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Sample records for prospective randomized evaluations

  1. Design of a prospective, randomized evaluation of an integrated nutrition program in rural Viet Nam.

    PubMed

    Marsh, David R; Pachón, Helena; Schroeder, Dirk G; Ha, Tran Thu; Dearden, Kirk; Lang, Tran Thi; Hien, Nguyen Dhanh; Tuan, Doan Anh; Thach, Tran Duc; Claussenius, David R

    2002-12-01

    Few prospective studies of child growth and its determinants take place in programmatic contexts. We evaluated the effect of Save the Children's (SC) community empowerment and nutrition program (CENP) on child growth, care, morbidity, empowerment, and behavioral determinants. This paper describes the research methods of this community-based study. We used a longitudinal, prospective, randomized design. We selected 12 impoverished communes with documented child malnutrition, three comparison, and three intervention communes in each of two districts in Phu Tho Province, west of Hanoi. SC taught district trainers in November 1999 to train local health volunteers to implement the 10-month CENP, including situation analysis, positive deviance (PD) inquiry, growth monitoring and promotion, nutrition education and rehabilitation program (NERP), deworming, and monitoring. PD inquiries aim to discover successful care practices in poor households that likely promote well-nourished children. NERPs are neighborhood-based, facilitated group learning sessions where caregivers of malnourished children learn and practice PD and other healthy behaviors. We dewormed all intervention and comparison children. We randomly selected 240 children 5 to 25 months of age (120 intervention and 120 comparison). We gathered information on nutritional status, diet, illness, care, behavioral determinants, empowerment, and program quality, monthly for six months with a re-survey at 12 months. We collected most information through maternal interview but also observed hygiene and program quality, and videotaped feedings at home. Some implementation and research limitations will attenuate CENP impact and measurement of its effectiveness.

  2. Randomized prospective evaluation of adjuvant hyaluronic acid therapy administered after knee arthroscopy.

    PubMed

    Westrich, Geoffrey; Schaefer, Sarah; Walcott-Sapp, Sarah; Lyman, Stephen

    2009-12-01

    Intra-articular injections of hyaluronic acid products may eliminate pain, improve mobility and quality of life, and delay osteoarthritis progression. In this study, we evaluated the safety and efficacy of sodium hyaluronate injections given after knee arthroscopy. Forty-six patients with early osteoarthritis and a symptomatic meniscus tear were prospectively randomized into study (injection) and control groups and underwent knee arthroscopy. Study patients received 3 sodium hyaluronate injections after surgery. Study and control outcomes were compared 3 and 6 months after surgery. The injection patients had significantly less pain (visual analog scale) at 3-month follow-up and more flexion at 6-month follow-up. Tenderness, pain on motion, and crepitus were significantly more likely to be absent from injection patients at the 3- and 6-month follow-ups. Patients with osteoarthritis and a symptomatic meniscus tear may experience more pain relief and functional mobility after arthroscopic surgery plus hyaluronic acid injections than after arthroscopy alone.

  3. The Efficacy of Intraoperative Neuromonitoring During Robotic Thyroidectomy: A Prospective, Randomized Case-Control Evaluation.

    PubMed

    Lee, Hye Yoon; Lee, Ju-Young; Dionigi, Gianlorenzo; Bae, Jeoung Won; Kim, Hoon Yub

    2015-11-01

    This study evaluates the efficacy of intraoperative neuromonitoring (IONM) on voice performance in robotic thyroidectomy. The study was based on a prospective randomized series. Between June 2011 to September 2012, 50 patients with thyroid cancer who underwent robotic thyroidectomy were enrolled. The IONM and non-IONM groups consisted of 25 patients each. Voice Handicap Index (VHI), voice range profile (VRP), and laryngoscopy were used to assess voice function before surgery and at 2 weeks, 3 months, and 6 months after the operation. No palsy was diagnosed by laryngoscopy in either group. VHI values were similar in both groups. In the IONM group, there was significantly earlier recovery in VRP minimum intensity compared with the non-IONM group. However, there were no differences of mean change of VRP maximum frequency and intensity or minimum frequency between the two groups. We found that IONM facilitated more rapid recovery of voice function, especially in VRP minimum intensity, during robotic thyroid surgery.

  4. A prospective, randomized evaluation of acellular human dermal matrix augmentation for arthroscopic rotator cuff repair.

    PubMed

    Barber, F Alan; Burns, Joseph P; Deutsch, Allen; Labbé, Marc R; Litchfield, Robert B

    2012-01-01

    To prospectively evaluate the safety and effectiveness of arthroscopic acellular human dermal matrix augmentation of large rotator cuff tear repairs. A prospective, institutional review board-approved, multicenter series of patients undergoing arthroscopic repair of 2-tendon rotator cuff tears measuring greater than 3 cm were randomized by sealed envelopes opened at the time of surgery to arthroscopic single-row rotator cuff repair with GraftJacket acellular human dermal matrix (Wright Medical Technology, Arlington, TN) augmentation (group 1) or without augmentation (group 2). Preoperative and postoperative functional outcome assessments were obtained by use of the American Shoulder and Elbow Surgeons (ASES), Constant, and University of California, Los Angeles scales. Gadolinium-enhanced magnetic resonance imaging (MRI) evaluation of these repairs was obtained at a mean of 14.5 months (range, 12 to 24 months). Adverse events were recorded. There were 22 patients in group 1 and 20 in group 2 with a mean age of 56 years. The mean follow-up was 24 months (range, 12 to 38 months). The ASES score improved from 48.5 to 98.9 in group 1 and from 46.0 to 94.8 in group 2. The scores in group 1 were statistically better than those in group 2 (P = .035). The Constant score improved from 41.0 to 91.9 in group 1 and from 45.8 to 85.3 in group 2. The scores in group 1 were statistically better than those in group 2 (P = .008). The University of California, Los Angeles score improved from 13.3 to 28.2 in group 1 and from 15.9 to 28.3 in group 2 (P = .43). Gadolinium-enhanced MRI scans showed intact cuffs in 85% of repairs in group 1 and 40% in group 2 (P < .01). No adverse events were attributed to the presence of the matrix grafts. Acellular human dermal matrix augmentation of large (>3 cm) cuff tears involving 2 tendons showed better ASES and Constant scores and more frequent intact cuffs as determined by gadolinium-enhanced MRI. Intact repairs were found in 85% of the augmented

  5. Prospective and randomized study to evaluate the clinical impact of cap assisted colonoscopy (CAC).

    PubMed

    Frieling, T; Neuhaus, F; Kuhlbusch-Zicklam, R; Heise, J; Kreysel, C; Hülsdonk, A; Blank, M; Czypull, M

    2013-12-01

    Although colonoscopy is the standard procedure in the diagnosis of colorectal neoplasia, a significant number of clinical relevant lesions may be missed even by experienced endoscopists using current technology. A transparent cap mounted at the tip of a colonoscope may be an easy way to extend the visual field during colonoscopy and may improve the detection rate of mucosal lesions. The significance of cap assisted (CAC) vs. conventional colonoscopy (CC) on polyp detection rate was evaluated in a prospective randomized controlled trial in 504 patients. CC and CAC detected polyps in 39.3 % and 31.8, not significantly different. There was also no significant difference between CAC and CC according to age, sex, indication for colonoscopy, diverticulosis, sedation, bowel cleansing, withdrawal time, time/number of attempts to intubate the cecal walve, number, localization, size or histology of polyps,. However, the time to reach the cecal floor and the overall time of colonoscopy were significantly lower for CAC (1 minute). CAC was without clinical impact on polyp detection rate or performance of colonoscopy. © Georg Thieme Verlag KG Stuttgart · New York.

  6. Prospective Randomized Clinical and Radiographic Evaluation of a Novel Bioabsorbable Biocomposite Tibial Tuberosity Advancement Cage Implant.

    PubMed

    Barnhart, Matthew D; Watson, Adam T; Thatcher, Lawrence G; Wotton, Harry; Naber, Steven J

    2016-07-01

    To evaluate the suitability of a novel bioabsorbable biocomposite cage (BC) implant for use in tibial tuberosity advancement (TTA) surgery in dogs with cranial cruciate ligament (CrCL) disease and to compare radiographic osteotomy healing scores and complications between groups that received either a BC or stainless steel cage (SSC). Prospective randomized clinical study. Dogs with unilateral CrCL rupture (n=56). TTA was performed in 60 consecutive dogs using either a BC (30 dogs) or SSC (30 dogs). Patient parameters, 6 week and 6 month postoperative radiographic osteotomy healing scores, time elapsed to postoperative rechecks, and complications were compared between groups. Osteotomy healing was graded using a 5-point (0-4) scale. Data were analyzed using Wilcoxon Rank Sum tests and χ(2) tests with significance set at P<.05. Fifty-six dogs (30 BC, 26 SSC) had complete medical and radiographic records at 6 months for inclusion in data analysis. Three complications occurred in the BC group (1 major, 2 minor) and 2 occurred in the SSC group (2 minor). There was no statistical difference in patient parameters, 6 week healing scores, or complications between BC and SSC groups. Healing scores at 6 months were significantly higher in the BC group (3.3 ± 0.52) compared to the SSC group (2.9 ± 0.69; P=.04). Based on improved BC osteotomy healing scores 6 months after surgery with no significant differences in complications compared to SSC, BC TTA cages are a viable alternative to SSC. © Copyright 2016 by The American College of Veterinary Surgeons.

  7. The evaluation of clopidogrel use in perioperative general surgery patients: a prospective randomized controlled trial.

    PubMed

    Chu, Edward W; Chernoguz, Artur; Divino, Celia M

    2016-06-01

    The perioperative safety profile of clopidogrel, a potent antiplatelet agent used in the management of cardiovascular disease, is unknown, and there are no evidence-based guidelines recommending for either its interruption or continuation at this time. The aim of this study was to determine whether patients who are maintained on clopidogrel before general surgical procedures are at increased risk of perioperative bleeding complications. Patients receiving clopidogrel at the time of elective general surgery were randomized to either discontinue clopidogrel 1 week before surgery (group A) or continue clopidogrel into surgery (group B). All other antiplatelet and anticoagulant agents were discontinued before surgery. The primary end points were perioperative bleeding requiring intraoperative or postoperative transfusion of blood or blood components and bleeding-related readmission, reoperation, or mortality within 90 days of surgery. The secondary end points were perioperative myocardial infarction or cerebrovascular accidents within 90 days of surgery. Thirty-nine patients were enrolled and underwent 43 general surgical operations. Twenty-one procedures were randomized to group A and 22 to group B. The most commonly performed individual procedures were open inguinal hernia repair (23%), laparoscopic cholecystectomy (21%), open ventral hernia repair (15%), laparoscopic ventral hernia repair (11%), and laparoscopic inguinal hernia repair (9%). No perioperative mortalities, bleeding events requiring blood transfusion, or reoperations occurred. One readmission for intra-abdominal hematoma requiring percutaneous drainage occurred in each group (group A: 4.8% vs group B: 4.5%; P = 1.0). No myocardial infarctions or cerebrovascular accidents were observed or reported. The outcomes from this prospective study suggest that, patients undergoing commonly performed elective general surgical procedures can be safely maintained on clopidogrel without increased perioperative

  8. A prospective randomized multicenter clinical evaluation of an anterior cervical fusion cage.

    PubMed

    Hacker, R J; Cauthen, J C; Gilbert, T J; Griffith, S L

    2000-10-15

    A prospective, concurrently controlled, randomized, multicenter trial of an anterior Bagby and Kuslich cervical fusion cage (BAK/C; Sulzer Spine-Tech, Minneapolis, MN) for treatment of degenerative disc disease of the cervical spine. To report clinical results with maximum 24-month follow-up of fusions performed with the BAK/C fusion cage. Threaded lumbar cages have been used during the past decade as a safe and effective surgical solution for chronic disabling low back pain. Threaded cages have now been developed for use in anterior cervical interbody fusions to obviate the need for allografts or autogenous bone grafting procedures while providing initial stability during the fusion process. Patients with symptomatic cervical discogenic radiculopathy were treated with either anterior cervical discectomy with uninstrumented bone-only fusion (ACDF) or BAK/C fusion cage(s). Independent radiographic assessment of fusion was made and patient-based outcome was assessed by visual analog pain scale and a Short Form (SF)-36 Health Status Questionnaire. Data analysis included 344 patients at 1 year and 180 at 2 years. When the two cage groups (hydroxya, patite-coated or noncoated) were compared with the ACDF group, similar outcomes were noted for duration of surgery, hospital stay, improvements in neck pain and radicular pain in the affected limb, improvements in the SF-36 Physical Component subscale and Mental Component subscale, and the patients' perception of overall surgical outcome. Symptom improvements were maintained at 2 years. A greater percentage of patients with ACDF needed an iliac crest bone harvest than did BAK/C patients (67% vs.- 3%). Successful fusion for one-level procedures at 12 months was 97.9% for the BAK/C groups and 89.7% for the ACDF group (P < 0.05). The complication rate for the ACDF group was 20.4% compared with an overall complication rate of 11.8% with BAK/C. There was no difference in complications that necessitated a second operative

  9. Evaluation of 5 versus 10 granulocyteaphaeresis sessions in steroid-dependent ulcerative colitis: A pilot, prospective, multicenter, randomized study

    PubMed Central

    Ricart, Elena; Esteve, Maria; Andreu, Montserrat; Casellas, Francesc; Monfort, David; Sans, Miquel; Oudovenko, Natalia; Lafuente, Raúl; Panés, Julián

    2007-01-01

    AIM: To evaluate the efficacy of 5 compared to 10 granulocyteaphaeresis sessions in patients with active steroid-dependent ulcerative colitis. METHODS: In this pilot, prospective, multicenter randomized trial, 20 patients with moderately active steroid-dependent ulcerative colitis were randomized to 5 or 10 granulocyteaphaeresis sessions. The primary objective was clinical remission at wk 17. Secondary measures included endoscopic remission and steroid consumption. RESULTS: Nine patients were randomized to 5 granulocyteaphaeresis sessions (group 1) and 11 patients to 10 granulocyteaphaeresis sessions (group 2). At wk 17, 37.5% of patients in group 1 and 45.45% of patients in group 2 were in clinical remission. Clinical remission was accompanied by endoscopic remission in all cases. Eighty-six percent of patients achieving remission were steroid-free at wk 17. Daily steroid requirements were significantly lower in group 2. Eighty-nine per cent of patients remained in remission during a one year follow-up. One serious adverse event, not related to the study therapy, was reported. CONCLUSION: Granulocyteaphaeresis is safe and effective for the treatment of steroid-dependent ulcerative colitis. In this population, increasing the number of aphaeresis sessions is not associated with higher remission rates, but affords a significant steroid-sparing effect. PMID:17465500

  10. Prospective, randomized evaluation of endoscopic versus open carpal tunnel release in bilateral carpal tunnel syndrome: an interim analysis.

    PubMed

    Michelotti, Brett; Romanowsky, Diane; Hauck, Randy M

    2014-12-01

    Most randomized trials have shown similar results with endoscopic carpal tunnel release (ECTR) and open carpal tunnel release (OCTR); however, there are studies suggesting less postoperative pain, faster improvement in grip and pinch strength, and earlier return to work with the endoscopic technique. The goal of this study was to prospectively examine subjective and functional outcomes, satisfaction, and complications after both ECTR and OCTR in the opposite hands of the same patient, serving as their own control. This was a prospective, randomized study in which patients underwent surgery for bilateral carpal tunnel syndrome. The first carpal tunnel release was performed on the most symptomatic hand-determined by the patient. Operative approach was randomly assigned and, approximately 1 month later, the alternative technique was performed on the contralateral side. Demographic data were obtained, and functional outcomes were recorded preoperatively and postoperatively, including pain score, 2-point discrimination, Semmes-Weinstein monofilament testing, thenar strength, and overall grip strength. The carpal tunnel syndrome-functional status score and carpal tunnel syndrome-symptom severity score were recorded before surgery and at 2, 4, 8, 12, and 24 weeks postoperatively. Overall satisfaction with each technique was recorded at the conclusion of the study. Currently, 25 subjects have completed final visit testing. There were no differences in pain score, 2-point discrimination, Semmes-Weinstein monofilament testing, thenar strength, or overall grip strength at any of the postoperative time points. Carpal tunnel syndrome-symptom severity score and carpal tunnel syndrome-functional status score were not significantly different between groups at any of the evaluations. Overall satisfaction, where patients recorded a number from 0 to 100, was significantly greater in the ECTR group (95.95 vs 91.60, P = 0.04). There were no complications with either technique. This

  11. Electromyography in evaluation of pain after different types of tonsillectomy: prospective randomized study.

    PubMed

    Vaiman, Michael; Gavrieli, Haim; Krakovski, Daniel

    2007-01-01

    Combined surface electromyography (sEMG) and visual analogue scale (VAS) pain assessment was performed on randomly assigned adults following tonsillectomy to research the effect of fibrin sealant (Group 1, n = 25), CO(2) laser (Group 2, n = 18) and electrocoagulation (Group 3, n = 40) on postsurgical pain. Timing and amplitude of sEMG activity of masseter, infrahyoid and submandibular muscles were measured during swallowing simultaneously with VAS assessment and compared to normative database. Postsurgical electric activity of masseter and infrahyoid was significantly higher in comparison with normative database. sEMG and VAS data showed that tonsillectomy ended with fibrin sealant caused less pain than laser or electrocoagulation techniques with no correlation between the VAS score and duration of swallows. Tonsillectomy affects muscle activity significantly by involving additional muscles (infrahyoid) in swallowing. Combined sEMG and VAS data indicated electrocautery as the most painful, laser as less painful, and fibrin sealant as the least painful technique.

  12. A randomized, controlled, prospective trial to evaluate the haemostatic effect of Lyostypt versus Surgicel in arterial bypass anastomosis: "COBBANA" trial

    PubMed Central

    Baumann, Petra; Schumacher, Hardy; Hüsing, Johannes; Luntz, Steffen; Knaebel, Hanns-Peter

    2009-01-01

    Background The development of suture hole bleeding at peripheral arterial bypass anastomoses using PTFE graft prostheses is a common problem in peripheral vascular surgery. Traditionally the problem is managed by compression with surgical swabs and reversal heparin or by using several haemostatic device (e.g. different forms of collagen, oxidized cellulose, gelatine sponge, ethylcyanoacrylate glue or fibrin) with various success. Preclinical data suggest that the haemostatic effect of collagen is stronger than that of oxidized cellulose, but no direct clinical comparison of their hemostatic performance has been published so far. Design This randomized, controlled, prospective trial evaluates the haemostatic effect of Lyostypt versus Surgicel in arterial bypass anastomosis. 28 patients undergoing an elective peripheral vascular reconstruction due to peripheral vascular disease will be included. Suture hole bleeding occurring at the arterial bypass anastomosis using a PTFE prostheses will be stopped by the application of Lyostypt and/or Surgicel. The proximal anastomoses will be randomized intraoperatively. The patients will be allocated into 4 different treatment groups. Group1 Lyostypt distal/Surgicel proximal; Group 2: Lyostypt proximal/Surgicel distal; Group 3: Surgicel distal and proximal; Group 4: Lyostypt distal and proximal. Primary endpoint of the study is time to haemostasis. Secondary endpoints are the number of intraoperatively used haemostatic devices, postoperative mortality within 30 days as well as the intraoperative efficacy rating of the two devices evaluated by the surgeon. As a safety secondary parameter, the local and general complication occurring till 30 ± 10 days postoperatively will also be analysed. After hospital discharge the investigator will examine the enrolled patients again at 30 days after surgery. Discussion The COBBANA trial aims to assess, whether the haemostatic effect of Lyostypt is superior to Surgicel in suture hole bleedings

  13. Evaluation of a New Needle Guidance System for Ultrasound: Results of a Prospective, Randomized, Blinded Study.

    PubMed

    Swenson, Jeffrey D; Klingler, Kendell R; Pace, Nathan L; Davis, Jennifer J; Loose, Evelyn C

    2016-01-01

    Accurate needle control during ultrasound (US)-guided nerve blocks may be an elusive goal for the anesthesiologist. Despite modifications to increase echogenicity, needle visibility still requires precise alignment within the transducer beam. In this study, we evaluated a magnetically guided ultrasound (MGU) system that produces a real-time, graphic display of the needle position and trajectory that is independent of the US beam. The MGU system was compared with echogenic needles and conventional ultrasound (CU) by anesthesiologists with and without prior experience performing US-guided nerve blocks. Participants were asked to perform tasks to quantify accuracy with respect to needle direction (directional accuracy) and needle tip position (positional accuracy). These evaluations were performed in a porcine tissue model. Regarding directional accuracy, inexperienced subjects were able to contact a target capsule with a single needle pass during both in-plane (IP) and out-of-plane (OOP) approaches using the magnetic guidance system. By contrast, using CU, subjects required redirection 3.8 ± 2.4 (P = 0.02), and 4.5 ± 3.9 (P = 0.04) times, respectively, for IP and OOP approaches. Experienced subjects contacted the target capsule with a single pass for both IP and OOP approaches when using the magnetic guidance system. With CU, experienced subjects were able to contact the target with a single pass using an IP approach but required redirection 3.4 ± 2.8 (P = 0.046) times during OOP approaches. Positional accuracy was also superior for both inexperienced (P = 0.04) and experienced (P = 0.02) users during an OOP approach. In a tissue model, the MGU system improved control of needle trajectory and needle tip position for both inexperienced and experienced subjects.

