. After screening for duplicates and relevance, a total of 78 articles were assessed by the investigators for eligibility. Thirty-eight were excluded and the full-text of 40 articles were included in the qualitative synthesis. Seven of these included only safety data and were included in the safety assessment. The remaining 33 articles included findings from 32 studies that enrolled a total of 2935 patients who were exposed to fibrin sealant. Among these 33 studies there were only 3 randomized controlled trials, with the remaining being prospective cohort analysis, case controlled studies, prospective or retrospective case series. One randomized controlled trial, with 89 patients exposed to fibrin sealant, found a greater rate of intraoperative watertight dura closure in the fibrin sealant group than the control group (92.1% versus 38.0%, p<0.001); however, post-operative cerebrospinal fluid leakage occurred in more fibrin sealant than control patients (6.7% versus 2.0%, p>0.05). Other clinical trials evaluated the effect of fibrin sealant in the postoperative prevention of cerebrospinal fluid leaks. These were generally lower level evidence studies (ie, not prospective, randomized, controlled trials) that were not designed or powered to demonstrate a significant advantage to fibrin sealant use. Two small case series studies evaluated the effect of fibrin sealants in persistent cerebrospinal fluid leak treatment, but did not establish firm efficacy conclusions. Specific adverse reports where fibrin sealants were used for dura sealing were limited, with only 8 cases reported in neurosurgical procedures since 1987 and most reporting only a speculative relationship/association with fibrin sealant exposure. Conclusions A major finding of this systematic literature review is that there is a paucity of randomized studies that have evaluated the effectiveness and safety of fibrin sealants in providing intraoperative watertight dura closure and post-operative cerebrospinal fluid leakage. Among the limited studies available, evidence from a single randomized, controlled trial indicates that fibrin sealants provide a higher rate of intraoperative watertight closure of the dura suture line than control, albeit with a higher rate of postoperative cerebrospinal fluid leakage. Evidence from non-randomized, controlled trials suggests that fibrin sealants may be effective in preventing cerebrospinal fluid leaks with an acceptable safety profile. There is a substantial need for randomized, controlled clinical trials or well-designed prospective observational trials where the conduct of a randomized trial is not feasible to fully assess the impact of fibrin sealant utilization on the rates of intraoperative dura closure, postoperative cerebrospinal leakage, and safety. PMID:27119993

Fibrin Sealants in Dura Sealing: A Systematic Literature Review.

PubMed

Esposito, Felice; Angileri, Filippo Flavio; Kruse, Peter; Cavallo, Luigi Maria; Solari, Domenico; Esposito, Vincenzo; Tomasello, Francesco; Cappabianca, Paolo

2016-01-01

Fibrin sealants are widely used in neurosurgery to seal the suture line, provide watertight closure, and prevent cerebrospinal fluid leaks. The aim of this systematic review is to summarize the current efficacy and safety literature of fibrin sealants in dura sealing and the prevention/treatment of cerebrospinal fluid leaks. A comprehensive electronic literature search was run in the following databases: Cochrane Database of Systematic Reviews, Cochrane Central Resister of Controlled Trials, clinicaltrials.gov, MEDLINE/PubMed, and EMBASE. Titles and abstracts of potential articles of interest were reviewed independently by 3 of the authors. A total of 1006 database records and additional records were identified. After screening for duplicates and relevance, a total of 78 articles were assessed by the investigators for eligibility. Thirty-eight were excluded and the full-text of 40 articles were included in the qualitative synthesis. Seven of these included only safety data and were included in the safety assessment. The remaining 33 articles included findings from 32 studies that enrolled a total of 2935 patients who were exposed to fibrin sealant. Among these 33 studies there were only 3 randomized controlled trials, with the remaining being prospective cohort analysis, case controlled studies, prospective or retrospective case series. One randomized controlled trial, with 89 patients exposed to fibrin sealant, found a greater rate of intraoperative watertight dura closure in the fibrin sealant group than the control group (92.1% versus 38.0%, p<0.001); however, post-operative cerebrospinal fluid leakage occurred in more fibrin sealant than control patients (6.7% versus 2.0%, p>0.05). Other clinical trials evaluated the effect of fibrin sealant in the postoperative prevention of cerebrospinal fluid leaks. These were generally lower level evidence studies (ie, not prospective, randomized, controlled trials) that were not designed or powered to demonstrate a significant advantage to fibrin sealant use. Two small case series studies evaluated the effect of fibrin sealants in persistent cerebrospinal fluid leak treatment, but did not establish firm efficacy conclusions. Specific adverse reports where fibrin sealants were used for dura sealing were limited, with only 8 cases reported in neurosurgical procedures since 1987 and most reporting only a speculative relationship/association with fibrin sealant exposure. A major finding of this systematic literature review is that there is a paucity of randomized studies that have evaluated the effectiveness and safety of fibrin sealants in providing intraoperative watertight dura closure and post-operative cerebrospinal fluid leakage. Among the limited studies available, evidence from a single randomized, controlled trial indicates that fibrin sealants provide a higher rate of intraoperative watertight closure of the dura suture line than control, albeit with a higher rate of postoperative cerebrospinal fluid leakage. Evidence from non-randomized, controlled trials suggests that fibrin sealants may be effective in preventing cerebrospinal fluid leaks with an acceptable safety profile. There is a substantial need for randomized, controlled clinical trials or well-designed prospective observational trials where the conduct of a randomized trial is not feasible to fully assess the impact of fibrin sealant utilization on the rates of intraoperative dura closure, postoperative cerebrospinal leakage, and safety.

Review and Analysis of Publication Trends over Three Decades in Three High Impact Medicine Journals.

PubMed

Ivanov, Alexander; Kaczkowska, Beata A; Khan, Saadat A; Ho, Jean; Tavakol, Morteza; Prasad, Ashok; Bhumireddy, Geetha; Beall, Allan F; Klem, Igor; Mehta, Parag; Briggs, William M; Sacchi, Terrence J; Heitner, John F

2017-01-01

Over the past three decades, industry sponsored research expanded in the United States. Financial incentives can lead to potential conflicts of interest (COI) resulting in underreporting of negative study results. We hypothesized that over the three decades, there would be an increase in: a) reporting of conflict of interest and source of funding; b) percentage of randomized control trials c) number of patients per study and d) industry funding. Original articles published in three calendar years (1988, 1998, and 2008) in The Lancet, New England Journal of Medicine and Journal of American Medical Association were collected. Studies were reviewed and investigational design categorized as prospective and retrospective clinical trials. Prospective trials were categorized into randomized or non-randomized and single-center or multi-center trials. Retrospective trials were categorized as registries, meta-analyses and other studies, mostly comprising of case reports or series. Study outcomes were categorized as positive or negative depending on whether the pre-specified hypothesis was met. Financial disclosures were researched for financial relationships and profit status, and accordingly categorized as government, non-profit or industry sponsored. Studies were assessed for reporting COI. 1,671 original articles were included in this analysis. Total number of published studies decreased by 17% from 1988 to 2008. Over 20 year period, the proportion of prospective randomized trials increased from 22 to 46% (p < 0.0001); whereas the proportion of prospective non-randomized trials decreased from 59% to 27% (p < 0.001). There was an increase in the percentage of prospective randomized multi-center trials from 11% to 41% (p < 0.001). Conversely, there was a reduction in non-randomized single-center trials from 47% to 10% (p < 0.001). Proportion of government funded studies remained constant, whereas industry funded studies more than doubled (17% to 40%; p < 0.0001). The number of studies with negative results more than doubled (10% to 22%; p<0.0001). While lack of funding disclosure decreased from 35% to 7%, COI reporting increased from 2% to 84% (p < 0.0001). Improved reporting of COI, clarity in financial sponsorship, increased publication of negative results in the setting of larger and better designed clinical trials represents a positive step forward in the scientific publications, despite the higher percentage of industry funded studies.

A comparison of Chevron and Lindgren-Turan osteotomy techniques in hallux valgus surgery: a prospective randomized controlled study.

PubMed

Uygur, Esat; Özkan, Namık Kemal; Akan, Kaya; Çift, Hakan

2016-01-01

The aim of this prospective randomized controlled single-blind study was to compare the results of Chevron and Lindgren-Turan osteotomy techniques for treatment of moderate hallux valgus. A total of 66 female patients (34 in Chevron group, 32 Lindgren-Turan group) were recruited in this study and followed up for an average of 26.08 months. Operative procedures were performed by 2 surgeons, and patients were evaluated by an another researcher who was blinded to the surgical technique. The groups were compared for their radiological and clinical results. Both techniques was clinically and radiologically effective (p<0.01). However, no significant differences were found between the 2 groups regarding American Orthopaedic Foot and Ankle Society's clinical rating system, Painful Foot Evaluation scale of Maryland University scores, or radiologic evaluation (p>0.05). Compared to the Chevron group, the Lindgren-Turan group was found to have shorter surgical duration (p<0.05) and significantly more shortening at the first metatarsal (p<0.05). In moderate hallux valgus deformity, both the Chevron and Lindgren-Turan osteotomy techniques are clinically and radiologically safe, effective, and reliable alternatives. No superiority was detected in either technique. Although shortening at the first metatarsal in the Lindgren-Turan group was radiologically significant, the results were clinically tolerable.

Laryngoscope plastic blades in scheduled general anesthesia patients: a comparative randomized study.

PubMed

Galinski, Michel; Catineau, Jean; Rayeh, Fatima; Muret, Jane; Ciebiera, Jean-Pierre; Plantevin, Frédéric; Foucrier, Arnaud; Tual, Loic; Combes, Xavier; Adnet, Frédéric

2011-03-01

To compare two brands of disposable plastic laryngoscope blades, Vital View plastic blades and Heine XP plastic blades, with the reusable Heine Classic+ Macintosh metal blades. Prospective randomized, controlled, single-blinded study. Operating room of a university-affiliated hospital. 519 patients without criteria for predicted difficult intubation, undergoing scheduled surgery during general anesthesia. Patients were randomized to three groups according to laryngoscope blade brand. Difficult tracheal intubation was evaluated by the Intubation Difficulty Scale (IDS) (IDS > 5 = procedure involving moderate to major difficulty). The percentage of intubations with an IDS > 5 was 3.1% in Group M (metal blade group), 5.1% in Group V (Vital View plastic blade group), and 10.0% in Group H (Heine plastic blade group). A significant difference was noted between Groups M and H (P = 0.02) but not between Groups M and V. Intubation may be more challenging when using Heine XP plastic blades but no significant difference exists between Vital-View plastic blades and Heine Classic+ metal blades. Copyright © 2011 Elsevier Inc. All rights reserved.

[Clinical study of tissue-selecting therapy in the treatment of mixed hemorrhoids: a single-blind randomized controlled trail].

PubMed

He, Hongyan; He, Ping; Liu, Ning

2014-06-01

To evaluate the clinical efficacy and safety of tissue-selecting therapy (TST) in treatment of mixed hemorrhoids. A single-blind randomized study was carried out. A total of 120 patients with mixed hemorrhoids from January to December 2012 were prospectively enrolled in the study and equally divided into two groups, TST group and procedure for prolapse and hemorrhoids(PPH) group. Surgical data, efficacy and postoperative complications were compared between the two groups. As compared to PPH group, patients in TST group had shorter operation time [(15.9±5.18) min vs. (22.6±7.1) min, P<0.05], lower scores of rectal urgency (0.5±0.2 vs. 1.5±1.4, P<0.05), and shorter hospital stay [(11.2±3.7) d vs. (14.8±3.7) d, P<0.05]. No anastomotic stricture case was found in TST group, while 11 cases(18.3%) developed anastomotic stricture in PPH group. There were no significant differences in effective rate and pain score of first defecation between the two groups. TST is reliable and safe for mixed hemorrhoids with the advantage of simple, rapid recovery and less complications.

Single-Incision Multiport/Single Port Laparoscopic Abdominal Surgery (SILAP): A Prospective Multicenter Observational Quality Study.

PubMed

Mantke, Rene; Diener, Markus; Kropf, Siegfried; Otto, Ronny; Manger, Thomas; Vestweber, Boris; Mirow, Lutz; Winde, Günther; Lippert, Hans

2016-09-07

Increasing experience with minimally invasive surgery and the development of new instruments has resulted in a tendency toward reducing the number of abdominal skin incisions. Retrospective and randomized prospective studies could show the feasibility of single-incision surgery without any increased risk to the patient. However, large prospective multicenter observational datasets do not currently exist. This prospective multicenter observational quality study will provide a relevant dataset reflecting the feasibility and safety of single-incision surgery. This study focuses on external validity, clinical relevance, and the patients' perspective. Accordingly, the single-incision multiport/single port laparoscopic abdominal surgery (SILAP) study will supplement the existing evidence, which does not currently allow evidence-based surgical decision making. The SILAP study is an international prospective multicenter observational quality study. Mortality, morbidity, complications during surgery, complications postoperatively, patient characteristics, and technical aspects will be monitored. We expect more than 100 surgical centers to participate with 5000 patients with abdominal single-incision surgery during the study period. Funding was obtained in 2012. Enrollment began on January 01, 2013, and will be completed on December 31, 2018. As of January 2016, 2119 patients have been included, 106 German centers are registered, and 27 centers are very active (>5 patients per year). This prospective multicenter observational quality study will provide a relevant dataset reflecting the feasibility and safety of single-incision surgery. An international enlargement and recruitment of centers outside of Germany is meaningful. German Clinical Trials Register: DRKS00004594; https://drks-neu.uniklinik-freiburg.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00004594 (Archived by WebCite at http://www.webcitation.org/6jK6ZVyUs).

A prospective randomized clinical trial to evaluate methods of postoperative care of hypospadias.

PubMed

McLorie, G; Joyner, B; Herz, D; McCallum, J; Bagli, D; Merguerian, P; Khoury, A

2001-05-01

Hypospadias repair is a common operation performed by pediatric urologists. Perhaps the greatest variable and source of controversy of postoperative care is the surgical dressing. We hypothesized that using no dressing would achieve surgically comparable results to those traditionally achieved by a postoperative dressing and it would also simplify postoperative parent delivered home care. Accordingly we designed a prospective randomized clinical trial to compare surgical outcome and postoperative care after hypospadias repair in boys with no dressing and those who received 1 of the 2 most common types of dressing. In a 12-month period 120 boys with an average age of 2.2 years underwent primary 1-stage hypospadias repair at a single center with 4 participating surgeons. Repair was performed in 60 boys with proximal and 60 with distal hypospadias on an outpatient basis. Ethics and Internal Review Board approval, and informed consent were obtained. Boys were then prospectively randomized to receive no dressing, an adhesive biomembrane dressing or a compressive wrap dressing. Comprehensive instructions on postoperative care were distributed to all families and a questionnaire was distributed to the parents at the initial followup. Surgical outcome was evaluated and questionnaire responses were analyzed. Fisher's exact test was done to test the significance of differences in surgical outcomes and questionnaire responses. A total of 117 boys completed the prospective randomized trial. Surgical staff withdrew 3 cases from randomized selection to place a dressing for postoperative hemostasis. We obtained 101 questionnaires for response analysis. The type or absence of the dressing did not correlate with the need for repeat procedures, urethrocutaneous fistula, or meatal stenosis or regression. Analysis revealed less narcotic use in the no dressing group and fewer telephone calls to the urology nurse, or on-call resident and/or fellow. These findings were statistically significant. In addition, there were more unscheduled visits to the urology clinic, emergency room or primary physician office by boys with than without a dressing. Furthermore, 29% of the parents were not psychologically prepared to remove the dressing and 12% were so reluctant that the dressing was removed at the urology outpatient clinic. The surgical outcome and rate of adverse events or complications were not compromised without a postoperative dressing. An absent dressing simplified postoperative ambulatory parent delivered home care. We recommend that dressings should be omitted from routine use after hypospadias repair.

Single-use instruments, cutting blocks, and trials increase efficiency in the operating room during total knee arthroplasty: a prospective comparison of navigated and non-navigated cases.

PubMed

Mont, Michael A; McElroy, Mark J; Johnson, Aaron J; Pivec, Robert

2013-08-01

The purpose of this prospective controlled trial was to determine if efficiency increases could be achieved in non-navigated and navigated total knee arthroplasties by replacing traditional saws, cutting blocks, and trials with specialized saws and single-use cutting blocks and trials. Various timing metrics during total knee arthroplasty, including operating room preparation times and specific intra-operative times, were measured in 400 procedures performed by eight different surgeons at 6 institutions. Efficiency increases were the result of statistically significant reductions in combined instrument setup and cleanup times as well as in adjusted surgical episode times in navigated total knee arthroplasties. Single-use instruments show promising benefits, but adequate patient follow-up is needed to confirm safety and efficacy before they can be widely adopted. Nevertheless, the authors believe that the use of single-use instruments, cutting guides, and trial implants for total knee arthroplasty will play an increasing role in improving operating room efficiency. Copyright © 2013 Elsevier Inc. All rights reserved.

Prospective randomized clinical trial: single and weekly viscosupplementation

PubMed Central

Zóboli, Alejandro Agustin Carri; de Rezende, Márcia Uchôa; de Campos, Gustavo Constantino; Pasqualin, Thiago; Frucchi, Renato; de Camargo, Olavo Pires

2013-01-01

OBJECTIVE: To compare two different dosages of an intermediate molecular weight sodium hyaluronate (HA) (Osteonil®-TRB Pharma) assessing whether a single 6 ml application of this HA has the same effectiveness as the classical three-weekly 2 ml dose. METHODS: 108 patients with knee osteoarthritis were randomized into two groups of 54 patients each. The groups were designated "single" (S) and "weekly" (W). Patients in group S underwent a viscosupplementation procedure by application of only 6 ml of sodium hyaluronate and 1 ml triamcinolone hexacetonide. Patients in group W underwent the procedure of viscosupplementation through three applications with 2 ml sodium hyaluronate with a week interval between them, and the first application was also performed with the infiltration of 1 ml (20 mg) of Triamcinolone Hexacetonide. Both groups were assessed before, at one month and three months after application, by responding to the WOMAC, Lequesne, IKDC and VAS questionnaires. RESULTS: There was no statistical difference between the single application of 6 ml of sodium hyaluronate and classic application with three weekly injections. However, only the classical regime showed statistically significant improvement in baseline pain (WOMAC pain and VAS). CONCLUSION: Our results suggest that both application schemes improve application function, but the three-weekly regimen of 2 ml was more effective in reducing pain. Level of Evidence I, Prospective Randomized, Clinical Trial. PMID:24453681

Interest of intra-operative 3D imaging in spine surgery: a prospective randomized study.

PubMed

Ruatti, Sébastien; Dubois, C; Chipon, E; Kerschbaumer, G; Milaire, M; Moreau-Gaudry, A; Tonetti, J; Merloz, Ph

2016-06-01

We report a single-center, prospective, randomized study for pedicle screw insertion in opened and percutaneous spine surgeries, using a computer-assisted surgery (CAS) technique with three-dimensional (3D) intra-operative images intensifier (without planification on pre-operative CT scan) vs conventional surgical procedure. We included 143 patients: Group C (conventional, 72 patients) and Group N (3D Fluoronavigation, 71 patients). We measured the pedicle screw running time, and surgeon's radiation exposure. All pedicle runs were assessed according to Heary by two independent radiologists on a post-operative CT scan. 3D Fluoronavigation appeared less accurate in percutaneous procedures (24 % of misplaced pedicle screws vs 5 % in Group C) (p = 0.007), but more accurate in opened surgeries (5 % of misplaced pedicle screws vs 17 % in Group C) (p = 0.025). For one vertebra, the average surgical running time reached 8 min in Group C vs 21 min in Group N for percutaneous surgeries (p = 3.42 × 10(-9)), 7.33 min in Group C vs 16.33 min in Group N (p = 2.88 × 10(-7)) for opened surgeries. The 3D navigation device delivered less radiation in percutaneous procedures [0.6 vs 1.62 mSv in Group C (p = 2.45 × 10(-9))]. For opened surgeries, it was twice higher in Group N with 0.21 vs 0.1 mSv in Group C (p = 0.022). The rate of misplaced pedicle screws with conventional techniques was nearly the same as most papers and a little bit higher with CAS. Surgical running time and radiation exposure were consistent with many studies. Our work hypothesis is partially confirmed, depending on the type of surgery (opened or closed procedure).

A RCT comparing 7-year clinical outcomes of one level symptomatic cervical disc disease (SCDD) following ProDisc-C total disc arthroplasty (TDA) versus anterior cervical discectomy and fusion (ACDF).

PubMed

Loumeau, Thomas P; Darden, Bruce V; Kesman, Thomas J; Odum, Susan M; Van Doren, Bryce A; Laxer, Eric B; Murrey, Daniel B

2016-07-01

The objective of this trial was to compare the safety and efficacy of TDA using the ProDisc-C implant to ACDF in patients with single-level SCDD between C3 and C7. We report on the single-site results from a larger multicenter trial of 13 sites using an approved US Food and Drug Administration protocol (prospective, randomized controlled non-inferiority design). Patients were randomized one-to-one to either the ProDisc-C device or ACDF. All enrollees were evaluated pre- and post-operatively at regular intervals through month 84. Visual Analog Scale (VAS) for neck and arm pain/intensity, Neck Disability Index (NDI), Short-Form 36 (SF-36), and satisfaction were assessed. Twenty-two patients were randomized to each arm of the study. Nineteen additional patients received the ProDisc-C via continued access. NDI improved with the ProDisc-C more than with ACDF. Total range of motion was maintained with the ProDisc-C, but diminished with ACDF. Neck and arm pain improved more in the ProDisc-C than ACDF group. Patient satisfaction remained higher in the ProDisc-C group at 7 years. SF-36 scores were higher in the TDA group than ACDF group at 7 years; the difference was not clinically significant. Six additional operations (two at the same level; four at an adjacent level) were performed in the ACDF, but none in the ProDisc-C group. The ProDisc-C implant appears to be safe and effective for the treatment of SCDD. Patients with the implant retained motion at the involved segment and had a lower reoperation rate than those with an ACDF.

A prospective randomized study comparing percutaneous nephrolithotomy under combined spinal-epidural anesthesia with percutaneous nephrolithotomy under general anesthesia.

PubMed

Singh, Vishwajeet; Sinha, Rahul Janak; Sankhwar, S N; Malik, Anita

2011-01-01

A prospective randomized study was executed to compare the surgical parameters and stone clearance in patients who underwent percutaneous nephrolithotomy (PNL) under combined spinal-epidural anesthesia (CSEA) versus those who underwent PNL under general anesthesia (GA). Between January 2008 to December 2009, 64 patients with renal calculi were randomized into 2 groups and evaluated for the purpose of this study. Group 1 consisted of patients who underwent PNL under CSEA and Group 2 consisted of patients who underwent PNL under GA. The operative time, stone clearance rate, visual pain analog score, mean analgesic dose and mean hospital stay were compared amongst other parameters. The difference between visual pain analog score after the operation and the dose of analgesic requirement was significant on statistical analysis between both groups. PNL under CSEA is as effective and safe as PNL under GA. Patients who undergo PNL under CESA require lesser analgesic dose and have a shorter hospital stay. Copyright © 2011 S. Karger AG, Basel.

Arthroscopic cartilage debridement by excimer laser in chondromalacia of the knee joint. A prospective randomized clinical study.

PubMed

Raunest, J; Löhnert, J

1990-01-01

A new operative technique in arthroscopic treatment of chondromalacia using ultraviolet laser systems is introduced. The postoperative results are evaluated in a prospective and randomized clinical trial. One hundred and forty patients stage II or III chondromalacia according to Outerbridge were randomly assigned to arthroscopic operation using either laser or mechanical instruments. After a 6-month follow-up period the clinical results were compared, guided by a specially designed modification of the Lysholm scoring scale. In the short-term follow-up laser surgery gave superior results in regard to reducing pain (P less than 0.05) and leading to a lower incidence of reactive synovitis (P less than 0.01). No difference was found in respect of disability and functional impairment. Our results lead to the conclusion that arthroscopic laser application seems to be a successful procedure in the treatment of degenerative cartilage disorders, providing precise ablation of tissue without significant thermal damage to the remaining cartilage.

Comparison of anastomotic leakage and stricture formation following layered and stapler oesophagogastric anastomosis for cancer: a prospective randomized controlled trial.

PubMed

Zhang, Y S; Gao, B R; Wang, H J; Su, Y F; Yang, Y Z; Zhang, J H; Wang, C

2010-01-01

The objective of this prospective, randomized, controlled trial, conducted from May 2002 to December 2007, was to compare post-operative anastomotic leakage and stricture formation following layered manual versus stapler oesophagogastric anastomosis in patients who underwent resection of oesophageal or gastric cardia carcinoma. Patients (n = 516) were randomized to receive either layered manual or circular stapled oesophagogastric anastomosis. Mean follow-up time was > 12 months. Anastomotic leakage occurred in one (0.4%) patient in the layered group and six (2.2%) in the stapler group; no statistically significant between-group difference. After operation, two (0.8%) patients in the layered group and 13 (5.0%) in the stapler group developed a benign oesophageal stricture; the difference between the groups was statistically significant. Compared with stapler anastomosis, layered manual anastomosis may significantly reduce the incidence of anastomotic strictures. This method is easy to apply and could be used as an alternative procedure for oesophagogastric anastomosis after resection for oesophageal or cardia carcinoma.

Effectiveness of adjuvant radiotherapy in patients with oropharyngeal and floor of mouth squamous cell carcinoma and concomitant histological verification of singular ipsilateral cervical lymph node metastasis (pN1-state)--a prospective multicenter randomized controlled clinical trial using a comprehensive cohort design.

PubMed

Moergel, Maximilian; Jahn-Eimermacher, Antje; Krummenauer, Frank; Reichert, Torsten E; Wagner, Wilfried; Wendt, Thomas G; Werner, Jochen A; Al-Nawas, Bilal

2009-12-23

Modern radiotherapy plays an important role in therapy of advanced head and neck carcinomas. However, no clinical studies have been published addressing the effectiveness of postoperative radiotherapy in patients with small tumor (pT1, pT2) and concomitant ipsilateral metastasis of a single lymph node (pN1), which would provide a basis for a general treatment recommendation. The present study is a non-blinded, prospective, multi-center randomized controlled trial (RCT). As the primary clinical endpoint, overall-survival in patients receiving postoperative radiation therapy vs. patients without adjuvant therapy following curative intended surgery is compared. The aim of the study is to enroll 560 adult males and females for 1:1 randomization to one of the two treatment arms (irradiation/no irradiation). Since patients with small tumor (T1/T2) but singular lymph node metastasis are rare and the amount of patients consenting to randomization is not predictable in advance, all patients rejecting randomization will be treated as preferred and enrolled in a prospective observational study (comprehensive cohort design) after giving informed consent. This observational part of the trial will be performed with maximum consistency to the treatment and observation protocol of the RCT. Because the impact of patient preference for a certain treatment option is not calculable, parallel design of RCT and observational study may provide a maximum of evidence and efficacy for evaluation of treatment outcome. Secondary clinical endpoints are as follows: incidence and time to tumor relapse (locoregional relapse, lymph node involvement and distant metastatic spread), Quality of life as reported by EORTC (QLQ-C30 with H&N 35 module), and time from operation to orofacial rehabilitation. All tumors represent a homogeneous clinical state and therefore additional investigation of protein expression levels within resection specimen may serve for establishment of surrogate parameters of patient outcome. The inherent challenges of a rare clinical condition (pN1) and two substantially different therapy arms would limit the practicality of a classical randomized study. The concept of a Comprehensive Cohort Design combines the preference of a randomized study, with the option of careful data interpretation within an observational study. ClinicalTrials.gov: NCT00964977.

Autologous Blood Versus Fibrin Glue in Pterygium Excision With Conjunctival Autograft Surgery.

PubMed

Nadarajah, Gaayathri; Ratnalingam, Vanitha Hema; Mohd Isa, Hazlita

2017-04-01

To evaluate graft stability and recurrence rate between fibrin glue and autologous blood in pterygium conjunctival autograft surgery. A prospective, randomized, single-blinded clinical trial to assess the efficacy of autologous blood in place of fibrin glue in pterygium surgery. A total of 120 eyes of 111 patients were randomized according to pterygium morphology, to undergo pterygium surgery with autografting using either autologous blood or fibrin glue. All patients were operated by a single surgeon; 58 eyes were operated using fibrin glue and 62 eyes had a conjunctival autograft with autologous blood. Patients were seen on postoperative day 1, 1 week, 1 month, 6 months, and 1 year after surgery. Graft stability and pterygium recurrence were graded by an independent observer who was masked to the method of treatment. All 120 eyes completed the 1-year follow-up. Graft loss was seen only in the autologous blood group. Of the 62 eyes in this group, a total of 15 (24.2%) grafts dislodged. Recurrence was calculated after excluding grafts that were dislodged. Of the 105 patients, there were a total of 7 recurrences, 2 (3.4%) from the fibrin adhesive method and 5 (10.6%) from the autologous blood method. This was not statistically significant (P = 0.238). Autologous blood does not exhibit similar graft stability seen with fibrin glue. Although the recurrence rate may not be significant, careful patient selection and a standard method needs to be laid out before the use of this method is widely accepted.

Phenobarbital for acute alcohol withdrawal: a prospective randomized double-blind placebo-controlled study.

PubMed

Rosenson, Jonathan; Clements, Carter; Simon, Barry; Vieaux, Jules; Graffman, Sarah; Vahidnia, Farnaz; Cisse, Bitou; Lam, Joseph; Alter, Harrison

2013-03-01

Acute alcohol withdrawal syndrome (AAWS) is encountered in patients presenting acutely to the Emergency Department (ED) and often requires pharmacologic management. We investigated whether a single dose of intravenous (i.v.) phenobarbital combined with a standardized lorazepam-based alcohol withdrawal protocol decreases intensive care unit (ICU) admission in ED patients with acute alcohol withdrawal. This was a prospective, randomized, double-blind, placebo-controlled study. Patients were randomized to receive either a single dose of i.v. phenobarbital (10 mg/kg in 100 mL normal saline) or placebo (100 mL normal saline). All patients were placed on the institutional symptom-guided lorazepam-based alcohol withdrawal protocol. The primary outcome was initial level of hospital admission (ICU vs. telemetry vs. floor ward). There were 198 patients enrolled in the study, and 102 met inclusion criteria for analysis. Fifty-one patients received phenobarbital and 51 received placebo. Baseline characteristics and severity were similar in both groups. Patients that received phenobarbital had fewer ICU admissions (8% vs. 25%, 95% confidence interval 4-32). There were no differences in adverse events. A single dose of i.v. phenobarbital combined with a symptom-guided lorazepam-based alcohol withdrawal protocol resulted in decreased ICU admission and did not cause increased adverse outcomes. Copyright © 2013 Elsevier Inc. All rights reserved.

Solo-Surgeon Single-Port Laparoscopic Anterior Resection for Sigmoid Colon Cancer: Comparative Study.

PubMed

Choi, Byung Jo; Jeong, Won Jun; Kim, Say-June; Lee, Sang Chul

2018-03-01

To report our experience with solo-surgeon, single-port laparoscopic anterior resection (solo SPAR) for sigmoid colon cancer. Data from sigmoid colon cancer patients who underwent anterior resections (ARs) using the single-port, solo surgery technique (n = 31) or the conventional single-port laparoscopic technique (n = 45), between January 2011 and July 2016, were retrospectively analyzed. In the solo surgeries, making the transumbilical incision into the peritoneal cavity was facilitated through the use of a self-retaining retractor system. After establishing a single port through the umbilicus, an adjustable mechanical camera holder replaced the human scope assistant. Patient and tumor characteristics and operative, pathologic, and postoperative outcomes were compared. The operative times and estimated blood losses were similar for the patients in both treatment groups. In addition, most of the postoperative variables were comparable between the two groups, including postoperative complications and hospital stays. In the solo SPAR group, comparable lymph nodes were attained, and sufficient proximal and distal cut margins were obtained. The difference in the proximal cut margin significantly favored the solo SPAR, compared with the conventional AR group (P = .000). This study shows that solo SPAR, using a passive camera system, is safe and feasible for use in sigmoid colon cancer surgery, if performed by an experienced laparoscopic surgeon. In addition to reducing the need for a surgical assistant, the oncologic requirements, including adequate margins and sufficient lymph node harvesting, could be fulfilled. Further evaluations, including prospective randomized studies, are warranted.

Single-stage laparoscopic common bile duct exploration and cholecystectomy versus two-stage endoscopic stone extraction followed by laparoscopic cholecystectomy for patients with concomitant gallbladder stones and common bile duct stones: a randomized controlled trial.

PubMed

Bansal, Virinder Kumar; Misra, Mahesh C; Rajan, Karthik; Kilambi, Ragini; Kumar, Subodh; Krishna, Asuri; Kumar, Atin; Pandav, Chandrakant S; Subramaniam, Rajeshwari; Arora, M K; Garg, Pramod Kumar

2014-03-01

The ideal method for managing concomitant gallbladder stones and common bile duct (CBD) stones is debatable. The currently preferred method is two-stage endoscopic stone extraction followed by laparoscopic cholecystectomy (LC). This prospective randomized trial compared the success and cost effectiveness of single- and two-stage management of patients with concomitant gallbladder and CBD stones. Consecutive patients with concomitant gallbladder and CBD stones were randomized to either single-stage laparoscopic CBD exploration and cholecystectomy (group 1) or endoscopic retrograde cholangiopancreatography (ERCP) for endoscopic extraction of CBD stones followed by LC (group 2). Success was defined as complete clearance of CBD and cholecystectomy by the intended method. Cost effectiveness was measured using the incremental cost-effectiveness ratio. Intention-to-treat analysis was performed to compare outcomes. From February 2009 to October 2012, 168 patients were randomized: 84 to the single-stage procedure (group 1) and 84 to the two-stage procedure (group 2). Both groups were matched with regard to demographic and clinical parameters. The success rates of laparoscopic CBD exploration and ERCP for clearance of CBD were similar (91.7 vs. 88.1 %). The overall success rate also was comparable: 88.1 % in group 1 and 79.8 % in group 2 (p = 0.20). Direct choledochotomy was performed in 83 of the 84 patients. The mean operative time was significantly longer in group 1 (135.7 ± 36.6 vs. 72.4 ± 27.6 min; p ≤ 0.001), but the overall hospital stay was significantly shorter (4.6 ± 2.4 vs. 5.3 ± 6.2 days; p = 0.03). Group 2 had a significantly greater number of procedures per patient (p < 0.001) and a higher cost (p = 0.002). The two groups did not differ significantly in terms of postoperative wound infection rates or major complications. Single- and two-stage management for uncomplicated concomitant gallbladder and CBD stones had similar success and complication rates, but the single-stage strategy was better in terms of shorter hospital stay, need for fewer procedures, and cost effectiveness.

Transverse vs torsional ultrasound: prospective randomized contralaterally controlled study comparing two phacoemulsification-system handpieces

PubMed Central

Assil, Kerry K; Harris, Lindsay; Cecka, Jeannie

2015-01-01

Purpose To compare surgical efficiency and multiple early clinical outcome variables in eyes undergoing phacoemulsification using either transversal or torsional ultrasound systems. Setting Assil Eye Institute, Beverly Hills, CA, USA. Design Prospective, randomized, clinician-masked, contralaterally controlled single-center evaluation. Patients and methods Patients seeking cataract removal in both eyes with implantation of multifocal intraocular lenses were randomly assigned to one of two treatment rooms for phacoemulsification with either a transverse ultrasound system or torsional handpiece system. The contralateral eye was treated at a later date with the alternate device. A total of 54 eyes of 27 patients having similar degrees of cataract, astigmatism, and visual potential were included. All operative data were collected for analysis, and patients were followed for 3 months after surgery. Results Similar visual acuity was reported at all postoperative visits between the two groups. Mean phacoemulsification time and total power required were both significantly lower with the transverse system than with the torsional technique (P<0.05 for both). Similarly, mean total balanced salt solution used was significantly less with the transverse system vs torsional (P<0.05). Postoperative safety demonstrated significantly lower endothelial cell loss at 1 day and 1 month (P<0.05) with transverse vs torsional. Macular swelling was less at 1 week, 1 month, and 3 months with transverse vs torsional, although the difference did not achieve significance (P=0.1) at any single time point. Clinically detectable corneal edema was reported less frequently at all postoperative time points with the transverse system. Conclusion The transverse ultrasound system was found to be possibly associated with less balanced salt-solution use, less phacoemulsification time, and less power required than the torsional phaco system. Postoperative data suggested that improved phaco efficiency may translate to a better overall safety profile for the patient. PMID:26345628

Randomized trial of low versus high carbon dioxide insufflation pressures in posterior retroperitoneoscopic adrenalectomy.

PubMed

Fraser, Sheila; Norlén, Olov; Bender, Kyle; Davidson, Joanne; Bajenov, Sonya; Fahey, David; Li, Shawn; Sidhu, Stan; Sywak, Mark

2018-05-01

Posterior retroperitoneoscopic adrenalectomy has gained widespread acceptance for the removal of benign adrenal tumors. Higher insufflation pressures using carbon dioxide (CO 2 ) are required, although the ideal starting pressure is unclear. This prospective, randomized, single-blinded, study aims to compare physiologic differences with 2 different CO 2 insufflation pressures during posterior retroperitoneoscopic adrenalectomy. Participants were randomly assigned to a starting insufflation pressure of 20 mm Hg (low pressure) or 25 mm Hg (high pressure). The primary outcome measure was partial pressure of arterial CO 2 at 60 minutes. Secondary outcomes included end-tidal CO 2 , arterial pH, blood pressure, and peak airway pressure. Breaches of protocol to change insufflation pressure were permitted if required and were recorded. A prospective randomized trial including 31 patients (low pressure: n = 16; high pressure: n = 15) was undertaken. At 60 minutes, the high pressure group had greater mean partial pressure of arterial CO 2 (64 vs 50 mm Hg, P = .003) and end-tidal CO 2 (54 vs 45 mm Hg, P = .008) and a lesser pH (7.21 vs 7.29, P = .0005). There were no significant differences in base excess, peak airway pressure, operative time, or duration of hospital stay. Clinically indicated protocol breaches were more common in the low pressure than the high pressure group (8 vs 3, P = .03). In posterior retroperitoneoscopic adrenalectomy, greater insufflation pressures are associated with greater partial pressure of arterial CO 2 and end-tidal CO 2 and lesser pH at 60 minutes, be significant. Commencing with lesser CO 2 insufflation pressures decreases intraoperative acidosis. Copyright © 2017 Elsevier Inc. All rights reserved.

Audit of lymphadenectomy in lung cancer resections using a specimen collection kit and checklist

PubMed Central

Osarogiagbon, Raymond U.; Sareen, Srishti; Eke, Ransome; Yu, Xinhua; McHugh, Laura M.; Kernstine, Kemp H.; Putnam, Joe B.; Robbins, Edward T.

2014-01-01

Background Audits of operative summaries and pathology reports reveal wide discordance in identifying the extent of lymphadenectomy performed (the communication gap). We tested the ability of a pre-labeled lymph node specimen collection kit and checklist to narrow the communication gap between operating surgeons, pathologists, and auditors of surgeons’ operation notes. Methods We conducted a prospective single cohort study of lung cancer resections performed with a lymph node collection kit from November 2010 to January 2013. We used the kappa statistic to compare surgeon claims on a checklist of lymph node stations harvested intraoperatively, to pathology reports, and an independent audit of surgeons’ operative summaries. Lymph node collection procedures were classified into 4 groups based on the anatomic origin of resected lymph nodes: mediastinal lymph node dissection, systematic sampling, random sampling and no sampling. Results From the pathology report, 73% of 160 resections had a mediastinal lymph node dissection or systematic sampling procedure, 27% had random sampling. The concordance with surgeon claims was 80% (kappa statistic 0.69 [CI 0.60 – 0.79]). Concordance between independent audits of the operation notes and either the pathology report (kappa 0.14 [0.04 – 0.23]), or surgeon claims (kappa 0.09 [0.03 – 0.22]), was poor. Conclusion A pre-labeled specimen collection kit and checklist significantly narrowed the communication gap between surgeons and pathologists in identifying the extent of lymphadenectomy. Audit of surgeons’ operation notes did not accurately reflect the procedure performed, bringing its value for quality improvement work into question. PMID:25530090

A randomized clinical trial to compare the efficacy of submucosal aprotinin injection and intravenous dexamethasone in reducing pain and swelling after third molar surgery: a prospective study.

PubMed

Arakeri, Gururaj; Rai, Kirthi Kumar; Shivakumar, H R; Jayade, Bhushan

2013-03-01

The purpose of this study was to compare two different groups of drugs, aprotinin and dexamethasone for its efficacy in reducing post operative swelling and pain after third molar surgery. Fifty consecutive patients requiring surgical removal of single mandibular third molar (class II position B) under local anesthesia were randomly divided into two groups, each group consisting of 25 patients. One group was administered 8 mg dexamethasone through intravenous route pre-operatively. The other group received 1 ml of Aprotinin through submucosal route in operating area after the onset of local anesthesia. Swelling was assessed by measuring facial contours at baseline and at 1st, 3rd and 7th post-operative days. Pain was measured on the 1st, 3rd and 7th post-operative days using visual analog scale. Based on statistical analysis (paired t test and Wilcoxon's signed ranking test), the results showed statistically significant difference in post operative swelling and pain on 3rd postoperative day in dexamethasone group as compared to aprotinin group. The results of present study showed a similar reduction in the severity of pain and swelling at the aprotinin and dexamethasone sites on 1st and 7th postoperative day. It was also noticed that the aprotinin promoted a greater reduction of swelling and pain on 3rd postoperative day. It appeared that, benefits of aprotinin against the risks of dexamethasone and its efficacy in controlling pain and swelling after third molar surgery makes aprotinin to be a valuable alternative to dexamethasone.

Conjunctival Autograft Alone or Combined With Adjuvant Beta-Radiation? A Randomized Clinical Trial

DOE Office of Scientific and Technical Information (OSTI.GOV)

Arruda Viani, Gustavo, E-mail: gusviani@gmail.com; Carrara Fonseca, Ellen; Department of Ophthalmology, Marilia Medical School, Marilia, Sao Paulo

2012-03-01

Purpose: To evaluate the effectiveness and safety of postoperative low single-dose of beta-irradiation ({beta}-RT) in pterygium comparing conjunctival autograft (CAG) surgery with CAG plus adjuvant {beta}-RT in a randomized clinical trial. Methods: This trial was designed as a prospective, randomized, single-center study. Surgery was performed in all cases according to the CAG technique. One hundred and eight pterygia were postoperatively randomized to CAG + {beta}-RT or CAG alone. In the case of {beta}-RT, a (90) Sr eye applicator was used to deliver 10 Gy to the sclera surface at a dose rate of between 200 and 250 cGy/min. After treatment,more » both an ophthalmologist and a radiation oncologist performed the follow-up examinations. The accumulated data were analyzed using a group sequential test. Results: Between February 2008 and September 2008, 116 eyes with primary pterygium were operated on according to the trial protocol. Adjuvant treatment was performed within 24 h postoperatively. Eight patients were lost to follow-up, resulting in 108 patients who could be analyzed. At a mean follow-up of 18 months (range, 8-33), in the 54 eyes randomized to receive CAG + {beta}-RT, 5 relapses occurred compared with 12 recurrences in the 54 eyes in CAG, for a crude control rate of 90.8 % vs. 78%; p = 0.032, respectively. The treatment complications as hyperemia, total dehiscence of the autograft and dellen were significantly more frequent in the CAG (p < 0.05). The arm of {beta}-RT resulted in better cosmetic results and improves of symptoms than CAG. Conclusions: A low single-dose of {beta}-RT of 10 Gy after CAG surgery was a simple, effective, and safe treatment that reduced the risk of primary pterygium recurrence, improved symptoms after surgery, resulting in a better cosmetic effect than only CAG.« less

Laparoendoscopic management of concomitant gallbladder stones and common bile duct stones: what is the best technique?

PubMed

El-Geidie, Ahmed Abdel-Raouf

2011-08-01

The intraoperative use of endoscopic retrograde cholangiopancreatography (ERCP) during laparoscopic cholecystectomy (LC) is a safe, single-stage option for the management of concomitant gallstones (GS) and common bile duct stones (CBDS). This study aims to compare between 2 techniques of combined laparoendoscopic management, which are laparoendoscopic Rendez-vous (LC/LERV) technique and standard ERCP after the completion of LC intraoperative endoscopic sphincterotomy (IOES). Patients with GS and suspected CBDS were included. They were divided into 2 groups; LC/LERV and LC/IOES. Both groups were compared for failure of endoscopic sphincterotomy/stone extraction, operative time, conversion rate, mortality/morbidity, and length of hospital stay. Between October 2007 and February 2010, 98 patients with GS and CBDS were eligible for inclusion in the study. They were prospectively randomized into 2 groups; LC/LERV (N=45) and LC/IOES (N=53). There were no differences in preoperative parameters between both groups. There was a significant difference in operative time (shorter for LC/IOES). No difference was noted in success/failure rate, post-ERCP pancreatitis. Both Standard ERCP after the completion of LC and LC/LERV are valid single-session management for CBD stones, but LC-ERCP may be preferred.

Prospective randomized study of chevron osteotomy versus Mitchell's osteotomy in hallux valgus.

PubMed

Buciuto, Robert

2014-12-01

We conducted a prospective randomized trial to compare the most popular osteotomy types of operative treatment of hallux valgus (HV) used in Norway, Mitchell's osteotomy (MO) and chevron osteotomy (CO). One hundred twenty adult female patients were prospectively randomized to treatment with either MO or CO. All operative procedures were performed with ankle block and with tourniquet applied. None of the patients received any antibiotic or antithrombotic prophylaxis. The follow-up period was 3 years. Clinical results were rated according to the American Orthopaedic Foot and Ankle Society (AOFAS) Clinical Rating System (CRS). HV in the MO group was reduced from 30 (range, 20 to 44) to 15 (range, 8 to 24) degrees and IM angle from 11 (range, 6 to 14) to 7 (range, 4 to 11) degrees. HV in the CO group was reduced from 31 (range, 22 to 42) to 16 (range, 6 to 24) degrees and IM angle from 14 (range, 8 to 20) to 6 (range, 2 to 10) degrees. Transfer metatarsalgia occurred in 36 (60%) patients and hammertoe in 6 (10%) patients in the MO group. In the CO group, metatarsalgia occurred in 5 patients. The median loss of postoperative HV correction was 4 (range, 2 to 10) degrees in mild deformity and 6 (6 to 10) degrees in moderate deformity. Patients treated with CO had significantly better results for AOFAS CRS, number of postoperative complications, patient satisfaction, and length of sick leave for the employed patients. Based on our results, we consider that in female patients CO should be regarded as the first-line procedure for treatment of mild and moderate HV. Level I, prospective randomized study. © The Author(s) 2014.

[Effect of Sijunzi Decoction and enteral nutrition on T-cell subsets and nutritional status in patients with gastric cancer after operation: a randomized controlled trial].

PubMed

Cai, Jun; Wang, Hua; Zhou, Sheng; Wu, Bin; Song, Hua-Rong; Xuan, Zheng-Rong

2008-01-01

To observe the effect of perioperative application of Sijunzi Decoction and enteral nutrition on T-cell subsets and nutritional status in patients with gastric cancer after operation. In this prospective, single-blinded, controlled clinical trial, fifty-nine patients with gastric cancer were randomly divided into three groups: control group (n=20) and two study groups (group A, n=21; group B, n=18). Sjunzi Decoction (100 ml) was administered via nasogastric tube to the patients in the study group B from the second postoperation day to the 9th postoperation day. Patients in the two study groups were given an isocaloric and isonitrogonous enteral diet, which was started on the second day after operation, and continued for eight days. Patients in the control group were given an isocaloric and isonitrogonous parenteral diet for 9 days. All variables of nutritional status such as serum albumin (ALB), prealbumin (PA), transferrin (TRF) and T-cell subsets were measured one day before operation, and one day and 10 days after operation. All the nutritional variables and the levels of CD3(+), CD4(+), CD4(+)/CD8(+) were decreased significantly after operation. Ten days after operation, T-cell subsets and nutritional variables in the two study groups were increased as compare with the control group. The levels of ALB, TRF and T-cell subsets in the study group B were increased significantly as compared with the study group A (P<0.05). Enteral nutrition assisted with Sijunzi Decoction can positively improve and optimize cellular immune function and nutritional status in the patients with gastric cancer after operation.

Outcomes of the modified Brostrom procedure using suture anchors for chronic lateral ankle instability--a prospective, randomized comparison between single and double suture anchors.

PubMed

Cho, Byung-Ki; Kim, Yong-Min; Kim, Dong-Soo; Choi, Eui-Sung; Shon, Hyun-Chul; Park, Kyoung-Jin

2013-01-01

The present prospective, randomized study was conducted to compare the clinical outcomes of the modified Brostrom procedure using single and double suture anchors for chronic lateral ankle instability. A total of 50 patients were followed up for more than 2 years after undergoing the modified Brostrom procedure. Of the 50 procedures, 25 each were performed using single and double suture anchors by 1 surgeon. The Karlsson scale had improved significantly to 89.8 points and 90.6 points in the single and double anchor groups, respectively. Using the Sefton grading system, 23 cases (92%) in the single anchor group and 22 (88%) in the double anchor group achieved satisfactory results. The talar tilt angle and anterior talar translation on stress radiographs using the Telos device had improved significantly to an average of 5.7° and 4.6 mm in the single anchor group and 4.5° and 4.3 mm in the double anchor group, respectively. The double anchor technique was superior with respect to the postoperative talar tilt. The single and double suture anchor techniques produced similar clinical and functional outcomes, with the exception of talar tilt as a reference of mechanical stability. The modified Brostrom procedure using both single and double suture anchors appears to be an effective treatment method for chronic lateral ankle instability. Copyright © 2013 American College of Foot and Ankle Surgeons. Published by Elsevier Inc. All rights reserved.

Cervical Disk Replacement With Discover Versus Fusion in a Single-Level Cervical Disk Disease: A Prospective Single-Center Randomized Trial With a Minimum 2-Year Follow-up.

PubMed

Rožanković, Marjan; Marasanov, Sergej M; Vukić, Miroslav

2017-06-01

Prospective randomized study. To compare the clinical outcome after Discover arthroplasty versus anterior cervical discectomy and fusion (ACDF) in patients treated for symptomatic single-level cervical disk disease. ACDF is still the gold standard for surgical treatment of cervical spine degenerative disk disease. However, results of many studies suggest that it may cause degenerative changes at levels immediately above and below the fusion, known as adjacent segment degenerative disease. Cervical arthroplasty has recently been introduced as an alternative to standard procedure of ACDF. It showed decreased surgical morbidity, decreased complications from postoperative immobilization, and an earlier return to previous level of function. A total of 105 consecutive patients with single-level cervical disk disease, producing radiculopathy and/or myelopathy were randomly divided into groups to undergo ACDF or Discover arthroplasty. All patients were evaluated with preoperative and postoperative serial radiographic studies and clinically, using Neck Disability Index, Visual Analog Scale and neurological status at 3, 6, 12, and 24 months. The results of our study indicate that cervical arthroplasty using Discover Artificial Cervical Disc provides favorable clinical and radiologic outcomes in a follow-up period of 24 months. There has been significant improvement in clinical parameters, Visual Analog Scale and Neck Disability Index, at 3, 6, 12, and 24 months in arthroplasty group comparing to control group. The Discover artificial cervical disc replacement offers favorable outcome compared with ACDF for a single-level cervical disk disease at short-term and long-term follow-up.

Ultrasound evaluation of arthroscopic full-thickness supraspinatus rotator cuff repair: single-row versus double-row suture bridge (transosseous equivalent) fixation. Results of a prospective, randomized study.

PubMed

Gartsman, Gary M; Drake, Gregory; Edwards, T Bradley; Elkousy, Hussein A; Hammerman, Steven M; O'Connor, Daniel P; Press, Cyrus M

2013-11-01

The purpose of this study was to compare the structural outcomes of a single-row rotator cuff repair and double-row suture bridge fixation after arthroscopic repair of a full-thickness supraspinatus rotator cuff tear. We evaluated with diagnostic ultrasound a consecutive series of ninety shoulders in ninety patients with full-thickness supraspinatus tears at an average of 10 months (range, 6-12) after operation. A single surgeon at a single hospital performed the repairs. Inclusion criteria were full-thickness supraspinatus tears less than 25 mm in their anterior to posterior dimension. Exclusion criteria were prior operations on the shoulder, partial thickness tears, subscapularis tears, infraspinatus tears, combined supraspinatus and infraspinatus repairs and irreparable supraspinatus tears. Forty-three shoulders were repaired with single-row technique and 47 shoulders with double-row suture bridge technique. Postoperative rehabilitation was identical for both groups. Ultrasound criteria for healed repair included visualization of a tendon with normal thickness and length, and a negative compression test. Eighty-three patients were available for ultrasound examination (40 single-row and 43 suture-bridge). Thirty of 40 patients (75%) with single-row repair demonstrated a healed rotator cuff repair compared to 40/43 (93%) patients with suture-bridge repair (P = .024). Arthroscopic double-row suture bridge repair (transosseous equivalent) of an isolated supraspinatus rotator cuff tear resulted in a significantly higher tendon healing rate (as determined by ultrasound examination) when compared to arthroscopic single-row repair. Copyright © 2013 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

A Prospective Randomized Study of Pfannenstiel Versus Expanded Port Site Incision for Intact Specimen Extraction in Laparoscopic Radical Nephrectomy.

PubMed

Binsaleh, Saleh; Madbouly, Khaled; Matsumoto, Edward D; Kapoor, Anil

2015-08-01

To compare intra- and postoperative outcome of patients undergoing laparoscopic radical nephrectomy with intact specimen extraction through a Pfannenstiel (PFN) transverse suprapubic or expanded port site (EPS) incision in a prospective randomized fashion. Patients undergoing laparoscopic transperitoneal radical nephrectomies for suspected renal tumors were randomized for intact renal specimen extraction via a PFN or EPS incision. Operative, perioperative, 1 week, 6 weeks, and 6 months postoperative parameters were prospectively recorded and analyzed including specimen weight, size in maximum diameter, incision length, total operative time, extraction time, estimated blood loss, length of hospital stay, pain score in the postoperative holding area and on the first post operative day, narcotic consumption, time to fluid intake/full diet intake, unassisted ambulation, cosmesis, and wound-related complications. A postoperative quality-of-life questionnaire was also filled out by all the patients. Our series included 51 patients: 26 in the PFN group and 25 in the EPS group. The two groups were similar in demographic characteristics and intraoperative and postoperative parameters apart from a longer PFN incision (P<0.00). First postoperative day pain score was significantly less in the PFN group than in the EPS group (P=0.023). Complication rate was less in the PFN group, although not statistically significant. Hospital stay was significantly shorter in the PFN than in the EPS group (P=0.01). Mean cosmesis and operative satisfaction scores at week 1, week 6, and 6 month visits were not significantly different between both groups. Compared with the EPS group, PFN group patients significantly will choose the same operation if they would do it again (P=0.004). PFN incision has less morbidity, pain score, and hospital stay compared with EPS incision for intact specimen extraction after transperitoneal laparoscopic radical nephrectomy. Both incisions are associated with high operative satisfaction, good cosmesis, and a low rate of wound complications.

A prospective randomized study comparing laparoscopic transabdominal preperitoneal (TAPP) versus Lichtenstein repair for bilateral inguinal hernias.

PubMed

Ielpo, Benedetto; Duran, Hipolito; Diaz, Eduardo; Fabra, Isabel; Caruso, Riccardo; Malavé, Luis; Ferri, Valentina; Lazzaro, Sara; Kalivaci, Denis; Quijano, Yolanda; Vicente, Emilio

2017-07-19

In literature, only a few studies have prospectively compared the results of laparoscopic with open inguinal hernia repair yet none have compared bilateral inguinal hernia repair. The aim of this study is to compare the open Lichtenstein repair (OLR) with laparoscopic trans-abdominal preperitoneal (TAPP) repair in patients undergoing surgery for bilateral inguinal hernia. Patients were prospectively randomized between March 2013 and March 2015. Outcome parameters included hospital stay, operation time, postoperative complications, immediate postoperative pain and chronic pain, recurrence and quality of life. Sixty-one patients underwent TAPP repair and 73 underwent OLR. TAPP procedure had less early post-operative pain up to 7 days from surgery (p = 0.003), a shorter length of hospital stay (p = 0.001), less postoperative complications (p = 0.012) and less chronic pain (0.04) when compared with the OLR approach. TAPP procedure for bilateral inguinal hernia effectively reduces early postoperative pain, hospital stay and postoperative complications. Copyright © 2017 Elsevier Inc. All rights reserved.

High and low negative pressure suction techniques in EUS-guided fine-needle tissue acquisition by using 25-gauge needles: a multicenter, prospective, randomized, controlled trial.

PubMed

Kudo, Taiki; Kawakami, Hiroshi; Hayashi, Tsuyoshi; Yasuda, Ichiro; Mukai, Tsuyoshi; Inoue, Hiroyuki; Katanuma, Akio; Kawakubo, Kazumichi; Ishiwatari, Hirotoshi; Doi, Shinpei; Yamada, Reiko; Maguchi, Hiroyuki; Isayama, Hiroyuki; Mitsuhashi, Tomoko; Sakamoto, Naoya

2014-12-01

EUS-guided FNA (EUS-FNA) has a high diagnostic accuracy for pancreatic diseases. However, although most reports have typically focused on cytology, histological tissue quality has rarely been investigated. The effectiveness of EUS-FNA combined with high negative pressure (HNP) suction was recently indicated for tissue acquisition, but has not thus far been tested in a prospective, randomized clinical trial. To evaluate the adequacy of EUS-FNA with HNP for the histological diagnosis of pancreatic lesions by using 25-gauge needles. Prospective, single-blind, randomized, controlled crossover trial. Seven tertiary referral centers. Patients referred for EUS-FNA of pancreatic solid lesions. From July 2011 to April 2012, 90 patients underwent EUS-FNA of pancreatic solid masses by using normal negative pressure (NNP) and HNP with 2 respective passes. The order of the passes was randomized, and the sample adequacy, quality, and histology were evaluated by a single expert pathologist. EUS-FNA by using NNP and HNP. The adequacy of tissue acquisition and the accuracy of histological diagnoses made by using the EUS-FNA technique with HNP. We found that 72.2% (65/90) and 90% (81/90) of the specimens obtained using NNP and HNP, respectively, were adequate for histological diagnosis (P = .0003, McNemar test). For 73.3% (66/90) and 82.2% (74/90) of the specimens obtained by using NNP and HNP, respectively, an accurate diagnosis was achieved (P = .06, McNemar test). Pancreatitis developed in 1 patient after this procedure, which subsided with conservative therapy. This was a single-blinded, crossover study. Biopsy procedures that combine the EUS-FNA with HNP techniques are superior to EUS-FNA with NNP procedures for tissue acquisition. ( UMIN000005939.). Copyright © 2014 American Society for Gastrointestinal Endoscopy. Published by Elsevier Inc. All rights reserved.

[Ultrasonic scissors. New vs resterilized instruments].

PubMed

Gärtner, D; Münz, K; Hückelheim, E; Hesse, U

2008-02-01

The aim of this study was to compare reliability in handling and function of resterilized and single-use disposable ultrasonic scissors. In a prospective randomized study, the surgeon blindly tested new and resterilized ultrasonographic scissors. The parameters were force of activation, cutting effect, coagulation effect, error messages, and disturbing generator noise. Fifty-one new and 49 resterilized instruments in 94 operations were evaluated. The differences in force of activation, cutting effect, and coagulation were not significant. Error messages and disturbing noises were rare in both groups. Six new instruments and two resterilized instruments had to be exchanged because of problems during surgery. This study demonstrates comparable reliability in function and handling of resterilized and new ultrasonic scissors. The use of resterilized instruments leads to distinctly reduced costs and could contribute to efficiency in laparoscopic surgery.

Postoperative analgesia in children when using clonidine in addition to fentanyl with bupivacaine given caudally.

PubMed

Jarraya, Anouar; Elleuch, Sahar; Zouari, Jawhar; Smaoui, Mohamed; Laabidi, Sofiene; Kolsi, Kamel

2016-01-01

The aim of the study was to evaluate the efficacy of clonidine in association with fentanyl as an additive to bupivacaine 0.25% given via single shot caudal epidural in pediatric patients for postoperative pain relief. In the present prospective randomized double blind study, 40 children of ASA-I-II aged 1-5 years scheduled for infraumblical surgical procedures were randomly allocated to two groups to receive either bupivacaine 0.25% (1 ml/kg) with fentanyl 1 μg/kg and clonidine 1μg/kg (group I) or bupivacaine 0.25% (1 ml/kg) with fentanyl 1 μg/kg (group II). Caudal block was performed after the induction of general anesthesia. Postoperatively patients were observed for analgesia, sedation, hemodynamic parameters, and side effects or complications. Both the groups were similar with respect to patient and various block characteristics. Heart rate and blood pressure were not different in 2 groups. Significantly prolonged duration of post-operative analgesia was observed in group I (P<0.05). Side effects such as respiratory depression, vomiting and bradycardia were similar in both groups. The adjunction of clonidine to fentanyl as additives to bupivacaine in single shot caudal epidural in children may provide better and longer analgesia after infraumblical surgical procedures.

Does intravenous ketamine enhance analgesia after arthroscopic shoulder surgery with ultrasound guided single-injection interscalene block?: a randomized, prospective, double-blind trial.

PubMed

Woo, Jae Hee; Kim, Youn Jin; Baik, Hee Jung; Han, Jong In; Chung, Rack Kyung

2014-07-01

Ketamine has anti-inflammatory, analgesic and antihyperalgesic effect and prevents pain associated with wind-up. We investigated whether low doses of ketamine infusion during general anesthesia combined with single-shot interscalene nerve block (SSISB) would potentiate analgesic effect of SSISB. Forty adult patients scheduled for elective arthroscopic shoulder surgery were enrolled and randomized to either the control group or the ketamine group. All patients underwent SSISB and followed by general anesthesia. During an operation, intravenous ketamine was infused to the patients of ketamine group continuously. In control group, patients received normal saline in volumes equivalent to ketamine infusions. Pain score by numeric rating scale was similar between groups at 1, 6, 12, 24, 36, and 48 hr following surgery, which was maintained lower than 3 in both groups. The time to first analgesic request after admission on post-anesthesia care unit was also not significantly different between groups. Intraoperative low dose ketamine did not decrease acute postoperative pain after arthroscopic shoulder surgery with a preincisional ultrasound guided SSISB. The preventive analgesic effect of ketamine could be mitigated by SSISB, which remains one of the most effective methods of pain relief after arthroscopic shoulder surgery.

Comparing adductor canal block with local infiltration analgesia in total knee arthroplasty: A prospective, blinded and randomized clinical trial.

PubMed

Tong, Qian Jun; Lim, Yean Chin; Tham, Huae Min

2018-05-01

Total knee arthroplasty (TKA) is associated with significant pain post-operatively. Our hypothesis is that adductor canal block (ACB) would be superior to local infiltration analgesia (LIA) in terms of providing analgesia, while still preserving quadriceps strength and enabling early postoperative rehabilitation. A prospective, blinded and randomized clinical trial between LIA and ACB was conducted. Tertiary care urban hospital. 40 patients (ASA I to III) undergoing primary TKA under single-dose spinal anesthesia were prospectively randomized from January 2014 to October 2015. The LIA group received local infiltration of Ropivacaine 150 mg, Ketorolac 30 mg, Morphine 10 mg, and Adrenaline 200 mcg in a total volume of 75 mls, administered intraoperatively by the surgeon. The ACB group was given an ACB postoperatively by one of the study investigators at the end of surgery with 30 mls of 0.5% Ropivacaine. The primary outcome was total Morphine consumption in the first 24 h. Secondary outcomes included total Morphine consumption in the first 48 h, pain scores, quadriceps strength, the Timed Up and Go test (TUG), the 30 s Chair Stand Test (30s-CST) and length of hospital stay. The median (interquartile range) 24 h Morphine consumption was 6 mg (2.3-18.3) in the ACB group and 17.5 mg (12-24.3) in the LIA group, p = 0.004. The 48 h Morphine consumption was 14.5 mg (7.5-28.5) in the ACB group as compared to 24 mg (14-33.8) in the LIA group, p = 0.03. There were no statistically significant differences in the other secondary outcomes. ACB group had statistically significant reduced total Morphine consumption in the first 24 and 48 hours as compared to LIA group, with no statistically significant differences in functional outcomes of TKA patients. Copyright © 2018 Elsevier Inc. All rights reserved.

A prospective single-blind randomized-controlled trial comparing two surgical techniques for the treatment of snoring: laser palatoplasty versus uvulectomy with punctate palatal diathermy.

PubMed

Uppal, S; Nadig, S; Jones, C; Nicolaides, A R; Coatesworth, A P

2004-06-01

The aim of this study was to compare laser palatoplasty with uvulectomy with punctate palatal diathermy as treatment modalities for snoring. The study design was a prospective, single-blind, randomized-controlled trial. Eighty-three patients entered the trial. After a mean follow-up period of more than 18 months there was no statistically significant difference between the two groups regarding the patient perception of benefit from surgery or the subjective improvement in snoring. However, there was a statistically significant difference in the degree of pain in the immediate postoperative period (mean difference = 22.14, 95% CI = 7.98-36.31, P = 0.003), with the pain being worse in the laser palatoplasty group. Relative risk of complications for laser palatoplasty was 1.42 (95% CI = 0.93-2.17). The snoring scores and Glasgow Benefit Inventory scores decreased with time in both the groups but there was no statistically significant difference between the two groups.

Single-mode SOA-based 1kHz-linewidth dual-wavelength random fiber laser.

PubMed

Xu, Yanping; Zhang, Liang; Chen, Liang; Bao, Xiaoyi

2017-07-10

Narrow-linewidth multi-wavelength fiber lasers are of significant interests for fiber-optic sensors, spectroscopy, optical communications, and microwave generation. A novel narrow-linewidth dual-wavelength random fiber laser with single-mode operation, based on the semiconductor optical amplifier (SOA) gain, is achieved in this work for the first time, to the best of our knowledge. A simplified theoretical model is established to characterize such kind of random fiber laser. The inhomogeneous gain in SOA mitigates the mode competition significantly and alleviates the laser instability, which are frequently encountered in multi-wavelength fiber lasers with Erbium-doped fiber gain. The enhanced random distributed feedback from a 5km non-uniform fiber provides coherent feedback, acting as mode selection element to ensure single-mode operation with narrow linewidth of ~1kHz. The laser noises are also comprehensively investigated and studied, showing the improvements of the proposed random fiber laser with suppressed intensity and frequency noises.

Triple-Loaded Single-Row Versus Suture-Bridge Double-Row Rotator Cuff Tendon Repair With Platelet-Rich Plasma Fibrin Membrane: A Randomized Controlled Trial.

PubMed

Barber, F Alan

2016-05-01

To compare the structural healing and clinical outcomes of triple-loaded single-row with suture-bridging double-row repairs of full-thickness rotator cuff tendons when both repair constructs are augmented with platelet-rich plasma fibrin membrane. A prospective, randomized, consecutive series of patients diagnosed with full-thickness rotator cuff tears no greater than 3 cm in anteroposterior length were treated with a triple-loaded single-row (20) or suture-bridging double-row (20) repair augmented with platelet-rich plasma fibrin membrane. The primary outcome measure was cuff integrity by magnetic resonance imaging (MRI) at 12 months postoperatively. Secondary clinical outcome measures were American Shoulder and Elbow Surgeons, Rowe, Simple Shoulder Test, Constant, and Single Assessment Numeric Evaluation scores. The mean MRI interval was 12.6 months (range, 12-17 months). A total of 3 of 20 single-row repairs and 3 of 20 double-row repairs (15%) had tears at follow-up MRI. The single-row group had re-tears in 1 single tendon repair and 2 double tendon repairs. All 3 tears failed at the original attachment site (Cho type 1). In the double-row group, re-tears were found in 3 double tendon repairs. All 3 tears failed medial to the medial row near the musculotendinous junction (Cho type 2). All clinical outcome measures were significantly improved from the preoperative level (P < .0001), but there was no statistical difference between groups postoperatively. There is no MRI difference in rotator cuff tendon re-tear rate at 12 months postsurgery between a triple-loaded single-row repair or a suture-bridging double-row repair when both are augmented with platelet-rich plasma fibrin membrane. No difference could be demonstrated between these repairs on clinical outcome scores. I, Prospective randomized study. Copyright © 2016 Arthroscopy Association of North America. All rights reserved.

A randomized prospective trial of radical (Halsted) mastectomy versus modified radical mastectomy in 311 breast cancer patients.

PubMed Central

Maddox, W A; Carpenter, J T; Laws, H L; Soong, S J; Cloud, G; Urist, M M; Balch, C M

1983-01-01

This study reports the results of a prospectively randomized trial for treatment of carcinoma of the breast comparing standard (Halsted) radical mastectomy to a modified radical mastectomy. Three hundred eleven patients with primary operable carcinoma of the breast were entered in a surgical and adjunctive chemotherapy trial in Alabama between 1975 and 1978. A total of 91 surgeons participated (all Diplomats of the American Board of Surgery and Members of the American College of Surgeons). All operative reports, pathology and therapy were reviewed by referees. Histologically node positive patients were randomized after operation to receive melphalan or C.M.F.(cytoxan, methotrexate, and 5-FU) for 1 year. After a median follow-up of 5.5 years, there was no significant difference in disease-free survival or in overall survival between the two groups. There was a trend toward improved 5-year survival rates in the radical mastectomy group compared to the modified radical mastectomy group (84% vs. 76%, p = 0.14). There was also an increased incidence of local wound recurrence in those patients receiving modified radical mastectomy, but the differences were not statistically significant (p = 0.09). Longer follow-up will be necessary to evaluate these results more fully. PMID:6870379

Single dose systemic acetaminophen to improve patient reported quality of recovery after ambulatory segmental mastectomy: A prospective, randomized, double-blinded, placebo controlled, clinical trial.

PubMed

De Oliveira, Gildasio S; Rodes, Meghan E; Bialek, Jane; Kendall, Mark C; McCarthy, Robert J

2017-11-15

Few systemic drug interventions are efficacious to improve patient reported quality of recovery after ambulatory surgery. We aimed to evaluate whether a single dose systemic acetaminophen improve quality of recovery in female patients undergoing ambulatory breast surgery. We hypothesized that patients receiving a single dose systemic acetaminophen at the end of the surgical procedure would have a better global quality of postsurgical recovery compared to the ones receiving saline. The study was a prospective randomized double blinded, placebo controlled, clinical trial. Healthy female subjects were randomized to receive 1 g single dose systemic acetaminophen at the end of the surgery or the same volume of saline. The primary outcome was the Quality of Recovery 40 (QOR-40) questionnaire at 24 hours after surgery. Other data collected included opioid consumption and pain scores. Data were analyzed using group t tests and the Wilcoxon exact test. The association between opioid consumption and quality of recovery was evaluated using Spearman rho. P < .05 was used to reject the null hypothesis for the primary outcome. Seventy subjects were randomized and sixty-five completed the study. Patients' baseline characteristics and surgical factors were similar between the study groups. There was a clinically significant difference in the global QoR-40 scores between the acetaminophen and the saline groups, median (IQR) of 189 (183 to 194) and 183 (175 to 190), respectively, P = .01. In addition, there was an inverse relationship (Spearman's rho= -0.33) between oral opioid consumption at home (oral morphine equivalents) and 24 hour postoperative quality of recovery, P = .007. A single dose of systemic acetaminophen improves patient reported quality of recovery after ambulatory breast surgery. The use of systemic acetaminophen is an efficacious strategy to improve patient perceived quality of postsurgical recovery and analgesic outcomes after hospital discharge for ambulatory breast surgery. © 2017 Wiley Periodicals, Inc.

Stand-alone anchored cage versus cage with plating for single-level anterior cervical discectomy and fusion: a prospective, randomized, controlled study with a 2-year follow-up.

PubMed

Nemoto, Osamu; Kitada, Akira; Naitou, Satoko; Tachibana, Atsuko; Ito, Yuya; Fujikawa, Akira

2015-07-01

To avoid complications associated with plating in anterior cervical discectomy and fusion (ACDF), stand-alone anchored PEEK cage was developed and favourable outcomes with a low rate of dysphasia have been described. The objective of this study was to compare the clinical and radiological outcomes of ACDF using a standalone anchored PEEK cage (PREVAIL; Medtronic Sofamor Danek, Memphis, TN) with those of a PEEK cage with plating in a prospective randomized manner. Fifty patients with single-level cervical radiculopathy were randomly assigned to a PREVAIL or a PEEK cage with plating. Following 3, 6, 12, and 24 months, clinical and radiological outcomes were assessed. The mean surgical time for the patients with a PREVAIL was significantly shorter than that for those with a PEEK cage with plating. The clinical outcomes evaluated by visual analogue scale for pain and the Odom's criteria were comparable between both the groups. Both the groups demonstrated the high fusion rate (92% in PREVAIL; 96% in PEEK cage with plating). The subsidence rate and the improvement of cervical alignment were comparable between both the groups. The incidence of adjacent-level ossification was significantly lower for patients with a PREVAIL than that for those with a PEEK cage with plating. The rate of dysphasia graded by the method of Bazaz and measurement of prevertebral soft tissue swelling indicated no significant differences between both the groups. Our prospective randomized study confirmed that stand-alone anchored PEEK cage is a valid alternative to plating in ACDF with a low rate of adjacent-level ossification. However, the potential to reduce the incidence of dysphasia was not confirmed.

Audit of lymphadenectomy in lung cancer resections using a specimen collection kit and checklist.

PubMed

Osarogiagbon, Raymond U; Sareen, Srishti; Eke, Ransome; Yu, Xinhua; McHugh, Laura M; Kernstine, Kemp H; Putnam, Joe B; Robbins, Edward T

2015-02-01

Audits of operative summaries and pathology reports reveal wide discordance in identifying the extent of lymphadenectomy performed (the communication gap). We tested the ability of a prelabeled lymph node specimen collection kit and checklist to narrow the communication gap between operating surgeons, pathologists, and auditors of surgeons' operation notes. We conducted a prospective single cohort study of lung cancer resections performed with a lymph node collection kit from November 2010 to January 2013. We used the kappa statistic to compare surgeon claims on a checklist of lymph node stations harvested intraoperatively with pathology reports and an independent audit of surgeons' operative summaries. Lymph node collection procedures were classified into four groups based on the anatomic origin of resected lymph nodes: mediastinal lymph node dissection, systematic sampling, random sampling, and no sampling. From the pathology reports, 73% of 160 resections had a mediastinal lymph node dissection or systematic sampling procedure, 27% had random sampling. The concordance with surgeon claims was 80% (kappa statistic 0.69, 95% confidence interval: 0.60 to 0.79). Concordance between independent audits of the operation notes and either the pathology report (kappa 0.14, 95% confidence interval: 0.04 to 0.23) or surgeon claims (kappa 0.09, 95% confidence interval: 0.03 to 0.22) was poor. A prelabeled specimen collection kit and checklist significantly narrowed the communication gap between surgeons and pathologists in identifying the extent of lymphadenectomy. Audit of surgeons' operation notes did not accurately reflect the procedure performed, bringing its value for quality improvement work into question. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

The efficacy of intravenous ketorolac for pain relief in single-stage adjustable strabismus surgery: a prospective, randomized, placebo-controlled trial

PubMed Central

Rhiu, S; Chung, S A; Kim, W K; Chang, J H; Bae, S J; Lee, J B

2011-01-01

Purpose To determine the efficacy of preoperative intravenous ketorolac in reducing intraoperative and postoperative pain and improving patient satisfaction in patients undergoing single-stage adjustable strabismus surgery. Methods A prospective, randomized, placebo-controlled clinical trial was performed with 67 patients who underwent horizontal recti muscle surgery with adjustable sutures. The test group received intravenous ketorolac (60 mg) before surgery, and the control group received intravenous normal saline. Topical 0.5% proparacaine was administered to both groups during surgery. Vital signs including heart rate and blood pressure were recorded every 10 min throughout the surgery. The patients were asked to rate their maximum intraoperative and postoperative pain scores using a numerical pain rating scale. Patient satisfaction was also assessed using a five-point analogue scale. Results The ketorolac-premedicated patients had less pain both during and after surgery (P=0.033 and P=0.024, respectively). There were no differences in vital signs during surgery and patient satisfaction between the two groups. Conclusions Intravenous ketorolac, when administered preoperatively for single-stage adjustable strabismus surgery under topical anaesthesia, was effective in reducing pain during and after surgery. PMID:21102493

Effectiveness of adjuvant radiotherapy in patients with oropharyngeal and floor of mouth squamous cell carcinoma and concomitant histological verification of singular ipsilateral cervical lymph node metastasis (pN1-state) - A prospective multicenter randomized controlled clinical trial using a comprehensive cohort design

PubMed Central

2009-01-01

Background Modern radiotherapy plays an important role in therapy of advanced head and neck carcinomas. However, no clinical studies have been published addressing the effectiveness of postoperative radiotherapy in patients with small tumor (pT1, pT2) and concomitant ipsilateral metastasis of a single lymph node (pN1), which would provide a basis for a general treatment recommendation. Methods/Design The present study is a non-blinded, prospective, multi-center randomized controlled trial (RCT). As the primary clinical endpoint, overall-survival in patients receiving postoperative radiation therapy vs. patients without adjuvant therapy following curative intended surgery is compared. The aim of the study is to enroll 560 adult males and females for 1:1 randomization to one of the two treatment arms (irradiation/no irradiation). Since patients with small tumor (T1/T2) but singular lymph node metastasis are rare and the amount of patients consenting to randomization is not predictable in advance, all patients rejecting randomization will be treated as preferred and enrolled in a prospective observational study (comprehensive cohort design) after giving informed consent. This observational part of the trial will be performed with maximum consistency to the treatment and observation protocol of the RCT. Because the impact of patient preference for a certain treatment option is not calculable, parallel design of RCT and observational study may provide a maximum of evidence and efficacy for evaluation of treatment outcome. Secondary clinical endpoints are as follows: incidence and time to tumor relapse (locoregional relapse, lymph node involvement and distant metastatic spread), Quality of life as reported by EORTC (QLQ-C30 with H&N 35 module), and time from operation to orofacial rehabilitation. All tumors represent a homogeneous clinical state and therefore additional investigation of protein expression levels within resection specimen may serve for establishment of surrogate parameters of patient outcome. Conclusion The inherent challenges of a rare clinical condition (pN1) and two substantially different therapy arms would limit the practicality of a classical randomized study. The concept of a Comprehensive Cohort Design combines the preference of a randomized study, with the option of careful data interpretation within an observational study. Trial registration ClinicalTrials.gov: NCT00964977 PMID:20028566

Transvaginal cholecystectomy versus single-incision laparoscopic cholecystectomy versus four-port laparoscopic cholecystectomy: a prospective cohort study.

PubMed

Solomon, Daniel; Shariff, Amir H; Silasi, Dan-Arin; Duffy, Andrew J; Bell, Robert L; Roberts, Kurt E

2012-10-01

This report describes the first prospective cohort study comparing transvaginal cholecystectomies (TVC) with single incision laparoscopic cholecystectomies (SILC) and four-port laparoscopic cholecystectomies (4PLC). Between May 2009 and August 2010, 14 patients underwent a TVC. These patients were compared with patients who underwent SILC (22 patients) or 4PLC (11 patients) in a concurrent, randomized, controlled trial. Demographic data, operative time, numerical pain scales, complications, and return to work were recorded. Mean age (TVC: 33.5 ± 3.0 year; SILC: 38.4 ± 3.3 year; 4PLC: 35.5 ± 4.1 year; p = 0.58) and mean BMI (TVC: 28.8 ± 1.5 kg/m(2); SILC: 31.8 ± 1 kg/m(2); 4PLC: 31.4 ± 2.2 kg/m(2); p = 0.35) were not statistically significant. However, mean operative time (TVC: 67 ± 3.9 min; SILC: 48.9 ± 2.6 min; 4PLC: 42.3 ± 3.9 min; p < 0.001) was significantly longer for TVC. Numerical pain scales showed significantly lower pain scores on POD 1 and 3 for TVC compared with SILC and 4PLC (TVC: 4.1 ± 0.5 and 2.9 ± 0.7; SILC: 6.1 ± 0.5 and 5.3 ± 0.5; 4PLC: 5.7 ± 0.4 and 4.7 ± 0.3; p = 0.02) with equilibration of pain scores by days 14 and 30. Return to work (TVC: 6.4 ± 1.5 days; SILC: 13.1 ± 1.3 days; 4PLC: 14.1 ± 1.4 days; p < 0.001) also was significantly faster for patients in the TVC group. One conversion in the TVC group to a 4PLC was necessary due to adhesions within the pelvis. One dislodged IUD was seen and immediately replaced in the TVC group. One hernia was observed in the SILC group. Transvaginal cholecystectomy is a safe and well-tolerated procedure with statistically significantly less pain at 1 and 3 days after surgery, with a faster return to work but longer operative times compared with single incision and four-port laparoscopic cholecystectomy.

[Effects of modified bazhen decoction in assistant with enteral nutrition on the growth hormone, the nutritional state, and the immune function in patients with gastric cancer after operation].

PubMed

Wang, Hong-xing; Li, Jian-ping

2011-10-01

To observe the effects of modified Bazhen Decoction (BZD) in assistant with enteral nutrition (EN) on the growth hormone, the nutritional state, and the immune function in patients with gastric cancer after operation. The prospective, random, single-blinded, controlled clinical trial was adopted. 88 patients receiving gastric cancer operation were randomly assigned to the parenteral nutrition group (Group A, 27 cases), the EN group (Group B, 30 cases), and the comprehensive group (Group C, BZD in assistant with EN, 31 cases). Isocaloric and isonitrogenous parenteral nutritional support was given to patients in Group A from the operation day to the ninth day. Isocaloric and isonitrogenous EN was given to patients in Group B and C from the second day of operation till the ninth day. 100 mL BZD was nasal fed to patients in Group C during the second day to the ninth day after operation. The levels of the growth hormone, immune indices such as IgA, IgG, CD4+, CD8+, and CD4+/CD8+, etc., and nutritional indices such as serum albumin, prealbumin, transferrin, etc. were detected in the three groups one day before operation, on the 1st day after operation, and on the tenth day after operation. The levels of IgA, IgG, CD4+, and CD4+/CD8+, serum albumin, prealbumin, transferrin decreased more than before operation in the three groups, with statistical difference (P<0.05). On the tenth day after operation, all indices in Group B and C were somewhat improved, showing statistical difference when compared with those in Group A (P<0.05). Besides, the aforesaid indices were higher in Group C than in Group B (P<0.05). Modified BZD in assistant with EN could further promote the elevation of the growth hormone levels. Besides, it could further improve the nutrition state and the immune function.

Post-operative bracing after ACL reconstruction has no effect on knee joint effusion. A prospective, randomized study.

PubMed

Lindström, Maria; Wredmark, Torsten; Wretling, Marie-Louise; Henriksson, Marketta; Felländer-Tsai, Li

2015-12-01

It is unclear what factors contribute to knee joint effusion after anterior cruciate ligament (ACL) injury and reconstruction. Knee homeostasis after injury and surgery is crucial for rehabilitation and knee well-being. We examined if effusion was affected by post-operative bracing, and if patients with effusion fit into a common profile. Patients were randomized to wearing or not wearing a post-operative brace for three weeks after ACL reconstruction with semitendinosus-gracilis tendons. Knee joint effusion was detected by computed tomography in 60 patients (22 women), before and three and 12 months after surgery. Joint effusion, clinical and subjective tests were analyzed. This is the first prospective, randomized study on post-operative bracing for patients with a semitendinosus-gracilis graft showed that bracing had no effect on three-months presence of joint effusion. Excessive joint effusion was present in 68% of the patients three months after surgery and was associated to prior meniscus injury (p=0.05) and higher prior Tegner activity level (p=0.006). We found a positive association between longer time from injury to surgery and joint effusion three months post-operatively (rho=0.29, p<0.05). Twelve months post-operatively, joint effusion had diminished to baseline levels. Subjective scores and activity levels were lower for women. Three-months joint effusion predicted lower final outcome scores in women. Prior meniscus injury and pre-injury Tegner activity levels are predictive significant variables for excessive knee joint effusion after ACL reconstruction. Post-operative bracing had no effect. A larger clinical cohort is needed to confirm findings of this logistic regression. Copyright © 2015 Elsevier B.V. All rights reserved.

Transverse pinning versus intramedullary pinning in fifth metacarpal's neck fractures: A randomized controlled study with patient-reported outcome.

PubMed

Galal, Sherif; Safwat, Wael

2017-01-01

The 5th metacarpal fractures accounts for 38% of all hand fractures given that the neck is the weakest point in metacarpals, so neck fracture is the most common metacarpal fracture. Surgical fixation is also advocated for such fractures to prevent mal-rotation of the little finger which will lead to fingers overlap in a clenched fist. Various methods are available for fixation of such fractures, like intramedullary & transverse pinning. There are very few reports in the literature comparing both techniques. Authors wanted to compare outcomes and complications of transverse pinning versus intramedullary pinning in fifth metacarpal's neck fractures. A single-center, parallel group, prospective, randomized study was conducted at an academic Level 1 Trauma Center from October 2014 to December 2016. A total of 80 patients with 5th metacarpal's neck fractures were randomized to pinning using either transverse pinning (group A) or intramedullary pinning (group B). Patients were assessed clinically on range of motion, patient-reported outcome using the Quick-DASH (Disabilities of the Arm, Shoulder, and Hand) questionnaire & radiographically. Two blinded observers assessed outcomes. At final follow up for each patient (12 months) the statistically significant differences were observed in operative time, the transverse pinning group showed shorter operative time, as well as complication rate as complications were observed only in intramedullary pinning group. No differences were found in range of motion or the Quick -DASH score. Both techniques are equally safe and effective treatment option for 5th metacarpal's neck fractures. The only difference was shorter operative time & less incidence of complications in transverse pinning group. Level II, Therapeutic study.

A randomized comparison of different ventilator strategies during thoracotomy for pulmonary resection.

PubMed

Maslow, Andrew D; Stafford, Todd S; Davignon, Kristopher R; Ng, Thomas

2013-07-01

Protective lung ventilation is reported to benefit patients with acute respiratory distress syndrome. It is not known whether protective lung ventilation is also beneficial to patients undergoing single-lung ventilation for elective pulmonary resection. In an institutional review board-approved prospective randomized trial, 34 patients undergoing elective pulmonary resection requiring single-lung ventilation were enrolled. Informed consent was obtained. Patients were randomized to 1 of 2 groups: (1) high tidal volume (Hi-TV) of 10 mL/kg, rate of 7 breaths/min, and zero positive end-expiratory pressure or (2) low tidal volume (Lo-TV) of 5 mL/kg, rate of 14 breaths/min, and 5 cmH2O positive end-expiratory pressure. Ventilator settings were continued during both double- and single-lung ventilation. Pulmonary functions, hemodynamics, and postoperative outcomes were recorded. Patient demographics, operative characteristics, intraoperative hemodynamics, and postoperative pain and sedation scores were similar between the 2 groups. During most time periods, airway pressures (peak and plateau) were significantly higher in the Hi-TV group; however, plateau pressures remained less than 30 cmH2O at all times for all patients. The Hi-TV group had significantly lower arterial carbon dioxide tension, less arterial carbon dioxide tension-end-tidal carbon dioxide gradient, lower alveolar dead space ratio, and higher dynamic pulmonary compliance. There were no differences in postoperative morbidity and hospital days between the 2 groups, but atelectasis scores on postoperative days 1 and 2 were lower in the Hi-TV group. The use of Hi-TV during single-lung ventilation for pulmonary resection resulted in no increase in morbidity and was associated with less hypercarbia, less dead space ventilation, better dynamic compliance, and less postoperative atelectasis. Copyright © 2013 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

Early Removal of Double-J Stents Decreases Urinary Tract Infections in Living Donor Renal Transplantation: A Prospective, Randomized Clinical Trial.

PubMed

Liu, S; Luo, G; Sun, B; Lu, J; Zu, Q; Yang, S; Zhang, X; Dong, J

2017-03-01

The optimal timing for stent removal after renal transplantation remains controversial. This article describes an interim analysis of a randomized, prospective, double-blind trial aimed at detecting differences in urological complications between early ureteral stent removal at 1 week and routine ureteral stent removal at 4 weeks. Between October 2010 and March 2015, 103 patients who underwent living donor renal transplantation at a single center were pre-operatively randomly assigned to the early ureteral stent removal (at 1 week) group or the routine ureteral stent removal (at 4 weeks) group. Urinary symptoms, auxiliary examination results, and obstruction events were recorded during 3 months of follow-up. A cost analysis of both the hospitalization and postoperative periods was discussed. In total, 52 patients in the 1-week stent group and 51 patients in the 4-week stent group were analyzed. No serious adverse events were reported. Three episodes of urinary tract infections (UTIs) occurred in the 1-week stent group, and 18 such episodes were recorded in the 4-week stent group (5.8% vs 29.4%; P = .002). After adjusting for age, sex, ischemia time, renal artery number, body mass index, multiple arteries, and associated medical illness, regression analysis indicated that only stent duration was associated with UTI (OR, 8.791; 95% CI, 1.984-38.943; P = .004). The results of our study demonstrate that ureteral stent removal at 1 week reduces the risk of UTIs compared with routine removal at 4 weeks. Similar effects of ureteral stent removal on complication rates are observed for these two removal times. Copyright © 2016 Elsevier Inc. All rights reserved.

Journal of Special Operations Medicine. Volume 4, Edition 1, Winter 2004

DTIC Science & Technology

2004-01-01

an ophthalmologist. He has been instrumental in PRK initiatives, has been a very productive mem- ber of the BISC, knows the risks of our missions...results to SOF mission commanders in a format suit- able for training at the unit level. 1999-3 PROSPECTIVE EVALUATION OF WAVE- FRONT-GUIDED PRK (Year...1 of 3) Conduct a prospective, randomized clinical trial to compare PRK for the treatment of naturally occurring myopia and astigmatism using

Brief report: pulmonary auscultation in the operating room: a prospective randomized blinded trial comparing electronic and conventional stethoscopes.

PubMed

Hoffmann, Clement; Falzone, Elisabeth; Verret, Catherine; Pasquier, Pierre; Leclerc, Thomas; Donat, Nicolas; Jost, Daniel; Mérat, Stephane; Maurice, Guillaume de Saint; Lenoir, Bernard; Auroy, Yves; Tourtier, Jean-Pierre

2013-09-01

We compared the subjective quality of pulmonary auscultation between 2 acoustic stethoscopes (Holtex Ideal® and Littmann Cardiology III®) and an electronic stethoscope (Littmann 3200®) in the operating room. A prospective double-blind randomized study with an evaluation during mechanical ventilation was performed in 100 patients. After each examination, the listeners using a numeric scale (0-10) rated the quality of auscultation. Auscultation quality was compared in patients among stethoscopes with a multilevel mixed-effects linear regression with random intercept (operator effect), adjusted on significant factors in univariate analysis. A significant difference was defined as P < 0.05. One hundred comparative evaluations of pulmonary auscultation were performed. The quality of auscultation was rated 8.2 ± 1.6 for the electronic stethoscope, 7.4 ± 1.8 for the Littmann Cardiology III, and 4.6 ± 1.8 for the Holtex Ideal. Compared with Holtex Ideal, auscultation quality was significantly higher with other stethoscopes (P < 0.0001). Compared with Littmann Cardiology III, auscultation quality was significantly higher with Littmann 3200 electronic stethoscope (β = 0.9 [95% confidence interval, 0.5-1.3]). An electronic stethoscope can provide a better quality of pulmonary auscultation than acoustic stethoscopes in the operating room, yet with a magnitude of improvement marginally higher than that provided with a high performance acoustic stethoscope. Whether this can translate into a clinically relevant benefit requires further studies.

Surgical versus Non-Operative Treatment for Lumbar Disc Herniation: Eight-Year Results for the Spine Patient Outcomes Research Trial (SPORT)

PubMed Central

Lurie, Jon D.; Tosteson, Tor D.; Tosteson, Anna N. A.; Zhao, Wenyan; Morgan, Tamara S.; Abdu, William A.; Herkowitz, Harry; Weinstein, James N.

2014-01-01

Study Design Concurrent prospective randomized and observational cohort studies. Objective To assess the 8-year outcomes of surgery vs. non-operative care. Summary of Background Data Although randomized trials have demonstrated small short-term differences in favor of surgery, long-term outcomes comparing surgical to non-operative treatment remain controversial. Methods Surgical candidates with imaging-confirmed lumbar intervertebral disc herniation meeting SPORT eligibility criteria enrolled into prospective randomized (501 participants) and observational cohorts (743 participants) at 13 spine clinics in 11 US states. Interventions were standard open discectomy versus usual non-operative care. Main outcome measures were changes from baseline in the SF-36 Bodily Pain (BP) and Physical Function (PF) scales and the modified Oswestry Disability Index (ODI - AAOS/Modems version) assessed at 6 weeks, 3 and 6 months, and annually thereafter. Results Advantages were seen for surgery in intent-to-treat analyses for the randomized cohort for all primary and secondary outcomes other than work status; however, with extensive non-adherence to treatment assignment (49% patients assigned to non-operative therapy receiving surgery versus 60% of patients assigned to surgery) these observed effects were relatively small and not statistically significant for primary outcomes (BP, PF, ODI). Importantly, the overall comparison of secondary outcomes was significantly greater with surgery in the intent-to-treat analysis (sciatica bothersomeness [p > 0.005], satisfaction with symptoms [p > 0.013], and self-rated improvement [p > 0.013]) in long-term follow-up. An as-treated analysis showed clinically meaningful surgical treatment effects for primary outcome measures (mean change Surgery vs. Non-operative; treatment effect; 95% CI): BP (45.3 vs. 34.4; 10.9; 7.7 to 14); PF (42.2 vs. 31.5; 10.6; 7.7 to 13.5) and ODI (−36.2 vs. −24.8; −11.2; −13.6 to −9.1). Conclusion Carefully selected patients who underwent surgery for a lumbar disc herniation achieved greater improvement than non-operatively treated patients; there was little to no degradation of outcomes in either group (operative and non-operative) from 4 to 8 years. PMID:24153171

Single-incision (with multi-input single-port) laparoscopic colorectal procedures: Early results

PubMed Central

Ertem, Metin; Gök, Hakan; Özveri, Emel

2013-01-01

Objective: Single incision laparoscopic surgery (SILS) is a “scar-less” new surgical technique which has been gaining popularity over recent years. In comparison to conventional multiport laparoscopic surgery, SILS is introduced as a less invasive method. This technique has also been applied to colorectal surgery. The aim of the presenting study is to investigate the applicability of SILS and report short term results. Material and Methods: We evaluated prospectively collected data of 24 patients who had been operated with “Single Incision Laparoscopic Colon Resection (SILCR)” in our clinic between June 2011–June 2013. Informed consent was obtained from all patients before surgery. Patient data such as ASA and BMI values, need for additional surgery, tumors, number of lymph nodes resected, length of hospital stay, length of surgery, timing of flatus, time to start oral feeding and complications were recorded. Results: SILCR was performed in 24 patients. In 13 patients, SILCR was performed for cancer treatment. There was no need for extra ports, conversion to open surgery and stoma creation was also not necessary. Drain was placed in 4 patients. Overall complication rate was 12.5%. The mean number of lymph nodes in 13 patients who underwent SILCR for tumor was found to be 23 (14–33). The mean operative time and length of hospital stay was 177 minutes (110–363) and 5.35 days (4–11) respectively. Anastomotic leakage was not seen in any of the patients. In one patient, urinoma formation due to ureteral leakage was seen which resulted from thermal injury. Conclusion: When we compare other series with almost the same number of patients’ reported SILS results in the literature, we believe that we could draw conclusions from our data. SILS appears to have comparable results to conventional multiport laparoscopic surgery in the hands of experienced surgeons. It seems advantegous as it can be done with conventional laparoscopic instruments in a “scar-less” manner. Prospective randomized trials are necessary to define the benefits of one procedure over the other. PMID:25931861

Conventional versus digital radiographs for intraoperative cervical spine-level localization: a prospective time and cost analysis.