  14. A prospective, randomized, double-blind evaluation of trigger-point injection therapy for low-back pain.

    PubMed

    Garvey, T A; Marks, M R; Wiesel, S W

    1989-09-01

    The efficacy of trigger-point injection therapy in treatment of low-back strain was evaluated in a prospective, randomized, double-blind study. The patient population consisted of 63 individuals with low-back strain. Patients with this diagnosis had nonradiating low-back pain, normal neurologic examination, absence of tension signs, and lumbosacral roentgenograms interpreted as being within normal limits. They were treated conservatively for 4 weeks before entering the study. Injection therapy was of four different types: lidocaine, lidocaine combined with a steroid, acupuncture, and vapocoolant spray with acupressure. Results indicated that therapy without injected medication (63% improvement rate) was at least as effective as therapy with drug injection (42% improvement rate), at a P value of 0.09. Trigger-point therapy seems to be a useful adjunct in treatment of low-back strain. The injected substance apparently is not the critical factor, since direct mechanical stimulus to the trigger-point seems to give symptomatic relief equal to that of treatment with various types of injected medication.

  15. Evaluation of Endotracheal Intubation with a Flexible Fiberoptic Bronchoscope in Lateral Patient Positioning: A Prospective Randomized Controlled Trial.

    PubMed

    Li, Hui; Wang, Wu; Lu, Ya-Ping; Wang, Yan; Chen, Li-Hua; Lei, Li-Pei; Fang, Xiang-Ming

    2016-09-05

    There is an unmet need for a reliable method of airway management for patients in the lateral position. This prospective randomized controlled two-center study was designed to evaluate the feasibility of intubation using a flexible fiberoptic bronchoscope in the lateral position during surgery. Seventy-two patients scheduled for elective nonobstetric surgery in the lateral decubitus position requiring tracheal intubation under general anesthesia at Lishui Central Hospital of Zhejiang Province and Jiaxing First Hospital of Zhejiang Province from April 1, 2015, to September 30, 2015, were enrolled in this study. Patients were randomly assigned to the supine position group (Group S, n = 38) and the lateral position group (Group L, n = 34). Experienced anesthetists performed tracheal intubation with a fiberoptic bronchoscope after general anesthesia. The time required for intubation, intubation success rates, and hemodynamic changes was recorded. Between-group differences were assessed using the Student's t-test, Mann-Whitney U-test, or Chi-square test. The median total time to tracheal intubation was significantly longer in Group S (140.0 [135.8, 150.0] s) compared to Group L (33.0 [24.0, 38.8] s) (P < 0.01). The first-attempt intubation success rate was significantly higher in Group L (97%) compared to Group S (16%). Hemodynamic changes immediately after intubation were more exaggerated in Group S compared to Group L (P = 0.02). Endotracheal intubation with a flexible fiberoptic bronchoscope may be an effective and timesaving technique for patients in the lateral position. Chinese Clinical Trial Register, ChiCTR-IIR-16007814; http://www.chictr.org.cn/showproj.aspx?proj=13183.

  16. Evaluation of Endotracheal Intubation with a Flexible Fiberoptic Bronchoscope in Lateral Patient Positioning: A Prospective Randomized Controlled Trial

    PubMed Central

    Li, Hui; Wang, Wu; Lu, Ya-Ping; Wang, Yan; Chen, Li-Hua; Lei, Li-Pei; Fang, Xiang-Ming

    2016-01-01

    Background: There is an unmet need for a reliable method of airway management for patients in the lateral position. This prospective randomized controlled two-center study was designed to evaluate the feasibility of intubation using a flexible fiberoptic bronchoscope in the lateral position during surgery. Methods: Seventy-two patients scheduled for elective nonobstetric surgery in the lateral decubitus position requiring tracheal intubation under general anesthesia at Lishui Central Hospital of Zhejiang Province and Jiaxing First Hospital of Zhejiang Province from April 1, 2015, to September 30, 2015, were enrolled in this study. Patients were randomly assigned to the supine position group (Group S, n = 38) and the lateral position group (Group L, n = 34). Experienced anesthetists performed tracheal intubation with a fiberoptic bronchoscope after general anesthesia. The time required for intubation, intubation success rates, and hemodynamic changes was recorded. Between-group differences were assessed using the Student's t-test, Mann–Whitney U-test, or Chi-square test. Results: The median total time to tracheal intubation was significantly longer in Group S (140.0 [135.8, 150.0] s) compared to Group L (33.0 [24.0, 38.8] s) (P < 0.01). The first-attempt intubation success rate was significantly higher in Group L (97%) compared to Group S (16%). Hemodynamic changes immediately after intubation were more exaggerated in Group S compared to Group L (P = 0.02). Conclusion: Endotracheal intubation with a flexible fiberoptic bronchoscope may be an effective and timesaving technique for patients in the lateral position. Trial Registration: Chinese Clinical Trial Register, ChiCTR-IIR-16007814; http://www.chictr.org.cn/showproj.aspx?proj=13183. PMID:27569229

  17. A prospective, randomized study: Evaluation of the effect of rosuvastatin in patients with chronic obstructive pulmonary disease and pulmonary hypertension.

    PubMed

    Chogtu, Bharti; Kuriachan, Sanitha; Magazine, Rahul; Shetty, K Ranjan; Kamath, Asha; George, Manu Mathew; Tripathy, Amruta; Kumar, D Mahesh

    2016-01-01

    Statins by their anti-inflammatory and endothelial stabilizing effect can be beneficial in patients with chronic obstructive pulmonary disease (COPD) and pulmonary hypertension (PH). The present study was done to evaluate the effect of rosuvastatin on pulmonary functions and quality of life (QOL) in patients with concomitant COPD and PH. It was a prospective, randomized, double-blind, placebo-controlled, study conducted in patients with COPD and PH. A total of sixty patients were assigned to receive either rosuvastatin 10 mg or placebo once a day in addition to their conventional treatment for 12 weeks. Routine blood investigations, pulmonary functions, echocardiogram, exercise capacity, and QOL using a questionnaire were assessed at the baseline and after 12 weeks. In patients of rosuvastatin group, there was a statistically significant increase in peak expiratory flow rate (PEFR) (P = 0.04) but no significant change in other pulmonary functions: Forced vital capacity (FVC), forced expiratory volume at 1 s (FVC, FEV1, FEV1/FVC), and echocardiogram parameters. There was a significant increase in 6-min walk test (6-min walk distance) (P = 0.03) at the end of 12 weeks. On comparing with placebo, rosuvastatin showed a significant reduction (P = 0.045) in COPD exacerbations while adverse effects did not differ. Statins have a favorable effect on patients with COPD and PH regarding the improvement in PEFR, COPD exacerbations, and exercise capacity. Such effects can be beneficial in these patients and more so in patients with concomitant coronary artery disease or hyperlipidemia where long-term benefits of statins have been established.

  18. A prospective, randomized study: Evaluation of the effect of rosuvastatin in patients with chronic obstructive pulmonary disease and pulmonary hypertension

    PubMed Central

    Chogtu, Bharti; Kuriachan, Sanitha; Magazine, Rahul; Shetty, K. Ranjan; Kamath, Asha; George, Manu Mathew; Tripathy, Amruta; Kumar, D. Mahesh

    2016-01-01

    Objectives: Statins by their anti-inflammatory and endothelial stabilizing effect can be beneficial in patients with chronic obstructive pulmonary disease (COPD) and pulmonary hypertension (PH). The present study was done to evaluate the effect of rosuvastatin on pulmonary functions and quality of life (QOL) in patients with concomitant COPD and PH. Materials and Methods: It was a prospective, randomized, double-blind, placebo-controlled, study conducted in patients with COPD and PH. A total of sixty patients were assigned to receive either rosuvastatin 10 mg or placebo once a day in addition to their conventional treatment for 12 weeks. Routine blood investigations, pulmonary functions, echocardiogram, exercise capacity, and QOL using a questionnaire were assessed at the baseline and after 12 weeks. Results: In patients of rosuvastatin group, there was a statistically significant increase in peak expiratory flow rate (PEFR) (P = 0.04) but no significant change in other pulmonary functions: Forced vital capacity (FVC), forced expiratory volume at 1 s (FVC, FEV1, FEV1/FVC), and echocardiogram parameters. There was a significant increase in 6-min walk test (6-min walk distance) (P = 0.03) at the end of 12 weeks. On comparing with placebo, rosuvastatin showed a significant reduction (P = 0.045) in COPD exacerbations while adverse effects did not differ. Conclusion: Statins have a favorable effect on patients with COPD and PH regarding the improvement in PEFR, COPD exacerbations, and exercise capacity. Such effects can be beneficial in these patients and more so in patients with concomitant coronary artery disease or hyperlipidemia where long-term benefits of statins have been established. PMID:27721534

  19. Evaluation of double-lumen endotracheal tube extubation force by extraction angle: a prospective randomized clinical trial.

    PubMed

    Kido, Haruki; Komasawa, Nobuyasu; Imajo, Yukihiro; Ueno, Takeshi; Minami, Toshiaki

    2016-03-01

    Gentle and noninvasive double-lumen tracheal tube (DLT) extubation is important for both airway and circulatory management, especially after lung resection. We performed a prospective randomized clinical trial comparing DLT extubation force based on 2 different extraction angles. Randomized clinical trial. Operating room. Sixty adult patients scheduled for elective surgery under general anesthesia using DLT with ASA physical status 1 to 3. Sixty patients who underwent lung resection with a DLT were randomly assigned to extraction angles of 60° (30 patients) and 90° (30 patients) relative to the ground. Extubation forces and changes in vital signs were compared between groups. Results were analysed with the Mann-Whitney U test, non-paired t test, and χ(2) test. P<.05 was considered significant. Less extraction force was needed at 60° compared to 90° (90°, 13.9±2.3 N; 60°; 7.1±2.1 N; P<.001). The rate of increase in systolic and diastolic blood pressure (post-extubation/pre-extubation) was significantly smaller at 60° than at 90° (systolic blood pressure, P<.001; diastolic blood pressure, P=.002). Our findings suggest that DLT extubation at 60° requires less force than at 90° and was accompanied by a smaller increase in blood pressure. Thus, extraction at 60° may be less invasive and beneficial for patients undergoing DLT extubation. Copyright © 2016 Elsevier Inc. All rights reserved.

  20. Evaluation of minimally invasive therapies and rationale for a prospective randomized trial to evaluate selective intra-arterial lysis for clinically complete central retinal artery occlusion.

    PubMed

    Mueller, Arthur J; Neubauer, Aljoscha S; Schaller, Ulrich; Kampik, Anselm

    2003-10-01

    To determine the effect of commonly used minimally invasive treatments for clinically complete nonarteritic central retinal artery occlusion (CRAO) and design a prospective randomized trial to evaluate selective intra-arterial lysis for this condition. In this retrospective noncomparative case series, all medical records of patients with a diagnosis of CRAO treated at the Department of Ophthalmology, Ludwig-Maximilians-Universität, Munich, Germany, from 1994 through 1999 were reviewed for treatments administered and course of visual acuity. Best-corrected visual acuity (BCVA) at initial and last visit. We identified 102 patient medical records; 71 were suitable for further analysis. Forty-four (62%) of the 71 patients included were treated with oral acetylsalicylate; 44 (62%), with oral acetazolamide; 32 (45%), with ocular massage; 22 (31%), with isovolemic hemodilution; 19 (27%), with oral pentoxifylline; 8 (11%), with topical beta-blocker; 6 (8%), with paracentesis of the anterior chamber; 4 (6%), with subcutaneous heparin. A mean +/- SD number of treatments of 2.5 +/- 1.4 was administered per patient, and BCVA increased by a mean +/- SD number of Snellen lines of 0.7 +/- 2.8. The BCVA in 11 patients (15%) increased by 3 or more lines. Multivariate stepwise regression did not reveal any single or combination treatment as a significant factor for improvement in BCVA. Patient age and duration of visual impairment before initial examination were not significant predictors of final BCVA. Commonly used minimally invasive treatments of CRAO do not improve the natural course of the disease. A prospective trial by the European Assessment Group for Lysis in the Eye is under way to evaluate selective intra-arterial lysis, and in this trial some of these minimally invasive treatments are used in the control group.

  1. Evaluation of minimal dose of atracurium for cataract surgery in children: A prospective randomized double-blind study

    PubMed Central

    Darlong, Vanlal; Garg, Rakesh; Pandey, Ravinder; Khokhar, Sudarshan; Chandralekha; Sinha, Renu; Punj, Jyotsna; Sinha, Rajesh

    2015-01-01

    Background: Cataract surgery when performed under general anesthesia, especially without neuromuscular blocking agents, eccentric position of the eye has been reported. However, no evidence exists for the need and optimal dose of neuromuscular blocking agents for surgical reasons when the anesthetic management may be done without its need. We hypothesize that the minimal dose atracurium may accomplish the surgical requirement of cataract surgery in children. Materials and Methods: After ethical committee approval, this double-blind, prospective, randomized study was conducted in children scheduled for cataract surgery under general anesthesia. Anesthesia was induced in a standardized manner and using laryngeal mask airway. The patients were randomized into four groups of 55 patients each and atracurium was administered as per group allocation: Group 0: No atracurium was administered; Group 50: Received atracurium at 50% dose of ED95; Group 75: Received atracurium at 75% dose of ED95; Group 100: Received atracurium of 100% dose of ED95. Surgeon was asked to grade surgical condition just after the stab incision in the cornea. The primary outcome variable included the need of atracurium supplementation based on grading of surgical conditions by the operating surgeon who was blinded to the randomized group. Results: The need of atracurium due to unacceptable surgical conditions based on surgeon satisfaction score was statistically significant when compared among the groups being maximum in Group 0 (P < 0.001). Also, the surgeon satisfaction score was statistically significant among the groups (P < 0.0001) with the least satisfaction in Group 0. The laryngeal mask airway (LMA) insertion score was statistically significant in the four groups (P - 0.001). However, number of attempts for LMA placement was comparable among the four groups (P - 0.766). Conclusion: We conclude that a balanced anesthetic technique including atracurium provided better surgical condition for

  2. Prospective Randomized Evaluation of Intraoperative Application of Autologous Platelet-Rich Plasma on Surgical Site Infection or Delayed Wound Healing.

    PubMed

    SanGiovanni, Thomas P; Kiebzak, Gary M

    2016-05-01

    Prevention of surgical site infections and the reduction of wound-related complication rates have become increasingly emphasized by hospital task groups and government agencies given the degree of economic burden it places on the health care system. Platelet-rich plasma (PRP) contains growth factors and other biomolecules that promote endogenous microbicidal activity. We hypothesized that PRP would help prevent postoperative infection and delayed wound healing (DWH). We randomized patients having foot or ankle surgery to the treatment group receiving intraoperative PRP (applied to operative field) and platelet-poor plasma at closing (PPP, on the sutured skin) or the control group (no PRP/PPP). The incidence of deep surgical site infection and DWH (collectively called endpoints) was compared between groups (n = 250/group). PRP had a mean 5.3-fold platelet concentration compared to whole blood, with concentrated white blood cells. Mean age (±SD) of patients was 52 years (±15), 65% were women. Minor and major operative procedures were included. Patients were followed for 60 days. Seventy controls had PRP prepared for assay of growth factors. Procedure mix, ASA scores, mean operative times, and comorbidity mix were similar between groups. The primary result was no difference in number of endpoints between groups: 19 patients in the PRP group (7.6%) versus 18 controls (7.2%). Endpoints were deep surgical site infections in 2 PRP/PPP patients and 1 control, and DWH in 17 PRP/PPP patients and 17 controls. Analysis of PRP samples revealed a large variation in growth factor concentrations between patients. Intraoperative application of PRP/PPP did not reduce the incidence of postoperative infection or DWH. Growth factor profiles varied greatly between patients, suggesting that the potentially therapeutic treatment delivered was not consistent from patient-to-patient. Level I, prospective randomized trial. © The Author(s) 2015.

  3. Comparative Evaluation of Volatile Anaesthetic Agents for Attenuation of Venous Cannulation Pain: A Prospective, Randomized Controlled Study

    PubMed Central

    Das, Pravin K; Gautam, Sujeet KS; Jaisawal, Parineeta; Kadiyala, Venkat N.; Rambhad, Sonal

    2016-01-01

    Introduction Topical application of volatile anaesthetic agents has been found to attenuate the response to a mechanical stimulus; however, this effect of volatile anaesthetic on perception of pain during venous cannulation is not known. Aim To compare the efficacy of topically administered volatile anaesthetic agents for attenuating venous cannulation pain. Materials and Methods This prospective, randomized, placebo controlled and double blind study was conducted on 120 patients, aged 20-60years. They were of American Society of Anaesthesiologists (ASA) I or II physical status, of either sex, planned for elective surgeries. These patients were randomized into 4 groups, of 30 each. Equipotent doses of halothane (1ml), isoflurane (1.5ml), sevoflurane (2.7ml) and sterile water (2.5ml; Control) were topically administered on the volar surface of forearm wrapped with cotton and aluminium foil; venous cannulation was performed with 18G intravenous cannula after 30 min. These patients were assessed for the incidence and severity of pain upon venous cannulation {visual analog scale (VAS), 0-100mm; 0 = no pain and 100 = worst imaginable pain}. Data were analysed by one-way ANOVA, Chi-square test and Kruskal-Wallis test. The p<0.05 was considered as significant. Results A significant reduction in the incidence of venous cannulation pain was observed in the halothane (79%) group as compared to control (100%; p<0.05), isoflurane (100%; p<0.05) and sevoflurane (100%; p<0.05) groups. The severity of venous cannulation pain as assessed by median (interquartile range, Q1-Q3). VAS scores was reduced in the halothane {10 (10-20); p<0.001}, isoflurane {20 (10-30); p<0.001} and sevoflurane {20 (20-30); p<0.001} groups as compared to the control group {40 (30-40)}; VAS score in the halothane group was significantly less as compared to isoflurane (p<0.05) and sevoflurane (p<0.05) groups. Conclusion Topical application of halothane is most effective in reducing incidence and severity of

  4. Results from a prospective, randomized, controlled study evaluating the acceptability and effects of routine pre-IVF counselling.

    PubMed

    Emery, M; Béran, M-D; Darwiche, J; Oppizzi, L; Joris, V; Capel, R; Guex, P; Germond, M

    2003-12-01

    The aim of this study was to evaluate a model of routine pre-IVF counselling focusing on the narrative capacities of couples. The acceptability of counselling, the effects on emotional factors and the participants' assessments were considered. The study included 141 consecutive childless couples preparing for their first IVF. Randomization was carried out through sealed envelopes attributing participants to counselled and non-counselled groups and was accepted by 100 couples. Another 12 couples refused randomization because they wanted counselling and 29 because they did not. Questionnaires including the State-Trait Anxiety Inventory, the Beck Depression Inventory and assessments of help were mailed to couples before IVF and counselling, and after the IVF outcome. Counselling was accepted by 79% (112/141) of couples. There was no significant effect of counselling on anxiety and depression scores which were within normal ranges at both times. Counselling provided help for 86% (75/87) of initially non-demanding subjects and 96% (25/26) of those initially requesting a session. Help was noted in areas of psychological assistance, technical explanations and discussing relationships. This model of routine counselling centred on the narrative provides an acceptable form of psychological assistance for pre-IVF couples.

  5. Randomized, Prospective Evaluation Comparing Intensity of Lymphodepletion Before Adoptive Transfer of Tumor-Infiltrating Lymphocytes for Patients With Metastatic Melanoma

    PubMed Central

    Dudley, Mark E.; Citrin, Deborah E.; Somerville, Robert P.; Wunderlich, John R.; Danforth, David N.; Zlott, Daniel A.; Yang, James C.; Sherry, Richard M.; Kammula, Udai S.; Klebanoff, Christopher A.; Hughes, Marybeth S.; Restifo, Nicholas P.; Langhan, Michelle M.; Shelton, Thomas E.; Lu, Lily; Kwong, Mei Li M.; Ilyas, Sadia; Klemen, Nicholas D.; Payabyab, Eden C.; Morton, Kathleen E.; Toomey, Mary Ann; Steinberg, Seth M.; White, Donald E.; Rosenberg, Steven A.

    2016-01-01

    Purpose Adoptive cell transfer, the infusion of large numbers of activated autologous lymphocytes, can mediate objective tumor regression in a majority of patients with metastatic melanoma (52 of 93; 56%). Addition and intensification of total body irradiation (TBI) to the preparative lymphodepleting chemotherapy regimen in sequential trials improved objective partial and complete response (CR) rates. Here, we evaluated the importance of adding TBI to the adoptive transfer of tumor-infiltrating lymphocytes (TIL) in a randomized fashion. Patients and Methods A total of 101 patients with metastatic melanoma, including 76 patients with M1c disease, were randomly assigned to receive nonmyeloablative chemotherapy with or without 1,200 cGy TBI before transfer of tumor-infiltrating lymphcytes. Primary end points were CR rate (as defined by Response Evaluation Criteria in Solid Tumors v1.0) and overall survival (OS). Clinical and laboratory data were analyzed for correlates of response. Results CR rates were 24% in both groups (12 of 50 v 12 of 51), and OS was also similar (median OS, 38.2 v 36.6 months; hazard ratio, 1.11; 95% CI, 0.65 to 1.91; P = .71). Thrombotic microangiopathy was an adverse event unique to the TBI arm and occurred in 13 of 48 treated patients. With a median potential follow-up of 40.9 months, only one of 24 patients who achieved a CR recurred. Conclusion Adoptive cell transfer can mediate durable complete regressions in 24% of patients with metastatic melanoma, with median survival > 3 years. Results were similar using chemotherapy preparative regimens with or without addition of TBI. PMID:27217459

  6. Evaluating the efficacy of lavender aromatherapy on peripheral venous cannulation pain and anxiety: A prospective, randomized study.

    PubMed

    Karaman, Tugba; Karaman, Serkan; Dogru, Serkan; Tapar, Hakan; Sahin, Aynur; Suren, Mustafa; Arici, Semih; Kaya, Ziya

    2016-05-01

    This study was designed to evaluate the effectiveness of lavender aromatherapy on pain, anxiety, and level of satisfaction associated with the peripheral venous cannulation (PVC) in patients undergoing surgery. One hundred and six patients undergoing surgery were randomized to receive aromatherapy with lavender essential oil (the lavender group) or a placebo (the control group) during PVC. The patients' pain, anxiety, and satisfaction scores were measured. There was no statistically significantly difference between the groups in terms of demographic data. After cannulation, the pain and anxiety scores (anxiety 2) of the patients in the lavender group were significantly lower than the control group (for p = 0.01 for pain scores; p < 0.001 for anxiety 2 scores). In addition, patient satisfaction was significantly higher in the lavender group than in the control group (p = 0.003). Lavender aromatherapy had beneficial effects on PVC pain, anxiety, and satisfaction level of patients undergoing surgery. Copyright © 2016 Elsevier Ltd. All rights reserved.

  7. Fractionated bipolar radiofrequency and bipolar radiofrequency potentiated by infrared light for treating striae: A prospective randomized, comparative trial with objective evaluation.

    PubMed

    Harmelin, Yona; Boineau, Dominique; Cardot-Leccia, Nathalie; Fontas, Eric; Bahadoran, Philippe; Becker, Anne-Lise; Montaudié, Henri; Castela, Emeline; Perrin, Christophe; Lacour, Jean-Philippe; Passeron, Thierry

    2016-03-01

    Very few treatments for striae are based on prospective randomized trials. The objective of this study was to assess the efficacy of bipolar fractional radiofrequency and bipolar radiofrequency potentiated with infrared light, alone or combined, for treating abdominal stretch marks. Bicentric prospective interventional randomized controlled trial in the department of Dermatology of University Hospital of Nice and Aesthetics Laser Center of Bordeaux, France. Men and women of age 18 years or above, who presented for the treatment of mature or immature abdominal striae were included. The patients' abdomens were divided into four equal quadrants. Bipolar radiofrequency potentiated with infrared light and fractional bipolar radiofrequency were applied, alone or combined, and compared to the remaining untreated quadrant. The main criterion of evaluation was the measurement of depth of striae, using 3D photography at 6 months follow-up. A global assessment was also rated by the physician performing the treatment and by the patients. Histological analysis and confocal laser microscopy were additionally performed. A total of 22 patients were enrolled, and 384 striae were measured. In per protocol analysis mean striae depth was decreased by 21.64%, observed at 6 months follow-up with the combined approach, compared to an increase of 1.73% in the control group (P < 0.0001). No significant difference in striae width was observed between the treated or control quadrants. Global assessment by the physician who performed the treatment and by the patient both showed greater improved with the combination treatment compared to control areas (P = 0.004 and P = 0.01, respectively). A more homogeneous interlacing pattern and thicker collagen fibers with a decreased proportion of elastic fibers was observed after treatment. Fractional bipolar radiofrequency, combined with bipolar radiofrequency potentiated by infrared light, is an effective treatment of both immature and

  8. Evaluation of an educational "toolbox" for improving nursing staff competence and psychosocial work environment in elderly care: results of a prospective, non-randomized controlled intervention.

    PubMed

    Arnetz, J E; Hasson, H

    2007-07-01

    Lack of professional development opportunities among nursing staff is a major concern in elderly care and has been associated with work dissatisfaction and staff turnover. There is a lack of prospective, controlled studies evaluating the effects of educational interventions on nursing competence and work satisfaction. The aim of this study was to evaluate the possible effects of an educational "toolbox" intervention on nursing staff ratings of their competence, psychosocial work environment and overall work satisfaction. The study was a prospective, non-randomized, controlled intervention. Nursing staff in two municipal elderly care organizations in western Sweden. In an initial questionnaire survey, nursing staff in the intervention municipality described several areas in which they felt a need for competence development. Measurement instruments and educational materials for improving staff knowledge and work practices were then collated by researchers and managers in a "toolbox." Nursing staff ratings of their competence and work were measured pre and post-intervention by questionnaire. Staff ratings in the intervention municipality were compared to staff ratings in the reference municipality, where no toolbox was introduced. Nursing staff ratings of their competence and psychosocial work environment, including overall work satisfaction, improved significantly over time in the intervention municipality, compared to the reference group. Both competence and work environment ratings were largely unchanged among reference municipality staff. Multivariate analysis revealed a significant interaction effect between municipalities over time for nursing staff ratings of participation, leadership, performance feedback and skills' development. Staff ratings for these four scales improved significantly in the intervention municipality as compared to the reference municipality. Compared to a reference municipality, nursing staff ratings of their competence and the

  9. Comparative Evaluation of Efficacy of Physics Forceps versus Conventional Forceps in Orthodontic Extractions: A Prospective Randomized Split Mouth Study

    PubMed Central

    Managutti, Anil M; Menat, Shailesh; Agarwal, Arvind; Shah, Dishan; Patel, Jigar

    2016-01-01

    Introduction Tooth extraction is one of the most commonly performed procedures in dentistry. It is usually a traumatic procedure often resulting in immediate destruction and loss of alveolar bone and surrounding soft tissues. Various instruments have been described to perform atraumatic extractions which can prevent damage to the paradental structures. Recently developed physics forceps is one of the instruments which is claimed to perform atraumatic extractions. Aim The aim of the present study was to compare the efficacy of physics forceps with conventional forceps in terms of operating time, prevention of marginal bone loss & soft tissue loss, postoperative pain and postoperative complications following bilateral premolar extractions for orthodontic purpose. Materials and Methods In this prospective split-mouth study, outcomes of the 2 groups (n = 42 premolars) requiring extraction of premolars for orthodontic treatment purpose using Physics forceps and Conventional forceps were compared. Clinical outcomes in form of time taken, loss of buccal soft tissue and buccal cortical plate based on extraction defect classification system, postoperative pain and other complication associated with extraction were recorded and compared. Results Statistically significant reduction in the operating time was noted in physics forceps group. Marginal bone loss and soft tissue loss was also significantly lesser in physics forceps group when compared to conventional forceps group. However, there was no statistically significant difference in severity of postoperative pain between both groups. Conclusion The results of the present study suggest that physics forceps was more efficient in reducing operating time and prevention of marginal bone loss & soft tissue loss when compared to conventional forceps in orthodontically indicated premolar extractions. PMID:27630951

  10. Comparative Evaluation of Efficacy of Physics Forceps versus Conventional Forceps in Orthodontic Extractions: A Prospective Randomized Split Mouth Study.

    PubMed

    Patel, Harsh S; Managutti, Anil M; Menat, Shailesh; Agarwal, Arvind; Shah, Dishan; Patel, Jigar

    2016-07-01

    Tooth extraction is one of the most commonly performed procedures in dentistry. It is usually a traumatic procedure often resulting in immediate destruction and loss of alveolar bone and surrounding soft tissues. Various instruments have been described to perform atraumatic extractions which can prevent damage to the paradental structures. Recently developed physics forceps is one of the instruments which is claimed to perform atraumatic extractions. The aim of the present study was to compare the efficacy of physics forceps with conventional forceps in terms of operating time, prevention of marginal bone loss & soft tissue loss, postoperative pain and postoperative complications following bilateral premolar extractions for orthodontic purpose. In this prospective split-mouth study, outcomes of the 2 groups (n = 42 premolars) requiring extraction of premolars for orthodontic treatment purpose using Physics forceps and Conventional forceps were compared. Clinical outcomes in form of time taken, loss of buccal soft tissue and buccal cortical plate based on extraction defect classification system, postoperative pain and other complication associated with extraction were recorded and compared. Statistically significant reduction in the operating time was noted in physics forceps group. Marginal bone loss and soft tissue loss was also significantly lesser in physics forceps group when compared to conventional forceps group. However, there was no statistically significant difference in severity of postoperative pain between both groups. The results of the present study suggest that physics forceps was more efficient in reducing operating time and prevention of marginal bone loss & soft tissue loss when compared to conventional forceps in orthodontically indicated premolar extractions.

  11. Patient’s self-evaluation of two education programs for age-related skin changes in the face: a prospective, randomized, controlled study

    PubMed Central

    Williams, Linda M; Alderman, Jane E; Cussell, Garry; Goldston, John; Hamilton, Neal; Lim, Adrian C; Goodman, Greg J; Halstead, Michael B; Rogers, John D

    2011-01-01

    Background: An interactive software program (HOYS) has been developed utilizing a database of digital images depicting various aspects and degrees of aging of exposed skin across seven geographic regions, representing a total of 35 facial and extrafacial subregions. A five-point photonumeric rating scale, which portrays age-related skin changes across five decades for each of these subregions, underpins this patient-based interactive self-assessment program. Based on the resulting outputs from this program, an individualized treatment prioritization list is generated for each region where significant differences between the patient’s chronological and esthetic ages exist. This provides guidance for the patient and the treating physician on treatment options. Methods: To evaluate the utility of HOYS in the clinic, relative to education programs currently used in Australian private esthetic clinics, a total of 95 esthetically-orientated patients were enrolled in a prospective, randomized, controlled, multicenter study. Results: Compared with a prospective cohort of patients completing a standard education program commonly utilized in Australian esthetic clinics, patients receiving the HOYS education program reported greater empowerment through improved knowledge of specific age-related skin changes. This was associated with a clearer understanding of treatment options available to them, and a perceived ability to participate in the selection of the treatments potentially administered to improve their appearance. These differences between the two education groups were highly significant. Conclusion: Patients completing the HOYS patient education program have an improved understanding of age-related changes to exposed skin of their face, neck, décolletage, and hands. Due to the patient-specific nature of the program, these patients perceive a greater role in the deciding which esthetic treatments should be subsequently administered to enhance their appearance

  12. Evaluation of surgically assisted rapid maxillary expansion with piezosurgery versus oscillating saw and chisel osteotomy - a randomized prospective trial.

    PubMed

    Rana, Majeed; Gellrich, Nils-Claudius; Rana, Madiha; Piffkó, Jozsef; Kater, Wolfgang

    2013-02-17

    Ultrasonic bone-cutting surgery has been introduced as a feasible alternative to the conventional sharp instruments used in craniomaxillofacial surgery because of its precision and safety. The piezosurgery medical device allows the efficient cutting of mineralized tissues with minimal trauma to soft tissues. Piezoelectric osteotome has found its role in surgically assisted rapid maxillary expansion (SARME), a procedure well established to correct transverse maxillary discrepancies. The advantages include minimal risk to critical anatomic structures. The purpose of this clinical comparative study (CIS 2007-237-M) was to present the advantages of the piezoelectric cut as a minimally invasive device in surgically assisted, rapid maxillary expansion by protecting the maxillary sinus mucosal lining. Thirty patients (18 females and 12 males) at the age of 18 to 54 underwent a surgically assisted palatal expansion of the maxilla with a combined orthodontic and surgical approach. The patients were randomly divided into two separate treatment groups. While Group 1 received conventional surgery using an oscillating saw, Group 2 was treated with piezosurgery. The following parameters were examined: blood pressure, blood values, required medication, bleeding level in the maxillary sinus, duration of inpatient stay, duration of surgery and height of body temperature. The results displayed no statistically significant differences between the two groups regarding laboratory blood values and inpatient stay. The duration of surgery revealed a significant discrepancy. Deploying piezosurgery took the surgeon an average of 10 minutes longer than working with a conventional-saw technique. However, the observation of the bleeding level in the paranasal sinus presented a major and statistically significant advantage of piezosurgery: on average the bleeding level was one category above the one of the remaining patients. This method of piezoelectric surgery with all its advantages is going

  13. Evaluation of surgically assisted rapid maxillary expansion with piezosurgery versus oscillating saw and chisel osteotomy - a randomized prospective trial

    PubMed Central

    2013-01-01

    Background Ultrasonic bone-cutting surgery has been introduced as a feasible alternative to the conventional sharp instruments used in craniomaxillofacial surgery because of its precision and safety. The piezosurgery medical device allows the efficient cutting of mineralized tissues with minimal trauma to soft tissues. Piezoelectric osteotome has found its role in surgically assisted rapid maxillary expansion (SARME), a procedure well established to correct transverse maxillary discrepancies. The advantages include minimal risk to critical anatomic structures. The purpose of this clinical comparative study (CIS 2007-237-M) was to present the advantages of the piezoelectric cut as a minimally invasive device in surgically assisted, rapid maxillary expansion by protecting the maxillary sinus mucosal lining. Methods Thirty patients (18 females and 12 males) at the age of 18 to 54 underwent a surgically assisted palatal expansion of the maxilla with a combined orthodontic and surgical approach. The patients were randomly divided into two separate treatment groups. While Group 1 received conventional surgery using an oscillating saw, Group 2 was treated with piezosurgery. The following parameters were examined: blood pressure, blood values, required medication, bleeding level in the maxillary sinus, duration of inpatient stay, duration of surgery and height of body temperature. Results The results displayed no statistically significant differences between the two groups regarding laboratory blood values and inpatient stay. The duration of surgery revealed a significant discrepancy. Deploying piezosurgery took the surgeon an average of 10 minutes longer than working with a conventional-saw technique. However, the observation of the bleeding level in the paranasal sinus presented a major and statistically significant advantage of piezosurgery: on average the bleeding level was one category above the one of the remaining patients. Conclusion This method of piezoelectric

  14. A prospective, randomized, multicentre trial for the treatment of refractory status epilepticus; experiences from evaluating the effect of the novel drug candidate, NS1209.

    PubMed

    Sabers, Anne; Wolf, Peter; Møller, Arne; Rysgaard, Karen; Ben-Menachem, Elinor

    2013-09-01

    Refractory status epilepticus (RSE) is a life-threatening condition that requires immediate and aggressive treatment. Unfortunately, sometimes standard antiepileptic treatment is insufficient. Furthermore, alternative therapeutic options are limited by low evidence of efficacy. The primary objective of this study was to evaluate the effects of the novel drug candidate, NS1209 versus third-line standard treatment (phenytoin/valproate) for RSE. Having not reached the study end-points, the purpose of this paper is to discuss the challenges that are encountered in conducting a controlled study of RSE. This was a phase II, prospective, multicentre, single-blinded, randomized clinical trial and included patients to two separate protocols for convulsive and non-convulsive RSE (NS1209-006 and NS1209-007). In total, 28 patients were included and 14 patients were exposed to NS1209. At study conclusion, the study was insufficiently powered to detect any statistically significant difference between the two treatment groups. This was especially true for the convulsive RSE protocol. We conclude that high-quality studies in RSE are difficult to conduct owing to a number of ethical and practical problems associated with this critical illness. Challenges for further studies are discussed. Copyright © 2013 Elsevier B.V. All rights reserved.

  15. A prospective, randomized controlled preclinical trial to evaluate different formulations of biphasic calcium phosphate in combination with a hydroxyapatite collagen membrane to reconstruct deficient alveolar ridges.

    PubMed

    Nevins, Myron; Nevins, Marc L; Schupbach, Peter; Kim, Soo-Woo; Lin, Zhao; Kim, David M

    2013-04-01

    Many patients and clinicians would prefer a synthetic particulate bone replacement graft, but most available alloplastic biomaterials have limited osteogenic potential. An alloplast with increased regenerative capacity would be advantageous for the treatment of localized alveolar ridge defects. This prospective, randomized controlled preclinical trial utilized 6 female foxhounds to analyze the osteogenic impact of different formulations of biphasic calcium phosphate (BCP) in combination with an hydroxyapatite-collagen membrane and their ability to reconstruct deficient alveolar ridges for future implant placement. The grafted sites were allowed to heal 3 months, and then trephine biopsies were obtained to perform light microscopic and histomorphometric analyses. All treated sites healed well with no early membrane exposure or adverse soft tissue responses during the healing period. The grafted sites exhibited greater radiopacity than the surrounding native bone with BCP particles seen as radiopaque granules. The graft particles appeared to be well-integrated and no areas of loose particles were observed. Histologic evaluation demonstrated BCP particles embedded in woven bone with dense connective tissue/marrow space. New bone growth was observed around the graft particles as well as within the structure of the graft particulate. There was intimate contact between the graft particles and newly formed bone, and graft particles were bridged by the newly formed bone in all biopsies from the tested groups. The present study results support the potential of these BCP graft particulates to stimulate new bone formation. Clinical studies are recommended to confirm these preclinical findings.

  16. Use of three types of synthetic mesh material in sling surgery: a prospective randomized clinical trial evaluating effectiveness and complications.

    PubMed

    Okulu, Emrah; Kayigil, Onder; Aldemir, Mustafa; Onen, Efe

    2013-06-01

    The aim of this study was to determine the surgical success and complication rates of mixed type of mesh materials compared with Prolene mesh in sling surgery over a 4-year follow-up period. Between 2005 and 2007, broad-based double-forced sling operations were performed in 144 women with stress incontinence using three different types of mesh material. Group I consisted of 48 patients in whom Vypro® mesh (Ethicon, USA) was used; group II of 48 patients in whom Ultrapro® mesh (Ethicon) and group III of 48 patients in whom Prolene® light mesh (Ethicon) was used. The patients' data and the success of the operation were evaluated based on the 24 h pad test, International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) scoring and Korman questionnaire analysis. The ICIQ-SF score, the number of pads used and the results of 24 h pad test were statistically lower in group II at postoperative month 48 (p < 0.05). The rate of postoperative complications was lower in Group II than in the other groups (p < 0.05). The continence rates of groups I, II and III were 84.7%, 91.6% and 85.1%, respectively, in the 48th postoperative month. Ultrapro mesh can be used in sling surgery owing to its higher success rates, and lower vaginal and urethral extrusion and de novo urgency rates, which have also been shown in clinical studies.

  17. 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.

  18. A Prospective Randomized Controlled Two-Arm Clinical Study Evaluating the Efficacy of a Bioelectric Dressing System for Blister Management in US Army Ranger Recruits.