PubMed

Steinmetz, Michael P; Mroz, Thomas E; Krishnaney, Ajit; Modic, Michael

2009-12-01

In today's health-care environment, operational efficiency is intrinsic to balancing the need for increased productivity driven by rising costs and potentially decreasing reimbursement. Other operational factors kept constant, decreasing the time for a procedure can be viewed as one marker for increased efficiency. To prospectively evaluate the time and operating room efficiency differences between the two methods for intraoperative level localization. STYDY DESIGN: Prospective nonrandomized study. Prospective consecutive patients undergoing a single-level anterior cervical discectomy and fusion (ACDF) with plate and allograft. Time for performance and interpretation of intraoperative localization radiograph. This is a prospective nonrandomized study of patients treated consecutively with a single-level ACDF with allograft and plating. All the patients underwent a conventional approach to the cervical spine. After exposure, a spinal needle was placed in the exposed intervertebral disc and a radiography was performed. Either a conventional or a digital radiography was used in each case. Eighteen patients were enrolled in this study. Ten patients underwent localization with conventional radiography, whereas eight patients underwent localization with digital imaging. The mean time for conventional radiography was 823 seconds (standard deviation [SD], 159), and for digital, it was 100 seconds (SD, 34; p<.001). Current technology provides options for level localization. Digital imaging provides equally accurate information as conventional radiography in a significantly reduced amount of time. Image quality, ease or archival, and manipulation provided by digital radiography are superior to those by provided fluoroscopy. Keeping operational factors constant, decreasing the time for a procedure, and increasing the efficiency of the environment may be viewed as a surrogate for improving the cost basis for a procedure.

Influence of an apical negative pressure irrigation system on bacterial elimination during endodontic therapy: a prospective randomized clinical study.

PubMed

Pawar, Rekha; Alqaied, Abdullah; Safavi, Kamran; Boyko, Jennifer; Kaufman, Blythe

2012-09-01

Recent in vitro studies that use an apical negative pressure irrigation system, EndoVac, have demonstrated promising results in the production of debris-free root canals, while also preventing potential extrusion of irrigants into the periapical region. We conducted a randomized, controlled, prospective clinical study to determine whether the use of EndoVac irrigation (EndoVac group) was more efficient compared with standard needle irrigation (control group) in obtaining canals from which microbes could not be cultivated. Routine endodontic therapy was performed in 48 patients with necrotic, single-rooted, single-canal teeth. The patients were randomly assigned to either the EndoVac group (n = 25) or control group (n = 23). Irrigation with either method was carried out with 0.5% sodium hypochlorite. After surface disinfection, before instrumentation and on completion of chemomechanical preparation, intracanal microbial samples were obtained and cultured under anaerobic conditions. The frequency of microbial cultivability by using either irrigation system was analyzed. The frequency of obtaining culture-negative root canals was 90.9% and 82.6% for the control group and EndoVac group, respectively. There was no significant difference in the antimicrobial efficacy of either control group or EndoVac group (Fisher exact test, P = .665). Furthermore, no significant association between study variables and the irrigation systems' antimicrobial efficacy was found (P > .05). The results of this prospective in vivo study demonstrate that the antimicrobial efficacy of EndoVac irrigation is comparable to that of standard irrigation. Copyright © 2012 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Postoperative morbidity and histopathologic characteristics of tonsillar tissue following coblation tonsillectomy in children: a prospective randomized single-blind study.

PubMed

Roje, Zeljka; Racić, Goran; Dogas, Zoran; Pisac, Valdi Pesutić; Timms, Michael

2009-03-01

The aim of this prospective randomized single blind study was to determine the depth of thermal damage to tonsillar tissue due to coblation, and to compare it with thermal damage to tonsillar tissue following conventional tonsillectomy; to correlate the depth of thermal damage to tonsillar tissue with the parameters of postoperative morbidity, to compare intraoperative blood loss, postoperative pain severity, time to resuming normal physical activity, and incidence of postoperative bleeding between two groups of tonsillectomized children aged up to 16 years. 72 children aged 3-16 years scheduled for tonsillectomy randomly assigned into two groups submitted either to conventional tonsillectomy with bipolar diathermy coagulation or to coblation tonsillectomy, with a 14-day follow up. Statistically significant differences were observed in the depth of thermal damage to tonsillar tissue (p < 0.001), intraoperative blood loss (p < 0.004), in postoperative pain severity (p < 0.05) and in time to resuming normal physical activity between the two groups (p < 0.001). There was no case of reactionary or secondary bleeding in either group. In this paper for the first time we have correlated postoperative morbidity and thermal tissue damage: less thermal damage is associated with less postoperative morbidity.

A prospective randomized single blind trial of Fleet phosphate enema versus glycerin suppositories as preparation for flexible sigmoidoscopy.

PubMed

Underwood, D; Makar, R R; Gidwani, A L; Najfi, S M; Neilly, P; Gilliland, R

2010-03-01

This study compared the efficacy and patient acceptability of two methods of bowel preparation for flexible sigmoidoscopy. Patients attending for outpatient flexible sigmoidoscopy were prospectively randomized to receive one Fleet ready-to-use enema or 2 x 4 g glycerin suppositories, 2 h preprocedure. Patient and endoscopist questionnaires were used to compare the outcomes. From November 2000 to August 2001, 203 (male = 95; female = 108) patients were randomized. Patient data available for 163 patients (enema = 93; suppository = 70) revealed: ease of use (enema = 52; suppository = 25; P < 0.02, Fisher's exact); assistance required (enema = 19; suppository = 3; P < 0.005, Fisher's exact); grade of effectiveness (enema = 83; suppository = 44; P < 0.0001, Fisher's exact), and whether patients wished to try another preparation in future (enema = 16; suppository = 24; P = 0.016, Fisher's exact). Endoscopist data available for 151 patients (enema = 76; suppository = 75) revealed: average depth of insertion (enema = 53.6 +/- 11.6 cm; suppository 46.3 +/- 13.7 cm; P < 0.001, Student's t test); acceptable (excellent + good) quality of preparation [enema = 60 (78.9%); suppository = 34 (45.3%); P < 0.0001, Fisher's exact]. Bowel preparation for flexible sigmoidoscopy using a single Fleet enema is acceptable to patients and more effective than glycerin suppositories.

Tonsillitis: MedlinePlus Health Topic

MedlinePlus

... Library of Medicine) Article: The debate continues: a prospective, randomised, single-blind study comparing Coblation... Article: Overnight in-hospital observation following tonsillectomy: retrospective study of post-operative intervention. Article: Immune thrombocytopenia ...

The effects of epidural analgesia on the course and outcome of labour.

PubMed

Finster, M; Santos, A C

1998-09-01

The potential effects of epidural analgesia on the progress and outcome of labour have been the subject of lasting controversy. Retrospective reviews indicate that epidurals are associated with longer labours and/or an increase in the incidence of instrumental or operative delivery. Similar results were obtained in non-randomized prospective studies. None of them established a causal relationship, because without randomization the selection bias cannot be ruled out. Other factors, such as premature rupture of membranes and maternal socioeconomic status, may affect the outcome of labour. It was also reported that introduction of the on-demand epidural service did not increase the primary caesarean section rate. The few prospective randomized studies are contradictory and not very reliable owing to small patient populations and high cross-over rates. There is, however, unanimity among the authors regarding the superiority of pain relief provided by epidural blocks over systemically administered opioids.

Accuracy of VarioGuide Frameless Stereotactic System Against Frame-Based Stereotaxy: Prospective, Randomized, Single-Center Study.

PubMed

Bradac, Ondrej; Steklacova, Anna; Nebrenska, Katerina; Vrana, Jiri; de Lacy, Patricia; Benes, Vladimir

2017-08-01

Frameless stereotactic brain biopsy systems are widely used today. VarioGuide (VG) is a relatively novel frameless system. Its accuracy was studied in a laboratory setting but has not yet been studied in the clinical setting. The purpose of this study was to determine its accuracy and diagnostic yield and to compare this with frame-based (FB) stereotaxy. Overall, 53 patients (33 males and 20 females, 60 ± 15 years old) were enrolled into this prospective, randomized, single-center study. Twenty-six patients were randomized into the FB group and 27 patients into the VG group. Real trajectory was pointed on intraoperative magnetic resonance. The distance of the targets and angle deviation between the planned and real trajectories were computed. The overall discomfort of the patient was subjectively assessed by the visual analog scale score. The median lesion volume was 5 mL (interquartile range [IQR]: 2-16 mL) (FB) and 16 mL (IQR: 2-27 mL) (VG), P = 0.133. The mean distance of the targets was 2.7 ± 1.1 mm (FB) and 2.9 ± 1.3 mm (VG), P = 0.456. Mean angle deviation was 2.6 ± 1.3 deg (FB) and 3.5 ± 2.1 deg (VG), P = 0.074. Diagnostic yield was 93% (25/27) in VG and 96% (25/26) in FB, P = 1.000. Mean operating time was 47 ± 26 minutes (FB) and 59 ± 31 minutes (VG), P = 0.140. One minor bleeding was encountered in the VG group. Overall patient discomfort was significantly higher in the FB group (visual analog scale score 2.5 ± 2.1 vs. 1.2 ± 0.6, P = 0,004). The VG system proved to be comparable in terms of the trajectory accuracy, rate of complications and diagnostic yield compared with the "gold standard" represented by the traditional FB stereotaxy for patients undergoing brain biopsy. VG is also better accepted by patients. Copyright © 2017 Elsevier Inc. All rights reserved.

[Topical hemostatic devices in surgery: between science and marketing].

PubMed

González, Héctor Daniel; Figueras Felip, Joan

2009-06-01

Topical hemostatic agents have been used in surgery with varying degrees of success. These agents include oxidized cellulose, absorbable gelatin sponges, microfibrillar collagen and fibrin seals. Fibrin seals have become widely used as they improve perioperative hemostasis, reduce the need for red blood cell transfusions and prevent biliary leaks. Their widespread use, however, contrasts with the scarcity of data from controlled studies to support their clinical effectiveness. Therefore, a prospective, randomized, controlled, single-center study was performed in 300 patients who underwent elective hepatectomy, with and without application of fibrin seal on the raw liver surface. None of the variables evaluated (blood loss, transfusions, biliary fistulas and postoperative results) differed between the two groups. We conclude that the application of fibrin seal does not seem justified and that discontinuing its routine use would substantially reduce costs. The use of a new agent, Tachosil, is supported by a single multicenter, prospective, randomized, controlled trial, which is limited by the small number of patients and by the fact that the variable analyzed--time from application to hemostasis--may not be clinically relevant.

Comparison of the effects of sodium hyaluronate-chondroitin sulphate and corticosteroid in the treatment of lateral epicondylitis: a prospective randomized trial.

PubMed

Tosun, Haci Bayram; Gumustas, Seyitali; Agir, Ismail; Uludag, Abuzer; Serbest, Sancar; Pepele, Demet; Ertem, Kadir

2015-09-01

Hyaluronic acid and glycosaminoglycans have shown positive effects in improving lateral epicondylitis and other tendinosis conditions. Therefore, we designed a prospective, randomized study to compare the effects of a combined sodium hyaluronate and chondroitin sulfate (HA + CS) injection versus a triamcinolone injection in the treatment of lateral epicondylitis. In total, 57 consecutive patients with clinically diagnosed lateral epicondylitis were divided randomly into two groups. In the HA + CS group, 25 patients received a single injection of a solution containing an HA + CS combination and prilocaine HCl, while the 32 patients in the triamcinolone group received a single injection of a solution of triamcinolone and prilocaine HCl. We evaluated the pain and function outcome measures using the Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaire at the beginning of the study, and 3 and 6 months after the injection. Additionally, the Minimum Clinically Important Difference values and percentage changes in the PRTEE subscale scores between the assessments were calculated. No serious adverse events were reported throughout the study. The mean pain and function scores for the HA + CS and triamcinolone groups had significantly improved at 3 months, but the mean function scores in the HA + CS group were statistically significantly better when compared to the triamcinolone group. At 6 months, both groups had significantly improved mean pain and function scores, compared to the baseline scores; however, the mean pain and function scores in the 6-month HA + CS treatment group were better than in the 6-month triamcinolone group. The relative change for the mean total score in the HA + CS group was much better when compared with the triamcinolone group, and the HA + CS treatment group showed clinically significant improvement when compared with triamcinolone group at 3 and 6 months. This study supports the idea that for a single injection treatment of patients with lateral epicondylitis, a combination injection of HA + CS may offer better pain benefits for 6 months after injection, when compared to triamcinolone. Level II, Randomized Clinical Trial, Prospective Comparative Study.

Single-ring ablation compared with standard circumferential pulmonary vein isolation using remote magnetic catheter navigation.

PubMed

Sohns, Christian; Bergau, Leonard; Seegers, Joachim; Lüthje, Lars; Vollmann, Dirk; Zabel, Markus

2014-10-01

In ablation of atrial fibrillation, the single-ring method aims for isolation of the posterior wall of the left atrium (LA) including the pulmonary veins (PVs) but avoiding posterior LA lesions. The aim of this randomized prospective study was to evaluate safety and efficacy of remote magnetic navigation (RMN)-guided single-ring ablation strategy as compared to standard RMN-guided circumferential PV ablation (PVA). Eighty consecutive patients undergoing PVA were enrolled prospectively and randomized equally into two study groups. RMN using the Stereotaxis system and open-irrigated 3.5-mm ablation catheters were used with a 3D mapping system in all procedures. Forty patients underwent RMN-guided single-ring ablation, and 40 patients received RMN-guided circumferential PVA. In the circumferential group, 3.3 ± 1.1 PVs were successfully isolated at the end of the procedure as compared to 3.1 ± 1.3 in the single-ring (box) group (p=0.38). All patients in the box group required additional posterior lesions in order to achieve electrical isolation of the PVs. Single-ring ablation was associated with longer procedure duration (p=0.01) and ablation time (p=0.001). After a single procedure, the proportion of patients free of any atrial tachycardia (AT)/atrial fibrillation (AF) episode at 12-month follow-up was 57 % in the box group and 58 % in the circ group. Using RMN, only minor complications have been observed. RMN-guided single-ring PVA provides comparable acute and long-term success rates as compared to RMN-guided circumferential PVA but requires additional posterior lesions to achieve PV isolation and increased procedure and ablation time. Procedural complication rates are low when using RMN.

The effects of steroids in preventing facial oedema, pain, and neurosensory disturbances after bilateral sagittal split osteotomy: a randomized controlled trial.

PubMed

Widar, F; Kashani, H; Alsén, B; Dahlin, C; Rasmusson, L

2015-02-01

A randomized, prospective, controlled trial was conducted to determine the efficacy of single and repeated betamethasone doses on facial oedema, pain, and neurosensory disturbances after bilateral sagittal split osteotomy. Thirty-seven patients (mean age 23.62 years, range 17-62 years) with either mandibular prognathism or retrognathism were enrolled consecutively into the study and divided into three groups: control (n=12), repeated dose 4+8+4mg betamethasone (n=14), single dose 16mg betamethasone (n=11). The intake of diclofenac and paracetamol was assessed individually. Measurements of facial oedema, pain, and sensitivity in the lower lip/chin were obtained 1 day, 7 days, 2 months, and 6 months postoperatively. Furthermore, we investigated the possible influences of gender, age, total operating time, amount of bleeding, postoperative hospitalization, and advancement versus setback of the mandible. A significant difference (P=0.017) was observed in percentage change between the two test groups and the control group regarding facial oedema (1 day postoperatively). Less bleeding was associated with improved pain recovery over time (P=0.043). Patients who required higher postoperative dosages of analgesics due to pain had significantly delayed recovery of the inferior alveolar nerve at 6 months postoperatively (P<0.001). Betamethasone did not reduce neurosensory disturbances over time. Copyright © 2014 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

Clinical Inquiry: Is megestrol acetate safe and effective for malnourished nursing home residents?

PubMed

Wen, Frances K; Millar, James; Oberst-Walsh, Linda; Nashelsky, Joan

2018-02-01

No. Megestrol acetate (MA) is neither safe nor effective for stimulating appetite in malnourished nursing home residents. It increases the risk of deep vein thrombosis (strength of recommendation [SOR]: C, 2 retrospective chart reviews), but isn't associated with other new or worsening events or disorders (SOR: B, single randomized controlled trial [RCT]). Over a 25-week period, MA wasn't associated with increased mortality (SOR: B, single RCT). After 44 months, however, MA-treated patients showed decreased median survival (SOR: B, single case-control study). Consistent, meaningful weight gain was not observed with MA treatment (SOR: B, single case-control study, single RCT, 2 retrospective chart reviews, single prospective case-series).

Comparison of Nerve Stimulation-guided Axillary Brachial Plexus Block, Single Injection versus Four Injections: A Prospective Randomized Double-blind Study.

PubMed

Badiger, Santoshi V; Desai, Sameer N

2017-01-01

A variety of techniques have been described for the axillary block using nerve stimulator, either with single injection, two, three, or four separate injections. Identification of all the four nerves is more difficult and time-consuming than other methods. Aim of the present study is to compare success rate, onset, and duration of sensory and motor anesthesia of axillary block using nerve stimulator, either with single injection after identification of any one of the four nerves or four separate injections following identification of each of nerve. Prospective, randomized, double-blind study. Patients undergoing forearm and hand surgeries under axillary block. One hundred patients, aged 18-75 years, were randomly allocated into two groups of 50 each. Axillary block was performed under the guidance of nerve stimulator with a mixture of 18 ml of 1.5% lignocaine and 18 ml of 0.5% bupivacaine. In the first group ( n = 50), all 36 ml of local anesthetic was injected after the identification of motor response to any one of the nerves and in Group 2, all the four nerves were identified by the motor response, and 9 ml of local anesthetic was injected at each of the nerves. The success rate of the block, onset, and duration of sensory and motor block was assessed. Categorical variables were compared using the Chi-square test, and continuous variables were compared using independent t -test. The success rate of the block with four injection technique was higher compared to single-injection technique (84% vs. 56%, P = 0.02). Four injection groups had a faster onset of sensory and motor block and prolonged duration of analgesia compared to single-injection group ( P < 0.001). There were no significant differences in the incidence of accidental arterial puncture and hemodynamic parameter between the groups. Identification of all the four nerves produced higher success rate and better quality of the block when compared to single-injection technique.

Early skin-to-skin contact after cesarean section: A randomized clinical pilot study

PubMed Central

Kollmann, Martina; Aldrian, Lisa; Scheuchenegger, Anna; Mautner, Eva; Herzog, Sereina A.; Urlesberger, Berndt; Raggam, Reinhard B.; Lang, Uwe; Obermayer-Pietsch, Barbara; Klaritsch, Philipp

2017-01-01

Objective Early bonding by skin-to-skin contact (SSC) has been demonstrated to be beneficial for mothers and newborns following vaginal delivery. The aim of this study was to investigate the impact of intraoperative bonding (early SSC) after cesarean section on neonatal adaptation, maternal pain and stress response. Study design This prospective, randomized-controlled pilot study was performed at a single academic tertiary hospital (Department of Obstetrics and Gynecology, Medical University of Graz, Austria) between September 2013 and January 2014. Women were randomly assigned to intraoperative (“early”) SCC (n = 17) versus postoperative (“late”) SCC (n = 18). Main variables investigated were neonatal transition (Apgar score, arterial oxygen saturation, heart rate and temperature), maternal pain perception and both maternal and neonatal stress response by measuring the stress biomarkers salivary free cortisol and salivary alpha amylase. Results There was no evidence for differences in parameters reflecting neonatal transition or stress response between the ‘Early SSC Group’ and the ‘Late SSC Group’. Maternal salivary cortisol and alpha-amylase levels as well as maternal wellbeing and pain did not differ between the groups. However, the rise of maternal salivary alpha-amylase directly after delivery was higher in the ‘Early SSC Group’ compared to the ‘Late SSC Group’ (p = 0.004). Conclusions This study did not reveal significant risks for the newborn in terms of neonatal transition when early SSC is applied in the operating room. Maternal condition and stress marker levels did not differ either, although the rise of maternal salivary alpha-amylase directly after delivery was higher in the ‘Early SSC Group’ compared to the ‘Late SSC Group’, which may indicate a stressor sign due to intensive activation of the sympathetic-adreno-medullary-system. This needs to be further evaluated in a larger prospective randomized trial. Trial registration ClinicalTrials.gov NCT01894880 PMID:28231274

Unilateral versus bilateral neck exploration for primary hyperparathyroidism: a prospective randomized controlled trial.

PubMed

Bergenfelz, Anders; Lindblom, Pia; Tibblin, Sten; Westerdahl, Johan

2002-11-01

To compare unilateral and bilateral neck exploration for primary hyperparathyroidism in a prospective randomized controlled trial. Based on the assumption that unilateral neck exploration for a solitary parathyroid adenoma should reduce operating time and morbidity, a variety of minimally invasive procedures have challenged the idea that bilateral neck exploration is the gold standard for the surgical treatment of primary hyperparathyroidism. However, to date, no open prospective randomized trial has been published comparing unilateral and bilateral neck exploration. Ninety-one patients with the preoperative diagnosis of primary hyperparathyroidism were randomized to unilateral or bilateral neck exploration. Preoperative scintigraphy and intraoperative parathyroid hormone measurement guided the unilateral exploration. Gross morphology and frozen section determined the extent of parathyroid tissue resection in the bilateral group. The primary end-point was the use of postoperative medication for hypocalcemic symptoms. Eighty-eight patients (97%) were cured. Histology and cure rate did not differ between the two groups. Patients in the bilateral group consumed more oral calcium, had lower serum calcium values on postoperative days 1 to 4, and had a higher incidence of early severe symptomatic hypocalcemia compared with patients in the unilateral group. In addition, for patients undergoing surgery for a solitary parathyroid adenoma, unilateral exploration was associated with a shorter operative time. The cost for the two procedures did not differ. Patients undergoing a unilateral procedure had a lower incidence of biochemical and severe symptomatic hypocalcemia in the early postoperative period compared with patients undergoing bilateral exploration. Unilateral neck exploration with intraoperative parathyroid hormone assessment is a valid surgical strategy in patients with primary hyperparathyroidism with distinct advantages, especially for patients with solitary parathyroid adenoma.

Comparison between lornoxicam quick-release and parecoxib for post-operative analgesia after laparoscopic cholecystectomy: A prospective randomized, placebo-controlled trial.

PubMed

Kouroukli, Irene; Zompolas, Vasilios; Tsekoura, Vasiliki; Papazoglou, Ioannis; Louizos, Antonis; Panaretou, Venetiana

2013-10-01

Non-steroidal anti-inflammatory drugs (NSAIDs) are valuable for post-operative pain as they reduce the use of opioids. Cyclooxygenase-2 inhibitors and traditional NSAIDs can be used. This is a prospective, randomized, placebo-controlled trial to study the efficacy and the safety of the oral administration of lornoxicam quick release tablets versus intravenously administered parecoxib for the management of pain after laparoscopic cholecystectomy (LC). One hundred and eight patients, American Society of Anesthesiologists I-II, were randomized to either group A (n = 36): Lornoxicam quick-release 8 mg PO, group B (n = 36): Parecoxib 40 mg intravenous (IV) or group C (n = 36) placebo, for post-operative analgesia, 30 min before the operation and 12 and 24 h post-operatively. All patients received a standard dose of meperidine 1 mg/kg intramuscularly before the incision and post-operatively as rescue analgesia, when visual analog scale (VAS) pain score was <4. Pain at rest and on movement was assessed at 20 min, 3, 6, 12, 18 and 24 h post-operatively. Total meperidine administration and adverse events were also recorded. There were significantly lower VAS pain scores at 20 min, 3, 6, 12 and 18 h at rest or with movement in the lornoxicam quick release and parecoxib groups compared with the placebo group. The number of patients requiring rescue analgesia (meperidine) was significantly higher in the placebo group (P = 0.001). The average dose of meperidine administered was significantly higher in the placebo group, both at 20 min (P = 0.013/0.007) and 24 h (P = 0.037/0.023) post-operatively. VAS scores and meperidine requirements were similar in patients who received lornoxicam or parecoxib. Parecoxib 40 mg IV and lornoxicam quick-release 8 mg PO every 12 h are equivalent adjuvant analgesics with a greater efficacy than placebo for post-operative analgesia in patients undergoing LC.

Acquisition and retention of laparoscopic skills is different comparing conventional laparoscopic and single-incision laparoscopic surgery: a single-centre, prospective randomized study.

PubMed

Ellis, Scott Michael; Varley, Martin; Howell, Stuart; Trochsler, Markus; Maddern, Guy; Hewett, Peter; Runge, Tina; Mees, Soeren Torge

2016-08-01

Training in laparoscopic surgery is important not only to acquire and improve skills but also avoid the loss of acquired abilities. The aim of this single-centre, prospective randomized study was to assess skill acquisition of different laparoscopic techniques and identify the point in time when acquired skills deteriorate and training is needed to maintain these skills. Sixty surgical novices underwent laparoscopic surgery (LS) and single-incision laparoscopic surgery (SILS) baseline training (BT) performing two validated tasks (peg transfer, precision cutting). The novices were randomized into three groups and skills retention testing (RT) followed after 8 (group A), 10 (group B) or 12 (group C) weeks accordingly. Task performance was measured in time with time penalties for insufficient task completion. 92 % of the participants completed the BT and managed to complete the task in the required time frame of proficiency. Univariate and multivariate analyses revealed that SILS (P < 0.0001) and precision cutting (P < 0.0001) were significantly more difficult. Males performed significantly better than females (P < 0.005). For LS, a deterioration of skills (comparison of BT vs RT) was not identified; however, for SILS a significant deterioration of skills (adjustment of BT and RT values) was demonstrated for all groups (A-C) (P < 0.05). Our data reveal that complex laparoscopic tasks (cutting) and techniques (SILS) are more difficult to learn and acquired skills more difficult to maintain. Acquired LS skills were maintained for the whole observation period of 12 weeks but SILS skills had begun to deteriorate at 8 weeks. These data show that maintenance of LS and SILS skills is divergent and training curricula need to take these specifics into account.

Single incision laparoscopic surgery for appendicectomy: a retrospective comparative analysis.

PubMed

Chow, Andre; Purkayastha, Sanjay; Nehme, Jean; Darzi, Lord Ara; Paraskeva, Paraskevas

2010-10-01

Single incision laparoscopic surgery (SILS) may further reduce the trauma of surgery leading to reduced port site complications and postoperative pain. The improved cosmetic result also may lead to improved patient satisfaction with surgery. Data were prospectively collected and retrospectively analyzed for all patients who underwent SILS appendicectomy at our institution and were compared with those who had undergone conventional laparoscopic appendicectomy during the same time period. This included patient demographic data, intraoperative, and postoperative outcomes. Thirty-three patients underwent conventional laparoscopic appendicectomy and 40 patients underwent SILS appendicectomy between January 26, 2008 and July 14, 2009. Operative time was shorter with SILS appendicectomy compared with conventional laparoscopic appendicectomy (p < 0.05). No patients in the SILS appendicectomy group required conversion to open surgery compared with two patients in the conventional laparoscopic appendicectomy group. Patients stayed an average of 1.36 days after SILS appendicectomy, and 2.36 days after conventional laparoscopic appendicectomy. SILS appendicectomy seems to be a safe and efficacious technique. Further work in the form of randomized studies is required to investigate any significant advantages of this new and attractive technique.

Prospective randomized trial of 5-fluorouracil, doxorubicin, and cyclophosphamide (FAC) versus paclitaxel and FAC (TFAC) in patients with operable breast cancer: impact of taxane chemotherapy on locoregional control.

PubMed

Albert, Jeffrey M; Buzdar, Aman U; Guzman, Reina; Allen, Pamela K; Strom, Eric A; Perkins, George H; Woodward, Wendy A; Hoffman, Karen E; Tereffe, Welela; Hunt, Kelly K; Buchholz, Thomas A; Oh, Julia L

2011-07-01

A previous randomized trial (CALGB 9344/Intergroup 0148) compared four cycles of adjuvant doxorubicin/cyclophosphamide (AC) to four cycles of AC plus four cycles of paclitaxel (AC + T) and demonstrated that the addition of paclitaxel improved locoregional control (LRC) in patients with node-positive breast cancer. However, it could not be determined whether it was the paclitaxel or the increased duration of chemotherapy that led to this improvement. The present study aimed to analyze whether the addition of paclitaxel to a doxorubicin-based regimen improves LRC in a cohort of patients who all received eight total cycles of chemotherapy. Five hundred eleven women with operable breast cancer were randomized on a single-institution prospective trial to receive 5-fluorouracil, doxorubicin, cyclophosphamide (FAC) × 8 cycles (n = 252) or FAC × 4 cycles plus paclitaxel × 4 cycles (TFAC) (n = 259). Rates of LRC and overall survival (OS) were analyzed. Median follow-up was 124 months (range 5-167 months). The 10-year LRC rate was 92.6 versus 93.1% in the FAC versus TFAC arms, respectively (P = 0.26). The LRC between treatment arms did not differ when analyzed by locoregional treatment group: breast conservation therapy (BCT), mastectomy alone (M), and mastectomy + radiation (M + RT). The 10-year LRC rates were 95.1% (FAC) versus 91.2% (TFAC) after BCT (P = 0.98), 89.5% (FAC) versus 93.4% (TFAC) after M (P = 0.24), and 94.7% (FAC) versus 96.5% (TFAC) after M + RT (P = 0.59). Additionally, there was no difference in OS between the treatment arms, with 10-year OS rates of 78.4% (FAC) versus 81.7% (TFAC) (P = 0.93). The addition of paclitaxel to a doxorubicin-based regimen had no impact on LRC, regardless of the type of local therapy received. Historically inferior LRC with AC chemotherapy alone versus AC + T may have been due to an inadequate duration of systemic therapy and not due to the absence of paclitaxel.

Inhibition of surgically induced miosis and prevention of postoperative macular edema with nepafenac

PubMed Central

Cervantes-Coste, Guadalupe; Sánchez-Castro, Yuriana G; Orozco-Carroll, Mónica; Mendoza-Schuster, Erick; Velasco-Barona, Cecilio

2009-01-01

Objective: To evaluate the effectiveness of prophylactic administration of nepafenac 0.1% in maintaining mydriasis and in preventing postoperative macular edema following cataract surgery. Methods: This was a prospective, randomized, single-masked comparative study in 60 patients undergoing phacoemulsification cataract surgery. Patients were randomized to either the nepafenac or the control group. Nepafenac was administered 3 times daily 1 day before surgery and continued for 6 weeks. The control group received tobramycin-dexamethasone treatment only. Trans-operative mydriasis was measured before surgery, after nuclear emulsification, following cortex aspiration, and at the conclusion of surgery. Macular optical coherence tomography determined central foveal thickness (FT) and total macular volume (TMV) before surgery and at 2 and 6 weeks after surgery. All patients received tobramycin-dexamethasone for 2 weeks after surgery. Results: The difference in mean pupil size, at the end of surgery, between the control group (6.84 ± 0.93 mm) and the nepafenac group (7.91 ± 0.74 mm) was statistically significant (p < 0.001). There were no significant differences in FT values between the two groups at any time point; however, TMV at 2 and at 6 weeks was statistically significantly different (p < 0.001), with higher TMV in the control group. Conclusion: Prophylactic use of nepafenac was effective in reducing macular edema after cataract surgery and in maintaining trans-operative mydriasis. PMID:19668569

Prospective randomized clinical trial of a change in gastric emptying and nutritional status after a pylorus-preserving pancreaticoduodenectomy: comparison between an antecolic and a vertical retrocolic duodenojejunostomy.

PubMed

Imamura, Naoya; Chijiiwa, Kazuo; Ohuchida, Jiro; Hiyoshi, Masahide; Nagano, Motoaki; Otani, Kazuhiro; Kondo, Kazuhiro

2014-04-01

Although an antecolic duodenojejunostomy was reported to reduce post-operative delayed gastric emptying (DGE) compared with a retrocolic duodenojejunostomy after a pylorus-preserving pancreaticoduodenectomy (PPPD), the long-term effects of these procedures have rarely been studied. The aim of this prospective, randomized, clinical trial was to investigate the influence of the reconstruction route on post-operative gastric emptying and nutrition. Reconstruction was performed in 116 patients with an antecolic duodenojejunostomy (A group, n = 58) or a vertical retrocolic duodenojejunostomy (VR group, n = 58). Post-operative complications, including DGE, gastric emptying variables assessed by (13) C-acetate breath test and nutrition, were compared between the two groups for 1 year post-operatively. The incidence of DGE was not significantly different between the procedures (A group: 12.1%; VR group: 20.7%, P = 0.316). At post-operative month 1, gastric emptying was prolonged in the VR versus the A group but not significantly so. At post-operative month 6, gastric emptying was accelerated significantly in the A versus the VR group. Post-operative weight recovery was significantly better in the VR versus the A group at post-operative month 12 (percentage of pre-operative weight, A group: 93.8 ± 1.2%; VR group: 98.5 ± 1.3%, P = 0.015). A vertical retrocolic duodenojejunostomy was an acceptable procedure for the lower incidence of DGE and may contribute to better weight gain affected by moderate gastric emptying. © 2013 International Hepato-Pancreato-Biliary Association.

Prospective randomized clinical trial of a change in gastric emptying and nutritional status after a pylorus-preserving pancreaticoduodenectomy: comparison between an antecolic and a vertical retrocolic duodenojejunostomy

PubMed Central

Imamura, Naoya; Chijiiwa, Kazuo; Ohuchida, Jiro; Hiyoshi, Masahide; Nagano, Motoaki; Otani, Kazuhiro; Kondo, Kazuhiro

2014-01-01

Background Although an antecolic duodenojejunostomy was reported to reduce post-operative delayed gastric emptying (DGE) compared with a retrocolic duodenojejunostomy after a pylorus-preserving pancreaticoduodenectomy (PPPD), the long-term effects of these procedures have rarely been studied. The aim of this prospective, randomized, clinical trial was to investigate the influence of the reconstruction route on post-operative gastric emptying and nutrition. Methods Reconstruction was performed in 116 patients with an antecolic duodenojejunostomy (A group, n = 58) or a vertical retrocolic duodenojejunostomy (VR group, n = 58). Post-operative complications, including DGE, gastric emptying variables assessed by 13C-acetate breath test and nutrition, were compared between the two groups for 1 year post-operatively. Results The incidence of DGE was not significantly different between the procedures (A group: 12.1%; VR group: 20.7%, P = 0.316). At post-operative month 1, gastric emptying was prolonged in the VR versus the A group but not significantly so. At post-operative month 6, gastric emptying was accelerated significantly in the A versus the VR group. Post-operative weight recovery was significantly better in the VR versus the A group at post-operative month 12 (percentage of pre-operative weight, A group: 93.8 ± 1.2%; VR group: 98.5 ± 1.3%, P = 0.015). Conclusions A vertical retrocolic duodenojejunostomy was an acceptable procedure for the lower incidence of DGE and may contribute to better weight gain affected by moderate gastric emptying. PMID:23991719

Comparison of Radiofrequency Thermal Ablation and Microdebrider-Assisted Turbinoplasty in Inferior Turbinate Hypertrophy: A Prospective, Randomized, and Clinical Study

PubMed Central

Akagün, Fatih; İmamoğlu, Mehmet; Çobanoğlu, Hatice Bengü; Ural, Ahmet

2016-01-01

Objective To compare the effectiveness of radiofrequency thermal ablation with those of microdebrider-assisted turbinoplasty, we designed a prospective, randomized clinical study. Methods Forty patients suffering from nasal obstruction due to bilateral inferior turbinate hypertrophy were enrolled. Half of the patients were operated by radiofrequency thermal ablation, while the other half underwent microdebrider-assisted turbinoplasty. The outcomes of both techniques were compared in terms of symptomatology, nasal patency, and mucociliary transport. Results A statistically significant difference existed between the two groups with respect to nasal obstruction and the frequency of obstruction at the first post-operative week and first and third post-operative months (p<0.05). Rhinomanometry detected a significant decrease in nasal resistance values in both surgical groups compared to the preoperative values. The mucociliary transport time was significantly prolonged in the first postoperative week and first postoperative month in microdebrider-assisted inferior turbinoplasty group. Conclusion Both radiofrequency thermal ablation and microdebrider-assisted turbinoplasty are effective techniques for treating inferior turbinate hypertrophy. The treatment modality should be individually determined, and parameters such as tissue healing, volume reduction, and mucociliary activity must be taken into account. PMID:29392030

Compressed-Sensing Multi-Spectral Imaging of the Post-Operative Spine

PubMed Central

Worters, Pauline W.; Sung, Kyunghyun; Stevens, Kathryn J.; Koch, Kevin M.; Hargreaves, Brian A.

2012-01-01

Purpose To apply compressed sensing (CS) to in vivo multi-spectral imaging (MSI), which uses additional encoding to avoid MRI artifacts near metal, and demonstrate the feasibility of CS-MSI in post-operative spinal imaging. Materials and Methods Thirteen subjects referred for spinal MRI were examined using T2-weighted MSI. A CS undersampling factor was first determined using a structural similarity index as a metric for image quality. Next, these fully sampled datasets were retrospectively undersampled using a variable-density random sampling scheme and reconstructed using an iterative soft-thresholding method. The fully- and under-sampled images were compared by using a 5-point scale. Prospectively undersampled CS-MSI data were also acquired from two subjects to ensure that the prospective random sampling did not affect the image quality. Results A two-fold outer reduction factor was deemed feasible for the spinal datasets. CS-MSI images were shown to be equivalent or better than the original MSI images in all categories: nerve visualization: p = 0.00018; image artifact: p = 0.00031; image quality: p = 0.0030. No alteration of image quality and T2 contrast was observed from prospectively undersampled CS-MSI. Conclusion This study shows that the inherently sparse nature of MSI data allows modest undersampling followed by CS reconstruction with no loss of diagnostic quality. PMID:22791572

Lathosterol to cholesterol ratio in serum predicts cholesterol lowering response to plant sterol consumption in a dual center, randomized, single-blind placebo controlled trial

USDA-ARS?s Scientific Manuscript database

Benefits of plant sterols (PS) for cholesterol lowering are compromised by large variability in efficacy across individuals. High fractional cholesterol synthesis measured by deuterium incorporation has been associated with non-response to PS consumption; however, prospective studies showing this as...

Robot-assisted single-site compared with laparoscopic single-incision cholecystectomy for benign gallbladder disease: protocol for a randomized controlled trial.

PubMed

Grochola, Lukasz Filip; Soll, Christopher; Zehnder, Adrian; Wyss, Roland; Herzog, Pascal; Breitenstein, Stefan

2017-02-09

Recent advances in robotic technology suggest that the utilization of the da Vinci Single-Site™ platform for cholecystectomy is safe, feasible and results in a shorter learning curve compared to conventional single-incision laparoscopic cholecystectomy. Moreover, the robot-assisted technology has been shown to reduce the surgeon's stress load compared to standard single-incision laparoscopy in an experimental setup, suggesting an important advantage of the da Vinci platform. However, the above-mentioned observations are based solely on case series, case reports and experimental data, as high-quality clinical trials to demonstrate the benefits of the da Vinci Single-Site™ cholecystectomy have not been performed to date. This study addresses the question whether robot-assisted Single-Site™ cholecystectomy provides significant benefits over single-incision laparoscopic cholecystectomy in terms of surgeon's stress load, while matching the standards of the conventional single-incision approach with regard to peri- and postoperative outcomes. It is designed as a single centre, single-blinded randomized controlled trial, which compares both surgical approaches with the primary endpoint surgeon's physical and mental stress load at the time of surgery. In addition, the study aims to assess secondary endpoints such as operating time, conversion rates, additional trocar placement, intra-operative blood loss, length of hospital stay, costs of procedure, health-related quality of life, cosmesis and complications. Patients as well as ward staff are blinded until the 1 st postoperative year. Sample size calculation based on the results of a previously published experimental setup utilizing an estimated effect size of surgeon's comfort of 0.8 (power of 0.8, alpha-error level of 0.05, error margin of 10-15%) resulted in a number of 30 randomized patients per arm. The study is the first randomized controlled trial that compares the da Vinci Single Site™ platform to conventional laparoscopic approaches in cholecystectomy, one of the most frequently performed operations in general surgery. This trial is registered at clinicaltrials.gov (trial number: NCT02485392 ). Registered February 19, 2015.

Transforaminal lumbar interbody graft placement using an articulating delivery arm facilitates increased segmental lordosis with superior anterior and midline graft placement.

PubMed

Shau, David N; Parker, Scott L; Mendenhall, Stephen K; Zuckerman, Scott L; Godil, Saniya S; Devin, Clinton J; McGirt, Matthew J

2015-05-01

Transforaminal lumbar interbody fusion (TLIF) is a frequently performed method of lumbar arthrodesis in patients failing medical management of back and leg pain. Accurate placement of the interbody graft and restoration of lordosis has been shown to be crucial when performing lumbar fusion procedures. We performed a single-surgeon, prospective, randomized study to determine whether a novel articulating versus traditional straight graft delivery arm system allows for superior graft placement and increased lordosis for single-level TLIF. Thirty consecutive patients undergoing single-level TLIF were included and prospectively randomized to one of the 2 groups (articulated vs. straight delivery arm system). Three radiographic characteristics were evaluated at 6-week follow-up: (1) degree of segmental lumbar lordosis at the fused level; (2) the percent anterior location of the interbody graft in disk space; and (3) the distance (mm) off midline of the interbody graft placement. Randomization yielded 16 patients in the articulated delivery arm cohort and 14 in the straight delivery arm cohort. The articulating delivery arm system yielded an average of 14.7-degree segmental lordosis at fused level, 35% anterior location, and 3.6 mm off midline. The straight delivery arm system yielded an average of 10.7-degree segmental lordosis at fused level, 46% anterior location, and 7.0 mm off midline. All 3 comparisons were statistically significant (P<0.05). The study suggests that an articulating delivery arm system facilitates superior anterior and midline TLIF graft placement allowing for increased segmental lordosis compared with a traditional straight delivery arm system.

Intraoperative fluid replacement and postoperative creatine phosphokinase levels in laparoscopic bariatric patients.

PubMed

Wool, Daniel B; Lemmens, Harry J M; Brodsky, Jay B; Solomon, Houman; Chong, Karen P; Morton, John M

2010-06-01

Morbid obesity and bariatric surgery are both risk factors for the development of postoperative rhabdomyolysis (RML). RML results from injury to skeletal muscle, and a serum creatine phosphokinase (CK) level >1,000 IU/L is considered diagnostic of RML. The aim of this study was to determine if intraoperative intravenous fluid (IVF) volume affects postoperative CK levels following laparoscopic bariatric operations. Prospective, single blinded, and randomized trial was conducted. Patients scheduled to undergo laparoscopic sleeve gastrectomy, adjustable gastric band, or Roux-en-Y gastric bypass operations were randomized into two groups. Subjects in Group A received 15 ml/kg total body weight (TBW) of IV crystalloid solution during surgery, while subjects in Group B received 40 ml/kg TBW. Preoperative and postoperative CK and creatinine levels and intra- and postoperative urine output were monitored and recorded. Forty-seven patients were assigned to Group A and 53 patients to Group B. Group B patients had significantly higher urine output in the operating room, in the post-anesthesia care unit (PACU), and on postoperative days 0 and 1. Group B patients also had significantly lower serum creatinine level in the PACU and a trend towards lower creatinine levels on postoperative days 0, 1, and 2. There were no statistical differences in CK levels at any time between the two groups. Four patients in Group A and three patients in Group B developed postoperative RML. Conservative (15 ml/kg) versus liberal (40 ml/kg) intraoperative IVF administration did not change the incidence of RML in patients undergoing laparoscopic bariatric operations. Since the occurrence of RML in this patient population is relatively high, postoperative CK levels should be routinely obtained in patients at special risk.

Asymmetrically dominated choice problems, the isolation hypothesis and random incentive mechanisms.

PubMed

Cox, James C; Sadiraj, Vjollca; Schmidt, Ulrich

2014-01-01

This paper presents an experimental study of the random incentive mechanisms which are a standard procedure in economic and psychological experiments. Random incentive mechanisms have several advantages but are incentive-compatible only if responses to the single tasks are independent. This is true if either the independence axiom of expected utility theory or the isolation hypothesis of prospect theory holds. We present a simple test of this in the context of choice under risk. In the baseline (one task) treatment we observe risk behavior in a given choice problem. We show that by integrating a second, asymmetrically dominated choice problem in a random incentive mechanism risk behavior can be manipulated systematically. This implies that the isolation hypothesis is violated and the random incentive mechanism does not elicit true preferences in our example.

What Is the Outcome of an Incision and Drainage Procedure in Endodontic Patients? A Prospective, Randomized, Single-blind Study.

PubMed

Beus, Hannah; Fowler, Sara; Drum, Melissa; Reader, Al; Nusstein, John; Beck, Mike; Jatana, Courtney

2018-02-01

There are no prospective endodontic studies to determine the outcome of an incision and drainage (I&D) procedure for swelling in healthy, endodontic patients. The purpose of this prospective, randomized, single-blind study was to compare the postoperative course of I&D with drain placement versus a mock I&D procedure with mock drain placement after endodontic debridement in swollen emergency patients with symptomatic teeth and a pulpal diagnosis of necrosis. Eighty-one adult emergency patients presenting with clinical swelling received either penicillin or, if allergic, clindamycin and complete endodontic debridement, and then were randomly divided into 2 treatment groups: I&D with drain placement or a mock I&D procedure with mock drain placement. At the end of the appointment, all patients received a combination of ibuprofen/acetaminophen and, if needed, an opioid-containing escape medication. Patients recorded their pain and medication use for 4 days postoperatively. Success was defined as no or mild postoperative pain and no use of an opioid-containing escape medication. Success was evaluated using repeated measure mixed model logistic regression. Both groups had a decrease in postoperative pain and medication use over the 4 days. The mock I&D group had significantly higher success than the I&D group (odds ratio = 2.00; 95% confidence interval, 1.16-3.41). The success rate was 45% with the mock I&D and 33% with the I&D. After endodontic debridement, patients who received a mock I&D procedure with mock drain placement had more success than patients who received I&D with drain placement. Both groups clinically improved over 4 days. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

A single dose of erythropoietin reduces perioperative transfusions in cardiac surgery: results of a prospective single-blind randomized controlled trial.

PubMed

Weltert, Luca; Rondinelli, Beatrice; Bello, Ricardo; Falco, Mauro; Bellisario, Alessandro; Maselli, Daniele; Turani, Franco; De Paulis, Ruggero; Pierelli, Luca

2015-07-01

We conducted a prospective single-blind randomized study to assess whether a single 80,000 IU dose of human recombinant erythropoietin (HRE), given just 2 days before cardiac surgery, could be effective in reducing perioperative allogeneic red blood cell transfusion (aRBCt). Six-hundred patients presenting with preoperative hemoglobin (Hb) level of not more than 14.5 g/dL were randomly assigned to either HRE or control. The primary endpoint was the incidence of perioperative aRBCt. The secondary endpoints were mortality and the incidence of adverse events in the first 45 days after surgery, Hb level on Postoperative Day 4, and number of units of RBC transfusions in the first 4 days after surgery. A total of 17% (HRE) versus 39% (control) required transfusion (relative risk, 0.436; p<0.0005). After baseline Hb was controlled for, there was no difference in the incidence of aRBCt between HRE (0%) and control (3.5%) among the patients with baseline Hb of 13.0 g/dL or more, which included the nonanemic fraction of the study population. The mean (range) Hb level on Postoperative Day 4 was 10.2 (9.9-10.6) g/dL (HRE) versus 8.7 (8.5-9.2) g/dL (control; p<0.0005). The distribution of number of units transfused was shifted toward fewer units in HRE (p<0.0005). The all-cause mortality at 45 days was 3.00% (HRE) versus 3.33% (control). The 45-day adverse event rate was 4.33% (HRE) versus 5.67% (control; both p=NS). In anemic patients (Hb<13 g/dL), a single high dose of HRE administered 2 days before cardiac surgery is effective in reducing the incidence of aRBCt without increasing adverse events. © 2015 AABB.

Double-layer versus single-layer bone-patellar tendon-bone anterior cruciate ligament reconstruction: a prospective randomized study with 3-year follow-up.

PubMed

Mei, Xiaoliang; Zhang, Zhenxiang; Yang, Jingwen

2016-12-01

To evaluate the clinical results of a randomized controlled trial of single-layer versus double-layer bone-patellar tendon-bone (BPTB) anterior cruciate ligament (ACL) reconstruction. Fifty-eight subjects who underwent primary ACL reconstruction with a BPTB allograft were prospectively randomized into two groups: single-layer reconstruction (n = 31) and double-layer reconstruction (n = 27). The following evaluation methods were used: clinical examination, KT-1000 arthrometer measurement, muscle strength, Tegner activity score, Lysholm score, subjective rating scale regarding patient satisfaction and sports performance level, graft retear, contralateral ACL tear, and additional meniscus surgery. Forty-eight subjects (24 in single-layer group and 24 in double-layer group) who were followed up for 3 years were evaluated. Preoperatively, there were no differences between the groups. At 3-year follow-up, the Lachman and pivot-shift test results were better in the double-layer group (P = 0.019 and P < 0.0001, respectively). KT measurements were better in the double-layer group (mean 2.9 versus 1.5 mm; P = 0.0025). The Tegner score was also better in the double-layer group (P = 0.024). There were no significant differences in range of motion, muscle strength, Lysholm score, subjective rating scale, graft retear, and secondary meniscal tear. In ACL reconstruction, double-layer BPTB reconstruction was significantly better than single-layer reconstruction regarding anterior and rotational stability at 3-year follow-up. The results of KT measurements and the Lachman and pivot-shift tests were significantly better in the double-layer group, whereas there was no difference in the anterior drawer test results. The Tegner score was also better in the double-layer group; however, there were no differences in the other subjective findings.

Complications and Adverse Events of a Randomized Clinical Trial Comparing 3 Graft Types for ACL Reconstruction.

PubMed

Mohtadi, Nicholas; Barber, Rhamona; Chan, Denise; Paolucci, Elizabeth Oddone

2016-05-01

Complications/adverse events of anterior cruciate ligament (ACL) surgery are underreported, despite pooled level 1 data in systematic reviews. All adverse events/complications occurring within a 2-year postoperative period after primary ACL reconstruction, as part of a large randomized clinical trial (RCT), were identified and described. Prospective, double-blind randomized clinical trial. Patients and the independent trained examiner were blinded to treatment allocation. University-based orthopedic referral practice. Three hundred thirty patients (14-50 years; 183 males) with isolated ACL deficiency were intraoperatively randomized to ACL reconstruction with 1 autograft type. Graft harvest and arthroscopic portal incisions were identical. Patients were equally distributed to patellar tendon (PT), quadruple-stranded hamstring tendon (HT), and double-bundle (DB) hamstring autograft ACL reconstruction. Adverse events/complications were patient reported, documented, and diagnoses confirmed. Two major complications occurred: pulmonary embolism and septic arthritis. Twenty-four patients (7.3%) required repeat surgery, including 25 separate operations: PT = 7 (6.4%), HT = 9 (8.2%), and DB = 8 (7.3%). Repeat surgery was performed for meniscal tears (3.6%; n = 12), intra-articular scarring (2.7%; n = 9), chondral pathology (0.6%; n = 2), and wound dehiscence (0.3%; n = 1). Other complications included wound problems, sensory nerve damage, muscle tendon injury, tibial periostitis, and suspected meniscal tears and chondral lesions. Overall, more complications occurred in the HT/DB groups (PT = 24; HT = 31; DB = 45), but more PT patients complained of moderate or severe kneeling pain (PT = 17; HT = 9; DB = 4) at 2 years. Overall, ACL reconstructive surgery is safe. Major complications were uncommon. Secondary surgery was necessary 7.3% of the time for complications/adverse events (excluding graft reinjury or revisions) within the first 2 years. Level 1 (therapeutic studies). This article reports on the complications/adverse events that were prospectively identified up to 2 years postoperatively, in a defined patient population participating in a large double-blind randomized clinical trial comparing PT, single-bundle hamstring, and DB hamstring reconstructions for ACL rupture.

Single-electron random-number generator (RNG) for highly secure ubiquitous computing applications

NASA Astrophysics Data System (ADS)

Uchida, Ken; Tanamoto, Tetsufumi; Fujita, Shinobu

2007-11-01

Since the security of all modern cryptographic techniques relies on unpredictable and irreproducible digital keys generated by random-number generators (RNGs), the realization of high-quality RNG is essential for secure communications. In this report, a new RNG, which utilizes single-electron phenomena, is proposed. A room-temperature operating silicon single-electron transistor (SET) having nearby an electron pocket is used as a high-quality, ultra-small RNG. In the proposed RNG, stochastic single-electron capture/emission processes to/from the electron pocket are detected with high sensitivity by the SET, and result in giant random telegraphic signals (GRTS) on the SET current. It is experimentally demonstrated that the single-electron RNG generates extremely high-quality random digital sequences at room temperature, in spite of its simple configuration. Because of its small-size and low-power properties, the single-electron RNG is promising as a key nanoelectronic device for future ubiquitous computing systems with highly secure mobile communication capabilities.

Impact of Microscope-Integrated OCT on Ophthalmology Resident Performance of Anterior Segment Surgical Maneuvers in Model Eyes.

PubMed

Todorich, Bozho; Shieh, Christine; DeSouza, Philip J; Carrasco-Zevallos, Oscar M; Cunefare, David L; Stinnett, Sandra S; Izatt, Joseph A; Farsiu, Sina; Mruthyunjaya, Privthi; Kuo, Anthony N; Toth, Cynthia A

2016-07-01

The integration of swept-source optical coherence tomography (SS-OCT) into the operating microscope enables real-time, tissue-level three-dimensional (3D) imaging to aid in ophthalmic microsurgery. In this prospective randomized controlled study, we evaluated the impact of SS microscope-integrated OCT (MI-OCT) on ophthalmology residents' performance of ophthalmic microsurgical maneuvers. Fourteen ophthalmology residents from a single institution were stratified by year of training and randomized to perform four anterior segment surgical maneuvers on porcine eyes with (MI-OCT+) or without (MI-OCT-) direct intraoperative OCT guidance. Subsequently, both groups repeated the same maneuvers without MI-OCT feedback to test whether initial MI-OCT experience affected subsequent surgical performance. Finally, the MI-OCT- group was crossed over and allowed to repeat the same maneuvers with direct MI-OCT guidance. Each resident completed a survey at the completion of the study. With direct MI-OCT feedback, residents demonstrated enhanced performance in depth-based anterior segment maneuvers (corneal suture passes at 50% and 90% depth and corneal laceration repair) compared with the residents operating without MI-OCT. Microscope-integrated OCT+ residents continued to outperform the controls when both groups subsequently operated without MI-OCT. For clear corneal wound geometry, there was no statistically significant effect of MI-OCT as applied in this study. Overall, the resident surgeons rated their subjective experience of using MI-OCT very favorably. Microscope-integrated OCT feedback enhances performance of ophthalmology residents in select anterior segment surgical maneuvers. Microscope-integrated OCT represents a valuable tool in the surgical education of ophthalmology residents.

Continuous passive motion and physical therapy (CPM) versus physical therapy (PT) versus delayed physical therapy (DPT) after surgical release for elbow contractures; a study protocol for a prospective randomized controlled trial.

PubMed

Viveen, Jetske; Doornberg, Job N; Kodde, Izaak F; Goossens, Pjotr; Koenraadt, Koen L M; The, Bertram; Eygendaal, Denise

2017-11-22

The elbow is prone to stiffness after trauma. To regain functional elbow motion several conservative- and surgical treatment options are available. Conservative treatment includes physical therapy, intra-articular injections with corticosteroids and a static progressive or dynamic splinting program. If conservative treatment fails, an operative release of the posttraumatic stiff elbow is often performed. The best Evidence-Based rehabilitation protocol for patients after an operative release is unknown to date and differs per surgeon, hospital and country. Options include early- or delayed motion supervised by a physical therapist, immediate continuous passive motion (CPM), (night) splinting and a static progressive or dynamic splinting program. The SET-Study (Stiff Elbow Trial) is a single-centre, prospective, randomized controlled trial. The primary objective of this study is to compare the active Range of Motion (ROM) (flexion arc and rotational arc) twelve months after surgery between three groups. The first group will receive in-hospital CPM in combination with early motion Physical Therapy (PT) supervised by a physical therapist, the second group will receive only in-hospital early motion PT supervised by a physical therapist and the third group will receive outpatient supervised PT from postoperative day seven till ten. Secondary outcome measures will be Patient Reported Outcome Measures (PROMs) including the Mayo Elbow Performance Score (MEPS), the Oxford Elbow Score (OES), the quick Disabilities of Arm, Shoulder and Hand (qDASH) score, Visual Analogue pain Scale in rest and activity (VAS), Pain Catastrophizing Scale (PCS), the Short Form (SF)-36, the Centre for Epidemiological Studies Depression Scale Revised (CESD-R) and the Work Rehabilitation Questionnaire (WORQ) for the upper limb. A successful completion of this trial will provide evidence on the best rehabilitation protocol in order to (re)gain optimal motion after surgical release of the stiff elbow. The trial is registered at the Dutch Trial Register: NTR6067 , 31-8-2016.

Postoperative pain after foraminal enlargement in anterior teeth with necrosis and apical periodontitis: a prospective and randomized clinical trial.

PubMed

Silva, Emmanuel João Nogueira Leal; Menaged, Karyne; Ajuz, Natasha; Monteiro, Maria Rachel Figueiredo Penalva; Coutinho-Filho, Tauby de Souza

2013-02-01

The aim of this randomized, controlled, prospective clinical study was to determine if foraminal enlargement instrumentation during endodontic treatment is associated with more postoperative pain compared with standard nonenlargement instrumentation. Forty volunteers with a single root canal were diagnosed with asymptomatic necrosis with apical periodontitis and randomized into 2 experimental groups (ie, the control group and the foraminal enlargement group). Endodontic treatment was performed in a single visit, and volunteers were instructed to record pain intensity (ie, none, slight, moderate, and severe). Scores from 1 to 4 were attributed to each kind of pain after 12, 24, and 48 hours. The Kolmogorov-Smirnov and Student's t tests were used to determine significant differences at P < .05. No statistically significant age difference was found between the groups (P > .05, Student's t test). Postoperative pain showed no statistically significant difference between the groups at any observation period (P > .05). Also, no significant difference was observed in the mean number of analgesic tablets used between the groups (P > .05). The foraminal enlargement and nonenlargement techniques resulted in the same postoperative pain and necessity for analgesic medication. This may suggest that the use of foraminal enlargement should be performed for endodontic treatment previsibility without increasing postoperative pain. Copyright © 2013 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

Staple Line Reinforcement During Laparoscopic Sleeve Gastrectomy: Absorbable Monofilament, Barbed Suture, Fibrin Glue, or Nothing? Results of a Prospective Randomized Study.

PubMed

Carandina, S; Tabbara, M; Bossi, M; Valenti, A; Polliand, C; Genser, L; Barrat, Christophe

2016-02-01

Laparoscopic sleeve gastrectomy (LSG) is associated with serious complications, such as staple line (SL) leaks and bleeding. In order to prevent the occurrence of these complications, surgeons have advocated the need to strengthen the staple line. The aim of this randomized controlled study was to compare the efficacy of three different ways of strengthening of the SL in LSG in preventing surgical post-operative complications. Between April 2012 and December 2014, 600 patients (pts) scheduled for LSG were prospectively randomized into groups without SL reinforcement (group A) or with SL reinforcement including fibrin glue coverage (group B), or oversewn SL with imbricating absorbable (Monocryl™; group C) or barbed (V lock®) running suture (group D). Primary endpoints were post-operative leaks, bleeding, and stenosis, while secondary outcomes consisted of the time to perform the staple line reinforcement (SLR) and total operative time. Mean SLR operative time was lower for group B (3.4 ± 1.3 min) compared with that for groups C (26.8 ± 8.5 min) and D (21.1 ± 8.4 min) (p < 0.0001). Mean total operative time was 100.7 ± 16.4 min (group A), 104.4 ± 22.1 min (group B), 126.2 ± 18.9 min (group C), and 124.6 ± 22.8 (group D) (p < 0.0001). Post-operative leaks, bleeding, and stenosis were recorded in 14 pts (2.3 %), 5 pts (0.8 %), and 7 pts (1.1 %), respectively, without statistical difference between the groups. Our study suggests that SLR during LSG, with an imbricating or non-imbricating running suture or with fibrin glue, is an unrewarding surgical act with the sole effect of prolonging the operative time.

Multimodal treatment with primary single-agent epirubicin in operable breast cancer: 5-year experience of the Michelangelo Cooperative Group.

PubMed

Bonadonna, G; Zambetti, M; Bumma, C; Donadio, M; Bolognesi, A; Robustelli Della Cuna, G; Ambrosini, G; Lelli, G; Mansutti, M; Verderio, P; Valagussa, P

2002-07-01

To assess the efficacy of primary single-agent epirubicin (120 mg/m(2) every 3 weeks for three cycles) in reducing tumor burden in operable breast cancer >or=2.5 cm in largest diameter at diagnosis and its effect on the rate of conservative surgery. A total of 319 eligible patients, who were all candidates for mastectomy, were enrolled on to a multicenter prospective non-randomized study. Tumor response was assessed clinically and pathologically. Relapse-free and overall survival were assessed on major prognostic variables. After primary epirubicin, complete disappearance of invasive neoplastic cells accounted for only 2.6% of patients, but 40% of patients had their primary tumor downstaged to

Bioactive glass granules: a suitable bone substitute material in the operative treatment of depressed lateral tibial plateau fractures: a prospective, randomized 1 year follow-up study.

PubMed

Heikkilä, Jouni T; Kukkonen, Juha; Aho, Allan J; Moisander, Susanna; Kyyrönen, Timo; Mattila, Kimmo

2011-04-01

Purpose of this study was to compare bioactive glass and autogenous bone as a bone substitute material in tibial plateau fractures. We designed a prospective, randomized study consisting of 25 consecutive operatively treated patients with depressed unilateral tibial comminuted plateau fracture (AO classification 41 B2 and B3).14 patients (7 females, 7 males, mean age 57 years, range 25-82) were randomized in the bioglass group (BG) and 11 patients (6 females, 5 males, mean age 50 years, range 31-82) served as autogenous bone control group (AB). Clinical examination of the patients was performed at 3 and 12 months, patients' subjective and functional results were evaluated at 12 months. Radiological analysis was performed preoperatively, immediately postoperatively and at 3 and 12 months. The postoperative redepression for both studied groups was 1 mm until 3 months and remained unchanged at 12 months. No differences were identified in the subjective evaluation, functional tests and clinical examination between the two groups during 1 year follow-up. We conclude that bioactive glass granules can be clinically used as filler material instead of autogenous bone in the lateral tibial plateau compression fractures.

Clinical comparison between open plating and minimally invasive plate osteosynthesis for displaced proximal humeral fractures: A prospective randomized controlled trial.

PubMed

Sohn, Hoon-Sang; Jeon, Yoon Sang; Lee, JuHan; Shin, Sang-Jin

2017-06-01

Recently, minimally invasive plate osteosynthesis (MIPO) has been widely used for the treatment of proximal humeral fractures. However, there is concern about whether the MIPO in comminuted proximal humeral fractures is also comparable to open plating. The purpose of this study was to compare the clinical and radiographic outcomes of open plating and MIPO for acute displaced proximal humeral fractures. In this prospective, randomized controlled study, 107 patients who had an acute proximal humeral fracture were randomized to either the open plating or MIPO techniques. Forty-five patients treated with open plating and 45 with the MIPO technique who were followed up at least 1year were evaluated. Shoulder functional assessment, operating time, several radiographic parameters, and complications were evaluated at final follow-up. The mean follow-up period was 15.0 months in the open plating and 14.3 months in the MIPO technique. There were no statistically significant differences in functional assessment scores and radiographic parameters between the two groups. High complications rates were found in 4-part fracture in both surgical methods The average operation time in the MIPO group were significantly lower compared to the open plating group (p<0.05). This study showed MIPO in proximal humerus fractures had similar clinical and radiographic outcomes compared to the open plating. However, the MIPO technique in proximal humerus fracture provided significantly shorter operation time than the open plating. Copyright © 2017 Elsevier Ltd. All rights reserved.

Comparison of manual and mechanical cervical esophagogastric anastomosis after esophageal resection for squamous cell carcinoma: a prospective randomized controlled trial.

PubMed

Hsu, Hsao-Hsun; Chen, Jin-Shing; Huang, Pei-Ming; Lee, Jang-Ming; Lee, Yung-Chie

2004-06-01

The use of a circular stapler in cervical esophagogastric anastomosis remains controversial. This study was to compare the postoperative and long-term results of manual and mechanical techniques for cervical esophagogastric anastomosis after resection for squamous cell carcinoma. A prospective randomized controlled trial was undertaken in 63 patients with curatively resectable squamous cell cancer of the thoracic esophagus between 1996 and 1999. Patients were randomized to receive either a hand-sewn (32 patients) or circular stapled (31 patients) cervical esophagogastric anastomosis. The mean operating time was longer when the hand-sewn method was used (524 vs. 447 min, P < 0.001). Anastomotic leakage was noted in seven patients (22%) in the hand-sewn group and eight patients (26%) in the stapler group (P = NS). Hospital mortality occurred in four patients (13%) of the hand-sewn group and in three patients (10%) of the stapler group (P = NS). After the operation, four patients (14%) in the hand-sewn group and five patients (18%) in the stapler group developed a benign esophageal stricture (P = NS). The mean follow-up time was 24 months, and the rates of freedom from benign stricture and survival were comparable in each group. Performing cervical esophagogastric anastomoses using a circular mechanical stapler had a shorter operating time and a comparable outcome to the hand-sewn method. The circular mechanical stapler could be used as an alternative for cervical esophagogastric anastomosis after resection for esophageal squamous cell cancer.

Comparison of visual evoked potential monitoring during spine surgeries under total intravenous anesthesia versus balanced general anesthesia.

PubMed

Uribe, Alberto A; Mendel, Ehud; Peters, Zoe A; Shneker, Bassel F; Abdel-Rasoul, Mahmoud; Bergese, Sergio D

2017-10-01

To determine the comparison of its clinical utility and safety profile for visual evoked potential (VEP) monitoring during prone spine surgeries under total intravenous anesthesia (TIVA) versus balanced general anesthesia using the SightSaver™ visual stimulator. The protocol was designed asa pilot, single center, prospective, randomized, and double-arm study. Subjects were randomized to receive either TIVA or balanced general anesthesia. Following induction and intubation, 8 electrodes were placed subcutaneously to collect VEP recordings. The SightSaver™ visual stimulator was placed on the subject's scalp before prone positioning. VEP waveforms were recorded every 30min and assessed by a neurophysiologist throughout the length of surgery. A total of 19 subjects were evaluated and VEP waveforms were successfully collected. TIVA group showed higher amplitude and lower latency than balanced anesthesia. Our data suggested that TIVA is associated with higher VEP amplitude and shorter latencies than balanced general anesthesia; therefore, TIVA could be the most efficient anesthesia regimen for VEP monitoring. The findings help to better understand the effect of different anesthesia regimens on intra-operative VEP monitoring. Copyright © 2017 International Federation of Clinical Neurophysiology. Published by Elsevier B.V. All rights reserved.

Informed consent: do information pamphlets improve post-operative risk-recall in patients undergoing total thyroidectomy: prospective randomized control study.

PubMed

Alsaffar, Hussain; Wilson, Lindsay; Kamdar, Dev P; Sultanov, Faizullo; Enepekides, Danny; Higgins, Kevin M

2016-02-13

Informed consent consists of basic five elements: voluntarism, capacity, disclosure, understanding, and ultimate decision-making. Physician disclosure, patient understanding, and information retention are all essential in the doctor-patient relationship. This is inclusive of helping patients make and manage their decisions and expectations better and also to deal with any consequences and/or complications that arise. This study investigates whether giving patients procedure-specific handouts pre-operatively as part of the established informed consent process significantly improves overall risk-recall following surgery. These handouts outline the anticipated peri-operative risks and complications associated with total thyroidectomy, as well as the corrective measures to address complications. In addition, the influence of potential confounders affecting risk-recall, such as anxiety and pre-existing memory disturbance, are also examined. Consecutive adult (≥18 years old) patients undergoing total thyroidectomy at a single academic tertiary care referral centre are included. Participants are randomly assigned into either the experimental group (with pamphlets) or the control group by a computerized randomization system (Clinstat). All participants filled out a Hospital Anxiety and Depression Scale (HADS) and they are tested by the physician for short-term memory loss using the Memory Impairment Screen (MIS) exam. All patients are evaluated at one week post-operatively. The written recall questionnaire test is also administered during this clinical encounter. Forty-nine patients are included--25 of them receive verbal consent only, while another 24 patients received both verbal consent and patient education information pamphlets. The overall average of correct answers for each group was 83% and 80% in the control and intervention groups, respectively, with no statistically significant differences. There are also no statistically significant differences between the two groups, in both interview duration, in time between interviews, and in recall tests. No correlation is also apparent between the pre-op HADS score and the recall questionnaire overall score. A pre-operative thyroid surgical information pamphlet alone might not be sufficient to enhance patient test scores and optimally educate the patient on their expected care pathway in thyroid surgery. Supplementation with alternative means of patient education perhaps using emerging technologies needs to be further investigated.

Efficacy of Single-dose and 2-dose Intravenous Administration of Ramosetron in Preventing Postoperative Nausea and Vomiting After Laparoscopic Gynecologic Operation: A Randomized, Double-blind, Placebo-controlled, Phase 2 Trial.

PubMed

Lee, Banghyun; Kim, Kidong; Suh, Dong Hoon; Shin, Hyun-Jung; No, Jae Hong; Lee, Jung Ryeol; Jee, Byung Chul; Hwang, Jung Won; Do, Sang Hwan; Kim, Yong Beom

2017-06-01

This randomized trial investigated whether a 2-dose administration of intravenous ramosetron (5-hydroxytryptamine type 3 receptor antagonist) is more effective than a single-dose administration in preventing postoperative nausea and vomiting (PONV) in 89 patients who were scheduled to undergo laparoscopic operation for benign gynecologic diseases and to receive intravenous patient-controlled analgesia for relief of postoperative pain. After assignment at a ratio of 1:1, intravenous ramosetron (0.3 mg) was initially administered at the end of skin closure in all patients. Thereafter, ramosetron (0.3 mg) and placebo were administered to the study and control groups, respectively, at 4 hours after the operation. The baseline and operative characteristics were similar between the groups. The incidence of PONV during the 24-hour period after operation which was assessed as the primary endpoint did not differ between the groups. No serious adverse events occurred in either group. A 2-dose administration of intravenous ramosetron may not be superior to a single-dose administration in preventing PONV in patients undergoing laparoscopic operation for benign gynecologic diseases.

Analgesic efficacy of ultrasound guided transversus abdominis plane block versus local anesthetic infiltration in adult patients undergoing single incision laparoscopic cholecystectomy: A randomized controlled trial.

PubMed

Bava, Ejas P; Ramachandran, Rashmi; Rewari, Vimi; Chandralekha; Bansal, Virinder Kumar; Trikha, Anjan

2016-01-01

Transversus abdominis plane (TAP) block has been used to provide intra- and post-operative analgesia with single incision laparoscopic (SIL) bariatric and gynecological surgery with mixed results. Its efficacy in providing analgesia for SIL cholecystectomy (SILC) via the same approach remains unexplored. The primary objective of our study was to compare the efficacy of bilateral TAP block with local anesthetic infiltration for perioperative analgesia in patients undergoing SILC. This was a prospective, randomized, controlled, double-blinded trial performed in a tertiary care hospital. Forty-two patients undergoing SILC were randomized to receive either ultrasound-guided (USG) bilateral mid-axillary TAP blocks with 0.375% ropivacaine or local anesthetic infiltration of the port site. The primary outcome measure was the requirement of morphine in the first 24 h postoperatively. The data were analyzed using t -test, Mann-Whitney test or Chi-square test. The 24 h morphine requirement (mean ± standard deviation) was 34.57 ± 14.64 mg in TAP group and 32.76 ± 14.34 mg in local infiltration group ( P = 0.688). The number of patients requiring intraoperative supplemental fentanyl in TAP group was 8 and in local infiltration group was 16 ( P = 0.028). The visual analog scale scores at rest and on coughing were significantly higher in the local infiltration group in the immediate postoperative period ( P = 0.034 and P = 0.007, respectively). USG bilateral TAP blocks were not effective in decreasing 24 h morphine requirement as compared to local anesthetic infiltration in patients undergoing SILC although it provided some analgesic benefit intraoperatively and in the initial 4 h postoperatively. Hence, the benefits of TAP blocks are not worth the effort and time spent for administering them for this surgery.

Postoperative pain after conventional laparoscopic versus single-port sleeve gastrectomy: a prospective, randomized, controlled pilot study.

PubMed

Morales-Conde, Salvador; Del Agua, Isaías Alarcón; Moreno, Antonio Barranco; Macías, María Socas

2017-04-01

Laparoscopic approach is the gold standard for surgical treatment of morbid obesity. The single-port (SP) approach has been demonstrated to be a safe and effective technique for the treatment of morbid obesity in several case control studies. Compare conventional multiport laparoscopy (LAP) with an SP approach for the treatment of morbid obesity using sleeve gastrectomy in terms of postoperative pain using a visual analog scale (VAS) 0-100, surgical outcome, weight loss, and aesthetical satisfaction at 6 months after surgery. University Hospital, Spain. Randomized, controlled pilot study. The trial enrolled patients suitable for bariatric surgery, with a body mass index lower than 50 kg/m 2 and xiphoumbilical distance lower than 25 cm. Patients were randomly assigned to receive LAP or SP sleeve gastrectomy. A total of 30 patients were enrolled; 15 were assigned to LAP group and 15 to SP group. No patients were lost during follow-up. Baseline characteristics were similar in both groups. A significantly higher level of pain during movement was noted for the patients in the LAP group on the first (mean VAS 49.3±12.2 versus 34.1±8.9, P = .046) and second days (mean VAS 35.9±10.2 versus 22.1±7.9, P = .044) but not the third day (mean VAS 20.1±5.2 versus 34.12.9 ±4.3, P = .620). No differences regarding pain at rest, operative time, complications, or weight loss at 6 months were observed. Higher aesthetical satisfaction was noticed in SP group. In selected patients, SP surgery presented less postoperative pain in sleeve gastrectomy compared with the conventional laparoscopic approach with similar surgical results. Copyright © 2017 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

Ankle Block vs Single-Shot Popliteal Fossa Block as Primary Anesthesia for Forefoot Operative Procedures: Prospective, Randomized Comparison.

PubMed

Schipper, Oliver N; Hunt, Kenneth J; Anderson, Robert B; Davis, W Hodges; Jones, Carroll P; Cohen, Bruce E

2017-11-01

Postoperative pain is often difficult to control with oral medications, requiring large doses of opioid analgesia. Regional anesthesia may be used for primary anesthesia, reducing the need for general anesthetic and postoperative pain medication requirements in the immediate postoperative period. The purpose of this study was to compare the analgesic effects of an ankle block (AB) to a single-shot popliteal fossa block (PFB) for patients undergoing orthopedic forefoot procedures. All patients having elective outpatient orthopedic forefoot procedures were invited to participate in the study. Patients were prospectively randomized to receive either an ultrasound-guided AB or PFB by a board-certified anesthesiologist prior to their procedure. Intraoperative conversion to general anesthesia and postanesthesia care unit (PACU) opioid requirements were recorded. Postoperative pain was assessed using the visual analog scale (VAS) at regular time intervals until 8 am on postoperative day (POD) 2. Patients rated the effectiveness of the block on a 1 to 5 scale, with 5 being very effective. A total of 167 patients participated in the study with 88 patients (53%) receiving an AB and 79 (47%) receiving a single-shot PFB. There was no significant difference in the rate of conversion to general anesthesia between the 2 groups (13.6% [12/88] AB vs 12.7% [10/79] PFB). PACU morphine requirements and doses were significantly reduced in the PFB group ( P = .004) when compared to the AB group. The VAS was also significantly lower for the PFB patients at 10 pm on POD 0 (4.6 vs 1.6, P < .001), 8 am on POD 1 (5.9 vs 4.2, P = .003), and 12 pm on POD 1 (5.4 vs 4.1, P = .01). Overall complication rates were similar between the groups (AB 9% vs PFB 10.1%, P = .51) and there were no significant differences in residual sensory paresthesias (AB 2.3% [2/88] vs PFB 5.1% [4/79], P = .29), motor loss (0% vs 0%), or block site pain and/or erythema (AB 6.9% [6/88] vs PFB 5.1% [4/79], P = .44). The analgesic effect of the PFB lasted significantly longer when compared to the ankle block (AB 14.5 hours vs PFB 20.9 hours, P < .001). There was no significant difference in patient-perceived effectiveness of the block between the 2 groups, with both blocks being highly effective (AB 4.79/5 vs PFB 4.82/5, P = .68). Regional anesthesia was a safe and reliable adjunct to perioperative pain management and highly effective in patients undergoing elective orthopedic forefoot procedures. However, patients who received a PFB had significantly better pain management and decreased opioid requirements in the immediate perioperative period than patients who received an ankle block. Level I, prospective randomized study.

To assess the efficacy of socket plug technique using platelet rich fibrin with or without the use of bone substitute in alveolar ridge preservation: a prospective randomised controlled study.

PubMed

Girish Kumar, N; Chaudhary, Rupanzal; Kumar, Ish; Arora, Srimathy S; Kumar, Nilesh; Singh, Hem

2018-06-01

The purpose of this study is to evaluate the efficacy of Platelet Rich Fibrin (PRF) as a socket plug with or without use of Plaster of Paris (POP) as bone substitute to preserve the alveolar ridge post-extraction. A prospective randomised single blind controlled study, was conducted for 18 months from November 2014 to May 2016 on 48 patients requiring extraction. All teeth were extracted atraumatically using periotomes and luxators without raising mucoperiosteal flap. Sockets were randomly allotted to groups A, B and C. Group A sockets were chosen as control, where figure of eight suture was placed. In group B sockets, PRF obtained by centrifugation was used as a socket plug and stabilised with figure of eight suture. Group C sockets were filled with POP and then covered with PRF. The socket was then closed with a figure of eight suture. Patients were informed of need for 6 months follow-up. Ninety sockets in 48 patients were subjected to our study. We found that results in the sockets where we have grafted POP showed better ridge preservation and post-operative comfort even though the difference in ridge resorption between the three groups was not statistically significant. Powered by Editorial Manager® and ProduXion Manager® from the Aries Systems Corporation. Atraumatic extraction may minimise the post-operative pain and discomfort to patient as well as the post-extraction alveolar height and width changes. The use of PRF and/or bone substitute even though clinically contributes to better post-operative healing and minimal loss of alveolar width and height, the values were not statistically significant.

Mandibular single-implant overdentures: a review with surgical and prosthodontic perspectives of a novel approach.

PubMed

Alsabeeha, Nabeel; Payne, Alan G T; De Silva, Rohana K; Swain, Michael V

2009-04-01

To review the literature on mandibular single-implant overdentures (opposing complete maxillary dentures), and present surgical and prosthodontic perspectives of a novel approach for this treatment option. An electronic search through the databases of Pubmed, Embase and Medline using the linked key words 'mandibular single implant overdentures' was performed. The search was limited to English language articles published up to August 2008. Hand searches through articles retrieved from the electronic search, peer-reviewed journals and recent conference proceedings were also conducted. A limited number of reports were identified on mandibular single-implant overdentures (opposing maxillary complete dentures). They comprised of case-series reports, short-term prospective trials and current randomized-controlled clinical trials. Different loading protocols with different implant systems have been used, but always with regular diameter implants. Specific anatomical and vascular dangers of the mandibular midline symphysis are identified including a novel surgical approach using a currently available short, wide diameter tapered implant. In addition, the prosthodontic rationale for using a larger attachment system (incorporating a platform switch) for mandibular single-implant overdentures is described. The review reveals that there is a lack of published randomized clinical trials using mandibular single-implant overdentures, opposing maxillary complete dentures. Without the evidence from randomized clinical trials, routine use of this novel approach cannot be recommended, compared with using regular diameter implants and matching attachment systems.

The effects of assertiveness training in patients with schizophrenia: a randomized, single-blind, controlled study.

PubMed

Lee, Tso-Ying; Chang, Shih-Chin; Chu, Hsin; Yang, Chyn-Yng; Ou, Keng-Liang; Chung, Min-Huey; Chou, Kuei-Ru

2013-11-01

In this study, we investigated the effects of group assertiveness training on assertiveness, social anxiety and satisfaction with interpersonal communication among patients with chronic schizophrenia. Only limited studies highlighted the effectiveness of group assertiveness training among inpatients with schizophrenia. Given the lack of group assertiveness training among patients with schizophrenia, further development of programmes focusing on facilitating assertiveness, self-confidence and social skills among inpatients with chronic schizophrenia is needed. This study used a prospective, randomized, single-blinded, parallel-group design. This study employed a prospective, randomized, parallel-group design. Seventy-four patients were randomly assigned to experimental group receiving 12 sessions of assertiveness training, or a supportive control group. Data collection took place for the period of June 2009-July 2010. Among patients with chronic schizophrenia, assertiveness, levels of social anxiety and satisfaction with interpersonal communication significantly improved immediately after the intervention and at the 3-month follow-up in the intervention group. The results of a generalized estimating equation (GEE) indicated that: (1) assertiveness significantly improved from pre- to postintervention and was maintained until the follow-up; (2) anxiety regarding social interactions significantly decreased after assertiveness training; and (3) satisfaction with interpersonal communication slightly improved after the 12-session intervention and at the 3-month follow-up. Assertivenss training is a non-invasive and inexpensive therapy that appears to improve assertiveness, social anxiety and interpersonal communication among inpatients with chronic schizophrenia. These findings may provide a reference guide to clinical nurses for developing assertiveness-training protocols. © 2013 Blackwell Publishing Ltd.

Comparing the effects of single shot sciatic nerve block versus posterior capsule local anesthetic infiltration on analgesia and functional outcome after total knee arthroplasty: a prospective, randomized, double-blinded, controlled trial.

PubMed

Safa, Ben; Gollish, Jeffrey; Haslam, Lynn; McCartney, Colin J L

2014-06-01

Peripheral nerve blocks appear to provide effective analgesia for patients undergoing total knee arthroplasty. Although the literature supports the use of femoral nerve block, addition of sciatic nerve block is controversial. In this study we investigated the value of sciatic nerve block and an alternative technique of posterior capsule local anesthetic infiltration analgesia. 100 patients were prospectively randomized into three groups. Group 1: sciatic nerve block; Group 2: posterior local anesthetic infiltration; Group 3: control. All patients received a femoral nerve block and spinal anesthesia. There were no differences in pain scores between groups. Sciatic nerve block provided a brief clinically insignificant opioid sparing effect. We conclude that sciatic nerve block and posterior local anesthetic infiltration do not provide significant analgesic benefits. Copyright © 2014 Elsevier Inc. All rights reserved.

Single-Use Energy Sources and Operating Room Time for Laparoscopic Hysterectomy: A Randomized Controlled Trial.

PubMed

Holloran-Schwartz, M Brigid; Gavard, Jeffrey A; Martin, Jared C; Blaskiewicz, Robert J; Yeung, Patrick P

2016-01-01

To compare the intraoperative direct costs of a single-use energy device with reusable energy devices during laparoscopic hysterectomy. A randomized controlled trial (Canadian Task Force Classification I). An academic hospital. Forty-six women who underwent laparoscopic hysterectomy from March 2013 to September 2013. Each patient served as her own control. One side of the uterine attachments was desiccated and transected with the single-use device (Ligasure 5-mm Blunt Tip LF1537 with the Force Triad generator). The other side was desiccated and transected with reusable bipolar forceps (RoBi 5 mm), and transected with monopolar scissors using the same Covidien Force Triad generator. The instrument approach used was randomized to the attending physician who was always on the patient's left side. Resident physicians always operated on the patient's right side and used the converse instruments of the attending physician. Start time was recorded at the utero-ovarian pedicle and end time was recorded after transection of the uterine artery on the same side. Costs included the single-use device; amortized costs of the generator, reusable instruments, and cords; cleaning and packaging of reusable instruments; and disposal of the single-use device. Operating room time was $94.14/min. We estimated that our single use-device cost $630.14 and had a total time savings of 6.7 min per case, or 3.35 min per side, which could justify the expense of the device. The single-use energy device had significant median time savings (-4.7 min per side, p < .001) and total intraoperative direct cost savings ($254.16 per case). A single-use energy device that both desiccates and cuts significantly reduced operating room time to justify its own cost, and it also reduced total intraoperative direct costs during laparoscopic hysterectomy in our institution. Operating room cost per minute varies between institutions and must be considered before generalizing our results. Copyright © 2016 AAGL. Published by Elsevier Inc. All rights reserved.

[Simulation-based training and OR apprenticeship for medical students : A prospective, randomized, single-blind study of clinical skills].

PubMed

Ott, T; Schmidtmann, I; Limbach, T; Gottschling, P F; Buggenhagen, H; Kurz, S; Pestel, G

2016-11-01

Simulation-based training (SBT) has developed into an established method of medical training. Studies focusing on the education of medical students have used simulation as an evaluation tool for defined skills. A small number of studies provide evidence that SBT improves medical students' skills in the clinical setting. Moreover, they were strictly limited to a few areas, such as the diagnosis of heart murmurs or the correct application of cricoid pressure. Other studies could not prove adequate transferability from the skills gained in SBT to the patient site. Whether SBT has an effect on medical students' skills in anesthesiology in the clinical setting is controversial. To explore this issue, we designed a prospective, randomized, single-blind trial that was integrated into the undergraduate anesthesiology curriculum of our department during the second year of the clinical phase of medical school. This study intended to explore the effect of SBT on medical students within the mandatory undergraduate anesthesiology curriculum of our department in the operating room with respect to basic skills in anesthesiology. After obtaining ethical approval, the participating students of the third clinical semester were randomized into two groups: the SIM-OR group was trained by a 225 min long SBT in basic skills in anesthesiology before attending the operating room (OR) apprenticeship. The OR-SIM group was trained after the operating room apprenticeship by SBT. During SBT the students were trained in five clinical skills detailed below. Further, two clinical scenarios were simulated using a full-scale simulator. The students had to prepare the patient and perform induction of anesthesia, including bag-mask ventilation after induction in scenario 1 and rapid sequence induction in scenario 2. Using the five-point Likert scale, five defined skills were evaluated at defined time points during the study period. 1) application of the safety checklist, 2) application of basic patient monitoring, 3) establishment of intravenous access, 4) bag-and-mask ventilation, and 5) adjustment of ventilatory parameters after the patients' airways were secured. A cumulative score of 5 points was defined as the best and a cumulative score of 25 as the worst rating for a defined time point. The primary endpoint was the cumulative score after day 1 in the operating room apprenticeship and the difference in cumulative scores from days 1 to 4. Our hypothesis was that the SIM-OR group would achieve a better score after day 1 in the operating room apprenticeship and would gain a larger increase in score from day 1 to day 4 than the OR-SIM group. 73 students were allocated to the OR-SIM group and 70 students to the SIM-OR group. There was no significant difference between the two groups after day 1 of the operating room apprenticeship and no difference in increase of the cumulative score from day 1 to day 4 (median of cumulative score on day 1: 'SIM-OR' 11.2 points vs. 'OR-SIM' 14.6 points; p = 0.067; median of difference from day 1 to day 4: 'SIM-OR' -3.7 vs. 'OR-SIM' -6.4; p = 0.110). With the methods applied, this study could not prove that 225 min of SBT before the operating room apprenticeship increased the medical students' clinical skills as evaluated in the operating room. Secondary endpoints indicate that medical students have better clinical skills at the end of the entire curriculum when they have been trained through SBT before the operating room apprenticeship. However, the authors believe that simulator training has a positive impact on students' acquisition of procedural and patient safety skills, even if the methods applied in this study may not mirror this aspect sufficiently.

Which is your choice for prolonging the analgesic duration of single-shot interscalene brachial blocks for arthroscopic shoulder surgery? intravenous dexamethasone 5 mg vs. perineural dexamethasone 5 mg randomized, controlled, clinical trial.

PubMed

Chun, Eun Hee; Kim, Youn Jin; Woo, Jae Hee

2016-06-01

The aim of this study was to compare the effect of intravenous (I.V.) dexamethasone with that of perineural dexamethasone on the prolongation of analgesic duration of single-shot interscalene brachial plexus blocks (SISB) in patients undergoing arthroscopic shoulder surgery. We performed a prospective, randomized, double-blind, placebo-controlled study. Patients undergoing elective arthroscopic shoulder surgery with ultrasound-guided SISB were enrolled and randomized into 2 groups. A total volume of 12 mL of the study drug was prepared with a final concentration of 0.5% ropivacaine. In the I.V. group, patients received SISB using ropivacaine 5 mg mL with normal saline (control) with dexamethasone 5 mg I.V. injection. In the perineural group, patients received SISB using ropivacaine 5 mg mL with dexamethasone 5 mg, with normal saline 1 mL I.V. injection. The primary outcome was the time to the first analgesic request, defined as the time between the end of the operation and the first request of analgesics by the patient. The secondary outcomes included patient satisfaction scores, side effects, and neurological symptoms. Patients were randomly assigned to 1 of the 2 groups using a computer-generated randomization table. An anesthesiologist blinded to the group assignments prepared the solutions for injection. The patients and the investigator participating in the study were also blinded to the group assignments. One hundred patients were randomized. Data were analyzed for 99 patients. One case in the I.V. group was converted to open surgery and was therefore not included in the study. Perineural dexamethasone significantly prolonged analgesic duration (median, standard error: 1080 minutes, 117.5 minutes) compared with I.V. dexamethasone (810 minutes, 48.1 minutes) (P = 0.02). There were no significant differences in side effects, neurological symptoms, or changes in blood glucose values between the 2 groups. Our results show that perineural dexamethasone 5 mg is more effective than I.V. dexamethasone 5 mg with regard to analgesic duration of SISB for arthroscopic shoulder surgery.

Fock space, symbolic algebra, and analytical solutions for small stochastic systems.

PubMed

Santos, Fernando A N; Gadêlha, Hermes; Gaffney, Eamonn A

2015-12-01

Randomness is ubiquitous in nature. From single-molecule biochemical reactions to macroscale biological systems, stochasticity permeates individual interactions and often regulates emergent properties of the system. While such systems are regularly studied from a modeling viewpoint using stochastic simulation algorithms, numerous potential analytical tools can be inherited from statistical and quantum physics, replacing randomness due to quantum fluctuations with low-copy-number stochasticity. Nevertheless, classical studies remained limited to the abstract level, demonstrating a more general applicability and equivalence between systems in physics and biology rather than exploiting the physics tools to study biological systems. Here the Fock space representation, used in quantum mechanics, is combined with the symbolic algebra of creation and annihilation operators to consider explicit solutions for the chemical master equations describing small, well-mixed, biochemical, or biological systems. This is illustrated with an exact solution for a Michaelis-Menten single enzyme interacting with limited substrate, including a consideration of very short time scales, which emphasizes when stiffness is present even for small copy numbers. Furthermore, we present a general matrix representation for Michaelis-Menten kinetics with an arbitrary number of enzymes and substrates that, following diagonalization, leads to the solution of this ubiquitous, nonlinear enzyme kinetics problem. For this, a flexible symbolic maple code is provided, demonstrating the prospective advantages of this framework compared to stochastic simulation algorithms. This further highlights the possibilities for analytically based studies of stochastic systems in biology and chemistry using tools from theoretical quantum physics.

Chronic subdural hematoma management: a systematic review and meta-analysis of 34,829 patients.

PubMed

Almenawer, Saleh A; Farrokhyar, Forough; Hong, Chris; Alhazzani, Waleed; Manoranjan, Branavan; Yarascavitch, Blake; Arjmand, Parnian; Baronia, Benedicto; Reddy, Kesava; Murty, Naresh; Singh, Sheila

2014-03-01

To compare the efficacy and safety of multiple treatment modalities for the management of chronic subdural hematoma (CSDH) patients. Current management strategies of CSDHs remain widely controversial. Treatment options vary from medical therapy and bedside procedures to major operative techniques. We searched MEDLINE (PubMed and Ovid), EMBASE, CINAHL, Google scholar, and the Cochrane library from January 1970 through February 2013 for randomized and observational studies reporting one or more outcome following the management of symptomatic patients with CSDH. Independent reviewers evaluated the quality of studies and abstracted the data on the safety and efficacy of percutaneous bedside twist-drill drainage, single or multiple operating room burr holes, craniotomy, corticosteroids as a main or adjuvant therapy, use of drains, irrigation of the hematoma cavity, bed rest, and treatment of recurrences following CSDH management. Mortality, morbidity, cure, and recurrence rates were examined for each management option. Randomized, prospective, retrospective, and overall observational studies were analyzed separately. Pooled estimates, confidence intervals (CIs), and relative risks (RRs) were calculated for all outcomes using a random-effects model. A total of 34,829 patients from 250 studies met our eligibility criteria. Sixteen trials were randomized, and the remaining 234 were observational. We included our unpublished single center series of 834 patients. When comparing percutaneous bedside drainage to operating room burr hole evacuation, there was no significant difference in mortality (RR, 0.69; 95% CI, 0.46-1.05; P = 0.09), morbidity (RR, 0.45; 95% CI, 0.2-1.01; P = 0.05), cure (RR, 1.05; 95% CI, 0.98-1.11; P = 0.15), and recurrence rates (RR, 1; 95% CI, 0.66-1.52; P = 0.99). Higher morbidity was associated with the adjuvant use of corticosteroids (RR, 1.97; 95% CI, 1.54-2.45; P = 0.005), with no significant improvement in recurrence and cure rates. The use of drains following CSDH drainage resulted in a significant decrease in recurrences (RR, 0.46; 95% CI, 0.27-0.76; P = 0.002). Craniotomy was associated with higher complication rates if considered initially (RR, 1.39; 95% CI, 1.04-1.74; P = 0.01); however, craniotomy was superior to minimally invasive procedures in the management of recurrences (RR, 0.22; 95% CI, 0.05-0.85; P = 0.003). Percutaneous bedside twist-drill drainage is a relatively safe and effective first-line management option. These findings may result in potential health cost savings and eliminate perioperative risks related to general anesthetic.

Prospective randomized double-blinded trial comparing 2 anti-MRSA agents with supplemental coverage of cefazolin before lower extremity revascularization.

PubMed

Stone, Patrick A; AbuRahma, Ali F; Campbell, James R; Hass, Stephen M; Mousa, Albeir Y; Nanjundappa, Aravinda; Srivastiva, Mohit; Modak, Asmita; Emmett, Mary

2015-09-01

To compare with antibiotics with methicillin-resistant microbial coverage in a prospective fashion. Current antibiotic prophylaxis for vascular procedures includes a first generation cephalosporin. No changes in recommendations have occurred despite changes in reports of incidence of MRSA related surgical site infections. Does supplemental anti-MRSA prophylactic coverage provide a significant reduction in Gram-positive or MRSA infections? Single center prospective double blinded randomized study of patients undergoing lower extremity vascular procedures from 2011 to 2014. One hundred seventy-eight (178) patients were evaluated at 90 days for surgical site infection. Infections were categorized as early infections less than 30 days of the index procedure and late after 90 days. Early vascular surgical site infection occurred in 7(8.24%) of patients in the Vancomycin arm, and 11 (11.83%) in the Daptomycin arm (P = 0.43). Gram-positive related infections and MRSA infections occurred in 1(1.18%)/0(0%) of Vancomycin patients and 9 (9.68%)/1 (1.08%) of Daptomycin patients, respectively (P < 0.02 and P = 1.00). Readmissions related to surgical site infections occurred in 4(4.71%) in the Vancomycin group and 11 (11.8%) in the Daptomycin group (P = 0.11). Patients undergoing operative exploration occurred in 5 (5.88%) in the Vancomycin group and 10 (10.75%) of the Daptomycin group (P = 0.17). Late infections were reported in 3 patients, 2 of which were in the combined Daptomycin group. Median hospital charges related to readmissions due to a surgical site infection was $50,823 in the combination Vancomycin arm and $110,920 in the combination Daptomycin group; however, no statistical significance was appreciated (P = 0.11). Vancomycin supplemental prophylaxis seems to reduce the incidence of Gram-positive infection compared with adding supplemental Daptomycin prophylaxis. The Incidence of MRSA-related surgical site infections is low with the addition of either anti-MRSA agents compared with historical incidence of MRSA-related infection.