    PubMed

    Housler, Greggory J; Cross, Sue; Marcel, Vanessa; Kennedy, Daniel O; Husband, Michael; Register, Andrew; Roberts, Thomas; Grubbs, Seth; Dudewicz, Douglas; Setka, Nathan; Bay, Curt; Wendelken, Martin E; Izadjoo, Mina J

    This study focused on a clinically relevant healthcare problem in the military: acute soft tissue wounds, or blisters. The trial was a prospective, controlled, randomized two-arm study evaluating the efficacy of a bioelectric dressing, Procellera®, applied topically two to three times per week for 2 weeks to blisters developed in Ranger trainees during training at Fort Benning, Georgia. A total of 80 US Army Ranger recruits with blister wounds below the knee were randomly assigned to one of two treatment groups (n = 40/group). The primary goal was to assess the clinical efficacy (rate of healing) of administered Procellera in conjunction with the standard-of-care (SOC) treatment, moleskin and Tegaderm ®, on the healing rate of blisters compared with the SOC treatment alone. The secondary end points for efficacy were the quantities of wound fluid biomarkers and bacterial bioburden. The tertiary end point was assessment of pain in the treatment group compared with that of the control group during the 2-week study. The results showed no statistical difference between the SOC and SOC+Procellera groups in wound healing and pain. Wound fluid was reported for 24 participants (64.9%) in the SOC group and 21 participants (56.8%) in SOC+Procellera group at the baseline measurement (ρ = .475); however, the wounds were devoid of fluid on follow-up visits. The mild nature of the wounds in this study was apparent by the low pain scores at the beginning of the study, which disappeared by the follow-up visits. The average wound sizes were 2.2cm2 and 1.5cm2 for the SOC and SOC+Procellera groups, respectively. This trial protocol should be conducted on open softtissue wounds in severe heat. To our knowledge, this is the first clinical study conducted within the US Army Rangers training doctrine. 2017.

  19. A prospective, randomized evaluation of the effects of epidural needle rotation on the distribution of epidural block.

    PubMed

    Borghi, Battista; Agnoletti, Vanni; Ricci, Alessandro; van Oven, Hanna; Montone, Nicoletta; Casati, Andrea

    2004-05-01

    We evaluated the effects of turning the tip of the Tuohy needle 45 degrees toward the operative side before threading the epidural catheter (45 degrees -rotation group, n = 24) as compared to a conventional insertion technique with the tip of the Tuohy needle oriented at 90 degrees cephalad (control group, n = 24) on the distribution of 10 mL of 0.75% ropivacaine with 10 microg sufentanil in 48 patients undergoing total hip replacement. The catheter was introduced 3 to 4 cm beyond the tip of the Tuohy needle. A blinded observer recorded sensory and motor blocks on both sides, quality of analgesia, and volumes of local anesthetic used during the first 48 h of patient-controlled epidural analgesia. Readiness to surgery required 21 +/- 6 min in the control group and 17 +/- 7 min in the 45 degree-rotation group (P > 0.50). The maximum sensory level reached on the operative side was T10 (T10-7) in the control group and T9 (T10-6) in the 45 degree-rotation group (P > 0.50); whereas the maximum sensory level reached on the nonoperative side was T10 (T12-9) in the control group and L3 (L5-T12) in the 45 degree-rotation group (P = 0.0005). Complete motor blockade of the operative limb was achieved earlier in the 45 degree-rotation than in the control group, and motor block of the nonoperative side was more intense in patients in the control group. Two-segment regression of sensory level on the surgical side was similar in the two groups, but occurred earlier on the nonoperative side in the 45 degree-rotation group (94 +/- 70 min) than in the control group (178 +/- 40 min) (P = 0.0005). Postoperative analgesia was similar in the 2 groups, but the 45 degree-rotation group consumed less local anesthetic (242 +/- 35 mL) than the control group (297 +/- 60 mL) (P = 0.0005). We conclude that the rotation of the Tuohy introducer needle 45 degrees toward the operative side before threading the epidural catheter provides a preferential distribution of sensory and motor block toward

  20. A prospective, randomized, multisite clinical evaluation of a transparent absorbent acrylic dressing and a hydrocolloid dressing in the management of Stage II and shallow Stage III pressure ulcers.

    PubMed

    Brown-Etris, Marie; Milne, Catherine; Orsted, Heather; Gates, Judy L; Netsch, Debra; Punchello, Marion; Couture, Nancy; Albert, Martine; Attrell, Edie; Freyberg, Julie

    2008-04-01

    To compare clinical performance of a transparent absorbent acrylic dressing (3M Tegaderm Absorbent Clear Acrylic Dressing ]TAAD[; 3M Company, St Paul, MN) and a hydrocolloid dressing (HD ]DuoDERM CGF, ConvaTec, ER Squibb & Sons, Princeton, NJ[) in the management of Stage II and shallow Stage III pressure ulcers. Prospective, open-label, randomized, comparative, multisite clinical evaluation. Patients were followed up for a maximum of 56 days or until their ulcer healed. At weekly intervals, investigators conducted wound assessments and dressing performance evaluations. Wound care clinics, home care, and long-term care. Thirty-five patients received the TAAD, and 37 received the HD. Dressing performance assessments, patient comfort, dressing wear time, and wound healing were measured. The majority of investigator assessments favored the TAAD. Considerations given included the ability to center dressings over the ulcer (P = .005), ability to assess the ulcer before (P < .001) and after (P < .001) absorption, barrier properties (P = .039), patient comfort during removal (P < .001), overall patient comfort (P = .048), conformability before (P = .026) and after (P = .001) absorption, ease of removal (P < .001), nonadherence to wound bed (P < .001), residue in the wound (P = .002), residue on periwound skin (P < .001), and odor after absorption (P = .016). Overall satisfaction favored the TAAD (P < .001), and a high value was placed on its transparent feature (P < .001). Mean (SD) wear time for the TAAD was 5.7 (2.55) days compared with 4.7 (2.29) days for the HD (P = .086). This 1-day difference in wear time was clinically noticeable by the investigators (P = .035). Wound closure for the 2 dressing groups was nearly identical (P = .9627). Performance results favored the TAAD over the HD as standard treatment for Stage II and shallow Stage III pressure ulcers.

  1. Evaluation of the effects of dietary soy phytoestrogens on canine health, steroidogenesis, thyroid function, behavior and skin and coat quality in a prospective controlled randomized trial

    PubMed Central

    Cerundolo, Rosario; Michel, Kathy E.; Reisner, Ilana R.; Phillips, Lucy; Goldschmidt, Michael; Court, Michael H.; Shrestha, Binu; Hao, Qin; Refsal, Kent; Oliver, Jack W.; Biourge, Vincent; Shofer, Frances S.

    2009-01-01

    Background Phytoestrogens are non-steroidal compounds possessing estrogenic activity present in significant amounts in soy-based pet foods. There is speculation that long-term consumption of phytoestrogen-rich diets could have biological effects but this has never been evaluated in dogs. Hypothesis Soy-based diets may affect general health, adrenocortical function, thyroid function, behavior and skin/coat quality in adult dogs. Animals Fifteen normal dogs were divided into two groups and fed either high-isoflavone (HID) or a low-isoflavone (LID) soy-based diet. Methods In this prospective controlled randomized trial end points of general health were assessed at baseline and up to one-year by evaluating body and dermatological condition, hematology, biochemistry profiles, urine-analysis (UA), serum concentrations of adrenal and thyroid hormones, and behavior. Student’s t-test (2 time points) analysis of variance with repeated measures (3 time points) was used to analyze differences in these parameters from baseline between diets. Results No differences were found in measures of skin/coat, body condition, or behavior, in either group. Results of hematology, biochemical profiles and urinalysis showed no differences between the two groups. Analysis of variance in repeated measures was used to analyze differences in hair follicles from baseline between diets when there were 2 time points. No differences were found in the evaluation of the skin, hair follicle and hair diameter size. Most adrenal and thyroid hormones did not change over time nor were they different by diet (P>.1). However, total T4 differences were higher in HI than LI group (15.3 vs −1.4 p=.07) and post-ACTH estradiol concentration differences were also increased in HI compared to LI groups (19 vs −5.6 pg/ml at 1 year, p=.0006). Conclusions and Clinical Importance These data suggest long-term ingestion of soy phytoestrogens may influence endocrine function in dogs and this could potentially impact

  2. Evaluation of the reliability of preoperative descriptive airway assessment tests in prediction of the Cormack-Lehane score: A prospective randomized clinical study.

    PubMed

    Selvi, Onur; Kahraman, Tugce; Senturk, Ozgur; Tulgar, Serkan; Serifsoy, Ercan; Ozer, Zeliha

    2017-02-01

    In this study we investigated and compared the predictive values of different airway assessments tests including thyromental height measurement test, which has been recently suggested, in difficult laryngoscopy (Cormack and Lehane [C-L] scores 3 and 4). In addition, we compared the effectiveness of methods and C-L scores, by IDS, in terms of predicting difficult intubation. Prospective, blinded study. Maltepe University. Four hundred fifty-one patients selected randomly who underwent general anesthesia. In this study we compared predictive value of thyromental height measurement test (TMH), which has been recently suggested, modified Mallampati test (MMT), upper lip bite test (ULBT), and thyromental distance measurement test (TMD) in difficult laryngoscopy. Final C-L scores were compared with intubation difficulty scale (IDS) in terms of predicting difficult intubation. Patient's American Society of Anesthesiology score, age and weight were recorded. TMH, TMD, MMT, ULBT, IDS and C-L scores were measured and determined. The optimal cut-off point for TMH for predicting difficult laryngoscopy was 43.5 mm and for TMD was 82.06 mm. Use of TMH <43.5 with MMT has the highest sensitivity for predicting difficult intubation (78.38) with 75.36% specificity and 97.50% negative predictive value. TMH showed sensitivity of 91.89% and specificity 52.17% at 50 mm cut-off value. In the comparison of the area under the receiver operating characteristic curve values, none of the tests came forth individually or in combination with MMT test. The present study demonstrates the practicality of TMH as a digitalized test however the clinical benefits of TMH in daily medical practice are drawn into question. The additional variable of race may have had some bearing on this and further studies, larger in patient sample size, may need to use different methodology concerning age-, sex-, and race-dependent variables in evaluating these tests. Copyright © 2016 Elsevier Inc. All rights reserved.

  3. Prospective randomized evaluation of therapeutic decompressive craniectomy in severe traumatic brain injury with mass lesions (PRECIS): study protocol for a controlled trial.

    PubMed

    Zhao, He-xiang; Liao, Yi; Xu, Ding; Wang, Qiang-ping; Gan, Qi; You, Chao; Yang, Chao-hua

    2016-01-05

    For cases of severe traumatic brain injury, during primary operation, neurosurgeons usually face a dilemma of whether or not to remove the bone flap after mass lesion evacuation. Decompressive craniectomy, which involves expansion of fixed cranial cavity, is used to treat intra-operative brain swelling and post-operative malignant intracranial hypertension. However, due to indefinite indication, the decision to perform this procedure heavily relies on personal experiences. In addition, decompressive craniectomy is associated with various complications, and the procedure lacks strong evidence of better outcomes. In the present study, we designed a prospective, randomized, controlled trial to clarify the effect of decompressive craniectomy in severe traumatic brain injury patients with mass lesions. PRECIS is a prospective, randomized, assessor-blind, single center clinical trial. In this trial, 336 patients with traumatic mass lesions will be randomly allocated to a therapeutic decompressive craniectomy group or a prophylactic decompressive craniectomy group. In the therapeutic decompressive craniectomy group, the bone flap will be removed or replaced depending on the emergence of brain swelling. In the prophylactic decompressive craniectomy group, the bone flap will be removed after mass lesion evacuation. A stepwise management of intracranial pressure will be provided according to the Brain Trauma Foundation guidelines. Salvage decompressive craniectomy will be performed for craniotomy patients once there is evidence of imaging deterioration and post-operative malignant intracranial hypertension. Participants will be assessed at 1, 6 and 12 months after randomization. The primary endpoint is favorable outcome according to the Extended Glasgow Outcome Score (5-8) at 12 months. The secondary endpoints include quality of life measured by EQ-5D, mortality, complications, intracranial pressure and cerebral perfusion pressure control and incidence of salvage craniectomy

  4. Randomized controlled trial evaluating the temporal effects of high-intensity exercise on learning, short-term and long-term memory, and prospective memory.

    PubMed

    Frith, Emily; Sng, Eveleen; Loprinzi, Paul D

    2017-09-18

    The broader purpose of this study was to examine the temporal effects of high-intensity exercise on learning, short-term and long-term retrospective memory and prospective memory. Among a sample of 88 young adult participants, 22 were randomized into one of four different groups: exercise before learning, control group, exercise during learning, and exercise after learning. The retrospective assessments (learning, short-term and long-term memory) were assessed using the Rey Auditory Verbal Learning Test. Long-term memory including a 20-min and 24-hr follow-up assessment. Prospective memory was assessed using a time-based procedure by having participants contact (via phone) the researchers at a follow-up time period. The exercise stimulus included a 15-min bout of progressive maximal exertion treadmill exercise. High-intensity exercise prior to memory encoding (vs. exercise during memory encoding or consolidation) was effective in enhancing long-term memory (for both 20-min and 24-h follow-up assessments). We did not observe a differential temporal effect of high-intensity exercise on short-term memory (immediate post-memory encoding), learning or prospective memory. The timing of high-intensity exercise may play an important role in facilitating long-term memory. © 2017 Federation of European Neuroscience Societies and John Wiley & Sons Ltd.

  5. Subcuticular closure versus Dermabond: a prospective randomized trial.

    PubMed

    Switzer, Erin F; Dinsmore, Robert C; North, James H

    2003-05-01

    2-Octylcyanoacrylate tissue adhesive (Dermabond, Ethicon, Inc, Somerville, NJ) is being used successfully for closure of minor lacerations. To date, however, there have been no studies evaluating its use in the operating room for surgical incisions. We conducted a prospective randomized trial to compare the closure of inguinal herniorrhaphy incisions using 2-octylcyanoacrylate tissue adhesive (Dermabond) with closures using 4-0 Monocryl (Ethicon, Inc) in a running subcuticular closure. A total of 46 incisions were randomized at the time of closure. Of these incisions 24 were randomized to Dermabond closure (TA) and 22 were randomized to subcuticular closure (SC). Performance measures included: time for closure, wound complications, and cosmesis. Cosmesis was evaluated by blinded evaluation of photographs of the incisions taken 4 weeks after surgery. Closure times for the TA group were faster than in the SC group (mean of 155 vs 286 seconds; P < 0.001). Wound complications were higher in the TA group (P = 0.045). Cosmesis was also felt to be better in the SC group with a score of 4.2 versus 3.88, but this did not reach statistical significance. Although the use of Dermabond did result in faster wound cultures it also resulted in an increase in wound complications. The difference in mean cosmetic score for each group was not statistically significant but trended toward better scores in the SC group. Based on these findings we do not feel Dermabond is an acceptable alternative to subcuticular suture closure in inguinal herniorrhaphy incisions.

  6. Is DVT prophylaxis overemphasized? A randomized prospective study.

    PubMed

    Kosir, M A; Kozol, R A; Perales, A; McGee, K; Beleski, K; Lange, P; Dahn, M

    1996-02-01

    This study was designed to prospectively evaluate a previously published prognostic index for predicting deep venous thrombosis (DVT) in general surgical patients with conventional prophylaxis. Patients undergoing procedures of at least 1 hr duration (abdominal, thoracic, head and neck, inguinal) requiring general or spinal anesthetic were prospectively randomized into the following groups: Group 1, sequential pneumatic compression devices during surgery and 2 days postoperatively; Group 2, subcutaneous heparin (5000 U q 12 hr) starting 1 hr before surgery and for 7 days postop; Group 3, control group. All patients underwent duplex evaluation of bilateral lower extremity deep venous systems preoperatively and on postoperative Days 1, 3, and 30. In addition, a previously developed predictive DVT incidence indicator, the prognostic index (PI), was calculated for each patient. A total of 137 patients were entered into the study with 29 removed for patient/staff reasons. There were no differences in PI among the three groups at the 0.05 level (ANOVA). The distribution of risk factors for DVT including increased age, body size, hemoglobin (Hb), and colorectal procedures were distributed evenly among the groups. Additional factors such as diabetes, COPD, PVD, immobilization, and cancer were also evenly distributed among the groups. The PI predicted a 20% incidence of DVT. For Groups 1 (n = 25), 2 (n = 38), and 3 (n = 45) no DVTs were detected over the 30 days of study. During the study period, 8 DVTs were detected by duplex evaluation in general surgical patients not in the study (1.5%). In conclusion, in a prospective randomized study using sequential pneumatic compression devices, subcutaneous heparin or no prophylaxis in matched general surgical patients at moderate to high risk for thromboembolism, no DVTs occurred for up to 30 days. Furthermore, neither a PI nor other factors associated with DVT accurately predicted the incidence of DVT in this patient population.

  7. A prospective, randomized-controlled clinical trial to evaluate bone preservation using implants with different geometry placed into extraction sockets in the maxilla.

    PubMed

    Sanz, Mariano; Cecchinato, Denis; Ferrus, Jorge; Pjetursson, E Bjarni; Lang, Niklaus P; Lindhe, Jan

    2010-01-01

    The primary objective of this study was to determine the association between the size of the void established by using two different implant configurations and the amount of buccal/palatal bone loss that occurred during 16 weeks of healing following their installation into extraction sockets. The clinical trial was designed as a prospective, randomized-controlled parallel-group multicenter study. Adults in need of one or more implants replacing teeth to be removed in the maxilla within the region 15-25 were recruited. Following tooth extraction, the site was randomly allocated to receive either a cylindrical (group A) or a tapered implant (group B). After implant installation, a series of measurements were made to determine the dimension of the ridge and the void between the implant and the extraction socket. These measurements were repeated at the re-entry procedure after 16 weeks. The study demonstrated that the removal of single teeth and the immediate placement of an implant resulted in marked alterations of the dimension of the buccal ridge (43% and 30%) and the horizontal (80-63%) as well as the vertical (69-65%) gap between the implant and the bone walls. Although the dimensional changes were not significantly different between the two-implant configurations, both the horizontal and the vertical gap changes were greater in group A than in group B. Implant placement into extraction sockets will result in significant bone reduction of the alveolar ridge.

  8. A prospective, randomized single-blind evaluation of effect of injection speed on anesthetic efficacy of inferior alveolar nerve block in patients with symptomatic irreversible pulpitis.

    PubMed

    Aggarwal, Vivek; Singla, Mamta; Miglani, Sanjay; Kohli, Sarita; Irfan, Mohammad

    2012-12-01

    Speed of injection may affect the solution spread in the pterygomandibular space. It was hypothesized that speed of injection will affect the anesthetic efficacy of inferior alveolar nerve block (IANB) in patients with symptomatic irreversible pulpitis. Fifty-nine adult volunteers who were actively experiencing pain participated in this prospective, randomized, single-blind study. The patients were divided into 2 groups on a random basis and received either slow or rapid IANB with 3.6 mL of 2% lidocaine with 1:200,000 epinephrine. Endodontic access preparation was initiated after 15 minutes of the initial IANB. Pain during treatment was recorded by using the Heft-Parker visual analogue scale. The primary outcome measure, and the definition of success, was the ability to undertake pulp access and canal instrumentation with no or mild pain (Heft-Parker visual analog scale score < 55 mm). Secondary outcome measure was the solution deposition pain. Statistical analysis was performed by using Mann-Whitney U test and χ(2) test. Slow and rapid injections gave 43% and 51% success rates, respectively. The difference was statistically insignificant. Slow injections produced less solution deposition pain than rapid injections. Rate of injection has no effect on anesthetic success of IANB, but slow injections were more comfortable than rapid injections. Copyright © 2012 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  9. An evaluation of the efficacy of aspirin and benzydamine hydrochloride gargle for attenuating postoperative sore throat: a prospective, randomized, single-blind study.

    PubMed

    Agarwal, Anil; Nath, S S; Goswami, Debolina; Gupta, Devendra; Dhiraaj, Sanjay; Singh, Prabhat K

    2006-10-01

    Postoperative sore throat (POST), although a minor complication, remains a source of postoperative morbidity. We compared the efficacy of dispersible aspirin gargle to benzydamine hydrochloride (a topical nonsteroidal anti inflammatory drug) gargles for prevention of POST. We enrolled 60 consecutive female patients, 16-60 yr of age, ASA physical status I or II, undergoing elective modified radical mastectomy under general anesthesia in this prospective, randomized, placebo-controlled, single-blind study. Patients were randomly divided into 3 groups of 20 subjects each: Group 1 (C) mineral water; Group 2 (AS) tab aspirin 350 mg; and Group 3 (BH) 15 mL of benzydamine hydrochloride (0.15%). All the medications were made into 30 mL of solution. Patients were asked to gargle this mixture for 30 s, 5 min before induction of anesthesia. Grading of POST was done at 0, 2, 4, and 24 h postoperatively on a 4-point scale (0-3). Aspirin gargles reduced the incidence of POST for 4 h whereas benzydamine hydrochloride gargles reduced POST for 24 h. POST was more severe in the control group at 0 and 2 h (P < 0.05). Aspirin and benzydamine hydrochloride gargles significantly reduced the incidence and severity of POST (P < 0.05).

  10. Acute Adverse Reactions to Nonionic Iodinated Contrast Media for CT: Prospective Randomized Evaluation of the Effects of Dehydration, Oral Rehydration, and Patient Risk Factors.

    PubMed

    Motosugi, Utaroh; Ichikawa, Tomoaki; Sano, Katsuhiro; Onishi, Hiroshi

    2016-11-01

    The objective of our study was to determine the effects of dehydration and oral rehydration on the incidence of acute adverse reactions to iodinated contrast media administered during abdominal and pelvic CT in outpatients. For our prospective randomized study performed at a single institution, adult outpatients undergoing contrast-enhanced abdominal CT were randomly divided into a rehydration group (n = 2244 patients [1379 men and 865 women]; mean age, 65.2 years; age range, 18-90 years) and a control group (n = 3715 [2112 male patients and 1603 female patients]; mean age, 65.8 years; age range, 17-96 years), which included an age- and sex-matched subgroup (adjusted control group, n = 2244). The rehydration group received an oral rehydration solution (500 mL of liquid in which osmotic pressure is adjusted to enhance gastrointestinal absorption) before abdominal and pelvic CT. Patients were also divided into subclinically dehydrated (n = 997) and hydrated (n = 4962) groups according to their answers to a questionnaire that they completed before the CT examination. The patients were interviewed about contrast-induced adverse reactions before they left the CT room, and the reactions were categorized as allergiclike or physiologic. The incidence of reactions was compared between the rehydration and control groups and between the subclinical dehydration and hydrated groups. The rehydration and control groups were compared with an unpaired t test or a chi-square or Fisher test. The overall incidence of an acute adverse reaction was 4.3% (254/5959); the acute adverse reactions included 136 allergiclike and 118 physiologic reactions. Fourteen allergiclike and nine physiologic reactions were moderate grade, and none was severe. There was no significant difference between the rehydration group and adjusted control group in the overall incidence of adverse reactions (99/2244 [4.4%] vs 100/2244 [4.5%], respectively; p = 0.9422) or between the subclinically dehydrated group

  11. PROSPECTIVE RANDOMIZED STUDY COMPARING TWO ANESTHETIC METHODS FOR SHOULDER SURGERY

    PubMed Central

    Ikemoto, Roberto Yukio; Murachovsky, Joel; Prata Nascimento, Luis Gustavo; Bueno, Rogerio Serpone; Oliveira Almeida, Luiz Henrique; Strose, Eric; de Mello, Sérgio Cabral; Saletti, Deise

    2015-01-01

    Objective: To evaluate the efficacy of suprascapular nerve block in combination with infusion of anesthetic into the subacromial space, compared with interscalene block. Methods: Forty-five patients with small or medium-sized isolated supraspinatus tendon lesions who underwent arthroscopic repair were prospectively and comparatively evaluated through random assignation to three groups of 15, each with a different combination of anesthetic methods. The efficacy of postoperative analgesia was measured using the visual analogue scale for pain and the analgesic, anti-inflammatory and opioid drug consumption. Inhalation anesthetic consumption during surgery was also compared between the groups. Results: The statistical analysis did not find any statistically significant differences among the groups regarding anesthetic consumption during surgery or postoperative analgesic efficacy during the first 48 hours. Conclusion: Suprascapular nerve block with infusion of anesthetic into the subacromial space is an excellent alternative to interscalene block, particularly in hospitals in which an electrical nerve stimulating device is unavailable. PMID:27022569

  12. Clinical Evaluation of a Royal Jelly Supplementation for the Restoration of Dry Eye: A Prospective Randomized Double Blind Placebo Controlled Study and an Experimental Mouse Model

    PubMed Central

    Inoue, Sachiko; Kawashima, Motoko; Hisamura, Ryuji; Imada, Toshihiro; Izuta, Yusuke; Nakamura, Shigeru; Ito, Masataka; Tsubota, Kazuo

    2017-01-01

    Background Dry eye is a multifactorial disease characterized by ocular discomfort and visual impairment. Lacrimal gland function has been shown to decrease with aging, a known potent risk factor for dry eye. We have previously found that orally administrated royal jelly (RJ) restored tear secretion in a rat model of dry eye. Methods and Findings We examined the effects of RJ oral administration on dry eye in this prospective, randomized, double-blind, placebo-controlled study. Forty-three Japanese patients aged 20–60 years with subjective dry eye symptoms were randomized to an RJ group (1200 mg/tablet, six tablets daily) or a placebo group for 8 weeks. Keratoconjunctival epithelial damage, tear film break-up time, tear secretion volume, meibum grade, biochemical data, and subjective dry eye symptoms based on a questionnaire were investigated at baseline, and at 4 and 8 weeks after intervention. Adverse events were reported via medical interviews. In the RJ group, tear volume significantly increased after intervention (p = 0.0009). In particular, patients with a baseline Schirmer value of ≤10 mm showed a significant increase compared with baseline volume (p = 0.0005) and volume in the placebo group (p = 0.0051). No adverse events were reported. We also investigated the effect of RJ (300 mg/kg per day) administration using a mouse model of dry eye. Orally repeated administration of RJ preserved tear secretion, potentially through direct activation of the secretory function of the lacrimal glands. Conclusion Our results suggest that RJ improves tear volume in patients with dry eye. Trial Registration Registered NO. the University Hospital Medical Information Network in Japan (UMIN000014446) PMID:28060936

  13. Prospective randomized trial of ketorolac after congenital heart surgery.

    PubMed

    Gupta, Anuja; Daggett, Casey; Drant, Stacey; Rivero, Niurka; Lewis, Alan

    2004-08-01

    Ketorolac is a potent nonsteroidal analgesic agent used to treat postoperative pain. It produces excellent analgesia without the sedating side effects of opioid analgesics. Routine use of ketorolac after cardiac surgery is limited by concerns of bleeding complications. The purpose of this study was to evaluate the risk of bleeding complications of ketorolac for treatment of pain after congenital heart surgery in infants and children. Prospective randomized, controlled trial. Pediatric cardiac intensive care unit in tertiary teaching hospital. Seventy infants and children, median age 10 months (range 2.5-174), who underwent congenital heart surgery requiring cardiopulmonary bypass were randomized in the trial. Pain control was performed with ketorolac and opioid analgesics in one arm of the study and opioid analgesics alone in the other arm. The main outcome evaluated was bleeding complications measured by chest-tube drainage and wound and gastrointestinal bleeding. Thirty-five patients were randomized to each treatment arm. In the ketorolac group, the median chest-tube drainage was 13.3 (range 4-22) mL/kg/d, no patient had significant wound bleeding, and 1 (0.03%) patient had gastrointestinal bleeding. In the control group, the median chest-tube drainage was 16.5 (range 3-24) mL/kg/d, 1 (0.03%) patient had wound bleeding, and no patient had gastrointestinal bleeding. Ketorolac can be used to treat pain after congenital heart surgery without an increased risk of bleeding complications.

  14. Upper Digestive Bleeding in Atrial Fibrillation: Evaluation of Gastroscopy Prior to Oral Anticoagulant Therapy (GOAT), Prospective, Randomized, Double Blind Study on a Community Population

    PubMed Central

    Lagi, Alfonso; Spini, Simona; Meucci, Elisa; Cartei, Alessandro; Cencetti, Simone

    2011-01-01

    Background The aim of this study was to investigate the incidence of digestive hemorrhages in patients with non-valvular atrial fibrillation (NVAF), scheduled for oral anticoagulant therapy. Methods We conducted, over 24 months, a prospective, randomized, population-based observational study on consecutive patients with recurrent paroxysmal, persistent, or permanent NVAF, scheduled for oral anticoagulant therapy. The study initially included 268 patients with NVAF (162 males and 106 females) with a mean age of 74 years (range 42-86 years). Patients were split into two groups: those undergoing preventive Esophago-Gastro-Duodenoscopy (EGD) (Group A) and those who did not (Group B). All patients positive by EGD underwent medical treatment and subsequent 30-day endoscopic controls showed complete healing. The primary outcome of the study was to determine if previous EGD in patients with NVAF resulted in a low risk of bleeding during oral anticoagulant therapy. The two groups were comparable for most variables. Results Significant differences were found between groups for the incidence of antiarrhythmic drugs and for early hemorrhage (P <0.001). The incidences of early hemorrhages were significantly different between the two groups with 12 in group B (12%) and 2 in group A (1.7%). Conclusions Preventive EGD can identify hidden digestive diseases, which may increase the incidence of early hemorrhages.

  15. Clinical and instrumental evaluation of two different regimens of tranexamic acid in total hip arthroplasty: a single-centre, prospective, randomized study with 80 patients.

    PubMed

    Piolanti, Nicola; Del Chiaro, Andrea; Matassi, Fabrizio; Graceffa, Angelo; Nistri, Lorenzo; Marcucci, Massimiliani

    2017-09-08

    The use of tranexamic acid (TXA) in total hip arthroplasty (THA) can significantly reduce blood losses with many clinical and economical advantages. However, no consensus has been reached regarding the optimal regimen for TXA administration. The aim of this study is to analyse and compare the haemostatic effect of two different intravenous (IV) regimens of TXA. We planned a single-centre, prospective, randomized study including 80 patients who underwent primary unilateral minimally invasive THA because of a hip osteoarthritic degeneration. We divided patients into two groups: the G10 group received two IV doses of 10 mg/kg of TXA, and the G20 group received two doses of 20 mg/kg. No significant differences in mean minimum levels of Hb and HcT stratified by days after surgery were uncovered between the two groups despite the use of two different dosages of TXA. Also the mean blood volume loss was statistically similar between two groups. No differences were also observed regarding the occurrence of adverse effects. In two IV bolus regimens of TXA administration, the use of a dose of 10 or 20 mg/kg provides statistically similar results in blood loss sparing. Therefore, the use of two 10 mg/kg doses could be considered more advisable in order to reduce the potential thromboembolic risks related to this drug.

  16. A prospective randomized controlled trial of the laryngeal mask airway versus the endotracheal intubation in the thyroid surgery: evaluation of postoperative voice, and laryngopharyngeal symptom.

    PubMed

    Chun, Byung-Joon; Bae, Ja-Sung; Lee, So-Hui; Joo, Jin; Kim, Eun-Sung; Sun, Dong-Il

    2015-07-01

    The present study was performed to determine whether thyroidectomy patients undergoing general anesthesia provided with a laryngeal mask airway (LMA) have a lower risk of voice-related complications and laryngopharyngeal symptoms than those undergoing endotracheal intubation (ETI). In a prospective, double-blinded, randomized clinical trial, we studied 64 patients undergoing elective thyroid lobectomy between July 2013 and February 2014. Acoustic analyses were performed preoperatively and at 48 h and 2 weeks postoperatively. The voice handicap index (VHI), M.D. Anderson dysphagia index (MDADI), and laryngopharyngeal symptom score (LPS) were determined preoperatively and at 24 h, 48 h, 1 week, and 2 weeks post-thyroidectomy. In acoustic analysis, jitter, shimmer and noise-to-harmonic ratio showed significantly better results in the LMA group than the ETI group 48 h after surgery, but there was no difference at 2 weeks. The incidence of postoperative lower-pitched voice in the LMA group was also significantly lower than that in the ETI group. In the LMA group, the VHI, MDADI, and LPS were better compared to those in the ETI group at 24 h postoperatively, and improved to the preoperative state within 1 week. However, those in the ETI group remained poorer than the preoperative values 1 week after surgery. Use of the LMA in general anesthesia for thyroid surgery has advantages over the ETI in decreasing patients' subjective and objective voice symptoms, reducing the duration of symptoms, and relieving the laryngopharyngeal symptoms.

  17. A Prospective Randomized Double-Blind Study Evaluating UP165 and S-Adenosyl-l-Methionine on Depression, Anxiety and Psychological Well-Being

    PubMed Central

    Kalman, Douglas S.; Feldman, Samantha; Rivas Vazquez, Rafeal; Krieger, Diane R.

    2015-01-01

    The primary objective of this pilot clinical trial was to evaluate the effects of UP165 (derived from Zea mays L., commonly known as corn) over time. The secondary objective was the comparison for outcomes versus S-adenosyl-methionine (SAM-e). Subjects with mild depression or anxiety were given the Beck Depression Inventory second edition (BDI-II), the Beck Anxiety Inventory (BAI), and the Schwartz Outcome Scale (SOS-10). Forty-two subjects (21–65 years old) were randomized to eight-weeks of supplementation with UP165 or SAM-e with questionnaires being administered at randomization, week four and eight. Those receiving UP165 achieved significant reduction from baseline at weeks four and eight, respectively for the BDI-II, as well as a trend for reduction in BAI at week four and significance at week eight. There was a trend for improvement on the SOS at week four and significance at week eight. SAM-e demonstrated a trend for improvement on the BDI-II by week eight over the UP165 with no differences between the two for the BAI or the SOS. Overall, this study indicates that there may be benefit to UP165 for mood enhancement in those with mild depression or anxiety. Randomized placebo comparator trials appear warranted. PMID:28231193

  18. Primary analysis of a prospective, randomized, single-blinded phase II trial evaluating the HER2 peptide GP2 vaccine in breast cancer patients to prevent recurrence

    PubMed Central

    Ardavanis, Alexandros; Litton, Jennifer K.; Shumway, Nathan M.; Hale, Diane F.; Murray, James L.; Perez, Sonia A.; Ponniah, Sathibalan; Baxevanis, Constantin N.; Papamichail, Michael

    2016-01-01

    GP2 is a HER2-derived, HLA-A2+ restricted peptide. Phase I studies showed GP2 administered with GM-CSF to be safe and immunogenic. Here we report the primary analysis of a prospective, randomized, multicenter phase II adjuvant trial conducted to determine the vaccine's efficacy. The trial enrolled HLA-A2+, clinically disease-free, node-positive and high-risk node-negative breast cancer patients with tumors expressing HER2 (immunohistochemistry[IHC] 1+-3+). Patients were randomized to GP2+GM-CSF versus GM-CSF alone. Disease-free survival (DFS) was analyzed in intention-to-treat (ITT) and per-treatment cohorts; pre-specified subgroup analyses were performed for patients with IHC 3+ or FISH+ disease. The trial enrolled 180 patients; 89 received GP2+GM-CSF and 91 received GM-CSF alone. The groups were well-matched for clinicopathologic characteristics. Toxicities have been minimal. The Kaplan-Meier estimated 5-year DFS rate in the ITT analyses was 88% (95% CI:78-94%) in vaccinated vs. 81% (95% CI:69-89%) (P = 0.43) in control patients after a 34 month median follow-up. In the per-treatment analysis, the estimated 5-year DFS rates were 94% (95% CI:83-98%) and 85% (73-92%) (P = 0.17). In IHC 3+/FISH+ patients, the estimated 5-year DFS rate was 94% (82-98%) in vaccinated patients (n = 51) vs. 89% (71-96%) in control patients (n = 50), (P = 0.86) in the ITT analyses and 100% vs. 89% (71-96%) in vaccinated vs. control patients in the per-treatment analyses (P = 0.08). While the overall ITT analysis did not demonstrate benefit to vaccination, this trial confirmed that the GP2 vaccine is safe and suggests that vaccination may have clinical activity, particularly in patients with HER2 overexpression who received the full vaccine series (ie per-treatment group). PMID:27589688

  19. A prospective randomized trial evaluating endoscopic Nd:YAG laser prostate ablation with or without potassium titanyl phosphate (KTP) laser bladder neck incision.

    PubMed

    Langley, S E; Gallegos, C R; Moisey, C U

    1997-12-01

    To investigate whether performing a potassium titanyl phosphate (KTP) laser bladder neck incision (BNI) in conjunction with a Nd:YAG endoscopic ablation of the prostate (ELAP) compared with an ELAP alone, improves early post-operative voiding rates and clinical outcome. A prospective randomized trial that was both double-blind and power-determined (80%) compared 88 patients with benign prostatic enlargement undergoing ELAP and those undergoing KTP BNI and ELAP. A dual-wavelength KTP/532TM (Laserscope) laser was used with Add/Stat side-firing fibres. A urethral catheter was inserted post-operatively and was removed after 18 h. Patients unable to void at this stage were then re-catheterized, discharged and readmitted 2 weeks later for catheter removal. Patients were followed up at 3 month intervals. Post-operatively, 80% of the patients undergoing KTP BNI and ELAP were able to void on catheter removal at 18 h, compared with only 57% of the patients undergoing ELAP alone (P < 0.05, chi-square). After 1 month, two patients from the former and four from the latter group failed to void and required further surgery. At 3 months, there was a significant improvement in the post-void residual volume, maximum flow rate, symptom and quality-of-life scores compared to the pre-operative values for both groups (P < 0.005). However, there was a greater improvement in the flow rate and symptom score in patients undergoing KTP BNI and ELAP (P < 0.05). This study shows the benefit of performing a KTP BNI with ELAP in terms of early voiding rates and initial clinical outcome, and this treatment is recommended.

  20. Evaluation of computer-assisted mandibular reconstruction with vascularized iliac crest bone graft compared to conventional surgery: a randomized prospective clinical trial

    PubMed Central

    2014-01-01

    Background Computer-assisted surgery plays an increasingly important role in mandibular reconstruction, ensuring the best possible masticatory function and aesthetic outcome. Methods Twenty patients were randomly assigned to computer-assisted or conventional mandibular reconstruction with vascularized iliac crest bone graft in a prospective study design. Virtual surgical planning was based on preoperative CT-data using specific surgical planning software. A rapid prototyping guide transferred the virtual surgery plan to the operation site. During surgery the transplant ischemic time, reconstruction time, time for shaping the transplant and amount of bone removed were measured. Additionally, the difference in the intercondylar distance before and after surgery was calculated. Results Computer-assisted surgery shortened the time of transplant ischemia (P < 0.005) and defect reconstruction (P < 0.001) compared to conventional surgery. The time to saw and shape the transplant at the donor site was shorter using conventional surgery (P < 0.005); therefore, the overall time for surgery didn’t change (P = 0.527). In the computer-assisted group, the amount of bone harvested equaled the defect size, whereas the transplant size in the conventional group exceeded the defect site by 16.8 ± 5.6 mm (P < 0.001) on average. The intercondylar distance before compared to after surgery was less affected in the computer-assisted than in the conventional group (P < 0.001). Conclusions The presented study shows that computer-assisted surgery can help reduce the time for mandibular defect reconstruction and consequently the transplant ischemic time. In the computer-assisted group, the iliac crest donor site defect was downsized and the postoperative condyle position was less altered, reducing possible risks of postoperative complications and donor site morbidity. Trial Registration DRKS00005181. PMID:24716651

  1. Prospective Evaluation of Ventriculostomy Infections

    PubMed Central

    Worley, Emmagene; Astle, Sonia

    2015-01-01

    Introduction: Hospital-acquired infections associated with external drainage of ventricular cerebrospinal fluid (CSF) are a significant source of concern for the patients and the provider team alike. Traditional rates of ventriculostomy infection range from 10-17% in a time-dependent fashion. Changing physician and nursing practices fueled this concern over infections.  Objective: We sought to prospectively identify the risk factors associated with ventriculostomy infections as part of a quality assurance project.  Methods: One hundred consecutive patients were evaluated and data were collected on 91. The primary indications for ventriculostomy were subarachnoid hemorrhage (46%), intracerebral hemorrhage (24%), and trauma (22%). Variables prospectively evaluated included pre-incision antibiotics, sterile technique bundling, setting of placement (operating room versus intensive care unit), experience of operator (attending, resident, or physician assistant), catheter type (antibiotic impregnated or not), use of a post-insertion dressing, and in-dwell time of the catheter.  Results: There was only one infection in 91 patients (1.1%). This infection occurred in a patient without an antibiotic-impregnated catheter that was inserted by a resident physician. Compliance with pre-insertion antibiotics was very high, but most other variables had modest deviations in compliance. Conclusion: Infection rate related to external ventricular drainage is very low. Our data suggest that non-antibiotic impregnated catheters may be associated with infection, but that other variables thought to be critical may be of less value. PMID:26430586

  2. Evaluation of the Etoricoxib-Mediated Pain-Relieving Effect in Patients Undergoing Lumbar Fusion Procedures for Degenerative Lumbar Scoliosis: A Prospective Randomized, Double-Blind Controlled Study.