A comparison of septal stapler to suture closure in septoplasty: a prospective, randomized trial evaluating the effect on operative time.

PubMed

Sowerby, Leigh J; Wright, Erin D

2013-11-01

Septoplasty requires coaptation of the mucosal flaps at the conclusion of the procedure; classically this is done with nasal packing. Quilting sutures provide a welcome alternative to packing, but can be time-consuming to place. A septal stapler has recently been developed that provides a rapid alternative to quilting sutures but the timesaving has not been quantified. This study was a prospective, randomized trial comparing a septal stapler to quilting suture for coaptation of mucosal flaps in septoplasty. After meeting inclusion criteria, patients underwent septoplasty and inferior turbinoplasty. The total operative time, surgical segment times, including time for closure was recorded. Preoperative and postoperative Nasal Obstruction Symptom Evaluation (NOSE) scores were recorded. A sample size of 16 was determined to detect a difference of 5 minutes in closure time. A total of 16 patients were enrolled in the study. The mean time for closure with septal stapler was 35 ± 22 seconds vs 7 minutes ± 1 minute 10 seconds for suture closure (p < 0.0001). The mean total operative time using the septal stapler was 28 minutes ± 6 minutes whereas 43 minutes ± 13 minutes was required for suture (p = 0.014). No difference in postoperative complications or mucosal healing was seen; preoperative and postoperative improvement in NOSE scores was comparable. Coaptation of the mucosal flaps in septoplasty with a septal stapler affords a timesaving in the operating room with no difference in operative outcome. © 2013 ARS-AAOA, LLC.

Prospective, randomized multicenter study of cervical arthroplasty versus anterior cervical discectomy and fusion: 5-year results with a metal-on-metal artificial disc.

PubMed

Coric, Domagoj; Guyer, Richard D; Nunley, Pierce D; Musante, David; Carmody, Cameron; Gordon, Charles; Lauryssen, Carl; Boltes, Margaret O; Ohnmeiss, Donna D

2018-03-01

OBJECTIVE Seven cervical total disc replacement (TDR) devices have received FDA approval since 2006. These devices represent a heterogeneous assortment of implants made from various biomaterials with different biomechanical properties. The majority of these devices are composed of metallic endplates with a polymer core. In this prospective, randomized multicenter study, the authors evaluate the safety and efficacy of a metal-on-metal (MoM) TDR (Kineflex|C) versus anterior cervical discectomy and fusion (ACDF) in the treatment of single-level spondylosis with radiculopathy through a long-term (5-year) follow-up. METHODS An FDA-regulated investigational device exemption (IDE) pivotal trial was conducted at 21 centers across the United States. Standard validated outcome measures including the Neck Disability Index (NDI) and visual analog scale (VAS) for assessing pain were used. Patients were randomized to undergo TDR using the Kineflex|C cervical artificial disc or anterior cervical fusion using structural allograft and an anterior plate. Patients were evaluated preoperatively and at 6 weeks and 3, 6, 12, 24, 36, 48, and 60 months after surgery. Serum ion analysis was performed on a subset of patients randomized to receive the MoM TDR. RESULTS A total of 269 patients were enrolled and randomly assigned to undergo either TDR (136 patients) or ACDF (133 patients). There were no significant differences between the TDR and ACDF groups in terms of operative time, blood loss, or length of hospital stay. In both groups, the mean NDI scores improved significantly by 6 weeks after surgery and remained significantly improved throughout the 60-month follow-up (both p < 0.01). Similarly, VAS pain scores improved significantly by 6 weeks and remained significantly improved through the 60-month follow-up (both p < 0.01). There were no significant changes in outcomes between the 24- and 60-month follow-ups in either group. Range of motion in the TDR group decreased at 3 months but was significantly greater than the preoperative mean value at the 12- and 24-month follow-ups and remained significantly improved through the 60-month period. There were no significant differences between the 2 groups in terms of reoperation/revision surgery or device-/surgery-related adverse events. The serum ion analysis revealed cobalt and chromium levels significantly lower than the levels that merit monitoring. CONCLUSIONS Cervical TDR with an MoM device is safe and efficacious at the 5-year follow-up. These results from a prospective randomized study support that Kineflex|C TDR as a viable alternative to ACDF in appropriately selected patients with cervical radiculopathy. Clinical trial registration no.: NCT00374413 (clinicaltrials.gov).

A Prospective Randomized Study Comparing Disposable with Reusable Blades for a Morcellator Device.

PubMed

Becker, Benedikt; Orywal, Ann Katrin; Hausmann, Teresa; Gross, Andreas J; Netsch, Christopher

2017-03-01

Transurethral enucleation of the prostate for the management of benign prostatic obstruction (BPO) involves two steps: the enucleation and morcellation procedure. The aim of our study was to assess the efficacy of a morcellator device using disposable and reusable blades with different settings of morcellation speed. A prospective randomized study was initiated for patients with symptomatic BPO undergoing Thulium laser enucleation of the prostate. Mechanical tissue morcellation was performed using the Piranha™ morcellator (R. Wolf, Knittlingen, Germany) with disposable or reusable blades at 850 (n = 24) or 1500 revolutions per minute (rpm) (n = 24). Patient characteristics, intraoperative complications, and the morcellation rate (g/min) were recorded. Data are expressed as median and interquartile range (IQR). Forty-eight patients were randomized using disposable (n = 24) or reusable blades (n = 24). For reusable blades, the morcellation rate did not increase when changing the morcellation speed from 850 to 1500 rpm (5 vs 4.53 g/min, p = 0.843). The morcellation rate increased significantly when changing the morcellation speed from 850 to 1500 rpm using single-use blades (4.77 vs 10 g/min, p ≤ 0.014). The morcellation rate was not different at 850 rpm between reusable and single-use blades (5 vs 4.77 g/min, p = 0.671). Conversely, the morcellation rate was significantly different at 1500 rpm between reusable and single-use blades (4.53 vs 10 g/min, p ≤ 0.017). The total morcellation rate (at 850 and 1500 rpm) was significantly increased using single-use blades compared to reusable blades (7.67 vs 4.8 g/min, p ≤ 0.026). Interestingly, enucleated weight (g) and the morcellation rate (g/min) correlated inversely using single-use blades at 1500 rpm (r = -0.742, p ≤ 0.004). Only one superficial bladder injury occurred at 1500 rpm, which needed no further interventions. The Piranha morcellator facilitates efficient tissue removal with single-use and reusable blades. Disposable morcellator blades increase tissue removal significantly at 1500 rpm.

Comparison of torsional and microburst longitudinal phacoemulsification: a prospective, randomized, masked clinical trial.

PubMed

Vasavada, Abhay R; Raj, Shetal M; Patel, Udayan; Vasavada, Vaishali; Vasavada, Viraj

2010-01-01

To compare intraoperative performance and postoperative outcome of three phacoemulsification technologies in patients undergoing microcoaxial phacoemulsification through 2.2-mm corneal incisions. The prospective, randomized, single-masked study included 360 eyes randomly assigned to torsional (Infiniti Vision System; Alcon Laboratories, Fort Worth, TX), microburst with longitudinal (Infiniti), or microburst with longitudinal (Legacy Everest, Alcon Laboratories) ultrasound. Assessments included surgical clock time, fluid volume, and intraoperative complications, central corneal thickness on day 1 and months 1 and 3 postoperatively, and endothelial cell density at 3 months postoperatively. Comparisons among groups were conducted. Torsional ultrasound required significantly less surgical clock time and fluid volume than the other groups. There were no intraoperative complications. Change in central corneal thickness and endothelial cell loss was significantly lower in the torsional ultrasound group at all postoperative visits (P < .001, Kruskal-Wallis test) compared to microburst longitudinal ultrasound modalities. Torsional ultrasound demonstrated quantitatively superior intraoperative performance and showed less increase in corneal thickness and less endothelial cell loss compared to microburst longitudinal ultrasound. Copyright 2010, SLACK Incorporated.

Sirolimus Associated with Tacrolimus at Low Doses in Elderly Kidney Transplant Patients: A Prospective Randomized Controlled Trial.

PubMed

Kojima, Cristiane Akemi; Nga, Hong Si; Takase, Henrique Mochida; Bravin, Ariane Moyses; Martinez Garcia, Márcia de Fátima Faraldo; Garcia, Paula Dalsoglio; Contti, Mariana Moraes; de Andrade, Luis Gustavo Modelli

2018-06-01

There is no consensus on the best immunosuppressive regimen for elderly renal transplant recipients. The objective of this study was to assess cytomegalovirus infection incidence and kidney transplant outcomes in elderly recipients treated with mammalian target of rapamycin inhibitors sirolimus/ tacrolimus at low doses compared with those receiving tacrolimus/mycophenolate sodium. In this single-center prospective randomized study (Trial Registration No. NCT02683291), kidney transplant recipients over 60 years of age were randomly allocated into 2 groups: tacrolimus-sirolimus (21 patients) and tacrolimus-mycophenolate (23 patients). Cytomegalovirus infection rate and patient survival, biopsy-proven acute rejection, and renal function at 12 months were assessed. Cytomegalovirus infection rate was higher in the mycophenolate group (60.9%) than in the sirolimus group (16.7%; P = .004). The rates of biopsy-proven acute rejection, patient survival, graft survival, and estimated glomerular filtration rate over 12 months did not significantly differ between groups. The incidence of cytomegalovirus infection was significantly lower in the sirolimus group. The use of tacrolimus combined with sirolimus in elderly kidney transplant recipients is safe.

Ultrasound-guided posterior quadratus lumborum block for postoperative pain after laparoscopic cholecystectomy: A randomized controlled double blind study.

PubMed

Ökmen, Korgün; Metin Ökmen, Burcu; Topal, Serra

2018-06-18

Laparoscopic techniques are commonly used in surgical operations of the gallbladder. There are very few regional anesthesia methods used to achieve this goal. We aimed to investigate the effect of ultrasound-guided posterior quadratus lumborum block (QLB), administered bilaterally on pain scores after laparoscopic cholecystectomy operations. Prospective, double blind, randomized controlled clinical trial. Single-institution, tertiary hospital. 60 patients underwent laparoscopic cholecystectomy were included in the study. Patients were randomized to either Group B (intravenous patient-controlled analgesia (IV PCA) + posterior QLB with 0.3 ml/kg 0.25% bupivacaine; n = 30) or Group S (IV PCA + posterior QLB with 0.3 ml/kg 0,9% saline; n = 30). Postoperative pain (during rest) was evaluated at the 30th minute, 2nd, 6th, 12th, and 24th hours using the VAS scores. Postoperative activity pain was also evaluated with VAS at the 2nd, 6th, 12th, and 24th hours. Postoperative 6th, 12th, and 24th hour follow-up results were recorded to identify the quantity of tramadol use. Secondary outcomes included the Ramsey sedation scale (RSS), side effect profile, and additional analgesic use. The VAS scores between the two groups were found to be statistically significantly lower in Group B (p < 0.001). The mean values of the quantity of tramadol use at the 6th, 12th, and 24th hours were found to be statistically significantly lower in Group B (p < 0.001). There was no statistically significant difference in the rate of side effects (p = 0.309) and RSS (p = 0.505) outcomes between the groups. As a result of this study, we think that posterior QLB administered for pain palliation after laparoscopic cholecystectomy operation is an effective analgesia technique. Copyright © 2018 Elsevier Inc. All rights reserved.

A prospective randomized study for efficacy of an uncovered double bare metal stent compared to a single bare metal stent in malignant biliary obstruction.

PubMed

Lee, Hyun Jik; Chung, Moon Jae; Park, Jeong Yup; Park, Seung Woo; Nam, Chung Mo; Song, Si Young; Bang, Seungmin

2017-08-01

A biliary self-expandable metal stent (SEMS) is commonly used to relieve malignant biliary obstruction. The aim of this study was to compare the efficacy of a conventional uncovered SEMS with that of a newly developed uncovered double bare metal stent in reducing the risk of stent occlusion caused by tumor ingrowth. We performed a prospective, open-labeled, randomized trial in 71 patients at Severance Hospital, Yonsei University College of Medicine from June 2013 to June 2014. Patients with inoperable malignant biliary obstruction were included and randomized to receive an uncovered single bare metal stent (SBSs; S&G Biotech Inc.), an uncovered single bare metal stent (SBSt; Taewoong Medical), or an uncovered double bare metal stent (DBS; S&G Biotech Inc.). The mean age was 66.6 years (range, 35-83), and 42 (59.2%) were male. The mean duration of stent patency was 212 days (±152) in the DBS group (n = 24) compared with 124 days (±98) in the SBSs group (n = 23; P = 0.022 for noninferiority) and 116 days (±79) in the SBSt group (n = 24; P = 0.010 for noninferiority). There were no differences in the incidences of early and delayed complications or migration. The newly developed DBS is noninferior to the conventional uncovered SEMSs on duration of stent patency and tumor ingrowth occurred less frequently in the DBS group. This might decrease the need for reintervention and offer a better quality of life. The trial is registered with Clinicaltrials.gov no: NCT01869894.

Randomized trial of single-dose versus divided-dose rabbit anti-thymocyte globulin induction in renal transplantation: an interim report.

PubMed

Stevens, R Brian; Mercer, David F; Grant, Wendy J; Freifeld, Alison G; Lane, James T; Groggel, Gerald C; Rigley, Theodore H; Nielsen, Kathleen J; Henning, Megan E; Skorupa, Jill Y; Skorupa, Anna J; Christensen, Kecia A; Sandoz, John P; Kellogg, Anna M; Langnas, Alan N; Wrenshall, Lucile E

2008-05-27

The optimal dosing protocol for rabbit anti-thymocyte globulin (rATG) induction in renal transplantation has not been determined, but evidence exists that rATG infusion before renal allograft reperfusion improves early graft function. Infusing a large rATG dose over a short interval has not previously been evaluated for its effect on renal function and allograft nephropathy in a prospective, randomized comparison against conventional rATG induction. Between April 20, 2004 and December 26, 2007 we enrolled renal transplant patients into a prospective, randomized, nonblinded trial of two rATG dosing protocols (single dose, 6 mg/kg vs. divided doses, 1.5 mg/kg every other day x 4; target enrollment=160) followed after 6 months by calcineurin-inhibitor withdrawal. Primary endpoints are renal function by calculated glomerular filtration rate (GFR) and chronic allograft nephropathy at protocol biopsy. We now present the early GFR data of all 160 patients and safety and efficacy data of the first 142 patients with 6 months follow up and before calcineurin inhibitor withdrawal (average follow up=23.3+/-11.6 months). There were no differences between groups in rATG-related adverse events, patient and graft survival, acute rejection, or chronic allograft nephropathy rate at 6 months. Calculated DeltaGFR (POD 1-4) was significantly better in the single-dose group (P=0.02), with a trend toward improved renal function from months 2 to 6 in recipients of deceased donor kidneys (P=0.08). This study demonstrates that administering 6 mg/kg of rATG over 24 hr is safe and is associated with improved early renal function compared with administering rATG in alternate-day doses.

Efficacy, Safety, and Preparation of Standardized Parenteral Nutrition Regimens: Three-Chamber Bags vs Compounded Monobags-A Prospective, Multicenter, Randomized, Single-Blind Clinical Trial.

PubMed

Yu, Jianchun; Wu, Guohao; Tang, Yun; Ye, Yingjiang; Zhang, Zhongtao

2017-08-01

Parenteral nutrition (PN) covering the need for carbohydrates, amino acids, and lipids can either be compounded from single nutrients or purchased as an industrially manufactured ready-to-use regimen. This study compares a commercially available 3-chamber bag (study group) with a conventionally compounded monobag regarding nutrition efficacy, safety, and regimen preparation time. This prospective, randomized, single-blind study was conducted at 5 Chinese hospitals from October 2010-October 2011. Postsurgical patients requiring PN for at least 6 days were randomly assigned to receive the study or control regimen. Plasma concentrations of prealbumin and C-reactive protein (CRP), regimen preparation time, length of hospital stay (LOS), 30-day mortality, safety laboratory parameters, and adverse events (AEs) were recorded. In total, 240 patients (121 vs 119 in study and control groups) participated in this study. Changes in prealbumin concentrations during nutrition support (Δ Prealb(StudyGroup) = 2.65 mg/dL, P < .001 vs Δ Prealb(ControlGroup) = 0.27 mg/dL, P = .606) and CRP values were comparable. Regimen preparation time was significantly reduced in the study group by the use of 3-chamber bags (t (StudyGroup) = 4.90 ± 4.41 minutes vs t (ControlGroup) = 12.13 ± 5.62 minutes, P < .001). No differences were detected for LOS, 30-day mortality, safety laboratory parameters, and postoperative AEs (37 vs 38 in study and control groups). The PN regimen provided by the 3-chamber bag was comparable to the compounded regimen and safe in use. Time savings during regimen preparation indicates that use of 3-chamber bags simplifies the process of regimen preparation.

Efficacy of RADPAD® protection drape in reducing radiation exposure to the primary operator during Transcatheter Aortic Valve Implantation (TAVI).

PubMed

Sharma, Divyesh; Ramsewak, Adesh; Manoharan, Ganesh; Spence, Mark S

2016-02-01

The efficacy of RADPAD® (a sterile, lead-free drape) has been demonstrated to reduce the scatter radiation to the primary operator during fluoroscopic procedures. However, the use of the RADPAD® during TAVI procedures has not been studied. Transcatheter aortic valve implantation (TAVI) is now an established treatment for patients with symptomatic severe aortic stenosis who are deemed inoperable or at high risk for conventional surgical aortic valve replacement (AVR). Consequently the radiation exposure to the patient and the interventional team from this procedure has become a matter of interest and importance. Methods to reduce radiation exposure to the interventional team during this procedure should be actively investigated. In this single center prospective study, we determined the radiation dose during this procedure and the efficacy of RADPAD® in reducing the radiation dose to the primary operator. Fifty consecutive patients due to undergo elective TAVI procedures were identified. Patients were randomly assigned to undergo the procedure with or without the use of a RADPAD® drape. There were 25 patients in each group and dosimetry was performed at the left eye level of the primary operator. The dosimeter was commenced at the start of the procedure, and the dose was recorded immediately after the end of the procedure. Fluoroscopy times and DAP were also recorded prospectively. Twenty-five patients underwent transfemoral TAVI using a RADPAD® and 25 with no-RADPAD®. The mean primary operator radiation dose was significantly lower in the RADPAD group at 14.8 mSv vs. 24.3 mSv in the no-RADPAD group (P=0.008). There was no significant difference in fluoroscopy times or dose-area products between the two patient groups. The dose to the primary operator relative to fluoroscopy time (RADPAD: slope=0.325; no RADPAD: slope=1.148; analysis of covariance F=7.47, P=0.009) and dose area product (RADPAD: slope=0.0007; no RADPAD: slope=0.002; analysis of covariance F=7.38; P=0.009) was smaller in the RADPAD group compared to no-RADPAD group. Use of a RADPAD® significantly reduces radiation exposure to the primary operator during TAVI procedures.

The efficacy of surgical drainage in cervicofacial rhytidectomy: a prospective, randomized, controlled trial.

PubMed

Jones, Barry M; Grover, Rajiv; Hamilton, Stephen

2007-07-01

Postoperative drainage is often used instinctively in face lifting on the assumption that it may reduce the likelihood of complications. This potential benefit should be balanced against cost, discomfort, and the possibility of provoking bleeding and hematoma on removal. Evidence-based decisions on drainage are problematic, since no prospective studies have examined its role. This study was designed to address this issue directly. Fifty consecutive patients undergoing face lift over a 3-month period were randomized to drainage of one side of the face only, with the contralateral side serving as a paired control. Bruising, swelling, and hematoma or seroma were assessed objectively, independently of the operating surgeon and subjectively by the patients. Postoperative hematoma and edema were not influenced by the use of drains (p > 0.5). Patients reported no difference between the two sides with respect to swelling (p = 0.6) or discomfort (p = 0.5). However, drains produced a statistically significant reduction in postoperative bruising both on clinical assessment (p = 0.005) and patient assessment (p = 0.002). This article represents the first prospective, randomized, controlled trial assessing the use of postoperative drainage in facial rejuvenation surgery. Surgical drains do not influence postoperative complications, but they do significantly reduce bruising and so may facilitate the patient's return to normal activity.

Benign painful elbow syndrome. First results of a single center prospective randomized radiotherapy dose optimization trial.

PubMed

Ott, O J; Hertel, S; Gaipl, U S; Frey, B; Schmidt, M; Fietkau, R

2012-10-01

The goal of the present study was to evaluate the efficacy of two different dose-fractionation schedules for radiotherapy (RT) of patients with painful elbow syndrome. Between February 2006 and February 2010, 199 consecutive evaluable patients were recruited for this prospective randomized trial. All patients received RT in orthovoltage technique. One RT course consisted of 6 single fractions/3 weeks. In case of insufficient remission of pain after 6 weeks a second radiation series was performed. Patients were randomly assigned to receive either single doses of 0.5 or 1.0 Gy. Endpoint was pain reduction. Pain was measured before, right after, and 6 weeks after RT by a visual analogue scale (VAS) and a comprehensive pain score (CPS). The overall response rate for all patients was 80% direct after and 91% 6 weeks after RT. The mean VAS values before, after and 6 weeks after treatment for the 0.5 and 1.0 Gy groups were 59.6 ± 20.2 and 55.7 ± 18.0 (p = 0.463), 32.1 ± 24.5 and 34.4 ± 22.5 (p = 0.256), and 27.0 ± 27.7 and 23.5 ± 21.6 (p = 0.818). The mean CPS before, after, and 6 weeks after treatment was 8.7 ± 2.9 and 8.1 ± 3.1 (p = 0.207), 4.5 ± 3.2 and 5.0 ± 3.4 (p = 0.507), 3.9 ± 3.6 and 2.8 ± 2.8 (p = 0.186), respectively. No statistically significant differences between the two single dose trial arms for early (p = 0.103) and delayed response (p = 0.246) were found. RT is an effective treatment option for the management of benign painful elbow syndrome. For radiation protection reasons the dose for a RT series is recommended not to exceed 3.0 Gy.

Heating and humidifying of carbon dioxide during pneumoperitoneum is not indicated: a prospective randomized trial.

PubMed

Davis, S S; Mikami, D J; Newlin, M; Needleman, B J; Barrett, M S; Fries, R; Larson, T; Dundon, J; Goldblatt, M I; Melvin, W S

2006-01-01

Carbon dioxide (CO2) pneumoperitoneum usually is created by a compressed gas source. This exposes the patient to cool dry gas delivered at room temperature (21 degrees C) with 0% relative humidity. Various delivery methods are available for humidifying and heating CO2 gas. This study was designed to determine the effects of heating and humidifying gas for the intraabdominal environment. For this study, 44 patients undergoing laparoscopic Roux-en-Y gastric bypass were randomly assigned to one of four arms in a prospective, randomized, single-blinded fashion: raw CO2 (group 1), heated CO2 (group 2), humidified CO2 (group 3), and heated and humidified CO2 (group 4). A commercially available CO2 heater-humidifier was used. Core temperatures, intraabdominal humidity, perioperative data, and postoperative outcomes were monitored. Peritoneal biopsies were taken in each group at the beginning and end of the case. Biopsies were subjected staining protocols designed to identify structural damage and macrophage activity. Postoperative narcotic use, pain scale scores, recovery room time, and length of hospital stay were recorded. One-way analysis of variance (ANOVA) and the nonparametric Kruskal-Wallis test were used to compare the groups. Demographics, volume of CO2 used, intraabdominal humidity, bladder temperatures, lens fogging, and operative times were not significantly different between the groups. Core temperatures were stable, and intraabdominal humidity measurements approached 100% for all the patients over the entire procedure. Total narcotic dosage and pain scale scores were not statistically different. Recovery room times and length of hospital stay were similar in all the groups. Only one biopsy in the heated-humidified group showed an increase in macrophage activity. The intraabdominal environment in terms of temperature and humidity was similar in all the groups. There was no significant difference in the intraoperative body temperatures or the postoperative variable measured. No histologic changes were identified. Heating or humidifying of CO2 is not justified for patients undergoing laparoscopic bariatric surgery.

Incidence of post-operative pain after single visit and multiple visit root canal treatment: A randomized controlled trial

PubMed Central

Singh, Smita; Garg, Aniket

2012-01-01

Aim: To compare the incidence and intensity of post-obturation pain after single or multi visit root canal treatment on single rooted teeth in a randomized controlled trial. Materials and Methods: Two hundred patients requiring root canal treatment on permanent single rooted teeth (both vital and non vital) were included. The patients were assigned randomly into two groups of 100 patients each. The teeth in Group1 (n = 100) were obturated at the first visit, whilst those in Group 2 (n = 100) were obturated in a second visit 7 days later. A modified Heft Parker visual analog scale was used to measure pre-operative pain and post-obturation pain at 6, 12, 24 and 48 hours after obturation. Independent-sample T-tests was used for statistical analysis. Results: Twelve patients were excluded from the study as they failed to follow the scheduled revisit. Data were obtained from the remaining 188 patients. There was no statistically significant difference in the incidence and intensity of post-obturation pain experienced by two groups. Conclusions: The incidence and intensity of post-obturation pain experience following one- or two-visit root canal treatment on teeth with a single canal were not significantly different. PMID:23112477

The Effect of Patella Eversion on Clinical Outcome Measures in Simultaneous Bilateral Total Knee Arthroplasty: A Prospective Randomized Controlled Trial.

PubMed

Zan, Pengfei; Wu, Zhong; Yu, Xiao; Fan, Lin; Xu, Tianyang; Li, Guodong

2016-03-01

During total knee arthroplasty (TKA), surgical exposure requires mobilization technique of the patella. With this trial, we intended to investigate the effect of patella eversion on clinical outcome measures in simultaneous bilateral TKA. We prospectively enrolled 44 patients (88 knees) from April 2008 to June 20l4.One knee was operated with patella eversion (group A) and the other with patella lateral retraction (group B) randomly. Follow-up results, including the operation time, complications, and the time of achieving straight leg raise (SLR) and 90° knee flexion, were recorded. The data of range of motion (ROM) and Visual Analogue Scale score were collected separately at 7 days, 3 months, 6 months, and 1 year postoperatively. The time of achieving SLR was 2.7 ± 0.8 days in group A and 2.1 ± 0.7 DAYS in group B, which were significantly different (P = .032). Significant difference was found on active and passive ROM during the follow-up times between groups A and B, except the passive ROM at 6 months postoperatively. No significant difference was found on operation time, complications, patella baja or tilt, time of achieving 90°knee flexion, and Visual Analogue Scale score during the follow-up times. Patellar eversion was adverse to the early knee function recovery after TKA; it would delay the time of achieving SLR and decrease the passive and active ROM. In addition, more carefully and scientifically designed randomized controlled trials are still required to further prove the claim. Copyright © 2016 Elsevier Inc. All rights reserved.

Literature review of non-operative management of patients with blunt splenic injury: impact of splenic artery embolization

PubMed Central

Sosada, Krystyn; Piecuch, Jerzy

2014-01-01

Splenic injuries constitute the most common injuries accompanying blunt abdominal traumas. Non-operative treatment is currently the standard for treating hemodynamically stable patients with blunt splenic injuries. The introduction of splenic angiography has increased the possibility of non-operative treatment for patients who, in the past, would have qualified for surgery. This cohort includes mainly patients with severe splenic injuries and with active bleeding. The results have indicated that applying splenic angioembolization reduces the frequency of non-operative treatment failure, especially in severe splenic injuries; however, it is still necessary to perform prospective, randomized clinical investigations. PMID:25337151

Literature review of non-operative management of patients with blunt splenic injury: impact of splenic artery embolization.

PubMed

Sosada, Krystyn; Wiewióra, Maciej; Piecuch, Jerzy

2014-09-01

Splenic injuries constitute the most common injuries accompanying blunt abdominal traumas. Non-operative treatment is currently the standard for treating hemodynamically stable patients with blunt splenic injuries. The introduction of splenic angiography has increased the possibility of non-operative treatment for patients who, in the past, would have qualified for surgery. This cohort includes mainly patients with severe splenic injuries and with active bleeding. The results have indicated that applying splenic angioembolization reduces the frequency of non-operative treatment failure, especially in severe splenic injuries; however, it is still necessary to perform prospective, randomized clinical investigations.

Short-term results of a prospective randomized evaluator blinded multicenter study comparing TVT and TVT-Secur.

PubMed

Andrada Hamer, Maria; Larsson, Per-Göran; Teleman, Pia; Etén-Bergqvist, Christina; Persson, Jan

2011-07-01

The aim of this prospective randomized multicenter study was to compare TVT (tension-free vaginal tape) with TVT-Secur in terms of efficacy and safety. We set out to enrol 280 stress incontinent women with a half time interim analysis of short-term cure and a continuous registration of adverse events. Of 133 randomized women, 126 were operated and 123 (TVT n = 62, TVT-Secur n = 61) available for 2 months follow-up. No significant differences were found between groups regarding demographics or grade of incontinence. At 2 months follow-up, subjective cure rate following TVT-Secur was significantly lower than for TVT (72% and 92%, respectively, p = 0.01). Three major complications occurred in the TVT-Secur group: tape erosion into the urethra, a tape inadvertently placed inside the bladder, and an immediate postoperative bleeding from the corona mortis. No major complications occurred in the TVT group. No significant differences were found between groups regarding perioperative bleeding, hospital stay, urge symptoms, or postoperative urinary tract infections. Median time for surgery was 13 and 22 min for TVT-Secur and TVT, respectively (p < 0.0001). In a prospective randomized controlled study, the TVT-Secur procedure had a significantly lower subjective cure rate than the retropubic TVT procedure. Due to this, in addition to three serious complications in the TVT-Secur group, we decided to stop further enrolment after the interim analysis. We discourage from further use of the TVT-Secur.

Impact of Microscope-Integrated OCT on Ophthalmology Resident Performance of Anterior Segment Surgical Maneuvers in Model Eyes

PubMed Central

Todorich, Bozho; Shieh, Christine; DeSouza, Philip J.; Carrasco-Zevallos, Oscar M.; Cunefare, David L.; Stinnett, Sandra S.; Izatt, Joseph A.; Farsiu, Sina; Mruthyunjaya, Privthi; Kuo, Anthony N.; Toth, Cynthia A.

2016-01-01

Purpose The integration of swept-source optical coherence tomography (SS-OCT) into the operating microscope enables real-time, tissue-level three-dimensional (3D) imaging to aid in ophthalmic microsurgery. In this prospective randomized controlled study, we evaluated the impact of SS microscope-integrated OCT (MI-OCT) on ophthalmology residents' performance of ophthalmic microsurgical maneuvers. Methods Fourteen ophthalmology residents from a single institution were stratified by year of training and randomized to perform four anterior segment surgical maneuvers on porcine eyes with (MI-OCT+) or without (MI-OCT−) direct intraoperative OCT guidance. Subsequently, both groups repeated the same maneuvers without MI-OCT feedback to test whether initial MI-OCT experience affected subsequent surgical performance. Finally, the MI-OCT− group was crossed over and allowed to repeat the same maneuvers with direct MI-OCT guidance. Each resident completed a survey at the completion of the study. Results With direct MI-OCT feedback, residents demonstrated enhanced performance in depth-based anterior segment maneuvers (corneal suture passes at 50% and 90% depth and corneal laceration repair) compared with the residents operating without MI-OCT. Microscope-integrated OCT+ residents continued to outperform the controls when both groups subsequently operated without MI-OCT. For clear corneal wound geometry, there was no statistically significant effect of MI-OCT as applied in this study. Overall, the resident surgeons rated their subjective experience of using MI-OCT very favorably. Conclusions Microscope-integrated OCT feedback enhances performance of ophthalmology residents in select anterior segment surgical maneuvers. Microscope-integrated OCT represents a valuable tool in the surgical education of ophthalmology residents. PMID:27409466

Clinical studies of photodynamic therapy for malignant brain tumors: facial nerve palsy after temporal fossa photoillumination

NASA Astrophysics Data System (ADS)

Muller, Paul J.; Wilson, Brian C.; Lilge, Lothar D.; Varma, Abhay; Bogaards, Arjen; Fullagar, Tim; Fenstermaker, Robert; Selker, Robert; Abrams, Judith

2003-06-01

In two randomized prospective studies of brain tumor PDT more than 180 patients have been accrued. At the Toronto site we recognized two patients who developed a lower motor neuron (LMN) facial paralysis in the week following the PDT treatment. In both cases a temporal lobectomy was undertaken and the residual tumor cavity was photo-illuminated. The surface illuminated included the temporal fossa floor, thus potentially exposing the facial nerve to the effect of PDT. The number of frontal, temporal, parietal, and occipital tumors in this cohort was 39, 24, 12 and 4, respectively. Of the 24 temporal tumors 18 were randomized to Photofrin-PDT. Of these 18 a temporal lobectomy was carried out exposing the middle fossa floor as part of the tumor resection. In two of the 10 patients where the lobectomy was carried out and the fossa floor was exposed to light there occurred a postoperative facial palsy. Both patients recovered facial nerve function in 6 and 12 weeks, respectively. 46 J/cm2 were used in the former and 130 J/cm2 in the latter. We did not encounter a single post-operative LMN facial plasy in the 101 phase 2 patients treated with Photofrin-PDT. Among 688 supratentorial brain tumor operations in the last decade involving all pathologies and all locations no case of early post-operative LMN facial palsy was identified in the absence of PDT. One further patient who had a with post-PDT facial palsy was identified at the Denver site. Although it is possible that these patients had incidental Bell's palsy, we now recommend shielding the temporal fossa floor during PDT.

Topical Mitomycin C in functional endoscopic sinus surgery.

PubMed

Venkatraman, Vaidyanathan; Balasubramanian, Deepak; Gopalakrishnan, Suria; Saxena, Sunil Kumar; Shanmugasundaram, Nirmal

2012-07-01

In recent literature, there has been an interest in the use of Mitomycin C to reduce post-operative complications following endoscopic sinus surgery. We report our results on a prospective, randomized controlled trial involving 50 patients with chronic bilateral rhino sinusitis. We eliminated various confounding factors by studying a single group of patients, with symmetrical disease, without pre-existing gross anatomical abnormalities. Patients requiring revision sinus surgery were excluded. On completion of the surgery, a cotton pledget soaked in Mitomycin C was placed in one nostril (test) and saline-soaked pledget (control) was placed in the other side of the nose, both in the middle meatus. The side of the nasal cavity receiving the topical Mitomycin C was randomized. The patients were assessed periodically (first week, first month, third month and sixth month) for synechiae formation and presence or absence of their symptoms. At the first week follow up, there was a statistically significant difference in the incidence of synechiae between the saline and Mitomycin C side. Furthermore, there was a statistically significant improvement with regards to patient symptoms (nasal block and discharge) in the Mitomycin C side when compared to the saline side. At the third and sixth month, there was no difference between the two groups. The incidence of adverse tissue reaction (granulation, discharge, polypoidal mucosa and crusting) was less in the Mitomycin C side when compared to the saline side at the first month follow up. Topically applied Mitomycin C reduces the incidence of synechiae in the immediate post-operative period in patients undergoing endoscopic sinus surgery. There is also an improvement in nasal obstruction and discharge with a reduction in the incidence of adverse tissue reaction in the early post-operative period.

A randomized prospective multicenter trial of a novel vascular sealant.

PubMed

Stone, William M; Cull, David L; Money, Samuel R

2012-11-01

Increasing use of anticoagulant medications, particularly antiplatelet therapies, can increase the difficulty in obtaining adequate suture line hemostasis. Multiple vascular sealants have been used as adjuncts to surgical procedures, but none of them have been universally successful. The aim of this study was to evaluate the safety and effectiveness of a new prophylactic vascular sealant in arterial surgery. A randomized prospective multi-institutional trial was undertaken comparing ArterX Vascular Sealant (AVS) with Gelfoam Plus during open arterial reconstruction. Three hundred thirty-one anastomotic sites in 217 patients were randomized. One hundred one of 167 (60.5%) anastomotic sites in the AVS group achieved immediate hemostasis compared with 65 of 164 (39.6%) in the control group (P = 0.001). In anastomoses with polytetrafluoroethylene grafts, 105 of 167 (62.5%) in the AVS group achieved immediate hemostasis compared with 56 of 164 (34.0%) in the control group (P < 0.001). No significant differences were noted in morbidity or mortality. Operative time was significantly less in the AVS group compared with the control group (3.2 vs. 3.8 hours, P < 0.01). Use of AVS results in superior hemostatic effectiveness compared with Gelfoam Plus, with no difference in safety. Although no cost analysis was performed, cost savings likely resulted from significantly decreased operative time. Copyright © 2012 Annals of Vascular Surgery Inc. Published by Elsevier Inc. All rights reserved.

Effects of mineralocorticoid receptor antagonists in patients with hypertension and diabetes mellitus: a systematic review and meta-analysis.

PubMed

Takahashi, S; Katada, J; Daida, H; Kitamura, F; Yokoyama, K

2016-09-01

Blood pressure (BP) control is important to ameliorate cardiovascular events in patients with diabetes mellitus (DM). However, achieving the target BP with a single drug is often difficult. The objective of this study was to evaluate the antihypertensive effects of mineralocorticoid receptor antagonists (MRAs) as add-on therapy to renin-angiotensin system (RAS) inhibitor(s) in patients with hypertension and DM. Studies were searched through October 2014 in MEDLINE, Embase and the Cochrane Central Register of Controlled Trials. Randomized, controlled trials or prospective, observational studies regarding concomitant administration of MRA and RAS inhibitor(s) in patients with DM were included. Articles were excluded if the mean systolic BP (SBP) was <130 mm Hg before randomization for interventional studies or at baseline for prospective cohort studies. We identified nine eligible studies (486 patients): five randomized placebo-controlled trials; three randomized active drug-controlled trials; and one single-arm observational study. The mean differences in office SBP and diastolic BP (DBP) between the MRA and placebo groups were -9.4 (95% confidence interval (CI) -12.9 to -5.9) and -3.8 (95% CI, -5.5 to -2.2) mm Hg, respectively. Subgroup analysis results for study type, age, baseline office SBP and follow-up duration were similar to those of the main analysis. MRA mildly increased serum potassium (0.4 mEq l(-1); 95% CI, 0.3-0.5 mEq l(-1)). A consistent reduction of albuminuria across these studies was also demonstrated. MRA further reduced SBP and DBP in patients with hypertension and DM already taking RAS inhibitors. Serum potassium levels should be monitored to prevent hyperkalemia.

[Efficacy of antiseptics in the prevention of post-operative infections of the proximal femur, hip and pelvis regions in orthopedic pediatric patients. Analysis of the first results].

PubMed

Kokavec, M; Fristáková, M

2008-04-01

In orthopedics an infected operative wound always presents a serious complication that, apart from many adverse effects on the patient, increases the costs of therapy. The aim of this study was to analyze the effectiveness of antiseptic agents in the prevention of postoperative complications associated with surgery on the proximal femur, hip and pelvis in children. This prospective randomized study included 162 patients with the following diagnoses: cerebral palsy, developmental hip dysplasia, Perthes' disease, epiphyseolysis of the femoral head, and tumors. A total of 182 surgical procedures were carried out on soft and bone tissues in the proximal femur, hip and pelvis regions. The patients were allocated to two groups according to the intra-operative conditions used. Group 1, including 89 patients, was treated with 3.5 % solution of betadine before final closing of the wound and group 2, comprising 73 patients, received no betadine irrigation during the intraoperative period. The other operative and post-operative conditions provided for the patients were identical; surgery was carried out in one operating theatre without laminar air flow. The average follow-up was 7.8 months (range, 2-14 months). No infected operative wound was observed in group 1, and two superficial wound infections were recorded in group 2. The first results of our study suggest the need of prophylactic intra-operative irrigation of wounds in the hip and pelvis region. Irrigation with a diluted betadine solution is indicated in accord with the risk factors of the patient's diagnosis and the site of surgery, and also when the operative time is longer, there is insufficient protection with single-use surgical toweling, laminar air flow is present in the operating theatre or for other reasons.

Efficacy of high-intensity focused ultrasound-assisted hepatic resection (HIFU-AR) on blood loss reduction in patients with liver metastases requiring hepatectomy: study protocol for a randomized controlled trial.

PubMed

Dupré, Aurélien; Pérol, David; Blanc, Ellen; Peyrat, Patrice; Basso, Valéria; Chen, Yao; Vincenot, Jérémy; Kocot, Anthony; Melodelima, David; Rivoire, Michel

2017-02-06

Liver resection is the only potentially curative treatment for colorectal liver metastases (LM). It is considered a safe procedure, but is often associated with blood loss during liver transection. Blood transfusions are frequently needed, but they are associated with increased morbidity and risk of recurrence. Many surgical devices have been developed to decrease blood loss. However, none of them has proven superior to the standard crushing technique. We developed a new, powerful intra-operative high-intensity focused ultrasound (HIFU) transducer which destroys tissue by coagulative necrosis. We aim to evaluate whether HIFU-assisted liver resection (HIFU-AR) results in reduced blood loss. This is a prospective, single-centre, randomized (1:1 ratio), comparative, open-label phase II study. Patients with LM requiring a hepatectomy for ≥ 2 segments will be included. Patients with cirrhosis or sinusoidal obstruction syndrome with portal hypertension will be excluded. The primary endpoint is normalized blood loss in millilitres per square centimetre of liver section plane. Secondary endpoints are: total blood loss, transection time, transection time per square centimetre of liver area, haemostasis time, clip density on the liver section area, rate and duration of the Pringle manœuvre, rate of patients needing a blood transfusion, length of hospital stay, morbidity, patients with positive resection margin, and local recurrence. Assuming a blood loss of 7.6 ± 3.7 mL/cm 2 among controls, the study will have 85% power to detect a twofold decrease of blood loss in the experimental arm, using a Wilcoxon (Mann-Whitney) rank-sum test with a 0.05 two-sided significance level. Twenty-one randomized patients per arm are required. Considering the risk of contraindications at surgery, up to eight patients may be enrolled in addition to the 42 planned, with an enrolment period of 24 months. Randomization will be stratified by surgeon. We previously demonstrated the safety and efficacy of intra-operative HIFU in patients operated on for LM. We also demonstrated the efficacy of HIFU-AR in a preclinical study. Participants in the HIFU-AR group of this randomized trial can expect to benefit from reduced blood loss and decreased ischemia of liver parenchyma. Clinicaltrial.gov, NCT02728167 . Registered on 22 March 2016.

The efficacy of hypotonic and near-isotonic saline for parenteral fluid therapy given at low maintenance rate in preventing significant change in plasma sodium in post-operative pediatric patients: protocol for a prospective randomized non-blinded study

PubMed Central

2011-01-01

Background Hyponatremia is the most frequent electrolyte abnormality observed in post-operative pediatric patients receiving intravenous maintenance fluid therapy. If plasma sodium concentration (p-Na+) declines to levels below 125 mmol/L in < 48 h, transient or permanent brain damage may occur. There is an intense debate as to whether the administered volume (full rate vs. restricted rate of infusion) and the composition of solutions used for parenteral maintenance fluid therapy (hypotonic vs. isotonic solutions) contribute to the development of hyponatremia. So far, there is no definitive pediatric data to support a particular choice of parenteral fluid for maintenance therapy in post-surgical patients. Methods/Design Our prospective randomized non-blinded study will be conducted in healthy children and adolescents aged 1 to 14 years who have been operated for acute appendicitis. Patients will be randomized either to intravenous hypotonic (0.23% or 0.40% sodium chloride in glucose, respectively) or near-isotonic (0.81% sodium chloride in glucose) solution given at approximately three-fourths of the average maintenance rate. The main outcome of interest from this study is to evaluate 24 h post-operatively whether differences in p-Na+ between treatment groups are large enough to be of clinical relevance. In addition, water and electrolyte balance as well as regulatory hormones will be measured. Discussion This study will provide valuable information on the efficacy of hypotonic and near-isotonic fluid therapy in preventing a significant decrease in p-Na+. Finally, by means of careful electrolyte and water balance and by measuring regulatory hormones our results will also contribute to a better understanding of the physiopathology of post-operative changes in p-Na+ in a population at risk for hyponatremia. Trial registration The protocol for this study is registered with the current controlled trials registry; registry number: ISRCTN43896775. PMID:21729308

Preemptive carprofen for peri-operative analgesia in dogs undergoing Tibial Plateau Leveling Osteotomy (TPLO): a prospective, randomized, blinded, placebo controlled clinical trial.

PubMed

Bufalari, A; Maggio, C; Cerasoli, I; Morath, U; Adami, C

2012-03-01

Eighteen client-owned dogs undergoing Tibial Plateau Leveling Osteotomy (TPLO) were included in this blinded clinical study and randomly assigned to one of two treatment groups. Group C (carprofen) received intravenous (IV) carprofen, 4 mg/kg, prior to anesthesia, whereas group P (placebo) received IV saline. General anesthesia was maintained with isoflurane in oxygen and a constant rate infusion (CRI) of sufentanyl IV. Intra-operatively, assessment of nociception was based on changes in physiological parameters and on the analgesics requirement, whereas in the post-operative period evaluation of pain was performed by using a Hellyer and Gaynor pain score and by comparing the doses of rescue buprenorphine required by the two treatment groups. Although no statistically significant differences in intra-operative sufentanyl doses were found between treatment groups, group C had superior cardiovascular stability, and lower post-operative pain scores and rescue buprenorphine doses than group P. Our results indicate that administration of carprofen prior to surgery was effective in improving peri-operative analgesia in dogs undergoing TPLO.

Comparison of the changes in blood glucose level during sedation with midazolam and propofol in implant surgery: a prospective randomized clinical trial.

PubMed

Kaviani, Nasser; Koosha, Farzad; Shahtusi, Mina

2014-09-01

Reducing the patients' stress can prevent, or at least, limit the increase in blood glucose level. The study compares the effect of propofol and midazolam on blood glucose level in the patients undergoing dental implant surgery. The effect of pre-operational stress on blood glucose level during the surgery is also evaluated. This prospective randomized clinical trial recruited 33 patients undergoing dental implant surgery and divided into two groups. Conscious sedation was performed by midazolam in one group and with propofol in another group. The pre-operational stress was scored and the blood glucose level was measured in 4 different stages; before the operation, two minutes after the local anesthetic injection; thirty minutes after the onset of operation and at the end of the operation. The results were analyzed by employing ANOVA and Pearson test. The p Value was adopted 0.05 and the confidence coefficient was assumed 95%. The average levels of the blood glucose in midazolam and propofol group were 93.82 mg/dl and 94 mg/dl before the operation which displayed a meaningful increase of blood glucose level in both groups as the operation went on. The values were 103.76 mg/dl for midazolam and 108.56 mg/dl for the propofol group (p< 0.05) at the end of the operation. No statistically significant difference was found in the average blood glucose level between two groups in the different stages of the operation (p= 0.466). The Pearson correlation coefficient test revealed a higher increase in the blood glucose level in the patients with a higher pre-operational stress score (r= 0.756, p< 0.001). Based on the results yielded by this study, patients who receive venous sedation, either by midazolam or propofol, experience increase in the blood glucose level while undergoing an operation. No statistically significant difference was detected between midazolam and propofol.

A prospective, single-arm study on the use of the da Vinci® Table Motion with the Trumpf TS7000dV operating table.

PubMed

Morelli, Luca; Palmeri, Matteo; Simoncini, Tommaso; Cela, Vito; Perutelli, Alessandra; Selli, Cesare; Buccianti, Piero; Francesca, Francesco; Cecchi, Massimo; Zirafa, Cristina; Bastiani, Luca; Cuschieri, Alfred; Melfi, Franca

2018-03-30

The da Vinci® Table Motion (dVTM) comprises a combination of a unique operating table (Trumpf Medical™ TruSystem® 7000dV) capable of isocenter motion connected wirelessly with the da Vinci Xi® robotic platform, thereby enabling patients to be repositioned without removal of instruments and or undocking the robot. Between May 2015 to October 2015, the first human use of dVTM was carried out in this prospective, single-arm, post-market study in the EU, for which 40 patients from general surgery (GS), urology (U), or gynecology (G) were enrolled prospectively. Primary endpoints of the study were dVTM feasibility, efficacy, and safety. Surgeons from the three specialties obtained targeting success and the required table positioning in all cases. Table movement/repositioning was necessary to gain exposure of the operating field in 106/116 table moves (91.3%), change target in 2/116 table moves (1.7%), achieve hemodynamic relief in 4/116 table moves (3.5%), and improve external access for tumor removal in 4/116 table moves (3.5%). There was a significantly higher use of tilt and tilt plus Trendelenburg in GS group (GS vs. U p = 0.055 and GS vs. G p = 0.054). There were no dVTM safety-related or adverse events. The dVTM with TruSystem 7000dV operating table in wireless communication with the da Vinci Xi is a perfectly safe and effective synergistic combination, which allows repositioning of the patient whenever needed without imposing any delay in the execution of the operation. Moreover, it is helpful in avoiding extreme positions and enables the anesthesiologist to provide immediate and effective hemodynamic relief to the patient when needed.

Rotator Cuff Calcific Tendinopathy: Randomized Comparison of US-guided Percutaneous Treatments by Using One or Two Needles.

PubMed

Orlandi, Davide; Mauri, Giovanni; Lacelli, Francesca; Corazza, Angelo; Messina, Carmelo; Silvestri, Enzo; Serafini, Giovanni; Sconfienza, Luca Maria

2017-11-01

Purpose To determine whether the use of one or two needles influences procedure performance and patient outcomes for ultrasonography (US)-guided percutaneous irrigation of calcific tendinopathy. Materials and Methods Institutional review board approval and written informed patient consent were obtained. From February 2012 to December 2014, 211 patients (77 men and 134 women; mean age, 41.6 years ± 11.6; range, 24-69 years) with painful calcific tendinopathy diagnosed at US were prospectively enrolled and randomized. Operators subjectively graded calcifications as hard, soft, or fluid according to their appearance at US. US-guided percutaneous irrigation of calcific tendinopathy (local anesthesia, needle lavage, intrabursal steroid injection) was performed in 100 patients by using the single-needle procedure and in 111 patients by using the double-needle procedure. Calcium dissolution was subjectively scored (easy = 1; intermediate = 2; difficult = 3). Procedure duration was recorded. Clinical evaluation was performed by using the Constant score up to 1 year after the procedure. The occurrence of postprocedural bursitis was recorded. Mann-Whitney U, χ 2 , and analysis of variance statistics were used. Results No difference in procedure duration was seen overall (P = .060). Procedure duration was shorter with the double-needle procedure in hard calcifications (P < .001) and with the single-needle procedure in fluid calcifications (P = .024). Ease of calcium dissolution was not different between single- and double-needle procedures, both overall and when considering calcification appearance (P > .089). No clinical differences were found (Constant scores for single-needle group: baseline, 55 ± 7; 1 month, 69 ± 7; 3 month, 90 ± 5; 1 year, 92 ± 4; double-needle group: 57 ± 6; 71 ± 9; 89 ± 7; 92 ± 4, respectively; P = .241). In the single-needle group, nine of 100 cases (9%) of postprocedural bursitis were seen, whereas four of 111 cases (3.6%) were seen in the double-needle group (P = .180). Conclusion The only difference between using the single- or double-needle procedure when performing US-guided percutaneous irrigation of calcific tendinopathy is procedure duration in hard and fluid calcifications. Clinical outcomes are similar up to 1 year. © RSNA, 2017.

Improvement of nutritional support strategies after surgery for benign liver tumor through nutritional risk screening: a prospective, randomized, controlled, single-blind clinical study.

PubMed

Lu, Xin; Li, Ying; Yang, Huayu; Sang, Xinting; Zhao, Haitao; Xu, Haifeng; Du, Shunda; Xu, Yiyao; Chi, Tianyi; Zhong, Shouxian; Yu, Kang; Mao, Yilei

2013-02-01

The rising of individualized therapy requires nutritional risk screening has become a major topic for each particular disease, yet most of the screenings were for malignancies, less for benign diseases. There is no report on the screening of patients with benign liver tumors postoperatively. We aim to evaluate the nutritional support strategies post operation for benign liver tumors through nutritional risk screening. In this prospective, randomized, controlled study, 95 patients who underwent hepatectomy for benign tumors were divided into two groups. Fifty patients in the control group were given routine permissive underfeeding nutritional supply (75 kJ/kg/d), and 45 patients in the experimental group were given lower energy (42 kJ/kg/d) in accordance of their surgical trauma. Routine blood tests, liver/kidney function were monitored before surgery and at the day 1, 3, 5, 9 after surgery, patients were observed for the time of flatus, complications, length of hospitalization (LOH), nutrition-related costs, and other clinical parameters. This completed study is registered with Clinicaltrials.gov, number NCT01292330. The nutrition-related expenses (494.0±181.0 vs. 1,514.4±348.4 RMB, P<0.05) and the total hospital costs (18,495.2±4735.0 vs. 21,432.7±8,291.2 RMB, P<0.05) for patients in the experimental group were significantly lower than those in the control group. Meanwhile, the lowered energy supply after the surgeries did not have adverse effects on clinical parameters, complications, and LOH. Patient with benign liver tumors can adopt an even lower postoperative nutritional supply that close to that for mild non-surgical conditions, and lower than the postoperative permissive underfeeding standard.

Effect of number and position of intraocular lens haptics on anterior capsule contraction: a randomized, prospective trial.

PubMed

Choi, Mihyun; Lazo, Marjorie Z; Kang, Minji; Lee, Jeehye; Joo, Choun-Ki

2018-03-20

The present study aimed to evaluate the degree of anterior capsule contraction (capsulorhexis contraction) with three different single-piece, hydrophilic acrylic intraocular lenses (IOLs). Patients were prospectively randomized to be implanted with one of three types of IOLs during cataract surgery: the Ophtec Precizon (IOL A), the Lucid Korea Microflex (IOL B), and the Carl Zeiss Asphina (IOL C). One week, 2 weeks, and 6 months after surgery, the area of the anterior capsule opening was measured using digital retro-illumination images after dilation of the pupil. The data were then evaluated using POCOman software. The study included 236 eyes of 202 patients. The area of the anterior capsule opening reduced by 3.53 ± 3.31 mm (17.06% ± 15.99%) between 1 week and 2 months post-operatively in the IOL A group, by 0.62 ± 1.32 mm (2.87% ± 6.03%) in the IOL B group, and by 1.09 ± 1.53 mm (4.72% ± 6.10%) in the IOL C group. The IOL B group showed minimal anterior capsule contraction 2 months after surgery (p < 0.001). IOLs with a four-plate haptic design (IOL B) showed more anterior capsular stability than those with a two-loop plate haptic (IOL A) or two-plate haptic (IOL C) design. The number and position of haptics in a capsular bag may affect anterior capsule contraction. We assume that supporting the zonules evenly may play a role in anterior capsular stability. Current Controlled Trials ISRCTN76566080 , Retrospectively registered (Date of registration: 14 Feb 2018).

Surgical treatment of hepatocellular carcinoma: evidence-based outcomes.

PubMed

Yamazaki, Shintaro; Takayama, Tadatoshi

2008-02-07

Surgeons may be severely criticized from the perspective of evidence-based medicine because the majority of surgical publications appear not to be convincing. In the top nine surgical journals in 1996, half of the 175 publications refer to pilot studies lacking a control group, 18% to animal experiments, and only 5% to randomized controlled trials (RCT). There are five levels of clinical evidence: level 1 (randomized controlled trial), level 2 (prospective concurrent cohort study), level 3 (retrospective historical cohort study), level 4 (pre-post study), and level 5 (case report). Recently, a Japanese evidence-based guideline for the surgical treatment of hepatocellular carcinoma (HCC) was made by a committee (Chairman, Professor Makuuchi and five members). We searched the literature using the Medline Dialog System with four keywords: HCC, surgery, English papers, in the last 20 years. A total of 915 publications were identified systematically reviewed. At the first selection (in which surgery-dominant papers were selected), 478 papers survived. In the second selection (clearly concluded papers), 181 papers survived. In the final selection (clinically significant papers), 100 papers survived. The evidence level of the 100 surviving papers is shown here: level-1 papers (13%), level-2 papers (11%), level-3 papers (52%), and level-4 papers (24%); therefore, there were 24% prospective papers and 76% retrospective papers. Here, we present a part of the guideline on the five main surgical issues: indication to operation, operative procedure, peri-operative care, prognostic factor, and post-operative adjuvant therapy.

Surgical treatment of hepatocellular carcinoma: Evidence-based outcomes

PubMed Central

Yamazaki, Shintaro; Takayama, Tadatoshi

2008-01-01

Surgeons may be severely criticized from the perspective of evidence-based medicine because the majority of surgical publications appear not to be convincing. In the top nine surgical journals in 1996, half of the 175 publications refer to pilot studies lacking a control group, 18% to animal experiments, and only 5% to randomized controlled trials (RCT). There are five levels of clinical evidence: level 1 (randomized controlled trial), level 2 (prospective concurrent cohort study), level 3 (retrospective historical cohort study), level 4 (pre-post study), and level 5 (case report). Recently, a Japanese evidence-based guideline for the surgical treatment of hepatocellular carcinoma (HCC) was made by a committee (Chairman, Professor Makuuchi and five members). We searched the literature using the Medline Dialog System with four keywords: HCC, surgery, English papers, in the last 20 years. A total of 915 publications were identified systematically reviewed. At the first selection (in which surgery-dominant papers were selected), 478 papers survived. In the second selection (clearly concluded papers), 181 papers survived. In the final selection (clinically significant papers), 100 papers survived. The evidence level of the 100 surviving papers is shown here: level-1 papers (13%), level-2 papers (11%), level-3 papers (52%), and level-4 papers (24%); therefore, there were 24% prospective papers and 76% retrospective papers. Here, we present a part of the guideline on the five main surgical issues: indication to operation, operative procedure, peri-operative care, prognostic factor, and post-operative adjuvant therapy. PMID:18205256

Two medical abortion regimens for late first-trimester termination of pregnancy: a prospective randomized trial.

PubMed

Dalenda, Chelly; Ines, Najar; Fathia, Boudaya; Malika, Affes; Bechir, Zouaoui; Ezzeddine, Sfar; Hela, Chelly; Badis, Channoufi Mohamed

2010-04-01

Medical abortion regimens based on the use of either misoprostol alone or in association with mifepristone have shown high efficacy and excellent safety profile in early pregnancy abortion. However, no clear recommendation is available for late first-trimester termination of pregnancy. A prospective randomized controlled trial included 122 women seeking medical abortion at 9 to 12 weeks of gestation. Seventy-three patients were given a fixed protocol of 200 mg of mifepristone followed 48 h later by 400 mcg oral misoprostol (Group 1). The second group of 49 patients was administered 800-mcg intravaginal single-dose misoprostol (Group 2). This study sought to compare safety, efficacy and acceptability of these two nonsurgical abortion regimens. Fifty-nine (80.8%) women in Group 1 had complete abortion vs. 38 (77.4%) women in Group 2 (p=.66). Abdominal pain was observed significantly more often in Group 2 (35/49 (71.4%) vs. 32/73 (43.8%) in Group 1, p<.0001. Medical abortion was equally acceptable among the two groups [37/49 (75.5%) and 55/73 (75.7%), p=.89]. For late first-trimester termination, a single 800-mcg vaginal dose of misoprostol seems to be as effective as the mifepristone+misoprostol regimen, with acceptable side effects. Copyright 2010 Elsevier Inc. All rights reserved.

Prospective, randomized, controlled trial of polymer cable ties versus standard wire closure of midline sternotomy.

PubMed

Marasco, Silvana F; Fuller, Louise; Zimmet, Adam; McGiffin, David; Seitz, Michael; Ch'ng, Stephanie; Gangahanumaiah, Shivanand; Bailey, Michael

2018-04-16

Midline sternotomy remains the most common access incision for cardiac operations. Traditionally, the sternum is closed with stainless steel wires. Wires are well known to stretch and break, however, leading to pain, nonunion, and potential deep sternal wound infection. We hypothesized that biocompatible plastic cable ties would achieve a more rigid sternal fixation, reducing postoperative pain and analgesia requirements. A prospective, randomized study compared the ZIPFIX (De Puy Synthes, West Chester, Pa) sternal closure system (n = 58) with standard stainless steel wires (n = 60). Primary outcomes were pain and analgesia requirements in the early postoperative period. Secondary outcome was sternal movement, as assessed by ultrasound at the postoperative follow-up visit. Groups were well matched in demographic and operative variables. There were no significant differences between groups in postoperative pain, analgesia, or early ventilatory requirements. Patients in the ZIPFIX group had significantly more movement in the sternum and manubrium on ultrasound at 4 weeks. ZIPFIX sternal cable ties provide reliable closure but no demonstrable benefit in this study in pain or analgesic requirements relative to standard wire closure after median sternotomy. Crown Copyright © 2018. Published by Elsevier Inc. All rights reserved.

Novel approach of single-port laparoscopic appendectomy as a solo surgery: A prospective cohort study.

PubMed

Kim, Say-June; Choi, Byung-Jo; Lee, Sang Chul

2015-09-01

Recent advances in medical equipment and surgical techniques have enabled solo surgery, wherein a surgeon operates alone without the participation of other surgical members. However, the application of solo surgery in single-port laparoscopic surgery (SPLS) has been rarely reported. Prospectively collected databases of 60 patients who underwent solo-SPLS for appendicitis between March 2013 and June 2014 were retrospectively reviewed. Making a transumbilical incision into the peritoneal cavity was facilitated by using a Lone Star self-retaining retractor. After the establishment of a single port through the umbilicus, we installed a mechanical adjustable camera holder (Endoworld®LAP53 Holding Systems). It was anchored to the operating table rail and firmly held the laparoscope with a possibility to adjust the same as required by the operator. The operative method was identical to the SPLS appendectomy, except for the use of these instruments. The median operation time was 50 min (25-120). None of the patients required open conversion, insertion of an additional port or help of a human assistant. The median length of hospital stay for all patients was 1.0 day (range: 1-3 days). The median dosage of required intravenous analgesics (ketorolac, 0.1 mg/kg of body weight) was 0.0 ampoule (0-4). The median interval to initiation of solid diet was 1 day (1-2). The incidence of postoperative complications was 8.3% (5/60). Our results shows that solo-SPLS appendectomy could be performed without increasing operation time or postoperative complications when performed by a surgeon competent in performing SPLS appendectomy. Copyright © 2015. Published by Elsevier Ltd.

Comparison of two nasoalveolar molding techniques in unilateral complete cleft lip patients: a randomized, prospective, single-blind trial to compare nasal outcomes.

PubMed

Chang, Chun-Shin; Wallace, Christopher Glenn; Pai, Betty Chien-Jung; Chiu, Yu-Ting; Hsieh, Yuh-Jia; Chen, I-Ju; Liao, Yu-Fang; Liou, Eric Jen-Wein; Chen, Philip Kuo-Ting

2014-08-01

Nasoalveolar molding became increasingly popular in the 1990s as a means of easing surgery and improving nasal outcomes for cleft lip repairs. In the late 1990s, three orthodontists from our center underwent nasoalveolar molding training: two at the Rush Craniofacial Center, in Chicago; and one at New York University Craniofacial Center. They brought two different nasoalveolar molding techniques back to Chang Gung Craniofacial Center: the modified Figueroa and the modified Grayson techniques. Outcomes following use of these techniques have not previously been compared prospectively. Between May of 2010 and March of 2013, a randomized, prospective, single-blind trial was conducted to compare the number of clinical visits, total costs, complications, and nasal symmetry between the two nasoalveolar molding techniques in 30 patients with unilateral complete cleft lip. There were no differences between nasoalveolar molding techniques in the number of clinical visits, total costs, nostril height, or nostril area ratio. Preoperatively but after nasoalveolar molding, the nostril width ratio was wider for the Figueroa group than for the Grayson group. Six months after surgical correction, there were no differences in nostril height, nostril width, nasal sill height, or nostril area ratio between nasoalveolar molding methods. Alveolar ulceration occurred more frequently in the Grayson group. The modified Grayson technique reduced nostril width more efficiently, but alveolar ulceration was more frequent and no differences in nostril width were found following surgery. Overall, the two nasoalveolar molding techniques produced similar nasal outcomes. Therapeutic, II.

Current challenges for clinical trials of cardiovascular medical devices.

PubMed

Zannad, Faiez; Stough, Wendy Gattis; Piña, Ileana L; Mehran, Roxana; Abraham, William T; Anker, Stefan D; De Ferrari, Gaetano M; Farb, Andrew; Geller, Nancy L; Kieval, Robert S; Linde, Cecilia; Redberg, Rita F; Stein, Kenneth; Vincent, Alphons; Woehrle, Holger; Pocock, Stuart J

2014-07-15

Several features of cardiovascular devices raise considerations for clinical trial conduct. Prospective, randomized, controlled trials remain the highest quality evidence for safety and effectiveness assessments, but, for instance, blinding may be challenging. In order to avoid bias and not confound data interpretation, the use of objective endpoints and blinding patients, study staff, core labs, and clinical endpoint committees to treatment assignment are helpful approaches. Anticipation of potential bias should be considered and planned for prospectively in a cardiovascular device trial. Prospective, single-arm studies (often referred to as registry studies) can provide additional data in some cases. They are subject to selection bias even when carefully designed; thus, they are generally not acceptable as the sole basis for pre-market approval of high risk cardiovascular devices. However, they complement the evidence base and fill the gaps unanswered by randomized trials. Registry studies present device safety and effectiveness in day-to-day clinical practice settings and detect rare adverse events in the post-market period. No single research design will be appropriate for every cardiovascular device or target patient population. The type of trial, appropriate control group, and optimal length of follow-up will depend on the specific device, its potential clinical benefits, the target patient population and the existence (or lack) of effective therapies, and its anticipated risks. Continued efforts on the part of investigators, the device industry, and government regulators are needed to reach the optimal approach for evaluating the safety and performance of innovative devices for the treatment of cardiovascular disease. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Low-pressure capnoperitoneum reduces stress responses during pediatric laparoscopic high ligation of indirect inguinal hernia sac: A randomized controlled study.

PubMed

Niu, Xiaoguang; Song, Xubin; Su, Aiping; Zhao, Shanshan; Li, Qinghao

2017-04-01

We aimed to evaluate the effect of different capnoperitoneum pressures on stress responses in pediatric laparoscopic inguinal hernia repair. In this prospective randomized controlled study, 68 children with indirect inguinal hernia who underwent high ligation of hernia sac were randomly divided into 3 groups: high-pressure group (12 mm Hg, HP group, n = 26); low-pressure group (8 mm Hg, LP group, n = 20); open operation group (OP group, n = 22). Heart rate (HR), blood pressure, and end-tidal CO2 (PetCO2) were recorded, as well as the levels of adrenocorticotropic hormone (ACTH) and cortisol (COR) were measured by ELISAs before operation, during operation, and after operation, respectively. After establishing capnoperitoneum, HR, blood pressure, and PetCO2 were significantly increased in the HP group compared with the OP and LP groups (P < 0.05). Comparing the intraoperatively measured ACTH and COR concentrations of the HP group to the LP group, we noted higher values in the first (P < 0.05). There was no significant difference in the postoperative concentrations of ACTH and COR among the HP, LP, and OP groups. Laparoscopic surgery under LP capnoperitoneum or open operation may reduce stress responses and are superior to HP capnoperitoneum.

Operative correction of abdominal rectus diastasis (ARD) reduces pain and improves abdominal wall muscle strength: A randomized, prospective trial comparing retromuscular mesh repair to double-row, self-retaining sutures.

PubMed

Emanuelsson, Peter; Gunnarsson, Ulf; Dahlstrand, Ursula; Strigård, Karin; Stark, Birgit

2016-11-01

The primary aim of this prospective, randomized, clinical, 2-armed trial was to evaluate the risk for recurrence using 2 different operative techniques for repair of abdominal rectus diastasis. Secondary aims were comparison of pain, abdominal muscle strength, and quality of life and to compare those outcomes to a control group receiving physical training only. Eighty-six patients were enrolled. Twenty-nine patients were allocated to retromuscular polypropylene mesh and 27 to double-row plication with Quill technology. Thirty-two patients participated in a 3-month training program. Diastasis was evaluated with computed tomography scan and clinically. Pain was assessed using the ventral hernia pain questionnaire, a quality-of-life survey, SF-36, and abdominal muscle strength using the Biodex System-4. One early recurrence occurred in the Quill group, 2 encapsulated seromas in the mesh group, and 3 in the suture group. Significant improvements in perceived pain, the ventral hernia pain questionnaire, and quality of life appeared at the 1-year follow-up with no difference between the 2 operative groups. Significant muscular improvement was obtained in all groups (Biodex System-4). Patient perceived gain in muscle strength assessed with a visual analog scale improved similarly in both operative groups. This improvement was significantly greater than that seen in the training group. Patients in the training group still experienced bodily pain at follow-up. There was no difference between the Quill technique and retromuscular mesh in the effect on abdominal wall stability, with a similar complication rate 1 year after operation. An operation improves functional ability and quality of life. Training strengthens the abdominal muscles, but patients still experience discomfort and pain. Copyright © 2016 Elsevier Inc. All rights reserved.

A novel hand-assisted laparoscopic versus conventional laparoscopic right hemicolectomy for right colon cancer: study protocol for a randomized controlled trial.

PubMed

Yang, Xuyang; Wu, Qingbin; Jin, Chengwu; He, Wanbin; Wang, Meng; Yang, Tinghan; Wei, Mingtian; Deng, Xiangbing; Meng, Wenjian; Wang, Ziqiang

2017-07-26

Although conventional laparoscopic and hand-assisted laparoscopic surgery for colorectal cancer is widely used today, there remain many technical challenges especially for right colon cancer in obese patients. Herein, we develop a novel hand-assisted laparoscopic surgery (HALS) with complete mesocolic excision (CME), D3 lymphadenectomy, and a total "no-touch" isolation technique (HALS-CME) in right hemicolectomy to overcome these issues. According to previous clinic practice, this novel procedure is not only feasible and safe but has several technical merits. However, the feasibility, short-term minimally invasive virtues, long-term oncological superiority, and potential total "no-touch" isolation technique benefits of HALS-CME should be confirmed by a prospective randomized controlled trial. This is a single-center, open-label, noninferiority, randomized controlled trial. Eligible participants will be randomly assigned to the HALS-CME group or to the laparoscopic surgery with CME, D3 lymphadenectomy, and total "no-touch" isolation technique (LAP-CME) group, or to conventional laparoscopic surgery with CME and D3 lymphadenectomy (cLAP) group at a 1:1:1 ratio using a centralized randomization list. Primary endpoints include safety, efficacy, and being oncologically clear, and 3-year disease-free, progression-free, and overall survival. Second endpoints include operative outcomes (operation time, blood loss, and incision length), pathologic evaluation (grading the plane of surgery, length of proximal and distal resection margins, distance between the tumor and the central arterial high tie, distance between the nearest bowel wall and the same high tie, area of mesentery resected, width of the chain of lymph-adipose tissue, length of the central lymph-adipose chain, number of harvested lymph nodes), and postoperative outcomes (pain intensity, postoperative inflammatory and immune responses, postoperative recovery). This trial will provide valuable clinical evidence for the feasibility, safety, and potential total "no-touch" isolation technique benefits of HALS-CME for right hemicolectomy. The hypothesis is that HALS-CME is feasible for the radical D3 resection of right colon cancer and offers short-term safety and long-term oncological superiority compared with conventional laparoscopic surgery. ClinicalTrials.gov, NCT02625272 . Registered on 8 December 2015.

A liberal preoperative fasting regimen improves patient comfort and satisfaction with anesthesia care in day-stay minor surgery.

PubMed

Bopp, C; Hofer, S; Klein, A; Weigand, M A; Martin, E; Gust, R

2011-07-01

The aim of this study was to evaluate whether a single preoperative limited oral intake of a carbohydrate drink could improve perioperative patient comfort and satisfaction with anesthesia care in elective day-stay ophthalmologic surgery. A single-center, prospective, randomized clinical trial was conducted in a university hospital. The study included ASA I-III patients undergoing ophthalmologic surgery. Patients undergoing both general anesthesia and local anesthesia were included in the study. The control group fasted in accordance to nil per os after midnight, while patients in the experimental group received 200 mL of a carbohydrate drink 2 h before the operation. Both groups were allowed to drink and eat until midnight ad libitum. Patient characteristics, subjective perceptions, taste of the drink, and satisfaction with anesthesia care were ascertained using a questionnaire administered three times: after the anesthesiologist's visit, before surgery and before discharge from the ward to assess patient comfort. An analysis of variance and the Mann-Whitney U-test were used for statistical analysis. A total of 123 patients were included and 109 patients were randomly assigned to one of two preoperative fasting regimens. Patients drinking 200 mL 2 h before surgery were not as hungry (P<0.05), not as thirsty preoperatively (P<0.001) and not as thirsty after surgery (P<0.05), resulting in increased postoperative satisfaction with anesthesia care (P<0.05). Standardized limited oral preoperative fluid intake increases patient comfort and satisfaction with anesthesia care and should be a part of modern day-stay ophthalmologic surgery.

Post endodontic pain following single-visit root canal preparation with rotary vs reciprocating instruments: a meta-analysis of randomized clinical trials.

PubMed

Hou, Xiao-Mei; Su, Zheng; Hou, Ben-Xiang

2017-05-25

In endodontic therapy, continuous rotary instrumentation reduced debris compared to reciprocal instrumentation, which might affect the incidence of post-endodontic pain (PP). The aim of our study was to assess whether PP incidence and levels were influenced by the choice of rotary or reciprocal instruments. In this meta-analysis the Pubmed and EM databases were searched for prospective clinical randomized trials published before April 20, 2016, using combinations of the keywords: root canal preparation/instrumentation/treatment/therapy; post-operative/endodontic pain; reciprocal and rotary instruments. Three studies were included, involving a total of 1,317 patients, 659 treated with reciprocating instruments and 658 treated with rotary instruments. PP was reported in 139 patients in the reciprocating group and 172 in the rotary group. The PP incidence odds ratio was 1.27 with 95% confidence interval (CI) (0.25, 6.52) favoring rotary instruments. The mild, moderate and severe PP levels odds ratios were 0.31 (0.11, 0.84), 2.24 (0.66, 7.59) and 11.71 (0.63, 218.15), respectively. No evidence of publication bias was found. Rotary instrument choice in endodontic therapy is associated with a lower incidence of PP than reciprocating instruments, while reciprocating instruments are associated with less mild PP incidence.

Post-operative pain following coblation or monopolar electrocautery tonsillectomy in children: a prospective, single-blinded, randomised comparison.

PubMed

Parker, N P; Walner, D L

2011-10-01

To compare post-operative pain following tonsillectomy by either coblation or monopolar electrocautery in children. A parallel-designed, prospective, single-blinded, randomised trial. Ambulatory surgical facility. Eighty otherwise healthy paediatric patients undergoing coblation or electrocautery tonsillectomy by a fellowship-trained paediatric otolaryngologist. (i) The number of post-operative days with severe pain based on subjective qualification by the caretaker, (ii) post-operative days with pain rated ≥ 5 on a scale of 1-10, (iii) post-operative days requiring oral paracetamol/acetaminophen with codeine solution and (iv) post-operative days until resumption of a regular diet were assessed and recorded daily using a post-operative pain survey as a form of daily diary that was returned at the 2-week follow-up visit. Patients were consecutively enrolled into two groups of 40 patients. Average ages were 5.2 years for coblation tonsillectomy and 6.0 years for electrocautery tonsillectomy. The average number of post-operative days with severe pain was 4.2 for coblation and 5.9 for electrocautery (P = 0.006), days rating pain ≥ 5 were 3.6 for coblation and 4.8 for electrocautery (P = 0.037), days of codeine use were 2.5 for coblation and 2.9 for electrocautery (P = 0.324), and days until resumption of a regular diet were 5.2 for coblation and 6.2 for electrocautery (0.329). Coblation tonsillectomy may reduce post-operative pain and the time until resumption of a regular diet compared to electrocautery tonsillectomy. © 2011 Blackwell Publishing Ltd.

The single chest tube versus double chest tube application after pulmonary lobectomy: A systematic review and meta-analysis.

PubMed

Zhang, Xuefei; Lv, Desheng; Li, Mo; Sun, Ge; Liu, Changhong

2016-12-01

Draining of the chest cavity with two chest tubes after pulmonary lobectomy is a common practice. The objective of this study was to evaluate whether using two tubes after a pulmonary lobectomy is more effective than using a single tube. We performed a meta-analysis of five randomized studies that compared the single chest tube with double chest tube application after pulmonary lobectomy. The primary end-point was amount of drainage and duration of chest tube drainage. The secondary end-points were the patient's numbers of new drain insertion after operation, hospital stay after operation, the patient's numbers of subcutaneous emphysema after operation, the patient's numbers of residual pleural air space, pain score, the number of patients who need thoracentesis, and cost. Five randomized controlled trials totaling 502 patients were included. Meta-analysis results are as follows: There were statistically significant differences in amount of drainage (risk ratio [RR] = -0.15; 95% confidence interval [CI] = -3.17, -0.12, P = 0. 03), duration of chest tube drainage (RR = -0.43; 95% CI = -0.57, -0.19, P = 0.02), pain score (P < 0.05). Compared with patients receiving the double chest tube group, there were no statistically significant differences between the two groups with regard to the patient's numbers of new drain insertion after operation. Compared with the double chest tube, the single chest tube significantly decreases amount of drainage, duration of chest tube drainage, pain score, the number of patients who need thoracentesis, and cost. Although there is convincing evidence to confirm the results mentioned herein, they still need to be confirmed by large-sample, multicenter, randomized, controlled trials.

Efficacy of clonidine versus phenobarbital in reducing neonatal morphine sulfate therapy days for neonatal abstinence syndrome. A prospective randomized clinical trial.

PubMed

Surran, B; Visintainer, P; Chamberlain, S; Kopcza, K; Shah, B; Singh, R

2013-12-01

To compare the efficacy of clonidine versus phenobarbital in reducing morphine sulfate treatment days for neonatal abstinence syndrome (NAS). Prospective, non-blinded, block randomized trial at a single level III NICU (Neonatal Intensive Care Unit). Eligible infants were treated with a combination of medications as per protocol. Primary outcome was treatment days with morphine sulfate. Secondary outcomes were the mean total morphine sulfate dose, outpatient phenobarbital days, adverse events and treatment failures. A total of 82 infants were eligible, of which 68 were randomized with 34 infants in each study group. Adjusting for covariates phenobarbital as compared with clonidine had shorter morphine sulfate treatment days (-4.6, 95% confidence interval (CI): -0.3, -8.9; P=0.037) with no difference in average morphine sulfate total dose (1.1 mg kg(-1), 95% CI: -0.1, 2.4; P=0.069). Post-discharge phenobarbital was continued for an average of 3.8 months (range 1 to 8 months). No other significant differences were noted. Phenobarbital as adjunct had clinically nonsignificant shorter inpatient but significant overall longer therapy time as compared with clonidine.

An anatomically sound surgical simulation model for myringotomy and tympanostomy tube insertion.

PubMed

Hong, Paul; Webb, Amanda N; Corsten, Gerard; Balderston, Janet; Haworth, Rebecca; Ritchie, Krista; Massoud, Emad

2014-03-01

Myringotomy and tympanostomy tube insertion (MT) is a common surgical procedure. Although surgical simulation has proven to be an effective training tool, an anatomically sound simulation model for MT is lacking. We developed such a model and assessed its impact on the operating room performance of senior medical students. Prospective randomized trial. A randomized single-blind controlled study of simulation training with the MT model versus no simulation training. Each participant was randomized to either the simulation model group or control group, after performing an initial MT procedure. Within two weeks of the first procedure, the students performed a second MT. All procedures were performed on real patients and rated with a Global Rating Scale by two attending otolaryngologists. Time to complete the MT was also recorded. Twenty-four senior medical students were enrolled. Control and intervention groups did not differ at baseline on their Global Rating Scale score or time to complete the MT procedure. Following simulation training, the study group received significantly higher scores (P=.005) and performed the MT procedure in significantly less time (P=.034). The control group did not improve their performance scores (P>.05) or the time to complete the procedure (P>.05). Our surgical simulation model shows promise for being a valuable teaching tool for MT for senior medical students. Such anatomically appropriate physical simulators may benefit teaching of junior trainees. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Minimizing the Disruptive Effects of Prospective Memory in Simulated Air Traffic Control

PubMed Central

Loft, Shayne; Smith, Rebekah E.; Remington, Roger

2015-01-01

Prospective memory refers to remembering to perform an intended action in the future. Failures of prospective memory can occur in air traffic control. In two experiments, we examined the utility of external aids for facilitating air traffic management in a simulated air traffic control task with prospective memory requirements. Participants accepted and handed-off aircraft and detected aircraft conflicts. The prospective memory task involved remembering to deviate from a routine operating procedure when accepting target aircraft. External aids that contained details of the prospective memory task appeared and flashed when target aircraft needed acceptance. In Experiment 1, external aids presented either adjacent or non-adjacent to each of the 20 target aircraft presented over the 40min test phase reduced prospective memory error by 11% compared to a condition without external aids. In Experiment 2, only a single target aircraft was presented a significant time (39min–42min) after presentation of the prospective memory instruction, and the external aids reduced prospective memory error by 34%. In both experiments, costs to the efficiency of non-prospective memory air traffic management (non-target aircraft acceptance response time, conflict detection response time) were reduced by non-adjacent aids compared to no aids or adjacent aids. In contrast, in both experiments, the efficiency of the prospective memory air traffic management (target aircraft acceptance response time) was facilitated by adjacent aids compared to non-adjacent aids. Together, these findings have potential implications for the design of automated alerting systems to maximize multi-task performance in work settings where operators monitor and control demanding perceptual displays. PMID:24059825

Prospective randomized assessment of single versus double-gloving for general surgical procedures.

PubMed

Na'aya, H U; Madziga, A G; Eni, U E

2009-01-01

There is increased tendency towards double-gloving by general surgeons in our practice, due probably to awareness of the risk of contamination with blood or other body fluids during surgery. The aim of the study was to compare the relative frequency of glove puncture in single-glove versus double glove sets in general surgical procedures, and to determine if duration of surgery affects perforation rate. Surgeons at random do single or double gloves at their discretion, for general surgical procedures. All the gloves used by the surgeons were assessed immediately after surgery for perforation. A total of 1120 gloves were tested, of which 880 were double-glove sets and 240 single-glove sets. There was no significant difference in the overall perforation rate between single and double glove sets (18.3% versus 20%). However, only 2.3% had perforations in both the outer and inner gloves in the double glove group. Therefore, there was significantly greater risk for blood-skin exposure in the single glove sets (p < 0.01). The perforation rate was also significantly greater during procedures lasting an hour or more compared to those lasting less than an hour (p < 0.01). Double-gloving reduces the risk of blood-skin contamination in all general surgical procedures, and especially so in procedures lasting an hour or more.

Comparison of caudal analgesia between ropivacaine and ropivacaine with clonidine in children: A randomized controlled trial

PubMed Central

Laha, Arpita; Ghosh, Sarmila; Das, Haripada

2012-01-01

Background: Addition of clonidine to ropivacaine (0.2%) can potentially enhance analgesia without producing prolonged motor blockade. The aim of the present study was to compare the post-operative pain relieving quality of ropivacaine 0.2% and clonidine mixture to that of plain ropivacaine 0.2% following caudal administration in children. Methods: In a prospective, double-blinded, randomized controlled trial, 30 ASA 1 pediatric patients undergoing infraumbilical surgery were randomly allocated to receive a caudal injection of either plain ropivacaine 0.2% (1 ml/kg) (group A) or a mixture of ropivacaine 0.2% (1 ml/kg) with clonidine 2 μg/kg (group B). Objective pain score and need for supplemental analgesics were compared during the 1st 24 hours postoperatively. Residual post-operative sedation and motor blockade were also assessed. Results: Significantly prolonged duration of post-operative analgesia was observed in group B (P<0.0001). Heart rate and blood pressure were not different in 2 groups. Neither motor blockade nor post-operative sedation varied significantly between the groups. Conclusion: The combination of clonidine (2 μg/kg) and ropivacaine 0.2% was associated with an improved quality of post-operative analgesia compared to plain 0.2% ropivacaine. The improved analgesic quality of the clonidine-ropivacaine mixture was achieved without causing any significant degree of post-operative sedation or prolongation of motor blockade. PMID:23162389

NASA's Single-Pilot Operations Technical Interchange Meeting: Proceedings and Findings

NASA Technical Reports Server (NTRS)

Comerford, Doreen; Brandt, Summer L.; Lachter, Joel B.; Wu, Shu-Chieh; Mogford, Richard H.; Battiste, Vernol; Johnson, Walter W.

2013-01-01

Researchers at the National Aeronautics and Space Administration (NASA) Ames Research Center and Langley Research Center are jointly investigating issues associated with potential concepts, or configurations, in which a single pilot might operate under conditions that are currently reserved for a minimum of two pilots. As part of early efforts, NASA Ames Research Center hosted a technical interchange meeting in order to gain insight from members of the aviation community regarding single-pilot operations (SPO). The meeting was held on April 10-12, 2012 at NASA Ames Research Center. Professionals in the aviation domain were invited because their areas of expertise were deemed to be directly related to an exploration of SPO. NASA, in selecting prospective participants, attempted to represent various relevant sectors within the aviation domain. Approximately 70 people representing government, academia, and industry attended. A primary focus of this gathering was to consider how tasks and responsibilities might be re-allocated to allow for SPO.

Myocardial revascularization with miniaturized extracorporeal circulation versus off pump: Evaluation of systemic and myocardial inflammatory response in a prospective randomized study.

PubMed

Formica, Francesco; Broccolo, Francesco; Martino, Antonello; Sciucchetti, Jennifer; Giordano, Vincenzo; Avalli, Leonello; Radaelli, Gianluigi; Ferro, Orazio; Corti, Fabrizio; Cocuzza, Clementina; Paolini, Giovanni

2009-05-01

This prospective randomized study sought to verify the systemic inflammatory response, inflammatory myocardial damage, and early clinical outcome in coronary surgery with the miniaturized extracorporeal circulation system or on the beating heart. Sixty consecutive patients were randomized to miniaturized extracorporeal circulation (n = 30) or off-pump coronary revascularization (off-pump coronary artery bypass grafting, n = 30). Intraoperative and postoperative data were recorded. Plasma levels of interleukin-6 and tumor necrosis factor-alpha were measured from systemic blood intraoperatively, at the end of operation, and 24 and 48 hours thereafter. Levels of the same markers and blood lactate were measured from coronary sinus blood intraoperatively to evaluate myocardial inflammation. Markers of myocardial damage were also analyzed. One patient died in the off-pump coronary artery bypass grafting group. There was no statistical difference in early clinical outcome in both groups. Release of interleukin-6 was higher in the off-pump coronary artery bypass grafting group 24 hours after the operation (P = .03), whereas levels of tumor necrosis factor-alpha were not different in both groups. Cardiac release of interleukin-6, tumor necrosis factor-alpha, and blood lactate were not different in both groups. Release of troponin T was not significantly different in both groups. Levels of creatine kinase mass were statistically higher in the miniaturized extracorporeal circulation group than in the off-pump coronary artery bypass grafting group, but only at the end of the operation (P < .0001). Hemoglobin levels were significantly higher in the miniaturized extracorporeal circulation group than in the off-pump coronary artery bypass grafting group after 24 hours (P = .01). Miniaturized extracorporeal circulation can be considered similar to off-pump surgery in terms of systemic inflammatory response, myocardial inflammation and damage, and early outcome.

Real-time ultrasound-guided PCNL using a novel SonixGPS needle tracking system.

PubMed

Li, Xiang; Long, Qingzhi; Chen, Xingfa; He, Dalin; Dalin, He; He, Hui

2014-08-01

SonixGPS is a successful ultrasound guidance position system. It helps to improve accuracy in performing complex puncture operations. This study firstly used SonixGPS to perform kidney calyx access in PCNL to investigate its effectiveness and safety. This was a prospectively randomized controlled study performed from September 2011 to October 2012. A total of 97 patients were prospectively randomized into two groups using random number generated from SAS software. 47 Patients were enrolled in conventional ultrasound-guided (US-guided) group and 50 patients were classified into SonixGPS-guided group. Nine patients were lost during follow-up. Hence, a total of 88 patients were qualified and analyzed. Preoperative examinations included urine analysis, urine culture, kidney function, coagulation profile and routine analysis of blood. Ultrasonography was used to evaluate the degree of hydronephrosis. The intraoperative findings, including blood loss, operating time, time to successful puncture, the number of attempts for successful puncture and hospital stay were recorded. The stone clearance rate and complications were analyzed. The present study showed no significant difference between the two groups in terms of demographic data, preoperative markers, stone clearance rate and the stone composition. However, the time to successful puncture, the number of trials for successful puncture, operating time and hospital length of stay were significantly decreased in the SonixGPS-guided group. Furthermore, the hemoglobin decrease was also obviously lower in the SonixGPS group than that in conventional US-guided group. SonixGPS needle tacking system guided PCNL is safe and effective in treating upper urinary tract stones. This novel technology makes puncturing more accuracy and can significantly decrease the incidence of relative hemorrhage and accelerate recovery.

Fuzzy correlation analysis with realization

NASA Astrophysics Data System (ADS)

Tang, Yue Y.; Fan, Xinrui; Zheng, Ying N.

1998-10-01

The fundamental concept of fuzzy correlation is briefly discussed. Based on the correlation coefficient of classic correlation, polarity correlation and fuzzy correlation, the relationship between the correlations are analyzed. A fuzzy correlation analysis has the merits of both rapidity and accuracy as some amplitude information of random signals has been utilized. It has broad prospects for application. The form of fuzzy correlative analyzer with NLX 112 fuzzy data correlator and single-chip microcomputer is introduced.

A single-dose regimen for antimicrobial prophylaxis to prevent perioperative infection in urological clean and clean-contaminated surgery.

PubMed

Higuchi, Yoshihide; Takesue, Yoshio; Yamada, Yusuke; Ueda, Yasuo; Suzuki, Toru; Aihara, Kinue; Maruyama, Takuo; Kondoh, Nobuyuki; Nojima, Michio; Yamamoto, Shingo

2011-04-01

A single dose of antimicrobial prophylaxis (AMP) was administered parenterally for the prevention of perioperative infection in a total of 788 patients undergoing urological surgery, including 380 endoscopic-instrumental, 328 clean, and 80 clean-contaminated operations performed at our institute between January 2007 and December 2009. Surgical site infections (SSIs), urinary tract infections (UTIs), and remote infections (RIs) were prospectively surveyed. The definition for a single dose of AMP allowed for the administration of an additional dose of an antimicrobial during surgery if the procedure was longer than 3 h, but not for the parenteral or oral administration at the end of the procedure in the recovery room, or at a later time over a period of more than 24 h. UTI was observed in 12 (3.2%) patients after endoscopic-instrumental operation, 1 (0.3%) after clean operation, and 1 (0.9%) after clean-contaminated operation. SSI was observed in 2 (0.6%) patients after clean operation but in none after clean-contaminated operations. RI was observed in 1 (0.3%) patient after endoscopic-instrumental operation, 3 (0.9%) after clean operation, and none after clean-contaminated operations. A single-dose regimen of AMP was effective and feasible for the prevention of perioperative infections, including SSIs, UTIs, and RIs, in endoscopic-instrumental, clean, and clean-contaminated urological surgical procedures.

Fibrin adhesive is better than sutures in pterygium surgery.

PubMed

Ratnalingam, Vanitha; Eu, Andrew Lim Keat; Ng, Gim Leong; Taharin, Rohana; John, Elizabeth

2010-05-01

To evaluate the recurrence rate, surgical time, and postoperative pain between conjunctival autografting with sutures and with fibrin adhesive in pterygium surgery. A prospective, randomized, double-blind, clinical trial on the benefits of using fibrin adhesive in place of sutures in pterygium surgery. One hundred seventy-five eyes with primary pterygium were randomized to undergo pterygium surgery with conjunctival autograft transplantation using either fibrin adhesive or sutures. One hundred thirty-seven eyes of 113 patients that were operated on by a single surgeon (V.R.) completed the 1-year follow-up. Sixty-eight eyes were operated with fibrin adhesive and 69 eyes with sutures. Patients were followed up at 1 day, 1 week, 1 month, 6 months, and 1 year after surgery. Pterygium recurrence and postoperative pain was graded by an independent observer (A.L.) masked to the method of treatment. Surgical time was measured with a stopwatch. All patients were followed up for 1 year. There were 3 recurrences (4.41%) in the fibrin adhesive group and 11 recurrences (15.9%) in the suture group. The mean duration required to complete surgery in the fibrin adhesive group was 16.93 +/- 2.85 minutes, whereas that of the suture group was 29.84 +/- 5.65 minutes, which was statistically significant (P < 0.001). The immediate postoperative pain score and week 1 postoperative pain score were significantly lower in the fibrin adhesive group (P < 0.05). No major complications were observed in either group. The use of fibrin adhesive in primary pterygium surgery with conjunctival autografts reduces the recurrence rate, surgical time, and postoperative pain when compared with sutures.

The effects of the formula of amino acids enriched BCAA on nutritional support in traumatic patients.

PubMed

Wang, Xin-Ying; Li, Ning; Gu, Jun; Li, Wei-Qin; Li, Jie-Shou

2003-03-01

To investigate the formula of amino acid enriched BCAA on nutritional support in traumatic patients after operation. 40 adult patients after moderate or large abdominal operations were enrolled in a prospective, randomly and single-blind-controlled study, and received total parenteral nutrition (TPN) with either formula of amino acid (AA group, 20 cases) or formula of amino acid enriched BCAA (BCAA group, 20 cases). From the second day after operation, total parenteral nutrition was infused to the patients in both groups with equal calorie and equal nitrogen by central or peripheral vein during more than 12 hours per day for 6 days. Meanwhile, nitrogen balance was assayed by collecting 24 hours urine for 6 days. The markers of protein metabolism were investigated such as amino acid patterns, levels of total protein, albumin, prealbumin, transferrin and fibronectin in serum. The positive nitrogen balance in BCAA group occurred two days earlier than that in AA group. The serum levels of total protein and albumin in BCAA group were increased more obviously than that in AA group. The concentration of valine was notably increased and the concentration of arginine was markedly decreased in BCAA group after the formula of amino acids enriched BCAA transfusion. The formula of amino acid enriched BCAA may normalize the levels of serum amino acids, reduce the proteolysis, increase the synthesis of protein, improve the nutritional status of traumatic patients after operation.

Efficacy of popliteal block in postoperative pain control after ankle fracture fixation: a prospective randomized study.

PubMed

Goldstein, Rachel Y; Montero, Nicole; Jain, Sudheer K; Egol, Kenneth A; Tejwani, Nirmal C

2012-10-01

To compare postoperative pain control in patients treated surgically for ankle fractures who receive popliteal blocks with those who received general anesthesia alone. Institutional Review Board approved prospective randomized study. Metropolitan tertiary-care referral center. All patients being treated with open reduction internal fixation for ankle fractures who met inclusion criteria and consented to participate were enrolled. Patients were randomized to receive either general anesthesia (GETA) or intravenous sedation and popliteal block. Patients were assessed for duration of procedure, total time in the operating room, and postoperative pain at 2, 4, 8, 12, 24, and 48 hours after surgery using a visual analog scale. Fifty-one patients agreed to participate in the study. Twenty-five patients received popliteal block, while 26 patients received GETA. There were no anesthesia-related complications. At 2, 4, and 8 hours postoperatively, patients who underwent GETA demonstrated significantly higher pain. At 12 hours, there was no significant difference between the 2 groups with regard to pain control. However, by 24 hours, those who had received popliteal blocks had significantly higher pain with no difference by 48 hours. Popliteal block provides equivalent postoperative pain control to general anesthesia alone in patients undergoing operative fixation of ankle fractures. However, patients who receive popliteal blocks do experience a significant increase in pain between 12 and 24 hours. Recognition of this "rebound pain" with early narcotic administration may allow patients to have more effective postoperative pain control.

A Prospective, Randomized, Open-Label, Blinded, Endpoint Study Exploring Platelet Response to Half-Dose Prasugrel and Ticagrelor in Patients with the Acute Coronary Syndrome: HOPE-TAILOR Study.

PubMed

Jin, Cai De; Kim, Moo Hyun; Bang, Junghee; Serebruany, Victor

The optimal dosing of novel oral P2Y12 receptor platelet inhibitors such as prasugrel or ticagrelor is unclear and especially challenging in East Asians. We hypothesize that half-dose prasugrel and ticagrelor may be sufficient for long-term maintenance management in Korean patients with the acute coronary syndrome (ACS) compared with conventional dosages. HOPE-TAILOR (Half Dose of Prasugrel and Ticagrelor in Platelet Response after Acute Coronary Syndromes) is a prospective, randomized, open-label, blinded, endpoint (PROBE) single-center, clinical trial. A total of 100 patients with ACS undergoing drug-eluting stent implantation will be randomly assigned to prasugrel, ticagrelor, or clopidogrel, and the patients in each treatment group will receive 1-month therapy with 100 mg q.d. aspirin plus prasugrel 10 mg q.d., ticagrelor 90 mg b.i.d., or clopidogrel 75 mg q.d., followed by half-dose prasugrel 5 mg q.d. or ticagrelor 45 mg b.i.d. for maintenance treatment but without clopidogrel dose reduction. The primary endpoint will be optimal platelet reactivity 3 months after coronary intervention, defined by VerifyNow Analyzer (PRU: 85-208) and vasodilator-stimulated phosphoprotein P2Y12 flow cytometry assay (platelet reactivity indices: 16-50%). Clinical outcomes will also be assessed, including major efficacy (composite of cardiac death, nonfatal myocardial infarction, repeat revascularization, or stroke) and safety (bleeding ≥2 according to the Bleeding Academic Research Consortium). HOPE-TAILOR is a prospective, randomized, open-label, blinded, endpoint study to explore the efficacy and safety of novel P2Y12 receptor inhibitors administered orally at half the dose in Korean patients with ACS. The results will be available late in 2017. © 2017 S. Karger AG, Basel.

Cognitive Factors in Sexual Arousal: The Role of Distraction

ERIC Educational Resources Information Center

Geer, James H.; Fuhr, Robert

1976-01-01

Four groups of male undergraduates were instructed to perform complex cognitive operations when randomly presented single digits of a dichotic listening paradigm. An erotic tape recording was played into the nonattended ear. Sexual arousal varied directly as a function of the complexity of the distracting cognitive operations. (Author)

Rotator cuff healing after needling of a calcific deposit using platelet-rich plasma augmentation: a randomized, prospective clinical trial.

PubMed

Verhaegen, Filip; Brys, Peter; Debeer, Philippe

2016-02-01

Arthroscopic needling of a rotator cuff calcification is a highly reliable operation in terms of pain relief and return of function. However, during the needling process, a cuff defect is created. Little is known about the evolution of this defect. We conducted a prospective, randomized controlled clinical trial to investigate the evolution of the aforementioned defect and the role of platelet-rich plasma (PRP) augmentation in this healing process. Patients were randomized to either group 1 (PRP, n = 20) or group 2 (no PRP [control group], n = 20). Patients in group 1 received a perioperative PRP infiltration at the rotator cuff defect, whereas the control group did not. Patients were assessed clinically preoperatively and postoperatively at 6 weeks, 3 and 6 months, and 1 year. The Constant score, Simple Shoulder Test, and QuickDASH (short version of Disabilities of the Arm, Shoulder and Hand questionnaire) were used as outcome measures. The evolution of the cuff defect was evaluated on sonography at 3 and 6 months and with magnetic resonance imaging after 1 year. All patients improved significantly after surgery (P < .05). There was no difference in clinical outcome or rotator cuff healing between groups. We observed a high rate of persistent rotator cuff defects after 1 year in both groups. The presence of residual cuff defects did not influence the clinical outcome. Arthroscopic needling is an operation with a predictive, good clinical outcome. We found a high rate of persistent rotator cuff defects after 1 year. This study could not identify any beneficial effect of the addition of PRP on rotator cuff healing. Level II; Randomized Controlled Trial; Treatment Study. Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Lumbar spinous process splitting decompression provides equivalent outcomes to conventional midline decompression in degenerative lumbar canal stenosis: a prospective, randomized controlled study of 51 patients.

PubMed

Rajasekaran, S; Thomas, Ashok; Kanna, Rishi M; Prasad Shetty, Ajoy

2013-09-15

Prospective, randomized controlled study. To compare the functional outcomes and extent of paraspinal muscle damage between 2 decompressive techniques for lumbar canal stenosis. Lumbar spinous process splitting decompression (LSPSD) preserves the muscular and liga-mentous attachments of the posterior elements of the spine. It can potentially avoid problems such as paraspinal muscle atrophy and trunk extensor weakness that can occur after conventional midline decompression. However, large series prospective randomized controlled studies are lacking. Patients with lumbar canal stenosis were randomly allocated into 2 groups: LSPSD (28 patients) and conventional midline decompression (23 patients). The differences in operative time, blood loss, time to comfortable mobilization, and hospital stay were studied. Paraspinal muscle damage was assessed by postoperative rise in creatine phosphokinase and C-reactive protein levels. Functional outcome was evaluated at 1 year by Japanese Orthopaedic Association score, neurogenic claudication outcome score, and visual analogue scale for back pain and neurogenic claudication. Fifty-one patients of mean age 56 years were followed-up for a mean 14.2 ± 2.9 months. There were no significant differences in the operative time, blood loss, and hospital stay. Both the groups showed significant improvement in the functional outcome scores at 1 year. Between the 2 groups, the Japanese Orthopaedic Association score, neurogenic claudication outcome score improvement, visual analogue scale for back pain, neurogenic claudication visual analogue scale, and the postoperative changes in serum C-reactive protein and creatine phosphokinase levels did not show any statistically significant difference. On the basis of the Japanese Orthopaedic Association recovery rate, it was found that 73.9% of conventional midline decompression group had good outcomes compared with only 60.7% after LSPSD. The functional outcome scores, back pain, and claudication pain in the immediate period and at the end of 1 year are similar in both the techniques. More patients had better functional outcomes after conventional decompression than the LSPSD technique. On the basis of this study, the superiority of one technique compared with the other is not established, mandating the need for further long-term studies. 2.

Intraoperative Sensorcaine significantly improves postoperative pain management in outpatient reduction mammaplasty.

PubMed

Culliford, Alfred T; Spector, Jason A; Flores, Roberto L; Louie, Otway; Choi, Mihye; Karp, Nolan S

2007-09-15

Breast reduction is one of the most frequently performed plastic surgical procedures in the United States; more than 160,500 patients underwent the procedure in 2005. Many outpatient reduction mammaplasty patients report the greatest postoperative discomfort in the first 48 hours. The authors' investigated the effect of intraoperative topical application of the long-acting local anesthetic agent bupivacaine (Sensorcaine or Marcaine) on postoperative pain, time to postanesthesia care unit discharge, and postoperative use of narcotic medication. In a prospective, randomized, single-blind trial, intraoperative use of Sensorcaine versus placebo (normal saline) was compared. Postoperative pain was quantified using the visual analogue scale, and time to discharge from the postanesthesia care unit was recorded. Patients documented their outpatient pain medication usage. Of the 37 patients enrolled in the study, 20 were treated with intraoperative topical Sensorcaine and 17 received placebo. Patients treated with Sensorcaine were discharged home significantly faster (2.9 hours versus 3.8 hours, p = 0.002). The control arm consistently had higher pain scores in the postanesthesia care unit (although not statistically significant) than the Sensorcaine group using the visual analogue scale system. Furthermore, patients receiving Sensorcaine required significantly less narcotic medication while recovering at home (mean, 3.5 tablets of Vicodin) than the control group (mean, 6.4 tablets; p = 0.001). There were no complications resulting from Sensorcaine usage. This prospective, randomized, single-blind study demonstrates that a single dose of intraoperative Sensorcaine provides a safe, inexpensive, and efficacious way to significantly shorten the length of postanesthesia care unit stay and significantly decrease postoperative opioid analgesic use in patients undergoing ambulatory reduction mammaplasty.

SINGLE-STAGE SPACESHIPS SHOULD BE OUR GOAL

DOE Office of Scientific and Technical Information (OSTI.GOV)

Hunter, M.W. Jr.

1963-02-01

The ultimate vehicle for manned space travel within the solar system was considered to be the high-performance single-stage spaceship---a vehicle that could travel from earth to points in space and back time after time. If the performance of single-stage rockets can be made high enough, one can begin to think of reusing equipment exactly as in transport airplane practice. The prospects for a practical gaseous fission rocket have brightened with the recent invention of a new family of systems that operates on a basically different principle. The propellant is heated by radiation from the fission plasma, rather than by directmore » intermixing. Several such systems were suggested. Safety factors were considered to make operation of a spaceship propelled by a gaseous-fission engine safe. (C.E.S.)« less

Laparoendoscopic single-site surgery versus standard laparoscopic simple nephrectomy: a prospective randomized study.

PubMed

Tugcu, Volkan; Ilbey, Yusuf Ozlem; Mutlu, Bircan; Tasci, Ali Ihsan

2010-08-01

Laparoendoscopic single-site surgery (LESS), an attempt to further enhance the cosmetic benefits of minimally invasive surgery while minimizing the potential morbidity associated with multiple incisions, has been developed recently. Our aim was to compare LESS simple nephrectomy (LESS-SN) and conventional transperitoneal laparoscopic simple nephrectomy (CTL-SN). In this randomized study that was conducted between December 2008 and September 2009, 27 patients who needed simple nephrectomy were randomized to either LESS-SN or CTL-SN. All procedures in both groups were performed by the first author, who is experienced in laparoscopic surgery. Patient characteristics, perioperative details, and time to return to work were recorded. Postoperative evaluation of pain and use of analgesic medication were recorded. There was no difference in median operative time (117.5 vs 114 min, P = 0.52), blood loss (50.71 vs 47.15 mL, P = 0.60), transfusion rates (0% for both), and hospitalization time (2.07 vs 2.11 days, P = 0.74) between the LESS-SN and CTL-SN groups. Time to return to normal activities was shorter in the LESS-SN group compared with the CTL-SN group (10.7 vs 13.5 days, P = 0.001). Both the visual analogue scale and the postoperative use of analgesics were significantly lower during postoperative days 1, 2, and 3 in patients who underwent LESS-SN, compared with patients who underwent CTL-SN. There were no intraoperative or postoperative complications in both groups. Compared with CTL-SN, LESS-SN was more expensive, but all patients undergoing LESS-SN were very pleased with the cosmetic outcome (no visible scars). The early experience described in this study suggests that LESS-SN is a safe and effective alternative to CTL-SN that provides surgeons with a minimally invasive surgical option and the ability to hide the surgical incision within the umbilicus; however, a larger series is necessary to confirm these findings and to determine if there are any benefits in pain, recovery, or cosmesis.

Analgesic efficacy of ultrasound guided transversus abdominis plane block versus local anesthetic infiltration in adult patients undergoing single incision laparoscopic cholecystectomy: A randomized controlled trial

PubMed Central

Bava, Ejas P.; Ramachandran, Rashmi; Rewari, Vimi; Chandralekha; Bansal, Virinder Kumar; Trikha, Anjan

2016-01-01

Background: Transversus abdominis plane (TAP) block has been used to provide intra- and post-operative analgesia with single incision laparoscopic (SIL) bariatric and gynecological surgery with mixed results. Its efficacy in providing analgesia for SIL cholecystectomy (SILC) via the same approach remains unexplored. Aims: The primary objective of our study was to compare the efficacy of bilateral TAP block with local anesthetic infiltration for perioperative analgesia in patients undergoing SILC. Settings and Design: This was a prospective, randomized, controlled, double-blinded trial performed in a tertiary care hospital. Materials and Methods: Forty-two patients undergoing SILC were randomized to receive either ultrasound-guided (USG) bilateral mid-axillary TAP blocks with 0.375% ropivacaine or local anesthetic infiltration of the port site. The primary outcome measure was the requirement of morphine in the first 24 h postoperatively. Statistical Analysis: The data were analyzed using t-test, Mann–Whitney test or Chi-square test. Results: The 24 h morphine requirement (mean ± standard deviation) was 34.57 ± 14.64 mg in TAP group and 32.76 ± 14.34 mg in local infiltration group (P = 0.688). The number of patients requiring intraoperative supplemental fentanyl in TAP group was 8 and in local infiltration group was 16 (P = 0.028). The visual analog scale scores at rest and on coughing were significantly higher in the local infiltration group in the immediate postoperative period (P = 0.034 and P = 0.007, respectively). Conclusion: USG bilateral TAP blocks were not effective in decreasing 24 h morphine requirement as compared to local anesthetic infiltration in patients undergoing SILC although it provided some analgesic benefit intraoperatively and in the initial 4 h postoperatively. Hence, the benefits of TAP blocks are not worth the effort and time spent for administering them for this surgery. PMID:27746552

Current Limitations and Perspectives in Single Port Surgery: Pros and Cons Laparo-Endoscopic Single-Site Surgery (LESS) for Renal Surgery

PubMed Central

Weibl, Peter; Klingler, Hans-Christoph; Klatte, Tobias; Remzi, Mesut

2010-01-01

Laparo-Endoscopic Single-Site surgery (LESS) for kidney diseases is quickly evolving and has a tendency to expand the urological armory of surgical techniques. However, we should not be overwhelmed by the surgical skills only and weight it against the basic clinical and oncological principles when compared to standard laparoscopy. The initial goal is to define the ideal candidates and ideal centers for LESS in the future. Modification of basic instruments in laparoscopy presumably cannot result in better functional and oncological outcomes, especially when the optimal working space is limited with the same arm movements. Single port surgery is considered minimally invasive laparoscopy; on the other hand, when using additional ports, it is no more single port, but hybrid traditional laparoscopy. Whether LESS is a superior or equally technique compared to traditional laparoscopy has to be proven by future prospective randomized trials. PMID:20169054

Prospective Randomized Double-blinded Trial Comparing 2 Anti-MRSA Agents With Supplemental Coverage of Cefazolin Before Lower Extremity Revascularization

PubMed Central

Stone, Patrick A.; AbuRahma, Ali F.; Campbell, James R.; Hass, Stephen M.; Mousa, Albeir Y.; Nanjundappa, Aravinda; Srivastiva, Mohit; Modak, Asmita; Emmett, Mary

2015-01-01

Objective To compare with antibiotics with methicillin-resistant microbial coverage in a prospective fashion. Background Current antibiotic prophylaxis for vascular procedures includes a first generation cephalosporin. No changes in recommendations have occurred despite changes in reports of incidence of MRSA related surgical site infections. Does supplemental anti-MRSA prophylactic coverage provide a significant reduction in Gram-positive or MRSA infections? Methods Single center prospective double blinded randomized study of patients undergoing lower extremity vascular procedures from 2011 to 2014. One hundred seventy-eight (178) patients were evaluated at 90 days for surgical site infection. Infections were categorized as early infections less than 30 days of the index procedure and late after 90 days. Results Early vascular surgical site infection occurred in 7(8.24%) of patients in the Vancomycin arm, and 11 (11.83%) in the Daptomycin arm (P = 0.43). Gram-positive related infections and MRSA infections occurred in 1(1.18%)/0(0%) of Vancomycin patients and 9 (9.68%)/1 (1.08%) of Daptomycin patients, respectively (P < 0.02 and P = 1.00). Readmissions related to surgical site infections occurred in 4(4.71%) in the Vancomycin group and 11 (11.8%) in the Daptomycin group (P = 0.11). Patients undergoing operative exploration occurred in 5 (5.88%) in the Vancomycin group and 10 (10.75%) of the Daptomycin group (P = 0.17). Late infections were reported in 3 patients, 2 of which were in the combined Daptomycin group. Median hospital charges related to readmissions due to a surgical site infection was $50,823 in the combination Vancomycin arm and $110,920 in the combination Daptomycin group; however, no statistical significance was appreciated (P = 0.11). Conclusions Vancomycin supplemental prophylaxis seems to reduce the incidence of Gram-positive infection compared with adding supplemental Daptomycin prophylaxis. The Incidence of MRSA-related surgical site infections is low with the addition of either anti-MRSA agents compared with historical incidence of MRSA-related infection. PMID:26258318

Negative pressure wound therapy for high-risk wounds in lower extremity revascularization: study protocol for a randomized controlled trial.

PubMed

Murphy, Patrick; Lee, Kevin; Dubois, Luc; DeRose, Guy; Forbes, Thomas; Power, Adam

2015-11-04

Rates of surgical site infections (SSIs) following groin incision for femoral artery exposure are much higher than expected of a clean operation. The morbidity and mortality is high, particularly with the use of prosthetic grafts. The vascular surgery population is at an increased risk of SSIs related to peripheral vascular disease (PVD), diabetes, obesity, previous surgery and presence of tissue loss. Negative pressure wound therapy (NPWT) dressings have been used on primarily closed incisions to reduce surgical site infections in other surgical disciplines. We have not come across any randomized controlled trials to support the prophylactic use of negative pressure wound therapy in high-risk vascular patients undergoing lower limb revascularization. In this single-center, prospective randomized controlled trial, patients scheduled for a lower limb revascularization requiring open femoral artery exposure who are at a high risk (BMI > 30 kg/m(2), previous femoral cutdown or Rutherford V or VI category for chronic limb ischemia) will be eligible for the study. A total of 108 groin incisions will be randomized to the use of a negative pressure wound device or standard adhesive gauze dressing. Patients will be followed in hospital and reassessed within the first 30 days postoperatively. The primary outcome is SSI within the first 30 days of surgery and will be determined using the intention-to-treat principle. Secondary outcomes include length of stay, emergency room visits, reoperation, amputation and mortality. A cost analysis will be performed. The trial is expected to define the role of NPWT in SSI prophylaxis for lower limb revascularization in high-risk vascular patients. The results of the study will be used to inform current best practice for perioperative care and the minimization of SSIs. NCT02084017 , March 2014.

Gaming in risk-adjusted mortality rates: effect of misclassification of risk factors in the benchmarking of cardiac surgery risk-adjusted mortality rates.

PubMed

Siregar, Sabrina; Groenwold, Rolf H H; Versteegh, Michel I M; Noyez, Luc; ter Burg, Willem Jan P P; Bots, Michiel L; van der Graaf, Yolanda; van Herwerden, Lex A

2013-03-01

Upcoding or undercoding of risk factors could affect the benchmarking of risk-adjusted mortality rates. The aim was to investigate the effect of misclassification of risk factors on the benchmarking of mortality rates after cardiac surgery. A prospective cohort was used comprising all adult cardiac surgery patients in all 16 cardiothoracic centers in The Netherlands from January 1, 2007, to December 31, 2009. A random effects model, including the logistic European system for cardiac operative risk evaluation (EuroSCORE) was used to benchmark the in-hospital mortality rates. We simulated upcoding and undercoding of 5 selected variables in the patients from 1 center. These patients were selected randomly (nondifferential misclassification) or by the EuroSCORE (differential misclassification). In the random patients, substantial misclassification was required to affect benchmarking: a 1.8-fold increase in prevalence of the 4 risk factors changed an underperforming center into an average performing one. Upcoding of 1 variable required even more. When patients with the greatest EuroSCORE were upcoded (ie, differential misclassification), a 1.1-fold increase was sufficient: moderate left ventricular function from 14.2% to 15.7%, poor left ventricular function from 8.4% to 9.3%, recent myocardial infarction from 7.9% to 8.6%, and extracardiac arteriopathy from 9.0% to 9.8%. Benchmarking using risk-adjusted mortality rates can be manipulated by misclassification of the EuroSCORE risk factors. Misclassification of random patients or of single variables will have little effect. However, limited upcoding of multiple risk factors in high-risk patients can greatly influence benchmarking. To minimize "gaming," the prevalence of all risk factors should be carefully monitored. Copyright © 2013 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

Urgent and Elective Robotic Single-Site Cholecystectomy: Analysis and Learning Curve of 150 Consecutive Cases.

PubMed

Kubat, Eric; Hansen, Nathan; Nguyen, Huy; Wren, Sherry M; Eisenberg, Dan

2016-03-01

The use of robotic single-site cholecystectomy has increased exponentially. There are few reports describing the safety, efficacy, and operative learning curve of robotic single-site cholecystectomy either in the community setting or with nonelective surgery. We performed a retrospective review of a prospective database of our initial experience with robotic single-site cholecystectomy. Demographics and perioperative outcomes were evaluated for both urgent and elective cholecystectomy. Cumulative sum analysis was performed to determine the surgeon's learning curve. One hundred fifty patients underwent robotic single-site cholecystectomy. Seventy-four (49.3%) patients underwent urgent robotic single-site cholecystectomy, and 76 (50.7%) underwent elective robotic single-site cholecystectomy. Mean total operative time for robotic single-site cholecystectomy was 83.3 ± 2.7 minutes. Mean operative time for the urgent cohort was significantly longer than for the elective cohort (95.0 ± 4.4 versus 71.9 ± 2.6 minutes; P < .001). There was one conversion in the urgent cohort and none in the elective cohort. There was one bile duct injury (0.7%) in the urgent cohort. Perioperative complications occurred in 8.7% of patients, and most consisted of superficial surgical-site infections. There were no incisional hernias detected. The surgeon's learning curve, inclusive of urgent and elective cases, was 48 operations. Robotic single-site cholecystectomy can be performed safely and effectively in both elective and urgent cholecystectomy with a reasonable learning curve and acceptable perioperative outcomes.

Prospective, randomized, blinded, comparative study of injectable micronized dehydrated amniotic/chorionic membrane allograft for plantar fasciitis--a feasibility study.

PubMed

Zelen, Charles M; Poka, Attila; Andrews, James

2013-10-01

Specialized treatment of plantar fasciitis that can reduce inflammation and promote healing may be a possible alternative prior to surgical intervention. We report the results of a randomized clinical trial examining the efficacy of micronized dehydrated human amniotic/chorionic membrane (mDHACM) injection as a treatment for chronic refractory plantar fasciitis. An institutional review board-approved, prospective, randomized, single-center clinical trial was performed. Forty-five patients were randomized to receive injection of 2 cc 0.5% Marcaine plain, then either 1.25 cc saline (controls), 0.5 cc mDHACM, or 1.25 cc mDHACM. Follow-up visits occurred over 8 weeks to measure function, pain, and functional health and well-being. Significant improvement in plantar fasciitis symptoms was observed in patients receiving 0.5 cc or 1.25 cc mDHACM versus controls within 1 week of treatment and throughout the study period. At 1 week, American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot scores increased by a mean of 2.2 ± 17.4 points for controls versus 38.7 ± 11.4 points for those receiving 0.5 cc mDHACM (P < .001) and 33.7 ± 14.0 points for those receiving 1.25 cc mDHACM (P < .001). By week 8 AOFAS Hindfoot scores increased by a mean of 12.9 ± 16.9 points for controls versus 51.6 ± 10.1 and 53.3 ± 9.4 for those receiving 0.5 cc and 1.25 cc mDHACM, respectively (both P < .001). No significant difference in treatment response was observed in patients receiving 0.5 cc versus 1.25 cc mDHACM. In patients with refractory plantar fasciitis, mDHACM is a viable treatment option. Larger studies are needed to confirm our findings. Level I, prospective randomized study.

Muscular and functional effects of partitioning exercising muscle mass in patients with chronic obstructive pulmonary disease - a study protocol for a randomized controlled trial.

PubMed

Nyberg, Andrè; Saey, Didier; Martin, Mickaël; Maltais, François

2015-04-27

Low-load, high-repetitive single-limb resistance training may increase limb muscle function and functional exercise capacity in patients with chronic obstructive pulmonary disease (COPD) while minimizing the occurrence of limiting exertional symptoms. Whether high-repetitive single-limb resistance training would perform better than high-repetitive two-limb resistance training is unknown. In addition, the mechanisms underlying possible benefits of high-repetitive resistance training has not been investigated. The aims of this study are to compare single versus two-limb high-repetitive resistance training in patients with COPD and to investigate mechanisms of action of these training modalities. This trial is a prospective, assessor-blind, randomized controlled trial. The participants are patients with stable severe to very severe COPD who are older than 40 years of age and healthy controls. The intervention is single-limb, high-repetitive, resistance training with elastic bands, three times/week for 8 weeks. The control is two-limb high-repetitive resistance training with elastic bands, three times/week for 8 weeks. The primary outcomes is change in the 6-min walking distance after 8 weeks of single-limb or two-limb high-repetitive resistance training. The secondary outcomes are changes in limb muscle strength and endurance capacity, key protein involved in quadriceps anabolic/catabolic signalization, fiber-type distribution and capillarization, subjective dyspnea and muscle fatigue, muscle oxygenation, cardiorespiratory demand and health-related quality-of-life after 8 weeks of single-limb or two-limb high-repetitive resistance training. The acute effects of single-limb versus two-limb high-repetitive resistance training on contractile fatigue, exercise stimulus (the product of number of repetition and load), subjective dyspnea and muscle fatigue, muscle oxygenation, and cardiorespiratory demand during upper and lower limb exercises will also be investigated in patients with COPD and healthy controls. Randomization will be performed using a random number generator by a person independent of the recruitment process, using 1:1 allocation to the intervention and the control group using random block sizes. All outcome assessors will be blinded to group assignment. The results of this project will provide important information to help developing and implementing customized exercise training programs for patients with COPD. ClinicalTrials.gov Identifier NCT02283580 Registration date: 4 November 2014. First participant randomized: 10 November 2014.

A randomized, blinded, prospective clinical trial of postoperative rehabilitation in dogs after surgical decompression of acute thoracolumbar intervertebral disc herniation.

PubMed

Zidan, Natalia; Sims, Cory; Fenn, Joe; Williams, Kim; Griffith, Emily; Early, Peter J; Mariani, Chris L; Munana, Karen R; Guevar, Julien; Olby, Natasha J

2018-05-01

Experimental evidence shows benefit of rehabilitation after spinal cord injury (SCI) but there are limited objective data on the effect of rehabilitation on recovery of dogs after surgery for acute thoracolumbar intervertebral disc herniations (TL-IVDH). Compare the effect of basic and intensive post-operative rehabilitation programs on recovery of locomotion in dogs with acute TL-IVDH in a randomized, blinded, prospective clinical trial. Thirty non-ambulatory paraparetic or paraplegic (with pain perception) dogs after decompressive surgery for TL-IVDH. Blinded, prospective clinical trial. Dogs were randomized (1:1) to a basic or intensive 14-day in-house rehabilitation protocol. Fourteen-day open field gait score (OFS) and coordination (regulatory index, RI) were primary outcomes. Secondary measures of gait, post-operative pain, and weight were compared at 14 and 42 days. Of 50 dogs assessed, 32 met inclusion criteria and 30 completed the protocol. There were no adverse events associated with rehabilitation. Median time to walking was 7.5 (2 - 37) days. Mean change in OFS by day 14 was 6.13 (confidence intervals: 4.88, 7.39, basic) versus 5.73 (4.94, 6.53, intensive) representing a treatment effect of -0.4 (-1.82, 1.02) which was not significant, P=.57. RI on day 14 was 55.13 (36.88, 73.38, basic) versus 51.65 (30.98, 72.33, intensive), a non-significant treatment effect of -3.47 (-29.81, 22.87), P = .79. There were no differences in secondary outcomes between groups. Early postoperative rehabilitation after surgery for TL-IVDH is safe but doesn't improve rate or level of recovery in dogs with incomplete SCI. Copyright © 2018 The Authors. Journal of Veterinary Internal Medicine published by Wiley Periodicals, Inc. on behalf of the American College of Veterinary Internal Medicine.

Low-pressure pneumoperitoneum versus standard pneumoperitoneum in laparoscopic cholecystectomy, a prospective randomized clinical trial.

PubMed

Sandhu, Trichak; Yamada, Sirikan; Ariyakachon, Veeravorn; Chakrabandhu, Thiraphat; Chongruksut, Wilaiwan; Ko-iam, Wasana

2009-05-01

Post-laparoscopic pain syndrome is well recognized and characterized by abdominal and particularly shoulder tip pain; it occurs frequently following laparoscopic cholecystectomy. The etiology of post-laparoscopic pain can be classified into three aspects: visceral, incision, and shoulder. The origin of shoulder pain is only partly understood, but it is commonly assumed that the cause is overstretching of the diaphragmatic muscle fibers owing to a high rate of insufflations. This study aimed to compare the frequency and intensity of shoulder tip pain between low-pressure (7 mmHg) and standard-pressure (14 mmHg) in a prospective randomized clinical trial. One hundred and forty consecutive patients undergoing elective laparoscopic cholecystectomy were randomized prospectively to either high- or low-pressure pneumoperitoneum and blinded by research nurses who assessed the patients during the postoperative period. The statistical analysis included sex, mean age, weight, American Society of Anesthesiologists (ASA) grade, operative time, complication rate, duration of surgery, conversion rate, postoperative pain by using visual analogue scale, number of analgesic injections, incidence and severity of shoulder tip pain, and postoperative hospital stay. p < 0.05 was considered indicative of significance. The characteristics of the patients were similar in the two groups except for the predominance of males in the standard-pressure group (controls). The procedure was successful in 68 of 70 patients in the low-pressure group compared with in 70 patients in the standard group. Operative time, number of analgesic injections, visual analogue score, and length of postoperative days were similar in both groups. Incidence of shoulder tip pain was higher in the standard-pressure group, but not statistically significantly so (27.9% versus 44.3%) (p = 0.100). Low-pressure pneumoperitoneum tended to be better than standard-pressure pneumoperitoneum in terms of lower incidence of shoulder tip pain, but this difference did not reach statistical significance following elective laparoscopic cholecystectomy.

Functional weight-bearing mobilization after Achilles tendon rupture enhances early healing response: a single-blinded randomized controlled trial.

PubMed

Valkering, Kars P; Aufwerber, Susanna; Ranuccio, Francesco; Lunini, Enricomaria; Edman, Gunnar; Ackermann, Paul W

2017-06-01

Functional weight-bearing mobilization may improve repair of Achilles tendon rupture (ATR), but the underlying mechanisms and outcome were unknown. We hypothesized that functional weight-bearing mobilization by means of increased metabolism could improve both early and long-term healing. In this prospective randomized controlled trial, patients with acute ATR were randomized to either direct post-operative functional weight-bearing mobilization (n = 27) in an orthosis or to non-weight-bearing (n = 29) plaster cast immobilization. During the first two post-operative weeks, 15°-30° of plantar flexion was allowed and encouraged in the functional weight-bearing mobilization group. At 2 weeks, patients in the non-weight-bearing cast immobilization group received a stiff orthosis, while the functional weight-bearing mobilization group continued with increased range of motion. At 6 weeks, all patients discontinued immobilization. At 2 weeks, healing metabolites and markers of procollagen type I (PINP) and III (PIIINP) were examined using microdialysis. At 6 and 12 months, functional outcome using heel-rise test was assessed. Healing tendons of both groups exhibited increased levels of metabolites glutamate, lactate, pyruvate, and of PIIINP (all p < 0.05). Patients in functional weight-bearing mobilization group demonstrated significantly higher concentrations of glutamate compared to the non-weight-bearing cast immobilization group (p = 0.045).The upregulated glutamate levels were significantly correlated with the concentrations of PINP (r = 0.5, p = 0.002) as well as with improved functional outcome at 6 months (r = 0.4; p = 0.014). Heel-rise tests at 6 and 12 months did not display any differences between the two groups. Functional weight-bearing mobilization enhanced the early healing response of ATR. In addition, early ankle range of motion was improved without the risk of Achilles tendon elongation and without altering long-term functional outcome. The relationship between functional weight-bearing mobilization-induced upregulation of glutamate and enhanced healing suggests novel opportunities to optimize post-operative rehabilitation.

Specific exercise training for reducing neck and shoulder pain among military helicopter pilots and crew members: a randomized controlled trial protocol.

PubMed

Murray, Mike; Lange, Britt; Nørnberg, Bo Riebeling; Søgaard, Karen; Sjøgaard, Gisela

2015-08-19

Flight-related neck/shoulder pain is frequent among military helicopter pilots and crew members. With a lifetime prevalence of 81% for pilots and 84% for crew members, the prevalence of neck pain is considered high compared to the general population. The aim of this study was to investigate whether a specifically tailored exercise intervention would reduce the prevalence and incidence rate of neck/shoulder pain among helicopter pilots and crew members. This study used a prospective, parallel group, single blinded, randomized controlled design. Participants were military helicopter pilots and crew members recruited from the Royal Danish Air Force. Inclusion criteria were: 1) employed within the Royal Danish Air Force as a helicopter pilot or onboard crew member (technician, systems-operator, tactical helicopter observer and/or navigator), 2) maintaining operational flight status at enrollment, and 3) operational flying within the previous 6 months. Primary outcome was change in neck and shoulder pain assessed by 1) a modified version of the "Standardized Nordic questionnaire for the analysis of musculoskeletal symptoms" and by 2) pressure pain threshold measurements. Secondary outcomes included: postural balance, strength, stability, and rate of force development for neck and shoulder muscles. Measurements at baseline and follow-up were conducted at four air force bases in Denmark. Sixty-nine participants were individually randomized to either a training group (TG) or a reference group (RG). Participants in the TG performed 20-weeks of physical exercise training divided into sessions of 3 × 20 min per week. Training was completed within working hours and consisted of specific exercise training for the neck and shoulder muscles based on the principles of "Intelligent Physical Exercise Training". The RG received no training. In spite of the high prevalence of flight related neck/shoulder pain among military helicopter pilots and crew members there are currently no evidence based guidelines for the prevention or clinical handling of neck pain among these occupational groups. Results from this study may therefore be beneficial for future establishment of such guidelines. Ethical committee of Southern Denmark (S-20120121) 29 August, 2012. Clinical Trail Registration (NCT01926262) 16 August, 2013.

Preoperative clonidine use in trans-sphenoidal pituitary adenoma surgeries - a randomized controlled trial.

PubMed

Bajaj, Jitin; Mittal, Radhe Shyam; Sharma, Achal

2017-02-01

Pituitary masses are common lesions accounting for about 15-20% of all brain tumours. Oozing blood is an annoyance in microscopic sublabial trans-sphenoidal approach for these masses. There have been many ways of reducing the ooze, having their own pros and cons. To find out the efficacy and safety of clonidine in reducing blood loss in pituitary adenoma surgery through a randomized masked trial. It was a prospective randomized controlled trial done. Total 50 patients of pituitary adenomas were randomized into two groups. Group A (25 patients) was given 200 μg clonidine orally, while Group B (25 patients) was given placebo. Surgeon, anaesthesiologist and patient were blinded for the trial. Sublabial trans-septal trans-sphenoidal approach to sella and excision of mass was performed in each patient. Patients were studied for pre-, intra- and post-operative blood pressure and heart rate, pre- and post-operative imaging findings, intra-operative blood loss, bleeding grading by surgeon, surgeon's satisfaction about condition of specific part and quality of surgical field, operative time and extent of resection. Blood loss during the surgery, operative time and bleeding grading by the surgeon were found significantly less in the clonidine group, while quality of surgical field, condition of the specific part and extent of resection were found significantly better in the clonidine group (p value <.05). There was no untoward adverse effect of the drug in the test group. Clonidine is a safe and effective drug to reduce bleeding in trans-sphenoidal microscopic pituitary adenoma surgeries.

A Pilot Study of a Novel Automated Somatosensory Evoked Potential (SSEP) Monitoring Device for Detection and Prevention of Intraoperative Peripheral Nerve Injury in Total Shoulder Arthroplasty Surgery.

PubMed

Chui, Jason; Murkin, John M; Drosdowech, Darren

2018-05-21

Peripheral nerve injury is a potentially devastating complication after total shoulder arthroplasty (TSA) surgery. This pilot study aimed to assess the feasibility of using an automated somatosensory evoked potential (SSEP) device to provide a timely alert/intervention to minimize intraoperative nerve insults during TSA surgery. A prospective, single-arm, observational study was conducted in a single university hospital. The attending anesthesiologist monitored the study participants using the EPAD automated SSEP device and an intervention was made if there was an alert during TSA surgery. The median, radial, and ulnar nerve SSEP on the operative arm, as well as the median nerve SSEP of the nonoperative arm were monitored for each patient. All patients were evaluated for postoperative neurological deficits 6 weeks postoperatively. In total, 21 patients were consented and were successfully monitored. In total, 4 (19%) patients developed intraoperative abnormal SSEP signal changes in the operative arm, in which 3 were reversible and 1 was irreversible till the end of surgery. Median and radial nerves were mostly involved (3/4 patients). The mean cumulative duration of nerve insult (abnormal SSEP) was 21.7±26.2 minutes. Univariate analysis did not identify predictor of intraoperative nerve insults. No patients demonstrated postoperative peripheral neuropathy at 6 weeks. A high incidence (19%) of intraoperative nerve insult was observed in this study demonstrating the feasibility of using an automated SSEP device to provide a timely alert and enable an intervention in order to minimize peripheral nerve injury during TSA. Further randomized studies are warranted.

A novel technique of harmonic tissue dissection reduces seroma formation after modified radical mastectomy compared to conventional electrocautery: a single-blind randomized controlled trial.

PubMed

Faisal, Mohammed; Fathy, Hamada; Shaban, Hamdy; Abuelela, Sameh T; Marie, Ahmed; Khaled, Islam

2018-01-01

Seroma is the most frequent postoperative complication following breast cancer surgery. Our aim was to evaluate the effect of the harmonic focus scalpel versus electrocautery in reducing seroma formation post-mastectomy and axillary clearance. A prospective randomized controlled trial study was conducted at the Department of Surgery of Suez Canal University Hospital from April 26th 2014 to 30th June 2016. Seventy-two women, in whom a mastectomy and axillary clearance for breast cancer were performed, were randomly allocated to either harmonic dissection ( n  = 36) or electrocautery ( n  = 36). The mean operative time was significantly longer for harmonic dissection compared with electrocautery (2.63 ± 0.41 vs. 1.75 ± 0.26 h; p  < 0.0001). In addition, a significantly smaller amount of intraoperative blood loss (69.4 ± 25.1 vs. 255.5 ± 41.6 ml; p  = 0.002) and total drainage volume (1277.8 ± 172.5 ml vs. 3300 ± 167.5 ml; p  = 0.002) were found in the harmonic group. Moreover, there was a significant reduction in the time of drain removal (10.9 ± 1.12 vs. 15.9 ± 1.44; p  = 0.001) and the incidence of seroma formation after drain removal [8.3% vs 33.3%; p  = 0.003] in the harmonic group compared with those in the electrocautery group. Harmonic dissection technique leads to significant decreases in intraoperative blood loss, total drainage volume and postoperative seroma in terms of shorter drain duration with a minimal increase in the operative time and better quality of life. Here, we recommend the use of the harmonic dissection technique in mastectomy and axillary clearance.

A Multi-Center, Randomized, Double-Blind Placebo-Controlled Trial of Intravenous-Ibuprofen (IV-Ibuprofen) for Treatment of Pain in Post-Operative Orthopedic Adult Patients

PubMed Central

Singla, Neil; Rock, Amy; Pavliv, Leo

2010-01-01

Objective To determine whether pre- and post-operative administration of intravenous ibuprofen (IV-ibuprofen) can significantly decrease pain and morphine use when compared with placebo in adult orthopedic surgical patients. Design This was a multi-center, randomized, double-blind placebo-controlled trial. Setting This study was completed at eight hospitals; six in the United States and two in South Africa. Patients A total of 185 adult patients undergoing elective orthopedic surgery. Interventions Patients were randomized to receive either 800 mg IV-ibuprofen or placebo every 6 hours, with the first dose administered pre-operatively. Additionally, all patients had access to intravenous morphine for rescue. Outcome Measures Efficacy of IV-ibuprofen was demonstrated by measuring the patient's self assessment of pain using a visual analog scale (VAS; assessed with movement and at rest) and a verbal response scale (VRS). Morphine consumption during the post-operative period was also assessed. Results In the immediate post-operative period, there was a 25.8% reduction in mean area under the curve-VAS assessed with movement (AUC-VASM) in patients receiving IV-ibuprofen (P < 0.001); a 31.8% reduction in mean AUC-VAS assessed at rest (AUC-VASR; P < 0.001) and a 20.2% reduction in mean VRS (P < 0.001) compared to those receiving placebo. Patients receiving IV-ibuprofen used 30.9% less morphine (P < 0.001) compared to those receiving placebo. Similar treatment emergent adverse events occurred in both study groups and there were no significant differences in the incidence of serious adverse events. Conclusion Pre- and post-operative administration of IV-ibuprofen significantly reduced both pain and morphine use in orthopedic surgery patients in this prospective randomized placebo-controlled trial. PMID:20609131

Prospective randomized study comparing coronary artery bypass grafting with the new mini-extracorporeal circulation Jostra System or with a standard cardiopulmonary bypass.

PubMed

Remadi, Jean Paul; Rakotoarivelo, Zava; Marticho, Paul; Benamar, Amar

2006-01-01

To assess the potential benefits of a new concept of cardiopulmonary bypass (CPB), the mini-extracorporeal circulation (MECC) Jostra System, we conducted a prospective randomized study among patients who underwent coronary artery bypass grafting (CABG) with a MECC Jostra System or with a standard CPB. In a prospective randomized study, 400 patients underwent elective CABG using a standard CPB (200 patients) or a Jostra MECC System (200 patients). The patients were randomly assigned to have preoperative data similar for both groups. The operative mortality rate (< 30 days) was 1.5% for the MECC group and 2.5% for the CPB group (P = NS). Low-cardiac-output syndrome occurred in 0.66% and 4% for the CPB group (P < .001.). The inflammatory response was significantly reduced with the MECC. Likewise, C-reactive protein release was significantly higher in group B at 24 hours (69.6 +/- 38.5 vs 40.8 +/- 21.8 mg/L for the group A, P < .01) and at 48 hours (116.7 +/- 47.0 vs 65.4 +/- 39.5 mg/L, P < .05) postoperatively. In the CPB group, there was a significantly higher decrease of hematocrit and hemoglobin rate. So, the intraoperative transfusion rate amounted to 6% for the MECC group and 12.8% for the CPB group (P < .001). Patients in the CPB group had significantly higher levels of postoperative blood creatinine and urea. The MECC system is a new concept of CPB that seems to be reliable and safe. To perform CABG, the MECC provides an excellent surgical exposure like a standard CPB and a better biologic profile like CABG without CPB.

Robotic Surgery Readiness (RSR): A Prospective Randomized Skills Decay Recognition and Prevention Study

DTIC Science & Technology

2016-08-01

AWARD NUMBER: W81XWH-15-2-0030 TITLE: Robotic Surgery Readiness (RSR): A Prospective Randomized Skills Decay Recognition and Prevention Study...20164. TITLE AND SUBTITLE Robotic Surgery Readiness (RSR): A Prospective Randomized Skills Decay 5a. CONTRACT NUMBER R ognition and Prevention Study...be recruited and many have completed the proficiency phase of this project and will be moving on to AIM 1. 15. SUBJECT TERMS Robotic Surgery

Comparison of single-dose nalbuphine versus tramadol for postoperative pain management in children: a randomized, controlled trial.

PubMed

Liaqat, Naeem; Dar, Sajid Hameed

2017-04-01

Acute postoperative pain control in children is an essential component of postoperative care, particularly in daycare procedures. Giving patients continuous narcotic analgesics can be risky; however, a single dose may be sufficient. This study used a prospective, randomized controlled design and was conducted at the Pediatric Surgery Unit, Services Hospital, Lahore. In total, 150 patients who underwent inguinal herniotomy (age range: 1-12 years) were randomly assigned to two groups: group A (nalbuphine) and group B (tramadol). Patients were given a single dose of either nalbuphine (0.2 mg/kg) or tramadol (2 mg/kg) immediately after surgery and pain was measured at 0, 1, 2, 4, and 8 h. The demographic characteristics were similar between the two groups. The mean pain score was lower in group A than in group B at 0 and 1 h (P < 0.05). However, at 4 h and 8 h, the pain scores in group A were still lower, but not significantly. In all, 9 patients (12.0%) required rescue analgesics in group A compared to 16 patients (21.3%) in group B (P = 0.051). The mean time for requirement of rescue analgesics was 6.5 ± 0.5 h in group A and 5.3 ± 1.7 h in group B (P = 0.06). A single dose of nalbuphine is sufficient, and superior to tramadol, for postoperative pain management in children who have undergone daycare procedures.

Prospective Randomized Trial Comparing Embryo Transfers of Cases with and without Catheter Rotation during Its Withdrawal.

PubMed

Yayla Abide, Cigdem; Ozkaya, Enis; Sanverdi, Ilhan; Bostancı Ergen, Evrim; Kurek Eken, Meryem; Devranoglu, Belgin; Bilgiç, Bulent Emre; Kilicci, Cetin; Kayatas Eser, Semra

2018-05-14

To compare embryo transfer (ET) technique based on catheter rotation during its withdrawal in cases with unexplained infertility in a prospective, randomized trial (NCT03097042). Two hundred intracytoplasmic sperm injection (ICSI) patients undergoing ET with cleaving or blastocyst-stage fresh embryos were randomized into 2 groups: cases with (n = 100), and without (n = 100) catheter rotation during its withdrawal. Groups were matched for age and some clinical parameters. A soft catheter was used to transfer a single embryo with catheter rotation during its withdrawal in the study group and without rotation in the control. The use of a stiff catheter or tenaculum was not needed in any case. Groups were compared in terms of cycle characteristics and clinical pregnancy rates. Pregnancy rate was significantly higher in the study group (41 vs. 26%, p = 0.04). Clinical pregnancy rate was also significantly higher in the study group (39 vs. 25%, OR 1.9 [1.1-3.5], p = 0.05). On the other hand, the ongoing pregnancy rate was similar between the 2 groups (33 vs. 23%, p = 0.2). Catheter rotation during its withdrawal may be associated with increased pregnancy and clinical pregnancy rates; however, the difference in ongoing pregnancy rates did not reach statistical significance. © 2018 S. Karger AG, Basel.

Impact of selected magnetic fields on the therapeutic effect in patients with lumbar discopathy: A prospective, randomized, single-blinded, and placebo-controlled clinical trial.

PubMed

Taradaj, Jakub; Ozon, Marcin; Dymarek, Robert; Bolach, Bartosz; Walewicz, Karolina; Rosińczuk, Joanna

2018-03-23

Interdisciplinary physical therapy together with pharmacological treatment constitute conservative treatment strategies related to low back pain (LBP). There is still a lack of high quality studies aimed at an objective evaluation of physiotherapeutic procedures according to their effectiveness in LBP. The aim of this study is to carry out a prospective, randomized, single-blinded, and placebocontrolled clinical trial to evaluate the effectiveness of magnetic fields in discopathy-related LBP. A group of 177 patients was assessed for eligibility based on inclusion and exclusion criteria. In the end, 106 patients were randomly assigned into 5 comparative groups: A (n = 23; magnetic therapy: 10 mT, 50 Hz); B (n = 23; magnetic therapy: 5 mT, 50 Hz); C (n = 20; placebo magnetic therapy); D (n = 20; magnetic stimulation: 49.2 μT, 195 Hz); and E (n = 20; placebo magnetic stimulation). All patients were assessed using tests for pain intensity, degree of disability and range of motion. Also, postural stability was assessed using a stabilographic platform. In this study, positive changes in all clinical outcomes were demonstrated in group A (p < 0.05). The most effective clinical effect was observed for pain reduction (p < 0.05), improvement of the range of motion (p < 0.05) and functional ability of the spine (p <0.05). It is also worth noting that the effects in the majority of the measured indicators were mostly short-term (p > 0.05). It was determined that the application of magnetic therapy (10 mT, 50 Hz, 20 min) significantly reduces pain symptoms and leads to an improvement of functional ability in patients with LBP.

Comparison of treatment outcomes according to output voltage during shockwave lithotripsy for ureteral calculi: a prospective randomized multicenter study.

PubMed

Park, Jinsung; Kim, Hong-Wook; Hong, Sungwoo; Yang, Hee Jo; Chung, Hong

2015-05-01

To investigate the effect of fixed versus escalating voltage during SWL on treatment outcomes in patients with ureteral calculi (UC). A prospective, randomized, multicenter trial was conducted on 120 patients who were diagnosed with a single radiopaque UC. The patients were randomized into group C (n = 60, constant 13 kV, 3,000 shock wave, 2 Hz) or group E (n = 60, 11.4-12.0-13 kV per 1,000 shock waves, 2 Hz). They were evaluated by plain abdominal radiography and urinalysis at 1 week after a single session of SWL, and repeat SWL was performed if needed. The primary endpoint was stone-free rate at 1 week (SFR1) after SWL. Secondary endpoints were post-SWL visual pain score (VPS), oral analgesic requirements during 1 week, and cumulative SFRs after the second and third sessions of SWL. Groups C and E were well balanced in terms of baseline patients and stone characteristics, including pre-SWL VPS, stone location, and stone size (6.24 ± 1.92 vs. 6.30 ± 2.13 mm). SFR1s were not significantly different between groups C and E (60.0 vs. 68.3%, p = 0.447). Analyses stratified by stone size (<6 vs. ≥6 mm) showed no difference in SFR1 (p = 0.148 vs. 0.808). In the analyses stratified by stone location, group E tended to be more effective in distal UC (81.0 vs. 50.0%, p = 0.052), whereas no difference was seen in proximal UC (p = 0.487). Secondary endpoints were also similar between the two groups. Our results suggest that voltage escalation during SWL in UC may not provide superior stone fragmentation compared to fixed voltage.

Scissor-type knife significantly improves self-completion rate of colorectal endoscopic submucosal dissection: Single-center prospective randomized trial.

PubMed

Yamashina, Takeshi; Takeuchi, Yoji; Nagai, Kengo; Matsuura, Noriko; Ito, Takashi; Fujii, Mototsugu; Hanaoka, Noboru; Higashino, Koji; Uedo, Noriya; Ishihara, Ryu; Iishi, Hiroyasu

2017-05-01

Colorectal endoscopic submucosal dissection (C-ESD) is recognized as a difficult procedure. Recently, scissors-type knives were launched to reduce the difficulty of C-ESD. The aim of this study was to evaluate the efficacy and safety of the combined use of a scissors-type knife and a needle-type knife with a water-jet function (WJ needle-knife) for C-ESD compared with using the WJ needle-knife alone. This was a prospective randomized controlled trial in a referral center. Eighty-five patients with superficial colorectal neoplasms were enrolled and randomly assigned to undergo C-ESD using a WJ needle-knife alone (Flush group) or a scissor-type knife-supported WJ needle-knife (SB Jr group). Procedures were conducted by two supervised residents. Primary endpoint was self-completion rate by the residents. Self-completion rate was 67% in the SB Jr group, which was significantly higher than that in the Flush group (39%, P = 0.01). Even after exclusion of four patients in the SB Jr group in whom C-ESD was completed using the WJ needle-knife alone, the self-completion rate was significantly higher (63% vs 39%; P = 0.03). Median procedure time among the self-completion cases did not differ significantly between the two groups (59 vs 51 min; P = 0.14). No fatal adverse events were observed in either group. In this single-center phase II trial, scissor-type knife significantly improved residents' self-completion rate for C-ESD, with no increase in procedure time or adverse events. A multicenter trial would be warranted to confirm the validity of the present study. © 2016 Japan Gastroenterological Endoscopy Society.

Air charged and microtip catheters cannot be used interchangeably for urethral pressure measurement: a prospective, single-blind, randomized trial.

PubMed

Zehnder, Pascal; Roth, Beat; Burkhard, Fiona C; Kessler, Thomas M

2008-09-01

We determined and compared urethral pressure measurements using air charged and microtip catheters in a prospective, single-blind, randomized trial. A consecutive series of 64 women referred for urodynamic investigation underwent sequential urethral pressure measurements using an air charged and a microtip catheter in randomized order. Patients were blinded to the type and sequence of catheter used. Agreement between the 2 catheter systems was assessed using the Bland and Altman 95% limits of agreement method. Intraclass correlation coefficients of air charged and microtip catheters for maximum urethral closure pressure at rest were 0.97 and 0.93, and for functional profile length they were 0.9 and 0.78, respectively. Pearson's correlation coefficients and Lin's concordance coefficients of air charged and microtip catheters were r = 0.82 and rho = 0.79 for maximum urethral closure pressure at rest, and r = 0.73 and rho = 0.7 for functional profile length, respectively. When applying the Bland and Altman method, air charged catheters gave higher readings than microtip catheters for maximum urethral closure pressure at rest (mean difference 7.5 cm H(2)O) and functional profile length (mean difference 1.8 mm). There were wide 95% limits of agreement for differences in maximum urethral closure pressure at rest (-24.1 to 39 cm H(2)O) and functional profile length (-7.7 to 11.3 mm). For urethral pressure measurement the air charged catheter is at least as reliable as the microtip catheter and it generally gives higher readings. However, air charged and microtip catheters cannot be used interchangeably for clinical purposes because of insufficient agreement. Hence, clinicians should be aware that air charged and microtip catheters may yield completely different results, and these differences should be acknowledged during clinical decision making.

Comparison of the Effect of Sensory-Level and Conventional Motor-Level Neuromuscular Electrical Stimulations on Quadriceps Strength After Total Knee Arthroplasty: A Prospective Randomized Single-Blind Trial.

PubMed

Yoshida, Yosuke; Ikuno, Koki; Shomoto, Koji

2017-12-01

To compare sensory-level neuromuscular electrical stimulation (NMES) and conventional motor-level NMES in patients after total knee arthroplasty. Prospective randomized single-blind trial. Hospital total arthroplasty center: inpatients. Patients with osteoarthritis (N=66; mean age, 73.5±6.3y; 85% women) were randomized to receive either sensory-level NMES applied to the quadriceps (the sensory-level NMES group), motor-level NMES (the motor-level NMES group), or no stimulation (the control group) in addition to a standard rehabilitation program. Each type of NMES was applied in 45-minute sessions, 5d/wk, for 2 weeks. Data for the quadriceps maximum voluntary isometric contraction, the leg skeletal muscle mass determined using multiple-frequency bioelectrical impedance analysis, the timed Up and Go test, the 2-minute walk test, the visual analog scale, and the range of motion of the knee were measured preoperatively and at 2 and 4 weeks after total knee arthroplasty. The motor-level NMES (P=.001) and sensory-level NMES (P=.028) groups achieved better maximum voluntary isometric contraction results than did the control group. The motor-level NMES (P=.003) and sensory-level NMES (P=.046) groups achieved better 2-minute walk test results than did the control group. Some patients in the motor-level NMES group dropped out of the experiment because of discomfort. Motor-level NMES significantly improved muscle strength and functional performance more than did the standard program alone. Motor-level NMES was uncomfortable for some patients. Sensory-level NMES was comfortable and improved muscle strength and functional performance more than did the standard program alone. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

Very late complications of cervical arthroplasty: results of 2 controlled randomized prospective studies from a single investigator site.

PubMed

Hacker, Francis M; Babcock, Rebecca M; Hacker, Robert J

2013-12-15

Prospective, single-site, randomized, Food and Drug Administration-approved investigational device exemption clinical trials of 2 cervical arthroplasty (CA) devices. To evaluate complications with CA occurring more than 4 years after the surgical procedure in Food and Drug Administration clinical trials of the Bryan and Prestige LP arthroplasty devices. Reports of several randomized clinical studies have shown CA to be a safe and effective alternative to anterior cervical fusion in the treatment of degenerative cervical disc disorders. A majority include follow-up intervals of 4 years or less. Between 2002 and 2006, 94 patients were enrolled in Food and Drug Administration studies of the Bryan and Prestige LP cervical disc devices. Charts, imaging studies, and hospital records were reviewed for those who underwent arthroplasty and returned more than 4 years after their surgical procedure with neck-related pain or dysfunction. Excluding adjacent segment disease that occurred with a similar rate for patients who underwent fusion and arthroplasty, 5 patients, all treated with arthroplasty, returned for evaluation of neck and arm symptoms between 48 and 72 months after surgery. Four patients had peridevice vertebral body bone loss. One patient had posterior device migration and presented with myelopathy. Three required revision surgery and 2 were observed. Four patients maintained follow-up and reported stabilization or improvement in symptoms. Despite their similarities, CA and fusion are not equivalent procedures in this study in regard to very late complications. Similar to large joint arthroplasty, delayed device-related complications may occur with CA. These complications commenced well beyond the time frame for complications associated with more traditional cervical spine procedures. Both patients and surgeons should be aware of the potential for very late device-related complications occurring with CA and the need for revision surgery. 1.

Early Rehabilitation of Distal Radius Fractures Stabilized by Volar Locking Plate: A Prospective Randomized Pilot Study

PubMed Central

Quadlbauer, Stefan; Pezzei, Christoph; Jurkowitsch, Josef; Kolmayr, Brigitta; Keuchel, Tina; Simon, Daniel; Hausner, Thomas; Leixnering, Martin

2016-01-01

Background Distal radius fractures are very common and an increased incidence of 50% is estimated by 2030. Therefore, both operative and postsurgical treatment remains pertinent. Main aim in treating intra-articular fractures is to restore the articular surface by internal fixation and early mobilization (EM). Questions/Purposes The purpose of this study was to compare functional results between EM immediately after surgery and 5 weeks of immobilization (IM). Patients and Methods In a randomized prospective study, 30 patients with an isolated distal radius fracture were treated by open reduction and internal fixation using a single volar locking plate excluding bone graft. Fifteen patients were randomized in the EM group and 15 in the IM group. At 6 weeks, 9 weeks, 3 months, 6 months, and 1 year postsurgery, range of motion, grip strength and X-rays were evaluated. Additionally, Quick Disability of the Arm, Shoulder and Hand (QuickDASH) questionnaire, Patient-Rated Wrist Evaluation (PRWE), modified Green O'Brien (Mayo) score, and pain according to the Visual Analog Scale score were analyzed. Results Patients in the EM group had a significantly better range of motion in the sagittal plane, in grip strength up to 6 months, in the frontal plane up to 9 weeks, and in forearm rotation up to 6 weeks. Also QuickDASH and PRWE scores were better up to 6 weeks postsurgery. The Green O'Brien score differed significantly up to 1 year. At 1 year, 93% “excellent” and “good” results in the Green O'Brien score with a mean QuickDASH of 5.98 ± 10.94 and PRWE score of 4.27 ± 9.23 were observed in the EM group. No differences regarding loss of reduction, pain, duration of physiotherapy, and sick leave were noted. Conclusion EM of surgically treated distal radius fractures (without bone graft) is a safe method for postoperative aftercare and leads to an improved range of motion and grip strength at 6 months postsurgery compared with an IM of 5 weeks. Level of Evidence This is a level Ib clinical study. PMID:28428911

Prospective, randomized comparison between pulsatile GnRH therapy and combined gonadotropin (FSH+LH) treatment for ovulation induction in women with hypothalamic amenorrhea and underlying polycystic ovary syndrome.

PubMed

Dubourdieu, Sophie; Fréour, Thomas; Dessolle, Lionel; Barrière, Paul

2013-05-01

To compare the efficacy of pulsatile GnRH therapy versus combined gonadotropins for ovulation induction in women with both hypothalamic amenorrhoea and polycystic ovarian syndrome (HA/PCOS) according to their current hypothalamic status. This single-centre, prospective, randomized study was conducted in the Nantes University Hospital, France. Thirty consecutive patients were treated for ovulation induction with either pulsatile GnRH therapy or combined gonadotropins (rFSH+rLH). Frequency of adequate ovarian response (mono- or bi-follicular) and clinical pregnancy rate were then compared between both groups. Ovarian response was similar in both groups with comparable frequency of adequate ovarian response (73% vs 60%), but the clinical pregnancy rate was significantly higher in the pulsatile GnRH therapy group than in the combined gonadotropin group (46% vs 0%). HA/PCOS is a specific subgroup of infertile women. Pulsatile GnRH therapy is an effective and safe method of ovulation induction that can be used successfully in these patients. Copyright © 2012 Elsevier Ireland Ltd. All rights reserved.

Out-of-hospital tracheal intubation with single-use versus reusable metal laryngoscope blades: a multicenter randomized controlled trial.

PubMed

Jabre, Patricia; Galinski, Michel; Ricard-Hibon, Agnes; Devaud, Marie Laure; Ruscev, Mirko; Kulstad, Erik; Vicaut, Eric; Adnet, Fréderic; Margenet, Alain; Marty, Jean; Combes, Xavier

2011-03-01

Emergency tracheal intubation is reported to be more difficult with single-use plastic than with reusable metal laryngoscope blades in both inhospital and out-of-hospital settings. Single-use metal blades have been developed but have not been compared with conventional metal blades. This controlled trial compares the efficacy and safety of single-use metal blades with reusable metal blades in out-of-hospital emergency tracheal intubation. This randomized controlled trial was carried out in France with out-of-hospital emergency medical units (Services de Médecine d'Urgence et de Réanimation). This was a multicenter prospective noninferiority randomized controlled trial in adult out-of-hospital patients requiring emergency tracheal intubation. Patients were randomly assigned to either single-use or reusable metal laryngoscope blades and intubated by a senior physician or a nurse anesthetist. The primary outcome was first-pass intubation success. Secondary outcomes were incidence of difficult intubation, need for alternate airway devices, and early intubation-related complications (esophageal intubation, mainstem intubation, vomiting, pulmonary aspiration, dental trauma, bronchospasm or laryngospasm, ventricular tachycardia, arterial desaturation, hypotension, or cardiac arrest). The study included 817 patients, including 409 intubated with single-use blades and 408 with a reusable blade. First-pass intubation success was similar in both groups: 292 (71.4%) for single-use blades, 290 (71.1%) for reusable blades. The 95% confidence interval (CI) for the difference in treatments (0.3%; 95% CI -5.9% to 6.5%) did not include the prespecified inferiority margin of -7%. There was no difference in rate of difficult intubation (difference 3%; 95% CI -7% to 2%), need for alternate airway (difference 4%; 95% CI -8% to 1%), or early complication rate (difference 3%; 95% CI -3% to 8%). First-pass out-of-hospital tracheal intubation success with single-use metal laryngoscopy blades was noninferior to first-pass success with reusable metal laryngoscope blades. Copyright © 2010 American College of Emergency Physicians. Published by Mosby, Inc. All rights reserved.

Role of patient information handouts following operative treatment of ankle fractures: a prospective randomized study.

PubMed

Mayich, D Joshua; Tieszer, Christina; Lawendy, Abdel; McCormick, William; Sanders, David

2013-01-01

Widespread evidence exists for directed patient information interventions (eg, pamphlets) in the setting of several orthopaedic conditions and interventions. Up until now, no study had assessed the role of these interventions in the management of patients following ankle fractures. Between 2005 and 2007, 40 patients who suffered an operative ankle fracture were randomized to either a standard treatment group for an ankle fracture or an enhanced information group who received an American Academy of Orthopaedic Surgeons ankle fracture information pamphlet that explained postoperative routine at our institution and a physiotherapy handout depicting a standard protocol. Study participants were followed for 3 months clinically and radiographically. At the 6-week and 3-month intervals, study participants completed the Olerud-Molander Questionnaire and 2 questions regarding their level of satisfaction. The primary outcome measure was the Likert-scale-based survey question determining the level of satisfaction with the treating staff. Participants in the enhanced information group were more satisfied with treatment at 3 months (9.2 vs 6.3; P < .001). There were significant improvements in work/activity ability at 6 weeks (P = .01), but this advantage disappeared at 3 months (P = .24). No differences in postoperative complication rates were noted. Information enhancement in the form of pamphlets can be helpful in providing patients with accessible information in the postoperative period. While they do not seem to have a sustained impact on postoperative outcomes, handouts may enhance the interaction between staff and patient at postoperative visits, improving patient satisfaction. Level I, appropriately powered randomized prospective cohort study.

The effect of different dosage regimens of tranexamic acid on blood loss in bimaxillary osteotomy: a randomized, double-blind, placebo-controlled study.

PubMed

Apipan, B; Rummasak, D; Narainthonsaenee, T

2018-05-01

The purpose of this study was to compare the effects of three dosage regimens of intravenous tranexamic acid and normal saline placebo on blood loss and the requirement for transfusion during bimaxillary osteotomy. A prospective, randomized, double-blind, placebo-controlled study was performed. Eighty patients scheduled for elective bimaxillary osteotomy were divided into four groups: a placebo group and three groups receiving a single dose of tranexamic acid 10, 15, or 20mg/kg body weight after the induction of anaesthesia. Demographic data, the anaesthetic time, the operative time, and the experience of the surgical team were similar in the four groups. Patients receiving placebo had increased blood loss compared to those receiving tranexamic acid. No significant difference in blood loss was found among those who received 10, 15, or 20mg/kg body weight of tranexamic acid. There was no significant difference in transfusion requirement, amount of 24-h postoperative vacuum drainage, length of hospital stay, or complications among the four groups. Prophylactic tranexamic acid decreased bleeding during bimaxillary osteotomy. Of the three dosages of tranexamic acid studied, the most efficacious and cost-effective dose to reduce bleeding was 10mg/kg body weight. Copyright © 2017 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

On operator strategic behavior

NASA Technical Reports Server (NTRS)

Hancock, P. A.

1991-01-01

Deeper and more detailed knowledge as to how human operators such as pilots respond, singly and in groups, to demands on their performance which arise from technical systems will support the manipulation of such systems' design in order to accommodate the foibles of human behavior. Efforts to understand how self-autonomy impacts strategic behavior and such related issues as error generation/recognition/correction are still in their infancy. The present treatment offers both general and aviation-specific definitions of strategic behavior as precursors of prospective investigations.

Validation of a structured training and assessment curriculum for technical skill acquisition in minimally invasive surgery: a randomized controlled trial.

PubMed

Palter, Vanessa N; Orzech, Neil; Reznick, Richard K; Grantcharov, Teodor P

2013-02-01

: To develop and validate an ex vivo comprehensive curriculum for a basic laparoscopic procedure. : Although simulators have been well validated as tools to teach technical skills, their integration into comprehensive curricula is lacking. Moreover, neither the effect of ex vivo training on learning curves in the operating room (OR), nor the effect on nontechnical proficiency has been investigated. : This randomized single-blinded prospective trial allocated 20 surgical trainees to a structured training and assessment curriculum (STAC) group or conventional residency training. The STAC consisted of case-based learning, proficiency-based virtual reality training, laparoscopic box training, and OR participation. After completion of the intervention, all participants performed 5 sequential laparoscopic cholecystectomies in the OR. The primary outcome measure was the difference in technical performance between the 2 groups during the first laparoscopic cholecystectomy. Secondary outcome measures included differences with respect to learning curves in the OR, technical proficiency of each sequential laparoscopic cholecystectomy, and nontechnical skills. : Residents in the STAC group outperformed residents in the conventional group in the first (P = 0.004), second (P = 0.036), third (P = 0.021), and fourth (P = 0.023) laparoscopic cholecystectomies. The conventional group demonstrated a significant learning curve in the OR (P = 0.015) in contrast to the STAC group (P = 0.032). Residents in the STAC group also had significantly higher nontechnical skills (P = 0.027). : Participating in the STAC shifted the learning curve for a basic laparoscopic procedure from the operating room into the simulation laboratory. STAC-trained residents had superior technical proficiency in the OR and nontechnical skills compared with conventionally trained residents. (The study registration ID is NCT01560494.).

Simultaneous repair of bilateral inguinal hernias: a prospective, randomized study of open, tension-free versus laparoscopic approach.

PubMed

Sarli, L; Iusco, D R; Sansebastiano, G; Costi, R

2001-08-01

No randomized trial exists that specifically addresses the issue of laparoscopic bilateral inguinal hernia repair. The purpose of the present prospective, randomized, controlled, clinical study was to assess short- and long-term results when comparing simultaneous bilateral hernia repair by an open, tension-free anterior approach with laparoscopic "bikini mesh" posterior repair. Forty-three low-risk male patients with bilateral primary inguinal hernia were randomly assigned to undergo either laparoscopic preperitoneal "bikini mesh" hernia repair (TAPP) or open Lichtenstein hernioplasty. There was no difference in operating time between the two groups. The mean cost of laparoscopic hernioplasty was higher (P < 0.001). The intensity of postoperative pain was greater in the open hernia repair group at 24 hours, 48 hours, and 7 days after surgery (P < 0.001), with a greater consumption of pain medication among these patients (P < 0.05). The median time to return to work was 30 days for the open hernia repair group and 16 days for the laparoscopic "bikini mesh" repair group (P < 0.05). Only 1 asymptomatic recurrence (4.3%) was discovered in the open group. The laparoscopic approach to bilateral hernia with "bikini mesh" appears to be preferable to the open Lichtenstein tension-free hernioplasty in terms of the postoperative quality of life and interruption of occupational activity.

True randomness from an incoherent source

NASA Astrophysics Data System (ADS)

Qi, Bing

2017-11-01

Quantum random number generators (QRNGs) harness the intrinsic randomness in measurement processes: the measurement outputs are truly random, given the input state is a superposition of the eigenstates of the measurement operators. In the case of trusted devices, true randomness could be generated from a mixed state ρ so long as the system entangled with ρ is well protected. We propose a random number generation scheme based on measuring the quadrature fluctuations of a single mode thermal state using an optical homodyne detector. By mixing the output of a broadband amplified spontaneous emission (ASE) source with a single mode local oscillator (LO) at a beam splitter and performing differential photo-detection, we can selectively detect the quadrature fluctuation of a single mode output of the ASE source, thanks to the filtering function of the LO. Experimentally, a quadrature variance about three orders of magnitude larger than the vacuum noise has been observed, suggesting this scheme can tolerate much higher detector noise in comparison with QRNGs based on measuring the vacuum noise. The high quality of this entropy source is evidenced by the small correlation coefficients of the acquired data. A Toeplitz-hashing extractor is applied to generate unbiased random bits from the Gaussian distributed raw data, achieving an efficiency of 5.12 bits per sample. The output of the Toeplitz extractor successfully passes all the NIST statistical tests for random numbers.

The AAHKS Clinical Research Award: Liposomal Bupivacaine and Periarticular Injection Are Not Superior to Single-Shot Intra-articular Injection for Pain Control in Total Knee Arthroplasty.

PubMed

Jain, Rajesh K; Porat, Manny D; Klingenstein, Greg G; Reid, Jeremy J; Post, Robert E; Schoifet, Scott D

2016-09-01

Intraoperative injections can help reduce early postoperative pain in total knee arthroplasty. We proposed that liposomal bupivacaine would not be superior to more common and cheaper injections. A single-blinded prospective randomized study with 207 consecutive patients was completed. Patients were randomized to treatment with periarticular liposomal bupivacaine injection, periarticular injection of bupivacaine/morphine, or intra-articular injection of bupivacaine/morphine at the conclusion of the procedure. Postoperative visual analog pain scores and narcotic consumption were recorded and analyzed. There was no significant difference in postoperative visual analog pain scores or narcotic consumption among the 3 study groups. Intra-articular injection of bupivacaine and morphine is as effective for postoperative pain control in total knee arthroplasty as periarticular bupivacaine/morphine injection and liposomal bupivacaine. Use of liposomal bupivacaine in total knee arthroplasty is costly and not justified. Copyright © 2016 Elsevier Inc. All rights reserved.

The inflammatory response between miniaturised and conventional cardiopulmonary bypass after cardiac surgery in an Asian population.

PubMed

Ng, R R G; Chew, S T H; Liu, W; Ong, P; Caleb, M G; Ti, L K

2015-09-01

We compared the systemic inflammatory response of the MCPB system to the CCPB system with cell salvage and phosphorylcholine-coated tubing amongst Asian patients undergoing coronary artery bypass grafting. Seventy-eight patients were randomly assigned to the MCPB or the CCPB groups equally and followed up in a prospective, single-blinded, randomised, controlled trial. Levels of TNF-α, IL-6, CRP and LDH were measured peri-operatively. The systemic inflammatory response was similar in both groups (TNF-α: p=0.222; IL-6: p=0.991; CRP: p=0.258). Only haemolysis was significantly higher in the CCPB group (LDH: p=0.011). The MCPB system was twice more expensive, but had a near 4-fold cost saving in tranfusions. Overall, the MCPB system cost 20% more than the modified CCPB system. These results corroborate with studies that demonstrated the avoidance of cardiotomy suction rather than the MCPB system, itself, leads to an attenuated inflammatory response. The absence of obvious clinical benefit and the higher costs involved with the MCPB system would preclude its routine use. © The Author(s) 2014.

Prospective, Randomized Comparison of One-level Mobi-C Cervical Total Disc Replacement vs. Anterior Cervical Discectomy and Fusion: Results at 5-year Follow-up

PubMed Central

Zigler, Jack E.; Jackson, Robert; Nunley, Pierce D.; Bae, Hyun W.; Kim, Kee D.; Ohnmeiss, Donna D.

2016-01-01

Introduction There is increasing interest in the role of cervical total disc replacement (TDR) as an alternative to anterior cervical discectomy and fusion (ACDF). Multiple prospective randomized studies with minimum 2 year follow-up have shown TDR to be at least as safe and effective as ACDF in treating symptomatic degenerative disc disease at a single level. The purpose of this study was to compare outcomes of cervical TDR using the Mobi-C® with ACDF at 5-year follow-up. Methods This prospective, randomized, controlled trial was conducted as a Food and Drug Administration regulated Investigational Device Exemption trial across 23 centers with 245 patients randomized (2:1) to receive TDR with Mobi-C® Cervical Disc Prosthesis or ACDF with anterior plate and allograft. Outcome assessments included a composite overall success score, Neck Disability Index (NDI), visual analog scales (VAS) assessing neck and arm pain, Short Form-12 (SF-12) health survey, patient satisfaction, major complications, subsequent surgery, segmental range of motion, and adjacent segment degeneration. Results The 60-month follow-up rate was 85.5% for the TDR group and 78.9% for the ACDF group. The composite overall success was 61.9% with TDR vs. 52.2% with ACDF, demonstrating statistical non-inferiority. Improvements in NDI, VAS neck and arm pain, and SF-12 scores were similar between groups and were maintained from earlier follow-up through 60 months. There was no significant difference between TDR and ACDF in adverse events or major complications. Range of motion was maintained with TDR through 60 months. Device-related subsequent surgeries (TDR: 3.0%, ACDF: 11.1%, p<0.02) and adjacent segment degeneration at the superior level (TDR: 37.1%, ACDF: 54.7%, p<0.03) were significantly lower for TDR patients. Conclusions Five-year results demonstrate the safety and efficacy of TDR with the Mobi-C as a viable alternative to ACDF with the potential advantage of lower rates of reoperation and adjacent segment degeneration, in the treatment of one-level symptomatic cervical degenerative disc disease. Clinical Relevance This prospective, randomized study with 5-year follow-up adds to the existing literature indicating that cervical TDR is a viable alternative to ACDF in appropriately selected patients. Level of Evidence This is a Level I study. PMID:27162712

Advantages of Arthroscopic Rotator Cuff Repair With a Transosseous Suture Technique: A Prospective Randomized Controlled Trial.

PubMed

Randelli, Pietro; Stoppani, Carlo Alberto; Zaolino, Carlo; Menon, Alessandra; Randelli, Filippo; Cabitza, Paolo

2017-07-01

Rotator cuff tear is a common finding in patients with painful, poorly functioning shoulders. The surgical management of this disorder has improved greatly and can now be fully arthroscopic. To evaluate clinical and radiological results of arthroscopic rotator cuff repair using 2 different techniques: single-row anchor fixation versus transosseous hardware-free suture repair. Randomized controlled trial; Level of evidence, 1. Sixty-nine patients with rotator cuff tears were enrolled: 35 patients were operated with metal anchors and 34 with standardized transosseous repair. The patients were clinically evaluated before surgery, during the 28 days after surgery, and at least 1 year after the operation by the use of validated rating scores (Constant score, QuickDASH, and numerical rating scale [NRS]). Final follow-up was obtained at more than 3 years by a QuickDASH evaluation to detect any difference from the previous follow-up. During the follow-up, rotator cuff integrity was determined through magnetic resonance imaging and was classified according to the 5 Sugaya categories. Patients operated with the transosseous technique had significantly less pain, especially from the 15th postoperative day: In the third week, the mean NRS value for the anchor group was 3.00 while that for transosseous group was 2.46 ( P = .02); in the fourth week, the values were 2.44 and 1.76, respectively ( P < .01). No differences in functional outcome were noted between the 2 groups at the final evaluation. In the evaluation of rotator cuff repair integrity, based on Sugaya magnetic resonance imaging classification, no significant difference was found between the 2 techniques in terms of retear rate ( P = .81). No significant differences were found between the 2 arthroscopic repair techniques in terms of functional and radiological results. However, postoperative pain decreased more quickly after the transosseous procedure, which therefore emerges as a possible improvement in the surgical repair of the rotator cuff. Registration: NCT01815177 ( ClinicalTrials.gov identifier).

Coblation versus unipolar electrocautery tonsillectomy: a prospective, randomized, single-blind study in adult patients.

PubMed

Noordzij, J Pieter; Affleck, Brian D

2006-08-01

To determine if the coblation tonsillectomy (subcapsular dissection) results in less postoperative pain, equivalent intraoperative blood loss, equivalent postoperative hemorrhage rates, and faster healing compared with tonsillectomy was performed using unipolar electrocautery in adult patients. The authors conducted a prospective clinical trial. Forty-eight patients underwent tonsillectomy and were randomly assigned to have one tonsil removed with coblation and the other with unipolar electrocautery. Outcome measures included time to remove each tonsil, intraoperative blood loss, patient-reported pain, postoperative hemorrhage, and amount of healing 2 weeks after surgery. Mean time to remove a single tonsil with coblation and electrocautery was 8.22 minutes and 6.33 minutes, respectively (P = .011). Mean intraoperative blood loss for each technique was less than 10 mL. Postoperative pain was significantly less with coblation as compared with electrocautery: 18.6% less painful during the first week of recovery. Seventy percent of blinded patients identified the coblation side as less painful during the overall 14-day convalescent period. Postoperative hemorrhage rates (2.1% for coblation and 6.2% for electrocautery) were not significantly different. No difference in tonsillar fossa healing was observed between the two techniques 2 weeks after surgery. During nine of the 48 surgeries, wires on the tip of the coblation handpiece experienced thinning to the point of discontinuity while removing a single tonsil. Coblation subcapsular tonsillectomy was less painful than electrocautery tonsillectomy in this 48-patient group. On average, intraoperative blood loss was less than 10 mL for both techniques. Postoperative hemorrhage rates and the degree of tonsillar fossa healing were similar between the two techniques. The coblation handpiece experienced degradation of vital wires in 18% of cases necessitating the use of a second, new handpiece.

[Considerations about the efficiency of treatment regimens with fixed Rifampicin-Isoniazid combinations in pulmonary tuberculosis].

PubMed

Munteanu, Ioana; Husar, Iulia; Didilescu, C; Stoicescu, I P

2004-01-01

Here are presented the results of a prospective, randomized study regarding the efficiency of regimens with fixed drug combination Rifampicin-Isoniazide manufactured by Antibiotics S.A. of Iasi in comparison with single drugs routinely used in treatment of patients with pulmonary tuberculosis. Newly diagnosed (confirmed by smear and culture) pulmonary tuberculosis patients were selected, and those who accepted to be included in the study, were admitted to the National Institute of Pneumology "Marius Nasta" between August 2001 and September 2002. At the time of admission, they were randomized into two groups: 20 patients received fixed drug combination RMP300 HIN150, and 18 patients received RMP and HIN in single drug tablets (2 patients were excluded). The follow-up of the patients was for one year from the date of enclosure. The smear conversion rate was 83,3% for the patients using single drug tablets, and 70% for those using fixed drug combination, motivated with some more severe TB patterns. The success rate was 100% for all TB patients. Although the present study was done for few patients, we can say that it demonstrated the same efficiency of fixed drug combination produced in Romania, with the single drug tablets, and it suggests a better compliance to treatment with a lower price.

Graphene based widely-tunable and singly-polarized pulse generation with random fiber lasers

PubMed Central

Yao, B. C.; Rao, Y. J.; Wang, Z. N.; Wu, Y.; Zhou, J. H.; Wu, H.; Fan, M. Q.; Cao, X. L.; Zhang, W. L.; Chen, Y. F.; Li, Y. R.; Churkin, D.; Turitsyn, S.; Wong, C. W.

2015-01-01

Pulse generation often requires a stabilized cavity and its corresponding mode structure for initial phase-locking. Contrastingly, modeless cavity-free random lasers provide new possibilities for high quantum efficiency lasing that could potentially be widely tunable spectrally and temporally. Pulse generation in random lasers, however, has remained elusive since the discovery of modeless gain lasing. Here we report coherent pulse generation with modeless random lasers based on the unique polarization selectivity and broadband saturable absorption of monolayer graphene. Simultaneous temporal compression of cavity-free pulses are observed with such a polarization modulation, along with a broadly-tunable pulsewidth across two orders of magnitude down to 900 ps, a broadly-tunable repetition rate across three orders of magnitude up to 3 MHz, and a singly-polarized pulse train at 41 dB extinction ratio, about an order of magnitude larger than conventional pulsed fiber lasers. Moreover, our graphene-based pulse formation also demonstrates robust pulse-to-pulse stability and wide-wavelength operation due to the cavity-less feature. Such a graphene-based architecture not only provides a tunable pulsed random laser for fiber-optic sensing, speckle-free imaging, and laser-material processing, but also a new way for the non-random CW fiber lasers to generate widely tunable and singly-polarized pulses. PMID:26687730

Graphene based widely-tunable and singly-polarized pulse generation with random fiber lasers.

PubMed

Yao, B C; Rao, Y J; Wang, Z N; Wu, Y; Zhou, J H; Wu, H; Fan, M Q; Cao, X L; Zhang, W L; Chen, Y F; Li, Y R; Churkin, D; Turitsyn, S; Wong, C W

2015-12-21

Pulse generation often requires a stabilized cavity and its corresponding mode structure for initial phase-locking. Contrastingly, modeless cavity-free random lasers provide new possibilities for high quantum efficiency lasing that could potentially be widely tunable spectrally and temporally. Pulse generation in random lasers, however, has remained elusive since the discovery of modeless gain lasing. Here we report coherent pulse generation with modeless random lasers based on the unique polarization selectivity and broadband saturable absorption of monolayer graphene. Simultaneous temporal compression of cavity-free pulses are observed with such a polarization modulation, along with a broadly-tunable pulsewidth across two orders of magnitude down to 900 ps, a broadly-tunable repetition rate across three orders of magnitude up to 3 MHz, and a singly-polarized pulse train at 41 dB extinction ratio, about an order of magnitude larger than conventional pulsed fiber lasers. Moreover, our graphene-based pulse formation also demonstrates robust pulse-to-pulse stability and wide-wavelength operation due to the cavity-less feature. Such a graphene-based architecture not only provides a tunable pulsed random laser for fiber-optic sensing, speckle-free imaging, and laser-material processing, but also a new way for the non-random CW fiber lasers to generate widely tunable and singly-polarized pulses.

Boson expansions based on the random phase approximation representation

DOE Office of Scientific and Technical Information (OSTI.GOV)

Pedrocchi, V.G.; Tamura, T.

1984-04-01

A new boson expansion theory based on the random phase approximation is presented. The boson expansions are derived here directly in the random phase approximation representation with the help of a technique that combines the use of the Usui operator with that of a new bosonization procedure, called the term-by-term bosonization method. The present boson expansion theory is constructed by retaining a single collective quadrupole random phase approximation component, a truncation that allows for a perturbative treatment of the whole problem. Both Hermitian, as well as non-Hermitian boson expansions, valid for even nuclei, are obtained.

COMPARING THE OUTCOME OF SINGLE VERSUS MULTIPLE SESSION LASER PHOTOABLATION OF FLAT NEOVASCULARIZATION IN ZONE 1 AGGRESSIVE POSTERIOR RETINOPATHY OF PREMATURITY: A Prospective Randomized Study.

PubMed

Vinekar, Anand; Jayadev, Chaitra; Mangalesh, Shwetha; Kumar, Anupama Kiran; Bauer, Noel; Capone, Antonio; Trese, Michael; Shetty, Bhujang

2015-10-01

To compare single versus 2-session laser photoablation for flat neovascularization in cases with Zone 1 aggressive posterior retinopathy of prematurity. Twenty-nine Asian Indian infants with aggressive posterior retinopathy of prematurity were randomized; each eye received 1 of 2 methods (29 each in Group A or B) proposed by the PHOTO-ROP group. Group A underwent single session laser to the avascular retina underlying the flat neovascularization by direct laser over the fronds. Group B underwent laser in 2 sessions; first, laser was delivered to the avascular periphery up to the flat neovascularization and 7 days later to the avascular bed exposed by the retraction of the fronds. Outcome and complications between the two groups were compared. Mean birthweight and gestational ages were 1,276 g and 30.1 weeks, respectively. All eyes showed favorable outcome at a minimum 12-month follow-up. Hemorrhages after laser (41.4% vs. 17.2%, P < 0.001) were more common in the single laser group. Large hemorrhages (>1 disk diameter) seen in Group A took longer than 8 weeks to resolve and developed focal fibrosis. This study demonstrates that the two-staged laser procedure produces fewer and smaller hemorrhages and no fibrosis compared with a single session. Both methods have comparable favorable outcomes in Asian Indian infants.

Single-Incision Transumbilical Surgery (SITUS) versus Single-Port Laparoscopic Surgery and conventional laparoscopic surgery: a prospective randomized comparative study of performance with novices in a dry laboratory.

PubMed

Schoenthaler, Martin; Avcil, Tuba; Sevcenco, Sabina; Nagele, Udo; Hermann, Thomas E W; Kuehhas, Franklin E; Shariat, Shahrokh F; Frankenschmidt, Alexander; Wetterauer, Ulrich; Miernik, Arkadiusz

2015-01-01

To evaluate the Single-Incision Transumbilical Surgery (SITUS) technique as compared to an established laparoendoscopic single-site surgery (LESS) technique (Single-Port Laparoscopic Surgery, SPLS) and conventional laparoscopy (CLS) in a surgical simulator model. Sixty-three medical students without previous laparoscopic experience were randomly assigned to one of the three groups (SITUS, SPLS and CLS). Subjects were asked to perform five standardized tasks of increasing difficulty adopted from the Fundamentals of Laparoscopic Surgery curriculum. Statistical evaluation included task completion times and accuracy. Overall performances of all tasks (except precision cutting) were significantly faster and of higher accuracy in the CLS and SITUS groups than in the SPLS group (p = 0.004 to p < 0.001). CLS and SITUS groups alone showed no significant difference in performance times and accuracy measurements for all tasks (p = 0.048 to p = 0.989). SITUS proved to be a simple, but highly effective technique to overcome restrictions of SPLS. In a surgical simulator model, novices were able to achieve task performances comparable to CLS and did significantly better than using a port-assisted LESS technique such as SPLS. The demonstrated advantages of SITUS may be attributed to a preservation of the basic principles of conventional laparoscopy, such as the use of straight instruments and an adequate degree of triangulation.

Blastocyst utilization rates after continuous culture in two commercial single-step media: a prospective randomized study with sibling oocytes.

PubMed

Sfontouris, Ioannis A; Kolibianakis, Efstratios M; Lainas, George T; Venetis, Christos A; Petsas, George K; Tarlatzis, Basil C; Lainas, Tryfon G

2017-10-01

The aim of this study is to determine whether blastocyst utilization rates are different after continuous culture in two different commercial single-step media. This is a paired randomized controlled trial with sibling oocytes conducted in infertility patients, aged ≤40 years with ≥10 oocytes retrieved assigned to blastocyst culture and transfer. Retrieved oocytes were randomly allocated to continuous culture in either Sage one-step medium (Origio) or Continuous Single Culture (CSC) medium (Irvine Scientific) without medium renewal up to day 5 post oocyte retrieval. Main outcome measure was the proportion of embryos suitable for clinical use (utilization rate). A total of 502 oocytes from 33 women were randomly allocated to continuous culture in either Sage one-step medium (n = 250) or CSC medium (n = 252). Fertilization was performed by either in vitro fertilization or intracytoplasmic sperm injection, and embryo transfers were performed on day 5. Two patients had all blastocysts frozen due to the occurrence of severe ovarian hyperstimulation syndrome. Fertilization and cleavage rates, as well as embryo quality on day 3, were similar in the two media. Blastocyst utilization rates (%, 95% CI) [55.4% (46.4-64.1) vs 54.7% (44.9-64.6), p = 0.717], blastocyst formation rates [53.6% (44.6-62.5) vs 51.9 (42.2-61.6), p = 0.755], and proportion of good quality blastocysts [36.8% (28.1-45.4) vs 36.1% (27.2-45.0), p = 0.850] were similar in Sage one-step and CSC media, respectively. Continuous culture of embryos in Sage one-step and CSC media is associated with similar blastocyst development and utilization rates. Both single-step media appear to provide adequate support during in vitro preimplantation embryo development. Whether these observations are also valid for other continuous single medium protocols remains to be determined. NCT02302638.

Comparison between intraoperative cholangiography and choledochoscopy for ductal clearance in laparoscopic CBD exploration: a prospective randomized study.

PubMed

Vindal, Anubhav; Chander, Jagdish; Lal, Pawanindra; Mahendra, Balu

2015-05-01

Laparoscopic CBD exploration (LCBDE) is an accepted treatment modality for single stage management of CBD stones in fit patients. A transcholedochal approach is preferred in patients with a dilated CBD and large impacted stones in whom ductal clearance remains problematic. There are very few studies comparing intraoperative cholangiography (IOC) with choledochoscopy to determine ductal clearance in patients undergoing transcholedochal LCBDE. This series represents the first of those comparing the two from Asia. Between April 2009 and October 2012, 150 consecutive patients with CBD stones were enrolled in a prospective randomized study to undergo transcholedochal LCBDE on an intent-to-treat basis. Patients with CBD diameter of less than 9 mm on preoperative imaging were excluded from the study. Out of the 132 eligible patients, 65 patients underwent IOC (Group A), and 67 patients underwent intraoperative choledochoscopy (Group B) to determine CBD clearance. There were no differences between the two groups in the demographic profile and the preoperative biochemical findings. There was no conversion to open procedures, and complete stone clearance was achieved in all the 132 cases. The mean CBD diameter and the mean number of CBD stones removed were comparable between the two groups. Mean operating time was 170 min in Group A and 140 min in Group B (p < 0.001). There was no difference in complications between the two groups. Nine patients in Group A (13.8%) showed non-passage of contrast into the duodenum on IOC which resolved after administration of i.v. glucagon, suggesting a transient spasm of sphincter of Oddi. Two patients (3%) showed a false-positive result on IOC which had to be resolved with choledochoscopy. The present study showed that intraoperative choledochoscopy is better than IOC for determining ductal clearance after transcholedochal LCBDE and is less cumbersome and less time-consuming.

Polypropylene-based composite mesh versus standard polypropylene mesh in the reconstruction of complicated large abdominal wall hernias: a prospective randomized study.

PubMed

Kassem, M I; El-Haddad, H M

2016-10-01

To compare polypropylene mesh positioned onlay supported by omentum and/or peritoneum versus inlay implantation of polypropylene-based composite mesh in patients with complicated wide-defect ventral hernias. This was a prospective randomized study carried out on 60 patients presenting with complicated large ventral hernia in the period from January 2012 to January 2016 in the department of Gastrointestinal Surgery unit and Surgical Emergency of the Main Alexandria University Hospital, Egypt. Large hernia had an abdominal wall defect that could not be closed. Patients were divided into two groups of 30 patients according to the type of mesh used to deal with the large abdominal wall defect. The study included 38 women (63.3 %) and 22 men (37.7 %); their mean age was 46.5 years (range, 25-70). Complicated incisional hernia was the commonest presentation (56.7 %).The operative and mesh fixation times were longer in the polypropylene group. Seven wound infections and two recurrences were encountered in the propylene group. Mean follow-up was 28.7 months (2-48 months). Composite mesh provided, in one session, satisfactory results in patients with complicated large ventral hernia. The procedure is safe and effective in lowering operative time with a trend of low wound complication and recurrence rates.

The learning curve of laparoendoscopic single-site (LESS) cholecystectomy: definable, short, and safe.

PubMed

Hernandez, Jonathan; Ross, Sharona; Morton, Connor; McFarlin, Kellie; Dahal, Sujat; Golkar, Farhaad; Albrink, Michael; Rosemurgy, Alexander

2010-11-01

The applications of laparoendoscopic single-site (LESS) surgery, including cholecystectomy, are occurring quickly, although little is generally known about issues associated with the learning curve of this new technique including operative time, conversion rates, and safety. We prospectively followed all patients undergoing LESS cholecystectomy, and compared operations undertaken at our institutions in cohorts of 25 patients with respect to operative times, conversion rates, and complications. One-hundred fifty patients of mean age 46 years underwent LESS cholecystectomy. No significant differences in operative times were demonstrable between any of the 25-patient cohorts operated on at our institution. A significant reduction in operative times (p < 0.001) after completion of 75 LESS procedures was, however, identified with the experience of a single surgeon. No significant reduction in the number of procedures requiring an additional trocar(s) or conversion to open operations was observed after completion of 25 LESS cholecystectomies. Complication rates were low, and not significantly different between any 25-patient cohorts. For surgeons proficient with multi-incision laparoscopic cholecystectomy, the learning curve for LESS cholecystectomy begins near proficiency. Operative complications and conversions were infrequent and unchanged across successive 25-patient cohorts, and were similar to those reported for multi-incision laparoscopic cholecystectomy after the learning curve. Copyright © 2010 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

Prebiopsy Multiparametric Magnetic Resonance Imaging for Prostate Cancer Diagnosis in Biopsy-naive Men with Suspected Prostate Cancer Based on Elevated Prostate-specific Antigen Values: Results from a Randomized Prospective Blinded Controlled Trial.

PubMed

Tonttila, Panu P; Lantto, Juha; Pääkkö, Eija; Piippo, Ulla; Kauppila, Saila; Lammentausta, Eveliina; Ohtonen, Pasi; Vaarala, Markku H

2016-03-01

Multiparametric magnetic resonance imaging (MP-MRI) may improve the detection of clinically significant prostate cancer (PCa). To compare MP-MRI transrectal ultrasound (TRUS)-fusion targeted biopsy with routine TRUS-guided random biopsy for overall and clinically significant PCa detection among patients with suspected PCa based on prostate-specific antigen (PSA) values. This institutional review board-approved, single-center, prospective, randomized controlled trial (April 2011 to December 2014) included 130 biopsy-naive patients referred for prostate biopsy based on PSA values (PSA <20 ng/ml or free-to-total PSA ratio ≤0.15 and PSA <10 ng/ml). Patients were randomized 1:1 to the MP-MRI or control group. Patients in the MP-MRI group underwent prebiopsy MP-MRI followed by 10- to 12-core TRUS-guided random biopsy and cognitive MRI/TRUS fusion targeted biopsy. The control group underwent TRUS-guided random biopsy alone. MP-MRI 3-T phased-array surface coil. The primary outcome was the number of patients with biopsy-proven PCa in the MP-MRI and control groups. Secondary outcome measures included the number of positive prostate biopsies and the proportion of clinically significant PCa in the MP-MRI and control groups. Between-group analyses were performed. Overall, 53 and 60 patients were evaluable in the MP-MRI and control groups, respectively. The overall PCa detection rate and the clinically significant cancer detection rate were similar between the MP-MRI and control groups, respectively (64% [34 of 53] vs 57% [34 of 60]; 7.5% difference [95% confidence interval (CI), -10 to 25], p=0.5, and 55% [29 of 53] vs 45% [27 of 60]; 9.7% difference [95% CI, -8.5 to 27], p=0.8). The PCa detection rate was higher than assumed during the planning of this single-center trial. MP-MRI/TRUS-fusion targeted biopsy did not improve PCa detection rate compared with TRUS-guided biopsy alone in patients with suspected PCa based on PSA values. In this randomized clinical trial, additional prostate magnetic resonance imaging (MRI) before prostate biopsy appeared to offer similar diagnostic accuracy compared with routine transrectal ultrasound-guided random biopsy in the diagnosis of prostate cancer. Similar numbers of cancers were detected with and without MRI. ClinicalTrials.gov identifier: NCT01357512. Copyright © 2015 European Association of Urology. Published by Elsevier B.V. All rights reserved.

The effect of concentrated bone marrow aspirate in operative treatment of fifth metatarsal stress fractures; a double-blind randomized controlled trial.