    PubMed

    Shi, Yongxiang; Wang, Ping; Hu, Xinlei; Ye, Zhaoming

    2015-04-01

    This randomized, double-blind study was carried out to evaluate the effectiveness of etoricoxib in controlling the pain during lumbar fusion surgery of the degenerative lumbar scoliosis patients. We found that perioperative use of etoricoxib produced a significant reduction in the degree of pain compared to the patients treated with placebo. Etoricoxib eased the pain and helped to manage the discomfort of lumbar fusion surgery. In addition, etoricoxib was well tolerated as it caused no serious adverse reaction, suggesting a safe profile. Etoricoxib also appeared to ensure and promote the positive effect of surgery, however, insignificantly. Thus, the results suggest that etoricoxib was effective in safely managing the pain during the lumbar fusion surgery and recovery thereafter.

  3. To evaluate the effectiveness of health care ethics consultation based on the goals of health care ethics consultation: a prospective cohort study with randomization

    PubMed Central

    2014-01-01

    Background The growing prevalence of health care ethics consultation (HCEC) services in the U.S. has been accompanied by an increase in calls for accountability and quality assurance, and for the debates surrounding why and how HCEC is evaluated. The objective of this study was to evaluate the effectiveness of HCEC as indicated by several novel outcome measurements in East Asian medical encounters. Methods Patients with medical uncertainty or conflict regarding value-laden issues, and requests made by the attending physicians or nurses for HCEC from December 1, 2009 to April 30, 2012 were randomly assigned to the usual care group (UC group) and the intervention group (HCEC group). The patients in the HCEC group received HCEC conducted by an individual ethics consultant. Data analysis was based on the intention-to-treat principle. Mann–Whitney test and Chi-squared test were used depending on the scale of measurement. Results Thirty-three patients (53.23%) were randomly assigned to the HCEC group and 29 patients were randomly assigned to the UC group. Among the 33 patients in the HCEC group, two (6.06%) of them ultimately did not receive a HCEC service. Among the 29 patients in the UC group, four (13.79%) of them received a HCEC service. The survival rate at hospital discharge did not differ between the two groups. Patients in the HCEC group showed significant reductions in the entire ICU stay and entire hospital stay. HCEC significantly facilitated achieving the goal of medical care (p < .01). Furthermore, patients in the HCEC group had a shorter ICU stay and shorter hospital stay after the occurrence of medical uncertainty or conflict regarding value-laden issues than those in the UC group. Conclusions Our findings demonstrated that HCEC were associated with reduced consumption of medical resources as indicated by shorter entire ICU stay, entire hospital stay, and shorter ICU and hospital stay after the occurrence of the medical uncertainty or conflict

  4. A Multicenter, Prospective, Randomized Controlled Trial to Evaluate the Additional Benefit of a Multistrain Synbiotic (Prodefen®) in the Clinical Management of Acute Viral Diarrhea in Children

    PubMed Central

    García-Menor, Emilia; García-Marín, Fátima; Vecino-López, Raquel; Horcajo-Martínez, Gloria; de Ibarrondo Guerrica-Echevarría, María-José; Gómez-González, Pedro; Velasco-Ortega, Syra; Suárez-Almarza, Javier; Nieto-Magro, Concepción

    2016-01-01

    This randomized, open-label study evaluated the additional benefits of the synbiotic Prodefen® in the clinical management of acute diarrhea of suspected viral origin in children between 6 months and 12 years of age. Study outcomes included the duration of diarrhea, the recovery from diarrhea, and the tolerability and acceptance of the treatment. The proportion of patients without diarrhea over the study period was greater in the synbiotic group than in the control group at all study time points, showing a statistically significant difference on the fifth day (95% vs 79%, p < 0.001). The duration of diarrhea (median and interquartile range) was reduced by 1 day in the synbiotic-treated patients (3 [2-5] vs 4 [3-5], p = 0.377). The tolerability of the treatment regimen, as evaluated by the parents, was significantly better in those receiving the synbiotic than in the control group. Overall, 96% of the parents of children receiving the synbiotic reported being satisfied to very satisfied with the treatment regimen. The results of this study indicate that the addition of the synbiotic Prodefen® is a well-tolerated and well-accepted approach that provides an additional benefit to the standard supportive therapy in the management of acute viral diarrhea in children. PMID:28229091

  5. Prospective, randomized, double-blind, clinical evaluation of Aloe vera Barbadensis, applied in combination with a tongue protector to treat burning mouth syndrome.

    PubMed

    López-Jornet, Pia; Camacho-Alonso, Fabio; Molino-Pagan, Diana

    2013-04-01

    The aim of this study was to evaluate the efficacy of aloe vera (AV) applied in combination with a tongue protector, comparing this with a placebo. A total of 75 patients with burning mouth syndrome (BMS) were divided into three groups randomly: Group I (tongue protector three times a day), Group II (tongue protector and 0.5 ml AV at 70% three times a day) and Group III (tongue protector and 0.5 ml placebo three times a day). Symptoms were evaluated by visual analogue scale (VAS), while patient psychological profiles were assessed using the Hospital Anxiety-Depression scale and their quality of life using the Oral Health Impact Profile 49 (OHIP-49). Treatment continued for 3 months. Visual analogue scale pain values improved for all three study groups but without statistically significant differences between the groups (P = 0.210). Regarding quality of life, no significant differences were found between groups with the exception of the OHIP-49 score for handicap. The overall clinical improvement was greater for Group II, with a difference almost reaching significance. The concomitant prescription of tongue protector and AV is effective for treating patients with BMS. © 2012 John Wiley & Sons A/S. All rights reserved.

  6. Evaluation of the Analgesic Efficacy of Melatonin in Patients Undergoing Cesarean Section Under S pinal Anesthesia: A Prospective Randomized Double-blind Study

    PubMed Central

    Beigom Khezri, Marzieh; Delkhosh Reihany, Morteza; Oveisy, Sonia; Mohammadi, Navid

    2016-01-01

    Melatonin has been suggested as a new natural pain killer in inflammatory pain and during surgical procedures. We designed this randomized double-blind controlled study to evaluate the analgesic efficacy and also optimal preemptive dose of melatonin in patients undergoing cesarean section under spinal anesthesia . One hundred twenty patients scheduled for cesarean section under spinal anesthesia were randomly allocated to one of three groups of 40 each to receive melatonin 3 milligram (mg) (group M3), melatonin 6 mg (group M6) or placebo (group P) sublingually 20 min before the spinal anesthesia. The time to first analgesic request, analgesic requirement in the first 24 h after surgery, hemodynamic variables, anxiety scores nd the incidence of adverse events were recorded. The duration of anesthesia and analgesia didn’t show significant differences between three groups. Total analgesic request during 24 h after surgery was different among the three groups (P = 0.035). The incidence of headache in group M6 was significantly higher than others (P<0.001). However, after adjusting headache between groups of the study, we were unable to show the significant difference in the total analgesic request during 24 h after surgery among the three groups (p = 0.058). Although premedication of patients with 3 mg sublingual melatonin prolonged time to first analgesic request after cesarean delivery compared to placebo group, the difference was not statistically significant. Meanwhile increasing dose of melatonin to 6 mg failed to enhance analgesia and also increase the incidence of headache in patients undergoing cesarean section under spinal anesthesia. PMID:28243296

  7. The clinical impact of immediate on-site cytopathology evaluation during endoscopic ultrasound-guided fine needle aspiration of pancreatic masses: a prospective multicenter randomized controlled trial.

    PubMed

    Wani, Sachin; Mullady, Daniel; Early, Dayna S; Rastogi, Amit; Collins, Brian; Wang, Jeff F; Marshall, Carrie; Sams, Sharon B; Yen, Roy; Rizeq, Mona; Romanas, Maria; Ulusarac, Ozlem; Brauer, Brian; Attwell, Augustin; Gaddam, Srinivas; Hollander, Thomas G; Hosford, Lindsay; Johnson, Sydney; Kushnir, Vladimir; Amateau, Stuart K; Kohlmeier, Cara; Azar, Riad R; Vargo, John; Fukami, Norio; Shah, Raj J; Das, Ananya; Edmundowicz, Steven A

    2015-10-01

    Observational data on the impact of on-site cytopathology evaluation (OCE) during endoscopic ultrasonography-guided fine needle aspiration (EUS-FNA) of pancreatic masses have reported conflicting results. We aimed to compare the diagnostic yield of malignancy and proportion of inadequate specimens between patients undergoing EUS-FNA of pancreatic masses with and without OCE. In this multicenter randomized controlled trial, consecutive patients with solid pancreatic mass underwent randomization for EUS-FNA with or without OCE. The number of FNA passes in the OCE+ arm was dictated by the on-site cytopathologist, whereas seven passes were performed in OCE- arm. EUS-FNA protocol was standardized, and slides were reviewed by cytopathologists using standardized criteria for cytologic characteristics and diagnosis. A total of 241 patients (121 OCE+, 120 OCE-) were included. There was no difference between the two groups in diagnostic yield of malignancy (OCE+ 75.2% vs. OCE- 71.6%, P=0.45) and proportion of inadequate specimens (9.8 vs. 13.3%, P=0.31). Procedures in OCE+ group required fewer EUS-FNA passes (median, OCE+ 4 vs. OCE- 7, P<0.0001). There was no significant difference between the two groups with regard to overall procedure time, adverse events, number of repeat procedures, costs (based on baseline cost-minimization analysis), and accuracy (using predefined criteria for final diagnosis of malignancy). There was no difference between the two groups with respect to cytologic characteristics of cellularity, bloodiness, number of cells/slide, and contamination. Results of this study demonstrated no significant difference in the diagnostic yield of malignancy, proportion of inadequate specimens, and accuracy in patients with pancreatic mass undergoing EUS-FNA with or without OCE.

  8. An evaluation of an expert system for detecting critical events during anesthesia in a human patient simulator: a prospective randomized controlled study.

    PubMed

    Görges, Matthias; Winton, Pamela; Koval, Valentyna; Lim, Joanne; Stinson, Jonathan; Choi, Peter T; Schwarz, Stephan K W; Dumont, Guy A; Ansermino, J Mark

    2013-08-01

    Perioperative monitoring systems produce a large amount of uninterpreted data, use threshold alarms prone to artifacts, and rely on the clinician to continuously visually track changes in physiological data. To address these deficiencies, we developed an expert system that provides real-time clinical decisions for the identification of critical events. We evaluated the efficacy of the expert system for enhancing critical event detection in a simulated environment. We hypothesized that anesthesiologists would identify critical ventilatory events more rapidly and accurately with the expert system. We used a high-fidelity human patient simulator to simulate an operating room environment. Participants managed 4 scenarios (anesthetic vapor overdose, tension pneumothorax, anaphylaxis, and endotracheal tube cuff leak) in random order. In 2 of their 4 scenarios, participants were randomly assigned to the expert system, which provided trend-based alerts and potential differential diagnoses. Time to detection and time to treatment were measured. Workload questionnaires and structured debriefings were completed after each scenario, and a usability questionnaire at the conclusion of the session. Data were analyzed using a mixed-effects linear regression model; Fisher exact test was used for workload scores. Twenty anesthesiology trainees and 15 staff anesthesiologists with a combined median (range) of 36 (29-66) years of age and 6 (1-38) years of anesthesia experience participated. For the endotracheal tube cuff leak, the expert system caused mean reductions of 128 (99% confidence interval [CI], 54-202) seconds in time to detection and 140 (99% CI, 79-200) seconds in time to treatment. In the other 3 scenarios, a best-case decrease of 97 seconds (lower 99% CI) in time to diagnosis for anaphylaxis and a worst-case increase of 63 seconds (upper 99% CI) in time to treatment for anesthetic vapor overdose were found. Participants were highly satisfied with the expert system (median

  9. Prospective evaluation of myopic keratomileusis.

    PubMed

    Swinger, C A; Barker, B A

    1984-07-01

    The initial results of a prospective evaluation of myopic keratomileusis are reported. The procedure was attempted on 42 eyes, with an average follow-up of 10 months. The average reductions of myopia were 7.05 D and 11.59 D when measured by keratometry and refraction, respectively. Regular astigmatism increased by 0.50 D on keratometry, but there was no change in the refractive cylinder. The majority of patients had some irregular astigmatism on corneoscopy. The average percent correction, based on refraction, was 94.1 +/- 24%, and the correlation coefficient was 0.43. Visual rehabilitation was rapid. No patient followed for 1 year or more had a decrease in the best-corrected acuity, and 63% of this group had an average improvement of 1.5 lines with as much as five lines. The final refraction may take up to 6 months to stabilize. Complications consisted of epithelium and debris in the interface and focal necrosis of Bowman's membrane. The technique is difficult but may have application in the visual rehabilitation of the high myope.

  10. 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.

  11. Placebo-controlled, double-blind, randomized, prospective study of a glycerol-based emollient on eczematous skin in atopic dermatitis: biophysical and clinical evaluation.

    PubMed

    Breternitz, M; Kowatzki, D; Langenauer, M; Elsner, P; Fluhr, J W

    2008-01-01

    Atopic dermatitis (AD) is a frequent, chronic inflammatory disease influenced by local, immunological, genetic and environmental factors. Important symptoms of AD are dry skin, intense pruritus and impaired epidermal barrier function. The therapeutic management of AD is difficult and needs individualized concepts. Moisturizing creams and emollients are useful and important treatment adjuncts for the daily skin care of patients with dry and inflamed skin, e.g. AD. Glycerol is known to increase stratum corneum (SC) hydration, improve epidermal barrier function and decrease clinical signs of inflammation. However, no controlled study on the efficacy of glycerol on barrier function and SC hydration in AD has been published. In the present study, a topical 20% glycerol preparation was compared with its vehicle in patients with AD. The aim of the present study was to evaluate the effect of a single emollient ingredient in AD within the full frame of a phase III drug study. 24 patients with AD were treated for 4 weeks twice daily with a glycerol-based emollient in a randomized, double-blind study. Transepidermal water loss, skin capacitance, erythema and skin surface pH were assessed with biophysical, non-invasive instruments. The SCORAD and a local severity score were evaluated. After a wash-out period of 2 weeks, these parameters were assessed in order to quantify the sustained effect of this treatment. SC hydration was significantly improved, and epidermal barrier function was restored under treatment with glycerol-containing cream compared to the glycerol-free placebo. No significant differences were detectable for erythema values, SCORAD and local severity between the glycerol-containing cream and placebo. However, an improvement over time was detectable in the assessed parameters in both groups indicating the importance of emollient treatment in AD. Glycerol-based emollients have a positive influence on the skin of patients with AD. They enhance the SC hydration

  12. Evaluation of the efficacy of an exercise program for pregnant women with low back and pelvic pain: a prospective randomized controlled trial.

    PubMed

    Ozdemir, Serpil; Bebis, Hatice; Ortabag, Tulay; Acikel, Cengizhan

    2015-08-01

    To evaluate the effect of exercise programs on pregnant women with pregnancy-related low back and pelvic pain. Low back and pelvic pain during pregnancy is a major health problem due to its frequent occurrence and such pain can limit pregnant women in many of their daily activities. A randomized trial with a control group (n = 48) and an intervention group (n = 48). Trial registration number NCT02189356. Department of Obstetrics and Gynecology, between December 2011-May 2012, an Education and Research Hospital in Turkey. Based on the intention-to-treat principle, all pregnant women were analysed according to the group they were assigned to, regardless of whether they received the intervention or not. Participants in the intervention group received health counselling and exercised regarding low back and pelvic pain for four weeks. The pregnant women in the control group received usual care, comprised of routine clinical practice for pregnancy-related low back and pelvic pain. According to Mann-Whitney U test analysis results, there was a statistically significant difference between the control and intervention groups' Visual Analogue Scale during relaxation scores and Visual Analogue Scale during activity scores at the end of the study. According to Mann-Whitney U test analysis results, the change in the mean Oswestry Disability Index score for the intervention group and the difference in the mean scores between the two groups was statistically significant. A four-week exercise program including individualized health counselling to relieve low back and pelvic pain improved the functional status in pregnant women. © 2015 John Wiley & Sons Ltd.

  13. A prospective, randomized trial to evaluate the efficacy of clean intermittent catheterization versus triamcinolone ointment and contractubex ointment of catheter following internal urethrotomy: long-term results.

    PubMed

    Ergün, Osman; Güzel, Ahmet; Armağan, Abdullah; Koşar, Alim; Ergün, Ayşe Gül

    2015-06-01

    Our aim was to evaluate clean intermittent catheterization (CIC) results in combination with triamcinolone ointment and contractubex ointment for lubrication of the catheter after optical internal urethrotomy (OIU). Ninety patients who underwent OIU were randomized into three groups. Two weeks after operation, patients were treated with CIC (group A), triamcinolone ointment CIC (group B), and contractubex ointment CIC (group C). Follow-up continued for 24 months after the OIU. Postoperative results were compared between the three groups. There were no significant differences in the baseline characteristics of the patients or the etiology of the urethral stricture between the three groups. The mean preoperative Q max was 4.31 ml/s. The average score of preoperative international prostate symptom score (IPSS) was 23.1 points. In both groups, after treatment, significant improvements in Q max and IPSS were noted at all follow-up period (p < 0.05). But for Q max and IPSS, there were not any significant differences between groups at all follow-up period (p > 0.05). Overall recurrence rate was 28.9 % (26 out of 90 patients) at the end of the study. Recurrence rates were, however, not found to be statistically significant between these three groups (p > 0.05). Our results indicate that the urethral dilation protocol with CIC after first OIU is a safe, simple, well-tolerated, office-based procedure. Triamcinolone or contractubex ointments of the CIC do not provide an additional benefit. Currently, urethral dilation with CIC after first OIU seems to be the only proven procedure that decreased the recurrence rate.

  14. Evaluation of efficacy of amikacin for attenuation of catheter-related bladder discomfort in patients undergoing percutaneous nephrolithotomy: A prospective, randomized, placebo-controlled, double-blind study

    PubMed Central

    Verma, Ruchi; Agarwal, Anil; Singh, Prabhat Kumar; Gupta, Devendra; Shamim, Rafat

    2016-01-01

    Context: Catheter-related bladder discomfort (CRBD) is the most distressing symptom in patients due to intraoperative urinary catheterization. Amikacin significantly inhibits detrusor contraction evoked by prejunctional stimulation. Aims: The aim of this study is to evaluate the efficacy of amikacin in prevention of CRBD in patients undergoing percutaneous nephrolithotomy. Settings and Design: Study areas were operation theater and postanesthesia care unit of the Department of Anesthesiology, SGPGIMS, Lucknow. Subjects and Methods: One hundred adult patients of either sex were randomly assigned into two groups of fifty each. Patients in control group received normal saline whereas patients in amikacin group received amikacin 10 mg/kg just before induction. Grading of CRBD was done as none, mild, moderate, and severe by a blinded observer at 0, 1, 6, 12, and 24 h after surgery. Statistical Analysis Used: Data were analyzed using Student's t-test and Chi-square test among groups. Incidence of CRBD was compared with Chi-square test whereas severity was analyzed by the test of proportions (Z-test). Visual analog score was compared using Mann–Whitney U-test for surgical site pain. Results: Incidence of CRBD in control group was 66% as compared to 44% observed in amikacin group (P < 0.05). During intergroup comparison at different time points, incidence of CRBD was reduced at 1 and 6 h in the amikacin group (P < 0.05). Significant reduction in the severity of CRBD (moderate) was also observed at 1 h in the amikacin group (P < 0.05). At rest of the time points, there was no significant difference. Conclusions: Amikacin can significantly reduce the incidence and severity of CRBD in the first few hours after surgery. PMID:27746561

  15. 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

  16. A crossover randomized prospective pilot study evaluating a central venous catheter team in reducing catheter-related bloodstream infections in pediatric oncology patients.

    PubMed

    Secola, Rita; Azen, Colleen; Lewis, Mary Ann; Pike, Nancy; Needleman, Jack; Sposto, Richard; Doering, Lynn

    2012-01-01

    Treatment for most children with cancer includes the use of a central venous catheter (CVC). CVCs provide reliable venous access for delivery of chemotherapy and supportive care. This advantage is mitigated by an increased risk of bloodstream infections (BSIs). Despite the ubiquitous use of CVCs, few prospective studies have been conducted to address infection prevention strategies in pediatric oncology patients. Prospective, crossover pilot study of a CVC team intervention versus standard care. Two inpatient oncology units in a metropolitan children's hospital. A total of 41 patients/135 admissions for the experimental unit (EU) and 41/129 admissions for the control unit (CU). Patients received a CVC blood draw bundle procedure by a CVC registered nurse (RN) team member (experimental intervention: EU) for 6 months and by the assigned bedside RN (standard care: CU) for 6 months. Feasibility of implementing a CVC RN team; a significant difference in CVC-related BSIs between the team intervention versus standard care and risk factors associated in the development of CVC-related BSIs were determined. There were 7 CVC-related BSIs/1238 catheter days in the EU group (5.7/1000 catheter days) versus 3 CVC-related BSIs/1419 catheter days in the CU group (2.1/1000 catheter days; P = .97). Selected risk factors were not significantly associated with the development of a CVC-related BSI. A CVC team in the care of pediatric oncology patients is feasible; however, a larger cohort will be required to adequately determine the effectiveness of the team reducing CVC-related BSIs.

  17. Results of a prospective, randomized, multicenter study evaluating sacral neuromodulation with InterStim therapy compared to standard medical therapy at 6-months in subjects with mild symptoms of overactive bladder.

    PubMed

    Siegel, Steven; Noblett, Karen; Mangel, Jeffrey; Griebling, Tomas L; Sutherland, Suzette E; Bird, Erin T; Comiter, Craig; Culkin, Daniel; Bennett, Jason; Zylstra, Samuel; Berg, Kellie Chase; Kan, Fangyu; Irwin, Christopher P

    2015-03-01

    This prospective, randomized, multicenter trial evaluated the 6-month success rate of sacral neuromodulation (SNM) with InterStim® Therapy versus standard medical therapy (SMT) for overactive bladder (OAB). Enrolled subjects discontinued OAB medications prior to and during baseline data collection and were randomized 1:1 to SNM or SMT. Subjects had bothersome symptoms of overactive bladder (OAB) including urinary urge incontinence (≥2 leaks/72 hr) and/or urgency-frequency (≥8 voids/day). Subjects failed at least one anticholinergic medication, and had at least one medication not yet attempted. The primary objective was to compare OAB therapeutic success rate at 6 months between SNM and SMT. Overall, 147 subjects were randomized (70 to SNM and 77 to SMT); 93% were female and mean age was 58. The primary intent to treat analysis showed OAB therapeutic success was significantly greater in the SNM group (61%) than the SMT group (42%; P = 0.02). In the as treated analysis, OAB therapeutic success was 76% for SNM and 49% for SMT (P = 0.002). The SNM group showed significant improvements in quality of life versus the SMT group (all P < 0.001) and 86% of SNM subjects reported improved or greatly improved urinary symptom interference score at 6 months, compared to 44% for SMT subjects. The device-related adverse event rate was 30.5% and the medication-related adverse event rate was 27.3%. This study demonstrates superior objective and subjective success of SNM compared to SMT. SNM is shown to be a safe and effective treatment for OAB patients with mild to moderate symptoms. Neurourol. Urodynam. 34:224-230, 2015. © 2014 Wiley Periodicals, Inc. © 2014 Wiley Periodicals, Inc.

  18. Evaluation of Safety and Efficacy of Qinming8631 DR Implantable Cardiac Pacemaker in Chinese Patients: A Prospective, Multicenter, Randomized Controlled Trial of the First Domestically Developed Pacemaker of China

    PubMed Central

    Xiang, Mei-Xiang; Wang, Dong-Qi; Xu, Jing; Zhang, Zheng; Hu, Jian-Xin; Wang, Dong-Mei; Gu, Xiang; Liu, He-Ping; Guo, Tao; Yang, Xiang-Jun; Ling, Feng; Lin, Jia-Feng; Cai, Shang-Lang; Zhu, Guo-Bin; Wang, Jian-An

    2016-01-01

    Background: High cost of imported pacemakers is a main obstacle for Chinese patients suffering from bradyarrhythmia, and a domestically developed pacemaker will help lower the burden. This study aimed to evaluate the safety and efficacy of Qinming8631 DR (Qinming Medical, Baoji, China), the first domestically developed dual-chamber pacemaker of China, compared with a commercially available pacemaker Talos DR (Biotronik, Berlin, Germany) in Chinese patients. Methods: A prospective randomized trial was conducted at 14 centers in China. Participants were randomized into trial (Qinming8631 DR) and control (Talos DR) groups. Parameters of the pacing systems were collected immediately after device implantation and during follow-ups. The effective pacing rate at 6-month follow-up was recorded as the primary end point. Electrical properties, magnet response, single- and double-pole polarity conversion, rate response function, and adverse events of the pacing system were analyzed. The Cochran-Mantel-Haenszel Chi-square test, paired t-test, and Wilcoxon signed-rank test were used for measuring primary qualitative outcomes and comparing normally and abnormally distributed measurement data. Results: A total of 225 patients with a diagnosis of bradyarrhythmia and eligible for this study were randomly enrolled into the trial (n = 113) and control (n = 112) groups. They underwent successful pacemaker implantation with acceptable postoperative pacing threshold and sensitivity. Effective pacing rates of trial and control groups were comparable both in the full analysis set and the per protocol set (81.4% vs. 79.5%, P = 0.712 and 95.4% vs. 89.5%, P = 0.143, respectively). In both data sets, noninferiority of the trial group was above the predefined noninferiority limit (−9.5%). Conclusions: This study established the noninferiority of Qinming8631 DR to Talos DR. The safety and efficacy of Qinming8631 DR pacemaker were comparable to those of Talos DR in treating patients with

  19. Evaluation of Safety and Efficacy of Qinming8631 DR Implantable Cardiac Pacemaker in Chinese Patients: A Prospective, Multicenter, Randomized Controlled Trial of the First Domestically Developed Pacemaker of China.

    PubMed

    Xiang, Mei-Xiang; Wang, Dong-Qi; Xu, Jing; Zhang, Zheng; Hu, Jian-Xin; Wang, Dong-Mei; Gu, Xiang; Liu, He-Ping; Guo, Tao; Yang, Xiang-Jun; Ling, Feng; Lin, Jia-Feng; Cai, Shang-Lang; Zhu, Guo-Bin; Wang, Jian-An

    2016-11-20

    High cost of imported pacemakers is a main obstacle for Chinese patients suffering from bradyarrhythmia, and a domestically developed pacemaker will help lower the burden. This study aimed to evaluate the safety and efficacy of Qinming8631 DR (Qinming Medical, Baoji, China), the first domestically developed dual-chamber pacemaker of China, compared with a commercially available pacemaker Talos DR (Biotronik, Berlin, Germany) in Chinese patients. A prospective randomized trial was conducted at 14 centers in China. Participants were randomized into trial (Qinming8631 DR) and control (Talos DR) groups. Parameters of the pacing systems were collected immediately after device implantation and during follow-ups. The effective pacing rate at 6-month follow-up was recorded as the primary end point. Electrical properties, magnet response, single- and double-pole polarity conversion, rate response function, and adverse events of the pacing system were analyzed. The Cochran-Mantel-Haenszel Chi-square test, paired t-test, and Wilcoxon signed-rank test were used for measuring primary qualitative outcomes and comparing normally and abnormally distributed measurement data. A total of 225 patients with a diagnosis of bradyarrhythmia and eligible for this study were randomly enrolled into the trial (n = 113) and control (n = 112) groups. They underwent successful pacemaker implantation with acceptable postoperative pacing threshold and sensitivity. Effective pacing rates of trial and control groups were comparable both in the full analysis set and the per protocol set (81.4% vs. 79.5%, P = 0.712 and 95.4% vs. 89.5%, P = 0.143, respectively). In both data sets, noninferiority of the trial group was above the predefined noninferiority limit(-9.5%). This study established the noninferiority of Qinming8631 DR to Talos DR. The safety and efficacy of Qinming8631 DR pacemaker were comparable to those of Talos DR in treating patients with cardiac bradyarrhythmia.

  20. Rationale and design of the Clinical Evaluation of Magnetic Resonance Imaging in Coronary heart disease 2 trial (CE-MARC 2): a prospective, multicenter, randomized trial of diagnostic strategies in suspected coronary heart disease.

    PubMed

    Ripley, David P; Brown, Julia M; Everett, Colin C; Bijsterveld, Petra; Walker, Simon; Sculpher, Mark; McCann, Gerry P; Berry, Colin; Plein, Sven; Greenwood, John P

    2015-01-01

    A number of investigative strategies exist for the diagnosis of coronary heart disease (CHD). Despite the widespread availability of noninvasive imaging, invasive angiography is commonly used early in the diagnostic pathway. Consequently, approximately 60% of angiograms reveal no evidence of obstructive coronary disease. Reducing unnecessary angiography has potential financial savings and avoids exposing the patient to unnecessary risk. There are no large-scale comparative effectiveness trials of the different diagnostic strategies recommended in international guidelines and none that have evaluated the safety and efficacy of cardiovascular magnetic resonance. CE-MARC 2 is a prospective, multicenter, 3-arm parallel group, randomized controlled trial of patients with suspected CHD (pretest likelihood 10%-90%) requiring further investigation. A total of 1,200 patients will be randomized on a 2:2:1 basis to receive 3.0-T cardiovascular magnetic resonance-guided care, single-photon emission computed tomography-guided care (according to American College of Cardiology/American Heart Association appropriate-use criteria), or National Institute for Health and Care Excellence guidelines-based management. The primary (efficacy) end point is the occurrence of unnecessary angiography as defined by a normal (>0.8) invasive fractional flow reserve. Safety of each strategy will be assessed by 3-year major adverse cardiovascular event rates. Cost-effectiveness and health-related quality-of-life measures will be performed. The CE-MARC 2 trial will provide comparative efficacy and safety evidence for 3 different strategies of investigating patients with suspected CHD, with the intension of reducing unnecessary invasive angiography rates. Evaluation of these management strategies has the potential to improve patient care, health-related quality of life, and the cost-effectiveness of CHD investigation. Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.

  1. Rationale and design of the Clinical Evaluation of Magnetic Resonance Imaging in Coronary heart disease 2 trial (CE-MARC 2): A prospective, multicenter, randomized trial of diagnostic strategies in suspected coronary heart disease

    PubMed Central

    Ripley, David P.; Brown, Julia M.; Everett, Colin C.; Bijsterveld, Petra; Walker, Simon; Sculpher, Mark; McCann, Gerry P.; Berry, Colin; Plein, Sven; Greenwood, John P.

    2015-01-01

    Background A number of investigative strategies exist for the diagnosis of coronary heart disease (CHD). Despite the widespread availability of noninvasive imaging, invasive angiography is commonly used early in the diagnostic pathway. Consequently, approximately 60% of angiograms reveal no evidence of obstructive coronary disease. Reducing unnecessary angiography has potential financial savings and avoids exposing the patient to unnecessary risk. There are no large-scale comparative effectiveness trials of the different diagnostic strategies recommended in international guidelines and none that have evaluated the safety and efficacy of cardiovascular magnetic resonance. Trial Design CE-MARC 2 is a prospective, multicenter, 3-arm parallel group, randomized controlled trial of patients with suspected CHD (pretest likelihood 10%-90%) requiring further investigation. A total of 1,200 patients will be randomized on a 2:2:1 basis to receive 3.0-T cardiovascular magnetic resonance–guided care, single-photon emission computed tomography–guided care (according to American College of Cardiology/American Heart Association appropriate-use criteria), or National Institute for Health and Care Excellence guidelines–based management. The primary (efficacy) end point is the occurrence of unnecessary angiography as defined by a normal (>0.8) invasive fractional flow reserve. Safety of each strategy will be assessed by 3-year major adverse cardiovascular event rates. Cost-effectiveness and health-related quality-of-life measures will be performed. Conclusions The CE-MARC 2 trial will provide comparative efficacy and safety evidence for 3 different strategies of investigating patients with suspected CHD, with the intension of reducing unnecessary invasive angiography rates. Evaluation of these management strategies has the potential to improve patient care, health-related quality of life, and the cost-effectiveness of CHD investigation. PMID:25497243

  2. Three-dimensional evaluation of postoperative swelling in treatment of zygomatic bone fractures using two different cooling therapy methods: a randomized, observer-blind, prospective study.

    PubMed

    Modabber, Ali; Rana, Madiha; Ghassemi, Alireza; Gerressen, Marcus; Gellrich, Nils-Claudius; Hölzle, Frank; Rana, Majeed

    2013-07-29

    Surgical treatment and complications in patients with zygomatic bone fractures can lead to a significant degree of tissue trauma resulting in common postoperative symptoms and types of pain, facial swelling and functional impairment. Beneficial effects of local cold treatment on postoperative swelling, edema, pain, inflammation, and hemorrhage, as well as the reduction of metabolism, bleeding and hematomas, have been described.The aim of this study was to compare postoperative cooling therapy applied through the use of cooling compresses with the water-circulating cooling face mask manufactured by Hilotherm in terms of beneficial impact on postoperative facial swelling, pain, eye motility, diplopia, neurological complaints and patient satisfaction. Forty-two patients were selected for treatment of unilateral zygomatic bone fractures and were divided randomly to one of two treatments: either a Hilotherm cooling face mask or conventional cooling compresses. Cooling was initiated as soon as possible after surgery until postoperative day 3 and was applied continuously for 12 hours daily. Facial swelling was quantified through a three-dimensional optical scanning technique. Furthermore, pain, neurological complaints, eye motility, diplopia and patient satisfaction were observed for each patient. Patients receiving a cooling therapy by Hilotherm demonstrated significantly less facial swelling, less pain, reduced limitation of eye motility and diplopia, fewer neurological complaints and were more satisfied compared to patients receiving conventional cooling therapy. Hilotherapy is more efficient in managing postoperative swelling and pain after treatment of unilateral zygomatic bone fractures than conventional cooling. German Clinical Trials Register ID: DRKS00004846.

  3. Evaluation of low-dose dexmedetomidine and neostigmine with bupivacaine for postoperative analgesia in orthopedic surgeries: A prospective randomized double-blind study

    PubMed Central

    Sharma, Ashima; Kumar, Naresh J; Azharuddin, Mohammad; Mohan, Lalith C; Ramachandran, Gopinath

    2016-01-01

    Background and Aims: Neuraxial adjuants to local anesthetics is an effective technique of improving the quality and duration of postoperative analgesia. The safety and efficacy of drugs like dexmedetomidine and neostigmine as epidural medications have been sparsely investigated. Material and Methods: Combined spinal-epidural anesthesia was performed in 60 American Society of Anesthesiologists I and II patients who required lower limb surgeries of ≤3 h duration. The epidural drug was administered at the end of surgery with patients randomized into three groups. Group I, II and III received 6 ml of 0.25% bupivacaine alone, with 1 ug/kg of neostigmine and with 0.5 ug/kg of dexmedetomidine + 1 ug/kg of neostigmine, respectively. The patients were prescribed 50 mg tramadol intravenous as rescue analgesic. Patients were assessed for hemodynamic parameters, pain scores, duration of analgesia, rescue analgesic requirements and the incidence of side-effects over the next 10 h. Data was analyzed using SPSS® version 17.0 (Chicago, IL, USA). P < 0.05 was considered as statistically significant. Results: Patients in Group III had significantly longer mean duration of analgesia (273.5 min) compared to Group II (176.25 min) and Group I (144 min). There was increased requirement of fluids to maintain blood pressures in Group III. Neostigmine did not cause significant incidence of gastrointestinal side effects. Conclusions: Epidurally administered dexmedetomidine and neostigmine exhibit synergism in analgesic action. The incidence of drug-related side-effects was low in our study. PMID:27275047

  4. Prospective unmasked randomized evaluation of the iStent inject® versus two ocular hypotensive agents in patients with primary open-angle glaucoma

    PubMed Central

    Fea, Antonio M; Belda, Jose I; Rękas, Marek; Jünemann, Anselm; Chang, Lydia; Pablo, Luis; Voskanyan, Lilit; Katz, L Jay

    2014-01-01

    Purpose The purpose of this study was to compare outcomes of subjects with open-angle glaucoma (OAG) not controlled on one medication who underwent either implantation of two iStent inject® trabecular micro-bypass devices or received medical therapy consisting of a fixed combination of latanoprost/timolol. Patients and methods Of 192 subjects who qualified for the study and were enrolled, 94 were randomized to surgery with implantation of two iStent inject® devices in the treated eye and 98 to receive medical therapy. Results At the month 12 visit, 94.7% of eyes (89/94) in the stent group reported an unmedicated intraocular pressure (IOP) reduction of ≥20% versus baseline unmedicated IOP, and 91.8% of eyes (88/98) in the medical therapy group reported an IOP reduction ≥20% versus baseline unmedicated IOP. A 17.5% between-group treatment difference in favor of the iStent inject group was statistically significant (P=0.02) at the ≥50% level of IOP reduction. An IOP ≤18 mmHg was reported in 92.6% of eyes (87/94) in the iStent inject group and 89.8% of eyes (88/98) in the medical therapy group. Mean (standard deviation) IOP decreases from screening of 8.1 (2.6) mmHg and 7.3 (2.2) mmHg were reported in the iStent inject and medical therapy groups, respectively. A high safety profile was also noted in this study in both the iStent inject and medical therapy groups, as measured by stable best corrected visual acuity, cup-to-disc ratio, and adverse events. Conclusion These data show that the use of iStent inject is at least as effective as two medications, with the clinical benefit of reducing medication burden and assuring continuous treatment with full compliance to implant therapy as well as having a highly favorable safety profile. PMID:24855336

  5. Randomized Prospective Double-Blind Studies to Evaluate the Cognitive Effects of Inositol-Stabilized Arginine Silicate in Healthy Physically Active Adults.

    PubMed

    Kalman, Douglas; Harvey, Philip D; Perez Ojalvo, Sara; Komorowski, James

    2016-11-18

    Inositol-stabilized arginine silicate (ASI; Nitrosigine(®)) has been validated to increase levels of arginine, silicon and nitric oxide production. To evaluate potential enhancement of mental focus and clarity, ASI (1500 mg/day) was tested in two double-blind placebo-controlled crossover (DBPC-X) studies using the Trail Making Test (TMT, Parts A and B). In the two studies, healthy males took ASI for 14 and 3 days, respectively. In the first study, after 14 days of dosing, TMT B time decreased significantly from baseline (28% improvement, p = 0.045). In the second study evaluating shorter-term effects, TMT B time decreased significantly compared to placebo (33% improvement, p = 0.024) in a 10-min period. After 3 days of dosing, TMT B time significantly decreased from baseline scores (35% improvement, p < 0.001). These findings show that ASI significantly improved the ability to perform complex cognitive tests requiring mental flexibility, processing speed and executive functioning.