PubMed

Weel, Hanneke; Mallee, Wouter H; van Dijk, C Niek; Blankevoort, Leendert; Goedegebuure, Simon; Goslings, J Carel; Kennedy, John G; Kerkhoffs, Gino M M J

2015-08-20

Fifth metatarsal (MT-V) stress fractures often exhibit delayed union and are high-risk fractures for non-union. Surgical treatment, currently considered as the gold standard, does not give optimal results, with a mean time to fracture union of 12-18 weeks. In recent studies, the use of bone marrow cells has been introduced to accelerate healing of fractures with union problems. The aim of this randomized trial is to determine if operative treatment of MT-V stress fractures with use of concentrated blood and bone marrow aspirate (cB + cBMA) is more effective than surgery alone. We hypothesize that using cB + cBMA in the operative treatment of MT-V stress fractures will lead to an earlier fracture union. A prospective, double-blind, randomized controlled trial (RCT) will be conducted in an academic medical center in the Netherlands. Ethics approval is received. 50 patients will be randomized to either operative treatment with cB + cBMA, harvested from the iliac crest, or operative treatment without cB + cBMA but with a sham-treatment of the iliac crest. The fracture fixation is the same in both groups, as is the post-operative care.. Follow up will be one year. The primary outcome measure is time to union in weeks on X-ray. Secondary outcome measures are time to resumption of work and sports, functional outcomes (SF-36, FAOS, FAAM), complication rate, composition of osteoprogenitors in cB + cBMA and cost-effectiveness. Furthermore, a bone biopsy is taken from every stress fracture and analysed histologically to determine the stage of the stress fracture. The difference in primary endpoint between the two groups is analysed using student's t-test or equivalent. This trial will likely provide level-I evidence on the effectiveness of cB + cBMA in the operative treatment of MT-V stress fractures. Netherlands Trial Register (reg.nr NTR4377 ).

Frequency of glove perforation and the protective effect of double gloves in gynecological surgery.

PubMed

Murta, Eddie F C; Silva, Cléber S; Júnior, Odilon R A

2003-06-01

The purposes of this prospective study were to verify the frequency of glove perforation during gynecological operations and to evaluate the efficacy of double gloving in preventing damage to the inner glove. From May 2000 to May 2001, three house staff and 12 residents were asked to place their used gloves in bags labeled with the following information: procedure performed, presence of a recognized glove perforation, and role in operating team (surgeon, first or second assistant, and instrumentalist). All glove sets were tested using the method of water pression. Damaged gloves were excluded from that analysis. In all, 35 and 51 operations were utilized with single and double gloves, respectively. There were 240 single gloves and 792 double gloves tested. Perforation occurred in 10.4% of the single gloves and 9.8% of the outer double gloves. There were no cases of perforation in the inner double gloves. In cases of operating time that lasted more than 2 h, 56% of the surgeries that used single gloves had perforation vs 58.5% of the double gloves. The first assistant had the major risk for glove perforation with the use of single or double gloves. The indicator finger of the non-dominant hand was the major risk for perforation. In conclusion, we recommend double gloving in all gynecological surgery to reduce the risk of contracting blood-borne diseases.

Laparoscopic surgery for chronic groin pain in athletes is more effective than nonoperative treatment: a randomized clinical trial with magnetic resonance imaging of 60 patients with sportsman's hernia (athletic pubalgia).

PubMed

Paajanen, Hannu; Brinck, Tuomas; Hermunen, Heikki; Airo, Ilari

2011-07-01

Chronic groin pain in athletes presents often a diagnostic and therapeutic challenge. Sportsman's hernia (also called "athletic pubalgia") is a deficiency of the posterior wall of the inguinal canal, which is often repaired by laparoscopic mesh placement. Endoscopic mesh repair may offer a faster recovery for athletes with sportsman's hernia than nonoperative therapy. A randomized, prospective study was conducted on 60 patients with a diagnosis of chronic groin pain and suspected sportsman's hernia. Clinical data and MRI were collected on all patients. After 3 to 6 months of groin symptoms, the patients were randomized into an operative or a physiotherapy group (n = 30 patients in each group). Operation was performed using a totally extraperitoneal repair in which mesh was placed behind the symphysis and painful groin area. Conservative treatment included at least 2 months of active physiotherapy, including corticosteroid injections and oral anti-inflammatory analgesics. The outcome measures were pre- and postoperative pain using a visual analogue scale and partial or full recovery to sports activity at 1, 3, 6, and 12 months after randomization. The athletes in both treatment groups had similar characteristics and pain scores. Operative repair was more effective than nonoperative treatment to decrease chronic groin pain after 1 month and up to 12 months of follow-up (P < .001). Of the 30 athletes who underwent operation, 27 (90%) returned to sports activities after 3 months of convalescence compared to 8 (27%) of the 30 athletes in the nonoperative group (P < .0001). Of the 30 athletes in the conservatively treated group, 7 (23 %) underwent operation later because of persistent groin pain. This randomized controlled study indicated that the endoscopic placement of retropubic mesh was more efficient than conservative therapy for the treatment of sportsman's hernia (athletic pubalgia). Copyright © 2011 Mosby, Inc. All rights reserved.

Prospective randomized controlled study on the validity and safety of an absorbable adhesion barrier (Interceed®) made of oxidized regenerated cellulose for laparoscopic colorectal surgery.

PubMed

Naito, Masanori; Ogura, Naoto; Yamanashi, Takahiro; Sato, Takeo; Nakamura, Takatoshi; Miura, Hirohisa; Tsutsui, Atsuko; Sakamoto, Yasutoshi; Tanaka, Rieko; Kumagai, Yuji; Watanabe, Masahiko

2017-02-01

Clinical use of an adhesion barrier made of oxidized, regenerated cellulose, Interceed®, has been reported in the field of obstetrics and gynecology to help prevent adhesions between the peritoneum and the bowel in various types of operations. In gastrointestinal surgery, sodium hyaluronate/carboxymethylcellulose has been reported as an absorbable membrane to reduce postoperative adhesions. The present study was a prospective randomized controlled study to investigate the safety and usefulness of Interceed in laparoscopic colorectal surgery. We analyzed 99 patients who underwent laparoscopic colorectal surgery from 2013 to 2014. The patients were randomly allocated to the group that used Interceed (Interceed group) or the group that did not (Non-Interceed group). Fifty cases used Interceed, and 49 cases did not. The incidence of adverse events was 12.0% in the Interceed group and 16.3% in the Non-Interceed group (P = 0.58). There were no significant differences, and no adhesive bowel obstructions were observed in the Interceed group. We have shown that using Interceed in laparoscopic colorectal surgery is valid and technically safe. © 2016 Japan Society for Endoscopic Surgery, Asia Endosurgery Task Force and John Wiley & Sons Australia, Ltd.

Radiosurgery with the world's first fully robotized Leksell Gamma Knife PerfeXion in clinical use: a 200-patient prospective, randomized, controlled comparison with the Gamma Knife 4C.

PubMed

Régis, Jean; Tamura, Manabu; Guillot, Cécile; Yomo, Shoji; Muraciolle, Xavier; Nagaje, Mariko; Arka, Yasser; Porcheron, Denis

2009-02-01

The world's first Leksell Gamma Knife PerfeXion (Elekta Instrument AB, Stockholm, Sweden) for radiosurgery of the head and neck became operational at Timone University Hospital in Marseille on July 10, 2006. To allow strict evaluation of the capabilities, advantages, disadvantages, and limitations of this new technology, patients were enrolled in a prospective, randomized trial. In 66 working days, between July 10 and December 20, 2006, 363 patients were treated by gamma knife surgery at Timone University Hospital, Marseille. Of these patients, 200 were eligible for the comparative prospective study (inclusion criteria were informed consent obtained, tumor or vascular indication, and no previous radiosurgery or radiotherapy). In accordance with the blinded randomization process, 100 patients were treated with the Leksell Gamma Knife 4C (Elekta Instrument AB) and Gamma Knife 100 (Elekta Instrument AB) with the Leksell Gamma Knife PerfeXion. Dose planning parameters, dosimetry measurements on the patient's body, workflow, patient comfort, quality assurance procedure, and a series of other treatment-related parameters were systematically and prospectively evaluated in both arms of the trial. No technical failure of the treatment procedure was encountered. The new dose-planning system led to the use of composite shots in 39.4% of the patients. The median number of different collimator sizes used was larger with the PerfeXion than with the 4C (2 and 1, respectively). The mean number of isocenters used was lower (10.67 and 13.08, respectively). The median total treatment time was significantly shorter with the PerfeXion (40 and 60 minutes, respectively), but there was no significant difference in the median radiation time (34.02 and 33.40 minutes, respectively). The procedure was performed using only a single run in 98.99% of the PerfeXion cases and in 42% of the 4C cases. Collision risk on the 4C forced us to change the frame gamma angle for at least 1 shot in 24% of the patients and led to treatment in manual mode for at least 1 shot in 21% of the patients. Collision risk requiring technical adaptation did not occur with the PerfeXion. In 1 patient treated with the PerfeXion, the system required a direct collision check. In terms of dose to structures outside the target area, the PerfeXion delivers 8.2 times less to the vertex, 10 times less to the thyroid, 12.9 times less to the sternum, and 15 times less to the gonads. Our prospective study indicates that procedures with the PerfeXion were collision-free, even with very eccentric lesions (e.g., multiple metastases). The duration of the surgical procedure, the amount of time required for nurse, physicist, and physician intervention on the machine, and the duration of the quality assurance procedure were all shown to be dramatically reduced with the PerfeXion gamma knife. Patient protection is greatly improved with the PerfeXion. In our experience, the technological advances of the Leksell Gamma Knife PerfeXion will make a very significant contribution to future progress in head and neck radiosurgery.

Clinical outcomes and costs of reusable and single-use flexible ureterorenoscopes: a prospective cohort study.

PubMed

Mager, R; Kurosch, M; Höfner, T; Frees, S; Haferkamp, A; Neisius, A

2018-01-22

The purpose of this study is to analyze clinical outcomes and costs of single-use flexible ureterorenoscopes in comparison with reusable flexible ureterorenoscopes in a tertiary referral center. Prospectively, 68 flexible ureterorenoscopies utilizing reusable (Flex-X2S, Flex-X C , Karl Storz) and 68 applying single-use flexible ureterorenoscopes (LithoVue, Boston Scientific) were collected. Clinical outcome parameters such as overall success rate, complication rates according to Clavien-Dindo, operation time and radiation exposure time were measured. Cost analysis was based on purchase costs and recurrent costs for repair and reprocessing divided by number of procedures. In each group 68 procedures were available for evaluation. In 91% of reusable and 88% of single-use ureterorenoscopies stone disease was treated with a mean stone burden of 101 ± 226 and 90 ± 244 mm 2 and lower pole involvement in 47 and 41%, respectively (p > 0.05). Comparing clinical outcomes of reusable vs. single-use instruments revealed no significant difference for overall success rates (81 vs. 87%), stone-free rates (82 vs. 85%), operation time (76.2 ± 46.8 vs. 76.8 ± 40.2 min), radiation exposure time (3.83 ± 3.15 vs. 3.93 ± 4.43 min) and complication rates (7 vs. 17%) (p > 0.05). A wide range of repair and purchase costs resulted in total to $1212-$1743 per procedure for reusable ureterorenoscopy whereas price of single-use ureterorenoscopy was $1300-$3180 per procedure. The current work provided evidence for equal clinical effectiveness of reusable and single-use flexible ureterorenoscopes. Partially overlapping ranges of costs for single-use and reusable scopes stress the importance to precisely know the expenses and caseload when negotiating purchase prices, repair prices and warranty conditions.

Comparison of the short-term efficacy of sequential treatment with intravesical single-port laparoscopic partial cystectomy with bladder preservation or open partial cystectomy in combination with cisplatin plus gemcitabine chemotherapy

PubMed Central

MAI, HAI-XING; LIU, JUN-LE; PEI, SHU-JUN; ZHAO, LI; QU, NAN; DONG, JIN-KAI; CHEN, BIAO; WANG, YA-LIN; HUANG, CHENG; CHEN, LI-JUN

2015-01-01

This study aimed to assess the short-term efficacy of sequential therapy for T2/T3a bladder cancer with intravesical single-port laparoscopic partial cystectomy or open partial cystectomy combined with cisplatin plus gemcitabine (GC) chemotherapy in a prospective randomized controlled study. Thirty patients with bladder cancer who underwent open partial cystectomy (group A) or single-port laparoscopic partial cystectomy (group B) and received standard GC chemotherapy were analyzed. Perioperative functional indicators and tumor recurrence during a 1-year postoperative follow-up were compared between the two groups. The baseline characteristics were comparable between the two groups. The mean operative time, amount of blood loss and duration of hospital stay were 90.3 min, 182.0 ml and 7.3 days, respectively, for group A, and 105.3 min, 49.3 ml and 5.8 days, respectively, for group B. No secondary postoperative bleeding, urine leakage, wound infection or other complications were observed in the two groups. Postoperative scarring was not evident in group B. The overall incidence of surgical complications, tumor recurrence rate and complications during chemotherapy in the postoperative follow-up period of 12 months were similar between the two groups. Single-port laparoscopic partial cystectomy surgery is an idea surgical method for the treatment of invasive bladder cancer, with good surgical effect, minimal invasiveness, rapid recovery and short hospital stay. The data from 1-year postoperative follow-up showed that laparoscopic surgery was superior with regard to perioperative bleeding, postoperative recovery and duration of indwelling urinary catheter use. However, regarding the tumor recurrence rate, long-term comparative details are required to determine the effect of laparoscopic surgery. PMID:26170915

Immediate mobilization following fixation of mandible fractures: a prospective, randomized study.

PubMed

Kaplan, B A; Hoard, M A; Park, S S

2001-09-01

To compare outcomes of open reduction and internal fixation of displaced mandible fractures followed by either immediate mobilization or 2 weeks of mandibular-maxillary fixation. A prospective, randomized, single-blinded study was performed. The study was performed between January 1, 1997, and March 30, 2000. Inclusion criteria were displaced fractures between the mandibular angles, age greater than 16 years, and no involvement of the alveolus, ramus, condyles, or maxilla. All fractures were repaired by means of open reduction and internal fixation using 2.0-mm titanium plates secured either in transoral fashion or percutaneously. Data were collected at 6-week and 3- and 6-month postoperative examinations. Variables were assessed by a surgeon blinded to the history of immobilization and included pain, malunion or nonunion, occlusion, trismus, wound status, infection rates, dental hygiene, and weight loss. Twenty-nine consecutive patients were enrolled, 16 patients to immediate function and 13 patients to 2 weeks of mandibular-maxillary fixation. No statistically significant differences were found between groups for any of the variables. Immediate release and temporary immobilization showed mean weight loss of 10 and 8 pounds and trismus of 4.2 and 4.6 cm, respectively. One wound separation and one infection were seen in the immobilization population, and no wound separation or infection was seen in the immediate-release group. Dental hygiene was similar between the groups. No malunion or nonunion was noted in either group. In this prospective and randomized study, no significant differences were noted between the groups receiving either immediate release or 2 weeks of mandibular-maxillary fixation. The findings support the treatment of selective mandible fractures with 2.0-mm miniplates and immediate mobilization.

Outcome of urethroplasty after parenteral testosterone in children with distal hypospadias.

PubMed

Menon, P; Rao, K L N; Handu, A; Balan, L; Kakkar, N

2017-06-01

Pre-operative testosterone use in hypospadias surgery is known to increase penile dimensions and vascularity, which should facilitate tension-less formation of the urethral tube and tissue healing. However, androgens can have a negative effect on wound healing. There are very few randomized studies on postoperative results after androgen use, and this study attempted to understand the utility of pre-operative testosterone in distal hypospadias. To study the effect of parenteral testosterone in children undergoing single stage urethroplasty for distal hypospadias, especially the occurrence of urethrocutaneous fistula and wound dehiscence. Patients were prospectively enrolled and randomized into two groups: Group 1 (control group) and Group 2 (receiving three injections of pre-operative intramuscular testosterone enanthate (2 mg/kg) at 1 monthly intervals; they were further subdivided into those operated 1 month (Group 2A) or 3 months (Group 2B) later. Patients with micropenis, previous testosterone use or any surgical intervention were excluded. Preputial skin was studied with hematoxylin and eosin (H&E) staining and CD31 immunohistochemistry. Patients were followed up for at least 18 months. Ninety four patients underwent urethroplasty over a 3.5-year period. Penile dimensions increased significantly after testosterone use (Summary table). On H&E staining, proliferating blood vessels and increased lymphocytic infiltrates were significantly increased in Group 2B. Group 2 patients tended to have more postoperative edema and inflammation. Although urethrocutaneous fistula rates were similar in Group 1 (n = 7) and Group 2 (n = 5) (P = 0.438), wound dehiscence occurred only in Group 2 (P = 0.01). The total number of patients in this study was small and this was a drawback. Although, several factors played a role in wound healing, the overall higher complication rate, especially wound dehiscence in Group 2, pointed to a higher incidence of inflammatory reaction and healing complication rates with testosterone use. Testosterone should be used judiciously in distal hypospadias. While tissue availability significantly increased, there was an increase in inflammatory reaction and edema, which increased the risk of wound dehiscence in cases of precocious surgery. Copyright © 2017 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.

Lumbar Sympathetic Plexus Block as a Treatment for Postamputation Pain: Methodology for a Randomized Controlled Trial.

PubMed

McCormick, Zachary L; Hendrix, Andrew; Dayanim, David; Clay, Bryan; Kirsling, Amy; Harden, Norman

2018-03-08

We present a technical protocol for rigorous assessment of patient-reported outcomes and psychophysical testing relevant to lumbar sympathetic blocks for the treatment of postamputation pain (PAP). This description is intended to inform future prospective investigation. Series of four participants from a blinded randomized sham-controlled trial. Tertiary, urban, academic pain medicine center. Four participants with a single lower limb amputation and associated chronic PAP. Participants were randomized to receive a lumbar sympathetic block with 0.25% bupivacaine or sham needle placement. Patient-rated outcome measures included the numerical rating scale (NRS) for pain, the McGill Pain Questionnaire-Short Form, Center for Epidemiological Studies Depression Scale, Pain and Anxiety Symptoms Scale-short version, and Pain Disability Index (PDI). Psychophysical and biometric testing was also performed, which included vibration sensation testing, pinprick sensation testing, brush sensation testing, Von Frey repeated weighted pinprick sensation, and thermal quantitative sensory testing. In the four described cases, treatment of PAP with a single lumbar sympathetic block but not sham intervention resulted in reduction of both residual limb pain and phantom limb pain as well as perceived disability on the PDI at three-month follow-up. An appropriately powered randomized controlled study using this methodology may not only aid in determining the possible clinical efficacy of lumbar sympathetic block in PAP, but could also improve our understanding of underlying pathophysiologic mechanisms of PAP.

TVT and TVT-O for surgical treatment of primary stress urinary incontinence: prospective randomized trial.

PubMed

Krofta, Ladislav; Feyereisl, Jaroslav; Otcenásek, Michal; Velebil, Petr; Kasíková, Eva; Krcmár, Michal

2010-02-01

A study was conducted to compare the efficacy and complications of TVT and TVT-O. This study is a prospective randomized trial involving 300 women with primary SUI; 149 received TVT, and 151 patients were treated with TVT-O. At the 1 year follow-up, 141 TVT patients and 147 TVT-O patients (dropout, 5.3% and 2.6%) were evaluated using urodynamic studies, validated questionnaires, and a 1-h pad test. The mean operating time was shorter in the TVT-O group (p < 0.001). Urinary retention was not significantly different (p > 0.05). Inner thigh discomfort was reported by 5.4% of TVT-O patients. In the TVT and the TVT-O groups, respectively, 90.1% and 88.4% women were objectively cured. The satisfaction with the surgical outcome reflects the significant decrease in the questionnaire mean symptom scores in both groups. Postoperative de novo urgency was significantly more common in the TVT-O patients (p = 0.015). The groups showed comparable objective and subjective cure rates.

Single bead near-infrared random laser based on silica-gel infiltrated with Rhodamine 640

NASA Astrophysics Data System (ADS)

Moura, André L.; Barbosa-Silva, Renato; Dominguez, Christian T.; Pecoraro, Édison; Gomes, Anderson S. L.; de Araújo, Cid B.

2018-04-01

Photoluminescence properties of single bead silica-gel (SG) embedded with a laser-dye were studied aiming at the operation of near-infrared (NIR) Random Lasers (RLs). The operation of RLs in the NIR spectral region is especially important for biological applications since the optical radiation has deep tissue penetration with negligible damage. Since laser-dyes operating in the NIR have poor stability and are poor emitters, ethanol solutions of Rhodamine 640 (Rh640) infiltrated in SG beads were used. The Rh640 concentrations in ethanol varied from 10-5 to 10-2 M and the excitation at 532 nm was made by using a 7 ns pulsed laser. The proof-of-principle RL scheme herein presented was adopted in order to protect the dye-molecules from the environment and to favor formation of aggregates. The RL emission from ≈650 nm to 720 nm, beyond the typical Rh640 monomer and dimer wavelengths emissions range, was attributed to the trade-off between reabsorption and reemission processes along the light pathways inside the SG bead and the contribution of Rh640 aggregates.

Ultrathin Silicon Sheet in the Management of Unilateral Post-traumatic Temporo-Mandibuar Joint Ankylosis in Children: A Good Alternative to Conventional Techniques.

PubMed

Aggarwal, Sushil Kumar; Ankur, Bhatnagar; Jain, R K

2015-09-01

We have described a new technique of using ultra-thin silicon sheet (0.2 mm) between two transected bony ends for temporo-mandibular joint (TMJ) ankylosis in children with advantages of short operative time, minimal foreign material insertion and faster recovery time post-operatively which makes our technique a good alternative to conventional techniques. Our study is a non-randomized prospective study conducted on 10 children aged between 4 and 15 years who presented to our tertiary care institute with severe trismus after traumatic injury and were willing to undergo this new technique. The main outcome measure taken into consideration was difference between pre-operative, intra-operative (on table) and post-operative mouth opening (minimum 2 years follow-up). The pre-operative mouth opening in our cases varied from 1 to 5 mm. The intra-operative mouth opening achieved ranged from 2.8 to 3.2 cm. The mouth opening was about more than 2.7 cm in all our cases at 2 years of follow-up. Our technique is a good alternative to conventional techniques used for TMJ ankylosis in children but few more randomized controlled trials are required to assess its effectiveness in comparison to conventional techniques and for universal adoption of this technique.

Intraindividual comparison of 1,470 nm diode laser versus carbon dioxide laser for tonsillotomy: a prospective, randomized, double blind, controlled feasibility trial.

PubMed

Havel, Miriam; Sroka, Ronald; Englert, Elsa; Stelter, Klaus; Leunig, Andreas; Betz, Christian S

2012-09-01

The need for reduction of post-tonsillectomy hemorrhage has led to promotion of tonsillotomy techniques for tonsil tissue reduction in obstructive tonsillar hypertrophy. This trial compares ablative tissue effects using 1,470 nm diode laser and carbon dioxide laser for tonsillotomy in an intraindividual design. 21 children aged 3-13 years (mean age 6.3 years) underwent laser tonsillotomy for obstructive tonsillar hypertrophy in this double blind, prospective, randomized, clinical feasibility trial. In each of the blinded patients, tonsillotomy was performed using fiber guided 1,470 nm diode laser (contact mode, 15 W power) on the one side and carbon dioxide laser (12 W power) on the other side. An independent, blinded physician documented clinical presentation and patients' symptoms preoperatively and on Days 1, 3, 7, 14, and 21 post-operatively using standardized questionnaire including VAS for each side separately. The mean duration of operative treatment was 2.7 min using 1,470 nm laser and 4.9 min using carbon dioxide laser respectively. Intraoperative bleeding and the frequency of bipolar forceps use for intraoperative bleeding control was significantly less using 1,470 nm diode laser system. There was no difference in post-operative pain scores between the carbon dioxide laser treated and the 1,470 nm fiber guided diode laser treated side. No infections, hemorrhages or other complications occurred in the course of the 3 weeks post-operative period. A fiber-guided 1,470 nm diode laser system offers an efficient and safe method for tonsillotomy as treatment of obstructive tonsillar hypertrophy. Compared to our standard practice (carbon dioxide laser), 1,470 nm laser application provides comparable tissue ablation effects with less intraoperative bleeding and shorter operation time. Copyright © 2012 Wiley Periodicals, Inc.

A prospective randomized controlled multicenter trial comparing antibiotic therapy with appendectomy in the treatment of uncomplicated acute appendicitis (APPAC trial).

PubMed

Paajanen, Hannu; Grönroos, Juha M; Rautio, Tero; Nordström, Pia; Aarnio, Markku; Rantanen, Tuomo; Hurme, Saija; Dean, Kirsti; Jartti, Airi; Mecklin, Jukka-Pekka; Sand, Juhani; Salminen, Paulina

2013-02-08

Although the standard treatment of acute appendicitis (AA) consists of an early appendectomy, there has recently been both an interest and an increase in the use of antibiotic therapy as the primary treatment for uncomplicated AA. However, the use of antibiotic therapy in the treatment of uncomplicated AA is still controversial. The APPAC trial is a randomized prospective controlled, open label, non-inferiority multicenter trial designed to compare antibiotic therapy (ertapenem) with emergency appendectomy in the treatment of uncomplicated AA. The primary endpoint of the study is the success of the randomized treatment. In the antibiotic treatment arm successful treatment is defined as being discharged from the hospital without the need for surgical intervention and no recurrent appendicitis during a minimum follow-up of one-year (treatment efficacy). Treatment efficacy in the operative treatment arm is defined as successful appendectomy evaluated to be 100%. Secondary endpoints are post-intervention complications, overall morbidity and mortality, the length of hospital stay and sick leave, treatment costs and pain scores (VAS, visual analoque scale). A maximum of 610 adult patients (aged 18-60 years) with a CT scan confirmed uncomplicated AA will be enrolled from six hospitals and randomized by a closed envelope method in a 1:1 ratio either to undergo emergency appendectomy or to receive ertapenem (1 g per day) for three days continued by oral levofloxacin (500 mg per day) plus metronidazole (1.5 g per day) for seven days. Follow-up by a telephone interview will be at 1 week, 2 months and 1, 3, 5 and 10 years; the primary and secondary endpoints of the trial will be evaluated at each time point. The APPAC trial aims to provide level I evidence to support the hypothesis that approximately 75-85% of patients with uncomplicated AA can be treated with effective antibiotic therapy avoiding unnecessary appendectomies and the related operative morbidity, also resulting in major cost savings.

A Prospective, Randomized Trial in the Emergency Department of Suggestive Audio-Therapy under Deep Sedation for Smoking Cessation.

PubMed

Rodriguez, Robert M; Taylor, Opal; Shah, Sushma; Urstein, Susan

2007-08-01

In a sample of patients undergoing procedural deep sedation in the emergency department (ED), we conducted a prospective, randomized, single-blinded trial of audio-therapy for smoking cessation. We asked subjects about their smoking, including desire to quit (0-10 numerical scale) and number of cigarettes smoked per day. Subjects were randomized to either a control tape (music alone) or a tape with repeated smoking-cessation messages over music. Tapes were started with first doses of sedation and stopped with patient arousal. Telephone follow-up occurred between two weeks and three months to assess the number of cigarettes smoked per day. Study endpoints were self-reported complete cessation and decrease of half or more in total cigarettes smoked per day. One hundred eleven patients were enrolled in the study, 54 to intervention and 57 to control. Mean desire to quit was 7.15 +/- 2.6 and mean cigarettes per day was 17.5 +/- 12.1. We successfully contacted 69 (62%) patients. Twenty-seven percent of intervention and 26% of control patients quit (mean difference = 1%; 95% CI: -22.0% to 18.8%). Thirty-seven percent of intervention and 51% of control patients decreased smoking by half or more (mean difference = 14.6%; 95% CI: -8.7% to 35.6%). Suggestive audio-therapy delivered during deep sedation in the ED did not significantly decrease self-reported smoking behavior.

Effects of moderate red wine consumption on liver fat and blood lipids: a prospective randomized study.

PubMed

Kechagias, Stergios; Zanjani, Sepehr; Gjellan, Solveig; Leinhard, Olof Dahlqvist; Kihlberg, Johan; Smedby, Orjan; Johansson, Lars; Kullberg, Joel; Ahlström, Håkan; Lindström, Torbjörn; Nystrom, Fredrik H

2011-11-01

There have been no human prospective randomized studies of the amount of alcohol that can induce hepatic steatosis. Thirty-two healthy women and twelve healthy men (34 ± 9 years of age) were randomized to consume 150 ml of red wine/day for women (16 g ethanol/day) or double that amount for men (33 g ethanol/day), or to alcohol abstention for 90 days. Participants underwent proton-nuclear magnetic-resonance spectroscopy for measurement of hepatic triglyceride content (HTGC). Blood samples for assessment of cardiovascular risk were drawn before and after the intervention. After exclusion of three subjects with steatosis at baseline a trend towards increased HTGC was apparent for red wine (before median: 1.1%, range 0.2-3.9%, after median: 1.1%, range 0.5-5.2 %, P = 0.059) a difference that was statistically significant compared with abstainers (p = 0.02). However, no subject developed hepatic steatosis. Low-density lipoprotein (LDL)-cholesterol was lowered by red wine (-0.3 mmol/l, SE -0.1, 95% CI -0.6 to -0.04). Moderate consumption of red wine during three months increased HTGC in subjects without steatosis at baseline. However, since not a single participant developed steatosis we suggest that the threshold of alcohol consumption to define nonalcoholic fatty liver disease should not be lower than the amount in our study.

Frequency of Hand Decontamination of Intraoperative Providers and Reduction of Postoperative Healthcare-Associated Infections: A Randomized Clinical Trial of a Novel Hand Hygiene System.

PubMed

Koff, Matthew D; Brown, Jeremiah R; Marshall, Emily J; O'Malley, A James; Jensen, Jens T; Heard, Stephen O; Longtine, Karen; O'Neill, Melissa; Longtine, Jaclyn; Houston, Donna; Robison, Cindy; Moulton, Eric; Patel, Hetal M; Loftus, Randy W

2016-08-01

BACKGROUND Healthcare provider hands are an important source of intraoperative bacterial transmission events associated with postoperative infection development. OBJECTIVE To explore the efficacy of a novel hand hygiene improvement system leveraging provider proximity and individual and group performance feedback in reducing 30-day postoperative healthcare-associated infections via increased provider hourly hand decontamination events. DESIGN Randomized, prospective study. SETTING Dartmouth-Hitchcock Medical Center in New Hampshire and UMass Memorial Medical Center in Massachusetts. PATIENTS Patients undergoing surgery. METHODS Operating room environments were randomly assigned to usual intraoperative hand hygiene or to a personalized, body-worn hand hygiene system. Anesthesia and circulating nurse provider hourly hand decontamination events were continuously monitored and reported. All patients were followed prospectively for the development of 30-day postoperative healthcare-associated infections. RESULTS A total of 3,256 operating room environments and patients (1,620 control and 1,636 treatment) were enrolled. The mean (SD) provider hand decontamination event rate achieved was 4.3 (2.9) events per hour, an approximate 8-fold increase in hand decontamination events above that of conventional wall-mounted devices (0.57 events/hour); P<.001. Use of the hand hygiene system was not associated with a reduction in healthcare-associated infections (odds ratio, 1.07 [95% CI, 0.82-1.40], P=.626). CONCLUSIONS The hand hygiene system evaluated in this study increased the frequency of hand decontamination events without reducing 30-day postoperative healthcare-associated infections. Future work is indicated to optimize the efficacy of this hand hygiene improvement strategy. Infect Control Hosp Epidemiol 2016;37:888-895.

Papillary vs Nonpapillary Puncture in Percutaneous Nephrolithotomy: A Prospective Randomized Trial.

PubMed

Kallidonis, Panagiotis; Kyriazis, Iason; Kotsiris, Dimitrios; Koutava, Adamantia; Kamal, Wissam; Liatsikos, Evangelos

2017-04-01

Literature suggests that the percutaneous punctures for percutaneous nephrolithotomy (PCNL) must be performed at the papilla of the renal calix and a puncture at the infundibulum or the direction of the pelvis is not advisable because of increased hemorrhagic risk. A prospective randomized study was conducted to investigate the safety in terms of blood loss of the infundibular approach for PCNL. Patients with renal stones with an accumulative size of at least 2 cm were randomly assigned to one of two parallel groups to undergo PCNL with either papillary (Group 1) or infundibular (Group 2) renal access. The primary outcome measures were the reduction in hemoglobin on first postoperative day and the need for transfusion during the first postoperative month. Secondary endpoints included the operative and fluoroscopy time, number of accesses performed, overall complication rate, hospitalization time, and complications up to 3 months. In total, 27 and 28 patients were enrolled in Groups 1 and 2, respectively. Patient age, body mass index, and stone size were similar among the groups (p = 0.672, 0.256, and 0.889, respectively). Reduction in hemoglobin and transfusion rate did not differ among Groups 1 and 2 (p = 0.916, p = 1.0, respectively). Operative time was higher in the case of Group 1 (p = 0.027). The overall complications rate was 7.4% for Group 1 and 7.14% for Group 2. Hospitalization time was not significantly different in the study groups (p = 0.724). The infundibular approach for PCNL to the posterior middle renal calices is not associated with higher blood loss or transfusion rate in comparison with the respective approach to the fornix of the papilla when the currently described technique is performed.

Thulium laser enucleation (ThuLEP) versus transurethral resection of the prostate in saline (TURis): A randomized prospective trial to compare intra and early postoperative outcomes.

PubMed

Bozzini, G; Seveso, M; Melegari, S; de Francesco, O; Buffi, N M; Guazzoni, G; Provenzano, M; Mandressi, A; Taverna, G

2017-06-01

To compare clinical intra and early postoperative outcomes between thulium laser transurethral enucleation of the prostate (ThuLEP) and transurethral bipolar resection of the prostate (TURis) for treating benign prostatic hyperplasia (BPH) in a prospective randomized trial. The study randomized 208 consecutive patients with BPH to ThuLEP (n=102) or TURis (n=106). For all patients were evaluated preoperatively with regards to blood loss, catheterization time, irrigation volume, hospital stay and operative time. At 3 months after surgery they were also evaluated by International Prostate Symptom Score (IPSS), maximum flow rate (Qmax), and postvoid residual urine volume (PVR). The patients in each study arm each showed no significant difference in preoperative parameters. Compared with TURIS, ThuLEP had same operative time (53.69±31.44 vs 61.66±18.70minutes, P=.123) but resulted in less hemoglobin decrease (0.45 vs 2.83g/dL, P=.005). ThuLEP also needed less catheterization time (1.3 vs 4.8 days, P=.011), irrigation volume (29.4 vs 69.2 L, P=.002), and hospital stay (1.7 vs 5.2 days, P=.016). During the 3 months of follow-up, the procedures did not demonstrate a significant difference in Qmax, IPSS, PVR, and QOLS. ThuLEP and TURis both relieve lower urinary tract symptoms equally, with high efficacy and safety. ThuLEP was statistically superior to TURis in blood loss, catheterization time, irrigation volume, and hospital stay. However, procedures did not differ significantly in Qmax, IPSS, PVR, and QOLS through 3 months of follow-up. Copyright © 2016 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

Unilateral Versus Bilateral Neck Exploration for Primary Hyperparathyroidism

PubMed Central

Bergenfelz, Anders; Lindblom, Pia; Tibblin, Sten; Westerdahl, Johan

2002-01-01

Objective To compare unilateral and bilateral neck exploration for primary hyperparathyroidism in a prospective randomized controlled trial. Summary Background Data Based on the assumption that unilateral neck exploration for a solitary parathyroid adenoma should reduce operating time and morbidity, a variety of minimally invasive procedures have challenged the idea that bilateral neck exploration is the gold standard for the surgical treatment of primary hyperparathyroidism. However, to date, no open prospective randomized trial has been published comparing unilateral and bilateral neck exploration. Methods Ninety-one patients with the preoperative diagnosis of primary hyperparathyroidism were randomized to unilateral or bilateral neck exploration. Preoperative scintigraphy and intraoperative parathyroid hormone measurement guided the unilateral exploration. Gross morphology and frozen section determined the extent of parathyroid tissue resection in the bilateral group. The primary end-point was the use of postoperative medication for hypocalcemic symptoms. Results Eighty-eight patients (97%) were cured. Histology and cure rate did not differ between the two groups. Patients in the bilateral group consumed more oral calcium, had lower serum calcium values on postoperative days 1 to 4, and had a higher incidence of early severe symptomatic hypocalcemia compared with patients in the unilateral group. In addition, for patients undergoing surgery for a solitary parathyroid adenoma, unilateral exploration was associated with a shorter operative time. The cost for the two procedures did not differ. Conclusions Patients undergoing a unilateral procedure had a lower incidence of biochemical and severe symptomatic hypocalcemia in the early postoperative period compared with patients undergoing bilateral exploration. Unilateral neck exploration with intraoperative parathyroid hormone assessment is a valid surgical strategy in patients with primary hyperparathyroidism with distinct advantages, especially for patients with solitary parathyroid adenoma. PMID:12409657

Radiation dose reduction in thoracic and lumbar spine instrumentation using navigation based on an intraoperative cone beam CT imaging system: a prospective randomized clinical trial.

PubMed

Pireau, Nathalie; Cordemans, Virginie; Banse, Xavier; Irda, Nadia; Lichtherte, Sébastien; Kaminski, Ludovic

2017-11-01

Spine surgery still remains a challenge for every spine surgeon, aware of the potential serious outcomes of misplaced instrumentation. Though many studies have highlighted that using intraoperative cone beam CT imaging and navigation systems provides higher accuracy than conventional freehand methods for placement of pedicle screws in spine surgery, few studies are concerned about how to reduce radiation exposure for patients with the use of such technology. One of the main focuses of this study is based on the ALARA principle (as low as reasonably achievable). A prospective randomized trial was conducted in the hybrid operating room between December 2015 and December 2016, including 50 patients operated on for posterior instrumented thoracic and/or lumbar spinal fusion. Patients were randomized to intraoperative 3D acquisition high-dose (standard dose) or low-dose protocol, and a total of 216 pedicle screws were analyzed in terms of screw position. Two different methods were used to measure ionizing radiation: the total skin dose (derived from the dose-area product) and the radiation dose evaluated by thermoluminescent dosimeters on the surgical field. According to Gertzbein and Heary classifications, low-dose protocol provided a significant higher accuracy of pedicle screw placement than the high-dose protocol (96.1 versus 92%, respectively). Seven screws (3.2%), all implanted with the high-dose protocol, needed to be revised intraoperatively. The use of low-dose acquisition protocols reduced patient exposure by a factor of five. This study emphasizes the paramount importance of using low-dose protocols for intraoperative cone beam CT imaging coupled with the navigation system, as it at least does not affect the accuracy of pedicle screw placement and irradiates drastically less.

The Misgav Ladach method for cesarean section compared to the Pfannenstiel method.

PubMed

Darj, E; Nordström, M L

1999-01-01

The aim of the study was to evaluate the outcome of two different methods of cesarean section (CS). The study was designed as a prospective, randomized, controlled trial. All CS were performed at the University Hospital in Uppsala, Sweden. Fifty women admitted to hospital for a first elective CS were consecutively included in the study. They were randomly allocated to two groups. One group was operated on by the Misgav Ladach method for CS and the other group by the Pfannenstiel method. All operations were performed by the same surgeon. Duration of operation, amount of bleeding, analgesics required, scar appearance and length of hospitalization. Operating time was significantly different between the two methods, with an average of 12.5 minutes with the Misgav Ladach method and 26 minutes with the Pfannenstiel method (p<0.001). The amount of blood loss differed significantly, with 448 ml and 608 ml respectively (p=0.017). Significantly less analgesic injections and tablets (p=0.004) were needed after the Misgav Ladach method. The Misgav Ladach method of CS has advantages over the Pfannenstiel method by being significantly quicker to perform, with a reduced amount of bleeding and diminished postoperative pain. The women were satisfied with the appearance of their scars. In this study no negative effects of the new operation technique were discovered.

Preoperative bowel preparation with meglumine and sodium diatrizoate (Gastrografin): a prospective randomised comparison.

PubMed

Koussidis, G A; Koussidis, A

2001-12-01

To test the use of meglumine and sodium diatrizoate (Gastrografin) as an agent for preoperative mechanical bowel preparation. Prospective randomised comparison. County general hospital, Greece. 58 patients listed for elective colorectal operations were randomly divided into 2 groups. The first (n = 30) was given Gastrografin 200 ml orally for 2 consecutive days before operation, and the second (n = 28) was given Ringer's solution through a nasogastric tube. Tolerability, acceptability, quality of cleansing, and complications. There were no disturbances in electrolyte concentrations, and other laboratory variables also remained unchanged. Two patients treated with Ringer's solution had appreciable increases in arterial blood pressure, but there were no significant overall changes. About half the patients given Ringer's felt nauseated and a third vomited. Such symptoms were uncommon in patients treated with Gastrografin (p < 0.01). 28/30 and 26/28 (93%) had a clean colonic lumen at operation, whereas in the reminder the lumen was evaluated as containing "slight residue". There were no operation-related complications. Gastrografin can be used successfully as an agent for mechanical bowel preparation before elective colorectal surgery, as it gives equally good cleansing results compared with the established method of whole gut irrigation. It also seems to be better tolerated and accepted by patients.

Holding Area LINQ Trial (HALT).

PubMed

Lee, John J; Weitz, Daniel; Anand, Rishi

Recent studies have shown that insertable cardiac monitors (ICMs) can be implanted out of the traditional hospital setting and efforts are being made to explore the feasibility of implanting these devices in a specific standardized location other than the operating room or a cardiac catherization/electrophysiology lab. This was a prospective, non-randomized, single center post-market clinical trial designed to occur in the holding area of a hospital operating room or cardiac catheterization/electrophysiology laboratory. The Medtronic Reveal LINQ ICM was implanted and patients were followed for 90 days post implant. This study was designed to observe any procedure related adverse events stemming from the holding area implantation. Twenty patients were implanted at our hospital in a holding room not traditionally associated with the electrophysiology/cardiac/operatory labs. One patient was lost to the 90-day follow up. In one case, ICM implantation led to diagnosis requiring removal of ICM before the 90 day follow up and insertion of a biventricular implantable cardioverter defibrillator (ICD). In the remaining 18 patients, there were no serious complications such as minor skin infections, systemic infections or procedure-related adverse events requiring device explant. When following a standardized protocol with attention to sterile technique, it is feasible to implant ICMs in a holding area with no procedure related adverse events (AE). Copyright © 2017 Indian Heart Rhythm Society. Production and hosting by Elsevier B.V. All rights reserved.

Development and Assessment of Memorial Sloan Kettering Cancer Center’s Surgical Secondary Events Grading System

PubMed Central

Strong, Vivian E.; Selby, Luke V.; Sovel, Mindy; Disa, Joseph J.; Hoskins, William; DeMatteo, Ronald; Scardino, Peter; Jaques, David P.

2015-01-01

Background Studying surgical secondary events is an evolving effort with no current established system for database design, standard reporting, or definitions. Using the Clavien-Dindo classification as a guide, in 2001 we developed a Surgical Secondary Events database based on grade of event and required intervention to begin prospectively recording and analyzing all surgical secondary events (SSE). Study Design Events are prospectively entered into the database by attending surgeons, house staff, and research staff. In 2008 we performed a blinded external audit of 1,498 operations that were randomly selected to examine the quality and reliability of the data. Results 1,498 of 4,284 operations during the 3rd quarter of 2008 were audited. 79% (N=1,180) of the operations did not have a secondary event while 21% (N=318) of operations had an identified event. 91% (1,365) of operations were correctly entered into the SSE database. 97% (129/133) of missed secondary events were Grades I and II. Three Grade III (2%) and one Grade IV (1%) secondary event were missed. There were no missed Grade 5 secondary events. Conclusion Grade III – IV events are more accurately collected than Grade I – II events. Robust and accurate secondary events data can be collected by clinicians and research staff and these data can safely be used for quality improvement projects and research. PMID:25319579

A randomized controlled trial of nonoperative treatment versus open reduction and internal fixation for stable, displaced, partial articular fractures of the radial head: the RAMBO trial

PubMed Central

2014-01-01

Background The choice between operative or nonoperative treatment is questioned for partial articular fractures of the radial head that have at least 2 millimeters of articular step-off on at least one radiograph (defined as displaced), but less than 2 millimeter of gap between the fragments (defined as stable) and that are not associated with an elbow dislocation, interosseous ligament injury, or other fractures. These kinds of fractures are often classified as Mason type-2 fractures. Retrospective comparative studies suggest that operative treatment might be better than nonoperative treatment, but the long-term results of nonoperative treatment are very good. Most experts agree that problems like reduced range of motion, painful crepitation, nonunion or bony ankylosis are infrequent with both nonoperative and operative treatment of an isolated displaced partial articular fracture of the radial head, but determining which patients will have problems is difficult. A prospective, randomized comparison would help minimize bias and determine the balance between operative and nonoperative risks and benefits. Methods/Design The RAMBO trial (Radial Head – Amsterdam – Amphia – Boston - Others) is an international prospective, randomized, multicenter trial. The primary objective of this study is to compare patient related outcome defined by the ‘Disabilities of Arm, Shoulder and Hand (DASH) score’ twelve months after injury between operative and nonoperative treated patients. Adult patients with partial articular fractures of the radial head that comprise at least 1/3rd of the articular surface, have ≥ 2 millimeters of articular step-off but less than 2 millimeter of gap between the fragments will be enrolled. Secondary outcome measures will be the Mayo Elbow Performance Index (MEPI), the Oxford Elbow Score (OES), pain intensity through the ‘Numeric Rating Scale’, range of motion (flexion arc and rotational arc), radiographic appearance of the fracture (heterotopic ossification, radiocapitellar and ulnohumeral arthrosis, fracture healing, and signs of implant loosening or breakage) and adverse events (infection, nerve injury, secondary interventions) after one year. Discussion The successful completion of this trial will provide evidence on the best treatment for stable, displaced, partial articular fractures of the radial head. Trial registration The trial is registered at the Dutch Trial Register: NTR3413. PMID:24885637

Mediterranean diet and life expectancy; beyond olive oil, fruits and vegetables

PubMed Central

Martinez-Gonzalez, Miguel A.; Martín-Calvo, Nerea

2018-01-01

Purpose to review the recent relevant evidence of the effects of the Mediterranean diet and lifestyle on health (2015 and first months of 2016). Recent findings Large observational prospective epidemiological studies with adequate control of confounding and two large randomized trials support the benefits of the Mediterranean dietary pattern to increase life expectancy, reduce the risk of major chronic disease, and improve quality of life and well-being. Recently, 19 new reports from large prospective studies showed –with nearly perfect consistency– strong benefits of the Mediterranean diet to reduce the risk of myocardial infarction, stroke, total mortality, heart failure and disability. Interestingly, two large and well-conducted cohorts reported significant cardiovascular benefits after using repeated measurements of diet during a long follow-up period. Besides, PREDIMED, the largest randomized trial with Mediterranean diet, recently reported benefits of this dietary pattern to prevent cognitive decline and breast cancer. Summary In the era of evidence-based medicine, the Mediterranean diet represents the gold standard in preventive medicine, probably due to the harmonic combination of many elements with antioxidant and antiinflammatory properties, which overwhelm any single nutrient or food item. The whole seems more important than the sum of its parts. PMID:27552476

Mediterranean diet and life expectancy; beyond olive oil, fruits, and vegetables.

PubMed

Martinez-Gonzalez, Miguel A; Martin-Calvo, Nerea

2016-11-01

The recent relevant evidence of the effects of the Mediterranean diet (MedDiet) and lifestyle on health (2015 and first months of 2016). Large observational prospective epidemiological studies with adequate control of confounding and two large randomized trials support the benefits of the Mediterranean dietary pattern to increase life expectancy, reduce the risk of major chronic disease, and improve quality of life and well-being. Recently, 19 new studies from large prospective studies showed - with nearly perfect consistency - strong benefits of the MedDiet to reduce the risk of myocardial infarction, stroke, total mortality, heart failure, and disability. Interestingly, two large and well conducted cohorts reported significant cardiovascular benefits after using repeated measurements of diet during a long follow-up period. In addition, Prevención con Dieta Mediterránea, the largest randomized trial with MedDiet, recently reported benefits of this dietary pattern to prevent cognitive decline and breast cancer. In the era of evidence-based medicine, the MedDiet represents the gold standard in preventive medicine, probably because of the harmonic combination of many elements with antioxidant and anti-inflammatory properties, which overwhelm any single nutrient or food item. The whole seems more important than the sum of its parts.

Duodenal Electric Stimulation: Results of a First-in-Man Study.

PubMed

Aberle, Jens; Busch, Philipp; Veigel, Jochen; Duprée, Anna; Roesch, Thomas; zu Eulenburg, Christine; Paschen, Björn; Scholz, Bernd M; Wolter, Stefan; Sauer, Nina; Ludwig, Kaja; Izbicki, Jakob; Mann, Oliver

2016-02-01

The aim of this study was to demonstrate feasibility and safety of a new electric duodenal stimulation system (EDS, BALANCE) in humans. Secondary objectives were to evaluate the effect on glycemic control and weight loss in patients with obesity and type 2 diabetes mellitus (T2DM). In an open-labeled, prospective, single-arm, non-randomized multicenter study, 12 obese T2DM patients with a mean HbA1c of 8.0% received laparoscopic implantation of the BALANCE duodenal stimulating device. Adverse events, changes in glycemic control, cardiovascular parameters, and weight were collected. The follow-up period after implantation was 12 months. Device related severe adverse events did not occur. Mean HbA1c decreased by 0.8% (p = 0.02) and mean fasting blood glucose level (FBG) was reduced by 19% (p = 0.038) after the 12 months. Mean HDL level increased from 44 to 48 mg/dl (p = 0.033). EDS is a feasible and safe procedure. Positive effects on T2DM and some cardiovascular parameters (HDL, weight) were seen. However, further prospective randomized blinded studies are needed in order to evaluate the potential of this new minimally invasive method.

Comparative Performance in Single-Port Versus Multiport Minimally Invasive Surgery, and Small Versus Large Operative Working Spaces: A Preclinical Randomized Crossover Trial.

PubMed

Marcus, Hani J; Seneci, Carlo A; Hughes-Hallett, Archie; Cundy, Thomas P; Nandi, Dipankar; Yang, Guang-Zhong; Darzi, Ara

2016-04-01

Surgical approaches such as transanal endoscopic microsurgery, which utilize small operative working spaces, and are necessarily single-port, are particularly demanding with standard instruments and have not been widely adopted. The aim of this study was to compare simultaneously surgical performance in single-port versus multiport approaches, and small versus large working spaces. Ten novice, 4 intermediate, and 1 expert surgeons were recruited from a university hospital. A preclinical randomized crossover study design was implemented, comparing performance under the following conditions: (1) multiport approach and large working space, (2) multiport approach and intermediate working space, (3) single-port approach and large working space, (4) single-port approach and intermediate working space, and (5) single-port approach and small working space. In each case, participants performed a peg transfer and pattern cutting tasks, and each task repetition was scored. Intermediate and expert surgeons performed significantly better than novices in all conditions (P < .05). Performance in single-port surgery was significantly worse than multiport surgery (P < .01). In multiport surgery, there was a nonsignificant trend toward worsened performance in the intermediate versus large working space. In single-port surgery, there was a converse trend; performances in the intermediate and small working spaces were significantly better than in the large working space. Single-port approaches were significantly more technically challenging than multiport approaches, possibly reflecting loss of instrument triangulation. Surprisingly, in single-port approaches, in which triangulation was no longer a factor, performance in large working spaces was worse than in intermediate and small working spaces. © The Author(s) 2015.

Small incision lenticule extraction (SMILE) versus laser in-situ keratomileusis (LASIK): study protocol for a randomized, non-inferiority trial.

PubMed

Ang, Marcus; Tan, Donald; Mehta, Jodhbir S

2012-05-31

Small incision lenticule extraction or SMILE is a novel form of 'flapless' corneal refractive surgery that was adapted from refractive lenticule extraction (ReLEx). SMILE uses only one femtosecond laser to complete the refractive surgery, potentially reducing surgical time, side effects, and cost. If successful, SMILE could potentially replace the current, widely practiced laser in-situ keratomileusis or LASIK. The aim of this study is to evaluate whether SMILE is non-inferior to LASIK in terms of refractive outcomes at 3 months post-operatively. Single tertiary center, parallel group, single-masked, paired-eye design, non-inferiority, randomized controlled trial. Participants who are eligible for LASIK will be enrolled for study after informed consent. Each participant will be randomized to receive SMILE and LASIK in each eye. Our primary hypothesis (stated as null) in this non-inferiority trial would be that SMILE differs from LASIK in adults (>21 years old) with myopia (> -3.00 diopter (D)) at a tertiary eye center in terms of refractive predictability at 3 months post-operatively. Our secondary hypothesis (stated as null) in this non-inferiority trial would be that SMILE differs from LASIK in adults (>21 years old) with myopia (> -3.00 D) at a tertiary eye center in terms of other refractive outcomes (efficacy, safety, higher-order aberrations) at 3 months post-operatively. Our primary outcome is refractive predictability, which is one of several standard refractive outcomes, defined as the proportion of eyes achieving a postoperative spherical equivalent (SE) within ±0.50 D of the intended target. Randomization will be performed using random allocation sequence generated by a computer with no blocks or restrictions, and implemented by concealing the number-coded surgery within sealed envelopes until just before the procedure. In this single-masked trial, subjects and their caregivers will be masked to the assigned treatment in each eye. This novel trial will provide information on whether SMILE has comparable, if not superior, refractive outcomes compared to the established LASIK for myopia, thus providing evidence for translation into clinical practice. Clinicaltrials.gov NCT01216475.

Laparoscopic extraperitoneal inguinal hernia repair versus open mesh repair: long-term follow-up of a randomized controlled trial.

PubMed

Hallén, Magnus; Bergenfelz, Anders; Westerdahl, Johan

2008-03-01

We have conducted a randomized controlled trial of totally extraperitoneal hernia repair (TEP) versus tension-free open repair (Lichtenstein repair); we have presented the results previously up to 1 year after the operation. The aim of this study was to compare patient outcome in both groups at a median follow-up of 7.3 years after operation. Of 168 patients included in a prospective, randomized controlled trial designed to compare TEP with an open tension-free technique, 154 patients (92%) answered a questionnaire and 147 patients (88%) were followed up at an outpatient clinic after a minimum of 6 years after operation. Overall, 89% of patients in the TEP group and 95% of patients in the open group reported complete long-term recovery (P = .23). Permanent impaired inguinal sensibility was more common in the open group (P = .004), whereas the proportion of patients with reported testicular pain was higher in the TEP group (P = .003). Three recurrences were found in the TEP group, and 4 recurrences were found in the open group (P = .99). Four patients in the TEP group underwent operations for complications related to the hernia repair (small bowel obstruction, umbilical hernia, testicular pain, and neuralgia). Overall, both groups showed good long-term results with low rates of recurrences. However, the TEP group was associated with a higher proportion of patients with long-term testicular pain, whereas impaired inguinal sensibility was more common in the open group.

A prospective randomized controlled trial comparing early postoperative complications in patients undergoing loop colostomy with and without a stoma rod.

PubMed

Franklyn, J; Varghese, G; Mittal, R; Rebekah, G; Jesudason, M R; Perakath, B

2017-07-01

A stoma rod or bridge has been traditionally placed under the bowel loop while constructing a loop colostomy. This is believed to prevent stomal retraction and provide better faecal diversion. However, the rod can cause complications such as mucosal congestion, oedema and necrosis. This single-centre prospective randomized controlled trial compared outcomes after creation of loop colostomy with and without a supporting stoma rod. The primary outcome studied was stoma retraction rate; other stoma-related complications were studied as secondary outcomes. One hundred and fifty-one patients were randomly allotted to one of two arms, colostomy with or without a supporting rod. Postoperative complications such as retraction, mucocutaneous separation, congestion and re-exploration for stoma-related complications were recorded. There was no difference in the stoma retraction rate between the two arms (8.1% in the rod arm and 6.6% in the no-rod arm; P = 0.719). Stomal necrosis (10.7% vs 1.3%; P = 0.018), oedema (23% vs 3.9%; P = 0.001), congestion (20.3% vs 2.6%; P = 0.001) and re-admission rates (8.5% vs 0%; P = 0.027) were significantly increased in the arm randomized to the rod. The stoma rod does not prevent stomal retraction. However, complication rates are significantly higher when a stoma rod is used. Routine use of a stoma rod for construction of loop colostomy can be avoided. Colorectal Disease © 2017 The Association of Coloproctology of Great Britain and Ireland.

Empiric versus imaging guided left ventricular lead placement in cardiac resynchronization therapy (ImagingCRT): study protocol for a randomized controlled trial.

PubMed

Sommer, Anders; Kronborg, Mads Brix; Poulsen, Steen Hvitfeldt; Böttcher, Morten; Nørgaard, Bjarne Linde; Bouchelouche, Kirsten; Mortensen, Peter Thomas; Gerdes, Christian; Nielsen, Jens Cosedis

2013-04-26

Cardiac resynchronization therapy (CRT) is an established treatment in heart failure patients. However, a large proportion of patients remain nonresponsive to this pacing strategy. Left ventricular (LV) lead position is one of the main determinants of response to CRT. This study aims to clarify whether multimodality imaging guided LV lead placement improves clinical outcome after CRT. The ImagingCRT study is a prospective, randomized, patient- and assessor-blinded, two-armed trial. The study is designed to investigate the effect of imaging guided left ventricular lead positioning on a clinical composite primary endpoint comprising all-cause mortality, hospitalization for heart failure, or unchanged or worsened functional capacity (no improvement in New York Heart Association class and <10% improvement in six-minute-walk test). Imaging guided LV lead positioning is targeted to the latest activated non-scarred myocardial region by speckle tracking echocardiography, single-photon emission computed tomography, and cardiac computed tomography. Secondary endpoints include changes in LV dimensions, ejection fraction and dyssynchrony. A total of 192 patients are included in the study. Despite tremendous advances in knowledge with CRT, the proportion of patients not responding to this treatment has remained stable since the introduction of CRT. ImagingCRT is a prospective, randomized study assessing the clinical and echocardiographic effect of multimodality imaging guided LV lead placement in CRT. The results are expected to make an important contribution in the pursuit of increasing response rate to CRT. Clinicaltrials.gov identifier NCT01323686. The trial was registered March 25, 2011 and the first study subject was randomized April 11, 2011.

Periarticular Injection of Liposomal Bupivacaine Offers No Benefit Over Standard Bupivacaine in Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial.

PubMed

Alijanipour, Pouya; Tan, Timothy L; Matthews, Christopher N; Viola, Jessica R; Purtill, James J; Rothman, Richard H; Parvizi, Javad; Austin, Matthew S

2017-02-01

Periarticular injection of liposomal bupivacaine has been adopted as part of multimodal pain management after total knee arthroplasty (TKA). In this prospective, randomized clinical trial, we enrolled 162 patients undergoing primary TKA in a single institution between January 2014 and May 2015. Eighty-seven patients were randomized to liposomal bupivacaine (experimental group), and 75 patients were randomized to free bupivacaine (control group). All patients received spinal anesthesia and otherwise identical surgical approaches, pain management, and rehabilitation protocols. Outcomes evaluated include the patient-reported visual analog pain scores, narcotic consumption, and narcotic-related side effects (Brief Pain Inventory) within 96 hours after surgery as well as functional outcomes using the Knee Society Score and the Short-Form 12 measured preoperatively and at 4-6 weeks after surgery. There were no statistically significant differences between the groups in terms of postoperative daily pain scores, narcotic consumption (by-day and overall), or narcotic-related side effects. There were no statistically significant differences between the groups in terms of surgical (P = .76) and medical complications or length of hospital stay (P = .35). There were no statistically significant differences in satisfaction between the groups (P = .56) or between the groups in postoperative Knee Society Score (P = .53) and the Short-Form 12 at 4-6 weeks (P = .82, P = .66). As part of multimodal pain management protocol, periarticular injection of liposomal bupivacaine compared with bupivacaine HCl did not result in any clinically or statistically significant improvement of the measured outcomes following TKA. Copyright © 2016 Elsevier Inc. All rights reserved.

Nonoperative management in children with early acute appendicitis: A systematic review.

PubMed

Xu, Jane; Adams, Susan; Liu, Yingrui Cyril; Karpelowsky, Jonathan

2017-09-01

Appendectomy has remained the gold standard treatment of acute appendicitis for more than 100years. Nonoperative management (NOM) has been shown to be a valid treatment alternative for acute uncomplicated appendicitis in adults. A systematic review of available evidence comparing operative management (OM) and NOM in children with acute uncomplicated appendicitis was performed. Systematic searches of MedLine, Embase, and a clinical trial register (https://clinicaltrials.gov/) were performed in March 2016. Only articles that studied NOM for uncomplicated appendicitis in children were included. Data generation was performed independently by two authors, and quality was assessed using the rating schema by the Oxford Centre for Evidence-Based Medicine. 15 articles were selected: four retrospective analyses, four prospective cohort studies, four prospective nonrandomized comparative trials and one randomized controlled trial (RCT). Initial success of the NOM groups (a cure within two weeks of intervention) ranged from 58 to 100%, with 0.1-31.8% recurrence at one year. Although present literature is scarce, publications support the feasibility of further studies investigating NOM of acute uncomplicated appendicitis in children. Higher quality prospective RCTs with larger sample sizes and robust randomization methods, studying the noninferiority of NOM with antibiotics compared with OM are required to establish its utility. This manuscript is a systematic review and thus assigned the lowest evidence used from the manuscripts analyzed which is a Level IV. Copyright © 2017. Published by Elsevier Inc.

The influence of prophylactic antibiotic administration on post-operative morbidity in dental implant surgery. A prospective double blind randomized controlled clinical trial.

PubMed

Nolan, Rory; Kemmoona, Maher; Polyzois, Ioannis; Claffey, Noel

2014-02-01

A prospective double-blind randomised controlled trial was conducted to test the effect of prophylactic antibiotics on post-operative morbidity and osseointegration of dental implants. Fifty-five subjects scheduled for implant surgery were enrolled. The patients were randomly assigned to the antibiotic (test group) and placebo (control group). Twenty-seven patients (test group) received 3 g amoxicillin one hour pre-operatively, and 28 patients (control group) received placebo capsules 1 h pre-operatively. No post-operative antibiotics were prescribed. Pain diaries and interference with daily activities diaries were kept by the patients for 1 week post-operatively. Signs of post-operative morbidity (swelling, bruising, suppuration and wound dehiscence) were recorded by the principal investigators at day 2 and day 7 following the operation. Osseointegration was assessed at 2nd stage surgery or 3-4 months post-operatively. The results of this study suggest that the use of prophylactic pre-operative antibiotics may result in higher dental implant survival rates (100% vs. 82%). Five implant failures, one in each of five patients, were reported in the placebo group and none in the antibiotic group (P = 0.0515). No significant differences were found for most of the signs of post-operative morbidity 2 and 7 days post-operatively. Only bruising at 2 days following the operation appeared to be higher in the placebo group (P = 0.0511). Post-operative pain (P = 0.01) and interference with daily activities (P = 0.01) appeared to be significantly lower for the antibiotic group after 7 days. Those patients with implant failure reported higher pain (based on the VAS scores) after 2 days (P = 0.003) and after 7 days (P = 0.0005), higher pain (based on the amount of analgesics used) after 7 days (P = 0.001) and higher interference with daily activities (based on the VAS scores) after 2 days (P = 0.005). The use of for dental implant surgery may be justified, as it appears to improve implant survival in the short term and also results in less post-operative pain and interference with daily activities. From the results of this study, it appears that prophylactic antibiotics may also be beneficial both in terms of implant survival, especially when the surgical procedure is prolonged due to its difficulty, high number of implants placed or operator's inexperience. © 2013 John Wiley & Sons A/S. Published by Blackwell Publishing Ltd.

Coherent-state information concentration and purification in atomic memory

NASA Astrophysics Data System (ADS)

Herec, Jiří; Filip, Radim

2006-12-01

We propose a feasible method of coherent-state information concentration and purification utilizing quantum memory. The method allows us to optimally concentrate and purify information carried by many noisy copies of an unknown coherent state (randomly distributed in time) to a single copy. Thus nonclassical resources and operations can be saved, if we compare information processing with many noisy copies and a single copy with concentrated and purified information.

A randomized trial for the study of the elective surgical treatment of portal hypertension in mansonic schistosomiasis.

PubMed Central

da Silva, L C; Strauss, E; Gayotto, L C; Mies, S; Macedo, A L; da Silva, A T; Silva, E F; Lacet, C M; Antonelli, R H; Fermanian, J

1986-01-01

From 1977 to 1983, 94 patients with esophageal varices and gastrointestinal bleeding secondary to mansonic schistosomiasis were entered into a prospective randomized trial comparing the three operations mainly used in Brazil: esophagogastric devascularization associated with splenectomy (EGDS, 32 patients), classical splenorenal shunt (SRS, 32 patients), and distal splenorenal shunt (DSRS, 30 patients). The randomization was interrupted because of a significant incidence of portosystemic encephalopathy (PSE) in the SRS group (26%), as compared to the DSRS (7%) and EGDS (0%) groups. The rate of rebleeding was the same in the three groups, but the rate of failure, as defined by the presence of technical problems, postoperative complications, or death, was significantly higher in the SRS group. This 2-year follow-up shows that SRS should be abandoned in hepatosplenic schistosomiasis and that a comparison between DSRS and EGDS with a longer follow-up is urgently needed. PMID:3090954

Do we need primer for orthodontic bonding? A randomized controlled trial.

PubMed

Nandhra, Sarabjit Singh; Littlewood, Simon J; Houghton, Nadine; Luther, Friedy; Prabhu, Jagadish; Munyombwe, Theresa; Wood, Simon R

2015-04-01

To evaluate the clinical performance of APC™II Victory Series™ (3M Unitek) brackets in direct orthodontic bonding with and without the use of primer. A single-operator, two-centre prospective, non-inferiority randomized controlled clinical trial. The Orthodontic departments at the Leeds Dental Institute and St Luke's Hospital, Bradford, UK. Ethical approval was granted by Leeds (East) Research Ethics Committee on 18th of December 2009 (Reference 09/H1306/102). The protocol was not published prior to trial commencement. Ninety-two patients requiring orthodontic treatment with fixed appliances were randomly allocated to the control (bonded with primer) or test groups (bonded without primer). Patients were randomly allocated to either the control or experimental group. This was performed by preparing opaque numbered sealed envelopes in advance using a random numbers table generated by a computer by an independent third party . Once the envelopes were opened, blinding of the operator and the patient was no longer possible due to the nature of the intervention. Patients were approached for inclusion in the trial if they qualified for NHS orthodontic treatment requiring fixed appliances and had no previous orthodontic treatment. Number of bracket failures, time to bond-up appliances, and the adhesive remnant index (ARI) when bracket failure occurred, over a 12-month period Failure rate with primer was 11.1 per cent and without primer was 15.8 per cent. Bonding without primer was shown statistically to be non-inferior to bonding with primer odds ratio 0.95-2.25 (P = 0.08). Mean difference in bond-up time per bracket was 0.068 minutes (4 seconds), which was not statistically significant (P = 0.402). There was a statistically significant difference in the Adhesive Remnant Index - ARI 0 with primer 49.4 per cent, no primer 76.5 per cent, (P < 0.0001). As the study was only performed by one operator, the results can therefore only be truly be applied to their practice. Also this study was powered to ascertain if there was no difference between the 2 groups up to 5%, however orthodontists may consider a change in the bracket failure rate of 2% to be clinically significant. When bonding with APC™II Victory Series™ brackets without primer was shown statistically to be non-inferior to bonding with primer (P =0.08). There was no significant difference in bond-up times. Bond failure was more likely to happen at the composite-enamel interface when bonded without a primer. No conflict of interest for all authors. No funding sources were used. Study was not registered on external databases. © The Author 2014. Published by Oxford University Press on behalf of the European Orthodontic Society. All rights reserved. For permissions, please email: journals.permissions@oup.com.

Evaluation of holmium laser versus cold knife in optical internal urethrotomy for the management of short segment urethral stricture.

PubMed

Jain, Sudhir Kumar; Kaza, Ram Chandra Murthy; Singh, Bipin Kumar

2014-10-01

SACHSE COLD KNIFE IS CONVENTIONALLY USED FOR OPTICAL INTERNAL URETHROTOMY INTENDED TO MANAGE URETHRAL STRICTURES AND HO: YAG laser is an alternative to it. The aim of this study was to evaluate the role of urethral stricture treatment outcomes, efficacy, and complications using cold knife and Ho: YAG (Holmium laser) for optical internal urethrotomy. In this prospective study included, 90 male patients age >18 years, with diagnosis of urethral stricture admitted for internal optical urethrotomy during April 2010 to March 2012. The patients were randomized into two groups containing 45 patients each using computer generated random number. In group A (Holmium group), internal urethrotomy was done with Holmium laser and in group B (Cold knife group) Sachse cold knife was used. Patients were followed up for 6 months after surgery in Out Patient Department on 15, 30 and 180 post-operative days. At each follow up visit physical examination, and uroflowmetry was performed along with noting complaints, if any. The peak flow rates (PFR) were compared between the two groups on each follow up. At 180 days (6 month interval) the difference between mean of PFR for Holmium and Cold knife group was statistically highly significant (P < 0.001). Complications were seen in 12.22% of cases. Both modalities are effective in providing immediate relief to patients with single and short segment (<2 cm long) urethral strictures but more sustained response was attained with Cold knife urethrotomy.

Intravenous Acetaminophen Does Not Decrease Persistent Surgical Pain After Cardiac Surgery.

PubMed

Turan, Alparslan; Karimi, Nika; Zimmerman, Nicole M; Mick, Stephanie L; Sessler, Daniel I; Mamoun, Negmeldeen

2017-12-01

The authors investigated the hypothesis that perioperative acetaminophen reduces incisional pain at 30 and 90 days. This was a prospective, randomized, double-blind trial. Tertiary-care hospital (single center) cardiac surgery unit. Patients undergoing cardiac surgery via median sternotomy. Patients were assigned randomly to intravenous (IV) acetaminophen or IV placebo. Patients were given 4 doses of 1 g of IV acetaminophen or an equal volume of saline placebo over 15 minutes every 6 hours for 24 hours starting in the operating room after sternal closure. Study participants were assessed by phone for incisional pain severity 30 and 90 days after surgery. Those reporting any incisional pain were asked to complete the Neuropathic Pain Questionnaire-Short Form and the modified Brief Pain Inventory. Patients were compared on 30- and 90-day incisional pain severity using separate multivariable linear regression models. IV acetaminophen had no effect on 30- and 90-day incisional pain, with an estimated difference in means (confidence interval) of 0.06 (-0.87 to 0.99) at 30 days (p = 0.88) and 0.07 (-0.71 to 0.86) at 90 days (p = 0.83). Low pain severity, neuropathic pain, and interference at both 30 and 90 days after surgery, regardless of treatment group, were observed. IV acetaminophen did not reduce the incidence or intensity of incisional pain at 30 days and 90 days after surgery. Copyright © 2017 Elsevier Inc. All rights reserved.

Effects of topical diquafosol pretreatment on intraoperative corneal wetting.

PubMed

Miyake, Goichiro; Ota, Ichiro; Miyake, Kensaku; Zako, Masahiro; Iwaki, Masayoshi

2014-10-01

To examine the effects of pretreatment with diquafosol 3.0% ophthalmic solution on corneal surface wetting during cataract surgery with intraocular lens (IOL) implantation in cases of senile cataract. Shohzankai Medical Foundation, Miyake Eye Hospital, Nagoya, Japan. Prospective randomized single-masked comparative study. Phacoemulsification and IOL implantation were performed in eyes with senile cataract. After a 2-week washout period, patients were randomly assigned to receive 1 drop of diquafosol 3.0% ophthalmic solution or artificial tears 6 times daily for 4 weeks before surgery. The main outcome measure, termed the corneal wetting property, was the time between when a clear image of the operating microscope light source appeared just after the corneal surface was irrigated with a balanced salt solution and the time at which that image began to blur. The study enrolled 51 patients (76 eyes). The mean time to corneal wetting was 50.1 seconds ± 10.8 (SD) in the diquafosol group and 45.3 ± 9.2 seconds in the artificial tears group. The difference between the 2 groups was statistically significant (P<.029). Four-week pretreatment with diquafosol 3.0% ophthalmic solution in patients with senile cataract scheduled for cataract surgery with IOL implantation was effective in enhancing the intraoperative corneal surface wetting property, which suggests improved optical clarity during surgery. No author has a financial or proprietary interest in any material or method mentioned. Copyright © 2014 ASCRS and ESCRS. Published by Elsevier Inc. All rights reserved.

Partial Removal of Nail Matrix in the Treatment of Ingrown Nails: Prospective Randomized Control Study Between Curettage and Electrocauterization.

PubMed

Kim, Maru; Song, In-Guk; Kim, Hyung Jin

2015-06-01

The aim of this study was to compare the result of electrocauterization and curettage, which can be done with basic instruments. Patients with ingrown nail were randomized to 2 groups. In the first group, nail matrix was removed by curettage, and the second group, nail matrix was removed by electrocautery. A total of 61 patients were enrolled; 32 patients were operated by curettage, and 29 patients were operated by electrocautery. Wound infections, as early complication, were found in 15.6% (5/32) of the curettage group, 10.3% (3/29) of the electrocautery group patients each (P = .710). Nonrecurrence was observed in 93.8% (30/32) and 86.2% (25/29) of the curettage and electrocautery groups, respectively, (lower limit of 1-sided 90% confidence interval = -2.3% > -15% [noninferiority margin]). To remove nail matrix, the curettage is effective as well as the electrocauterization. Further study is required to determine the differences between the procedures. © The Author(s) 2014.

Rectus abdominus fascial sheath usage for crural reinforcement during surgical management of GERD: preliminary report of a prospective randomized clinical trial.

PubMed

Yigit, Taner; Coskun, Ali Kagan; Sinan, Huseyin; Harlak, Ali; Kantarcioglu, Murat; Kilbas, Zafer; Kozak, Orhan; Cetiner, Sadettin

2012-08-01

Many materials are currently being used to reinforce the crural repair. Perforation, intensive fibrosis, and price are limiting the usage of these materials. Our purpose was to seek an alternative, cheap, always available, and inert material to use for cruroplasty reinforcement. Twenty-four patients participated and were randomly divided into 2 groups (graft+laparoscopic Nissen fundoplication and laparoscopic Nissen fundoplication alone) with 12 patients in each group. Total operation time, postoperative dysphagia rate, dysphagia improvement time, postoperative pain, recurrence, and incisional hernia rate were compared. There was no difference in terms of study parameters between both groups except for the mean operation time. Autograft hiatoplasty seems to be a good alternative for crural reinforcement. It provides safe reinforcement, has the same dysphagia rates as meshless hiatoplasty, and avoids potential complications of redo surgery by minimizing extensive fibrosis. Furthermore, the rectus abdominus sheath is always available and inexpensive.

Evaluation of distributed practice schedules on retention of a newly acquired surgical skill: a randomized trial.

PubMed

Mitchell, Erica L; Lee, Dae Y; Sevdalis, Nick; Partsafas, Aaron W; Landry, Gregory J; Liem, Timothy K; Moneta, Gregory L

2011-01-01

practice influences new skill acquisition. The aim of this study was to prospectively investigate the impact of practice distribution (weekly vs monthly) on complex motor skill (end-side vascular anastomosis) acquisition and 4-month retention. twenty-four surgical interns were randomly assigned to weekly training for 4 weeks or monthly training for 4 months, with equal total training times. Performance was assessed before training, immediately after training, after the completion of distributed training, and 4 months later. there was no statistical difference in surgical skill acquisition and retention between the weekly and monthly scheduled groups, as measured by procedural checklist scores, global rating scores of operative performance, final product analysis, and overall performance or assessment of operative "competence." distributed practice results in improvement and retention of a newly acquired surgical skill independent of weekly or monthly practice schedules. Flexibility in a surgical skills laboratory curriculum is possible without adversely affecting training. 2011 Elsevier Inc. All rights reserved.

Pre-emptive effect of dexamethasone injection and consumption on post-operative swelling, pain, and trismus after third molar surgery. A prospective, double blind and randomized study.

PubMed

Chaudhary, Pradeep D; Rastogi, Sanjay; Gupta, Prashant; Niranjanaprasad Indra, B; Thomas, Roy; Choudhury, Rupshikha

2015-01-01

To evaluate the preventative effect of intravenous 4 mg of dexamethasone and 8 mg oral dexamethasone on post-operative pain, swelling and trismus after the surgical extraction of mandibular third molars. A randomized clinical trial comprised of 200 patients (control group I intravenous and experimental group II orally) with impacted lower third molars, average age 20.8 years with no local or systemic problems, with bilateral impacted lower third molars, were operated under local anesthesia. Group I was given 4 mg IV and group II was given 8 mg orally of dexamethasone 1 h before procedure. The choice of which side to operate first and the amount of concentration of medication to use was made randomly and double-blindly. Post-operative pain was evaluated using a visual analog scale (VAS) and the degree of swelling was evaluated through facial reference points' variation. The presence of trismus was analyzed through measurement of the interincisal distance (IID). These assessments were obtained before the operation and 24 h, 48 h and 7th POD. No significant difference was found in facial swelling and trismus between IV 4 mg injection and oral 8 mg consumption after lower third molar surgery (student t test P > 0.05). The visual analogue scale scores for pain assessment showed no significant difference between IV injection and oral route of dexamethasone (student t test P > 0.05). Patients can be administered 8 mg oral dexamethasone is as effective as 4 mg intra venous route without much difference in final outcome at any given point of time.

Paint-only is equivalent to scrub-and-paint in preoperative preparation of abdominal surgery sites.

PubMed

Ellenhorn, Joshua D I; Smith, David D; Schwarz, Roderich E; Kawachi, Mark H; Wilson, Timothy G; McGonigle, Kathryn F; Wagman, Lawrence D; Paz, I Benjamin

2005-11-01

Antiseptic preoperative skin site preparation is used to prepare the operative site before making a surgical incision. The goal of this preparation is a reduction in postoperative wound infection. The most straightforward technique necessary to achieve this goal remains controversial. A prospective randomized trial was designed to prove equivalency for two commonly used techniques of surgical skin site preparation. Two hundred thirty-four patients undergoing nonlaparoscopic abdominal operations were consented for the trial. Exclusion criteria included presence of active infection at the time of operation, neutropenia, history of skin reaction to iodine, or anticipated insertion of prosthetic material at the time of operation. Patients were randomized to receive either a vigorous 5-minute scrub with povidone-iodine soap, followed by absorption with a sterile towel, and a paint with aqueous povidone-iodine or surgical site preparation with a povidone-iodine paint only. The primary end point of the study was wound infection rate at 30 days, defined as presence of clinical signs of infection requiring therapeutic intervention. Patients randomized to the scrub-and-paint arm (n = 115) and the paint-only arm (n = 119) matched at baseline with respect to age, comorbidity, wound classification, mean operative time, placement of drains, prophylactic antibiotic use, and surgical procedure (all p > 0.09). Wound infection occurred in 12 (10%) scrub-and-paint patients, and 12 (10%) paint-only patients. Based on our predefined equivalency parameters, we conclude equivalence of infection rates between the two preparations. Preoperative preparation of the abdomen with a scrub with povidone-iodine soap followed by a paint with aqueous povidone-iodine can be abandoned in favor of a paint with aqueous povidone-iodine alone. This change will result in reductions in operative times and costs.

Whole body vibration exercise for chronic low back pain: study protocol for a single-blind randomized controlled trial.

PubMed

Wang, Xue-Qiang; Pi, Yan-Lin; Chen, Pei-Jie; Chen, Bin-Lin; Liang, Lei-Chao; Li, Xin; Wang, Xiao; Zhang, Juan

2014-04-02

Low back pain affects approximately 80% of people at some stage in their lives. Exercise therapy is the most widely used nonsurgical intervention for low back pain in practice guidelines. Whole body vibration exercise is becoming increasingly popular for relieving musculoskeletal pain and improving health-related quality of life. However, the efficacy of whole body vibration exercise for low back pain is not without dispute. This study aims to estimate the effect of whole body vibration exercise for chronic low back pain. We will conduct a prospective, single-blind, randomized controlled trial of 120 patients with chronic low back pain. Patients will be randomly assigned into an intervention group and a control group. The intervention group will participate in whole body vibration exercise twice a week for 3 months. The control group will receive general exercise twice a week for 3 months. Primary outcome measures will be the visual analog scale for pain, the Oswestry Disability Index and adverse events. The secondary outcome measures will include muscle strength and endurance of spine, trunk proprioception, transversus abdominis activation capacity, and quality of life. We will conduct intention-to-treat analysis if any participants withdraw from the trial. Important features of this study include the randomization procedures, single-blind, large sample size, and a standardized protocol for whole body vibration in chronic low back pain. This study aims to determine whether whole body vibration exercise produces more beneficial effects than general exercise for chronic low back pain. Therefore, our results will be useful for patients with chronic low back pain as well as for medical staff and health-care decision makers. Chinese Clinical Trial Registry: ChiCTR-TRC-13003708.

Evaluation of the effect of aromatherapy with lavender essential oil on post-tonsillectomy pain in pediatric patients: a randomized controlled trial.

PubMed

Soltani, Rasool; Soheilipour, Saeed; Hajhashemi, Valiollah; Asghari, Gholamreza; Bagheri, Mahdi; Molavi, Mahdi

2013-09-01

To evaluate the effect of aromatherapy with Lavandula angustifolia essential oil on post-tonsillectomy pain in pediatric patients. This was a randomized controlled prospective clinical trial. In this study, 48 post-tonsillectomy patients aged 6-12 years were randomly assigned to two groups (24 patients in each group). After tonsillectomy surgery, all patients received acetaminophen (10-15 mg/kg/dose, PO) every 6h as necessary to relieve pain. The patients of the case group also inhaled lavender essential oil. The frequencies of daily use of acetaminophen and nocturnal awakening due to pain, and pain intensity (evaluated using visual analog scale [VAS]) were recorded for each patient for 3 days after surgery. Finally, the mean values of variables were compared between two groups separately for each post-operative day. The use of lavender essential oil caused statistically significant reduction in daily use of acetaminophen in all three post-operative days but had not significant effects on pain intensity and frequency of nocturnal awakening. Aromatherapy with lavender essential oil decreases the number of required analgesics following tonsillectomy in pediatric patients. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Single-incision Laparoscopic Surgery (SILS) in general surgery: a review of current practice.

PubMed

Froghi, Farid; Sodergren, Mikael Hans; Darzi, Ara; Paraskeva, Paraskevas

2010-08-01

Single-incision laparoscopic surgery (SILS) aims to eliminate multiple port incisions. Although general operative principles of SILS are similar to conventional laparoscopic surgery, operative techniques are not standardized. This review aims to evaluate the current use of SILS published in the literature by examining the types of operations performed, techniques employed, and relevant complications and morbidity. This review considered a total of 94 studies reporting 1889 patients evaluating 17 different general surgical operations. There were 8 different access techniques reported using conventional laparoscopic instruments and specifically designed SILS ports. There is extensive heterogeneity associated with operating methods and in particular ways of overcoming problems with retraction and instrumentation. Published complications, morbidity, and hospital length of stay are comparable to conventional laparoscopy. Although SILS provides excellent cosmetic results and morbidity seems similar to conventional laparoscopy, larger randomized controlled trials are needed to assess the safety and efficacy of this novel technique.

Rocuronium duration of action under sevoflurane, desflurane or propofol anaesthesia.

PubMed

Maidatsi, P G; Zaralidou, A Th; Gorgias, N K; Amaniti, E N; Karakoulas, K A; Giala, M M

2004-10-01

We conducted a prospective randomized study to evaluate whether the duration of action of a single bolus dose of rocuronium is influenced by maintenance of anaesthesia with sevoflurane, desflurane or propofol infusion. Fifty-seven ASA I-II patients undergoing elective abdominal surgery were enrolled in this study. Anaesthesia was induced with thiopental 3-5 mg kg(-1) or propofol 2.5 mg kg(-1) and fentanyl 5 microg kg(-1) and tracheal intubation was facilitated with rocuronium 0.9 mg kg(-1). Thereafter patients were randomly allocated to three different groups to receive sevoflurane, desflurane or propofol for maintenance of anaesthesia. Recovery of neuromuscular function was monitored by single twitch stimulation of the ulnar nerve and by recording the adductor pollicis response using accelerometry. Intergroup recovery times to 5% of control value of single twitch were analysed using analysis of variance with Bonferroni correction. The mean (95% confidence interval) recovery time to 5% of control value of single twitch during desflurane anaesthesia was 90.18 (86.11-94.25) min. Significantly shorter recovery times were observed during sevoflurane or propofol anaesthesia, 58.86 (54.73-62.99) min and 51.11 (45.47-56.74) min, respectively (P < 0.001). There were also significant differences in the recovery time between groups receiving desflurane vs. sevoflurane (P < 0.001) and desflurane vs. propofol (P < 0.001). Desflurane anaesthesia significantly prolongs the duration of action of rocuronium at 0.9 mg kg(-1) single bolus dose, compared to sevoflurane or propofol anaesthesia maintenance regimens.

Prospective, randomized comparison of transperitoneal versus retroperitoneal laparoscopic adrenalectomy.

PubMed

Rubinstein, Mauricio; Gill, Inderbir S; Aron, Monish; Kilciler, Mete; Meraney, Anoop M; Finelli, Antonio; Moinzadeh, Ali; Ukimura, Osamu; Desai, Mihir M; Kaouk, Jihad; Bravo, Emmanuel

2005-08-01

We report a prospective, randomized comparison of transperitoneal laparoscopic adrenalectomy (TLA) vs retroperitoneal laparoscopic adrenalectomy (RLA) for adrenal lesions with long-term followup. Between December 1997 and November 1999, 57 consecutive eligible patients with surgical adrenal disease were prospectively randomized to undergo TLA (25) or RLA (32). Study exclusion criteria were patient age greater than 80 years, body mass index greater than 40, bilateral adrenalectomy and significant prior abdominal surgery in the quadrant of interest. Mean followup was 5.96 years in the 2 groups. The groups were matched in regard to patient age (p = 0.84), body mass index (p = 0.43), American Society of Anesthesiologists class (p = 0.81) and laterality (p = 0.12). Median adrenal mass size was 2.7 cm (range 1 to 9) in the TLA group and 2.6 cm (range 0.5 to 6) in the RLA group (p = 0.83). TLA was comparable to RLA in terms of operative time (130 vs 126.5 minutes, p = 0.64), estimated blood loss (p = 0.92), specimen weight (p = 0.81), analgesic requirements (p = 0.25), hospital stay (p = 0.56) and the complication rate (p = 0.58). One case per group was electively converted to open surgery. Pathology data on the intact extracted specimens were similar between the groups. Averaged convalescence was 4.7 weeks in the TLA group and 2.3 weeks in the RLA group (p = 0.02). During a mean followup of 6 years 2 patients in the TLA group had a late complication (port site hernia). Mortality occurred in 5 patients, including 1 with TLA and 4 with RLA, during the 6-year followup. For most benign adrenal lesions requiring surgery laparoscopic adrenalectomy can be performed safely and effectively by the transperitoneal or the retroperitoneal approach.

Low-molecular-weight heparinoid compared with warfarin for prophylaxis of deep-vein thrombosis in patients who are operated on for fracture of the hip. A prospective, randomized trial

DOE Office of Scientific and Technical Information (OSTI.GOV)

Gerhart, T.N.; Yett, H.S.; Robertson, L.K.

In a randomized, prospective trial, a low-molecular-weight heparinoid (Org 10172 (Lomoparan)) was compared with warfarin for efficacy and safety in preventing deep-vein thrombosis in 263 patients who had an operatively treated fracture of the hip. One group of patients received Org 10172 in a dose of 750 units subcutaneously every twelve hours until the ninth postoperative day; on the seventh postoperative day, warfarin was added to the regimen. The other group received only warfarin. Both drugs were begun preoperatively, immediately after the admission evaluation. In the patients who received warfarin, the desired prothrombin time was one and one-half times themore » control level. Deep-vein thrombosis was detected by {sup 125}I-fibrinogen scanning and impedance plethysmography and was confirmed by phlebography and compression ultrasonography. Deep-vein thrombosis was found in nine (7 per cent) of the 132 patients who received Org 10172 and in twenty-eight (21 per cent) of the 131 patients who received warfarin (p less than 0.001). Adverse reactions were not significantly different in the two groups. Major bleeding complications occurred in eight patients in the Org-10172 group, only four of whom were receiving the drug at the time of bleeding, and in five patients who were receiving warfarin (not significant). There was no difference in intraoperative loss of blood or in requirements for transfusion. We concluded that the low-molecular-weight heparinoid Org 10172 is a safe, convenient, effective antithrombotic agent for the prevention of venous thrombosis after an operation for fracture of the hip.« less

A prospective double-blinded randomized controlled trial comparing systemic stress response in Laparoascopic cholecystectomy between low-pressure and standard-pressure pneumoperitoneum.

PubMed

Shoar, Saeed; Naderan, Mohammad; Ebrahimpour, Hossein; Soroush, Ahmadreza; Nasiri, Shirzad; Movafegh, Ali; Khorgami, Zhamak

2016-04-01

Laparoscopic cholecystectomy (LC) has become the gold-standard treatment for gallstone diseases. However, despite huge reduction in operative injury, systemic stress response remains high. This randomized controlled trial (RCT) aimed to compare systemic stress response between 2 different techniques of CO2 pneumoperitoneum. Trough a prospective, double-blinded RCT, serum levels of cortisol, adrenaline, glucose, and C-reactive protein (CRP) were compared between the two groups consisted of 50 patients undergoing LC under low-pressure and standard-pressure CO2 pneimoperitoneum. A total of fifty patients undergoing LC were equally assigned to 2 groups of twenty five patients. Average age was 48 ± 13.8 years (range, 19-74 years). Operative time was similar between standard-pressure group (47.8 ± 16.8 min) and low-pressure group (53.6 ± 25.1). Moreover, intra-operative IV volume administration and urine output did not differ significantly between the 2 groups (p > 0.05). Although the average heart rate and mean arterial pressure were slightly higher in a standard-pressure group compared with a low-pressure group, serial measurements of these parameters were statistically similar between the 2 groups. Serial changes of serum levels of cortisol, glucose, adrenaline, and CRP were compared between surgery day, postoperative 6-h and 1st postoperative day, which did not differ significantly between the standard-pressure and the low-pressure groups (p > 0.05). Our study did not reveal any alteration in systemic stress response with reduction in intra-abdominal pressure of pneumoperitoneum in LC. RCT REGISTRATION: irct.ir ID: IRCT201110072982N5. Copyright © 2016 IJS Publishing Group Limited. Published by Elsevier Ltd. All rights reserved.

Evaluating the Effectiveness of an Antimicrobial Stewardship Program on Reducing the Incidence Rate of Healthcare-Associated Clostridium difficile Infection: A Non-Randomized, Stepped Wedge, Single-Site, Observational Study.

PubMed

DiDiodato, Giulio; McArthur, Leslie

2016-01-01

The incidence rate of healthcare-associated Clostridium difficile infection (HA-CDI) is estimated at 1 in 100 patients. Antibiotic exposure is the most consistently reported risk factor for HA-CDI. Strategies to reduce the risk of HA-CDI have focused on reducing antibiotic utilization. Prospective audit and feedback is a commonly used antimicrobial stewardship intervention (ASi). The impact of this ASi on risk of HA-CDI is equivocal. This study examines the effectiveness of a prospective audit and feedback ASi on reducing the risk of HA-CDI. Single-site, 339 bed community-hospital in Barrie, Ontario, Canada. Primary outcome is HA-CDI incidence rate. Daily prospective and audit ASi is the exposure variable. ASi implemented across 6 wards in a non-randomized, stepped wedge design. Criteria for ASi; any intravenous antibiotic use for ≥ 48 hrs, any oral fluoroquinolone or oral second generation cephalosporin use for ≥ 48 hrs, or any antimicrobial use for ≥ 5 days. HA-CDI cases and model covariates were aggregated by ward, year and month starting September 2008 and ending February 2016. Multi-level mixed effect negative binomial regression analysis was used to model the primary outcome, with intercept and slope coefficients for ward-level random effects estimated. Other covariates tested for inclusion in the final model were derived from previously published risk factors. Deviance residuals were used to assess the model's goodness-of-fit. The dataset included 486 observation periods, of which 350 were control periods and 136 were intervention periods. After accounting for all other model covariates, the estimated overall ASi incidence rate ratio (IRR) was 0.48 (95% 0.30, 0.79). The ASi effect was independent of antimicrobial utilization. The ASi did not seem to reduce the risk of Clostridium difficile infection on the surgery wards (IRR 0.87, 95% CI 0.45, 1.69) compared to the medicine wards (IRR 0.42, 95% CI 0.28, 0.63). The ward-level burden of Clostridium difficile as measured by the ward's previous month's total CDI cases (CDI Lag) and the ward's current month's community-associated CDI cases (CA-CDI) was significantly associated with an increased risk of HA-CDI, with the estimated CDI Lag IRR of 1.21 (95% 1.15, 1.28) and the estimated CA-CDI IRR of 1.10 (95% CI 1.01, 1.20). The ward-level random intercept and slope coefficients were not significant. The final model demonstrated good fit. In this study, a daily prospective audit and feedback ASi resulted in a significant reduction in the risk of HA-CDI on the medicine wards, however, this effect was independent of an overall reduction in antibiotic utilization. In addition, the ward-level burden of Clostridium difficile was shown to significantly increase the risk of HA-CDI, reinforcing the importance of the environment as a source of HA-CDI.

Promoting patient safety through prospective risk identification: example from peri-operative care.

PubMed

Smith, A; Boult, M; Woods, I; Johnson, S

2010-02-01

Investigation of patient safety incidents has focused on retrospective analyses once incidents have occurred. Prospective risk analysis techniques complement this but have not been widely used in healthcare. Prospective risk identification of non-operative risks associated with adult elective surgery under general anaesthesia using a customised structured "what if" checklist and development of risk matrix. Prioritisation of recommendations arising by cost, ease and likely speed of implementation. Groups totalling 20 clinical and administrative healthcare staff involved in peri-operative care and risk experts convened by the UK National Patient Safety Agency. 102 risks were identified and 95 recommendations made. The top 20 recommendations together were judged to encompass about 75% of the total estimated risk attributable to the processes considered. Staffing and organisational issues (21% of total estimated risk) included recommendations for removing distractions from the operating theatre, ensuring the availability of senior anaesthetists and promoting standards and flexible working among theatre staff. Devices and equipment (19% of total estimated risk) could be improved by training and standardisation; airway control and temperature monitoring were identified as two specific areas. Pre-assessment of patients before admission to hospital (12% of estimated risk) could be improved by defining a data set for adequate pre-assessment and making this available throughout the NHS. This technique can be successfully applied by healthcare staff but expert facilitation of groups is advisable. Such wider-ranging processes can potentially lead to more comprehensive risk reduction than "single-issue" risk alerts.

Balloon catheter versus basket catheter for endoscopic bile duct stone extraction: a multicenter randomized trial.

PubMed

Ishiwatari, Hirotoshi; Kawakami, Hiroshi; Hisai, Hiroyuki; Yane, Kei; Onodera, Manabu; Eto, Kazunori; Haba, Shin; Okuda, Toshinori; Ihara, Hideyuki; Kukitsu, Takehiro; Matsumoto, Ryusuke; Kitaoka, Keisuke; Sonoda, Tomoko; Hayashi, Tsuyoshi

2016-04-01

Endoscopic bile duct stone (BDS) removal is a well-established treatment; however, the preference for basket or balloon catheters for extraction is operator-dependent. We therefore conducted a multicenter prospective randomized trial to compare catheter performance. We enrolled patients with a BDS diameter ≤ 10 mm and common bile duct diameter ≤ 15 mm. Participants were randomly assigned to groups that were treated with basket or balloon catheters between October 2013 and September 2014. The primary endpoint was the rate of complete clearance of the duct; the secondary endpoints were the rate and time to complete clearance in one endoscopic session. We initially enrolled 172 consecutive patients; 14 were excluded after randomization. The complete clearance rates were 92.3 % (72/78) in the balloon group and 80.0 % (64 /80) in the basket group. The difference in the rates between the two groups was 12.3 percentage points, indicating non-inferiority of the balloon method (non-inferiority limit -10 %; P < 0.001 for non-inferiority). Moreover, the balloon was superior to the basket (P = 0.037). The rate of complete clearance in one endoscopic session was 97.4 % using the balloon and 97.5 % using the basket (P = 1.00). The median times to complete clearance in one endoscopic session were 6.0 minutes (1 - 30) and 7.8 minutes (1 - 37) in the balloon and basket groups, respectively (P = 0.15). For extraction of BDSs ≤ 10 mm, complete endoscopic treatment with a single catheter is more likely when choosing a balloon catheter over a basket catheter.University Hospital Medical Information Network Trials Registry: UMIN000011887. © Georg Thieme Verlag KG Stuttgart · New York.

Design of the Revascularization With Open Bypass vs Angioplasty and Stenting of the Lower Extremity Trial (ROBUST): a randomized clinical trial.

PubMed

Malas, Mahmoud B; Qazi, Umair; Glebova, Natalia; Arhuidese, Isibor; Reifsnyder, Thomas; Black, James; Perler, Bruce A; Freischlag, Julie A

2014-12-01

To our knowledge, there is no level 1 evidence comparing open bypass with angioplasty and stenting in TransAtlantic Inter-Society Consensus (TASC II) B and C superficial femoral artery lesions. The Revascularization With Open Bypass vs Angioplasty and Stenting of the Lower Extremity Trial (ROBUST) is the first prospective randomized clinical trial comparing both treatments. To report the design of the ROBUST trial. The primary aim of the trial is to compare (1) the patency rate (primary, primary assisted, and secondary patency at 6 and 12 months), (2) improvement of quality of life, (3) clinical improvement (at least 1 Rutherford category), and (4) wound healing and limb salvage in patients presenting with critical limb ischemia; secondary aims include (1) cost-effectiveness by factoring procedure and hospital admission costs including rehabilitation, readmission, and reintervention costs, (2) amputation-free survival, (3) reintervention rate, and (4) 30-day operative mortality, morbidity, and wound and access complications. ROBUST is a prospective randomized clinical trial with the aim to enroll 320 patients with intermittent claudication that does not respond to medical management and patients with critical limb ischemia. The maximum level of medical therapy will be administered using antiplatelet agents and statins, as well as measures to control hypertension and diabetes mellitus. Patients with TASC II B or C lesions are prospectively randomized to receive either femoropopliteal bypass or percutaneous transluminal angioplasty and stenting; patients with TASC II A and D lesions are not randomized and receive percutaneous transluminal angioplasty and stenting or femoropopliteal bypass, respectively. All patients will be evaluated at 1, 6, and 12 months postoperatively with physical examination, ankle brachial index, duplex, and a quality-of-life questionnaire. The trial is actively enrolling participants. At the time of writing, 29 patients have been enrolled; most are male (60%) and white (65%). Providing level 1 evidence, ROBUST may help to establish guidelines for the treatment of superficial femoral artery lesions, eliminate unnecessary procedures, and reduce health care costs. clinicaltrials.gov Identifier: NCT01602159.

Lifshits Tails for Randomly Twisted Quantum Waveguides

NASA Astrophysics Data System (ADS)

Kirsch, Werner; Krejčiřík, David; Raikov, Georgi

2018-03-01

We consider the Dirichlet Laplacian H_γ on a 3D twisted waveguide with random Anderson-type twisting γ . We introduce the integrated density of states N_γ for the operator H_γ , and investigate the Lifshits tails of N_γ , i.e. the asymptotic behavior of N_γ (E) as E \\downarrow \\inf supp dN_γ . In particular, we study the dependence of the Lifshits exponent on the decay rate of the single-site twisting at infinity.

Minimalist design of a robust real-time quantum random number generator

NASA Astrophysics Data System (ADS)

Kravtsov, K. S.; Radchenko, I. V.; Kulik, S. P.; Molotkov, S. N.

2015-08-01

We present a simple and robust construction of a real-time quantum random number generator (QRNG). Our minimalist approach ensures stable operation of the device as well as its simple and straightforward hardware implementation as a stand-alone module. As a source of randomness the device uses measurements of time intervals between clicks of a single-photon detector. The obtained raw sequence is then filtered and processed by a deterministic randomness extractor, which is realized as a look-up table. This enables high speed on-the-fly processing without the need of extensive computations. The overall performance of the device is around 1 random bit per detector click, resulting in 1.2 Mbit/s generation rate in our implementation.

Effect of trimetazidine on recurrent angina pectoris and left ventricular structure in elderly multivessel coronary heart disease patients with diabetes mellitus after drug-eluting stent implantation: a single-centre, prospective, randomized, double-blind study at 2-year follow-up.

PubMed

Xu, Xiaohan; Zhang, Weijun; Zhou, Yujie; Zhao, Yingxin; Liu, Yuyang; Shi, Dongmei; Zhou, Zhiming; Ma, Hanying; Wang, Zhijian; Yu, Miao; Ma, Qian; Gao, Fei; Shen, Hua; Zhang, Jianwei

2014-04-01

Trimetazidine has been shown to improve angina pectoris and left ventricular (LV) function in diabetic patients with ischaemic cardiomyopathy. The objective of this study was to evaluate the effects of trimetazidine on recurrent angina pectoris and LV structure after drug-eluting stent (DES) implantation in elderly multivessel coronary heart disease (CHD) patients with diabetes mellitus (DM) and a left ventricular ejection fraction (LVEF) of ≥ 50 %. This was a single-centre, prospective, randomized, double-blind evaluation study. Between January 2010 and September 2010, 700 CHD patients with DM who were aged ≥ 65 years and undergoing coronary angiography at An Zhen Hospital (Beijing, China) were recruited and prospectively randomized to receive trimetazidine (20 mg three times daily) or placebo after DES implantation as an addition to conventional CHD treatment. The primary end points were the incidence of recurrent angina pectoris and measures of various echocardiographic parameters, which included LVEF. At 2-year follow-up, patients in the trimetazidine group (n = 255) showed significant improvements in the incidence (P = 0.024) and severity of angina pectoris, compared with the control group, as well as silent myocardial ischaemia (P = 0.009) and angina pectoris-free survival (P = 0.011). LV function and structure in trimetazidine-treated patients were relatively stable at 2-year follow-up, while they deteriorated in the control group (n = 255) with a significant difference between groups (all P < 0.01). The E peak to A peak (E/A) ratio in trimetazidine-treated patients and in the control group decreased after 2 years; the E/A ratio in trimetazidine-treated patients was slightly better than that in the control group, without a significant difference (P = 0.170). There was no significant difference in event-free survival for the composite end point including death, myocardial infarction, cerebrovascular accident (P = 0.422) and subsequent revascularization (P = 0.073). Adjunctive therapy with trimetazidine after DES implantation can have a beneficial effect on recurrent angina pectoris as well as LV function and structure in elderly multivessel CHD patients with DM.

Effects of fixed orthodontic treatment and two new mouth rinses on gingival health: A prospective cohort followed by a single-blind placebo-controlled randomized clinical trial.

PubMed

Sobouti, Farhad; Rakhshan, Vahid; Heydari, Mohaddeseh; Keikavusi, Shohreh; Dadgar, Sepideh; Shariati, Mahsa

2018-03-01

Routine brushing protocols might not suffice to reduce the increased plaque accumulation in orthodontic patients. Antimicrobial mouth rinses are favorable in this regard. This two-phase study evaluated the effects of orthodontic treatment and the application of two mouthwashes not studied before on oral health indices. In this two-phase study (a prospective cohort followed by a parallel randomized controlled trial), plaque index (PI), gingival index (GI), gingival bleeding index (GBI), and pocket probing depth (PPD) were measured in 54 orthodontic patients before orthodontic treatment and 4 months later. Then patients were randomized into three groups of mouthrinses: Persica (herbal), Ortho-Kin (containing diluted chlorhexidine), and Placebo (n=18×3). The effects of orthodontic treatment and mouthrinses were analyzed statistically (α=0.05). All the 4 indices increased between the baseline and 4th month of treatment (P values<0.01, paired t-test). They decreased back to baseline levels or below them, after one month of mouthwash application (P values<0.002). Both mouthwashes showed therapeutic effects compared to placebo in terms of PI and GBI. In the case of GI, only Persica showed significantly better results compared to placebo. Regarding PPD, only Ortho-Kin acted better than placebo (P values≤0.05, Tukey). Lack of positive control (regular chlorhexidine mouth rinse) and negative control (a group with no mouthwashes, even without the placebo). Lack of sample size predetermination based on a priori power calculations. The difference between the regime of Persica with that of Ortho-Kin and placebo (which had similar application protocols) disallowed perfectly effective blinding of the patients (hence, single-blind). Fixed orthodontic treatment might disrupt gingival health. Antimicrobial mouthwashes might reverse this. Both evaluated mouthwashes might have therapeutic effects. Copyright © 2018 CEO. Published by Elsevier Masson SAS. All rights reserved.

Does 360° lumbar spinal fusion improve long-term clinical outcomes after failure of conservative treatment in patients with functionally disabling single-level degenerative lumbar disc disease? Results of 5-year follow-up in 75 postoperative patients.

PubMed

Zigler, Jack E; Delamarter, Rick B

2013-01-01

Surgical treatment of patients with mechanical degenerative disc disease has been controversial, but improvements in clinical outcomes have been shown in properly selected patients with disease-specific diagnoses, with fusion arguably now becoming the "gold standard" for surgical management of these patients. No published study thus far has been designed for prospective enrollment of patients with specific inclusion/exclusion criteria in whom at least 6 months of conservative therapy has failed and who are then offered a standardized surgical procedure and are followed up for 5 years. The study group was composed of the patients in the prospective, randomized Food and Drug Administration Investigational Device Exemption trial comparing ProDisc-L (Synthes Spine, West Chester, Pennsylvania) with 360° fusion for the treatment of single-level symptomatic disc degeneration. Of 80 patients randomized to 360° fusion after failure of non-operative care, 75 were treated on protocol with single-level fusions. Follow-up of this treatment cohort was 97% at 2 years and 75% at 5 years and serves as the basis for this report. Patients in the trial were required to have failure of at least 6 months of nonoperative care and in fact had failure of an average of 9 months of nonoperative treatment. The mean Oswestry Disability Index score indicated greater than 60% impairment. The mean entry-level pain score on a visual analog scale was greater than 8 of 10. After fusion, not only did patients have significant improvements in measurable clinical outcomes such as the Oswestry Disability Index score and pain score on a visual analog scale but there were also substantial improvements in their functional status and quality of life. Specifically, over 80% of patients in this study had improvements in recreational status that was maintained 5 years after index surgery, indicating substantial improvements in life quality that were not afforded by months of conservative care. The percentage of patients using narcotics at the 5-year follow-up visit was less than half the percentage of patients who had used narcotics as part of their prior conservative treatment. The 5-year results of this post hoc analysis of 75 patients involved in a multicenter, multi-surgeon trial support 360° fusion surgery as a predictable and lasting treatment option to improve pain and function in properly selected patients with mechanical degenerative disc disease. These improvements occurred dramatically immediately after surgery and have been maintained through the scope of this follow-up period, with 98% follow-up at 2 years and 75% of patients available at 5 years.

Prospective Observational Study of Single-Site Multiport Per-umbilical Laparoscopic Endosurgery versus Conventional Multiport Laparoscopic Cholecystectomy: Critical Appraisal of a Unique Umbilical Approach

PubMed Central

Jategaonkar, Priyadarshan Anand; Yadav, Sudeep Pradeep

2014-01-01

Purpose. This prospective observational study compares an innovative approach of Single-Site Multi-Port Per-umbilical Laparoscopic Endo-surgery (SSMPPLE) cholecystectomy with the gold standard—Conventional Multi-port Laparoscopic Cholecystectomy (CMLC)—to assess the feasibility and efficacy of the former. Methods. In all, 646 patients were studied. SSMPPLE cholecystectomy utilized three ports inserted through three independent mini-incisions at the umbilicus. Only the day-to-day rigid laparoscopic instruments were used in all cases. The SSMPPLE cholecystectomy group had 320 patients and the CMLC group had 326 patients. The outcomes were statistically compared. Results. SSMPPLE cholecystectomy had average operative time of 43.8 min and blood loss of 9.4 mL. Their duration of hospitalization was 1.3 days (range, 1–5). Six patients (1.9%) of this group were converted to CMLC. Eleven patients had controlled gallbladder perforations at dissection. The Visual Analogue Scores for pain on postoperative days 0 and 7, the operative time, and the scar grades were significantly better for SSMPPLE than CMLC. However, umbilical sepsis and seroma outcomes were similar. We had no bile-duct injuries or port-site hernias in this study. Conclusion. SSMPPLE cholecystectomy approach complies with the principles of laparoscopic triangulation; it seems feasible and safe method of minimally invasive cholecystectomy. Overall, it has a potential to emerge as an economically viable alternative to single-port surgery. PMID:24876955

The protective efficacy and safety of bandage contact lenses in children aged 5 to 11 after frontalis muscle flap suspension for congenital blepharoptosis: A single-center randomized controlled trial.

PubMed

Chen, Lin; Pi, Lianhong; Ke, Ning; Chen, Xinke; Liu, Qing

2017-09-01

Postoperative complications, lagophthalmos and exposure keratopathy sometimes occur after surgery for congenital blepharoptosis. Bandage contact lenses (BCL) can help prevent some ocular surface disorders. The study aims to evaluate the efficacy and safety of BCL for protection of the ocular surface in children aged 5 to 11 years after frontalis muscle flap suspension for congenital blepharoptosis. We conducted a prospective randomized clinical study of 30 eyes of 30 patients with congenital blepharoptosis consecutively enrolled at the Ophthalmology Ward of the Children's Hospital of Chongqing Medical University, China from September 1, 2016, to February 30, 2017. After frontalis muscle flap suspension surgery, patients were randomly assigned to undergo BCL application (BCL group, 15 eyes) or no BCL application (control group, 15 eyes). All patients were treated with bramycin 0.3% and polyvinyl alcohol drops after surgery. The primary outcomes were dry eye assessed by tear film break time (TFBUT), fluoresce in corneal staining (FCS) on slit-lamp on days 1, 3, and 15 postoperatively, and lower tear meniscus height (LTMH) on optical coherence tomography on days 1 and 15 postoperatively. Secondary outcomes were pairwise correlation of TFBUT, FCS and LTMH. In the BCL group, abnormal TFBUT and FCS were only found in 2 patients (13.33%) on postoperative day 15. In the control group, the incidence of dry eye assessed by TFBUT was 67.00% (10/15 eyes) on day 1, 73.33% (11/15 eyes) on day 3, and 53.33% (8/15 eyes) on day 15 (P < .001). LTMH were significantly higher in the BCL group than the control group postoperatively (P < .001). Significant positive correlations were found between LTMH and TFBUT pre-operation and on days 1 and 15 post-operation. For LTMH and FCSS (R = -0.815, P < .001), and TFBUT and FCS (R = -0.837, P < .001), the Pearson coefficient was negative on postoperative day 1, but not correlated on day 15. Silicone hydrogel BCL were safe and efficacious for protective use in children after frontalis muscle flap suspension for congenital blepharoptosis.

Sexual function and quality of life following retropubic TVT and single-incision sling in women with stress urinary incontinence: results of a prospective study.

PubMed

Naumann, Gert; Steetskamp, Joscha; Meyer, Mira; Laterza, Rosa; Skala, Christine; Albrich, Stefan; Koelbl, Heinz

2013-05-01

The objective of this prospective cohort study was to compare effectiveness, morbidity, quality of life (QoL) and sexual function in women treated with tension-free vaginal tape (TVT) versus single-incision sling (SIS) in the treatment of female stress urinary incontinence (SUI). Retropubic TVT sling or SIS was implanted in local anesthesia and patients were followed post-operatively for 6 months. Evaluation was performed to assess post-operative rate of continence, complications, changes in sexual function and patient reported quality of life. Female sexual function was evaluated before and after sling procedure using Female Sexual Function Index (FSFI) in sexually active patients. From January 2009 to December 2011, 150 patients were enrolled and underwent a procedure to implant the retropubic TVT (n = 75) or the MiniArc(®) and Ajust(®) SIS (n = 75). Overall, 93.3 % of the patients who successfully received SIS demonstrated total restoration (84 %) or improvement of continence (9.3 %) at the 6 month post-operative study visit. In TVT group we found 88 % total continence and 6.7 % improvement, respectively. Improvements were seen in the QoL scores related to global bladder feeling (89.3 %) in SIS group and 96 % for TVT. Post-operative FSFI score improves significantly and were comparable in both groups (SIS pre-operative 24.30 ± 4.56 to 27.22 ± 4.66 (P < 0.001) post-operative; TVT 24.63 ± 6.62 to 28.47 ± 4.41, respectively). The SIS procedure appears to be as effective in improving incontinence-related quality of life and sexual function as the TVT through 6 months of post-operative follow-up. No differences in complications and sexual function were demonstrated between the groups.

System reliability, performance and trust in adaptable automation.

PubMed

Chavaillaz, Alain; Wastell, David; Sauer, Jürgen

2016-01-01

The present study examined the effects of reduced system reliability on operator performance and automation management in an adaptable automation environment. 39 operators were randomly assigned to one of three experimental groups: low (60%), medium (80%), and high (100%) reliability of automation support. The support system provided five incremental levels of automation which operators could freely select according to their needs. After 3 h of training on a simulated process control task (AutoCAMS) in which the automation worked infallibly, operator performance and automation management were measured during a 2.5-h testing session. Trust and workload were also assessed through questionnaires. Results showed that although reduced system reliability resulted in lower levels of trust towards automation, there were no corresponding differences in the operators' reliance on automation. While operators showed overall a noteworthy ability to cope with automation failure, there were, however, decrements in diagnostic speed and prospective memory with lower reliability. Copyright © 2015. Published by Elsevier Ltd.

Grafton and local bone have comparable outcomes to iliac crest bone in instrumented single-level lumbar fusions.

PubMed

Kang, James; An, Howard; Hilibrand, Alan; Yoon, S Tim; Kavanagh, Eoin; Boden, Scott

2012-05-20

Prospective multicenter randomized clinical trail. The goal of our 2-year prospective study was to perform a randomized clinical trial comparing the outcomes of Grafton demineralized bone matrix (DBM) Matrix with local bone with that of iliac crest bone graft (ICBG) in a single-level instrumented posterior lumbar fusion. There has been extensive research and development in identifying a suitable substitute to replace autologous ICBG that is associated with known morbidities. DBMs are a class of commercially available grafting agents that are prepared from allograft bone. Many such products have been commercially available for clinical use; however, their efficacy for spine fusion has been mostly based on anecdotal evidence rather than randomized controlled clinical trials. Forty-six patients were randomly assigned (2:1) to receive Grafton DBM Matrix with local bone (30 patients) or autologous ICBG (16 patients). The mean age was 64 (females [F] = 21, males [M] = 9) in the DBM group and 65 (F = 9, M = 5) in the ICBG group. An independent radiologist evaluated plain radiographs and computed tomographic scans at 6-month, 1-year, and 2-year time points. Clinical outcomes were measured using Oswestry Disability Index (ODI) and Medical Outcomes Study 36-Item Short Form Health Survey. Forty-one patients (DBM = 28 and ICBG = 13) completed the 2-year follow-up. Final fusion rates were 86% (Grafton Matrix) versus 92% (ICBG) (P = 1.0 not significant). The Grafton group showed slightly better improvement in ODI score than the ICBG group at the final 2-year follow-up (Grafton [16.2] and ICBG [22.7]); however, the difference was not statistically significant (P = 0.2346 at 24 mo). Grafton showed consistently higher physical function scores at 24 months; however, differences were not statistically significant (P = 0.0823). Similar improvements in the physical component summary scores were seen in both the Grafton and ICBG groups. There was a statistically significant greater mean intraoperative blood loss in the ICBG group than in the Grafton group (P < 0.0031). At 2-year follow-up, subjects who were randomized to Grafton Matrix and local bone achieved an 86% overall fusion rate and improvements in clinical outcomes that were comparable with those in the ICBG group.

Two injection digital block versus single subcutaneous palmar injection block for finger lacerations.

PubMed

Okur, O M; Şener, A; Kavakli, H Ş; Çelik, G K; Doğan, N Ö; Içme, F; Günaydin, G P

2017-12-01

We aimed to compare two digital nerve block techniques in patients due to traumatic digital lacerations. This was a randomized-controlled study designed prospectively in the emergency department of a university-based training and research hospital. Randomization was achieved by sealed envelopes. Half of the patients were randomised to traditional (two-injection) digital nerve block technique while single-injection digital nerve block technique was applied to the other half. Score of pain due to anesthetic infiltration and suturing, onset time of total anesthesia, need for an additional rescue injection were the parameters evaluated with both groups. Epinephrin added lidocaine hydrochloride preparation was used for the anesthetic application. Visual analog scale was used for the evaluation of pain scores. Outcomes were compared by using Mann-Whitney U test and Student t-test. Fifty emergency department patients ≥18 years requiring digital nerve block were enrolled in the study. Mean age of the patients was 33 (min-max: 19-86) and 39 (78 %) were male. No statistically significant difference was found between the two groups in terms of our main parameters; anesthesia pain score, suturing pain score, onset time of total anesthesia and rescue injection need. Single injection volar digital nerve block technique is a suitable alternative for digital anesthesias in emergency departments.

Stenting or not prior to extracorporeal shockwave lithotripsy for ureteral stones? Results of a prospective randomized study.

PubMed

Sfoungaristos, Stavros; Polimeros, Nikolaos; Kavouras, Adamantios; Perimenis, Petros

2012-06-01

To determine the need for pre-treatment stenting in patients undergoing extracorporeal shockwave lithotripsy (ESWL) for ureteral stones sized 4-10 mm. A prospective randomized study was conducted between September 2009 and March 2011. Included 156 patients randomized in stented and non-stented groups and underwent a maximum of 3 ESWL sessions. Radiographic follow-up was used to assess the stone fragmentation and clearance. Results were compared in terms of stone-free rates, post-treatment morbidity and complications. Overall efficacy was 76.9%. Stone-free rates were statistically significantly lower (P = 0.026) in the stented group (68.6%) compared to the non-stented ones (83.7%). Furthermore, stenting was significantly correlated with post-treatment lower urinary tract symptoms (P ≤ 0.001), need for more ESWL sessions (P = 0.019) and possibility for operation due to ESWL failure (P = 0.026). A multivariate analysis was conducted to identify the parameters which may predict complete stone removal after ESWL. Stone size (P = 0.026), stone location (P = 0.011) and stenting (P = 0.007) were the most significant factors. ESWL is an efficient and safe treatment for 4- to 10-mm ureteral stones. Pre-treatment stenting is limiting stone-free rates and is significantly influencing post-ESWL morbidity and quality of life in a negative manner, while it contributes minimally to the prophylaxis of complications.

Use of Multiple Metabolic and Genetic Markers to Improve the Prediction of Type 2 Diabetes: the EPIC-Potsdam Study

PubMed Central

Schulze, Matthias B.; Weikert, Cornelia; Pischon, Tobias; Bergmann, Manuela M.; Al-Hasani, Hadi; Schleicher, Erwin; Fritsche, Andreas; Häring, Hans-Ulrich; Boeing, Heiner; Joost, Hans-Georg

2009-01-01

OBJECTIVE We investigated whether metabolic biomarkers and single nucleotide polymorphisms (SNPs) improve diabetes prediction beyond age, anthropometry, and lifestyle risk factors. RESEARCH DESIGN AND METHODS A case-cohort study within a prospective study was designed. We randomly selected a subcohort (n = 2,500) from 26,444 participants, of whom 1,962 were diabetes free at baseline. Of the 801 incident type 2 diabetes cases identified in the cohort during 7 years of follow-up, 579 remained for analyses after exclusions. Prediction models were compared by receiver operatoring characteristic (ROC) curve and integrated discrimination improvement. RESULTS Case-control discrimination by the lifestyle characteristics (ROC-AUC: 0.8465) improved with plasma glucose (ROC-AUC: 0.8672, P < 0.001) and A1C (ROC-AUC: 0.8859, P < 0.001). ROC-AUC further improved with HDL cholesterol, triglycerides, γ-glutamyltransferase, and alanine aminotransferase (0.9000, P = 0.002). Twenty SNPs did not improve discrimination beyond these characteristics (P = 0.69). CONCLUSIONS Metabolic markers, but not genotyping for 20 diabetogenic SNPs, improve discrimination of incident type 2 diabetes beyond lifestyle risk factors. PMID:19720844

Distraction osteogenesis versus orthognathic surgery for the treatment of maxillary hypoplasia in cleft lip and palate patients: a systematic review.

PubMed

Austin, S L; Mattick, C R; Waterhouse, P J

2015-05-01

To compare the effectiveness of distraction osteogenesis to orthognathic surgery for the treatment of maxillary hypoplasia in individuals with cleft lip and palate. A systematic review of prospective randomized, quasi-randomized or controlled clinical trials. MEDLINE, EMBASE, Scopus, Web of Science, CINAHL, CENTRAL, trial registers and grey literature were searched. Hand searching of five relevant journals was completed. Two reviewers independently completed inclusion assessment. Data extraction and risk of bias assessment were completed by a single reviewer and checked by a second reviewer. Five publications all reporting different outcomes of a single randomized controlled trial are included within the review. The quality of the evidence was low with a high risk of bias. Both surgical interventions produce significant soft tissue improvement. Horizontal relapse of the maxilla was statistically significantly greater following orthognathic surgery. There was no statistically significant difference in speech and velo-pharyngeal function between the interventions. Maxillary distraction initially lowered social self-esteem, but this improved with time resulting in higher satisfaction with life in the long term. The low quality of evidence included within the review means there is insufficient evidence to conclude whether there is a difference in effectiveness between maxillary distraction and osteotomy for the treatment of cleft-related maxillary hypoplasia. There is a need for further high-quality randomized controlled trials to allow conclusive recommendations to be made. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Psorinum Therapy in Treating Stomach, Gall Bladder, Pancreatic, and Liver Cancers: A Prospective Clinical Study

PubMed Central

Chatterjee, Aradeep; Biswas, Jaydip; Chatterjee, Ashim; Bhattacharya, Sudin; Mukhopadhyay, Bishnu; Mandal, Syamsundar

2011-01-01

We prospectively studied the clinical efficacy of an alternative cancer treatment “Psorinum Therapy” in treating stomach, gall bladder, pancreatic and liver cancers. Our study was observational, open level and single arm. The participants' eligibility criteria included histopathology/cytopathology confirmation of malignancy, inoperable tumor, and no prior chemotherapy or radiation therapy. The primary outcome measures of the study were (i) to assess the radiological tumor response (ii) to find out how many participants survived at least 1 year, 2 years, 3 years, 4 years and finally 5 years after the beginning of the study considering each type of cancer. Psorinum-6x was administered orally to all the participants up to 0.02 ml/Kg body weight as a single dose in empty stomach per day for 2 years along with allopathic and homeopathic supportive cares. 158 participants (42 of stomach, 40 of gall bladder, 44 of pancreatic, 32 of liver) were included in the final analysis of the study. Complete tumor response occurred in 28 (17.72%) cases and partial tumor response occurred in 56 (35.44%) cases. Double-blind randomized controlled clinical trial should be conducted for further scientific exploration of this alternative cancer treatment. PMID:21197093

Laparoendoscopic Single-site Surgery (LESS) for Prophylactic Salpingo-oophorectomy Improves Cosmetic Satisfaction Compared to Standard Laparoscopy.

PubMed

Miailhe, Gregoire; Dauchy, Sarah; Bentivegna, Enrica; Gouy, Sebastien; Charles, Cecile; Delaloge, Suzette; Morice, Philippe; Uzan, Catherine

2015-11-01

Less invasive prophylactic bilateral salpingo-oophorectomy (PBSO) may diminish the general consequences of surgery for BRCA mutation carriers. The objective of the present study was to compare the psychological impact and satisfaction following minimal-invasive laparoendoscopic single-site surgery (LESS) versus that observed with the standard procedure. This prospective longitudinal study was proposed to all consecutive patients who underwent ambulatory PBSO between January 2012 and January 2014 at our Center. The psychological impact and esthetic satisfaction were prospectively studied. Patients rated their satisfaction using the 4-grade Likert scale. Their emotional state and postoperative pain were explored respectively with validated questionnaires (IES-R, PANAS) and the Verbal Numerical Rating Scale (VNRS). Operative outcomes were also analyzed. Twenty patients underwent LESS PBSO and 10 patients had the standard laparoscopic (SL) PBSO. The mean satisfaction scores were significantly higher in the LESS group one month and six months after surgery. Both groups reported a reduction of intrusive thoughts and negative affects after surgery. Postoperative pain and operative outcomes were similar. A significant improvement of cosmetic satisfaction after LESS compared to SL could help patients accept PBSO. The emotional impact of PBSO is not modified by ambulatory LESS. Copyright© 2015 International Institute of Anticancer Research (Dr. John G. Delinassios), All rights reserved.

A single active nanoelectromechanical tuning fork front-end radio-frequency receiver

NASA Astrophysics Data System (ADS)

Bartsch, Sebastian T.; Rusu, A.; Ionescu, Adrian M.

2012-06-01

Nanoelectromechanical systems (NEMS) offer the potential to revolutionize fundamental methods employed for signal processing in today’s telecommunication systems, owing to their spectral purity and the prospect of integration with existing technology. In this work we present a novel, front-end receiver topology based on a single device silicon nanoelectromechanical mixer-filter. The operation is demonstrated by using the signal amplification in a field effect transistor (FET) merged into a tuning fork resonator. The combination of both a transistor and a mechanical element into a hybrid unit enables on-chip functionality and performance previously unachievable in silicon. Signal mixing, filtering and demodulation are experimentally demonstrated at very high frequencies ( > 100 MHz), maintaining a high quality factor of Q = 800 and stable operation at near ambient pressure (0.1 atm) and room temperature (T = 300 K). The results show that, ultimately miniaturized, silicon NEMS can be utilized to realize multi-band, single-chip receiver systems based on NEMS mixer-filter arrays with reduced system complexity and power consumption.

Comparison of intra-articular bupivacaine-morphine with bupivacaine-tenoxicam combinations on post-operative analgesia in patients with arthroscopic meniscectomy: a prospective, randomised study.

PubMed

Sanel, Selim; Arpaz, Osman; Unay, Koray; Turkmen, Ismail; Simsek, Selcuk; Ugutmen, Ender

2016-03-01

There are many alternatives for post-operative pain relief in patients who have had general anaesthesia. The aim of this study was to evaluate the efficacy of intra-articular bupivacaine + morphine and bupivacaine + tenoxicam applications in post-operative pain control in patients undergoing knee arthroscopy with general anaesthesia. This was a prospective study. Standard anaesthesia procedures were applied to each patient, and the 240 patients chosen at random were then divided into two groups. Each group received a different combination of drugs for this double-blind study. The first group (group A: 120 patients) received 0.5% bupivacaine 100 mg + tenoxicam 20 mg (22 ml); the second group (group B) received 0.5% bupivacaine 100 mg + morphine 2 mg (22 ml); both groups received their drugs at the end of the intra-articular operation before tourniquet deflation. Before the operation, patients were asked about their post-operative pain at particular periods over the following 24 hours using the visual analogue scale (VAS) and the numeric rating scale (NRS). An additional analgaesic requirement and possible side effects were also recorded. Group A patients needed analgaesics sooner after operation than patients in group B. In Group B, VAS and NRS values were statistically higher compared with group A at the 12th hour. There were also fewer side effects seen in group A versus group B. Effective and reliable results were obtained in post-operative pain control in bupivacaine added to the morphine or tenoxicam groups following arthroscopic meniscectomy. In the tenoxicam group, patients reported less pain, fewer side effects and less need for analgesics at 12 hours after the operation. level 1, therapeutic, randomised, multicentric study.

Randomized Clinical Trial of Azithromycin vs. Erythromycin for the Treatment of Chlamydia Cervicitis in Pregnancy

PubMed Central

Edwards, M. S.; Carter, S. G.; LeBoeuf, F. W.; Menard, M. K.; Rainwater, K. P.

1996-01-01

Objective: The purpose of this study was to prospectively test the null hypothesis that there is no difference in the clinical effectiveness of azithromycin and erythromycin for the treatment of chlamydia cervicitis in pregnancy. Methods: All antepartum obstetrical patients underwent routine screening for chlamydia cervicitis using a DNA probe assay (Gen-Probe Pace, San Diego, CA). Women who tested positive for chlamydia cervicitis were prospectively randomized to receive either azithromycin 1 g orally at enrollment, or erythromycin 500 mg orally 4 times a day for 7 days. Sexual partners were referred to the county health department for evaluation and treatment. A test of cure was repeated in 2 weeks. Results were analyzed by chi-square analysis and Fisher's exact test when indicated. Results: One hundred forty women tested positive for chlamydia cervicitis and agreed to randomization. There were 4 (6.2%) treatment failures in the azithromycin group and 18 (27.7%) in the erythromycin group (P = 0.005). Gastrointestinal side effects were reported by 42 (65.5%) of the women taking erythromycin, but only 12 (19.4%) of those taking azithromycin (P < 0.002). Gastrointestinal side effects and resultant noncompliance were significantly related to treatment failure with erythromycin. Conclusions: The findings of this study support the conclusion that a single dose of azithromycin is a significantly more effective and better tolerated treatment regimen for chlamydia cervicitis in pregnancy than erythromycin which is currently recommended. PMID:18476121

Effect of perioperative parecoxib sodium on postoperative pain control for transcatheter arterial chemoembolization for inoperable hepatocellular carcinoma: a prospective randomized trial.

PubMed

Lv, Ning; Kong, Yanan; Mu, Luwen; Pan, Tao; Xie, Qiankun; Zhao, Ming

2016-10-01

Pain is one of the most common side effects of transcatheter arterial chemoembolization (TACE) treatment. This study aimed to assess the analgesic effect of parecoxib sodium for postoperative pain control in patients with inoperable hepatocellular carcinoma (HCC) undergoing TACE. This randomized placebo-controlled prospective clinical study was conducted at a single cancer centre. Patients were randomly assigned to receive parecoxib sodium (experimental group; n = 60) or 0.9 % sodium chloride (control group; n = 60) 1 h before TACE and once every 12 h for 2 days after TACE. Pain level, morphine consumption, adverse events, and quality of life were evaluated and compared between the two groups. Pain scores, percentage distribution of pain categories, and morphine consumption were significantly lower in the experimental group than in the control group (P < 0.05). Fever score comparisons revealed significantly better body temperature balance in the experimental group than in the control group (P = 0.024). Quality-of-life scores in the experimental group were significantly better than those in the control group (P < 0.05). Our results demonstrate that the perioperative administration of parecoxib significantly improved its effectiveness in the control of postoperative pain after TACE. • Perioperative administration of parecoxib is effective for control of pain after TACE. • COX-2 inhibitors provide effective and safe pain control. • Parecoxib helps improve quality-of-life after TACE for patients with inoperable hepatocellular carcinoma.

Single-dose radiation therapy for prevention of heterotopic ossification after total hip arthroplasty

DOE Office of Scientific and Technical Information (OSTI.GOV)

Healy, W.L.; Lo, T.C.; Covall, D.J.

1990-12-01

Single-dose radiation therapy was prospectively evaluated for its efficacy in prevention of heterotopic ossification in patients at high risk after total hip arthroplasty. Thirty-one patients (34 hips) were treated between 1981 and 1988. Risk factors for inclusion in the protocol included prior evidence of heterotopic ossification, ankylosing spondylitis, and diffuse idiopathic skeletal hyperostosis. Patients with hypertrophic osteoarthritis or traumatic arthritis with osteophytes were not included. Operations on 34 hips included 19 primary total and 11 revision total hip arthroplasties and 4 excisions of heterotopic ossification. All patients received radiotherapy to the hip after operation with a single dose of 700more » centigray. Radiotherapy is recommended on the first postoperative day. After this single-dose radiation treatment, no patient had clinically significant heterotopic ossification. Recurrent disease developed in two hips (6%), as seen on radiography (grades 2 and 3). This series documents a 100% clinical success rate and a 94% radiographic success rate in preventing heterotopic ossification in patients at high risk after total hip arthroplasty. Single-dose radiotherapy is as effective as other radiation protocols in preventing heterotopic ossification after total hip arthroplasty. It is less expensive and easier to administer than multidose radiotherapy.« less

The Combination of IV and Perineural Dexamethasone Prolongs the Analgesic Duration of Intercostal Nerve Blocks Compared with IV Dexamethasone Alone.

PubMed

Maher, Dermot P; Serna-Gallegos, Derek; Mardirosian, Rodney; Thomas, Otto J; Zhang, Xiao; McKenna, Robert; Yumul, Roya; Zhang, Vida

2017-06-01

 The use of multiple-level, single-injection intercostal nerve blocks for pain control following video-assisted thorascopic surgery (VATS) is limited by the analgesic duration of local anesthetics. This study examines whether the combination of perineural and intravenous (IV) dexamethasone will prolong the duration of intraoperatively placed intercostal nerve blocks following VATS compared with IV dexamethasone and a perineural saline placebo.  Prospective, double-blind, randomized placebo-controlled trial.  Single level-1 academic trauma center.  Forty patients undergoing a unilateral VATS under the care of a single surgeon.  Patients were randomly assigned to two groups and received an intercostal nerve block containing 1) 0.5% bupivacaine with epinephrine and 1 ml of 0.9% saline or 2) 0.5% bupivacaine with epinephrine and 1 ml of a 4 mg/ml dexamethasone solution. All patients received 8 mg of IV dexamethasone.  Group 2 had lower NRS-11 scores at post-operative hours 8 (5.05, SD = 2.13 vs 3.50, SD = 2.50; p  = 0.04), 20 (4.30, SD = 2.96 vs 2.26, SD = 2.31; p  = 0.02), and 24 (4.53, SD = 1.95 vs 2.26, SD = 2.31; p  = 0.02). Equianalgesic opioid requirement was decreased in group 2 at 32 hours (5.78 mg, SD = 5.77 vs 1.67 mg, SD = 3.49; p  = 0.02). Group 2 also had greater FEV1 measured at 8, 12, 24, and 44 hours; greater FVC at 24 hours; greater PEF at 28 through 48 hours; and greater FEV1/FVC at 8 and 36 hours.  The combination of IV and perineural dexamethasone prolonged the duration of a single-injection bupivacaine intercostal nerve block as measured by NRS-11 compared with IV dexamethasone alone at 24 hours. Reduced NRS-11 at other times, reduced opioid requirements, and increased PFTs were observed in group 2. © 2016 American Academy of Pain Medicine. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com

Development and assessment of Memorial Sloan Kettering Cancer Center's Surgical Secondary Events grading system.

PubMed

Strong, Vivian E; Selby, Luke V; Sovel, Mindy; Disa, Joseph J; Hoskins, William; Dematteo, Ronald; Scardino, Peter; Jaques, David P

2015-04-01

Studying surgical secondary events is an evolving effort with no current established system for database design, standard reporting, or definitions. Using the Clavien-Dindo classification as a guide, in 2001 we developed a Surgical Secondary Events database based on grade of event and required intervention to begin prospectively recording and analyzing all surgical secondary events (SSE). Events are prospectively entered into the database by attending surgeons, house staff, and research staff. In 2008 we performed a blinded external audit of 1,498 operations that were randomly selected to examine the quality and reliability of the data. Of 4,284 operations, 1,498 were audited during the third quarter of 2008. Of these operations, 79 % (N = 1,180) did not have a secondary event while 21 % (N = 318) had an identified event; 91 % of operations (1,365) were correctly entered into the SSE database. Also 97 % (129 of 133) of missed secondary events were grades I and II. There were 3 grade III (2 %) and 1 grade IV (1 %) secondary event that were missed. There were no missed grade 5 secondary events. Grade III-IV events are more accurately collected than grade I-II events. Robust and accurate secondary events data can be collected by clinicians and research staff, and these data can safely be used for quality improvement projects and research.

The Radical Extent of lymphadenectomy - D2 dissection versus complete mesocolic excision of LAparoscopic Right Colectomy for right-sided colon cancer (RELARC) trial: study protocol for a randomized controlled trial.

PubMed

Lu, Jun-Yang; Xu, Lai; Xue, Hua-Dan; Zhou, Wei-Xun; Xu, Tao; Qiu, Hui-Zhong; Wu, Bin; Lin, Guo-Le; Xiao, Yi

2016-12-08

The extent of lymphadenectomy during laparoscopic right colectomy can affect the oncological outcome and the safety of surgery. The principle of complete mesocolic excision (CME) has been gradually accepted and increasingly applied by colorectal surgeons. The aim of this study is to investigate whether extended lymphadenectomy (CME) in laparoscopic colectomy could improve the oncological outcomes of patients with right-sided colon cancers, compared with D2 lymphadenectomy. The Radical Extent of lympadenectomy: D2 dissection versus complete mesocolic excision of LAparoscopic Right Colectomy for right-sided colon cancer (RELARC) study is a prospective, multicenter, randomized controlled trial in which 1072 eligible patients with right-sided colon cancers will be randomly assigned to the CME group or the D2 dissection group during laparoscopic right colectomy. Inclusion criteria are locally advanced colon cancers situated from the cecum to the right third of the transverse colon and clinically staged as T2-4aN0M0 or TanyN + M0. The primary endpoint of this trial is 3-year disease-free survival. Secondary endpoints include 3-year overall survival, postoperative complication rates, perioperative mortality rates, and rates of positive central lymph nodes (the station 3 nodes). The RELARC trial is a prospective, multicenter, randomized controlled trial that will provide evidence on the optimal extent of lymphadenectomy during laparoscopic right colectomy in terms of better oncological outcome and operation safety. ClinicalTrials.gov: NCT02619942 . Registered on 29 November 2015.

Assessment of postoperative pain after reciprocating or rotary NiTi instrumentation of root canals: a randomized, controlled clinical trial.

PubMed

Relvas, João Bosko Formigas; Bastos, Mariana Mena Barreto; Marques, André Augusto Franco; Garrido, Angela Delfina Bitencourt; Sponchiado, Emílio Carlos

2016-11-01

The aim of this study was to assess postoperative pain in a prospective randomized clinical trial comparing two groups, using the Reciproc® system in one group and the ProTaper® rotary system in the other. The study included 78 male patients, aged 18-64 years (mean age of 26 years), with asymptomatic pulp necrosis in mandibular molar teeth (n = 78). The single-session endodontic treatment was performed by a single operator specialized in Endodontics. Mechanical preparation of the root canals was performed using the ProTaper® and Reciproc® instrumentation techniques. Postoperative pain was recorded using a verbal rating scale (VRS) and verbal description with well-defined categories at the three following time intervals: 24 h, 72 h, and 7 days after the endodontic procedure. The assessment of postoperative pain was recorded as no pain, mild pain, moderate pain, and severe pain or flare-up. Data were analyzed using the nonparametric Mann-Whitney test with the aid of the STATA® software. The incidence of postoperative pain in the ProTaper group (PT) 24 h after the endodontic procedure was 17.9 and 5.1 % after 72 h. In the Reciproc group (RP), the incidence after 24 h was 15.3 and 2.5 % after 72 h. No patients presented severe pain at the time intervals assessed. No significant difference (p > 0.05) in postoperative pain was found between the ProTaper® and Reciproc® instrumentation technique during endodontic treatment in this study. According to our findings and the results of the clinical trial, the occurrence of postoperative pain was low and similar between the reciprocating and rotary techniques during the time intervals assessed. These results are different from basic laboratory studies that affirm that the reciprocating techniques tend to promote more postoperative pain since extrusion of debris is greater.

Intraoperative ketorolac dose of 15mg versus the standard 30mg on early postoperative pain after spine surgery: A randomized, blinded, non-inferiority trial.

PubMed

Duttchen, Kaylene M; Lo, Andy; Walker, Andrew; McLuckie, Duncan; De Guzman, Cecilia; Roman-Smith, Helen; Davis, Melinda

2017-09-01

The primary aim of this study is to show the non-inferiority of 15mg intraoperative dose of ketorolac as compared to the standard 30mg ketorolac by looking at the visual analog scale pain (VAS) scores 4h after an adult spine surgery. The study design is a prospective randomized non-inferiority clinical trial looking at non-inferiority of intraoperative 15mg ketorolac from the standard 30mg dose. Quaternary care center. 50 adult (18-65years of age) undergoing lumbar decompression spine surgery. Group A received a single intraoperative dose of 15mg ketorolac at the end of surgery and group B received single intraoperative dose of 30mg ketorolac. The primary outcome was the visual analog scale (VAS) pain scores 4h after an adult spine surgery. Secondary measures were morphine usage in the first 8 and 24h postoperatively, numeric rating scores (NRS) up to 24h, sedation, nausea, vomiting, respiratory depression, pruritus and bleeding complications. Intention to treat analysis showed a mean increase in 4h VAS pain score of 7.9mm (95% CI: -4.5mm to 20.4mm) in patients administered 15mg ketorolac. This difference was neither statistically (P=0.207) nor clinically significant (<18mm on VAS scale). A similar increase in the 15mg group was noted through a per protocol analysis, 6.9mm (95% CI: -6.6mm to 20.5mm, P=0.307) greater in the 15mg group. Non-inferiority of 15mg was not confirmed. No significant difference was found in secondary endpoints. Ketorolac 30mg intravenous was not superior to 15mg intravenous for post-operative pain management after spine surgery. However, 15mg failed to meet the pre-specified criteria for non-inferiority to the 30mg dose. Copyright © 2017 Elsevier Inc. All rights reserved.

Aloe Vera Gel and Cesarean Wound Healing; A Randomized Controlled Clinical Trial

PubMed Central

Molazem, Zahra; Mohseni, Fatemeh; Younesi, Masoumeh; Keshavarzi, Sareh

2015-01-01

Background: Failure in complete healing of the wound is one of the probable complications of cesarean. The present study aimed to determine the effectiveness of dressing with aloe vera gel in healing of cesarean wound. Methods: This prospective randomized double-blind clinical trial was conducted on 90 women who had undergone cesarean operation in Amir-al-Momenin hospital (Gerash, Iran). The participants were randomly divided into two groups each containing 45 patients. In one group, the wound was dressed with aloe vera gel, while simple dressing was used in the control group. Wound healing was assessed 24 hours and 8 days after the cesarean operation using REEDA scale. The data were analyzed through Chi-square and t-test. Results: The participants’ mean age was 27.56±4.20 in the aloe vera group and 26.62±4.88 in the control group, but the difference was not statistically significant. However, a significant difference was found between the two groups concerning body mass index, heart rate, and systolic blood pressure (P<0.05). Also, a significant difference was observed between the two groups with respect to the wound healing score 24 hours after the operation (P=0.003). After 8 days, however, the difference in the wound healing score was not significant (P=0.283). Overall, 45 participants in the aloe vera group and 35 ones in the control group had obtained a zero score 24 hours after the operation. These measures were respectively obtained as 42 and 41eight days after the operation. Conclusion: According to the findings of this study, the women are recommended to be informed regarding the positive effects of dressing with aloe vera gel. PMID:25560349

Aloe vera gel and cesarean wound healing; a randomized controlled clinical trial.

PubMed

Molazem, Zahra; Mohseni, Fatemeh; Younesi, Masoumeh; Keshavarzi, Sareh

2014-08-31

Failure in complete healing of the wound is one of the probable complications of cesarean. The present study aimed to determine the effectiveness of dressing with aloe vera gel in healing of cesarean wound. This prospective randomized double-blind clinical trial was conducted on 90 women who had undergone cesarean operation in Amir-al-Momenin hospital (Gerash, Iran). The participants were randomly divided into two groups each containing 45 patients. In one group, the wound was dressed with aloe vera gel, while simple dressing was used in the control group. Wound healing was assessed 24 hours and 8 days after the cesarean operation using REEDA scale. The data were analyzed through Chi-square and t-test. The participants' mean age was 27.56±4.20 in the aloe vera group and 26.62±4.88 in the control group, but the difference was not statistically significant. However, a significant difference was found between the two groups concerning body mass index, heart rate, and systolic blood pressure (P<0.05). Also, a significant difference was observed between the two groups with respect to the wound healing score 24 hours after the operation (P=0.003). After 8 days, however, the difference in the wound healing score was not significant (P=0.283). Overall, 45 participants in the aloe vera group and 35 ones in the control group had obtained a zero score 24 hours after the operation. These measures were respectively obtained as 42 and 41eight days after the operation. According to the findings of this study, the women are recommended to be informed regarding the positive effects of dressing with aloe vera gel.

Separating the Laparoscopic Camera Cord From the Monopolar "Bovie" Cord Reduces Unintended Thermal Injury From Antenna Coupling: A Randomized Controlled Trial.

PubMed

Robinson, Thomas N; Jones, Edward L; Dunn, Christina L; Dunne, Bruce; Johnson, Elizabeth; Townsend, Nicole T; Paniccia, Alessandro; Stiegmann, Greg V

2015-06-01

The monopolar "Bovie" is used in virtually every laparoscopic operation. The active electrode and its cord emit radiofrequency energy that couples (or transfers) to nearby conductive material without direct contact. This phenomenon is increased when the active electrode cord is oriented parallel to another wire/cord. The parallel orientation of the "Bovie" and laparoscopic camera cords cause transfer of energy to the camera cord resulting in cutaneous burns at the camera trocar incision. We hypothesized that separating the active electrode/camera cords would reduce thermal injury occurring at the camera trocar incision in comparison to parallel oriented active electrode/camera cords. In this prospective, blinded, randomized controlled trial, patients undergoing standardized laparoscopic cholecystectomy were randomized to separated active electrode/camera cords or parallel oriented active electrode/camera cords. The primary outcome variable was thermal injury determined by histology from skin biopsied at the camera trocar incision. Eighty-four patients participated. Baseline demographics were similar in the groups for age, sex, preoperative diagnosis, operative time, and blood loss. Thermal injury at the camera trocar incision was lower in the separated versus parallel group (31% vs 57%; P = 0.027). Separation of the laparoscopic camera cord from the active electrode cord decreases thermal injury from antenna coupling at the camera trocar incision in comparison to the parallel orientation of these cords. Therefore, parallel orientation of these cords (an arrangement promoted by integrated operating rooms) should be abandoned. The findings of this study should influence the operating room setup for all laparoscopic cases.

Cosmetic outcome of skin adhesives versus transcutaneous sutures in laparoscopic port-site wounds: a prospective randomized controlled trial.

PubMed

Buchweitz, Olaf; Frye, Christian; Moeller, Claus Peter; Nugent, Wolfgang; Krueger, Eckart; Nugent, Andreas; Biel, Peter; Juergens, Sven

2016-06-01

In an elective laparoscopic surgery, the cosmetic outcome becomes increasingly important. We conducted a study to evaluate the cosmetic outcome 3 months after a laparoscopic procedure and compared skin adhesive (SA) versus transcutaneous suture (TS). A randomized, controlled, prospective study was conducted at a single study centre in Hamburg, Germany. Seventy-seven patients undergoing laparoscopic surgery with two lower abdominal port sites met the study requirements. It was decided randomly which port site would be closed with SA. The opposite site was closed with TS. Wounds were assessed after 7-12 days and after 3 months. Cosmetic outcome was measured by a visual analogue scale (VAS) completed by the patient, by the Hollander wound evaluation scale (HWES) and by the judgement of blinded investigators. Seventy-seven subjects were randomized. Complete data from the 3-month follow-up visit were available from 56 patients (72.7 %). The VAS scale ranged from 0 to 100 mm with "0" representing the best possible cosmetic outcome. Median satisfaction was 2 mm in the TS group and 3 mm in the SA group. The mean was high in both groups 4.6 (s = 13.1) versus 3.8 mm (s = 4.6). The outcome was neither clinically nor statistically significant. Cosmetic outcome was assessed by an investigator, and the HWES showed no difference. In regard to complications, no difference was found between SA and TS, either. In conclusion this study demonstrated that closure of laparoscopic port-site wounds leads to equivalent outcomes whether SAs or TSs are used. Complications are rare in both methods. Thus, SAs seem to be a valid alternative to sutures in laparoscopic surgery. Registration site: www.clinicaltrials.gov . NCT02179723.

Prospective, Randomized, Multi-centered Clinical Trial Assessing Safety and Efficacy of a Synthetic Cartilage Implant Versus First Metatarsophalangeal Arthrodesis in Advanced Hallux Rigidus.

PubMed

Baumhauer, Judith F; Singh, Dishan; Glazebrook, Mark; Blundell, Chris; De Vries, Gwyneth; Le, Ian L D; Nielsen, Dominic; Pedersen, M Elizabeth; Sakellariou, Anthony; Solan, Matthew; Wansbrough, Guy; Younger, Alastair S E; Daniels, Timothy

2016-05-01

Although a variety of great toe implants have been tried in an attempt to maintain toe motion, the majority have failed with loosening, malalignment/dislocation, implant fragmentation and bone loss. In these cases, salvage to arthrodesis is more complicated and results in shortening of the ray or requires structural bone graft to reestablish length. This prospective study compared the efficacy and safety of this small (8/10 mm) hydrogel implant to the gold standard of a great toe arthrodesis for advanced-stage hallux rigidus. In this prospective, randomized non-inferiority study, patients from 12 centers in Canada and the United Kingdom were randomized (2:1) to a synthetic cartilage implant or first metatarsophalangeal (MTP) joint arthrodesis. VAS pain scale, validated outcome measures (Foot and Ankle Ability Measure [FAAM] sport scale), great toe active dorsiflexion motion, secondary procedures, radiographic assessment, and safety parameters were evaluated. Analysis was performed using intent-to-treat (ITT) and modified ITT (mITT) methodology. The primary endpoint for the study consisted of a single composite endpoint using the 3 primary study outcomes (pain, function, and safety). The individual subject's outcome was considered a success if all of the following criteria were met: (1) improvement (decrease) from baseline in VAS pain of ≥30% at 12 months; (2) maintenance of function from baseline in FAAM sports subscore at 12 months; and (3) absence of major safety events at 2 years. The proportion of successes in each group was determined and 1-sided 95% confidence interval for the difference between treatment groups was calculated. Noninferiority of the implant to arthrodesis was considered statistically significant if the 1-sided 95% lower confidence interval was greater than the equivalence limit (<15%). A total of 236 patients were initially enrolled; 17 patients withdrew prior to randomization, 17 patients withdrew after randomization, and 22 were nonrandomized training patients, leaving 152 implant and 50 arthrodesis patients. Standard demographics and baseline outcomes were similar for both groups. VAS pain scores decreased significantly in both the implant and arthrodesis groups from baseline at 12 and 24 months. Similarly, the FAAM sports and activity of daily living subscores improved significantly at 12 and 24 months in both groups. First MTP active dorsiflexion motion improvement was 6.2 degrees (27.3%) after implant placement and was maintained at 24 months. Subsequent secondary surgeries occurred in 17 (11.2%) implant patients (17 procedures) and 6 (12.0%) arthrodesis patients (7 procedures). Fourteen (9.2%) implants were removed and converted to arthrodesis, and 6 (12.0%) arthrodesis patients (7 procedures [14%]) had isolated screws or plate and screw removal. There were no cases of implant fragmentation, wear, or bone loss. When analyzing the ITT and mITT population for the primary composite outcome of VAS pain, function (FAAM sports), and safety, there was statistical equivalence between the implant and arthrodesis groups. A prospective, randomized (2:1), controlled, noninferiority clinical trial was performed to compare the safety and efficacy of a small synthetic cartilage bone implant to first MTP arthrodesis in patients with advanced-stage hallux rigidus. This study showed equivalent pain relief and functional outcomes. The synthetic implant was an excellent alternative to arthrodesis in patients who wished to maintain first MTP motion. The percentage of secondary surgical procedures was similar between groups. Less than 10% of the implant group required revision to arthrodesis at 2 years. Level I, prospective randomized study. © The Author(s) 2016.

Efficacy of leukocyte- and platelet-rich fibrin in wound healing: a randomized controlled clinical trial.

PubMed

Chignon-Sicard, Bérengère; Georgiou, Charalambos A; Fontas, Eric; David, Sylvain; Dumas, Pierre; Ihrai, Tarik; Lebreton, Elisabeth

2012-12-01

Application of platelet concentrates to wounds could speed healing. Leukocyte- and platelet-rich fibrin, a relatively recent development, stands out from the other preparations. This prospective, randomized, controlled clinical trial studied the rate of healing of postoperative hand wounds after a single application of leukocyte- and platelet-rich fibrin. Eligible patients were healthy individuals older than 18 years who had been scheduled for elective McCash (open palm) surgery for Dupuytren disease at the Plastic and Hand Surgery Department of Nice's University Hospital between August of 2007 and February of 2010. The control group received the reference care of petroleum jelly mesh (Vaselitulle), and test patients had leukocyte- and platelet-rich fibrin applied. The primary endpoint was healing delay measured in postoperative days. Secondary endpoints included pain, bleeding, and wound exudate. The trial was carried out as a single-blind trial. Among the 68 randomized patients, 33 patients in the leukocyte- and platelet-rich fibrin group and 31 in the Vaselitulle group were analyzed. Primary endpoint analysis showed a median healing delay of 24 days (interquartile range, 18 to 28 days) for the fibrin group and 29 days (interquartile range, 26 to 35 days) for the Vaselitulle group (p = 0.014, log-rank test). Postoperative pain assessment, bleeding, and exudate were always lower for the fibrin group, but not significantly so. The authors trial demonstrates that a single leukocyte- and platelet-rich fibrin application on fresh postoperative hand wounds shows a median improvement of 5 days in comparison with the standard treatment. Therapeutic, II.

Ulcerative colitis patients with an inflammatory response upon mesalazine cannot be desensitized: a randomized study.

PubMed

Buurman, Dorien J; De Monchy, Jan G R; Schellekens, Reinout C A; van der Waaij, Laurens A; Kleibeuker, Jan H; Dijkstra, Gerard

2015-04-01

Mesalazine is a key drug in the treatment of ulcerative colitis (UC). Intolerance to mesalazine has been described, including fever and gastrointestinal symptoms. Several case reports reported successful desensitization of patients with mesalazine intolerance. The aim was to assess the number of UC patients who are persistently intolerant to mesalazine after single-blinded rechallenge and to test the effectiveness of a rapid desensitization protocol in UC patients demonstrated mesalazine intolerance. This is a prospective, single-blind randomized study in UC patients who discontinued mesalazine because of intolerance. Patients with severe reactions were excluded. Eligible patients underwent a skin patch test with mesalazine followed by a single-blinded randomized crossover rechallenge with 500 mg mesalazine or placebo. Patients with symptoms upon rechallenge were admitted to the hospital for 3 days oral desensitization. Nine of the 37 identified UC patients who discontinued mesalazine because of intolerance were included. All nine patients had negative patch tests, seven patients had symptoms (fever, nausea, vomiting and diarrhea) within 2 h upon rechallenge. Four of these seven patients participated in the desensitization protocol and in none a successful desensitization could be performed. All four had an inflammatory intolerance reaction with rise in C-reactive protein. There were no elevations in serum tryptase or urinary-methylhistamine levels observed and no signs of immediate type allergic reactions, like urticaria, bronchial obstruction or anaphylaxis. We recommend not to rechallenge UC patients with an inflammatory response upon mesalazine and these patients will not benefit from a rapid desensitization protocol.

A comparison of the outcome using Ligasure™ small jaw and clamp-and-tie technique in thyroidectomy: a randomized single center study.

PubMed

Coiro, S; Frattaroli, F M; De Lucia, F; Manna, E; Fabi, F; Frattaroli, J M; Pappalardo, G

2015-02-01

Hypoparathyroidism and paralysis of the recurrent laryngeal nerve (RLN) still remain the most frequent specific complications of thyroid surgery. This study evaluates the effects of employment of a recently introduced device (LigaSure™ Small Jaw, LSJ), compared to the traditional clamp-and-tie (CT) technique, on the short- and long-term outcome of the patients who underwent thyroidectomy. This prospective, randomized study included 190 patients enrolled from October 2011 to July 2013. The numbers of patients in the LSJ group and the CT group were both 95. We studied the following: operative times, intraoperative and postoperative blood losses, intact parathormone (iPTH) and calcium serum levels, and the incidence of RLN paralysis. The two cohorts were homogeneous for age, sex, surgical indication, BMI, ASA score, and estimated thyroid volume. Operation time has been 73.90 ± 23.35 min in group CT and 60.20 ± 22.36 min in group LSJ (p = 0.002). Intraoperative blood losses have been 47 ± 18 ml in group CT and 38 ± 14 in group LSJ (p = 0.002), while postoperative blood losses have been 45 ± 21 ml in group CT and 40 ± 20 in group LSJ (p = 0.105). The mean calcium blood level in group CT has been 8.12, 7.79, and 7.92 mg/dl in the first, second, and third postoperative days, respectively, as well as 8.26, 7.97, and 8.22 mg/dl for group LSJ (p > 0.05). Basal and post-thyroidectomy iPTH levels have been 46.49 and 23.64 pg/ml in group CT (Δ = 49.15 %), as well as 51.06 and 27.73 (Δ = 45.69 %) in group LSJ (p > 0.05). Permanent RLN paralysis was 1.05 % in LSJ group and 0 % in CT group. The employment of LSJ reduces in a statistically significant way both operative times and intraoperative blood losses. No significant differences were found as far as postoperative RLN paralysis and hypoparathyroidism.

Individualized deliberate practice on a virtual reality simulator improves technical performance of surgical novices in the operating room: a randomized controlled trial.

PubMed

Palter, Vanessa N; Grantcharov, Teodor P

2014-03-01

The purpose of this study was to investigate whether individualized deliberate practice on a virtual reality (VR) simulator results in improved technical performance in the operating room. Training on VR simulators has been shown to improve technical performance in the operating room (OR). Currently described VR curricula consist of trainees practicing the same tasks until expert proficiency is reached. It has yet to be investigated whether the individualized deliberate practice, where curricula tasks vary depending on prior levels of technical proficiency, would translate into the OR. This single-blinded prospective trial randomized 16 novice surgical residents to a deliberate practice (DP) group and a conventional residency training group. Both groups performed a laparoscopic cholecystectomy in the OR that was video-recorded. Technical performance of DP group residents in the OR was assessed using 3 validated assessment tools. A score of less than 60% on any component of the assessment tool resulted in the trainee practicing a specific task on the VR simulator. The DP group practiced on the simulator as per their individualized schedule. Both groups then performed another laparoscopic cholecystectomy. A blinded expert assessed the OR recordings using a validated global rating scale. Although both groups had similar technical abilities preintervention [DP: median score, 13.5 (9.3-15.0); control: median score, 14.5 (9.3-17.8); P = 0.45], the DP residents had a superior technical performance postintervention [DP: median score, 17.0 (15.3-18.5); control: median score, 12.5 (7.5-14.0); P = 0.03]. Of 8 DP residents, 6 practiced 5 basic VR tasks (median 1 trial to pass), and 7 of 8 practiced 2 advanced tasks (median 4 trials to pass). A curriculum of deliberate individualized practice on a VR simulator improves technical performance in the OR. This has implications to greatly improve the feasibility of implementing simulation-based curricula in residency training programs, rather then having them being limited to research protocols.

A randomized open-label study of guideline-driven antiemetic therapy versus single agent antiemetic therapy in patients with advanced cancer and nausea not related to anticancer treatment.

PubMed

Hardy, Janet; Skerman, Helen; Glare, Paul; Philip, Jennifer; Hudson, Peter; Mitchell, Geoffrey; Martin, Peter; Spruyt, Odette; Currow, David; Yates, Patsy

2018-05-02

Nausea/vomiting (N/V) not related to anti-cancer treatment is common in patients with advanced cancer. The standard approach to management is to define a dominant cause, and treat with an antiemetic selected through pathophysiologic knowledge of emetic pathways. High rates of N/V control have been reported using both etiology-based guideline-driven antiemetic regimens and an empiric approach using single agents in uncontrolled studies. These different approaches had never been formally compared. This randomized, prospective, open label, dose-escalating study used readily available antiemetics in accordance with etiology-based guidelines or single agent therapy with haloperidol. Participants had a baseline average nausea score of ≥3/10. Response was defined as a ≥ 2/10 point reduction on a numerical rating scale of average nausea score with a final score < 3/10 at 72 h. Nausea scores and distress from nausea improved over time in the majority of the 185 patients randomized. For those who completed each treatment day, a greater response rate was seen in the guideline arm than the single agent arm at 24 h (49% vs 32%; p = 0.02), but not at 48 or 72 h. Response rates at 72 h in the intention to treat analysis were 49 and 53% respectively, with no significant difference between arms (0·04; 95% CI: -0·11, 0·19; p = 0·59). Over 80% of all participants reported an improved global impression of change. There were few adverse events worse than baseline in either arm. An etiology-based, guideline-directed approach to antiemetic therapy may offer more rapid benefit, but is no better than single agent treatment with haloperidol at 72 h. Australian New Zealand Clinical Trials Registry: ANZCTRN12610000481077 .

A Prospective Randomized Clinical Study of the Influence of Primary Closure or Dressing on Post-operative Morbidity after Mandibular Third Molar Surgery

PubMed Central

Egbor, Peter E; Saheeb, Birch D

2014-01-01

Objective: The aim of the following study is to determine the effect of primary closure or dressing on post-operative morbidity after impacted lower third molar surgery. Materials and Methods: This was a randomized clinical study of 72 patients who had surgical extraction of impacted mandibular third molars. The subjects were divided into two groups of A and B. Group A had total closure (primary closure) and Group B had whitehead varnish dressing of the socket. Pain, swelling and trismus were evaluated pre-operatively using visual analogue scale, flexible tape measuring method and inter-incisal distance measurement with Vernier Callipers respectively as well as post-operatively on 1st, 2nd, 3rd, 5th and 7th day. Results: The study participants consisted of 27 males and 45 females in a ratio 1:1.7. With a mean age of 24.7 ± 4.9 years (range 19-33 years) for Group A and 25.5 ± 4.3 years (range 20-39 years) for Group B. Post-operative pain was not significantly affected by the closure techniques (P > 0.05). Dressing was found to significantly reduce the degree of swelling and trismus peaking on the 2nd day (P = 0.0207 and P = 0.010 respectively). Conclusion: The use of dressing was more effective than primary closure to reduce the degree of swelling and trismus though its effect on post-operative pain reduction was not significant. PMID:25191094

Pain control after primary total knee replacement. A prospective randomised controlled trial of local infiltration versus single shot femoral nerve block.

PubMed

Ashraf, Anam; Raut, Videsh V; Canty, Stephen J; McLauchlan, George J

2013-10-01

We report a prospective blinded randomised trial of local infiltration versus femoral nerve block in patients undergoing primary total knee replacement (TKR), in accordance with the CONSORT statement 2010. Fifty patients in a teaching hospital were consented for the study. The study arms were intraoperative local anaesthesia (150ml 0.2% ropivacaine/1ml 1:1000 adrenaline/30mg ketolorac) and femoral nerve block (30ml 0.2% ropivacaine) with a primary outcome of pain score at 4h post operatively. Secondary outcomes were pain at 2h, pain scores before and after physiotherapy on day one, total opiate administered, time to physiotherapy goals and length of stay. Randomisation was by sealed envelope. The assessor was blinded and the patients partially blinded to the intervention. Ten patients were excluded, eight before randomisation. The trial is complete. Forty patients were analysed for the primary outcome measure. The local infiltration group had significantly lower pain scores at 4h post-operatively; mean [SD] score 2.1 [2.6] versus 6.8 [3.2], p<0.00001 and on post-operative day one prior to physiotherapy; mean score 2.4 [2.3] versus 4.4 [2.3], p<0.05. Total opiate use was also significantly lower in the local infiltration group; mean total 115 [50.3]mg versus 176.5 [103.5]mg, p<0.01. There was no difference in any other outcome. There were no harms as a result of either intervention. Intraoperative local infiltration gives superior pain relief compared to single shot femoral nerve block over the first 24h following primary TKR and minimises post-operative opiate use. Copyright © 2013 Elsevier B.V. All rights reserved.

A prospective cohort and extended comprehensive-cohort design provided insights about the generalizability of a pragmatic trial: the ProtecT prostate cancer trial.

PubMed

Donovan, Jenny L; Young, Grace J; Walsh, Eleanor I; Metcalfe, Chris; Lane, J Athene; Martin, Richard M; Tazewell, Marta K; Davis, Michael; Peters, Tim J; Turner, Emma L; Mills, Nicola; Khazragui, Hanan; Khera, Tarnjit K; Neal, David E; Hamdy, Freddie C

2018-04-01

Randomized controlled trials (RCTs) deliver robust internally valid evidence but generalizability is often neglected. Design features built into the Prostate testing for cancer and Treatment (ProtecT) RCT of treatments for localized prostate cancer (PCa) provided insights into its generalizability. Population-based cluster randomization created a prospective study of prostate-specific antigen (PSA) testing and a comprehensive-cohort study including groups choosing treatment or excluded from the RCT, as well as those randomized. Baseline information assessed selection and response during RCT conduct. The prospective study (82,430 PSA-tested men) represented healthy men likely to respond to a screening invitation. The extended comprehensive cohort comprised 1,643 randomized, 997 choosing treatment, and 557 excluded with advanced cancer/comorbidities. Men choosing treatment were very similar to randomized men except for having more professional/managerial occupations. Excluded men were similar to the randomized socio-demographically but different clinically, representing less healthy men with more advanced PCa. The design features of the ProtecT RCT provided data to assess the representativeness of the prospective cohort and generalizability of the findings of the RCT. Greater attention to collecting data at the design stage of pragmatic trials would better support later judgments by clinicians/policy-makers about the generalizability of RCT findings in clinical practice. Copyright © 2018 The Authors. Published by Elsevier Inc. All rights reserved.

Validation of Fourier analysis of videokeratographic data.

PubMed

Sideroudi, Haris; Labiris, Georgios; Ditzel, Fienke; Tsaragli, Efi; Georgatzoglou, Kimonas; Siganos, Haralampos; Kozobolis, Vassilios

2017-06-15

The aim was to assess the repeatability of Fourier transfom analysis of videokeratographic data using Pentacam in normal (CG), keratoconic (KC) and post-CXL (CXL) corneas. This was a prospective, clinic-based, observational study. One randomly selected eye from all study participants was included in the analysis: 62 normal eyes (CG group), 33 keratoconus eyes (KC group), while 34 eyes, which had already received CXL treatment, formed the CXL group. Fourier analysis of keratometric data were obtained using Pentacam, by two different operators within each of two sessions. Precision, repeatability and Intraclass Correlation Coefficient (ICC), were calculated for evaluating intrassesion and intersession repeatability for the following parameters: Spherical Component (SphRmin, SphEcc), Maximum Decentration (Max Dec), Regular Astigmatism, and Irregularitiy (Irr). Bland-Altman analysis was used for assessing interobserver repeatability. All parameters were presented to be repeatable, reliable and reproductible in all groups. Best intrasession and intersession repeatability and reliability were detected for parameters SphRmin, SphEcc and Max Dec parameters for both operators using ICC (intrasession: ICC > 98%, intersession: ICC > 94.7%) and within subject standard deviation. Best precision and lowest range of agreement was found for the SphRmin parameter (CG: 0.05, KC: 0.16, and CXL: 0.2) in all groups, while the lowest repeatability, reliability and reproducibility was detected for the Irr parameter. The Pentacam system provides accurate measurements of Fourier tranform keratometric data. A single Pentacam scan will be sufficient for most clinical applications.

[Sports participation after joint arthroplasty].

PubMed

Dauty, M; Letenneur, J

2007-12-01

To recommand sports activities after joint arthroplasty from the literature analysis, the French surgeon's opinion and wish patients. From the Medline data base interrogation according to keywords: Sports, Arthroplasty, Athletics, Physical training, two different readers, an orthopedic surgeon and a Physical Medicine and Rehabilitation physician selected articles in French or English language according to the level of proofs of the french classification of the Accreditation and Health Evaluation National Agency (Anaes). Professional practices were estimated by the interrogation of 30 orthopedic surgeons members of the french West Orthopaedics Society (SOO). The demand of sports practice was studied with patients recently operated for a primary total knee arthroplasty (TKA) after gonarthrosis. Twenty-two articles were selected from 305 articles obtained by the search according to keywords. Ten literature reviews are limited by the absence of prospective randomized study. A level II study and eleven level IV articles are reported. According to the subjective orthropedic surgeon's opinion, the objective results based on the joint load studied and the percentage of arthroplasty revision, sport is beneficial for the individual health but perhaps not for the arthroplasty survey. However, aerobic and leisure activities are recommended (walking, swimming, cycling) in agreement with the demand of the patients recently operated with a TKA. TKA differs from Total Hip Arthroplasty for jogging because of knee joint constraints during the knee flexion. A single study reports sports possibilities after shoulder arthroplasty and ankle arthroplasty and no study reports results after elbow arthroplasty.

A Prospective Randomized Clinical Trial of Single vs. Double Layer Closure of Hysterotomy at the Time of Cesarean Delivery: The Effect on Uterine Scar Thickness.

PubMed

Bamberg, Christian; Dudenhausen, Joachim W; Bujak, Verena; Rodekamp, Elke; Brauer, Martin; Hinkson, Larry; Kalache, Karim; Henrich, Wolfgang

2018-06-01

 We undertook a randomized clinical trial to examine the outcome of a single vs. a double layer uterine closure using ultrasound to assess uterine scar thickness.  Participating women were allocated to one of three uterotomy suture techniques: continuous single layer unlocked suturing, continuous locked single layer suturing, or double layer suturing. Transvaginal ultrasound of uterine scar thickness was performed 6 weeks and 6 - 24 months after Cesarean delivery. Sonographers were blinded to the closure technique.  An "intent-to-treat" and "as treated" ANOVA analysis included 435 patients (n = 149 single layer unlocked suturing, n = 157 single layer locked suturing, and n = 129 double layer suturing). 6 weeks postpartum, the median scar thickness did not differ among the three groups: 10.0 (8.5 - 12.3 mm) single layer unlocked vs. 10.1 (8.2 - 12.7 mm) single layer locked vs. 10.8 (8.1 - 12.8 mm) double layer; (p = 0.84). At the time of the second follow-up, the uterine scar was not significantly (p = 0.06) thicker if the uterus had been closed with a double layer closure 7.3 (5.7 - 9.1 mm), compared to single layer unlocked 6.4 (5.0 - 8.8 mm) or locked suturing techniques 6.8 (5.2 - 8.7 mm). Women who underwent primary or elective Cesarean delivery showed a significantly (p = 0.03, p = 0.02, "as treated") increased median scar thickness after double layer closure vs. single layer unlocked suture.  A double layer closure of the hysterotomy is associated with a thicker myometrium scar only in primary or elective Cesarean delivery patients. © Georg Thieme Verlag KG Stuttgart · New York.

Conventional versus computer-navigated TKA: a prospective randomized study.

PubMed

Todesca, Alessandro; Garro, Luca; Penna, Massimo; Bejui-Hugues, Jacques

2017-06-01

The purpose of this study was to assess the midterm results of total knee arthroplasty (TKA) implanted with a specific computer navigation system in a group of patients (NAV) and to assess the same prosthesis implanted with the conventional technique in another group (CON); we hypothesized that computer navigation surgery would improve implant alignment, functional scores and survival of the implant compared to the conventional technique. From 2008 to 2009, 225 patients were enrolled in the study and randomly assigned in CON and NAV groups; 240 consecutive mobile-bearing ultra-congruent score (Amplitude, Valence, France) TKAs were performed by a single surgeon, 117 using the conventional method and 123 using the computer-navigated approach. Clinical outcome assessment was based on the Knee Society Score (KSS), the Hospital for Special Surgery Knee Score and the Western Ontario Mac Master University Index score. Component survival was calculated by Kaplan-Meier analysis. Median follow-up was 6.4 years (range 6-7 years). Two patients were lost to follow-up. No differences were seen between the two groups in age, sex, BMI and side of implantation. Three patients of CON group referred feelings of instability during walking, but clinical tests were all negative. NAV group showed statistical significant better KSS Score and wider ROM and fewer outliers from neutral mechanical axis, lateral distal femoral angle, medial proximal tibial angle and tibial slope in post-operative radiographic assessment. There was one case of early post-operative superficial infection (caused by Staph. Aureus) successfully treated with antibiotics. No mechanical loosening, mobile-bearing dislocation or patellofemoral complication was seen. At 7 years of follow-up, component survival in relation to the risk of aseptic loosening or other complications was 100 %. There were no implant revisions. This study demonstrates superior accuracy in implant positioning and statistical significant better functional outcomes of computer-navigated TKA. Computer navigation for TKAs should be used routinely in primary implants. II.

A prospective, randomized evaluation of a novel everolimus-eluting coronary stent: the PLATINUM (a Prospective, Randomized, Multicenter Trial to Assess an Everolimus-Eluting Coronary Stent System [PROMUS Element] for the Treatment of Up to Two de Novo Coronary Artery Lesions) trial.

PubMed

Stone, Gregg W; Teirstein, Paul S; Meredith, Ian T; Farah, Bruno; Dubois, Christophe L; Feldman, Robert L; Dens, Joseph; Hagiwara, Nobuhisa; Allocco, Dominic J; Dawkins, Keith D

2011-04-19

We sought to evaluate the clinical outcomes with a novel platinum chromium everolimus-eluting stent (PtCr-EES) compared with a predicate cobalt chromium everolimus-eluting stent (CoCr-EES) in patients undergoing percutaneous coronary intervention (PCI). Randomized trials have demonstrated an excellent safety and efficacy profile for the CoCr-EES. The PtCr-EES uses the identical antiproliferative agent and polymer but with a novel platinum chromium scaffold designed for enhanced deliverability, vessel conformability, side-branch access, radiopacity, radial strength, and fracture resistance. A total of 1,530 patients undergoing PCI of 1 or 2 de novo native lesions were randomized at 132 worldwide sites to CoCr-EES (n = 762) or PtCr-EES (n = 768). The primary endpoint was the 12-month rate of target lesion failure (TLF), the composite of target vessel-related cardiac death, target vessel-related myocardial infarction (MI), or ischemia-driven target lesion revascularization (TLR) in the per-protocol population (patients who received ≥1 assigned study stent), powered for noninferiority. The 12-month rate of TLF in the per-protocol population occurred in 2.9% versus 3.4% of patients assigned to CoCr-EES versus PtCr-EES, respectively (difference: 0.5%, 95% confidence interval: -1.3% to 2.3%, p(noninferiority) = 0.001, p(superiority) = 0.60). By intention-to-treat, there were no significant differences between CoCr-EES and PtCr-EES in the 12-month rates of TLF (3.2% vs. 3.5%, p = 0.72), cardiac death or MI (2.5% vs. 2.0%, p = 0.56), TLR (1.9% vs. 1.9%, p = 0.96), or Academic Research Consortium definite or probable stent thrombosis (0.4% vs. 0.4%, p = 1.00). In this large-scale, prospective, single-blind randomized trial, a novel PtCr-EES was noninferior to the predicate CoCr-EES for TLF, with nonsignificant differences in measures of safety and efficacy through 12-month follow-up after PCI. Copyright © 2011 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.

A prospective, randomized, double-blinded single-site control study comparing blood loss prevention of tranexamic acid (TXA) to epsilon aminocaproic acid (EACA) for corrective spinal surgery.

PubMed

Verma, Kushagra; Errico, Thomas J; Vaz, Kenneth M; Lonner, Baron S

2010-04-06

Multilevel spinal fusion surgery has typically been associated with significant blood loss. To limit both the need for transfusions and co-morbidities associated with blood loss, the use of anti-fibrinolytic agents has been proposed. While there is some literature comparing the effectiveness of tranexamic acid (TXA) to epsilon aminocaproic acid (EACA) in cardiac procedures, there is currently no literature directly comparing TXA to EACA in orthopedic surgery. Here we propose a prospective, randomized, double-blinded control study evaluating the effects of TXA, EACA, and placebo for treatment of adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis (NMS), and adult deformity (AD) via corrective spinal surgery. Efficacy will be determined by intraoperative and postoperative blood loss. Other clinical outcomes that will be compared include transfusion rates, preoperative and postoperative hemodynamic values, and length of hospital stay after the procedure. The primary goal of the study is to determine perioperative blood loss as a measure of the efficacy of TXA, EACA, and placebo. Based on current literature and the mechanism by which the medications act, we hypothesize that TXA will be more effective at reducing blood loss than EACA or placebo and result in improved patient outcomes. ClinicalTrials.gov ID: NCT00958581.

Complications of hysteroscopic surgery: "Beyond the learning curve".

PubMed

Shveiky, David; Rojansky, Nathan; Revel, Ariel; Benshushan, Abraham; Laufer, Neri; Shushan, Asher

2007-01-01

To investigate the actual complication rate of hysteroscopic surgery performed by experienced endoscopic surgeons in a single medical center. A prospective descriptive study (Canadian Task Force classification III). An endoscopic gynecology unit at a tertiary care university hospital. Women from 21 to 82 (median 45.0) years, undergoing operative hysteroscopy for uterine disease. Operative hysteroscopy with glycine or saline solution used as an irrigation medium. Data of short-term complications were prospectively collected during surgery and at the 2-week follow-up visit. Six hundred procedures were investigated. The total complication rate was 3%, with 1% of uterine perforations. Two-thirds of the complications were related to cervical dilation or uterine entry, and infertility was found to be a risk factor. Hysteroscopic surgery, performed by a well-trained hysteroscopic surgeon, is a safe procedure with an overall complication rate of 3%. Most complications are related to cervical dilation or uterine entry techniques. Efforts therefore should be focused on identifying the patients at risk and finding novel techniques for cervical priming.

Transcutaneous Electrical Nerve Stimulation Reduces Post-Thoractomy Ipsilateral Shoulder Pain. A Prospective Randomized Study.

PubMed

Esteban González, Pedro; Novoa, Nuria M; Varela, Gonzalo

2015-12-01

The patient's position during an axillary thoracotomy can cause postoperative pain and decrease mobility of the ipsilateral shoulder. In this study, we assessed whether the implementation of a standardized analgesia program using transcutaneous electrical nerve stimulation (TENS) decreases local pain and improves ipsilateral shoulder mobility. Randomized, single-blind, single-center clinical trial of 50 patients who had undergone anatomical lung resection via axillary muscle-sparing thoracotomy. Patients were treated with TENS devices for 30 minutes every 8 hours, beginning on postoperative day 1. Pain and mobility of the affected limb were recorded at the same time on postoperative days 1 through 3. A visual analogue scale was used for pain assessment and shoulder mobility was assessed with a goniometer. Results were compared using a non-parametric test. Twenty-five patients were randomized to each group. Mean age of the control group was 62.7±9.3 years and 63.4±10.2 years in the experimental group. Shoulder mobility parameters were similar in both groups on all postoperative days. However, pain during flexion significantly decreased on day 2 (P=.03) and day 3 (P=.04) in the experimental group. The use of TENS decreases pain from shoulder flexion in patients undergoing axillary thoracotomy for pulmonary resection. Copyright © 2014 SEPAR. Published by Elsevier Espana. All rights reserved.

2 L PEG plus ascorbic acid versus 4 L PEG plus simethicon for colonoscopy preparation: a randomized single-blind clinical trial.

PubMed

Gentile, Maurizio; De Rosa, Michele; Cestaro, Giovanni; Forestieri, Pietro

2013-06-01

The 2 L polyethylene glycol (PEG) lavage solution has been proved to be similarly safe and effective as 4 L PEG formulations, in spite of the reduced volume. To compare low-volume PEG-based solution combined with ascorbic acid with high-volume PEG-based solution combined with simethicon in terms of efficacy and patient tolerability. This was a single-blind prospective randomized trial. Patients were randomized to receive either 2 L PEG plus ascorbic acid (PEG+Asc) or 4 L PEG plus simethicon (PEG+Sim). The primary endpoint was overall colon cleansing evaluation, assessed by blinded investigators using Aronchick score. Secondary end points included patient compliance and tolerability and adverse events. Sixty patients received PEG+Asc and 60 received PEG+Sim. Overall bowel cleansing score was considered adequate in 81.67% of the PEG+Asc and 80% of the PEG+Sim groups, respectively. Excellent and good ratings were recorded in 11.6% and 38.3% receiving PEG+Asc as compared with 26.6% and 23.3% of patients receiving PEG+Sim. Patient tolerability and safety were similar with both the preparations. According to our data, low-volume PEG+Asc has comparable efficacy, safety, and tolerability as high-volume PEG+Sim; therefore, it can be considered as a good alternative solution for bowel preparation. More improvements are necessary to achieve the target of a perfect preparation.

Improving prospective memory in persons with Parkinson disease: A randomized controlled trial

PubMed Central

Foster, Erin R.; McDaniel, Mark A.; Rendell, Peter G.

2017-01-01

Background Prospective memory is essential for productive and independent living and necessary for compliance with prescribed health behaviors. Parkinson disease (PD) can cause prospective memory deficits that are associated with activity limitations and reduced quality of life. Forming implementation intentions is an encoding strategy that may improve prospective memory in this population. Objective To determine the effect of implementation intentions on prospective memory performance in PD. Methods This was a laboratory-based randomized controlled trial. Participants with mild to moderate PD without dementia (N = 62) performed a computerized prospective memory test (Virtual Week) under standard instructions. One week later they were randomly allocated to perform it again while using either implementation intentions or a rehearsal encoding strategy. Results Prospective memory performance was better with the use of both strategies relative to standard instructions. This effect was larger for tasks with event-based compared to time-based cues. In addition, implementation intentions resulted in a larger effect than rehearsal for the non-repeated tasks. Conclusions Strategies that support full encoding of prospective memory cues and actions can improve prospective memory performance among people with PD, particularly for tasks with cues that are readily available in the environment. Implementation intentions may be more effective than rehearsal for non-repeated tasks, but this finding warrants verification. Future work should address transfer of strategy use from the laboratory to everyday life. Targeted strategies to manage prospective memory impairment could improve function and quality of life and significantly impact clinical care for people with PD. (NCT01469741) PMID:28176547

Are bowel purgatives and prokinetics useful for small-bowel capsule endoscopy? A prospective randomized controlled study.

PubMed

Postgate, Aymer; Tekkis, Paris; Patterson, Neil; Fitzpatrick, Aine; Bassett, Paul; Fraser, Chris

2009-05-01

Capsule endoscopy (CE) is limited by incomplete small-bowel transit and poor view quality in the distal bowel. Currently, there is no consensus regarding the use of bowel purgatives or prokinetics in CE. To evaluate the usefulness of bowel purgatives and prokinetics in small-bowel CE. Prospective single-blind randomized controlled study. Academic endoscopy unit. A total of 150 patients prospectively recruited. Patients were randomized to 1 of 4 preparations: "standard" (fluid restriction then nothing by mouth 12 hours before the procedure, water and simethicone at capsule ingestion [S]); "standard" + 10 mg oral metoclopramide before the procedure (M); Citramag + senna bowel-purgative regimen the evening before CE (CS); Citramag + senna + 10 mg metoclopramide before the procedure (CSM). Gastric transit time (GTT) and small-bowel transit time (SBTT), completion rates (CR), view quality, and patient acceptability. positive findings, diagnostic yield. No significant difference was noted among groups for GTT (median [minutes] M, CS, and CSM vs S: 17.3, 24.7, and 15.1 minutes vs 16.8 minutes, respectively; P = .62, .18, and .30, respectively), SBTT (median [minutes] M, CS, and CSM vs S: 260, 241, and 201 vs 278, respectively; P = .91, .81, and .32, respectively), or CRs (85%, 85%, and 88% vs 89% for M, CS, and CSM vs S, respectively; P = .74, .74, and 1.00, respectively). There was no significant difference in view quality among groups (of 44: 38, 37, and 40 vs 37 for M, CS, and CSM, vs S, respectively; P = .18, .62, and .12, respectively). Diagnostic yield was similar among the groups. CS and CSM regimens were significantly less convenient (P < .001), and CS was significantly less comfortable (P = .001) than standard preparation. Bowel purgatives and prokinetics do not improve CRs or view quality at CE, and bowel purgatives reduce patient acceptability.

Salvage therapy for locally recurrent prostate cancer after radiation.

PubMed

Marcus, David M; Canter, Daniel J; Jani, Ashesh B; Dobbs, Ryan W; Schuster, David M; Carthon, Bradley C; Rossi, Peter J

2012-12-01

External beam radiotherapy (EBRT) is widely utilized as primary therapy for clinically localized prostate cancer. For patients who develop locally recurrent disease after EBRT, local salvage therapy may be indicated. The primary modalities for local salvage treatment in this setting include radical prostatectomy, cryotherapy, and brachytherapy. To date, there is little data describing outcomes and toxicity associated with each of these salvage modalities. A review of the literature was performed to identify studies of local salvage therapy for patients who had failed primary EBRT for localized prostate cancer. We focused on prospective trials and multi-institutional retrospective series in order to identify the highest level of evidence describing these therapies. The majority of reports describing the use of local salvage treatment for recurrent prostate cancer after EBRT are single-institution, retrospective reports, although small prospective studies are available for salvage cryotherapy and salvage brachytherapy. Clinical outcomes and toxicity for each modality vary widely across studies, which is likely due to the heterogeneity of patient populations, treatment techniques, and definitions of failure. In general, most studies demonstrate that local salvage therapy after EBRT may provide long-term local control in appropriately selected patients, although toxicity is often significant. As there are no randomized trials comparing salvage treatment modalities for localized prostate cancer recurrence after EBRT, the selection of a local treatment modality should be made on a patient-by-patient basis, with careful consideration of each patient's disease characteristics and tolerance for the risks of treatment. Additional data, ideally from prospective randomized trials, is needed to guide decision making for patients with local recurrence after EBRT failure.

Small incision lenticule extraction (SMILE) versus laser in-situ keratomileusis (LASIK): study protocol for a randomized, non-inferiority trial

PubMed Central

2012-01-01

Background Small incision lenticule extraction or SMILE is a novel form of ‘flapless’ corneal refractive surgery that was adapted from refractive lenticule extraction (ReLEx). SMILE uses only one femtosecond laser to complete the refractive surgery, potentially reducing surgical time, side effects, and cost. If successful, SMILE could potentially replace the current, widely practiced laser in-situ keratomileusis or LASIK. The aim of this study is to evaluate whether SMILE is non-inferior to LASIK in terms of refractive outcomes at 3 months post-operatively. Methods/Design Single tertiary center, parallel group, single-masked, paired-eye design, non-inferiority, randomized controlled trial. Participants who are eligible for LASIK will be enrolled for study after informed consent. Each participant will be randomized to receive SMILE and LASIK in each eye. Our primary hypothesis (stated as null) in this non-inferiority trial would be that SMILE differs from LASIK in adults (>21 years old) with myopia (> −3.00 diopter (D)) at a tertiary eye center in terms of refractive predictability at 3 months post-operatively. Our secondary hypothesis (stated as null) in this non-inferiority trial would be that SMILE differs from LASIK in adults (>21 years old) with myopia (> −3.00 D) at a tertiary eye center in terms of other refractive outcomes (efficacy, safety, higher-order aberrations) at 3 months post-operatively. Our primary outcome is refractive predictability, which is one of several standard refractive outcomes, defined as the proportion of eyes achieving a postoperative spherical equivalent (SE) within ±0.50 D of the intended target. Randomization will be performed using random allocation sequence generated by a computer with no blocks or restrictions, and implemented by concealing the number-coded surgery within sealed envelopes until just before the procedure. In this single-masked trial, subjects and their caregivers will be masked to the assigned treatment in each eye. Discussion This novel trial will provide information on whether SMILE has comparable, if not superior, refractive outcomes compared to the established LASIK for myopia, thus providing evidence for translation into clinical practice. Trial registration Clinicaltrials.gov NCT01216475. PMID:22647480

The hemodynamic effects of intravenous paracetamol (acetaminophen) vs normal saline in cardiac surgery patients: A single center placebo controlled randomized study

PubMed Central

Churilov, Leonid

2018-01-01

The hemodynamic effects of intravenous (IV) paracetamol in patients undergoing cardiac surgery are unknown. We performed a prospective single center placebo controlled randomized study with parallel group design in adult patients undergoing elective cardiac surgery. Participants received paracetamol (1 gram) IV or placebo (an equal volume of 0.9% saline) preoperatively followed by two postoperative doses 6 hours apart. The primary endpoint was the absolute change in systolic (SBP) 30 minutes after the preoperative infusion, analysed using an ANCOVA model. Secondary endpoints included absolute changes in mean arterial pressure (MAP) and diastolic blood pressure (DPB), and other key hemodynamic variables after each infusion. All other endpoints were analysed using random-effect generalized least squares regression modelling with individual patients treated as random effects. Fifty participants were randomly assigned to receive paracetamol (n = 25) or placebo (n = 25). Post preoperative infusion, paracetamol decreased SBP by a mean (SD) of 13 (18) mmHg, p = 0.02, compared to a mean (SD) of 1 (11) mmHg with saline. Paracetamol decreased MAP and DBP by a mean (SD) of 9 (12) mmHg and 8 (9) mmHg (p = 0.01 and 0.02), respectively, compared to a mean (SD) of 1 (8) mmHg and 0 (6) mmHg with placebo. Postoperatively, there were no significant differences in pressure or flow based hemodynamic parameters in both groups. This study provides high quality evidence that the administration of IV paracetamol in patients undergoing cardiac surgery causes a transient decrease in preoperative blood pressure when administered before surgery but no adverse hemodynamic effects when administered in the postoperative setting. PMID:29659631

The hemodynamic effects of intravenous paracetamol (acetaminophen) vs normal saline in cardiac surgery patients: A single center placebo controlled randomized study.

PubMed

Chiam, Elizabeth; Bellomo, Rinaldo; Churilov, Leonid; Weinberg, Laurence

2018-01-01

The hemodynamic effects of intravenous (IV) paracetamol in patients undergoing cardiac surgery are unknown. We performed a prospective single center placebo controlled randomized study with parallel group design in adult patients undergoing elective cardiac surgery. Participants received paracetamol (1 gram) IV or placebo (an equal volume of 0.9% saline) preoperatively followed by two postoperative doses 6 hours apart. The primary endpoint was the absolute change in systolic (SBP) 30 minutes after the preoperative infusion, analysed using an ANCOVA model. Secondary endpoints included absolute changes in mean arterial pressure (MAP) and diastolic blood pressure (DPB), and other key hemodynamic variables after each infusion. All other endpoints were analysed using random-effect generalized least squares regression modelling with individual patients treated as random effects. Fifty participants were randomly assigned to receive paracetamol (n = 25) or placebo (n = 25). Post preoperative infusion, paracetamol decreased SBP by a mean (SD) of 13 (18) mmHg, p = 0.02, compared to a mean (SD) of 1 (11) mmHg with saline. Paracetamol decreased MAP and DBP by a mean (SD) of 9 (12) mmHg and 8 (9) mmHg (p = 0.01 and 0.02), respectively, compared to a mean (SD) of 1 (8) mmHg and 0 (6) mmHg with placebo. Postoperatively, there were no significant differences in pressure or flow based hemodynamic parameters in both groups. This study provides high quality evidence that the administration of IV paracetamol in patients undergoing cardiac surgery causes a transient decrease in preoperative blood pressure when administered before surgery but no adverse hemodynamic effects when administered in the postoperative setting.

A prospective randomized trial of 1 versus 2 injections during EUS-guided celiac plexus block for chronic pancreatitis pain.

PubMed

LeBlanc, Julia K; DeWitt, Jon; Johnson, Cynthia; Okumu, Wycliffe; McGreevy, Kathleen; Symms, Michelle; McHenry, Lee; Sherman, Stuart; Imperiale, Thomas

2009-04-01

The efficacy of 1-injection versus a 2-injections method of EUS-guided celiac plexus block (EUS-CPB) in patients with chronic pancreatitis is not known. To compare the clinical effectiveness and safety of EUS-CPB by using 1 versus 2 injections in patients with chronic pancreatitis and pain. The secondary aim is to identify factors that predict responsiveness. A prospective randomized study. EUS-CPB was performed by using bupivacaine and triamcinolone injected into 1 or 2 sites at the level of the celiac trunk during a single EUS-CPB procedure. Duration of pain relief, onset of pain relief, and complications. Fifty [corrected] subjects were enrolled (23 received 1 injection, 27 [corrected] received 2 injections). The median duration of pain relief in the 31 responders was 28 days (range 1-673 days). [corrected] Fifteen [corrected] of 23 (65%) [corrected] subjects who received 1 injection [corrected] had relief from pain compared with 16 of 27 (59%) [corrected] subjects who received 2 injections [corrected] (P = .67). [corrected] The median times to onset in the 1-injection and 2-injections groups were 21 and 14 days, respectively (P = .99). No correlation existed between duration of pain relief and time to onset of pain relief or onset within 24 hours. Age, sex, race, prior EUS-CPB, and smoking or alcohol history did not predict duration of pain relief. Telephone interviewers were not blinded. There was no difference in duration of pain relief or onset of pain relief in subjects with chronic pancreatitis and pain when the same total amount of medication was delivered in 1 or 2 injections during a single EUS-CPB procedure. Both methods were safe.

[A prospective multicenter randomized controlled clinical study on the efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution].

PubMed

Lu, Quan

2010-03-01

To evaluate efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution for the treatment of cough, expectoration, nasal congestion and runny nose in children. This was a prospective multicenter randomized single-blind, parallel-controlled clinical study. A total of 10 centers participated in this study, the actual number of cases in line with the program was 412, of whom 205 cases in trial group were treated with Guaifenesin compound pseudoephedrine hydrochloride oral solution, and 207 cases in control group with ambroxol hydrochloride oral solution, treatment of both groups persisted for 7 days. The improvement rate of each single symptom and the combined symptoms and the overall effective rate were compared between the two groups. The adverse drug reactions and compliance were assessed as well. The treatment of both groups showed efficacy. Except sputum stickiness, the improvement of all symptoms in trial group was superior to that in the control group on the 3rd day after treatment (P < 0.05) and except nasal congestion, the efficacy in all the other symptoms of trial group was better than that in the control group as well on the 7th day (P < 0.01). The improvement rate for combined symptoms of Guaifenesin compound pseudoephedrine hydrochloride oral solution was 82.9% and the overall efficacy rate was 89.3%. Guaifenesin compound Pseudoephedrine hydrochloride oral solution had higher compliance and its adverse event rate was merely 0.92%. Guaifenesin compound pseudoephedrine hydrochloride oral solution showed significant efficacy and safety in children for treatment of cough, expectoration, nasal congestion and runny nose caused by common cold or acute tracheobronchitis.

Comparative study of the efficacy of transdermal buprenorphine patches and prolonged-release tramadol tablets for postoperative pain control after spinal fusion surgery: a prospective, randomized controlled non-inferiority trial.

PubMed

Kim, Ho-Joong; Ahn, Hyo Sae; Nam, Yunjin; Chang, Bong-Soon; Lee, Choon-Ki; Yeom, Jin S

2017-11-01

To compare the efficacy of a transdermal buprenorphine patch (5, 10, 15, and 20 μg/h) with that of oral tramadol (150, 200, 250, and 300 mg) for postoperative pain control after single level spinal fusion surgery. The present study (ClinicalTrials.gov, number NCT02416804) was a prospective, randomized controlled non-inferiority trial designed to determine the efficacy of buprenorphine TDS for alleviating postoperative pain following patient controlled analgesia (PCA) in persons underwent a single level posterior lumbar interbody fusion surgery through 1:1 allocation. The primary outcome was the Visual Analog Pain Scale (VAS) score for postoperative back pain at 7 days after surgery. The non-inferior margin of the VAS was set at δ = 1.5 points. The VAS score (primary outcome) for postoperative back pain at 7 days after surgery in the Buprenorphine group was not inferior compared to the Tramadol group. The overall changes in VAS scores for postoperative pain during follow-up assessments over a 2-week period did not differ between both groups. However, the VAS scores for postoperative pain significantly improved with time after surgery in both groups. The patterns of changes in the VAS scores for postoperative pain during the follow-up period were not significantly different between the both groups. The efficacy of buprenorphine TDS was not inferior to that of oral tramadol medication for alleviating postoperative pain in the subacute period from 72 h after surgery, following PCA administration. In addition, adverse events were similar between both groups.

Effect of extracorporeal shock wave therapy on scar pain in burn patients: A prospective, randomized, single-blind, placebo-controlled study.

PubMed

Cho, Yoon Soo; Joo, So Young; Cui, Huisong; Cho, Sung-Rae; Yim, Haejun; Seo, Cheong Hoon

2016-08-01

Extracorporeal shock wave therapy (ESWT) has been used to reduce pain in patients with various musculoskeletal diseases and wounds. We investigated the effect of ESWT on scar pain after complete wound epithelialization in burn patients. A prospective, single-blind, placebo-controlled study was conducted from February 2014 to 2015. Forty patients with burn scar pain despite standard therapy (medication, physical therapy, and burn rehabilitation massage therapy) were randomized into ESWT or control (sham ESWT) groups. ESWT was administered at 100 impulses/cm (0.05-0.15 mJ/mm) once per week for 3 weeks. The treatment effects were assessed using the numerical rating scale (NRS), pain threshold, Nirschl pain phase system, and Roles and Maudsley scores. The characteristics of patients between the 2 study groups were balanced (P >0.05) for age, sex, and total burn surface area (%). In both groups, the NRS, pain threshold (Ib/cm), and Nirschl pain phase system values significantly improved (P <0.05) after 3 sessions of ESWT or sham therapy, and there were significant differences between the 2 groups in terms of these 3 variables (P <0.001, P <0.001, P = 0.013, respectively). The Roles and Maudsley scores significantly improved; among 20 patients, 17 reported a score of poor (85%) and 3 reported fair (15%) before ESWT, whereas 3 reported poor (15%), 8 reported fair (40%), 5 reported good (25%), and 4 reported excellent (20%) after ESWT (P = 0.004). The scores did not improve in the control group (P = 0.128). ESWT significantly reduced scar pain in burn patients after wound recovery.

Laparoscopic extraperitoneal inguinal hernia repair versus open mesh repair: a prospective randomized controlled trial.

PubMed

Andersson, Bodil; Hallén, Magnus; Leveau, Per; Bergenfelz, Anders; Westerdahl, Johan

2003-05-01

This study was designed to compare an open tension-free technique (Lichtenstein repair) with a laparoscopic totally extraperitoneal hernia repair (TEP). One hundred sixty-eight men aged 30 to 65 years with primary or recurrent inguinal hernia were randomized to TEP or open mesh technique in the manner of Lichtenstein. Follow-up was after 1 and 6 weeks, and 1 year. Eighty-one patients were randomized to TEP, and 87 to open repair. For 1 patient in each group, the operation was converted to a different type of repair. No difference was seen in overall complications between the 2 groups. However, 1 patient in the TEP group underwent operation for small bowel obstruction after surgery. A higher frequency of postoperative hematomas was seen in the open group (P <.05). Patients in the TEP group consumed less analgesic after surgery (P <.001), returned to work earlier (P <.01), and had a shorter time to full recovery (P <.01). Two recurrences occurred in the TEP group 1 year after surgery. The TEP technique was associated with less postoperative pain, a shorter time to full recovery, and an earlier return to work compared with the open tension-free repair. No difference was seen in overall complications. However, 2 recurrences did occur after 1 year in the TEP group.

Reusable single-port access device shortens operative time and reduces operative costs.

PubMed

Shussman, Noam; Kedar, Asaf; Elazary, Ram; Abu Gazala, Mahmoud; Rivkind, Avraham I; Mintz, Yoav

2014-06-01

In recent years, single-port laparoscopy (SPL) has become an attractive approach for performing surgical procedures. The pitfalls of this approach are technical and financial. Financial concerns are due to the increased cost of dedicated devices and prolonged operating room time. Our aim was to calculate the cost of SPL using a reusable port and instruments in order to evaluate the cost difference between this approach to SPL using the available disposable ports and standard laparoscopy. We performed 22 laparoscopic procedures via the SPL approach using a reusable single-port access system and reusable laparoscopic instruments. These included 17 cholecystectomies and five other procedures. Operative time, postoperative length of stay (LOS) and complications were prospectively recorded and were compared with similar data from our SPL database. Student's t test was used for statistical analysis. SPL was successfully performed in all cases. Mean operative time for cholecystectomy was 72 min (range 40-116). Postoperative LOS was not changed from our standard protocols and was 1.1 days for cholecystectomy. The postoperative course was within normal limits for all patients and perioperative morbidity was recorded. Both operative time and length of hospital stay were shorter for the 17 patients who underwent cholecystectomy using a reusable port than for the matched previous 17 SPL cholecystectomies we performed (p < 0.001). Prices of disposable SPL instruments and multiport access devices as well as extraction bags from different manufacturers were used to calculate the cost difference. Operating with a reusable port ended up with an average cost savings of US$388 compared with using disposable ports, and US$240 compared with standard laparoscopy. Single-port laparoscopic surgery is a technically challenging and expensive surgical approach. Financial concerns among others have been advocated against this approach; however, we demonstrate herein that using a reusable port and instruments reduces operative time and overall operative costs, even beyond the cost of standard laparoscopy.

Blastocyst Development in a Single Medium Compared to Sequential Media: A Prospective Study With Sibling Oocytes.

PubMed

Sfontouris, Ioannis A; Kolibianakis, Efstratios M; Lainas, George T; Petsas, George K; Tarlatzis, Basil C; Lainas, Trifon G

2017-09-01

The aim of the present study was to compare blastocyst formation rates after embryo culture in a single medium (Global) as compared to sequential media (ISM1/BlastAssist). In this prospective trial with sibling oocytes, 542 metaphase II (ΜΙΙ) oocytes from 31 women were randomly and equally divided to be fertilized and cultured to the blastocyst stage in either sequential media (ISM1/BlastAssist; n = 271 MII oocytes) or a single medium (Global; n = 271 MII oocytes). In both groups, embryos were cultured in an interrupted fashion with media changes on day 3. Embryo transfer was performed on day 5. Blastocyst formation rates on day 5 (61.7% ± 19.9% vs 37.0% ± 25.5%, P < .001) were significantly higher following culture in Global as compared to ISM1/BlastAssist, respectively. Fertilization rates, cleavage rates, and percentage of good quality embryos on day 3 were similar between Global and ISM1/BlastAssist, respectively. The percentages of good quality blastocysts (63.0% ± 24.8% vs 32.1% ± 37.2%, P < .001), blastocysts selected for transfer (27.8% ± 19.2% vs 11.1% ± 14.4%, P = .005), and utilization rates (62.5% ± 24.8% vs 39.0% ± 25.2%, P < .001) were significantly higher in Global as compared to ISM1/BlastAssist, respectively. In conclusion, culture in Global was associated with higher blastocyst formation rates compared to ISM1/BlastAssist, suggesting that the single medium may provide better support to the developing embryo.

Single-port one-stage bilateral thoracoscopic sympathicotomy for severe hyperhidrosis: prospective analysis of a standardized approach

PubMed Central

2013-01-01

Background Primary palmar and/or axillary focal hyperhidrosis is a frequent disorder characterized by excessive sweating beyond physiological needs, often leading to a substantial impairment of quality of life. Over the years several minimally invasive surgical treatments have been described, however results vary, and due to a lack of uniform surgical approach, technique and nomenclature are often difficult to compare. In this prospective study we sought to evaluate the safety and effectiveness of our standardized technique of single-port, one-stage bilateral thoracoscopic sympathicotomy. Methods On a prospective basis a hundred consecutive patients with severe or intolerable primary hyperhidrosis underwent one-stage bilateral single-port thoracoscopic sympathicotomy. Primary outcome was measured in pre- vs. post-operative Hyperhidrosis Disease Severity Scale scores. Location and extend of compensatory hyperhidrosis, and satisfaction with the procedure were registered. Results A significant reduction in mean Hyperhidrosis Disease Severity Scale score (3.69 ± 0.47 preoperatively vs. 1.06 ± 0.34 postoperatively) (p < 0.001) was observed. In 97 (97%) out of the 100 enrolled patients a >80% reduction in sweat production was achieved. Compensatory hyperhidrosis was seen in 27 patients (27%). It was rated as mild by 21 patients (78%) and as moderate by 6 (22%) of these patients. No severe compensatory hyperhidrosis was reported. Major complications, such as intraoperative bleeding, infections, and Horner’s syndrome were not observed. Conclusions Highly selective sympathicotomy at well-defined levels with a one-stage bilateral single-port transaxillary thoracoscopic approach is a save procedure, with excellent and reproducible immediate results in the treatment of primary palmar and/or axillary hyperhidrosis. PMID:24279511

Tissue welding tonsillectomy provides an enhanced recovery compared to that after monopolar electrocautery technique in adults: a prospective randomized clinical trial.

PubMed

Silvola, Juha; Salonen, Aarre; Nieminen, Jouko; Kokki, Hannu

2011-02-01

We have compared tonsillectomy (TE) with tissue welding (TW) technology using a specially designed forceps versus conventional monopolar electrocautery to evaluate whether this new technology may improve recovery after TE. This was a single-blind, randomized clinical trial with two parallel groups. Sixty healthy adult day-surgery patients were allocated into the TW-TE group (n = 31) and the monopolar electrocautery-TE group (n = 29). We recorded intraoperative events and short- and long-term recovery for 2 weeks postoperatively. The patients and study nurses evaluating patients during recovery were blinded to the operation method used. All patients in the TW-TE group completed the study as per protocol, but in the monopolar electrocautery-TE group, there was one drop-out in the hospital and another after discharge. There was no difference in the perioperative parameters and early recovery between the two groups. After discharge, recovery was significantly faster in the TW group than in the monopolar group: (1) the duration of postoperative pain was 2 days shorter, and (2) activities of normal daily living were less affected, and (3) the need for hospital contacts after discharge, and (4) the incidence of postoperative bleeding was less in the TW group than that in the monopolar group. No patients in the TW group developed secondary bleeding versus three patients in the monopolar group requiring electrocautery to control bleeding. In conclusion; our results indicate that, TW technique may provide reduced pain, faster recovery, and fewer complications compared to electrocautery TE.

Results of the prospective, randomized, controlled multicenter Food and Drug Administration investigational device exemption study of the ProDisc-C total disc replacement versus anterior discectomy and fusion for the treatment of 1-level symptomatic cervical disc disease.

PubMed

Murrey, Daniel; Janssen, Michael; Delamarter, Rick; Goldstein, Jeffrey; Zigler, Jack; Tay, Bobby; Darden, Bruce

2009-04-01

Cervical total disc replacement (TDR) is intended to address radicular pain and preserve functional motion between two vertebral bodies in patients with symptomatic cervical disc disease (SCDD). The purpose of this trial is to compare the safety and efficacy of cervical TDR, ProDisc-C (Synthes Spine Company, L.P., West Chester, PA), to anterior cervical discectomy and fusion (ACDF) surgery for the treatment of one-level SCDD between C3 and C7. The study was conducted at 13 sites. A noninferiority design with a 1:1 randomization was used. Two hundred nine patients were randomized and treated (106 ACDF; 103 ProDisc-C). Visual analog scale (VAS) pain and intensity (neck and arm), VAS satisfaction, neck disability index (NDI), neurological exam, device success, adverse event occurrence, and short form-36 (SF-36) standardized questionnaires. A prospective, randomized, controlled clinical trial was performed. Patients were enrolled and treated in accordance with the US Food and Drug Administration (FDA)-approved protocol. Patients were assessed pre- and postoperatively at six weeks, 3, 6, 12, 18, and 24 months. Demographics were similar between the two patient groups (ProDisc-C: 42.1+/-8.4 years, 44.7% males; Fusion: 43.5 +/- 7.1 years, 46.2% males). The most commonly treated level was C5-C6 (ProDisc-C: 56.3%; Fusion=57.5%). NDI and SF-36 scores were significantly less compared with presurgery scores at all follow-up visits for both the treatment groups (p<.0001). VAS neck pain intensity and frequency as well as VAS arm pain intensity and frequency were statistically lower at all follow-up timepoints compared with preoperative levels (p<.0001) but were not different between treatments. Neurologic success (improvement or maintenance) was achieved at 24 months in 90.9% of ProDisc-C and 88.0% of Fusion patients (p=.638). Results show that at 24 months postoperatively, 84.4% of ProDisc-C patients achieved a more than or equal to 4 degrees of motion or maintained motion relative to preoperative baseline at the operated level. There was a statistically significant difference in the number of secondary surgeries with 8.5% of Fusion patients needing a re-operation, revision, or supplemental fixation within the 24 month postoperative period compared with 1.8% of ProDisc-C patients (p=.033). At 24 months, there was a statistically significant difference in medication usage with 89.9% of ProDisc-C patients not on strong narcotics or muscle relaxants, compared with 81.5% of Fusion patients. The results of this clinical trial demonstrate that ProDisc-C is a safe and effective surgical treatment for patients with disabling cervical radiculopathy because of single-level disease. By all primary and secondary measures evaluated, clinical outcomes after ProDisc-C implantation were either equivalent or superior to those same clinical outcomes after Fusion.

Percutaneous ultrasonic tenotomy for chronic elbow tendinosis: a prospective study.

PubMed

Barnes, Darryl E; Beckley, James M; Smith, Jay

2015-01-01

Elbow tendinopathy is the most common cause of elbow pain affecting active populations. Surgical excision is reserved for patients with refractory symptoms. Percutaneous ultrasonic tenotomy performed under local anesthesia also removes degenerated tissue and therefore provides an alternative treatment option to surgical excision. This investigation prospectively documented the safety and 1-year efficacy of ultrasonic percutaneous tenotomy performed by a single operator. Nineteen patients, aged 38 to 67 years, in whom >6 months of conservative management for medial (7) or lateral (12) elbow tendinopathy had failed were prospectively studied. All patients were treated with percutaneous ultrasonic tenotomy of the elbow by a single operator. Visual analog scale (VAS) for pain, the 11-item version of the Disabilities of the Arm, Shoulder, and Hand (Quick DASH) index, and the Mayo Elbow Performance Score (MEPS) were assessed by an independent observer before treatment and at 6 weeks, 3 months, 6 months, and 12 months after treatment. No procedural complications occurred. Total treatment time was <15 minutes, and ultrasonic energy time averaged 38.6 ± 8.8 seconds per procedure. Average VAS scores were significantly improved from 6.4 to 2.6 at 6 weeks and were 0.7 at 12 months (P < .0001). Similar improvement occurred with the Quick DASH (pretreatment, 44.1; 12 months, 8.6, P < .0001) and MEPS (pretreatment, 59.1; 12 months, 83.4; P < .0001). Percutaneous ultrasonic tenotomy performed under local anesthesia appears to be a safe and effective treatment option for chronic, refractory lateral or medial elbow tendinopathy up to 1 year after the procedure. Copyright © 2015 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Elsevier Inc. All rights reserved.

Evaluation of intradermal absorbable and mattress sutures to close pilonidal sinus wounds with Limberg flap: a prospective randomized comparative study.

PubMed

Çetin, Kenan; Sikar, Hasan Ediz; Kocaoğlu, Aytaç Emre; Kündeş, Muhammet Fikri; Karahan, Mehmet; Kaptanoğlu, Levent

2018-02-01

We aimed to compare skin closure techniques, standard (intermittent mattress) and continuous subcuticular sutures, following Limberg flap procedure. From July 2013 to July 2015, 92 patients with sacrococcygeal pilonidal disease were prospectively randomized into 2 groups consisting of 46 patients for both. Patients underwent sinus excision and closure with Limberg flap; continuous subcuticular suture was used in subcuticular group (SG) and intermittent mattress sutures were used in mattress group (MG) for skin closure. Characteristics of patients, features of pilonidal disease, macerations, infections, wound dehiscence, flap necrosis, operation time, time of drain removal, wound complications, early recurrences, and time till return to work were compared between the 2 groups. There was no statistical difference between groups per sex, age, body mass index, smoking, number of sinuses, depth of intergluteal sulcus, distance of incision to anus, volume of extracted tissue, number of hair follicles per cm 2 , recurrence, operation, and mean follow-up time. Two patients showed signs of wound complications (4.4%) in SG, whereas 8 cases (17.4%) showed signs in MG (P < 0.05). One patient in SG had surgical site infection and required antibiotics (2.2%), where as there were 6 cases treated in MG (13.0%) (P < 0.05). Removal of drain tube, and time till return to work rates are lower for SG than MG (P < 0.05). In conclusion, surgical procedures which include Limberg flap method and subcuticular closure may reduce infection and maceration rates. Future studies are needed to achieve greater detailed evaluation.

A prospective randomized trial of postoperative pain following different insufflation pressures during gynecologic laparoscopy.

PubMed

Topçu, H O; Cavkaytar, S; Kokanalı, K; Guzel, A I; Islimye, M; Doganay, M

2014-11-01

To determine the effects of different intra-abdominal pressure values on visceral pain following gynecologic laparoscopic surgery in the Trendelenburg position. This randomized, controlled prospective trial was conducted at a tertiary education hospital and included 150 patients who underwent gynecologic laparoscopy with different abdominal insufflation pressures. There were 54 patients in the 8 mmHg low pressure group (LPG), 45 in the 12 mmHg standard pressure group (SPG), and 51 in the 15 mmHg high pressure group (HPG). We assessed mean age, body mass index (BMI), duration of surgery, analgesic consumption, length of hospital stay, amount of CO2 expended and volume of hemorrhage. Visceral pain and referred visceral pain were assessed 6, 12, and 24 h postoperatively using a visual analog scale (VAS). There was no significant difference in age, BMI, analgesic consumption or length of hospital stay among groups. The mean operative time and total CO2 expended during surgery were higher in the LPG compared with the SPG and HPG. The mean intensity of postoperative pain assessed by the VAS score at 6 and 12 h was less in the LPG than in the SPG and HPG and was reduced significantly at 12 h. VAS scores at 24 h in the LPG and SPG were lower than in the HPG. Pain is reduced by low insufflation pressure compared with standard and high insufflation pressure following gynecologic laparoscopic surgery in the Trendelenburg position. However, low insufflation pressure may result in longer operation times and increased hemorrhage. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Treatment with GLP1 receptor agonists reduce serum CRP concentrations in patients with type 2 diabetes mellitus: A systematic review and meta-analysis of randomized controlled trials.

PubMed

Mazidi, Mohsen; Karimi, Ehsan; Rezaie, Peyman; Ferns, Gordon A

2017-07-01

To undertake a systematic review and meta-analysis of randomized controlled trials of the effect of glucagon-like peptide-1 receptor agonist (GLP-1 RAs) therapy on serum C-reactive protein (CRP) concentrations. PubMed-Medline, SCOPUS, Web of Science and Google Scholar databases were searched for the period up until March 16, 2016. Prospective studies evaluating the impact of GLP-1 RAs on serum CRP were identified. A random effects model (using the DerSimonian-Laird method) and generic inverse variance methods were used for quantitative data synthesis. Sensitivity analysis was conducted using the leave-one-out method. Heterogeneity was quantitatively assessed using the I 2 index. Random effects meta-regression was performed using unrestricted maximum likelihood method to evaluate the impact of potential moderator. International Prospective Register for Systematic Reviews (PROSPERO) number CRD42016036868. Meta-analysis of the data from 7 treatment arms revealed a significant reduction in serum CRP concentrations following treatment with GLP-1 RAs (WMD -2.14 (mg/dL), 95% CI -3.51, -0.78, P=0.002; I 2 96.1%). Removal of one study in the meta-analysis did not change the result in the sensitivity analysis (WMD -2.14 (mg/dL), 95% CI -3.51, -0.78, P=0.002; I 2 96.1%), indicating that our results could not be solely attributed to the effect of a single study. Random effects meta-regression was performed to evaluate the impact of potential moderator on the estimated effect size. Changes in serum CRP concentration were associated with the duration of treatment (slope -0.097, 95% CI -0.158, -0.042, P<0.001). This meta-analysis suggests that GLP-1 RAs therapy causes a significant reduction in CRP. Copyright © 2016 Elsevier Inc. All rights reserved.

Clinical evaluations of mineralized collagen in the extraction sites preservation

PubMed Central

Feng, Lu; Zhang, Liang; Cui, Yun; Song, Tian-Xi; Qiu, Zhi-Ye; Wang, Xiu-Mei; Tan, Bao-Sheng

2016-01-01

The purpose of this study was to explore the different effects between biomimetic mineralized collagen (MC) and ordinary physically blended hydroxyapatite/collagen (HA/Col) composite in evaluating new bone formation and regenerated bone height in human extraction sockets. Thirty-four patients who cannot retain teeth caused by trauma or decay were randomly selected from Department of Stomatology of Dongzhimen Hospital from December 2013 to December 2014. The patients were randomly divided into two groups. After the operation of tooth extraction, 17 patients were implanted with biomimetic MC (MC group), and other 17 patients were implanted with ordinary physically blended nHA/Col composite (nHA/Col group). X-ray positioning projection by auto-photographing was taken to test the distance between the lowest position and the neighboring CEJm-CEJd immediately, 1 month and 3 months after the operation. The height of new bone formation of the MC group was significantly higher than the nHA/Col group. Biomimetic MC showed better clinical outcomes in the bone formation for extraction site preservation and would have broad application prospect in the field of oral and maxillofacial surgeries. PMID:26815224

Unipedicular versus bipedicular percutaneous vertebroplasty for osteoporotic vertebral compression fractures: a prospective randomized study.

PubMed

Zhang, Liang; Liu, Zhongjun; Wang, Jingcheng; Feng, Xinmin; Yang, Jiandong; Tao, Yuping; Zhang, Shengfei

2015-06-14

Percutaneous vertebroplasty (PVP) typically involves conventional lower-viscosity cement injection via bipedicular approach. Limited evidence is available comparing the clinical outcomes and complications in treating osteoporotic vertebral compression fractures (OVCFs) with PVP using high-viscosity cement through unipedicular or bipedicular approach. Fifty patients with OVCFs were randomly allocated into two groups adopting unipedicular or bipedicular PVP. The efficacy of unipedicular and bipedicular PVP was assessed by comparing operation time, X-ray exposure time, incidence of complications, vertebral height restoration, and improvement of the visual analogue scale (VAS), Oswestry disability index (ODI) and Short Form-36 (SF-36) General Health Survey scores. The mean operative and exposure time to X-rays in the unipedicular PVP group was less than that of the bipedicular group (p < 0.05). No statistically significant differences were observed in the VAS score, ODI score, SF-36 score, cement leakage rate or vertebral height restoration between the two groups (p > 0.05). Unipedicular and bipedicular PVP are safe and effective treatments for OVCF. Compared with bipedicular PVP, unipedicular PVP entails a shorter surgical time and lower X-ray irradiation.

To Cement or Not? Two-Year Results of a Prospective, Randomized Study Comparing Cemented Vs. Cementless Total Knee Arthroplasty (TKA).

PubMed

Fricka, Kevin B; Sritulanondha, Supatra; McAsey, Craig J

2015-09-01

The optimal mode of fixation in total knee arthroplasty (TKA) is a subject of debate. We enrolled 100 TKA patients randomized to cemented or cementless fixation. Knee Society Scores (KSS), Oxford scores and pain visual analog scales (VAS) were collected pre-operatively and post-operatively. Two-year follow-up was obtained for 93 patients. The mean VAS trended higher for the cementless group at 4 months (P=0.06). At 2 years, the KSS functional scores, Oxford scores, and self-reported questions for satisfaction, less pain and better function were similar but the cemented group had higher KSS clinical scores (96.4 vs. 92.3, P=0.03). More radiolucencies were seen in cementless knees (P<0.001). The cementless group had one revision for instability and one cemented knee was revised for infection. Cementless TKA showed equivalent survivorship (revision for any reason as the endpoint) compared to cemented TKA at this early follow-up. Close monitoring of radiolucencies is important with continued follow-up. Copyright © 2015 Elsevier Inc. All rights reserved.

Single-incision laparoscopic cholecystectomy vs. conventional laparoscopic cholecystectomy: a meta-analysis of randomized controlled trials.

PubMed

Garg, Pankaj; Thakur, Jai Deep; Garg, Mahak; Menon, Geetha R

2012-08-01

We analyzed different morbidity parameters between single-incision laparoscopic cholecystectomy (SILC) and conventional laparoscopic cholecystectomy (CLC). Pubmed, Ovid, Embase, SCI database, Cochrane, and Google Scholar were searched. The primary endpoints analyzed were cosmetic result and the postoperative pain (at 6 and 24 h) and the secondary endpoints were operating time, hospital stay, incidence of overall postoperative complications, wound-related complications, and port-site hernia. Six hundred fifty-nine patients (SILC-349, CLC-310) were analyzed from nine randomized controlled trials. The objective postoperative pain scores at 6 and 24 h and the hospital stay were similar in both groups. The total postoperative complications, wound-related problems, and port-site hernia formation, though higher in SILC, were also comparable in both groups. SILC had significantly favorable cosmetic scoring compared to CLC [weighted mean difference = 1.0, p = 0.0001]. The operating time was significantly longer in SILC [weighted mean difference = 15.63, p = 0.0001]. Single-incision laparoscopic cholecystectomy does not confer any benefit in postoperative pain (6 and 24 h) and hospital stay as compared to conventional laparoscopic cholecystectomy while having significantly better cosmetic results at the same time. Postoperative complications, though higher in SILC, were statistically similar in both the groups.

A randomized, prospective, double-blind study of the efficacy of dexpanthenol nasal spray on the postoperative treatment of patients with chronic rhinosinusitis after endoscopic sinus surgery.

PubMed

Tantilipikorn, Pongsakorn; Tunsuriyawong, Prayuth; Jareoncharsri, Perapun; Bedavanija, Anan; Assanasen, Paraya; Bunnag, Chaweewan; Metheetrairut, Choakchai

2012-01-01

To assess the efficacy of dexpanthenol nasal spray compared with normal saline spray in the postoperative treatment of patients with chronic rhinosinusitis (CRS) who underwent endoscopic sinus surgery (ESS). A prospective, randomized controlled study was conducted in CRS patients who underwent ESS. The enrolled patients had never been operated intranasally. These patients received either dexpanthenol or normal saline nasal spray intranasally four times a day for six weeks post-operatively. Fifty CRS patients were recruited in the present study. Age ranged from 23 to 63 years (means 43.4 +/- 11.2 years). Forty-four percent of patients were diagnosed as CRS without nasal polyps (NP) (CRSs NP) and 56% were CRS with NP (CRSw NP). Twenty-five cases were randomly assigned to use dexpanthenol nasal spray whereas the other 25 cases used normal saline nasal spray. The preoperative severity of CRS, determined by the computerized tomography (CT) scan scoring system of Lund-McKay was 13.9 +/- 6.2 in the dexpanthenol group and 13.6 +/- 6.9 in the normal saline group, which were not statistically different (p > 0.05). The endoscopic scoring was 10.2 +/- 2 in the dexpanthenol group and 10.7 +/- 3 in the normal saline group, which were not statistically different (p > 0.05). The mucociliary transit time improvement (time difference between pre- and post-treatment by nasal spray) was 8.4 +/- 3.3 minutes in the dexpanthenol group and 1.7 +/- 1.2 minutes in the normal saline group, which were statistically different (p < 0.05). The majority of the postoperative symptom scores and all of the endoscopic scores of the dexpanthenol group were not statistically different from those of the normal saline group. However, dexpanthenol nasal spray has superior efficacy compared with normal saline nasal spray on improvement of mucociliary clearance and nasal discharge in the postoperative care of CRS patients after ESS.

Effectiveness of Liposomal Bupivacaine in Colorectal Surgery: A Pragmatic Nonsponsored Prospective Randomized Double Blinded Trial in a Community Hospital.

PubMed

Knudson, Rachel A; Dunlavy, Paul W; Franko, Jan; Raman, Shankar R; Kraemer, Soren R

2016-09-01

Prior industry conducted studies have shown that long acting liposomal bupivacaine injection improves pain control postoperatively. To evaluate whether liposomal bupivacaine reduced the use of postoperative opioid (http://links.lww.com/DCR/A253) pain medication as compared to standard bupivacaine following colorectal surgery. A double blinded, prospective, randomized controlled trial comparing liposomal bupivacaine versus standard bupivacaine in patients undergoing elective colon resection. Community hospital with general surgery residency program with all cases performed by colorectal surgeons. Fifty-seven patients were randomized and reported as intention-to-treat analysis with 6 protocol violations. Sensitivity analysis excluding these 6 patients demonstrated no change in study results or conclusion. Mean age was 67 ± 2 years and 56% were male. There were 36 patients who underwent minimally invasive surgery, and 21 patients had an open colon resection. Experimental arm received liposomal bupivacaine while control arm received standard bupivacaine. Primary outcome measure was intravenous hydromorphone equivalent used via PCA during first 48 hours after operation. There was no significant difference between the two groups in the amount of opioid used orally or intravenously in the postoperative period. The primary outcome measure was PCA hydromorphone consumption during first two postoperative days after operation (hydromorphone equivalent use in standard bupivacaine group 11.3 ± 8.9 mg versus 13.3 ± 11.9 mg in liposomal bupivacaine group, p = 0.58 Mann-Whitney test). Small pragmatic trials typically remain underpowered for secondary analyses. A larger study could help to further delineate other outcomes that are impacted by postoperative pain. Liposomal bupivacaine did not change the amount of opioid used postoperatively. Based on our study, liposomal bupivacaine does not provide any added benefit over conventional bupivacaine after colon resection. (ClinicalTrials.gov: NCT02052557).

A Prospective Randomized Study on Operative Treatment for Simple Distal Tibial Fractures-Minimally Invasive Plate Osteosynthesis Versus Minimal Open Reduction and Internal Fixation.

PubMed

Kim, Ji Wan; Kim, Hyun Uk; Oh, Chang-Wug; Kim, Joon-Woo; Park, Ki Chul

2018-01-01

To compare the radiologic and clinical results of minimally invasive plate osteosynthesis (MIPO) and minimal open reduction and internal fixation (ORIF) for simple distal tibial fractures. Randomized prospective study. Three level 1 trauma centers. Fifty-eight patients with simple and distal tibial fractures were randomized into a MIPO group (treatment with MIPO; n = 29) or a minimal group (treatment with minimal ORIF; n = 29). These numbers were designed to define the rate of soft tissue complication; therefore, validation of superiority in union time or determination of differences in rates of delayed union was limited in this study. Simple distal tibial fractures treated with MIPO or minimal ORIF. The clinical outcome measurements included operative time, radiation exposure time, and soft tissue complications. To evaluate a patient's function, the American Orthopedic Foot and Ankle Society ankle score (AOFAS) was used. Radiologic measurements included fracture alignment, delayed union, and union time. All patients acquired bone union without any secondary intervention. The mean union time was 17.4 weeks and 16.3 weeks in the MIPO and minimal groups, respectively. There was 1 case of delayed union and 1 case of superficial infection in each group. The radiation exposure time was shorter in the minimal group than in the MIPO group. Coronal angulation showed a difference between both groups. The American Orthopedic Foot and Ankle Society ankle scores were 86.0 and 86.7 in the MIPO and minimal groups, respectively. Minimal ORIF resulted in similar outcomes, with no increased rate of soft tissue problems compared to MIPO. Both MIPO and minimal ORIF have high union rates and good functional outcomes for simple distal tibial fractures. Minimal ORIF did not result in increased rates of infection and wound dehiscence. Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Effect of Aggregation Operators on Network-Based Disease Gene Prioritization: A Case Study on Blood Disorders.

PubMed

Grewal, Nivit; Singh, Shailendra; Chand, Trilok

2017-01-01

Owing to the innate noise in the biological data sources, a single source or a single measure do not suffice for an effective disease gene prioritization. So, the integration of multiple data sources or aggregation of multiple measures is the need of the hour. The aggregation operators combine multiple related data values to a single value such that the combined value has the effect of all the individual values. In this paper, an attempt has been made for applying the fuzzy aggregation on the network-based disease gene prioritization and investigate its effect under noise conditions. This study has been conducted for a set of 15 blood disorders by fusing four different network measures, computed from the protein interaction network, using a selected set of aggregation operators and ranking the genes on the basis of the aggregated value. The aggregation operator-based rankings have been compared with the "Random walk with restart" gene prioritization method. The impact of noise has also been investigated by adding varying proportions of noise to the seed set. The results reveal that for all the selected blood disorders, the Mean of Maximal operator has relatively outperformed the other aggregation operators for noisy as well as non-noisy data.

The role of family and maternal factors in childhood obesity.

PubMed

Gibson, Lisa Y; Byrne, Susan M; Davis, Elizabeth A; Blair, Eve; Jacoby, Peter; Zubrick, Stephen R

2007-06-04

To investigate the relationship between a child's weight and a broad range of family and maternal factors. Cross-sectional data from a population-based prospective study, collected between January 2004 and December 2005, for 329 children aged 6-13 years (192 healthy weight, 97 overweight and 40 obese) and their mothers (n=265) recruited from a paediatric hospital endocrinology department and eight randomly selected primary schools in Perth, Western Australia. Height, weight and body mass index (BMI) of children and mothers; demographic information; maternal depression, anxiety, stress and self-esteem; general family functioning; parenting style; and negative life events. In a multilevel model, maternal BMI and family structure (single-parent v two-parent families) were the only significant predictors of child BMI z scores. Childhood obesity is not associated with adverse maternal or family characteristics such as maternal depression, negative life events, poor general family functioning or ineffective parenting style. However, having an overweight mother and a single-parent (single-mother) family increases the likelihood of a child being overweight or obese.

PRK and butterfly LASEK: prospective, randomized, contralateral eye comparison of epithelial healing and ocular discomfort.

PubMed

Ghanem, Vinícius C; Souza, Giselle C; Souza, Denise C; Viese, Juliana M Z; Weber, Sarah L P; Kara-José, Newton

2008-06-01

To compare corneal reepithelialization, pain scores, ocular discomfort, and tear production after photorefractive keratectomy (PRK) and butterfly laser epithelial keratomileusis (LASEK). This prospective, randomized, double-masked study comprised 102 eyes of 51 patients who underwent laser refractive surgery. Each patient was randomized to have one eye operated on with PRK and the other with butterfly LASEK. Patients were followed for 1 year. The mean reepithelialization time in the PRK group was 4.35+/-0.48 days (range: 4 to 5 days) and 4.75+/-0.72 days (range: 4 to 6 days) in the butterfly LASEK group (P<.002). Pain scores and ocular discomfort were not statistically different between groups, although a trend towards a lower pain level with PRK was noted (3.31+/-4.09 vs 4.43+/-4.27; P=.18). Schirmer test values were significantly reduced from preoperative levels through 12 months with both PRK (23.6+/-8.1 vs 19.4+/-10.1; P<.002) and butterfly LASEK (22.4+/-8.7 vs 18.9+/-9.7; P=.01); however, no difference between groups was noted at any time. Photorefractive keratectomy showed a modest but statistically significant shorter reepithelialization time and a tendency towards lower pain scores than butterfly LASEK. The reepithelialization time was strongly associated with the duration of surgery in both techniques. A similar reduction of Schirmer test values was observed up to 1 year postoperatively in both groups.

Outcomes assessment in men undergoing open retropubic radical prostatectomy, laparoscopic radical prostatectomy, and robotic-assisted radical prostatectomy.

PubMed

Kowalczyk, Keith J; Yu, Hua-Yin; Ulmer, William; Williams, Stephen B; Hu, Jim C

2012-02-01

To review the various methods of outcomes assessment used for effectiveness studies comparing retropubic radical prostatectomy (RRP), laparoscopic radical prostatectomy (LRP), and robotic-assisted laparoscopic prostatectomy (RALP). A review of the peer reviewed literature was performed for reported series of RRP, LRP, and RALP using Pubmed and MEDLINE with emphasis on comparing perioperative, functional, and oncologic outcomes. Common methods used for outcomes assessment were categorized and compared, highlighting the pros and cons of each approach. The majority of the literature comparing RRP, LRP, and RALP comes in the form of observational data or administrative data from secondary datasets. While randomized controlled trials are ideal for outcomes assessment, only one such study was identified and was limited. Non-randomized observational studies contribute to the majority of data, however are limited due to retrospective study design, lack of consistent endpoints, and limited application to the general community. Administrative data provide accurate assessment of operative outcomes in both academic and community settings, however has limited ability to convey accurate functional outcomes. Non-randomized observational studies and secondary data are useful resources for assessment of outcomes; however, limitations exist for both. Neither is without flaws, and conclusions drawn from either should be viewed with caution. Until standardized prospective comparative analyses of RRP, LRP, and RALP are established, comparative outcomes data will remain imperfect. Urologic researchers must strive to provide the best available outcomes data through accurate prospective data collection and consistent outcomes reporting.

Encoding Sequential Information in Semantic Space Models: Comparing Holographic Reduced Representation and Random Permutation

PubMed Central

Recchia, Gabriel; Sahlgren, Magnus; Kanerva, Pentti; Jones, Michael N.

2015-01-01

Circular convolution and random permutation have each been proposed as neurally plausible binding operators capable of encoding sequential information in semantic memory. We perform several controlled comparisons of circular convolution and random permutation as means of encoding paired associates as well as encoding sequential information. Random permutations outperformed convolution with respect to the number of paired associates that can be reliably stored in a single memory trace. Performance was equal on semantic tasks when using a small corpus, but random permutations were ultimately capable of achieving superior performance due to their higher scalability to large corpora. Finally, “noisy” permutations in which units are mapped to other units arbitrarily (no one-to-one mapping) perform nearly as well as true permutations. These findings increase the neurological plausibility of random permutations and highlight their utility in vector space models of semantics. PMID:25954306

Arithmetic Practice Can Be Modified to Promote Understanding of Mathematical Equivalence

ERIC Educational Resources Information Center

McNeil, Nicole M.; Fyfe, Emily R.; Dunwiddie, April E.

2015-01-01

This experiment tested if a modified version of arithmetic practice facilitates understanding of math equivalence. Children within 2nd-grade classrooms (N = 166) were randomly assigned to practice single-digit addition facts using 1 of 2 workbooks. In the control workbook, problems were presented in the traditional "operations = answer"…

[Injuries after lobectomy: a prospective randomized comparison of video-assisted thoracoscopic surgery and mini-thoracotomy].

PubMed

Long, Hao; Lin, Zhi-chao; Situ, Dong-rong

2008-03-15

To compare the differences of injuries and recovery between video-assisted thoracoscopic surgery (VATS) and mini-thoracotomy (MT) in patients with clinical early stage non-small cell lung cancer (NSCLC) after lobectomy. From March 2004 to December 2006, 47 consecutive patients with early stage NSCLC with a diameter of tumor less than 6 cm were recruited and randomized to VATS group and MT group. Incision length, duration of operation and intraoperative blood loss were recorded. Postoperative pain was assessed using a visual analogue scale before operation and daily for the first 7 days after operation. The serum levels of interleukin-6 (IL-6) and interleukin-10 (IL-10) were measured by cytometric bead array before operation and at 4, 24, and 48 h after operation. Karnofsky performance status (KPS) was assessed before operation and daily for the first 7 days after operation. Incision length was (6.0 +/- 0. 9) cm in the VATS group and (12.5 +/- 1.5) cm in the MT group. There was no significant difference in duration of operation and intraoperative blood loss between the VATS group and the MT group. Postoperative pain was significantly less in the VATS group in the 5th to 7th day postoperatively (P < 0.05). There was no significant difference of serum concentrations of IL-6 and IL-10 between the VATS group and the MT group at 4, 24, and 48 h after operation. KPS score was significantly higher in the VATS group on 2nd to 7th day postoperatively (P < 0.05). Compared with MT, VATS for lobectomy has less postoperative pain, faster recovery, but can't reduce postoperative release of cytokines.

Tumor necrosis factor-α blockade in recurrent and disabling chronic sciatica associated with post-operative peridural lumbar fibrosis: results of a double-blind, placebo randomized controlled study.

PubMed

Nguyen, Christelle; Palazzo, Clémence; Grabar, Sophie; Feydy, Antoine; Sanchez, Katherine; Zee, Nathalie; Quinquis, Laurent; Ben Boutieb, Myriam; Revel, Michel; Lefèvre-Colau, Marie-Martine; Poiraudeau, Serge; Rannou, François

2015-11-19

The aim of this study was to assess the efficacy and safety of tumor necrosis factor (TNF)-α inhibition with infliximab (IFX) in treating recurrent and disabling chronic sciatica pain associated with post-operative peridural lumbar fibrosis. A double-blind, placebo-controlled study randomized 35 patients presenting with sciatica pain associated with post-operative peridural lumbar fibrosis to two groups: IFX (n = 18), a single intravenous injection of 3 mg/kg IFX; and placebo (n = 17), a single saline serum injection. The primary outcome was a 50 % reduction in sciatica pain on a visual analog scale (VAS) at day 10. Secondary outcomes were radicular and lumbar VAS pain at day 0 and radicular and lumbar VAS pain, Québec disability score, drug-sparing effect and tolerance at days 10, 30, 90, and 180. At day 10, the placebo and IFX groups did not differ in the primary outcome (50 % reduction in sciatica pain observed in three (17.6 %) versus five (27.8 %) patients; p = 0.69). The number of patients reaching the patient acceptable symptom state for radicular pain was significantly higher in the placebo than IFX group after injection (12 (70.6 %) versus five (27.8 %) patients; p = 0.01). The two groups were comparable for all other secondary outcomes. Treatment with a single 3 mg/kg IFX injection for post-operative peridural lumbar fibrosis-associated sciatica pain does not significantly reduce radicular symptoms at day 10 after injection. ClinicalTrials.gov NCT00385086 ; registered 4 October 2006 (last updated 15 October 2015).

A randomized controlled trial of electrocoagulation-enabled biopsy versus conventional biopsy in the diagnosis of endobronchial lesions.

PubMed

Khan, Ajmal; Aggarwal, Ashutosh N; Agarwal, Ritesh; Bal, Amanjit; Gupta, Dheeraj

2011-01-01

Although electrocoagulation at time of endobronchial biopsy can potentially reduce procedure-related bleeding during fiberoptic bronchoscopy (FOB), it can also impair quality of tissue specimen; credible data for either are lacking. To evaluate the impact of hot biopsy on the quality of tissue samples and to quantify the amount of procedure-related bleeding during endobronchial biopsy. In this single-center, prospective, single-blind, randomized controlled study we included adult patients referred for FOB and having endobronchial lesions. Patients were randomized to bronchial biopsy using an electrocoagulation-enabled biopsy forceps, with (EC+ group) or without (EC- group) application of electrocoagulation current (40 W for 10 s in a monopolar mode). Procedure-related bleeding was semi-quantified by observer description, as well as through a visual analogue scale. Overall quality of biopsy specimen and tissue damage were assessed and graded by a pulmonary pathologist blinded to FOB details. 160 patients were randomized to endobronchial biopsy with (n = 81) or without (n = 79) the application of electrocoagulation. There were no severe bleeding episodes in either group, and severity of bleeding in the EC+ and EC- groups was similar (median visual analogue scale scores of 14 and 16, respectively). Histopathological diagnosis was similar in the EC+ and EC- groups (77.8% and 82.3%, respectively). There was no significant difference in tissue quality between the two groups. Use of electrocoagulation-enabled endobronchial biopsy does not alter specimen quality and does not result in any significant reduction in procedure-related bleeding. Copyright © 2010 S. Karger AG, Basel.

Damage/fault diagnosis in an operating wind turbine under uncertainty via a vibration response Gaussian mixture random coefficient model based framework

NASA Astrophysics Data System (ADS)

Avendaño-Valencia, Luis David; Fassois, Spilios D.

2017-07-01

The study focuses on vibration response based health monitoring for an operating wind turbine, which features time-dependent dynamics under environmental and operational uncertainty. A Gaussian Mixture Model Random Coefficient (GMM-RC) model based Structural Health Monitoring framework postulated in a companion paper is adopted and assessed. The assessment is based on vibration response signals obtained from a simulated offshore 5 MW wind turbine. The non-stationarity in the vibration signals originates from the continually evolving, due to blade rotation, inertial properties, as well as the wind characteristics, while uncertainty is introduced by random variations of the wind speed within the range of 10-20 m/s. Monte Carlo simulations are performed using six distinct structural states, including the healthy state and five types of damage/fault in the tower, the blades, and the transmission, with each one of them characterized by four distinct levels. Random vibration response modeling and damage diagnosis are illustrated, along with pertinent comparisons with state-of-the-art diagnosis methods. The results demonstrate consistently good performance of the GMM-RC model based framework, offering significant performance improvements over state-of-the-art methods. Most damage types and levels are shown to be properly diagnosed using a single vibration sensor.

Does Pharmacogenomic Testing Improve Clinical Outcomes for Major Depressive Disorder? A Systematic Review of Clinical Trials and Cost-Effectiveness Studies.

PubMed

Rosenblat, Joshua D; Lee, Yena; McIntyre, Roger S

2017-06-01

Pharmacogenomic testing has become scalable and available to the general public. Pharmacogenomics has shown promise for predicting antidepressant response and tolerability in the treatment of major depressive disorder (MDD). In theory, pharmacogenomics can improve clinical outcomes by guiding antidepressant selection and dosing. The current systematic review examines the extant literature to determine the impact of pharmacogenomic testing on clinical outcomes in MDD and assesses its cost-effectiveness. The MEDLINE/PubMed and Google Scholar databases were systematically searched for relevant articles published prior to October 2015. Search terms included various combinations of the following: major depressive disorder (MDD), depression, mental illness, mood disorder, antidepressant, response, remission, outcome, pharmacogenetic, pharmacogenomics, pharmacodynamics, pharmacokinetic, genetic testing, genome wide association study (GWAS), CYP450, personalized medicine, cost-effectiveness, and pharmacoeconomics. Of the 66 records identified from the initial search, relevant clinical studies, written in English, assessing the cost-effectiveness and/or efficacy of pharmacogenomic testing for MDD were included. Each publication was critically examined for relevant data. Two nonrandomized, open-label, 8-week, prospective studies reported overall greater improvement in depressive symptom severity in the group of MDD subjects receiving psychiatric care guided by results of combinatorial pharmacogenomic testing (GeneSight) when compared to the unguided group. One industry-sponsored, randomized, double-blind, 10-week prospective study reported a trend for improved outcomes for the GeneSight-guided group; however, the trend did not reach statistical significance. Another industry-sponsored, randomized, double-blind, 12-week prospective study reported a 2.5-fold increase in remission rates in the CNSDose-guided group (P < .0001). One naturalistic, unblinded, industry-sponsored study showed clinical improvement when pharmacogenomics testing guided prescribing; however, this study lacked a control group. A single cost-effectiveness study concluded that single gene testing was not cost-effective. Conversely, a separate study reported that combinatorial pharmacogenomic testing is cost-effective. A limited number of studies have shown promise for the clinical utility of pharmacogenomic testing; however, cost-effectiveness of pharmacogenomics, as well as demonstration of improved health outcomes, is not yet supported with replicated evidence. © Copyright 2017 Physicians Postgraduate Press, Inc.

Do Arthroscopic Fluid Pumps Display True Surgical Site Pressure During Hip Arthroscopy?

PubMed

Ross, Jeremy A; Marland, Jennifer D; Payne, Brayden; Whiting, Daniel R; West, Hugh S

2018-01-01

To report on the accuracy of 5 commercially available arthroscopic fluid pumps to measure fluid pressure at the surgical site during hip arthroscopy. Patients undergoing hip arthroscopy for femoroacetabular impingement were block randomized to the use of 1 of 5 arthroscopic fluid pumps. A spinal needle inserted into the operative field was used to measure surgical site pressure. Displayed pump pressures and surgical site pressures were recorded at 30-second intervals for the duration of the case. Mean differences between displayed pump pressures and surgical site pressures were obtained for each pump group. Of the 5 pumps studied, 3 (Crossflow, 24K, and Continuous Wave III) reflected the operative field fluid pressure within 11 mm Hg of the pressure readout. In contrast, 2 of the 5 pumps (Double Pump RF and FMS/DUO+) showed a difference of greater than 59 mm Hg between the operative field fluid pressure and the pressure readout. Joint-calibrated pumps more closely reflect true surgical site pressure than gravity-equivalent pumps. With a basic understanding of pump design, either type of pump can be used safely and efficiently. The risk of unfamiliarity with these differences is, on one end, the possibility of pump underperformance and, on the other, potentially dangerously high operating pressures. Level II, prospective block-randomized study. Copyright © 2017. Published by Elsevier Inc.

A Clinical Comparison of Anterior Cervical Plates Versus Stand-Alone Intervertebral Fusion Devices for Single-Level Anterior Cervical Discectomy and Fusion Procedures.

PubMed

Panchal, Ripul R; Kim, Kee D; Eastlack, Robert; Lopez, John; Clavenna, Andrew; Brooks, Daina M; Joshua, Gita

2017-03-01

To compare radiologic and clinical outcomes, including rates of dysphagia and dysphonia, using a no-profile stand-alone intervertebral spacer with integrated screw fixation versus an anterior cervical plate and spacer construct for single-level anterior cervical discectomy and fusion (ACDF) procedures. This multicenter, randomized, prospective study included 54 patients with degenerative disc disease requiring ACDF at a single level at C3-C7. Twenty-six patients underwent single-level ACDF with stand-alone spacers, and 28 with plate fixation and spacers. Analyses were based on comparison of perioperative outcomes, radiologic and clinical metrics, and incidence of dysphagia and/or dysphonia. Mean patient age was 48.8 ± 10.1years (53.7% female). No significant differences were observed between groups in operative time (101.8 ± 34.4 minutes, 114.4 ± 31.5 minutes), estimated blood loss (44.8 ± 76.5 mL, 82.5 ± 195.1 mL), or length of hospital stay (1.2 ± 0.6 days, 1.3 ± 0.6 days). Mean visual analog scale pain scores and Neck Disability Index scores improved significantly from preoperative to last follow-up (10.8 ± 2.6 months) in both groups (P < 0.05). Mean Voice Handicap Index and Eating Assessment Tool scores improved significantly from discharge to last follow-up in both groups (P < 0.05). From discharge to 6 months, the stand-alone spacers group consistently demonstrated greater improvement in Voice Handicap Index. Preoperative intervertebral disc and neuroforaminal heights increased significantly across treatment groups (P < 0.01), and no cases required surgical revision at index or adjacent levels. Anterior cervical discectomy and fusion with stand-alone spacers resulted in similar clinical and radiologic outcomes as compared with plate and spacers and may help minimize postoperative dysphonia. Copyright © 2016 Elsevier Inc. All rights reserved.

Adding left atrial appendage closure to open heart surgery provides protection from ischemic brain injury six years after surgery independently of atrial fibrillation history: the LAACS randomized study.

PubMed

Park-Hansen, Jesper; Holme, Susanne J V; Irmukhamedov, Akhmadjon; Carranza, Christian L; Greve, Anders M; Al-Farra, Gina; Riis, Robert G C; Nilsson, Brian; Clausen, Johan S R; Nørskov, Anne S; Kruuse, Christina R; Rostrup, Egill; Dominguez, Helena

2018-05-23

Open heart surgery is associated with high occurrence of atrial fibrillation (AF), subsequently increasing the risk of post-operative ischemic stroke. Concomitant with open heart surgery, a cardiac ablation procedure is commonly performed in patients with known AF, often followed by left atrial appendage closure with surgery (LAACS). However, the protective effect of LAACS on the risk of cerebral ischemia following cardiac surgery remains controversial. We have studied whether LAACS in addition to open heart surgery protects against post-operative ischemic brain injury regardless of a previous AF diagnosis. One hundred eighty-seven patients scheduled for open heart surgery were enrolled in a prospective, open-label clinical trial and randomized to concomitant LAACS vs. standard care. Randomization was stratified by usage of oral anticoagulation (OAC) planned to last at least 3 months after surgery. The primary endpoint was a composite of post-operative symptomatic ischemic stroke, transient ischemic attack or imaging findings of silent cerebral ischemic (SCI) lesions. During a mean follow-up of 3.7 years, 14 (16%) primary events occurred among patients receiving standard surgery vs. 5 (5%) in the group randomized to additional LAACS (hazard ratio 0.3; 95% CI: 0.1-0.8, p = 0.02). In per protocol analysis (n = 141), 14 (18%) primary events occurred in the control group vs. 4 (6%) in the LAACS group (hazard ratio 0.3; 95% CI: 0.1-1.0, p = 0.05). In a real-world setting, LAACS in addition to elective open-heart surgery was associated with lower risk of post-operative ischemic brain injury. The protective effect was not conditional on AF/OAC status at baseline. LAACS study, clinicaltrials.gov NCT02378116 , March 4th 2015, retrospectively registered.

Randomized prospective study comparing tri-cortical iliac crest autograft to allograft in the lateral column lengthening component for operative correction of adult acquired flatfoot deformity.

PubMed

Dolan, Christopher M; Henning, Jeffrey A; Anderson, John G; Bohay, Donald R; Kornmesser, Marc J; Endres, Terrence J

2007-01-01

Operative treatment of stage II posterior tibial tendon insufficiency (PTTI) is controversial. Many soft-tissue and bony procedures and various combinations of the two have been reported for treatment of stage II PTTI. Orthopaedists recognize the lateral column lengthening component of the procedure as a successful reconstructive technique. The use of cortical allograft for lateral column lengthening in the correction of pes planus in the pediatric patient population has been routine. In the adult population, however, tricortical iliac crest autograft has been the bone graft of choice. Harvest of this autograft can precipitate significant morbidity and cost. Therefore, we undertook this randomized controlled trial to compare graft incorporation and healing of allograft and autograft in the lateral column lengthening component of adult flatfoot reconstruction. Lateral column lengthening was done as a component of operative correction for stage II PTTI in adult patients (older than 18 years) by two surgeons using similar procedures. The patients were randomized to either the allograft or autograft procedures. The primary endpoint was graft incorporation and healing as assessed by radiographs. The study included 33 randomized feet in 31 patients. We followed 18 feet in the allograft group and 15 in the autograft group to the point of union. There were 21 women and 10 men. There were no delayed unions, nonunions, or hardware failures. All patients in both groups achieved bony union by the 12-week followup evaluation. Two superficial foot infections were successfully treated with oral antibiotics. Two patients in the autograft group continued to have hip donor site pain at 3 months. This study suggests that union rates of allograft and autograft (iliac crest bone graft) are equal. The use of allograft in the lateral column lengthening component of operative correction of adult stage II PTTI appears to be a viable alternative to the use of iliac crest autograft and eliminates the morbidity and increased cost associated with autograft harvest.

[Prevention of post-operative pain and haemorrhage in PPH (Procedure for Prolapse and Hemorrhoids) and STARR (Stapled Trans-Anal Rectal Resection). Preliminary results in 261 cases].

PubMed

Mongardini, M; Custureri, F; Schillaci, F; Cola, A; Maturo, A; Fanello, G; Corelli, S; Pappalardo, G

2005-04-01

Intra- and early (first week) post-operative haemorrhages are the most common complications in stapled hemorrhoidectomy PPH (Procedure for Prolapse and Hemorrhoids) and in circumferential resection of the rectal prolapse STARR (Stapled Trans Anal Rectal Resection). Performing PPH and STARR we employed a gelatin based haemostatic sealant with thrombin component (FloSeal) to control intra-operative bleeding and to reduce post-operative bleeding avoiding haemostatic stitches on suture line. We report the preliminary results on 197 PPH and 64 STARR; 44 PPH (22.4%) and 27 STARR (42.2%) were treated by FloSeal. No major post-operative bleeding was observed in all patients treated by FloSeal, compared to 1.3% and 2.7% of hemorrhage respectively in PPH and STARR patients treated without sealant. Post-operative pain was less severe in patients treated by FloSeal, without a difference statistically significant. The data are preliminary and must be confirmed in prospective randomized trials in larger series.

Impaired laparoscopic performance of novice surgeons due to phone call distraction: a single-centre, prospective study.

PubMed

Yang, Cui; Heinze, Julia; Helmert, Jens; Weitz, Juergen; Reissfelder, Christoph; Mees, Soeren Torge

2017-12-01

Distractions such as phone calls during laparoscopic surgery play an important role in many operating rooms. The aim of this single-centre, prospective study was to assess if laparoscopic performance is impaired by intraoperative phone calls in novice surgeons. From October 2015 to June 2016, 30 novice surgeons (medical students) underwent a laparoscopic surgery training curriculum including two validated tasks (peg transfer, precision cutting) until achieving a defined level of proficiency. For testing, participants were required to perform these tasks under three conditions: no distraction (control) and two standardised distractions in terms of phone calls requiring response (mild and strong distraction). Task performance was evaluated by analysing time and accuracy of the tasks and response of the phone call. In peg transfer (easy task), mild distraction did not worsen the performance significantly, while strong distraction was linked to error and inefficiency with significantly deteriorated performance (P < 0.05). Precision cutting (difficult task) was not slowed down by mild distraction, but surgical and cognitive errors were significantly increased when participants were distracted (P < 0.05). Compared to mild distraction, participants reported a more severe subjective disturbance when they were diverted by strong distraction (P < 0.05). Our data reveals that phone call distractions result in impaired laparoscopic performance under certain circumstances. To ensure patient safety, phone calls should be avoided as far as possible in operating rooms.

Semi-quantum Dialogue Based on Single Photons

NASA Astrophysics Data System (ADS)

Ye, Tian-Yu; Ye, Chong-Qiang

2018-02-01

In this paper, we propose two semi-quantum dialogue (SQD) protocols by using single photons as the quantum carriers, where one requires the classical party to possess the measurement capability and the other does not have this requirement. The security toward active attacks from an outside Eve in the first SQD protocol is guaranteed by the complete robustness of present semi-quantum key distribution (SQKD) protocols, the classical one-time pad encryption, the classical party's randomization operation and the decoy photon technology. The information leakage problem of the first SQD protocol is overcome by the classical party' classical basis measurements on the single photons carrying messages which makes him share their initial states with the quantum party. The security toward active attacks from Eve in the second SQD protocol is guaranteed by the classical party's randomization operation, the complete robustness of present SQKD protocol and the classical one-time pad encryption. The information leakage problem of the second SQD protocol is overcome by the quantum party' classical basis measurements on each two adjacent single photons carrying messages which makes her share their initial states with the classical party. Compared with the traditional information leakage resistant QD protocols, the advantage of the proposed SQD protocols lies in that they only require one party to have quantum capabilities. Compared with the existing SQD protocol, the advantage of the proposed SQD protocols lies in that they only employ single photons rather than two-photon entangled states as the quantum carriers. The proposed SQD protocols can be implemented with present quantum technologies.

Prospective, randomized, controlled comparison of SYSTANE UD eye drops versus VISINE INTENSIV 1% EDO eye drops for the treatment of moderate dry eye.

PubMed

Jacobi, Christina; Kruse, Friedrich E; Cursiefen, Claus

2012-12-01

The aim of this prospective, randomized, clinical, single-center study was to compare the safety and efficacy of 2 ocular surface lubricant eye drops: preservative-free hydroxypropyl (HP)-Guar (SYSTANE UD(®)) eye drops versus preservative-free Tamarindus indica seed polysaccharide (TSP) 1% (VISINE INTENSIV 1% EDO(®)) eye drops. Fifty-six eyes of 28 patients with moderate keratoconjunctivitis sicca (DEWS severity level 2) were enrolled in the trial. Patients were randomized for 2 treatment groups (SYSTANE UD eye drops vs. VISINE INTENSIV 1% EDO eye drops). The eye drops in both groups were applied 5 times per day for 3 months. Statistical analyses were performed using Statistica™ software (Mann-Whitney U-test and Wilcoxon test). P-Values<0.05 were considered significant. After 3 months of treatment the patients of both groups had subjective benefit in the relief of symptoms of dry eye disease evaluated by the Ocular Surface Disease Index (OSDI) questionnaire score. Patients treated with HP-Guar and TSP showed improvements in tear film stability measured by tear break-up time (TBUT), which are statistically significant in the HP-Guar group (P=0.02). The results of this clinical trial show improvements of symptoms and signs in patients with moderate dry eye after the consistent use of preservative-free HP-Guar and TSP lubricant eye drops. Both artificial tear formulations produce amelioration in tear film stability improving eye conditions and patient quality of life. HP-Guar seems to be slightly more effective in improving ocular surface protection by decreasing tear film evaporation.

Prospective randomized clinical trial comparing laparoscopic cholecystectomy and hybrid natural orifice transluminal endoscopic surgery (NOTES) (NCT00835250).

PubMed

Noguera, José F; Cuadrado, Angel; Dolz, Carlos; Olea, José M; García, Juan C

2012-12-01

Natural orifice transluminal endoscopic surgery (NOTES) is a technique still in experimental development whose safety and effectiveness call for assessment through clinical trials. In this paper we present a three-arm, noninferiority, prospective randomized clinical trial of 1 year duration comparing the vaginal and transumbilical approaches for transluminal endoscopic surgery with the conventional laparoscopic approach for elective cholecystectomy. Sixty female patients between the ages of 18 and 65 years who were eligible for elective cholecystectomy were randomized in a ratio of 1:1:1 to receive hybrid transvaginal NOTES (TV group), hybrid transumbilical NOTES (TU group) or conventional laparoscopy (CL group). The main study variable was parietal complications (wound infection, bleeding, and eventration). The analysis was by intention to treat, and losses were not replaced. Cholecystectomy was successfully performed on 94% of the patients. One patient in the TU group was reconverted to CL owing to difficulty in maneuvering the endoscope. After a minimum follow-up period of 1 year, no differences were noted in the rate of parietal complications. Postoperative pain, length of hospital stay, and time off from work were similar in the three groups. No patient developed dyspareunia. Surgical time was longer among cases in which a flexible endoscope was used (CL, 47.04 min; TV, 64.85 min; TU, 59.80 min). NOTES approaches using the flexible endoscope are not inferior in safety or effectiveness to conventional laparoscopy. The transumbilical approach with flexible endoscope is as effective and safe as the transvaginal approach and is a promising, single-incision approach.

Investigating the Quality of Service of Current and Future Tactical Information Exchanges - Net Warrior

DTIC Science & Technology

2010-05-01

as Link-11, Link-16 and VMF. It also includes future systems such as Link-22 (using the typical HF & UHF frequency bands) and technologies that...triangulate and find the precise geolocation of the enemy target. If the target happens to relocate, TTNT is able to update the target with high accuracy...22 operates in either the HF or UHF frequency bands. In each of these frequency bands the system can operate on a single frequency or a pseudo-random

Threshold quantum state sharing based on entanglement swapping

NASA Astrophysics Data System (ADS)

Qin, Huawang; Tso, Raylin

2018-06-01

A threshold quantum state sharing scheme is proposed. The dealer uses the quantum-controlled-not operations to expand the d-dimensional quantum state and then uses the entanglement swapping to distribute the state to a random subset of participants. The participants use the single-particle measurements and unitary operations to recover the initial quantum state. In our scheme, the dealer can share different quantum states among different subsets of participants simultaneously. So the scheme will be very flexible in practice.

Selective reminding of prospective memory in Multiple Sclerosis.

PubMed

McKeever, Joshua D; Schultheis, Maria T; Sim, Tiffanie; Goykhman, Jessica; Patrick, Kristina; Ehde, Dawn M; Woods, Steven Paul

2017-04-19

Multiple sclerosis (MS) is associated with prospective memory (PM) deficits, which may increase the risk of poor functional/health outcomes such as medication non-adherence. This study examined the potential benefits of selective reminding to enhance PM functioning in persons with MS. Twenty-one participants with MS and 22 healthy adults (HA) underwent a neuropsychological battery including a Selective Reminding PM (SRPM) experimental procedure. Participants were randomly assigned to either: (1) a selective reminding condition in which participants learn (to criterion) eight prospective memory tasks in a Selective Reminding format; or (2) a single trial encoding condition (1T). A significant interaction was demonstrated, with MS participants receiving greater benefit than HAs from the SR procedure in terms of PM performance. Across diagnostic groups, participants in the SR conditions (vs. 1T conditions) demonstrated significantly better PM performance. Individuals with MS were impaired relative to HAs in the 1T condition, but performance was statistically comparable in the SR condition. This preliminary study suggests that selective reminding can be used to enhance PM cue detection and retrieval in MS. The extent to which selective reminding of PM is effective in naturalistic settings and for health-related behaviours in MS remains to be determined.

Use of a transanal drainage tube for prevention of anastomotic leakage and bleeding after anterior resection for rectal cancer.

PubMed

Zhao, Wen-Tao; Hu, Feng-Liang; Li, Yu-Ying; Li, Hong-Jie; Luo, Wei-Ming; Sun, Feng

2013-01-01

The aim of the present study was to investigate the usefulness of the transanal drainage tube for prevention of anastomotic leakage and bleeding after anterior resection for rectal cancer. Between January 2007 and May 2011 a nonrandomized prospective study of patients undergoing anterior resection for rectal cancer was done. The patients were divided into the transanal drainage tube (TDT) and non-transanal drainage tube (NTDT) groups according to whether the transanal drainage tube was used in the operation. Clinical characteristics and postoperative complications were compared between the TDT and NTDT groups. The study included 81 patients in the TDT group and 77 patients in the NTDT group. In the TDT group, anastomotic leakage occurred in 2 patients and no anastomotic bleeding occurred. In the NTDT group, anastomotic leakage occurred in 7 patients and anastomotic bleeding occurred in 2 patients. The TDT group had significantly fewer anastomotic complications compared with the NTDT group (2.5 vs 11.7 %; P = 0.029). Furthermore, the TDT group showed an obvious reduction in the rate of anastomotic leakage and anastomotic bleeding compared with the NTDT group (2.5 vs 7.8 % and 0.0 vs 2.6 %), but because the number of cases is relatively small, the difference did not reach statistical significance (P = 0.160 and P = 0.236). The use of a transanal drainage tube in anterior resection for rectal cancer may be a simple, safe, and effective means of preventing or reducing the occurrence of anastomotic leakage and bleeding. A larger-scale single or multi-center prospective randomized study or a meta-analysis including similar studies is necessary for further elucidation of this issue.

Simple Circumcision Device: Proof-of-Concept for a Single-visit, Adjustable Device to Facilitate Safe Adult Male Circumcision

PubMed Central

Hotaling, James M; Leddy, Laura S; Haider, Mahum A; Mossanen, Matthew; Bailey, Michael R; MacConaghy, Brian; Olson, Francis; Krieger, John N

2014-01-01

Objective To conduct a proof-of-concept study to determine the potential utility of a novel, adjustable single-visit, disposable device to facilitate rapid adult circumcision. Design Prospective pilot trial of a novel surgical device Setting Tertiary care Veterans Administration medical center Patients 5 adult males Interventions Circumcisions performed by junior trainees using an adjustable, single-size surgical-assist device constructed by the University of Washington Applied Physics Laboratory. Main Outcome Measure(s) The attending surgeon and trainees completed standardized forms after each procedure to assess technical problems and ease of use. Follow-up visits were scheduled to evaluate adverse events, post-operative pain, cosmetic outcomes and participant satisfaction at 3, 8, 30 and 90 days post-operatively. Results The average operative time was 16.4 minutes. All cases were performed with local anesthesia and no case required electrocautery or conversion to standard surgery. At the post-operative day 3 visit all subjects were happy with their results and would recommend the procedure to another patient. One participant had a minor wound separation noted at the 30-day visit that resolved during follow-up. There were no wound infections, hematomas or other adverse events. Conclusions This proof-of-study suggests that the Simple Circumcision Device (SCD) may facilitate delivery of safe adult male circumcision services. PMID:24613534

Design and patient characteristics of ESHOL study, a Catalonian prospective randomized study.

PubMed

Maduell, Francisco; Moreso, Francesc; Pons, Mercedes; Ramos, Rosa; Mora-Macià, Josep; Foraster, Andreu; Soler, Jordi; Galceran, Josep M; Martinez-Castelao, Alberto

2011-01-01

Retrospective studies showed that online hemodiafiltration (OL-HDF) is associated with a risk reduction of mortality over standard hemodialysis (HD) in patients with end-stage renal disease. Until now, no information was available from prospective randomized clinical trials. A prospective, randomized, multicenter, open study was designed to be conducted in HD units from Catalonia (Spain). The aim of the study is to compare 3-year survival in prevalent end-stage renal disease patients randomized to OL-HDF or to continue on standard HD. The minimum sample size was calculated according to Catalonian mortality of patients on dialysis and assuming a risk reduction associated with OL-HDF of 35% (1-sided p<0.05 and a statistical power of 0.8) and a rate of dropout due to renal transplantation or loss to follow-up of 30%. From May 2007 to September 2008, 906 patients were included and randomized to OL-HDF (n=456) or standard HD (n=450). Demographics and analytical data at the time of randomization were not different between both groups of patients. Patients will be followed during a 3-year period. The present study will contribute to evaluating the benefit for patient survival of OL-HDF over standard HD.

Comparison of lignocaine gel-soaked Falope rings vs rectal diclofenac suppository for pain relief in laparoscopic sterilization.

PubMed

Sharma, Jai Bhagwan; Ghosh, Bhaswati; Kumar, Praveen; Mittal, Suneeta; Kumar, Sunesh; Roy, Kallol Kumar

2011-01-01

To compare the analgesic efficacy of lignocaine gel-soaked Silastic bands compared with rectal diclofenac suppositories in patients undergoing interval laparoscopic sterilization under conscious sedation. Prospective, randomized, controlled, single-blinded, clinical trial. Day-case center in a tertiary care hospital in India. Ninety-six women undergoing interval laparoscopic sterilization using Silastic bands (Yoon rings) randomly allocated by computer-generated random numbers into 3 groups. All women received intravenous sedation with injection diazepam and pentazocine along with local infiltration lignocaine injected at the site of the incision meant for insertion of the single site laparocator. In group 1 (n = 32), the Silastic bands (Falope rings) were presoaked in 2% sterile lignocaine gel; in group 2 (n = 32), women received a 100-mg rectal diclofenac suppository while on the operating table; and women in group 3 received only conventional analgesic. Pain perception was assessed using an 11-point visual analog score just after the procedure while still on the table (zero minutes), at 30 minutes and 1 hour after the procedure, and at discharge. The women in all 3 groups were comparable insofar as age and parity. At zero minutes (while on the operating table), the pain score in all 3 groups was similar. However, the pain scores at 30 and 60 minutes, and at discharge were significantly lower in groups 1 and group 2 compared with group 3. However, 2 women (6.25%) in group 2 and 6 (18.75%) in group 3 required supplemental analgesia within 1 hour, and were administered a 500-mg oral dose of mefenamic acid. The need for further analgesia was significantly lower in groups 1 and 2 compared with group 3 (p = .02). Comparison of groups 1 and 3 revealed that in group 1, the pain scores were significantly lower at 30 minutes (p = .02), 1 hour (p = .005), and at discharge (p = .004). No patients in group 1 requested analgesia, whereas 6 women in group 3 asked for further analgesia within an hour postoperatively (p = .01). Similarly in groups 2 and 3, women who received diclofenac suppositories had significantly lower pain scores at the specified intervals (p = 0.02, 0.002, and 0.02, respectively). Application of lignocaine gel to Falope rings and preoperative insertion of a rectal diclofenac suppository are simple and effective measures for pain control in the early postoperative period in patients undergoing day-case laparoscopic sterilization under conscious sedation. Either method could be incorporated into routine practice, depending on patient and physician choice. Copyright © 2010 AAGL. Published by Elsevier Inc. All rights reserved.

[The randomized study of efficiency of preoperative photodynamic].

PubMed

Akopov, A L; Rusanov, A A; Molodtsova, V P; Gerasin, A V; Kazakov, N V; Urtenova, M A; Chistiakov, I V

2013-01-01

The authors made a prospective randomized comparison of results of preoperative photodynamic therapy (PhT) with chemotherapy, preoperative chemotherapy in initial unresectable central non-small cell lung cancer in stage III. The efficiency and safety of preoperative therapy were estimated as well as the possibility of subsequent surgical treatment. The research included patients in stage IIIA and IIIB of central non-small cell lung cancer with lesions of primary bronchi and lower section of the trachea, which initially were unresectable, but potentially the patients could be operated on after preoperative treatment. The photodynamic therapy was performed using chlorine E6 and the light of wave length 662 nm. Since January 2008 till December 2011,42 patients were included in the research, 21 patients were randomized in the group for photodynamic therapy and 21--in group without PhT. These groups were compared according to their sex, age, stage of the disease and histological findings. After nonadjuvant treatment the remissions were reached in 19 (90%) patients of the group with PhT and in 16 (76%) patients without PhT and all the patients were operated on. The explorative operations were made on 3 patients out of 16 operated on in the group without PhT (19%). In the group PhT 14 pneumonectomies and 5 lobectomies were perfomed opposite 10 pneumonectomies and 3 lobectomies in group without PhT. The degree of radicalism of resection appears to be reliably higher in the group PhT (RO-89%, R1-11% as against RO-54%, R1-46% in group without PhT), p = 0.038. The preoperative endobronchial PhT conducted with chemotherapy was characterized by efficiency and safety, allowed the surgical treatment and elevated the degree of radicalism of this treatment in selected patients, initially assessed as unresectable.

Randomized trial for superiority of high field strength intra-operative magnetic resonance imaging guided resection in pituitary surgery.

PubMed

Tandon, Vivek; Raheja, Amol; Suri, Ashish; Chandra, P Sarat; Kale, Shashank S; Kumar, Rajinder; Garg, Ajay; Kalaivani, Mani; Pandey, Ravindra M; Sharma, Bhawani S

2017-03-01

Till date there are no randomized trials to suggest the superiority of intra-operative magnetic resonance imaging (IOMRI) guided trans-sphenoidal pituitary resection over two dimensional fluoroscopic (2D-F) guided resections. We conducted this trial to establish the superiority of IOMRI in pituitary surgery. Primary objective was to compare extent of tumor resection between the two study arms. It was a prospective, randomized, outcome assessor and statistician blinded, two arm (A: IOMRI, n=25 and B: 2D-F, n=25), parallel group clinical trial. 4 patients from IOMRI group cross-over to 2D-F group and were consequently analyzed in latter group, based on modified intent to treat method. A total of 50 patients were enrolled till completion of trial (n=25 in each study arm). Demographic profile and baseline parameters were comparable among the two arms (p>0.05) except for higher number of endoscopic procedures and experienced neurosurgeons (>10years) in arm B (p=0.02, 0.002 respectively). Extent of resection was similar in both study arms (A, 94.9% vs B, 93.6%; p=0.78), despite adjusting for experience of operating surgeon and use of microscope/endoscope for surgical resection. We observed that use of IOMRI helped optimize the extent of resection in 5/20 patients (25%) for pituitary tumor resection in-group A. Present study failed to observe superiorty of IOMRI over conventional 2D-F guided resection in pituitary macroadenoma surgery. By use of this technology, younger surgeons could validate their results intra-operatively and hence could increase EOR without causing any increase in complications. Copyright © 2016 Elsevier Ltd. All rights reserved.

Effects of preoperative aspirin on perioperative platelet activation and dysfunction in patients undergoing off-pump coronary artery bypass graft surgery: A prospective randomized study.

PubMed

Lee, Jiwon; Jung, Chul-Woo; Jeon, Yunseok; Kim, Tae Kyong; Cho, Youn Joung; Koo, Chang-Hoon; Choi, Yoon Hyeong; Kim, Ki-Bong; Hwang, Ho Young; Kim, Hang-Rae; Park, Ji-Young

2017-01-01

The benefit of aspirin use after coronary artery bypass graft surgery has been well proven. However, the effect of preoperative aspirin use in patients undergoing off-pump coronary artery bypass graft surgery (OPCAB) has not been evaluated sufficiently. To evaluate platelet function changes during OPCAB due to preoperative aspirin use, we conducted a randomized controlled trial using flow cytometry and the Multiplate® analyzer. Forty-eight patients scheduled for elective OPCAB were randomized to the aspirin continuation (100 mg/day until operative day) and discontinuation (4 days before the operative day) groups. Platelet function was measured using the platelet activation markers CD62P, CD63, and PAC-1 by flow cytometry, and platelet aggregation was measured using the Multiplate® analyzer, after the induction of anesthesia (baseline), at the end of the operation, and 24 and 48 h postoperatively. Findings of conventional coagulation assays, thromboelastography by ROTEM® assays, and postoperative bleeding-related clinical outcomes were compared between groups. No significant change in CD62P, CD63, or PAC-1 was observed at the end of the operation or 24 or 48 h postoperatively compared with baseline in either group. The area under the curve for arachidonic acid-stimulated platelet aggregation, measured by the Multiplate® analyzer, was significantly smaller in the aspirin continuation group (P < 0.01). However, chest tube drainage and intraoperative and postoperative transfusion requirements did not differ between groups. Our study showed that preoperative use of aspirin for OPCAB did not affect perioperative platelet activation, but it impaired platelet aggregation, which did not affect postoperative bleeding, by arachidonic acid.

Effects of a laboratory-based skills curriculum on laparoscopic proficiency: a randomized trial.

PubMed

Coleman, Robert L; Muller, Carolyn Y

2002-04-01

The purpose of this study was to determine the effect and validity of an intensive laboratory-based laparoscopic skills training curriculum on operative proficiency in obstetrics and gynecology residents. This was a prospective, randomized, block-design trial of postgraduate year 3 and 4 residents. The following study schedule was used: week 1 (pre-randomization) included an orientation to study objectives, the administration of a laparoscopic experience questionnaire, timed video-laparoscopic drills (5 total), and the performance of a video-recorded laparoscopic partial salpingectomy; during weeks 2 and 3, the skills group residents repeated the laparoscopic drills 30 minutes daily for 10 days, and the control group residents had no formal practice sessions; during week 4, the week 1 evaluation was repeated. Operative proficiency was quantified by the Global Skills Assessment Tool through blinded, independent scoring of videotapes. Twenty-six residents (skills group, 12; control group, 14) consented to the trial. Patient-related issues excluded 8 residents (30%). At week 1, no significant differences existed in previous laparoscopic experience, timed video skills, or resident operative proficiency (Global Skills Assessment Tool score) between cohorts. At week 4, both groups significantly improved their timed drill test scores. The percent reduction in time from baseline was of greater magnitude in the skills group versus control group (51% vs 18%,P <.0001). Laparoscopic performance also improved in both cohorts (P =.002). However, only the skills group demonstrated significant intra-cohort improvement from baseline (mean, 4.9 points; P =.015; 95% CI, 1-7.5). A core curriculum of intensive video laparoscopic skills training improves not only technical but also operative performance among postgraduate year 3 and 4 residents.

Pain management after laparoscopic cholecystectomy-a randomized prospective trial of low pressure and standard pressure pneumoperitoneum.

PubMed

Singla, Sanjeev; Mittal, Geeta; Raghav; Mittal, Rajinder K

2014-02-01

Abdominal pain and shoulder tip pain after laparoscopic cholecystectomy are distressing for the patient. Various causes of this pain are peritoneal stretching and diaphragmatic irritation by high intra-abdominal pressure caused by pneumoperitoneum . We designed a study to compare the post operative pain after laparoscopic cholecystectomy at low pressure (7-8 mm of Hg) and standard pressure technique (12-14 mm of Hg). Aim : To compare the effect of low pressure and standard pressure pneumoperitoneum in post laparoscopic cholecystectomy pain . Further to study the safety of low pressure pneumoperitoneum in laparoscopic cholecystectomy. A prospective randomised double blind study. A prospective randomised double blind study was done in 100 ASA grade I & II patients. They were divided into two groups -50 each. Group A patients underwent laparoscopic cholecystectomy with low pressure pneumoperitoneum (7-8 mm Hg) while group B underwent laparoscopic cholecystectomy with standard pressure pneumoperitoneum (12-13 mm Hg). Both the groups were compared for pain intensity, analgesic requirement and complications. Demographic data and intraoperative complications were analysed using chi-square test. Frequency of pain, intensity of pain and analgesics consumption was compared by applying ANOVA test. Post-operative pain score was significantly less in low pressure group as compared to standard pressure group. Number of patients requiring rescue analgesic doses was more in standard pressure group . This was statistically significant. Also total analgesic consumption was more in standard pressure group. There was no difference in intraoperative complications. This study demonstrates the use of simple expedient of reducing the pressure of pneumoperitoneum to 8 mm results in reduction in both intensity and frequency of post-operative pain and hence early recovery and better outcome.This study also shows that low pressure technique is safe with comparable rate of intraoperative complications.

Addition of Lubiprostone to polyethylene glycol(PEG) enhances the quality & efficacy of colonoscopy preparation: a randomized, double-blind, placebo controlled trial.

PubMed

Banerjee, Rupa; Chaudhari, Hrushikesh; Shah, Nirish; Saravanan, Arjunan; Tandan, Manu; Reddy, D Nageshwar

2016-10-13

Adequate bowel preparation is an essential prerequisite for complete mucosal visualization during colonoscopy. Polyethylene glycol (PEG) solutions are commonly used. However the large volume of the solution is often poorly tolerated. Addition of Lubiprostone (LB) could improve the adequacy of standard PEG preparation & reduce requirement. The aims to assess adequacy of PEG preparation with addition of single dose LB (24mcg) vs placebo and efficacy of reduced dose PEG + LB compared with full dose PEG + LB. Single center prospective double blind randomized controlled trial. Part I: 442 patients for colonoscopy randomized to receive placebo (GrA) or single dose of LB (GrB) prior to PEG preparation. Quality of bowel preparation graded 0-9 according to Boston Bowel Preparation Scale (BBPS). BBPS-9: excellent and BBPS 0-4: repeat procedure. Part II: 146 patients randomized to receive LB + 1.5 L PEG (GrC; 75) or LB + 1 L PEG (GrD; 71). BBPS score compared with GrB (2 L PEG). Part I: 442 patients (221 GrA & 221 Gr B). LB resulted in significant improvement in total BBPS (7.44 + 0.14 vs. 6.36 + 0.16, p < 0.0001). 66.5 % Gr B vs 38 % Gr A had excellent prep; 42.5 % GrB vs 24 % GrA had adequate prep. Repeat procedure needed 9.5 % Gr B vs 16.7 % Gr A (P < 0.01). Part II: No difference in BBPS scores with lower doses (Gr C&D) compared to standard (GrB) (Mean BBPS 7.44 + 0.14 GrA,7.30 + 0.25 GrC;7.25 + 0.26 GrD;p >0.05). Single dose LB prior to PEG significantly enhanced bowel preparation compared to PEG alone. There was no significant difference in quality of preparation with lower doses of PEG when combined with LB. The study protocol was approved by institutional review board and the trial was registered on March 22, 2011 with clinicaltrials.gov ( NCT01324284 ).

Evaluation of the effects of fulvestrant and micronized progesterone on the post-operative adhesion formation and ovarian reserve in rat model with immunohistochemical and biochemical analysis.

PubMed

Oner, Gokalp; Ulug, Pasa; Demirci, Elif; Kumtepe, Yakup; Gündogdu, Cemal

2015-01-01

To evaluate the effects of fulvestrant and micronized progesterone on post-operative adhesion formation and ovarian reserve in a rat uterine horn adhesion. In this prospective randomized controlled trial, 32 female Wistar albino rats were randomly divided into four groups including control group (Group 1), the control adhesion group (Group 2), 1 mg/kg daily intramuscular fulvestrant received group (Group 3) and 1 mg/kg daily oral micronized progesterone received group (Group 4). The extent and severity of adhesions were scored and samples were taken from adhesion areas to investigate the grades of adhesions according to the immunohistochemical scoring system. Ovarian reserves were measured with anti-Müllerian hormone (AMH) and histological ovarian follicles count. The extent, severity and total adhesion scores were reduced in all treatment groups compared to control adhesion group (Group 2). Similarly, immunohistochemical adhesion scores were lower in the treatment groups. AMH and follicle count were significantly found lower in adhesion groups compared with control group. However, treatment groups were found to have higher ovarian reserve compared to control adhesion group (Group 2). Fulvestrant and micronized progesterone were found to reduce post-operative adhesion formations and have decreased detrimental effects of adhesion formation on ovarian reserve.

Single-dose intra-articular bupivacaine plus morphine versus bupivacaine alone after arthroscopic knee surgery: a meta-analysis of randomized controlled trials.

PubMed

Yang, Ye; Zeng, Chao; Wei, Jie; Li, Hui; Yang, Tuo; Deng, Zhen-Han; Li, Yu-Sheng; Yang, Tu-Bao; Lei, Guang-Hua

2017-03-01

The purpose of this meta-analysis was to compare the efficacy and safety of single-dose intra-articular bupivacaine plus morphine versus bupivacaine alone for pain management following arthroscopic knee surgery. A comprehensive literature search was conducted to identify randomized controlled trials that used single-dose intra-articular bupivacaine plus morphine and bupivacaine alone for post-operative pain, using MEDLINE (1966-2014), Cochrane Library and EMBASE databases. The weighted mean difference (WMD), relative risk (RR) and their corresponding 95 % confidence intervals (CIs) were calculated using RevMan statistical software. A total of twenty-nine trials (n = 1167) were included. The post-operative visual analog scale (VAS) pain score of the bupivacaine plus morphine group compared with the bupivacaine alone group was significantly lower (WMD -1.15, 95 % CI -1.67 to -0.63, p < 0.0001). As far as safety, there was no significant difference in side effects between the two groups (RR 1.10, 95 % CI 0.59-2.04, n.s.). Sensitivity analyses suggested that the results of these two primary outcomes were stable and reliable. However, the current evidence did not suggest a superior effect with respect to the time to first analgesic request (WMD 51.33, 95 % CI -110.99 to 213.65, n.s.) and the number of patients requiring supplementary analgesia (RR 1.13, 95 % CI 0.92-1.39, n.s.). On the basis of the currently available literature, this study is the first to suggest that single-dose intra-articular bupivacaine plus morphine was shown to be significantly better than bupivacaine alone at relieving post-operative pain after arthroscopic knee surgery without increasing the short-term side effects. Routine use of single-dose intra-articular bupivacaine plus morphine is an effective way for pain management after arthroscopic knee surgery. II.

Intrathecal versus IV fentanyl in pediatric cardiac anesthesia.

PubMed

Pirat, Arash; Akpek, Elif; Arslan, Gülnaz

2002-11-01

Systemic large-dose opioids are widely used in pediatric cardiac anesthesia, but there are no randomized, prospective studies regarding the use of intrathecal (IT) opioids for these procedures. In this randomized, prospective study, we compared cardiovascular and neurohumoral responses during IT or IV fentanyl anesthesia for pediatric cardiac surgery. Thirty children aged 6 mo to 6 yr were anesthetized with an IV fentanyl bolus of 10 micro g/kg. This was followed by a fentanyl infusion of 10 micro g. kg(-1). h(-1) (Group IV; n = 10), 2 micro g/kg of IT fentanyl (Group IT; n = 10), or combined IV and IT protocols (Group IV + IT; n = 10). Heart rate, mean arterial blood pressure, additional fentanyl doses, time to first analgesic requirement, COMFORT and Children's Hospital of Eastern Ontario Pain Scale scores, and extubation time were recorded. Blood cortisol, insulin, glucose, and lactate levels were measured presurgery, poststernotomy, during the rewarming phase of cardiopulmonary bypass (CPB), and 6 and 24 h after surgery. The patients' urinary cortisol excretion rates were also measured during the first postoperative day. The findings in all three groups were statistically similar, except for higher blood glucose levels during CPB in Group IT compared with Group IV (P < 0.004). Group IV + IT was the only group in which the increases in heart rate and mean arterial blood pressure from presurgery to poststernotomy were not significant. The 24-h urinary cortisol excretion rates ( micro g. kg(-1). d(-1)) were 61.51 +/- 39, 92.54 +/- 67.55, and 40.15 +/- 29.69 for Groups IV, IT, and IV + IT, respectively (P > 0.05). A single IT injection of fentanyl 2 micro g/kg offers no advantage over systemic fentanyl (10 micro g/kg bolus and 10 micro g. kg(-1). h(-1)) with regard to hemodynamic stability or suppression of stress response. The combination of these two regimens may provide better hemodynamic stability during the pre-CPB period and may be associated with a decreased 24-h urinary cortisol excretion rate. In this prospective, randomized study, we investigated the adequacy of a single intrathecal injection of fentanyl for intraoperative analgesia, compared the effects of IT and IV fentanyl on stress response, and assessed for an additive effect of IT and IV fentanyl administration in pediatric cardiac anesthesia. The results with these three different anesthetic regimens were similar regarding anesthesia depth and level of stress response. However, the combination of IT and IV routes may provide better hemodynamic stability and a less pronounced stress response, as reflected by 24-h urinary cortisol excretion.

Resonantly driven CNOT gate for electron spins.

PubMed

Zajac, D M; Sigillito, A J; Russ, M; Borjans, F; Taylor, J M; Burkard, G; Petta, J R

2018-01-26

Single-qubit rotations and two-qubit CNOT operations are crucial ingredients for universal quantum computing. Although high-fidelity single-qubit operations have been achieved using the electron spin degree of freedom, realizing a robust CNOT gate has been challenging because of rapid nuclear spin dephasing and charge noise. We demonstrate an efficient resonantly driven CNOT gate for electron spins in silicon. Our platform achieves single-qubit rotations with fidelities greater than 99%, as verified by randomized benchmarking. Gate control of the exchange coupling allows a quantum CNOT gate to be implemented with resonant driving in ~200 nanoseconds. We used the CNOT gate to generate a Bell state with 78% fidelity (corrected for errors in state preparation and measurement). Our quantum dot device architecture enables multi-qubit algorithms in silicon. Copyright © 2018, The Authors, some rights reserved; exclusive licensee American Association for the Advancement of Science. No claim to original U.S. Government Works.

A prospective, multicenter pilot study to investigate the feasibility and safety of a 1-year controlled exercise training after adjuvant chemotherapy in colorectal cancer patients.

PubMed

Piringer, Gudrun; Fridrik, Michael; Fridrik, Alfred; Leiherer, Andreas; Zabernigg, August; Greil, Richard; Eisterer, Wolfgang; Tschmelitsch, Jörg; Lang, Alois; Frantal, Sophie; Burgstaller, Sonja; Gnant, Michael; Thaler, Josef

2018-04-01

Despite advances in adjuvant chemotherapy, 20-30% of patients in stages II-III colorectal cancer will eventually relapse. Observational studies showed a reduction in relapse rate, colon cancer-specific mortality, and overall mortality by physical activity. Results from prospective randomized interventional studies to confirm these observational data are lacking. The aims of this prospective single-arm multicenter pilot study are to evaluate feasibility and safety of exercise training after adjuvant chemotherapy in colorectal cancer patients. The training was performed three times per week for 1 year and was increased gradually in three phases until reaching 18 metabolic equivalent task hours per week. Overall, 30 patients were included. The planned training intensity could be achieved in all three phases. Patients experienced a performance increase of median 35.5 watt, a weight-loss of a median of 3.0 kg, and a reduction in body fat content of median 1.0% during this exercise training. The analysis showed early study termination due to non-compliance in 10/30 patients (33.3%), disease progression in 4 patients (13.3%), and serious adverse events in 2 patients (6.7%). About half of patients (46.7%) completed the pilot study as planned. Biomarker analysis from 20 patients showed a non-significant reduction in insulin-like growth factor 1 (IGF-1), insulin-like growth factor 2 (IGF-2) and insulin-like growth factor binding protein 3 (IGF-BP3) levels, significant increases in adiponectin and leptin levels, and a non-significant increase in C-peptide levels. Exercise training is feasible in patients with colorectal cancer after completion of adjuvant chemotherapy. The main problem encountered during the study was compliance. To improve compliance of exercise training, several measures were adapted for the upcoming prospective randomized ABCSG C08 Exercise II study.

The wind power prediction research based on mind evolutionary algorithm

NASA Astrophysics Data System (ADS)

Zhuang, Ling; Zhao, Xinjian; Ji, Tianming; Miao, Jingwen; Cui, Haina

2018-04-01

When the wind power is connected to the power grid, its characteristics of fluctuation, intermittent and randomness will affect the stability of the power system. The wind power prediction can guarantee the power quality and reduce the operating cost of power system. There were some limitations in several traditional wind power prediction methods. On the basis, the wind power prediction method based on Mind Evolutionary Algorithm (MEA) is put forward and a prediction model is provided. The experimental results demonstrate that MEA performs efficiently in term of the wind power prediction. The MEA method has broad prospect of engineering application.

Gait analysis following treadmill training with body weight support versus conventional physical therapy: a prospective randomized controlled single blind study.

PubMed

Lucareli, P R; Lima, M O; Lima, F P S; de Almeida, J G; Brech, G C; D'Andréa Greve, J M

2011-09-01

Single-blind randomized, controlled clinical study. To evaluate, using kinematic gait analysis, the results obtained from gait training on a treadmill with body weight support versus those obtained with conventional gait training and physiotherapy. Thirty patients with sequelae from traumatic incomplete spinal cord injuries at least 12 months earlier; patients were able to walk and were classified according to motor function as ASIA (American Spinal Injury Association) impairment scale C or D. Patients were divided randomly into two groups of 15 patients by the drawing of opaque envelopes: group A (weight support) and group B (conventional). After an initial assessment, both groups underwent 30 sessions of gait training. Sessions occurred twice a week, lasted for 30 min each and continued for four months. All of the patients were evaluated by a single blinded examiner using movement analysis to measure angular and linear kinematic gait parameters. Six patients (three from group A and three from group B) were excluded because they attended fewer than 85% of the training sessions. There were no statistically significant differences in intra-group comparisons among the spatial-temporal variables in group B. In group A, the following significant differences in the studied spatial-temporal variables were observed: increases in velocity, distance, cadence, step length, swing phase and gait cycle duration, in addition to a reduction in stance phase. There were also no significant differences in intra-group comparisons among the angular variables in group B. However, group A achieved significant improvements in maximum hip extension and plantar flexion during stance. Gait training with body weight support was more effective than conventional physiotherapy for improving the spatial-temporal and kinematic gait parameters among patients with incomplete spinal cord injuries.

The Norwegian Cervical Arthroplasty Trial (NORCAT): 2-year clinical outcome after single-level cervical arthroplasty versus fusion-a prospective, single-blinded, randomized, controlled multicenter study.

PubMed

Sundseth, Jarle; Fredriksli, Oddrun Anita; Kolstad, Frode; Johnsen, Lars Gunnar; Pripp, Are Hugo; Andresen, Hege; Myrseth, Erling; Müller, Kay; Nygaard, Øystein P; Zwart, John-Anker

2017-04-01

Standard surgical treatment for symptomatic cervical disc disease has been discectomy and fusion, but the use of arthroplasty, designed to preserve motion, has increased, and most studies report clinical outcome in its favor. Few of these trials, however, blinded the patients. We, therefore, conducted the Norwegian Cervical Arthroplasty Trial, and present 2-year clinical outcome after arthroplasty or fusion. This multicenter trial included 136 patients with single-level cervical disc disease. The patients were randomized to arthroplasty or fusion, and blinded to the treatment modality. The surgical team was blinded to randomization until nerve root decompression was completed. Primary outcome was the self-rated Neck Disability Index. Secondary outcomes were the numeric rating scale for pain and quality of life questionnaires Short Form-36 and EuroQol-5Dimension-3 Level. There was a significant improvement in the primary and all secondary outcomes from baseline to 2-year follow-up for both arthroplasty and fusion (P < 0.001), and no observed significant between-group differences at any follow-up times. However, linear mixed model analyses, correcting for baseline values, dropouts and missing data, revealed a difference in Neck Disability Index (P = 0.049), and arm pain (P = 0.027) in favor of fusion at 2 years. The duration of surgery was longer (P < 0.001), and the frequency of reoperations higher (P = 0.029) with arthroplasty. The present study showed excellent clinical results and no significant difference between treatments at any scheduled follow-up. However, the rate of index level reoperations was higher and the duration of surgery longer with arthroplasty. http://www.clinicaltrials.gov NCT 00735176.19.

A prospective randomized phase II study comparing metronomic chemotherapy with chemotherapy (single agent cisplatin), in patients with metastatic, relapsed or inoperable squamous cell carcinoma of head and neck.

PubMed

Patil, Vijay Maruti; Noronha, Vanita; Joshi, Amit; Muddu, Vamshi Krishna; Dhumal, Sachin; Bhosale, Bharatsingh; Arya, Supreeta; Juvekar, Shashikant; Banavali, Shripad; D'Cruz, Anil; Bhattacharjee, Atanu; Prabhash, Kumar

2015-03-01

Cetuximab based treatment is the recommended chemotherapy for head and neck squamous cell cancers in the palliative setting. However, due to financial constraints, intravenous (IV) chemotherapy without cetuximab is commonly used in lesser developed countries. We believe that oral metronomic chemotherapy may be safer and more effective in this setting. We conducted an open label, superiority, parallel design, randomized phase II trial comparing oral MCT [daily celecoxib (200mg twice daily) and weekly methotrexate (15mg/m(2))] to intravenous single agent cisplatin (IP) (75mg/m(2)) given 3 weekly. Eligible patients had head and neck cancers requiring palliative chemotherapy with ECOG PS 0-2 and adequate organ functions who could not afford cetuximab. The primary end point was progression-free survival. 110 Patients were recruited between July 2011 to May 2013, 57 randomized to the MCT arm and 53 to the IP arm. Patients in the MCT arm had significantly longer PFS (median 101 days, 95% CI: 58.2-143.7 days) compared to the IP arm (median 66 days, 95% CI; 55.8-76.1 days) (p=0.014). The overall survival (OS) was also increased significantly in the MCT arm (median 249 days, 95% CI: 222.5-275.5 days) compared to the IP arm (median 152 days, 95% CI: 104.2-199.8 days) (p=0.02). There were fewer grade 3/4 adverse effects with MCT, which was not significant. (18.9% vs. 31.4%, P=0.14). Oral metronomic chemotherapy has significantly better PFS and OS than single agent platinum in the palliative setting. Copyright © 2014 Elsevier Ltd. All rights reserved.

Half versus full vacuum suction drainage after modified radical mastectomy for breast cancer- a prospective randomized clinical trial[ISRCTN24484328

PubMed Central

Chintamani; Singhal, Vinay; Singh, JP; Bansal, Anju; Saxena, Sunita

2005-01-01

Background Suction drains are routinely used after modified radical mastectomy and are an important factor contributing to increased hospital stay as the patients are often discharged only after their removal. Amongst various factors that influence the amount of postoperative drainage, the negative suction pressure applied to the drain has been reported to be of great significance. While a high negative suction pressure is expected to drain the collection and reduce the dead space promptly, it may also prevent the leaking lymphatics from closing and lead to increased drainage from the wound. Against this background a prospective randomized clinical study was conducted to compare the amount and duration of drainage between a half negative suction and full vacuum suction drainage in patients following modified radical mastectomy. The associated postoperative morbidity was also compared between the two groups. Methods 85 FNAC (fine needle aspiration cytology) proven cases of locally advanced breast cancer were randomized. (Using randomly ordered sealed envelops, which were opened immediately before the closure of the wound) in to 50 patients with full vacuum suction (pressure = 700 g/m2) and 35 cases in to half vacuum suction drainage (pressure = 350 g/m2) groups. The two groups were comparable in respect of age, weight, and technique of operation and extent of axillary dissection. Surgery was performed by the same surgical team comprising of five surgeons (two senior and three resident surgeons) using a standardized technique with electrocautery. External compression dressing was provided over the axilla for first 48 hrs and following that patients were encouraged to do active and passive shoulder exercises. The outcomes measured were postoperative morbidity and the length of hospital stay. Statistical methods used: Descriptive studies were performed with SPSS version 10 and group characteristics were compared using student t-test. Results Half vacuum suction drains were removed earlier than the full suction vacuum suction drains. There was no significant difference in the incidence of seroma formation in the two groups and there was a significant reduction in the total hospital stay in patients with half vacuum suction drainage systems as compared to the full suction drainage group (p < 0.001) without any added morbidity. Conclusions Half negative suction drains provide an effective compromise between no suction and full or high suction drainage after modified radical mastectomy by reducing the hospital stay and the post operative morbidity including post operative seromas. PMID:15676064

Circular vs. three-quadrant hemorrhoidectomy for end-stage hemorrhoids: short- and long-term outcomes of a prospective randomized trial.

PubMed

Qarabaki, Maia A; Mukhashavria, Gela A; Mukhashavria, Gia G; Giorgadze, Nodari G

2014-04-01

Circumferential excisional hemorrhoidectomy (CEH) enables the surgeon to remove the encircling hemorrhoids completely. The purpose of this study is to compare the efficacy of CEH with that of Ferguson hemorrhoidectomy (FH) for end-stage hemorrhoids. Between February 1998 and December 2011, a prospective randomized trial was conducted with 688 patients who presented with end-stage hemorrhoids and underwent FH or CEH at our center. The patient demographics, mean operative times, lengths of hospital stay, and cumulative rates of postoperative complications were similar in the study groups. Significant differences were revealed in the incidence of postoperative hemorrhage (9 vs. 0 patients in the FH and CEH groups, respectively; p = 0.002) and in the tendency to form anal stricture (15 vs. 32 patients in the FH and CEH groups, respectively; p = 0.02). However, all cases of anal strictures were easily managed by digital dilatations. At a mean follow-up of 7.4 (range, 1-14) years, accessible patients from the CEH group remained symptom free, whereas 126 of 308 patients in the FH group indicated that they had recurrent hemorrhoidal symptoms. Without increasing postoperative complications, CEH demonstrates an advantage compared with FH, with regard to reducing the rate of recurrence to 0 through complete hemorrhoid removal.

Wound complications and clinical results of electrocautery versus a scalpel to create a cutaneous flap in thyroidectomy: a prospective randomized trial.

PubMed

Uludag, Mehmet; Yetkin, Gurkan; Ozel, Alper; Ozguven, M Banu Yilmaz; Yener, Senay; Isgor, Adnan

2011-08-01

The use of electrocautery for tissue dissection is becoming increasingly popular, despite the associated risk of poor wound healing and excessive scarring. We conducted this study to compare the wound complications and early and late clinical results resulting from electrocautery versus the scalpel to create a cutaneous flap during thyroidectomy. The subjects of this study were 100 patients, randomized prospectively to either a scalpel group (group S, n = 50) or an electrocautery group (group E, n = 50). Thickness of tissue damage, postoperative thickness of the flap, discomfort in the neck 7 days after surgery, and hypoesthesia and paresthesia in the neck 3 months after surgery were significantly higher in group E than in group S. There were no significant differences in overall postoperative wound complications, postoperative pain, satisfaction with the cosmetic result, or overall outcome of the operation between the groups. Although the incidence of seroma was higher in group E (20%) than in group S (8%), the difference was not significant. Although electrocautery was associated with increased histological tissue damage, postoperative flap edema, discomfort, and other complications in the early stage, the clinical and cosmetic results of flaps made using electrocautery or a scalpel were similar and satisfactory 6 months after surgery.

Pelvic joint fusion in patients with severe pelvic girdle pain - a prospective single-subject research design study.

PubMed

Kibsgård, Thomas J; Røise, Olav; Stuge, Britt

2014-03-15

The fusion of the pelvic joints in patients with severe pelvic girdle pain (PGP) is a controversial and insufficiently studied procedure. The aims of this study were to evaluate physical function and pain after sacroiliac joint (SIJ) fusion. A single-subject research design study with repeated measurements was conducted; pre-operatively and at 3, 6 and 12 months post-operatively. The outcome measures considered were the Oswestry disability index (ODI), visual analogue scale (VAS), and SF-36. Eight patients with severe PGP received open-accessed unilateral anterior SIJ fusion and fusion of the pubic symphysis. Seven patients reported positive results from the surgery. At 1 year post-operation, significant (p < 0.001) reductions in ODI (54 to 37) and VAS (82 to 57) were reported. The physical functioning, bodily pain, and social functioning scores in the SF-36 were also improved. Positive and significant changes in disability and pain at 1 year after SIJ fusion were observed. Despite these positive results, open accessed anterior fusion of the SIJ was associated with adverse events and complications such as infection and nerve damage.

Pure transumbilical SILS gastric bypass with mechanical circular gastrojejunal anastomosis feasibility.

PubMed

Pitot, Denis; Takieddine, Mazen; Abbassi, Ziad; Agrafiotis, Apostolos; Bruyns, Laurence; Ceuterick, Michel; Daoudi, Nabil; Dolimont, Amaury; Soulimani, Abdelak; Vaneukem, Pol

2014-10-01

Since Wittgrove introduced the laparoscopic version of the gastric bypass in 1994, the interest still remains in the decrease of the abdominal wall trauma in order to optimize the benefits of laparoscopy on postoperative pain, cosmesis, hospital stay, and convalescence in bariatric patients. This work is to report the feasibility of gastric bypass surgery by a pure transumbilical single-incision laparoscopic surgery (SILS) with a mechanical circular gastrojejunal anastomosis. Thirty-four patients (10 males and 24 females) were offered to receive gastric bypass with circular mechanical gastrojejunal anastomosis by Single Incision Laparoscopic Surgery (SILS) using pure transumbilical access. Anastomotic leak occurrence was the primary end-point. Patients demographics, operative time, additional trocarts, hemorrhage, intra abdominal abscess, length of post-operative stay, readmission, 30 days death, gastrojejunal anastomosis stricture, marginal ulcers, reflux complains, seromas, incisional hernias, and % excess BMI loss were also recorded in a prospective database. Primary end-point showed no anastomotic leak occurrence during the hospital stay or during the first 30 post-operative days. SILS gastric bypass with a circular mechanical gastrojejunal anastomosis is feasible and seems to be safe.

Brief electrical stimulation after facial nerve transection and neurorrhaphy: a randomized prospective animal study.

PubMed

Mendez, Adrian; Seikaly, Hadi; Biron, Vincent L; Zhu, Lin Fu; Côté, David W J

2016-02-01

Recent studies have examined the effects of brief electrical stimulation (BES) on nerve regeneration, with some suggesting that BES accelerates facial nerve recovery. However, the facial nerve outcome measurement in these studies has not been precise or accurate. The objective of this study is to assess the effect of BES on accelerating facial nerve functional recovery from a transection injury in the rat model. A prospective randomized animal study using a rat model was performed. Two groups of 9 rats underwent facial nerve surgery. Both group 1 and 2 underwent facial nerve transection and repair at the main trunk of the nerve, with group 2 additionally receiving BES on post-operative day 0 for 1 h using an implantable stimulation device. Primary outcome was measured using a laser curtain model, which measured amplitude of whisking at 2, 4, and 6 weeks post-operatively. At week 2, the average amplitude observed for group 1 was 4.4°. Showing a statistically significant improvement over group 1, the group 2 mean was 14.0° at 2 weeks post-operatively (p = 0.0004). At week 4, group 1 showed improvement having an average of 9.7°, while group 2 remained relatively unchanged with an average of 12.8°. Group 1 had an average amplitude of 13.63° at 6-weeks from surgery. Group 2 had a similar increase in amplitude with an average of 15.8°. There was no statistically significant difference between the two groups at 4 and 6 weeks after facial nerve surgery. This is the first study to use an implantable stimulator for serial BES following neurorrhaphy in a validated animal model. Results suggest performing BES after facial nerve transection and neurorrhaphy at the main trunk of the facial nerve is associated with accelerated whisker movement in a rat model compared with a control group.

Spot the difference: Operational event sequence diagrams as a formal method for work allocation in the development of single-pilot operations for commercial aircraft.

PubMed

Harris, Don; Stanton, Neville A; Starr, Alison

2015-01-01

Function Allocation methods are important for the appropriate allocation of tasks between humans and automated systems. It is proposed that Operational Event Sequence Diagrams (OESDs) provide a simple yet rigorous basis upon which allocation of work can be assessed. This is illustrated with respect to a design concept for a passenger aircraft flown by just a single pilot where the objective is to replace or supplement functions normally undertaken by the second pilot with advanced automation. A scenario-based analysis (take off) was used in which there would normally be considerable demands and interactions with the second pilot. The OESD analyses indicate those tasks that would be suitable for allocation to automated assistance on the flight deck and those tasks that are now redundant in this new configuration (something that other formal Function Allocation approaches cannot identify). Furthermore, OESDs are demonstrated to be an easy to apply and flexible approach to the allocation of function in prospective systems. OESDs provide a simple yet rigorous basis upon which allocation of work can be assessed. The technique can deal with the flexible, dynamic allocation of work and the deletion of functions no longer required. This is illustrated using a novel design concept for a single-crew commercial aircraft.

The feasibility of single-port laparoscopic appendectomy using a solo approach: a comparative study.

PubMed

Kim, Say-June; Choi, Byung-Jo; Jeong, Wonjun; Lee, Sang Chul

2016-03-01

To investigate the feasibility and safety of solo surgery with single-port laparoscopic appendectomy, which is termed herein solo-SPLA (solo-single-port laparoscopic appendectomy). This study prospectively collected and retrospectively analyzed data from patients who had undergone either non-solo-SPLA (n = 150) or solo-SPLA (n = 150). Several devices were utilized for complete, skin-to-skin solo-SPSA, including a Lone Star Retractor System and an adjustable mechanical camera holder. Operating times were not significantly different between solo- and non-solo-SPLA (45.0 ± 21.0 minutes vs. 46.7 ± 26.1 minutes, P = 0.646). Most postoperative variables were also comparable between groups, including the necessity for intravenous analgesics (0.7 ± 1.2 ampules [solo-SPLA] vs. 0.9 ± 1.5 ampules [non-solo-SPLA], P = 0.092), time interval to gas passing (1.3 ± 1.0 days vs. 1.4 ± 1.0 days, P = 0.182), and the incidence of postoperative complications (4.0% vs. 8.7%, P = 0.153). Moreover, solo-SPLA effectively lowered the operating cost by reducing surgical personnel expenses. Solo-SPLA economized staff numbers and thus lowered hospital costs without lengthening of operating time. Therefore, solo-SPLA could be considered a safe and feasible alternative to non-solo-SPLA.

Motor, cognitive, and functional declines contribute to a single progressive factor in early HD.

PubMed

Schobel, Scott A; Palermo, Giuseppe; Auinger, Peggy; Long, Jeffrey D; Ma, Shiyang; Khwaja, Omar S; Trundell, Dylan; Cudkowicz, Merit; Hersch, Steven; Sampaio, Cristina; Dorsey, E Ray; Leavitt, Blair R; Kieburtz, Karl D; Sevigny, Jeffrey J; Langbehn, Douglas R; Tabrizi, Sarah J

2017-12-12

To identify an improved measure of clinical progression in early Huntington disease (HD) using data from prospective observational cohort studies and placebo group data from randomized double-blind clinical trials. We studied Unified Huntington Disease Rating Scale (UHDRS) and non-UHDRS clinical measures and brain measures of progressive atrophy in 1,668 individuals with early HD followed up prospectively for up to 30 to 36 months of longitudinal clinical follow-up. The results demonstrated that a composite measure of motor, cognitive, and global functional decline best characterized clinical progression and was most strongly associated with brain measures of progressive corticostriatal atrophy. Use of a composite motor, cognitive, and global functional clinical outcome measure in HD provides an improved measure of clinical progression more related to measures of progressive brain atrophy and provides an opportunity for enhanced clinical trial efficiency relative to currently used individual motor, cognitive, and functional outcome measures. © 2017 American Academy of Neurology.

Comparison of Pelican single-use multibite biopsy forceps and traditional double-bite forceps: evaluation in a porcine model.

PubMed

Zaidman, Jeffrey S; Frederick, William G; Furth, Emma E; Su, Chinyu G; Ginsberg, Gregory G

2006-10-01

The multibite biopsy forceps is intended for consecutive acquisition of numerous tissue specimens with a single pass. The Pelican multibite forceps is equipped with a sleeve for tissue retention that allows up to 6 specimens to be obtained with each pass of the device through the accessory channel. Reducing the need for device exchange could decrease the total procedure time for colon cancer surveillance in patients with longstanding inflammatory bowel disease (IBD). The aim of this study was to evaluate a new multibite biopsy forceps in comparison with a standard double-bite forceps. Prospective randomized animal model trial. Multicenter university and community hospitals. By using a live porcine model, multiple colonoscopic biopsy specimens were obtained with both the Pelican multibite forceps and the Radial Jaw 3 (RJ3) double-bite forceps to mimic colorectal cancer surveillance in patients with IBD. Six biopsy specimens were obtained with each of 6 passes when using the Pelican forceps, and 2 biopsy specimens were obtained with each of 18 passes when using the RJ3 forceps. All trials were timed. Two independent pathologists blinded to the forceps used evaluated the specimens. Tissue acquisition when using the Pelican multibite forceps was significantly faster than with a standard double-bite forceps. The devices compared equivalently for specimen retention and quality. The operator could not be blinded to the devices used. This study uses an animal model to extrapolate how the devices might perform in human use. These findings support the evaluation of the Pelican forceps for colon cancer surveillance in patients with longstanding IBD.

Prospective Randomized Trial of the Military Anti-Shock Garment

DTIC Science & Technology

1987-12-20

No prospective, controlled, randomized studies of !.’AST use were available in the scientific literature. Numerous --ports of MAST use were available...in the scientific literature. ,umerous reports of MAST causing compartment syndromes and amputations did appear in the literature. Beginning in 1983...research funding, computerization of these work sheets became possible, making analysis possible. In that no definitive or scientific clinically controlled

A study of intrauterine infusion of human chorionic gonadotropin (hCG) before frozen-thawed embryo transfer after two or more implantation failures.

PubMed

Huang, Pinxiu; Wei, Lihong; Li, Xinlin

2017-01-01

To investigate the effect of intrauterine infusion of human chorionic gonadotropin (hCG) before frozen-thawed embryo transfer (FET) after two or more implantation failures (TIFs). The study was a prospective randomized single-blind study of 161 cycles in patients undergoing FET who had TIFs. The intervention group received an intrauterine injection of 1000 IU of hCG before embryo transfer (ET) (n = 62). A placebo group (n = 49) received an intrauterine injection of physiological saline before ET. A control group (n = 50) did not receive an intrauterine injection. Clinical pregnancy rates, abortion rates, and ongoing pregnancy rates were compared between the three groups. The clinical pregnancy rates were 59.68%, 53.06%, and 32.00% in the hCG group, placebo group, and control group, respectively. The clinical pregnancy rates were significantly higher in the hCG and placebo groups than in the control group. There were no significant differences in the abortion rates among the three groups. An intrauterine administration of hCG before FET significantly improved the pregnancy rates after TIFs. But local injury caused by the operation of intrauterine perfusion may play an important role in improving clinical pregnancy rates.

Prophylactic tracheotomy and lung cancer resection in patient with low predictive pulmonary function: a randomized clinical trials.

PubMed

Filaire, Marc; Tardy, Marie M; Richard, Ruddy; Naamee, Adel; Chadeyras, Jean Baptiste; Da Costa, Valence; Bailly, Patrick; Eisenmann, Nathanaël; Pereira, Bruno; Merle, Patrick; Galvaing, Géraud

2015-12-01

Whether prophylactic tracheotomy can shorten the duration of mechanical ventilation (MV) in high risk patients eligible for lung cancer resection. The objective was to compare duration of MV and outcome in 39 patients randomly assigned to prophylactic tracheotomy or control. Prospective randomized controlled, single-center trial (ClinicalTrials.gov Identifier: NCT01053624). The primary outcome measure was the cumulative number of MV days after operation until discharge. The secondary outcome measures were the 60 days mortality rate, the ICU and the hospital length of stay, the incidence of postoperative respiratory, cardiac and general complications, the reventilation rate, the need of noninvasive ventilation (NIV), the need of a tracheotomy in control group and the tracheal complications. The duration of MV was not significantly different between the tracheotomy group (3.5±6 days) and the control group (4.7±9.3 days) (P=0.54). Among patients needing prolonged MV >4 days, tracheotomy patients had a shortened duration of MV than control patients (respectively 11.4±7.1 and 20.4±9.6 days, P=0.04). The rate of respiratory complications were significantly lower in the tracheotomy group than in the control group (28% vs. 51%, P=0.03). Six patients (15%) needed a postoperative tracheotomy in the control group because of a prolonged MV >7 days. Tracheotomy was associated with a reduced need of NIV (P=0.04). There was no difference in 60-day mortality rate, cardiac complications, intensive care unit and hospital length of stay. No death was related with the tracheotomy. Prophylactic tracheotomy in patients with ppo FEV1 <50% who underwent thoracotomy for lung cancer resection provided benefits in terms of duration of prolonged MV and respiratory complications but was not associated with a decreased mortality rate, ICU and hospital length of stay and non-respiratory complications.

Comparing blastocyst quality and live birth rates of intravaginal culture using INVOcell™ to traditional in vitro incubation in a randomized open-label prospective controlled trial.

PubMed

Doody, Kevin J; Broome, E Jason; Doody, Kathleen M

2016-04-01

The purpose of this study is to to compare the efficacy of intravaginal culture (IVC) of embryos in INVOcell™ (INVO Bioscience, MA, USA) to traditional in vitro fertilization (IVF) incubators in a laboratory setting using a mild pre-determined stimulation regimen based solely on anti-mullerian hormone (AMH) and body weight with minimal ultrasound monitoring. The primary endpoint examined was total quality blastocysts expressed as a percentage of total oocytes placed in incubation. Secondary endpoints included percentage of quality blastocysts transferred, pregnancy, and live birth rates. In this prospective randomized open-label controlled single-center study, 40 women aged <38 years of age with a body mass index (BMI) of <36 and an AMH of 1-3 ng/mL were randomized prior to trigger to receive either IVC or IVF. Controlled ovarian stimulation was administered with human menopausal gonadotropin (hMG) in a fixed gonadotropin-releasing hormone (GnRH) agonist cycle based solely on AMH and body weight. A single ultrasound-monitoring visit was performed on the 10th day of stimulation. One or two embryos were transferred following 5 days of culture. IVF produced a greater percentage of total quality embryos as compared to IVC (50.6 vs. 30.7 %, p = 0.0007, respectively). There was no significant difference between in IVF and IVC in the percentage of quality blastocysts transferred (97.5 vs. 84.9 %, p = 0.09) or live birth rate (60 % IVF, 55 % IVC). IVF was shown to be superior to IVC in creating quality blastocysts. However, both IVF and IVC produced identical blastocysts for transfer resulting in similar live birth rates. IVC using INVOcell™ is effective and may broaden access to fertility care in selected patient populations by ameliorating the need for a traditional IVF laboratory setting. Further studies will help elucidate the potential physiological, psychological, geographic, and financial impact of IVC on the delivery of fertility care.

Effects of closed-loop stimulation vs. DDD pacing on haemodynamic variations and occurrence of syncope induced by head-up tilt test in older patients with refractory cardioinhibitory vasovagal syncope: the Tilt test-Induced REsponse in Closed-loop Stimulation multicentre, prospective, single blind, randomized study.

PubMed

Palmisano, Pietro; Dell'Era, Gabriele; Russo, Vincenzo; Zaccaria, Maria; Mangia, Rolando; Bortnik, Miriam; De Vecchi, Federica; Giubertoni, Ailia; Patti, Fabiana; Magnani, Andrea; Nigro, Gerardo; Rago, Anna; Occhetta, Eraldo; Accogli, Michele

2018-05-01

Closed-loop stimulation (CLS) seemed promising in preventing the recurrence of vasovagal syncope (VVS) in patients with a cardioinhibitory response to head-up tilt test (HUTT) compared with conventional pacing. We hypothesized that the better results of this algorithm are due to its quick reaction in high-rate pacing delivered in the early phase of vasovagal reflex, which increase the cardiac output and the blood pressure preventing loss of consciousness. This prospective, randomized, single-blind, multicentre study was designed as an intra-patient comparison and enrolled 30 patients (age 62.2 ± 13.5 years, males 60.0%) with cardioinhibitory VVS, carrying a dual-chamber pacemaker incorporating CLS algorithm. Two HUTTs were performed one week apart: one during DDD-CLS 60-130/min pacing and the other during DDD 60/min pacing; patients were randomly and blindly assigned to two groups: in one the first HUTT was performed in DDD-CLS (n = 15), in the other in DDD (n = 15). Occurrence of syncope and haemodynamic variations induced by HUTT was recorded during the tests. Compared with DDD, DDD-CLS significantly reduced the occurrence of syncope induced by HUTT (30.0% vs. 76.7%; P < 0.001). In the patients who had syncope in both DDD and DDD-CLS mode, DDD-CLS significantly delayed the onset of syncope during HUTT (from 20.8 ± 3.9 to 24.8 ± 0.9 min; P = 0.032). The maximum fall in systolic blood pressure recorded during HUTT was significantly lower in DDD-CLS compared with DDD (43.2 ± 30.3 vs. 65.1 ± 25.8 mmHg; P = 0.004). In patients with cardioinhibitory VVS, CLS reduces the occurrence of syncope induced by HUTT, compared with DDD pacing. When CLS is not able to abort the vasovagal reflex, it seems to delay the onset of syncope.

A Prospective Randomized Comparison Between Shock Wave Lithotripsy and Flexible Ureterorenoscopy for Lower Caliceal Stones ≤2 cm: A Single-Center Experience.

PubMed

Kumar, Anup; Vasudeva, Pawan; Nanda, Biswajit; Kumar, Niraj; Das, Manoj Kumar; Jha, Sanjeev Kumar

2015-05-01

The optimal management method of lower caliceal calculi is still undefined. We performed a prospective randomized comparison to evaluate safety and efficacy of shock wave lithotripsy (SWL) and flexible ureteroscopy (RIRS) for lower caliceal calculus ≤2 cm. Between December 2011 and January 2012, 195 patients with single radio-opaque lower caliceal calculi ≤2 cm were included in the study. Randomization was done into two groups-group A: SWL performed as an outpatient procedure using the electromagnetic lithotripter (Dornier compact delta) and group B: RIRS was performed using the 6F/7.5F flexible ureteroscope (Richard Wolf) with holmium laser intracorporeal lithotripsy. Demographic characteristics, success, retreatment, and auxiliary procedure rates and complications were analyzed statistically. Of 195 patients, 97 and 98 patients were enrolled in group A and B, respectively. Mean stone size was 12.1 mm in group A vs 12.3 mm in group B (p=0.52). The overall 3 month stone-free rate was (74/90) 82.2% for group A vs (78/90) 86.6% for group B (p=0.34); for stones <10 mm, it was (45/55) 84.9% for group A vs (43/51) 87.7% for group B (p=0.32) and for 10-20 mm stones, it was (29/35) 78.4% for group A vs (35/39) 85.4% for group B (p=0.12). Retreatment rate was significantly greater in group A compared with group B (61.1% vs 11.1%; p<0.001). Auxiliary procedure rate was comparable (21.1% vs 17.7%; p=0.45). The complication rate was 6.6% in group A vs 11.1% in group B (p=0.21). Both SWL and RIRS are safe and efficacious for lower caliceal calculi ≤20 mm. For stones <10 mm, SWL was less invasive and safer than RIRS with efficacy comparable to it. However, for 10-20 mm stones, RIRS was more effective, with lesser retreatment rate.

The subtle central effect of nutraceuticals: Is it placebo or nocebo?

PubMed Central

Al-Gareeb, Ali I.

2015-01-01

Background: Herbal medicines are often perceived by the general public as a “soft” alternative to Western Medicine, but the use of these substances can be risky since they can induce nocebo effect. Aim: The aim was to evaluate the nocebo effects of Nigella sativa oil, garlic and coenzyme Q10 (CoQ10) on the integrative function of the central nervous system and psychomotor performance. Materials and Methods: This is a randomized, double-blind, controlled, and prospective study conducted in the Department of Pharmacology, College of Medicine, Al-Mustansiriya University, Baghdad, Iraq during February 2013. A total of 160 medical students participated in this study were randomly assigned equally to one of the following groups: Group A: Received single dose of N. sativa oil (500 ml capsule); Group B: Received single dose of garlic (500 mg capsule); Group C: Received single dose of CoQ10 (120 mg capsule) and; Group D: received single dose of matching oral placebo (300 mg starch capsule). For all participants, reaction time and flicker fusion threshold were measured by the Leeds psychomotor performance test battery before and after 3 h of taking the drugs Results: Neither placebo nor nutraceuticals exerted significant effect on total reaction time. Although the recognition reaction time is insignificantly reduced by 2.77% (placebo), 5.83% (Nigella sativa), 7.21% (garlic) and 12.64% (CoQ10) from the pretreatment values, they are adversely affect the motor reaction time to reach the significant level in subjects pretreated with Garlic (P = 0.02). Conclusion: Nutraceuticals are not free from nocebo effect on psychomotor performance. PMID:26401411

The subtle central effect of nutraceuticals: Is it placebo or nocebo?

PubMed

Al-Gareeb, Ali I

2015-01-01

Herbal medicines are often perceived by the general public as a "soft" alternative to Western Medicine, but the use of these substances can be risky since they can induce nocebo effect. The aim was to evaluate the nocebo effects of Nigella sativa oil, garlic and coenzyme Q10 (CoQ10) on the integrative function of the central nervous system and psychomotor performance. This is a randomized, double-blind, controlled, and prospective study conducted in the Department of Pharmacology, College of Medicine, Al-Mustansiriya University, Baghdad, Iraq during February 2013. A total of 160 medical students participated in this study were randomly assigned equally to one of the following groups: Group A: Received single dose of N. sativa oil (500 ml capsule); Group B: Received single dose of garlic (500 mg capsule); Group C: Received single dose of CoQ10 (120 mg capsule) and; Group D: received single dose of matching oral placebo (300 mg starch capsule). For all participants, reaction time and flicker fusion threshold were measured by the Leeds psychomotor performance test battery before and after 3 h of taking the drugs. Neither placebo nor nutraceuticals exerted significant effect on total reaction time. Although the recognition reaction time is insignificantly reduced by 2.77% (placebo), 5.83% (Nigella sativa), 7.21% (garlic) and 12.64% (CoQ10) from the pretreatment values, they are adversely affect the motor reaction time to reach the significant level in subjects pretreated with Garlic (P = 0.02). Nutraceuticals are not free from nocebo effect on psychomotor performance.

Risk of surgical site infection in paediatric herniotomies without any prophylactic antibiotics: A preliminary experience.

PubMed

Vaze, Dhananjay; Samujh, Ram; Narasimha Rao, Katragadda Lakshmi

2014-01-01

Different studies underline the use of pre-operative antibiotic prophylaxis in clean surgeries like herniotomy and inguinal orchiopexy. But, the meta-analyses do not recommend nor discard the use of prophylactic pre-operative antibiotics. The scarcity of controlled clinical trials in paediatric population further vitiates the matter. This study assessed the difference in the rate of early post-operative wound infection cases in children who received single dose of pre-operative antibiotics and children who did not receive antibiotics after inguinal herniotomy and orchiopexy. This randomised prospective study was conducted in Paediatric Surgery department of PGIMER Chandigarh. Out of 251 patients, 112 patients were randomised to the case group and 139 were ascribed to the control group. The patients in control group were given a standard regimen of single dose of intravenous antibiotic at the time of induction followed by 3-4 days of oral antibiotic. Case group patients underwent the surgical procedure in similar manner with no antibiotic either at the time of induction or post-operatively. The incidence of surgical site infection in case group was 3.73 % and that in control group was 2.22%. The observed difference in the incidence of surgical site infection was statistically insignificant (P value = 0.7027). The overall infection rate in case and control group was 2.89%. Our preliminary experience suggests that there is no statistically significant difference in the proportion of early post-operative wound infection between the patients who received single dose of pre-operative antibiotics and the patients who received no antibiotics after inguinal herniotomy and orchiopexy. The risk of surgical site infection in paediatric heriotomies does not increase even if the child's weight is less than his/her expected weight for age.

Results of a Prospective Randomized, Open-Label, Noninferiority Study of Tbo-Filgrastim (Granix) versus Filgrastim (Neupogen) in Combination with Plerixafor for Autologous Stem Cell Mobilization in Patients with Multiple Myeloma and Non-Hodgkin Lymphoma.

PubMed

Bhamidipati, Pavan Kumar; Fiala, Mark A; Grossman, Brenda J; DiPersio, John F; Stockerl-Goldstein, Keith; Gao, Feng; Uy, Geoffrey L; Westervelt, Peter; Schroeder, Mark A; Cashen, Amanda F; Abboud, Camille N; Vij, Ravi

2017-12-01

Autologous hematopoietic stem cell transplantation (auto-HSCT) improves survival in patients with multiple myeloma (MM) and non-Hodgkin lymphoma (NHL). Traditionally, filgrastim (Neupogen; recombinant G-CSF) has been used in as a single agent or in combination with plerixafor for stem cell mobilization for auto-HSCT. In Europe, a biosimilar recombinant G-CSF (Tevagrastim) has been approved for various indications similar to those of reference filgrastim, including stem cell mobilization for auto-HSCT; however, in the United States, tbo-filgrastim (Granix) is registered under the original biological application and is not approved for stem cell mobilization. In retrospective studies, stem cell mobilization with tbo-filgrastim has shown similar efficacy and toxicity as filgrastim, but no prospective studies have been published to date. We have conducted the first prospective randomized trial comparing the safety and efficacy of tbo-filgrastim in combination with plerixafor with that of filgrastim in combination with plerixafor for stem cell mobilization in patients with MM and NHL. This is a phase 2 prospective randomized (1:1) open-label single-institution noninferiority study of tbo-filgrastim and filgrastim with plerixafor in patients with MM or NHL undergoing auto-HSCT. Here 10 µg/kg/day of tbo-filgrastim/filgrastim was administered s.c. for 5 days (days 1 to 5). On day 4 at approximately 1800 hours, 0.24 mg/kg of plerixafor was administered s.c. Apheresis was performed on day 5 with a target cumulative collection goal of at least 5.0 × 10 6 CD34 + cells/kg. The primary objective was to compare day 5 CD34 +  cells/kg collected. Secondary objectives included other mobilization endpoints, safety, engraftment outcomes, and hospital readmission rate. A total of 97 evaluable patients were enrolled (tbo-filgrastim, n = 46; filgrastim, n = 51). Tbo-filgrastim was not inferior to filgrastim in terms of day 5 CD34 +  cell collection (mean, 11.6 ± 6.7 CD34 + cells/kg versus 10.0  ± 6.8 CD34 + cells/kg. Multivariate analysis revealed a trend toward increased mobilization in the tbo-filgrastim arm, but this was not statistically significant. The tbo-filgrastim and filgrastim arms were similar in all secondary endpoints. Tbo-filgrastim is not inferior in efficacy and has similar safety compared to reference filgrastim when used for stem cell mobilization in patients with MM and NHL. Granix can be safely used instead of Neupogen for stem cell collection in patients undergoing auto-HSCT for MM or NHL. The study is registered at https://clinicaltrials.gov/ct2/show/NCT02098109. Copyright © 2017 The American Society for Blood and Marrow Transplantation. Published by Elsevier Inc. All rights reserved.

Will musculoskeletal, visual and psychosocial stress change for visual display unit (VDU) operators when moving from a single-occupancy office to an office landscape?

PubMed

Helland, Magne; Horgen, Gunnar; Kvikstad, Tor Martin; Garthus, Tore; Aarås, Arne

2008-01-01

This study investigated the effect of moving from single-occupancy offices to a landscape environment. Thirty-two visual display unit (VDU) operators reported no significant change in visual discomfort. Lighting conditions and glare reported subjectively showed no significant correlation with visual discomfort. Experience of pain was found to reduce subjectively rated work capacity during VDU tasks. The correlation between visual discomfort and reduced work capacity for single-occupancy offices was rs=.88 (p=.000) and for office landscape rs=.82 (p=.000). Eye blink rate during habitual VDU work was recorded for 12 operators randomly selected from the 32 participants in the office landscape. A marked drop in eye blink rate during VDU work was found compared to eye blink rate during easy conversation. There were no significant changes in pain intensity in the neck, shoulder, forearm, wrist/hand, back or headache (.24

Intravenous dexamethasone versus ketamine gargle versus intravenous dexamethasone combined with ketamine gargle for evaluation of post-operative sore throat and hoarseness: A randomized, placebo-controlled, double blind clinical trial

PubMed Central

Safavi, Mohammadreza; Honarmand, Azim; Fariborzifar, Arghavan; Attari, Mohammadali

2014-01-01

Background: Sore throat and hoarseness are the most frequent subjective complaints after tracheal intubation for general anesthesia. We conducted a prospective, randomized, double-blind, placebo controlled study to evaluate the efficacy of intravenous (IV) dexamethasone plus ketamine gargle for reducing the incidence and severity of post-operative sore throat (POST) and hoarseness. Materials and Methods: 140 patients (aged 16-65 year) scheduled for elective surgery were enrolled. Patients were randomly allocated into four groups of 35 subjects each: Group K, gargled 40 mg ketamine in 30 ml saline; Group D, were infused 0.2 mg/kg IV dexamethasone; Group KD, gargled 40 mg ketamine in 30 ml saline plus 0.2 mg/kg IV dexamethasone; Group P (placebo) that received saline (gargle and IV). POST was graded at 0, 2, 4, 8, 16 and 24 h after operation on a four-point scale (0-3). Results: The incidence and severity of POST were significantly lower in Group KD, compared with the other groups at all times after tracheal extubation for up to 24 h (P < 0.05). Also the incidence and severity of hoarseness were significantly lower in each Groups of KD and K and D compared with group placebo (P < 0.05). Conclusion: The prophylactic use of 0.2 mg/kg of IV dexamethasone plus ketamine gargle significantly reduced the incidence and severity of POST compared with using each of these drugs alone or using placebo. PMID:25371869

Duration of antimicrobial prophylaxis in patients undergoing hepatectomy: a prospective randomized controlled trial using flomoxef.

PubMed

Togo, Shinji; Tanaka, Kuniya; Matsuo, Kenichi; Nagano, Yasuhiko; Ueda, Michio; Morioka, Daisuke; Endo, Itaru; Shimada, Hiroshi

2007-05-01

Although the usefulness of antimicrobial prophylaxis for clean-contaminated surgery has been recognized, only a few randomized controlled studies on the duration of administration after hepatectomy have been performed. We investigated the duration of antimicrobial prophylaxis after hepatectomy. The subjects were 180 patients who underwent hepatectomy without reconstruction of the biliary or intestinal tract between April 2003 and March 2006 at our department. The patients were randomly allocated to groups to be treated with flomoxef sodium as antimicrobial prophylaxis for 2 days (89 patients) or 5 days (91 patients), including the operation day. The presence or absence of systemic inflammatory response syndrome (SIRS) and infections was investigated. No significant differences were noted in patient background between the two groups. Infections occurred in seven and six patients in the 2 day and 5 day treatment groups (7.9% and 6.6%), respectively, showing no significant difference between the two groups. No significant difference was noted when the cases were divided into surgical site infections and remote infections. The positive rate of SIRS was significantly higher in the 2 day treatment group than in the 5 day treatment group on days 2 and 3 after surgery. The risk factors in patients who developed infections were blood loss, operation time and the complication of biliary fistula. Two day administration of flomoxef sodium may be sufficient for antimicrobial prophylaxis after hepatectomy. However, when SIRS is positive on post-operative day 2, and induction of liver failure is of concern, it may be safer to continue antimicrobial drug administration until SIRS is eliminated.

Effects of Fluoxetine on Neural Functional Prognosis after Ischemic Stroke: A Randomized Controlled Study in China.

PubMed

He, Yi-Tao; Tang, Bing-Shan; Cai, Zhi-Li; Zeng, Si-Ling; Jiang, Xin; Guo, Yi

2016-04-01

We investigated the effects of fluoxetine on the short-term and long-term neural functional prognoses after ischemic stroke. In this prospective randomized controlled single-blind clinical study in China, eligible patients afflicted with ischemic stroke were randomized into control and treatment groups. Patients in the treatment group received fluoxetine in addition to the basic therapies in the control group over a period of 90 days. The follow-up period was 180 days. We evaluated the effects of fluoxetine on the National Institutes of Health Stroke Scale (NIHSS) score and Barthel Index (BI) score after ischemic stroke through single- and multiple-factor analysis. The mean NIHSS score on day 180 after treatment was significantly lower in the treatment group than in the control group (P = .009). The mean BI scores on days 90 and 180 were significantly higher in the treatment group (P = .026) than in the control group (P = .011). The improvements in the NIHSS and BI scores on days 90 and 180 compared with baseline in the treatment group were all significantly greater than that in the control group (P = .033, P = .013, P = .013, P = .019, respectively). Treatment with fluoxetine was an independent factor affecting the NIHSS and BI scores on day 180 after treatment. Treatment with fluoxetine for 90 days after ischemic stroke can improve the long-term neural functional outcomes. Copyright © 2016 National Stroke Association. Published by Elsevier Inc. All rights reserved.

The use of fibrin tissue adhesive to reduce blood loss and the need for blood transfusion after total knee arthroplasty. A prospective, randomized, multicenter study.

PubMed

Levy, O; Martinowitz, U; Oran, A; Tauber, C; Horoszowski, H

1999-11-01

Total knee arthroplasty is associated with major postoperative blood loss of approximately 800 to 1200 milliliters, and blood transfusion is frequently required. With the increased concern about the risks of blood transfusion, various methods of blood conservation in orthopaedic surgery have been studied. The most appropriate solution, however, is to reduce the loss of blood during and after an operation. The present prospective, controlled, randomized study was designed to evaluate the hemostatic efficacy of the use of fibrin tissue adhesive in patients managed with total knee arthroplasty. Fifty-eight patients who were scheduled to have a total knee arthroplasty were randomly divided into two groups: a control group, in which the standard means of hemostasis were applied, and a treatment group, in which the standard means to control local bleeding were applied and a fibrin tissue adhesive was sprayed on the internal aspects of the operative field before skin closure. All operations were performed in a bloodless field with use of a pneumatic tourniquet. All patients received low-molecular-weight heparin as thromboprophylaxis twelve hours before the operation and every twelve hours postoperatively. Blood loss during the operation was evaluated by measuring the volume in the suction apparatus and by estimating the amount of lost blood in the swabs at the end of the operation. The apparent postoperative lost blood was determined by measuring the volume in the suction-drain bottles. All blood transfusions were recorded. The mean apparent postoperative blood loss (and standard deviation) in the fibrin-tissue-adhesive group was 360+/-287.7 milliliters compared with 878+/-403.0 milliliters in the control group, with a mean difference of 518 milliliters (p<0.001). The decrease in the level of hemoglobin was 25+/-10 grams per liter in the treatment group compared with 37+/-12 grams per liter in the control group (p<0.001). Sixteen patients (55 percent) in the control group required a blood transfusion and eight (28 percent) required two units of blood, whereas only five (17 percent) of the patients in the fibrin-tissue-adhesive group required a blood transfusion and only one (3 percent) required two units (p = 0.004). The number of adverse events was comparable between the two groups. None of the adverse events were considered to be related to the use of fibrin tissue adhesive. One death, which was due to massive pulmonary embolism, was reported in the control group. No seroconversion was reported at three and six months after the operation. The use of fibrin tissue adhesive in total knee arthroplasty seems to be an effective and safe means with which to reduce blood loss and blood-transfusion requirements. Furthermore, the importance of these findings was enhanced by a significant reduction in blood loss, in the postoperative decrease in the level of hemoglobin, and in blood-transfusion requirements despite preoperative thromboprophylaxis with low-molecular-weight heparin.

LMA Supreme for neonatal resuscitation: study protocol for a randomized controlled trial

PubMed Central

2014-01-01

Background The most important action in the resuscitation of a newborn in the delivery room is to establish effective assisted ventilation. The face mask and endotracheal tube are the devices used to achieve this goal. Laryngeal mask airways that fit over the laryngeal inlet have been shown to be effective for ventilating newborns at birth and should be considered as an alternative to facemask ventilation or endotracheal intubation among newborns weighing >2,000 g or delivered ≥34 weeks’ gestation. A recent systematic review and meta-analysis of supraglottic airways in neonatal resuscitation reported the results of four randomized controlled trials (RCTs) stating that fewer infants in the group using laryngeal mask airways required endotracheal intubation (1.5%) compared to the group using face masks (12.0%). However, there were methodological concerns over all the RCTs including the fact that the majority of the operators in the trials were anesthesiologists. Our hypothesis is based on the assumption that ventilating newborns needing positive pressure ventilation with a laryngeal mask airway will be more effective than ventilating with a face mask in a setting where neonatal resuscitation is performed by midwives, nurses, and pediatricians. The primary aim of this study will be to assess the effectiveness of the laryngeal mask airway over the face mask in preventing the need for endotracheal intubation. Methods/design This will be an open, prospective, randomized, single center, clinical trial. In this study, 142 newborns weighing >1,500 g or delivered ≥34 weeks gestation needing positive pressure ventilation at birth will be randomized to be ventilated with a laryngeal mask airway (LMA SupremeTM, LMA Company, UK - intervention group) or with a face mask (control group). Primary outcome: Proportion of newborns needing endotracheal intubation. Secondary outcomes: Apgar score at 5 minutes, time to first breath, onset of the first cry, duration of resuscitation, death or moderate to severe hypoxic-ischemic encephalopathy within 7 days of life. Trial registration ClinicalTrials.gov identifier: NCT01963936 (October 11, 2013). PMID:25027230

A prospective, randomized, double-blinded single-site control study comparing blood loss prevention of tranexamic acid (TXA) to epsilon aminocaproic acid (EACA) for corrective spinal surgery

PubMed Central

2010-01-01

Background Multilevel spinal fusion surgery has typically been associated with significant blood loss. To limit both the need for transfusions and co-morbidities associated with blood loss, the use of anti-fibrinolytic agents has been proposed. While there is some literature comparing the effectiveness of tranexamic acid (TXA) to epsilon aminocaproic acid (EACA) in cardiac procedures, there is currently no literature directly comparing TXA to EACA in orthopedic surgery. Methods/Design Here we propose a prospective, randomized, double-blinded control study evaluating the effects of TXA, EACA, and placebo for treatment of adolescent idiopathic scoliosis (AIS), neuromuscular scoliosis (NMS), and adult deformity (AD) via corrective spinal surgery. Efficacy will be determined by intraoperative and postoperative blood loss. Other clinical outcomes that will be compared include transfusion rates, preoperative and postoperative hemodynamic values, and length of hospital stay after the procedure. Discussion The primary goal of the study is to determine perioperative blood loss as a measure of the efficacy of TXA, EACA, and placebo. Based on current literature and the mechanism by which the medications act, we hypothesize that TXA will be more effective at reducing blood loss than EACA or placebo and result in improved patient outcomes. Trial Registration ClinicalTrials.gov ID: NCT00958581 PMID:20370916

Colonoscopy in automated peritoneal dialysis patients: value of prophylactic antibiotics: a prospective study on a single antibiotic.

PubMed

Al-Hwiesh, Abdullah K; Abdul-Rahman, Ibrahiem S; Hussameldeen, Mohammad A; Al-Audah, Nadia; Abdelrahman, Abdalla; Moaigel, Hala M; El-Salamony, Tamer; Noor, Abdul-Salam; Al-Osail, Aisha; Al-Sayel, Dalal; Al-Dossari, Nourah

2017-10-13

To evaluate the need for prophylactic antibiotics in automated peritoneal dialysis (APD) patients undergoing flexible colonoscopy. A total of 93 patients on automated peritoneal dialysis (APD) undergoing diagnostic colonoscopy were enrolled in a prospective, randomized study. Patients were randomized into 2 age- and sex-matched groups; group A (46 patients) with intraperitoneal (IP) ceftazidime prior to colonoscopy and group B (47 patients) without prophylactic antibiotics. The relations between peritonitis and different parameters were analyzed. Of all colonoscopies, 60.2% showed normal findings, 17.2% with colonic polyps at different sites, 12.9% with angiodysplastic-like lesions, 5.4% with colonic ulcer(s), 3.2% with diverticulae without diverticulitis and 1.1% had transverse colon stricture. Post-colonoscopy peritonitis was documented in 3 (6.5%) and 4 (8.5%) patients in groups A and B, respectively (p = 0.2742); the causative organisms were mainly gram negative bacteria. Polypectomy was not associated with increased peritonitis episodes. By multiple logistic regression analysis, diabetes mellitus was the only independent variable that entered into the best predictive equation over the development of post-colonoscopy peritonitis but not antibiotic use. The relation between prophylactic antibiotic use prior to colonoscopy in APD patients and the risk of peritonitis was lacking. Only diabetes mellitus appears to be of significance. Polypectomy did not increase peritonitis episodes.

Remifentanil in combination with ketamine versus remifentanil in spinal fusion surgery--a double blind study.

PubMed

Hadi, B A; Al Ramadani, R; Daas, R; Naylor, I; Zelkó, R

2010-08-01

This study is aimed at conducting a program for two different anesthetic methods used during a spinal fusion surgery to ensure better intra-operative hemodynamic stability and post-operative pain control. A prospective, randomized, double blind study in patients scheduled for spinal fusion surgery, who were randomly allocated to two groups, G1 and G2, (n = 15 per group), class I-II ASA, was carried out. Both groups received pre-operatively midazolam, followed intra-operatively by propofol, sevoflurane, atracurium, and either remifentanil infusion 0.2 microg/kg/min (G1), or the same dose of remifentanil infusion and low doses of ketamine infusion 1 microg/kg/min (G2) anesthetics, antidote medication and post-operative morphine doses. HR, MAP, vital signs, surgical bleeding, urine output, duration of surgery and duration of anesthesia were recorded. In a 24-h recovery period in a post-anesthesia care unit (PACU) the recovery time, the first pain score and analgesic requirements were measured. Intra-operative HR and arterial BP were significantly less (p < 0.05) in G1 as compared to G2. In the PACU the first pain scores were significantly less (p < 0.05) in G2 than in G1. The time for the first patient analgesia demand dose was greater in G2, as also morphine consumption which was greater in G1 than G2 (p < 0.05). Other results were the same. None of the patients had any adverse drug reaction. Adding low doses of ketamine hydrochloride could be a routine therapy to improve the hemodynamic stability and reduce the post-operative morphine consumption during spinal fusion surgery.

Does partial coating with titanium improve the radiographic fusion rate of empty PEEK cages in cervical spine surgery? A comparative analysis of clinical data.

PubMed

Kotsias, Andreas; Mularski, Sven; Kühn, Björn; Hanna, Michael; Suess, Olaf

2017-01-01

Anterior cervical diskectomy and fusion (ACDF) is a well-established surgical treatment. Several types of intervertebral spacers can be used, but there is increasing evidence that PEEK cages yield insufficient fusion and thus less clinical improvement. The study aim was to assess the outcomes of single-level ACDF with an empty PEEK cage partially coated with titanium. This prospective multicenter single-arm clinical study collected follow-up data at 6, 12, and 18 months. A post hoc comparison was made to closely matched patients from another similar trial treated with identically designed, empty, uncoated PEEK cages. There were 49 of 50 patients (98%) who met the MCID of 3+ points of improvement on VAS pain or had an 18-month VAS ≤ 1. Yet even by 18 months post-op, only 40 of 50 (80%) PEEK + Ti patients achieved complete bony fusion. The PEEK + Ti group ( n  = 49) seemed to have somewhat better fusion scores and significantly better pain relief at 6 M than the matched controls ( n  = 49), but these differences did not persist at 12 M or 18 M. Patients (with either implant) who achieved complete bony fusion had significantly better improvement of pain at 6 M and disability at 6 M and 12 M than patients that remained unfused. ACDF is effective treatment for cervical myelopathy and radiculopathy. Although this and other studies show that titanium fuses better, partial coating of a PEEK cage does not improve the fusion rate sufficiently or confer other lasting clinical benefit. PEEK cages fully coated with titanium should be tested in prospective randomized comparative trials. Prospective, multicenter, single-arm clinical observational study without an individual Trial registration number. Study design and post hoc data analysis according to the "PIERCE-PEEK study", ISRCTN42774128, retrospectively registered 14 April 2009.

The Role of Unilateral Balloon Kyphoplasty for the Treatment of Patients with OVCFS: A Systematic Review and Meta-Analysis.

PubMed

Xiang, Guang-Heng; Tong, Min-Ji; Lou, Chao; Zhu, Si-Pin; Guo, Wei Jun; Ke, Chen Rong

2018-05-01

An increasing number of studies have been conducted to apply unilateral balloon kyphoplasty in the treatment of ostroporotic vertebral compression fractures (OVCFs). However, the efficacy and safety of unilateral kyphoplasty and whether a unilateral or a bilateral approach is superior is controversial. The purpose of this study was to evaluate the role of unilateral balloon kyphoplasty and use meta-analysis to compare the efficacy and safety of unilateral and bilateral kyphoplasty in patients with OVCFs. A systematic literature search was conducted from 1970 to April 2017 using Medline database and the Cochrane Central Register of Controlled Trials. Articles were limited to those published in English. Randomized controlled trials and nonrandomized comparative studies were also included. The following search terms were used: "osteoporotic vertebral compression fractures," or "OVCF," and "unilateral kyphoplasty," or "unipedicular approach," or "single balloon kyphoplasty," or "one balloon kyphoplasty." A comprehensive search of reference lists of retrieved articles and previous published reviews was also performed to ensure inclusion of all possible studies. All potential articles were independently reviewed by 2 investigators for inclusion into the final analysis. MINORS score was used for nonrandomized studies, and Detsky quality index was applied for prospective randomized controlled trials. Systematic review and meta-analysis was performed for the included studies. After unilateral balloon kyphoplasty the mean postoperative visual analog score (VAS) was from 1.74 to 4.77, mean postoperative kyphotic angle was from 5.9º to 11.22º, and complications involving cement leaks was from 6.8 to 21.9% or adjacent level fractures was from 0 to 5.6%). Unilateral kyphoplasty had significantly lower operative time, and less bone cement volume; however, the postoperative VAS, Oswestry Disability Index (ODI), vertebral height restoration rate, and cement leakage and adjacent vertebral fracture rate, were similar to bilateral kyphoplasty. Only 6 randomized controlled trials and 3 retrospective comparative studies were selected for analysis. Heterogeneity was detected among the studies when we pooled the outcomes. Based on the available evidence, the clinical and radiological results of unilateral balloon kyphoplasty were as good as those of bilateral balloon kyphoplasty for the treatment of OVCFs. And unilateral kyphoplasty had advantages in terms of operation time, radiation exposure, and cost. Unilateral balloon kyphoplasty, bilateral balloon kyphoplasty, osteoporotic vertebral compression fractures, complications of balloon kyphoplasty, meta-analysis.

Single-port thoracoscopic sympathicotomy using a double-lumen electrocautery tube and cautery hook for primary palmar hyperhidrosis: a randomized controlled trial.

PubMed

Jin, Cheng-Hua; Liu, Kai; Yu, Kai-Zhong; Tian, Hui; Mao, Zheng-Chun; Shen, Wei-Yu

2014-08-01

The objective of this study is to assess the use of a novel, double-lumen electrocautery tube (DLET) device for ablating the sympathetic nerve chain in patients with primary palmar hyperhidrosis (PPH). Forty-six patients with severe PPH were recruited into the study between November 2010 and February 2012. All patients underwent single port, bilateral video-assisted thoracoscopic sympathicotomy. Twenty-four patients were randomized to receive sympathicotomy using a conventional 5-mm electrocautery hook (hook group) and 22 patients were randomized to the DLET group. The mean postoperative follow-up period was 8.1 months (range: 1 to 15 months). After surgery the hands of all patients became dry and warm. Mean incision size was 10.6 ± 1.0 in the hook group and 6.5 ± 0.5 mm in the DLET group (p = 0.001). The mean pain score was 1.4 ± 0.6 with hook surgery and 0.9 ± 0.6 with the DLET device (p = 0.016). The mean operative time was longer in the hook group (36.8 ± 3.4 min) than in the DLET group (30.5 ± 3.9 min; p = 0.001). There were no significant differences between the two procedures in terms of hospital stay and compensatory sweating, or patient satisfaction. Pneumothorax occurred in two (8.3%) patients in the hook group and in one (4.5%) patient in the DLET group. None of the patients required chest drainage and none developed Horner syndrome. Single-port video-assisted thoracoscopic sympathicotomy using hook or DLET procedures is effective, safe, and minimally invasive method for palmar hyperhidrosis. The DLET device allows a shorter operation time, smaller incision, better cosmetic results, less pain, and better clarity of video, making it suitable for single-port thoracoscopic sympathicotomy. Georg Thieme Verlag KG Stuttgart · New York.

The efficacy of Labetalol versus Nitroglycerin for induction of controlled hypotension during sinus endoscopic surgery. A prospective, double-blind and randomized study.

PubMed

El-Shmaa, Nagat S; Ezz, Hoda Alsaid Ahmed; Younes, Ahmed

2017-06-01

To assess the efficacy of labetalol versus nitroglycerin for induction of controlled hypotension during sinus endoscopic surgery. A prospective, double-blind and randomized study. Carried out in operating room in university hospital. 60 patients of both sexes, American Society of Anesthesiologists (ASA) physical status I and II, age range from 20 to 60years; scheduled for elective sinus endoscopic surgery under general anesthesia (GA). Patients were divided into two groups (30 each). NTG group received nitroglycerin infusion at a dose of 2-5μg/kg/min, LAB group received labetalol infusion at a dose of 0.5-2mg/min. Surgical condition was assessed by surgeon using average category scale (ACS) of 0-5, a value of 2-3 being ideal. In both groups mean arterial blood pressure (MAP) was gradually reduced till the ideal ACS for assessment of surgical condition, the target of ACS was 2-3 or lower. Both studied drugs achieved desired hypotension and improved visualization of surgical field by decreasing bleeding in the surgical site, but ideal surgical conditions were created at mild hypotension (MAP 70-75) in LAB group while same conditions were created at MAP of 65-69mmHg in NTG group. Mean heart rate (HR) was significantly higher in NTG group as compared to LAB group. Blood loss decreased significantly in LAB group. Both labetalol and NTG are effective and safe drugs for induction of controlled hypotension during sinus endoscopic surgery. While, labetalol was better as it offered optimum operative condition with mild decrease in blood pressure, decreased surgical bleeding and less tachycardia during the surgery. Copyright © 2017 Elsevier Inc. All rights reserved.

Prospective randomized comparison of mitomycin C application in endoscopic and external dacryocystorhinostomy.

PubMed

Mudhol, Rekha R; Zingade, N D; Mudhol, R S; Harugop, Anil S; Das, Amal T

2013-08-01

The aim of the study is to compare the subjective (relief of symptoms) and objective (endoscopic visualization of ostium patency at the time of syringing) outcomes at the end of two procedures-Endonasal DCR versus External DCR with Mitomycin C and to assess the role of Mitomycin C in maintaining patency of nasolacrimal drainage system. Prospective randomized comparative study was performed. Thirty-five patients were enrolled in each endoscopic and external dacryocystorhinostomy groups with Mitomycin C (MMC) application. The 37 eyes underwent endonasal DCR (28 unilateral primary eyes + 1 bilateral primary eyes + 5 unilateral revision eyes + 1 bilateral revision eye) while 35 eyes underwent external DCR (34 unilateral primary eyes + 1 unilateral revision eye). Mitomycin C 0.2 mg/ml was applied intra-operatively for 5 min to the ostium site at the end of endonasal or external DCR procedure. Objective assessment by syringing at the end of 1 year in the endonasal group showed 35 eyes (94%) were patent, 1 (3%) was partially blocked and 1(3%) was completely blocked; while in external group all 35 eyes (100%) were patent. Endoscopic visualization of the ostium at the time of syringing showed only one eye (3%) in the endonasal group was blocked while all the other eyes in both groups were patent. Both groups had a mean follow-up of 6-36 months. No complications were associated with use of Mitomycin C. In conclusion, intra-operative use of Mitomycin C in both endoscopic DCR and external DCR is safe and effective in increasing the success rate.

A comparison between orthogonal and parallel plating methods for distal humerus fractures: a prospective randomized trial.

PubMed

Lee, Sang Ki; Kim, Kap Jung; Park, Kyung Hoon; Choy, Won Sik

2014-10-01

With the continuing improvements in implants for distal humerus fractures, it is expected that newer types of plates, which are anatomically precontoured, thinner and less irritating to soft tissue, would have comparable outcomes when used in a clinical study. The purpose of this study was to compare the clinical and radiographic outcomes in patients with distal humerus fractures who were treated with orthogonal and parallel plating methods using precontoured distal humerus plates. Sixty-seven patients with a mean age of 55.4 years (range 22-90 years) were included in this prospective study. The subjects were randomly assigned to receive 1 of 2 treatments: orthogonal or parallel plating. The following results were assessed: operating time, time to fracture union, presence of a step or gap at the articular margin, varus-valgus angulation, functional recovery, and complications. No intergroup differences were observed based on radiological and clinical results between the groups. In our practice, no significant differences were found between the orthogonal and parallel plating methods in terms of clinical outcomes, mean operation time, union time, or complication rates. There were no cases of fracture nonunion in either group; heterotrophic ossification was found 3 patients in orthogonal plating group and 2 patients in parallel plating group. In our practice, no significant differences were found between the orthogonal and parallel plating methods in terms of clinical outcomes or complication rates. However, orthogonal plating method may be preferred in cases of coronal shear fractures, where posterior to anterior fixation may provide additional stability to the intraarticular fractures. Additionally, parallel plating method may be the preferred technique used for fractures that occur at the most distal end of the humerus.

Comparison between the short-term results of onlay and sublay mesh placement in the management of uncomplicated para-umbilical hernia: a prospective randomized study.

PubMed

Bessa, S S; El-Gendi, A M; Ghazal, A H A; Al-Fayoumi, T A

2015-02-01

The aim of this study was to compare between the short-term results of onlay and sublay mesh placement in the prosthetic repair of uncomplicated para-umbilical hernia (PUH). Eighty patients with a defect size ranging from 4 to 10 cm were prospectively randomized to either the onlay group (40 patients) or the sublay group (40 patients). The operative time, postoperative complications and short-term recurrence were reported. There were no statistically significant differences between both study groups as regards the patients' demographics, associated co-morbidities and mean defect size. The median operative time was significantly shorter in the onlay group compared to that in the sublay group (52 vs. 91 min respectively, p < 0.001). No statistically significant difference was found in the daily median pain score throughout the first postoperative week. The time required to remove the suction drain was significantly shorter in the sublay group compared to that in the onlay group (3 vs. 7 days respectively, p < 0.001).Complications were encountered in 4 patients (10%) in the onlay group compared to 3 patients (7.5%) in the sublay group (p = 1.000). Superficial wound infection was encountered in 1 patient (2.5%) in the sublay group, Seroma was encountered in 2 patients (5%) in the onlay group, Deep vein thrombosis was encountered in 1 patient (2.5%) in the onlay group, Chest infection was encountered in 2 patients (5%) in the sublay group compared to 1 patient (2.5%) in the onlay group. Throughout the 22 months median follow-up duration (range 6-42 months), 2 recurrences (5%) were encountered in either study group. Both techniques are safe, efficient and are associated with comparable complication and recurrence rates.

Use of a surgical rehearsal platform and improvement in aneurysm clipping measures: results of a prospective, randomized trial.

PubMed

Chugh, A Jessey; Pace, Jonathan R; Singer, Justin; Tatsuoka, Curtis; Hoffer, Alan; Selman, Warren R; Bambakidis, Nicholas C

2017-03-01

OBJECTIVE The field of neurosurgery is constantly undergoing improvements and advances, both in technique and technology. Cerebrovascular neurosurgery is no exception, with endovascular treatments changing the treatment paradigm. Clipping of aneurysms is still necessary, however, and advances are still being made to improve patient outcomes within the microsurgical treatment of aneurysms. Surgical rehearsal platforms are surgical simulators that offer the opportunity to rehearse a procedure prior to entering the operative suite. This study is designed to determine whether use of a surgical rehearsal platform in aneurysm surgery is helpful in decreasing aneurysm dissection time and clip manipulation of the aneurysm. METHODS The authors conducted a blinded, prospective, randomized study comparing key effort and time variables in aneurysm clip ligation surgery with and without preoperative use of the SuRgical Planner (SRP) surgical rehearsal platform. Initially, 40 patients were randomly assigned to either of two groups: one in which surgery was performed after use of the SRP (SRP group) and one in which surgery was performed without use of the SRP (control group). All operations were videotaped. After exclusion of 6 patients from the SRP group and 9 from the control group, a total of 25 surgical cases were analyzed by a reviewer blinded to group assignment. The videos were analyzed for total microsurgical time, number of clips used, and number of clip placement attempts. Means and standard deviations (SDs) were calculated and compared between groups. RESULTS The mean (± SD) amount of operative time per clip used was 920 ± 770 seconds in the SRP group and 1294 ± 678 seconds in the control group (p = 0.05). In addition, the mean values for the number of clip attempts, total operative time, ratio of clip attempts to clips used, and time per clip attempt were all lower in the SRP group, although the between-group differences were not statistically significant. CONCLUSIONS Preoperative rehearsal with SRP increased efficiency and safety in aneurysm microsurgery as demonstrated by the statistically significant improvement in time per clip used. Although the rest of the outcomes did not demonstrate statistically significant between-group differences, the fact that the SRP group showed improvement in mean values for all measures studied suggests that preoperative rehearsal may increase the efficiency and safety of aneurysm microsurgery. Future studies aimed at improving patient outcome and safety during surgical clipping of aneurysms will be needed to keep pace with the quickly advancing endovascular field.

Minimally invasive video-assisted thyroidectomy: four-year experience of a single team in a General Surgery Unit.

PubMed

Scerrino, G; Paladino, N C; Di Paola, V; Morfino, G; Inviati, A; Amodio, E; Gulotta, G; Bonventre, S

2013-06-01

Minimally invasive video-assisted thyroidectomy (MIVAT) is a surgical technique that has showed increasingly good results, particularly in endocrine surgery centers. The aim of this prospective, non-randomized study was to evaluate feasibility, advantages and critical aspects of MIVAT in a general surgery unit. Two hundred twenty-four patients underwent total thyroidectomy for benign thyroid disease from May, 2008 to April, 2011. They were divided into two groups: one underwent conventional thyroidectomy (CT), and the other underwent MIVAT. The inclusion criteria were thyroid volume ≤35 mL and main nodule size ≤35 mm. For each patient, socio-demographic variables, hospitalization data and outcome measures (complication rate, operating time, post-operative pain, observer and patient scar assessment scale [OSAS and PSAS, respectively]) were collected. Multivariate regression analyses were done to assess the principal covariates affecting these outcome measures. There were 125 MIVATs and 99 CTs performed. The two groups were characterized by difference in age (38.4 vs. 50.9 years) and thyroid volume (18.6 vs. 23.3 mL). OSAS/PSAS scores were statistically significant in the MIVAT group (P<0.001 and P<0.001, respectively) even after adjusting for age and thyroid volume. Complication rate was similar in the two groups. MIVAT significantly decreased postoperative pain and improved cosmetic results. It can be performed in younger patients and in all cases in which there is a clear indication for the procedure. Its advantages were confirmed in a general surgery unit where correct indications were followed.

The 'INMARSAT' international maritime satellite communication system

NASA Astrophysics Data System (ADS)

Atserov, Iu. S.

1982-12-01

The history, design, operating characteristics, achievements, and prospects of INMARSAT are discussed. More than 1300 ships are presently equipped to operate within the system, and this number is expected to rise to about 5000 by 1986. The principle of operation involves single coordinating earth stations allocating telephone channels in their zones between other earth stations. The messages reach a common signalling channel with which all ship stations keep in touch. The ship stations are connected to the international telex network. The INMARSAT system enables ships in the automated mode of operation to establish telephone and telegraph comunication with any subscriber on the shore of any country. The quality of the communication is practically independent of the distance between ship and shore at any time of year and under any meteorological conditions. Estimates indicate that the use of satellite communication with ships reduces losses from accidents by 10 percent per year.

Comprehensive Anti-error Study on Power Grid Dispatching Based on Regional Regulation and Integration

NASA Astrophysics Data System (ADS)

Zhang, Yunju; Chen, Zhongyi; Guo, Ming; Lin, Shunsheng; Yan, Yinyang

2018-01-01

With the large capacity of the power system, the development trend of the large unit and the high voltage, the scheduling operation is becoming more frequent and complicated, and the probability of operation error increases. This paper aims at the problem of the lack of anti-error function, single scheduling function and low working efficiency for technical support system in regional regulation and integration, the integrated construction of the error prevention of the integrated architecture of the system of dispatching anti - error of dispatching anti - error of power network based on cloud computing has been proposed. Integrated system of error prevention of Energy Management System, EMS, and Operation Management System, OMS have been constructed either. The system architecture has good scalability and adaptability, which can improve the computational efficiency, reduce the cost of system operation and maintenance, enhance the ability of regional regulation and anti-error checking with broad development prospects.

TaOx-based resistive switching memories: prospective and challenges

PubMed Central

2013-01-01

Resistive switching memories (RRAMs) are attractive for replacement of conventional flash in the future. Although different switching materials have been reported; however, low-current operated devices (<100 μA) are necessary for productive RRAM applications. Therefore, TaOx is one of the prospective switching materials because of two stable phases of TaO2 and Ta2O5, which can also control the stable low- and high-resistance states. Long program/erase endurance and data retention at high temperature under low-current operation are also reported in published literature. So far, bilayered TaOx with inert electrodes (Pt and/or Ir) or single layer TaOx with semi-reactive electrodes (W and Ti/W or Ta/Pt) is proposed for real RRAM applications. It is found that the memory characteristics at current compliance (CC) of 80 μA is acceptable for real application; however, data are becoming worst at CC of 10 μA. Therefore, it is very challenging to reduce the operation current (few microampere) of the RRAM devices. This study investigates the switching mode, mechanism, and performance of low-current operated TaOx-based devices as compared to other RRAM devices. This topical review will not only help for application of TaOx-based nanoscale RRAM devices but also encourage researcher to overcome the challenges in the future production. PMID:24107610

Cost-utility analysis modeling at 2-year follow-up for cervical disc arthroplasty versus anterior cervical discectomy and fusion: A single-center contribution to the randomized controlled trial

PubMed Central

Warren, Daniel; Andres, Tate; Hoelscher, Christian; Ricart-Hoffiz, Pedro; Bendo, John; Goldstein, Jeffrey

2013-01-01

Background Patients with cervical disc herniations resulting in radiculopathy or myelopathy from single level disease have traditionally been treated with Anterior Cervical Discectomy and Fusion (ACDF), yet Cervical Disc Arthroplasty (CDA) is a new alternative. Expert suggestion of reduced adjacent segment degeneration is a promising future result of CDA. A cost-utility analysis of these procedures with long-term follow-up has not been previously reported. Methods We reviewed single institution prospective data from a randomized trial comparing single-level ACDF and CDA in cervical disc disease. Both Medicare reimbursement schedules and actual hospital cost data for peri-operative care were separately reviewed and analyzed to estimate the cost of treatment of each patient. QALYs were calculated at 1 and 2 years based on NDI and SF-36 outcome scores, and incremental cost effectiveness ratio (ICER) analysis was performed to determine relative cost-effectiveness. Results Patients of both groups showed improvement in NDI and SF-36 outcome scores. Medicare reimbursement rates to the hospital were $11,747 and $10,015 for ACDF and CDA, respectively; these figures rose to $16,162 and $13,171 when including physician and anesthesiologist reimbursement. The estimated actual cost to the hospital of ACDF averaged $16,108, while CDA averaged $16,004 (p = 0.97); when including estimated physicians fees, total hospital costs came to $19,811 and $18,440, respectively. The cost/QALY analyses therefore varied widely with these discrepancies in cost values. The ICERs of ACDF vs CDA with Medicare reimbursements were $18,593 (NDI) and $19,940 (SF-36), while ICERs based on actual total hospital cost were $13,710 (NDI) and $9,140 (SF-36). Conclusions We confirm the efficacy of ACDF and CDA in the treatment of cervical disc disease, as our results suggest similar clinical outcomes at one and two year follow-up. The ICER suggests that the non-significant added benefit via ACDF comes at a reasonable cost, whether we use actual hospital costs or Medicare reimbursement values, though the actual ICER values vary widely depending upon the CUA modality used. Long term follow-up may illustrate a different profile for CDA due to reduced cost and greater long-term utility scores. It is crucial to note that financial modeling plays an important role in how economic treatment dominance is portrayed. PMID:25694905

Open versus percutaneous repair in the treatment of acute Achilles tendon rupture: a randomized prospective study.

PubMed

Gigante, A; Moschini, A; Verdenelli, A; Del Torto, M; Ulisse, S; de Palma, L

2008-02-01

There is no agreement on the ideal type of surgical management for Achilles tendon rupture. The present randomized prospective study was performed to compare outcome data of open and percutaneous repair in the treatment of Achilles tendon rupture. Forty consecutive patients with acute rupture of Achilles tendon were recruited. Patients were randomized to receive open (group A) or percutaneous repair with Tenolig (group B). All patients followed the same rehabilitation protocol except for slight differences in the duration of immobilization. Follow-up included objective evaluation (at 4 and 12 months), subjective evaluation using the SF-12 questionnaire (at 24 months), and bilateral ultrasound scanning and isokinetic testing (at 12 months). The differences in the parameters evaluated clinically were not significant except for ankle circumference, which was significantly greater in group B. There were two minor complications in the open repair group and one case of failed repair in the percutaneous group. SF-12 questionnaire, ultrasound and isokinetic test data did not show significant differences between the groups. The present study demonstrates that the open and the percutaneous technique are both safe and effective in repairing the ruptured Achilles tendon and that both afford the same degree of restoration of clinical, ultrasound and isokinetic patterns. Medium-term results were substantially comparable. Percutaneous repair is performed on a day-surgery basis, it reduces cutaneous complications and operation times, and enables faster recovery, enhancing overall patient compliance. To us, these characteristics make it preferable to open repair in managing subcutaneous ruptures of Achilles tendon in non-professional sports practicing adults.

Timing of urinary catheter removal after uncomplicated total abdominal hysterectomy: a prospective randomized trial.

PubMed

Ahmed, Magdy R; Sayed Ahmed, Waleed A; Atwa, Khaled A; Metwally, Lobna

2014-05-01

To assess whether immediate (0h), intermediate (after 6h) or delayed (after 24h) removal of an indwelling urinary catheter after uncomplicated abdominal hysterectomy can affect the rate of re-catheterization due to urinary retention, rate of urinary tract infection, ambulation time and length of hospital stay. Prospective randomized controlled trial conducted at Suez Canal University Hospital, Egypt. Two hundred and twenty-one women underwent total abdominal hysterectomy for benign gynecological diseases and were randomly allocated into three groups. Women in group A (73 patients) had their urinary catheter removed immediately after surgery. Group B (81 patients) had the catheter removed 6h post-operatively while in group C (67 patients) the catheter was removed after 24h. The main outcome measures were the frequency of urinary retention, urinary tract infections, ambulation time and length of hospital stay. There was a significantly higher number of urinary retention episodes requiring re-catheterization in the immediate removal group compared to the intermediate and delayed removal groups (16.4% versus 2.5% and 0% respectively). Delayed urinary catheter removal was associated with a higher incidence of urinary tract infections (15%), delayed ambulation time (10.3h) and longer hospital stay (5.6 days) compared to the early (1.4%, 4.1h and 3.2 days respectively) and intermediate (3.7%, 6.8h and 3.4 days respectively) removal groups. Removal of the urinary catheter 6h postoperatively appears to be more advantageous than early or late removal in cases of uncomplicated total abdominal hysterectomy. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

J-pouch vs. side-to-end anastomosis after hand-assisted laparoscopic low anterior resection for rectal cancer: A prospective randomized trial on short and long term outcomes including life quality and functional results.

PubMed

Okkabaz, Nuri; Haksal, Mustafa; Atici, Ali Emre; Altuntas, Yunus Emre; Gundogan, Ersin; Gezen, Fazli Cem; Oncel, Mustafa

2017-11-01

To analyze the outcomes of j-pouch and side-to-end anastomosis in rectal cancer patients treated with laparoscopic hand-assisted low anterior resection. Prospective trial on cases randomized to have a colonic j-pouch or a side-to-end anastomosis after low anterior resection. Demographics, characteristics of disease and treatment, perioperative results, and functional outcomes and life quality were compared between the groups. Seventy four patients were randomized. Reservoir creation was withdrawn in 17 (23%) patients, mostly related to reach problem (n = 11, 64.7%). Anastomotic leakage rate was significantly higher in j-pouch group (8 [27.6%] vs. 0, p = 0.004). Stoma closure could not be achieved in 16 (28.1%) patients. Life quality and functional outcomes, measured 4, 8 and 12 months after the stoma reversal, were similar. Colonic j-pouch and side-to-end anastomosis are similar regarding perioperative measures including operation time, rates of postoperative complications, reoperation and 30-day mortality, and hospitalization period except anastomotic leak rate, which is higher in j-pouch group. Postoperative aspects are not different in patients receiving either technique including functional outcomes and life quality for the first year after stoma closure. In our opinion, both techniques may be preferred during the daily practice while performing laparoscopic surgery; but surgeons may be aware of a possibly higher anastomotic leak rate in case of a j-pouch. Copyright © 2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

Long-term follow-up of DDD and VDD pacing: a prospective non-randomized single-centre comparison of patients with symptomatic atrioventricular block.

PubMed

Marchandise, Sébastien; Scavée, Christophe; le Polain de Waroux, Jean-Benoit; de Meester, Christophe; Vanoverschelde, Jean-Louis; Debbas, Nadia

2012-04-01

This prospective non-randomized single-centre registry compared clinical outcome, pacing parameters, and long-term survival in patients receiving VDD or DDD pacemaker (PMs) for symptomatic atrioventricular (AV) block. Single-lead VDD (n= 166) and DDD (n= 254) PMs were implanted in 420 successive patients with isolated AV block between January 2001 and December 2009. At the end of the follow-up period [median 25 (1-141) months], there was no difference in the incidence of atrial fibrillation [11.2% in the VDD group; 11.4% in the DDD group (P= 0.95)], myocardial infarction [31.1% in the VDD group; 25.2% in the DDD group (P= 0.20)], or dilated cardiomyopathy [9.9% in the VDD group; 8.9% in the DDD group (P= 0.74)]. At last follow-up, 65.9% of the VDD PMs and 89.3% of the DDD PMs were still programmed in their original mode with good atrial sensing. Due to permanent atrial fibrillation, 7.9% patients out of the VDD group had been switched to VVIR mode and 8.7% patients out of the DDD group to VVIR or DDIR mode. The P-wave amplitude was poor (sensed P-wave <0.5 mV) in 19.1% of the VDD PM and 1.6% of the DDD PM (P< 0.001) and 7.1% of the VDD patients and 0.4% of the DDD patients had been switched to VVIR pacing mode due to P-wave undersensing and AV dissociation (P= 0.003). Symptomatic atrial undersensing requiring upgrading was similar in both groups. The overall survival, adjusted for age, was not significantly different in the VDD and the DDD group (log rank: 0.26). Moreover, Cox survival analysis excluded the pacing mode as a significant predictor of mortality [hazard ratio (HR) = 0.79, confidence interval (CI) (0.46-1.35), P= 0.39]. Comparing VDD and DDD pacing, a significantly larger number of VDD-paced patients developed poor atrial signal detection without clinical impact. However, atrial under sensing did not influence the incidence of atrial fibrillation, myocardial infarction, dilated cardiomyopathy, or mortality.

A Prospective Randomized Trial of Two Different Prostate Biopsy Schemes

ClinicalTrials.gov

2016-07-03

Prostate Cancer; Local Anesthesia; Prostate-Specific Antigen/Blood; Biopsy/Methods; Image-guided Biopsy/Methods; Prostatic Neoplasms/Diagnosis; Prostate/Pathology; Prospective Studies; Humans; Male; Ultrasonography, Interventional/Methods

Investigations of an Environmentally Induced Long Duration Hall Thruster Start Transient (PREPRINT)

DTIC Science & Technology

2006-02-06

Hall thruster start transient is produced by exposure of the thruster to ambient laboratory atmosphere. This behavior was first observed during operation of a cluster of four 200 W BHT-200 Hall effect thrusters where large anode discharge fluctuations, visible as increased anode current and a diffuse plume structure, occurred in an apparently random manner. During operation of a single thruster, the start transient appears as a quickly rising and later smoothly decaying elevated anode current with a diffuse plume that persists for less than 500 seconds. The start transient

Selecting promising treatments in randomized Phase II cancer trials with an active control.

PubMed

Cheung, Ying Kuen

2009-01-01

The primary objective of Phase II cancer trials is to evaluate the potential efficacy of a new regimen in terms of its antitumor activity in a given type of cancer. Due to advances in oncology therapeutics and heterogeneity in the patient population, such evaluation can be interpreted objectively only in the presence of a prospective control group of an active standard treatment. This paper deals with the design problem of Phase II selection trials in which several experimental regimens are compared to an active control, with an objective to identify an experimental arm that is more effective than the control or to declare futility if no such treatment exists. Conducting a multi-arm randomized selection trial is a useful strategy to prioritize experimental treatments for further testing when many candidates are available, but the sample size required in such a trial with an active control could raise feasibility concerns. In this study, we extend the sequential probability ratio test for normal observations to the multi-arm selection setting. The proposed methods, allowing frequent interim monitoring, offer high likelihood of early trial termination, and as such enhance enrollment feasibility. The termination and selection criteria have closed form solutions and are easy to compute with respect to any given set of error constraints. The proposed methods are applied to design a selection trial in which combinations of sorafenib and erlotinib are compared to a control group in patients with non-small-cell lung cancer using a continuous endpoint of change in tumor size. The operating characteristics of the proposed methods are compared to that of a single-stage design via simulations: The sample size requirement is reduced substantially and is feasible at an early stage of drug development.

[Impact of topical application of autologous platelet-rich gel on medical expenditure and length of stay in hospitals in diabetic patients with refractory cutaneous ulcers].

PubMed

Li, Lan; Wang, Chun; Wang, Yan; He, Li-Ping; Yang, Yan-Zhi; Chen, Li-Hong; Chen, Da-Wei; Li, Xiu-Jun; Ran, Xing-Wu

2012-09-01

To evaluate the potential financial benefit of topical application of autologous platelet-rich gel (APG) in treating diabetic refractory cutaneous ulcers. A single-center prospective randomized controlled trial was undertaken, with 117 patients with proven diabetic refractory cutaneous ulcers participating in the study. The patients who gave informed consents were randomly assigned into standard care group (n = 58) or standard care plus topical application of APG treatment group (n = 59). The outcome of healing and the medical expenditur and length of stay in the patients were compared between the two groups. The APG-treated group had better healing outcomes than the standard-treated group. The APG-treated group had 84.750 (50/59) complete healing and 98.31% improvement, higher than the 68.97% (40/58) and 75.86%, respectively, in the standard-treated group (P = 0.026). The median length for healing in the APG-treated patients was 36 days, shorter than the 45 days in the standard-treated patients (P = 0.012). The total medical expenditure and length of stay in hospitals were not significantly different between APG-treated patients [yen 38223 (23070-57398); 57 (41-94) days] and standard-treated patients [yen 35070 (24436-53649); 58 (31.75-58.50) days) (P = 0.455 and 0.301 respectively). Spendings on items such as medicine, artificial treatment, materials, interventional operation, surgical procedures, laboratory tests and other auxiliary examination, accommodations, meals, nursing care and debridement and dressing change were similar between the two groups (P > 0.05). There is an advantage for the topical application of APG on diabetic refractory cutaneous ulcers in terms of the healing outcomes. APG is a cost-effective choice for patients with diabetic refractory cutaneous ulcers.

The Effect of Written Information on Recall of Surgical Risks of Carpal Tunnel Release Surgery: A Randomized Controlled Study.

PubMed

Wong, Alison L; Martin, Janet; Tang, David; LeBlanc, Martin; Morris, Steven F; Paletz, Justin; Stein, John; Wong, Michael J; Bezuhly, Michael

2016-12-01

Written information has been thought to help patients recall surgical risks discussed during the informed consent process, but has not been assessed for carpal tunnel release, a procedure with the rare but serious risk of complex regional pain syndrome. The authors' objective was to determine whether providing a pamphlet would improve patients' ability to remember the risks of surgery. Sixty patients seen for carpal tunnel release were included in this prospective, single-blind, randomized study. Patients received either a written pamphlet of the risks of surgery or no additional information following a standardized consultation. Two weeks after the initial consultation, patients were contacted to assess their risk recall and whether they had read about the operation from any source. There was no difference in terms of the number of risks recalled between pamphlet (1.33 ± 1.21) or control groups (1.45 ± 1.22; p = 0.73). Recall of infection was better in the pamphlet group (p < 0.05). No patients remembered complex regional pain syndrome. There was no difference in the proportion of people who read additional information about carpal tunnel release surgery between the pamphlet (34.8 percent) and control groups (21.4 percent; p = 0.39), but reading about carpal tunnel release surgery was associated with improved recall (2.45 ± 1.13 versus 0.77 ± 0.91; p < 0.01). Reading about surgery improved risk recall, but providing this information in the form of a pamphlet did not, nor did it affect patients' ability to recall the risk of complex regional pain syndrome. These results demonstrate that surgeons should implement additional measures to improve comprehension of surgical risks. Therapeutic, I.

Open lung ventilation improves functional residual capacity after extubation in cardiac surgery.

PubMed

Reis Miranda, Dinis; Struijs, Ard; Koetsier, Peter; van Thiel, Robert; Schepp, Ronald; Hop, Wim; Klein, Jan; Lachmann, Burkhard; Bogers, Ad J J C; Gommers, Diederik

2005-10-01

After cardiac surgery, functional residual capacity (FRC) after extubation is reduced significantly. We hypothesized that ventilation according to the open lung concept (OLC) attenuates FRC reduction after extubation. A prospective, single-center, randomized, controlled clinical study. Cardiothoracic operating room and intensive care unit of a university hospital. Sixty-nine patients scheduled for elective coronary artery bypass graft and/or valve surgery with cardiopulmonary bypass. Before surgery, patients were randomly assigned to three groups: (1) conventional ventilation (CV); (2) OLC, started after arrival in the intensive care unit (late open lung); and (3) OLC, started directly after intubation (early open lung). In both OLC groups, recruitment maneuvers were applied until Pao2/Fio2 was >375 Torr (50 kPa). No recruitment maneuvers were applied in the CV group. FRC was measured preoperatively and 1, 3, and 5 days after extubation. Peripheral hemoglobin saturation (Spo2) was measured daily till the third day after extubation while the patient was breathing room air. Hypoxemia was defined by an Spo2 value < or =90%. Averaged over the 5 postoperative days, FRC was significantly higher in the early open lung group and tended to be higher in the late open lung group, in comparison with the CV group (mean +/- sem: CV, 1.8 +/- 0.1; late open lung,1.9 +/- 0.1; and early open lung, 2.2 +/- 0.1l). In the CV group, 37% of the patients were hypoxic on the third day after extubation, compared with none of the patients in both OLC groups. After cardiac surgery, earlier application of OLC resulted in a significantly higher FRC and fewer episodes of hypoxemia than with CV after extubation.

Single-shot intraoperative local anaesthetic infiltration does not reduce morphine consumption after total hip arthroplasty: a double-blinded placebo-controlled randomized study.

PubMed

Zoric, L; Cuvillon, P; Alonso, S; Demattei, C; Vialles, N; Asencio, G; Ripart, J; Nouvellon, E

2014-04-01

The infiltration of local anaesthetic (LA), ketorolac, and epinephrine has been suggested to be effective for analgesia after total hip arthroplasty (THA). The part of action of each component of the mixture remains unclear. We investigated the contribution of infiltration of ropivacaine alone on the morphine consumption during the first 24 h after surgery. Sixty patients undergoing primary THA were included in this prospective randomized double-blinded placebo-controlled trial, after IRB approval and informed consent. Surgical and general anaesthetic management were standardized. At the end of surgery, 80 ml of ropivacaine 0.2% (160 mg) or saline was infiltrated. The primary endpoint was morphine consumption 24 h after surgery. The secondary endpoints were: visual analogue scale scores and opioid side-effects at H2, H4, H8, H12, H24, D1, D2, D3, D4, D5, rehabilitation programme progress, chronic pain level, analgesic consumption, and surgical result at 3 months and 1 yr after surgery. The observation period was 1 yr. Groups were similar for patient characteristic and perioperative characteristics. The ropivacaine wound infiltration did not reduce morphine consumption at 24 h [median (25th and 75th inter-quartile) 27 (17-37) mg in the ropivacaine group vs 24 (18-34) mg in the placebo group, P=0.51] or its side-effects. No effect was found on rehabilitation progress or chronic pain after 3 months or 1 yr, but these were not the main endpoints of the study. Ropivacaine infiltration alone did not reduce morphine consumption at 24 h after operation nor did it improve postoperative rehabilitation.

Microbial contamination of meat during the skinning of beef carcass hindquarters at three slaughtering plants.

PubMed

Gill, C O; McGinnis, J C; Bryant, J

1998-07-21

The microbiological effects on the product of the series of operations for skinning the hindquarters of beef carcasses at three packing plants were assessed. Samples were obtained at each plant from randomly selected carcasses, by swabbing specified sites related to opening cuts, rump skinning or flank skinning operations, randomly selected sites along the lines of the opening cuts, or randomly selected sites on the skinned hindquarters of carcasses. A set of 25 samples of each type was collected at each plant, with the collection of a single sample from each selected carcass. Aerobic counts, coliforms and Escherichia coli were enumerated in each sample, and a log mean value was estimated for each set of 25 counts on the assumption of a log normal distribution of the counts. The data indicated that the hindquarters skinning operations at plant A were hygienically inferior to those at the other two plants, with mean numbers of coliforms and E. coli being about two orders of magnitude greater, and aerobic counts being an order of magnitude greater on the skinned hindquarters of carcasses from plant A than on those from plants B or C. The data further indicated that the operation for cutting open the skin at plant C was hygienically superior to the equivalent operation at plant B, but that the operations for skinning the rump and flank at plant B were hygienically superior to the equivalent operations at plant C. The findings suggest that objective assessment of the microbiological effects on carcasses of beef carcass dressing processes will be required to ensure that Hazard Analysis: Critical Control Point and Quality Management Systems are operated to control the microbiological condition of carcasses.

A comparison of 2 cesarean section methods, modified Misgav-Ladach and Pfannenstiel-Kerr: A randomized controlled study.

PubMed

Şahin, Nur; Genc, Mine; Turan, Gülüzar Arzu; Kasap, Esin; Güçlü, Serkan

2018-03-13

The modified Misgav-Ladach method (MML) is a minimally invasive cesarean section procedure compared with the classic Pfannenstiel-Kerr (PK) method. The aim of the study was to compare the MML method and the PK method in terms of intraoperative and short-term postoperative outcomes. This prospective, randomized controlled trial involved 252 pregnant women scheduled for primary emergency or elective cesarean section between October, 2014 and July, 2015. The primary outcome measures were the duration of surgery, extraction time, Apgar score, blood loss, wound complications, and number of sutures used. Secondary outcome measures were the wound infection, time of bowel restitution, visual analogue scale (VAS) scores at 6 h and 24 h after the operation, limitations in movement, and analgesic requirements. At 6 weeks after surgery, the patients were evaluated regarding late complications. There was a significant reduction in total operating and extraction time in the MML group (p < 0.001). Limitations in movement were lower at 24 h after the MML operation, and less analgesic was required in the MML group. There was no difference between the 2 groups in terms of febrile morbidity or the duration of hospitalization. At 6 weeks after the operation, no complaints and no additional complications from the surgery were noted. The MML method is a minimally invasive cesarean section. In the future, as surgeons' experience increases, MML will likely be chosen more often than the classic PK method.

Bupivacaine application reduces post thyroidectomy pain: Cerrahpasa experience

PubMed Central

Teksoz, Serkan; Soylu, Selen; Erbabacan, Safak Emre; Ozcan, Murat; Bukey, Yusuf

2016-01-01

Background We aimed to evaluate the impact of bupivacaine administration into the surgical field after total thyroidectomy on post-operative pain and analgesic requirement with a double-blind, prospective, clinical and randomized study. Methods The study was performed between 2010 and 2011. Pain assessment was performed with the visual analog score (VAS). Patients were pre-operatively, randomly divided into two groups to receive either bupivacaine or saline. One group received a 10-mL of bupivacaine solution while the other group was treated with the same volume of 0.9% NaCl through the drain after completion of total thyroidectomy procedure. All patients were anesthetized and operated with the same anesthesia and surgical team. Results Ninety-one patients (20 males) were included in the study. No patient dropped out of the study during the procedures. No mortality was seen. The VAS scores were significantly lower in the bupivacaine administered group at post-operative minute 30 (3.7±3.2 vs. 5±2.9; P=0.03), hour one (3.04±2.4 vs. 4.2±2.8; P=0.04), and hour eight (1.8±2.04 vs. 3.2±2.1; P=0.005). Thirteen patients required analgesia during their hospital stay in the bupivacaine group while this number was twenty-two in the saline group (P=0.005). Conclusions Local bupivacaine administration into the surgical field after total thyroidectomy reduces pain and analgesic requirement during the hospital stay. PMID:28149801