  6. Randomized Prospective Double-Blind Studies to Evaluate the Cognitive Effects of Inositol-Stabilized Arginine Silicate in Healthy Physically Active Adults

    PubMed Central

    Kalman, Douglas; Harvey, Philip D.; Perez Ojalvo, Sara; Komorowski, James

    2016-01-01

    Inositol-stabilized arginine silicate (ASI; Nitrosigine®) has been validated to increase levels of arginine, silicon and nitric oxide production. To evaluate potential enhancement of mental focus and clarity, ASI (1500 mg/day) was tested in two double-blind placebo-controlled crossover (DBPC-X) studies using the Trail Making Test (TMT, Parts A and B). In the two studies, healthy males took ASI for 14 and 3 days, respectively. In the first study, after 14 days of dosing, TMT B time decreased significantly from baseline (28% improvement, p = 0.045). In the second study evaluating shorter-term effects, TMT B time decreased significantly compared to placebo (33% improvement, p = 0.024) in a 10-min period. After 3 days of dosing, TMT B time significantly decreased from baseline scores (35% improvement, p < 0.001). These findings show that ASI significantly improved the ability to perform complex cognitive tests requiring mental flexibility, processing speed and executive functioning. PMID:27869715

  7. Durability of flexible ureteroscopes: a randomized, prospective study.

    PubMed

    Monga, Manoj; Best, Sara; Venkatesh, Ramakrishna; Ames, Caroline; Lee, Courtney; Kuskowski, Michael; Schwartz, Steven; Vanlangendock, Richard; Skenazy, Jason; Landman, Jaime

    2006-07-01

    We performed a randomized, prospective, multi-institutional study evaluating the durability of commercially available flexible ureteroscopes. A total of 192 patients were randomized to the use of 7 less than 9Fr flexible ureteroscopes, including the Storz 11274AA and Flex-X, the ACMI DUR-8 and DUR-8 Elite, Wolf models 7330.170 and 7325.172, and the Olympus URF-P3. Information about total and lower pole use time, the number and method of ureteroscope insertion, and they type and duration of accessory instrumentation was recorded. Surgeons were asked to rate the visibility and maneuverability of the instrument on a scale of 0-poor to 10-excellent. The indication for ureteroscopy was upper tract calculi in 87% of cases. Of ureteroscope insertions 97% were performed through an access sheath. The average of number of cases before repair ranged from 3.25 for the Wolf 7325 to 14.4 for the ACMI DUR-8 Elite. Average ureteroscope operative time was statistically longer for the DUR-8 Elite (494 minutes) than for the Flex-X (p = 0.047), and the Wolf 7325 and 7330 (p = 0.001 and 0.001, respectively). Duration of use before repair for the URF-P3 (373 minutes) was statistically longer than for the Wolf 7325 and 7330 (p = 0.016 and 0.017, respectively). Minutes of use with an instrument in the working channel were significantly more with the DUR-8 Elite and the URF-P3 than the Wolf 7330 (p = 0.017 and 0.008) and 7325 (p = 0.012 and 0.005, respectively). The ureteroscope that experienced the greatest average duration of lower pole use was the URF-P3, while the shortest was the Wolf 7325 (103 vs 20 minutes, p = 0.005). Average minutes of laser use before breakage was significantly longer for the DUR-8 Elite than for the Wolf 7325 (110 vs 21 minutes, p = 0.021) and 7330 (24 minutes, p = 0.025). Currently available less than 9Fr flexible ureteroscopes remain fragile instruments. The DUR-8 Elite and Olympus URF-P3 proved to be the most durable devices.

  8. Controlled, prospective, randomized, clinical split-mouth evaluation of partial ceramic crowns luted with a new, universal adhesive system/resin cement: results after 18 months.

    PubMed

    Vogl, Vanessa; Hiller, Karl-Anton; Buchalla, Wolfgang; Federlin, Marianne; Schmalz, Gottfried

    2016-12-01

    A new universal adhesive with corresponding luting composite was recently marketed which can be used both, in a self-etch or in an etch-and-rinse mode. In this study, the clinical performance of partial ceramic crowns (PCCs) inserted with this adhesive and the corresponding luting material used in a self-etch or selective etch approach was compared with a self-adhesive universal luting material. Three PCCs were placed in a split-mouth design in 50 patients. Two PCCs were luted with a combination of a universal adhesive/resin cement (Scotchbond Universal/RelyX Ultimate, 3M ESPE) with (SB+E)/without (SB-E) selective enamel etching. Another PCC was luted with a self-adhesive resin cement (RelyX Unicem 2, 3M ESPE). Forty-eight patients were evaluated clinically according to FDI criteria at baseline and 6, 12 and 18 months. For statistical analyses, the chi-square test (α = 0.05) and Kaplan-Meier analysis were applied. Clinically, no statistically significant differences between groups were detected over time. Within groups, clinically significant increase for criterion "marginal staining" was detected for SB-E over 18 months. Kaplan-Meier analysis revealed significantly higher retention rates for SB+E (97.8 %) and SB-E (95.6 %) in comparison to RXU2 (75.6 %). The 18-month clinical performance of a new universal adhesive/composite combination showed no differences with respect to bonding strategy and may be recommended for luting PCCs. Longer-term evaluation is needed to confirm superiority of SB+E over SB-E. At 18 months, the new multi-mode adhesive, Scotchbond Universal, showed clinically reliable results when used for luting PCCs.

  9. The PRAISE study: a prospective, multi-center, randomized, double blinded, placebo-controlled study for the evaluation of iloprost in the early postoperative period after liver transplantation (ISRCTN12622749).

    PubMed

    Bärthel, Erik; Rauchfuss, Falk; Hoyer, Heike; Breternitz, Maria; Jandt, Karin; Settmacher, Utz

    2013-01-29

    Liver graft dysfunction can deteriorate to complete organ failure and increases perioperative morbidity and mortality after liver transplantation. Therapeutic strategies reducing the rate of graft dysfunction are of current clinical relevance. One approach is the systemic application of prostaglandins, which were demonstrated to be beneficial in reducing ischemia-reperfusion injury. Preliminary data indicate a positive effect of prostacyclin analogue iloprost on allograft viability after liver transplantation. The objective of the study is to evaluate the impact of iloprost in a multi-center trial. A prospective, double-blinded, randomized, placebo-controlled multicenter study in a total of 365 liver transplant recipients was designed to assess the effect of intravenous iloprost after liver transplantation. Primary endpoint will be the primary graft dysfunction characterized as presentation of one or more of the following criteria: ALAT or ASAT level>2000 IU/ml within the first 7 postoperative days, bilirubine  ≥ 10 mg/dl on postoperative day 7; INR ≥ 1.6 on postoperative day 7 or initial non-function. Secondary endpoints are parameters of post-transplant morbidity, like rates of infections, biliary complications, need of clotting factors or renal replacement therapy and the graft and patient survival. A well-established treatment concept to avoid graft dysfunction after liver transplantation does not exist at the moment. If the data of this research project confirm prior findings, iloprost would improve the general outcome after liver transplantation. German Clinical Trials Register: DRKS00003514. Current Controlled Trials Register: ISRCTN12622749.

  10. Comparative Evaluation of Continuous Thoracic Paravertebral Block and Thoracic Epidural Analgesia Techniques for Post-operative Pain Relief in Patients Undergoing Open Nephrectomy: A Prospective, Randomized, Single-blind Study.

    PubMed

    Gautam, Sujeet Kumar Singh; Das, Pravin Kumar; Agarwal, Anil; Kumar, Sanjay; Dhiraaj, Sanjay; Keshari, Abhishek; Patro, Abinash

    2017-01-01

    Open surgical procedures are associated with substantial postoperative pain; an alternative method providing adequate pain relief with minimal side effects is very much required. The aim of this study was a comparative evaluation of the efficacy of continuous thoracic paravertebral block (PVB) and thoracic epidural analgesia (EA) for postoperative pain relief in patients undergoing open nephrectomy. Prospective, randomized, and single-blind study. Sixty adult patients undergoing open nephrectomy under general anesthesia were randomized to receive a continuous thoracic epidural infusion (Group E) or continuous thoracic paravertebral infusion (Group P) with bupivacaine 0.1% with 1 μg/ml fentanyl at 7 ml/h; both infusions were started after induction of anesthesia. The primary outcome measures were postoperative pain during rest (static pain), deep inspiration, coughing, and movement (getting up from supine to sitting position); the secondary outcome measures were postoperative nausea and vomiting, requirement of rescue antiemetic, hypotension, sedation, pruritus, motor block, and respiratory depression. These were assessed till the morning of the third postoperative day. Results were analyzed by the one-way ANOVA, Chi-square test, and Mann-Whitney U-test. P < 0.05 was considered significant. Both the groups were similar with regard to demographic factors (P > 0.05). The visual analog scale scores at rest, deep breathing, coughing and movement, and postoperative fentanyl consumption were similar in the two groups (P > 0.05); the incidence of side effects was also similar in the two groups (P > 0.05). Continuous thoracic PVB is as effective as continuous thoracic EA in providing pain relief in patients undergoing open nephrectomy in the postoperative period. The side effect profile of the two techniques was also similar.

  11. The Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial

    PubMed Central

    Eichhorn, Eric J; Bristow, Michael R

    2001-01-01

    Previous trials (Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure [MERIT-HF], Cardiac Insufficiency Bisoprolol Study [CIBIS] II) have demonstrated a mortality benefit of β-adrenergic blockade in patients with mild to moderate heart failure. The recent Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial has extended these results to a more advanced patient population. This trial did not, however, include patients who could not reach compensation, patients with far advanced heart failure symptoms, or a significant number of black patients. Future studies of β-blockade may focus on these patients or patients with asymptomatic left ventricular dysfunction. PMID:11806769

  12. The Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial.

    PubMed

    Eichhorn, Eric J; Bristow, Michael R

    2001-01-01

    Previous trials (Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure [MERIT-HF], Cardiac Insufficiency Bisoprolol Study [CIBIS] II) have demonstrated a mortality benefit of beta-adrenergic blockade in patients with mild to moderate heart failure. The recent Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial has extended these results to a more advanced patient population. This trial did not, however, include patients who could not reach compensation, patients with far advanced heart failure symptoms, or a significant number of black patients. Future studies of beta-blockade may focus on these patients or patients with asymptomatic left ventricular dysfunction.

  13. Prospective randomized clinical evaluation of conventional single-bundle, anatomic single-bundle, and anatomic double-bundle anterior cruciate ligament reconstruction: 281 cases with 3- to 5-year follow-up.

    PubMed

    Hussein, Mohsen; van Eck, Carola F; Cretnik, Andrej; Dinevski, Dejan; Fu, Freddie H

    2012-03-01

    Three different techniques of anterior cruciate ligament (ACL) reconstruction--conventional (transtibial) single bundle (CSB), anatomic single bundle (ASB), and anatomic double bundle (ADB)--have been described. To determine if double-bundle reconstruction is needed to restore rotational stability or if anatomic placement of a single bundle can yield similar results. Randomized controlled trial; Level of evidence, 1. From December 2005 to December 2007, 320 patients were prospectively randomized into 3 groups: ADB, ASB, and CSB reconstruction. The average follow-up was 51.15 months (range, 39-63 months). At the final follow-up, 281 patients were available. In all groups, hamstring tendons were used with suspensory fixation on the femoral side and bioabsorbable interference screw fixation on the tibial side. The outcomes were evaluated by an independent blinded observer using the Lysholm score and subjective International Knee Documentation Committee (IKDC) form. The KT-1000 arthrometer was used to evaluate anteroposterior stability, and the pivot-shift test was used to determine rotational stability. Anatomic single-bundle reconstruction resulted in better anteroposterior and rotational stability than CSB reconstruction (average side-to-side difference for anterior tibial translation was 1.6 mm in the ASB group vs 2.0 mm in the CSB group; P = .002). Negative pivot shift was 66.7% vs 41.7% (P = .003). In other parameters, the differences between groups were not statistically significant. The results of the ADB group were also superior to the ASB group for anteroposterior and rotational stability (average side-to-side difference for anterior tibial translation was 1.2 mm in the ADB group vs 1.6 mm in the ASB group; P = .002). Negative pivot shift was 93.1% vs 66.7%, respectively (P < .001), and range of motion was also significantly different (P = .005). The Lysholm score was 90.9, 91.8, and 93.0 in the CSB, ASB, and ADB groups, respectively. The difference was

  14. The PRAISE study: A prospective, multi-center, randomized, double blinded, placebo-controlled study for the evaluation of iloprost in the early postoperative period after liver transplantation (ISRCTN12622749)

    PubMed Central

    2013-01-01

    Background Liver graft dysfunction can deteriorate to complete organ failure and increases perioperative morbidity and mortality after liver transplantation. Therapeutic strategies reducing the rate of graft dysfunction are of current clinical relevance. One approach is the systemic application of prostaglandins, which were demonstrated to be beneficial in reducing ischemia-reperfusion injury. Preliminary data indicate a positive effect of prostacyclin analogue iloprost on allograft viability after liver transplantation. The objective of the study is to evaluate the impact of iloprost in a multi-center trial. Methods/Design A prospective, double-blinded, randomized, placebo-controlled multicenter study in a total of 365 liver transplant recipients was designed to assess the effect of intravenous iloprost after liver transplantation. Primary endpoint will be the primary graft dysfunction characterized as presentation of one or more of the following criteria: ALAT or ASAT level > 2000 IU/ml within the first 7 postoperative days, bilirubine ≥ 10 mg/dl on postoperative day 7; INR ≥ 1.6 on postoperative day 7 or initial non-function. Secondary endpoints are parameters of post-transplant morbidity, like rates of infections, biliary complications, need of clotting factors or renal replacement therapy and the graft and patient survival. Discussion A well-established treatment concept to avoid graft dysfunction after liver transplantation does not exist at the moment. If the data of this research project confirm prior findings, iloprost would improve the general outcome after liver transplantation. Trial Registration German Clinical Trials Register: DRKS00003514. Current Controlled Trials Register: ISRCTN12622749. PMID:23356494

  15. A Prospective, Multicenter, Randomized Phase II Study to Evaluate the Efficacy and Safety of Eculizumab in Patients with Guillain-Barré Syndrome (GBS): Protocol of Japanese Eculizumab Trial for GBS (JET-GBS)

    PubMed Central

    Yamaguchi, Nobuko; Sato, Yasunori; Nagashima, Kengo; Katayama, Kanako; Sekiguchi, Yukari; Iwai, Yuta; Amino, Hiroshi; Suichi, Tomoki; Yokota, Takanori; Nishida, Yoichiro; Kohara, Nobuo; Hirata, Koichi; Nishiyama, Kazutoshi; Yabe, Ichiro; Kaida, Ken-Ichi; Suzuki, Norihiro; Nodera, Hiroyuki; Tsuji, Shoji; Koike, Haruki; Kira, Jun-Ichi; Hanaoka, Hideki; Kusunoki, Susumu; Kuwabara, Satoshi

    2016-01-01

    Background Guillain-Barré syndrome (GBS) is an immune-mediated neuropathy that causes acute flaccid paralysis. Immunoglobulin and plasma exchange are established treatments for GBS; however, a substantial number of patients, particularly those with severe disease, have poor recovery and residual deficits. Recent studies suggest that complement activation plays a pivotal role in GBS-associated axonal degeneration, and eculizumab is a humanized monoclonal antibody that specifically binds to complement component 5 and potently inhibits complement activation. Objective This clinical trial aims to evaluate the efficacy and safety of eculizumab, a humanized monoclonal antibody directed against complement component 5, for treatment of GBS. Methods The Japanese Eculizumab Trial for GBS (JET-GBS) is a prospective, multicenter, placebo-controlled, double-blind, randomized phase II study conducted at 13 tertiary neurology centers and is funded by the Japan Agency for Medical Research and Development. A total of 33 GBS patients unable to walk independently within 2 weeks from symptom onset (Hughes functional grade 3-5) were randomized at a 2:1 ratio to receive either intravenous eculizumab (900 mg/day) or placebo once weekly for 4 weeks, followed by 20 weeks of follow-up. The primary endpoint for efficacy is the proportion of patients who regain their ability to walk without aid at 4 weeks after the first dose of the study treatment, while primary safety outcomes are the incidence of adverse events and serious adverse events during the trial. Results Enrollment for the trial began in August 2015. This trial is still ongoing. All participants have been enrolled, and follow-up will be completed in October 2016. Conclusions This study is the first to investigate the efficacy and safety of eculizumab for GBS. In case of a positive result, we will plan a phase III trial to investigate this issue in a larger number of patients. ClinicalTrial UMIN Clinical Trials Registry UMIN

  16. The treatment of soft-tissue sarcomas of the extremities - prospective randomized evaluations of (1) limb-sparing surgery plus radiation therapy compared with amputation and (2) the role of adjuvant chemotherapy

    SciTech Connect

    Rosenberg, S.A.; Tepper, J.; Glatstein, E.

    1982-09-01

    Between May 1975 and April 1981, 43 adult patients with high-grade soft tissue sarcomas of the extremities were prospectively randomized to receive either amputation at or above the joint proximal to the tumor, including all involved muscle groups, or to receive a limb-sparing resection plus adjuvant radiation therapy. The limb-sparing resection group received wide local excision followed by 5000 rads to the entire anatomic area at risk for local spread and 6000 to 7000 rads to the tumor bed. Both randomization groups received postoperative chemotherapy with doxorubicin (maximum cumulative dose 550 mg/m/sup 2/), cyclophosphamide, and high-dose methotrexate. Twenty-seven patients randomized to receive limb-sparing resection and radiotherapy, and 16 received amputation (randomization was 2:1). There were four local recurrences in the limb-sparing group and none in the amputation group (p/sub 1/ = 0.06 generalized Wilcoxon test). However, there were no differences in disease-free survival rates (83% and 88% at five years; p/sub 2/ = 0.99) between the limb-sparing group and the amputation treatment groups. Multivariate analysis indicated that the only correlate of local recurrence was the final margin of resection. Patients with positive margins of resection had a higher likelihood of local recurrence compared with those with negative margins (p/sub 1/ < 0.00001) even when postoperative radiotherapy was used. A simultaneous prospective randomized study of postoperative chemotherapy in 65 patients with high-grade soft-tissue sarcomas of the extremities revealed a marked advantage in patients receiving chemotherapy compared with those without chemotherapy in three-year continuous disease-free (92% vs. 60%; p/sub 1/ = 0.00008) and overall survival (95% vs. 74%; p/sub 1/ = 0.04).

  17. Prospective, randomized trial of higher goal hemoglobin after subarachnoid hemorrhage.

    PubMed

    Naidech, Andrew M; Shaibani, Ali; Garg, Rajeev K; Duran, Isis M; Liebling, Storm M; Bassin, Sarice L; Bendok, Bernard R; Bernstein, Richard A; Batjer, H Hunt; Alberts, Mark J

    2010-12-01

    In patients with subarachnoid hemorrhage (SAH), higher hemoglobin (HGB) has been associated with better outcomes, but packed red blood cell (PRBC) transfusions with worse outcomes. We performed a prospective pilot trial of goal HGB after SAH. Forty-four patients with SAH and high risk for vasospasm were randomized to goal HGB concentration of at least 10 or 11.5 g/dl. We obtained blinded clinical outcomes at 14 days (NIH Stroke Scale and modified Rankin Scale, mRS), 28 days (mRS), and 3 months (mRS), and blinded interpretation of brain MRI for cerebral infarction at 14 days. This trial is registered at www.stroketrials.org. Forty-four patients were randomized. Patients with goal HGB 11.5 g/dl received more PRBC units per transfusion [1 (1-2) vs. 1 (1-1), P < 0.001] and more total PRBC units [3 (2-4) vs. 2 (1-3), P = 0.045]. Prospectively defined safety endpoints were not different between groups. HGB concentration was different between study groups from day 4 onwards. The number of cerebral infarctions on MRI (6 of 20 vs. 9 of 22), NIH Stroke Scale scores at 14 days [1 (0-9.75) vs. 2 (0-16)], and rates of independence on the mRS at 14 days (65% vs. 44%) and 28 days (80% vs. 67%) were similar, but favored higher goal HGB (P > 0.1 for all). Higher goal hemoglobin in patients with SAH seems to be safe and feasible. A phase III trial of goal HGB after SAH is warranted.

  18. 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

  19. Clinical and radiological evaluation of Trabecular Metal and the Smith-Robinson technique in anterior cervical fusion for degenerative disease: a prospective, randomized, controlled study with 2-year follow-up.

    PubMed

    Löfgren, Håkan; Engquist, M; Hoffmann, P; Sigstedt, B; Vavruch, L

    2010-03-01

    A prospective, randomized, controlled study was carried out to compare the radiological and clinical outcomes after anterior cervical decompression and fusion (ACDF) with Trabecular Metal (TM) to the traditional Smith-Robinson (SR) procedure with autograft. The clinical results of cervical fusion with autograft from the iliac crest are typically satisfactory, but implications from the donor site are frequently reported. Alternative materials for cervical body interfusion have shown lower fusion rates. Trabecular Metal is a porous tantalum biomaterial with structure and mechanical properties similar to that of trabecular bone and with proven osteoconductivity. As much as 80 consecutive patients planned for ACDF were randomized for fusion with either TM or tricortical autograft from the iliac crest (SR) after discectomy and decompression. Digitized plain radiographic images of 78 (98%) patients were obtained preoperatively and at 2-year follow-up and were subsequently evaluated by two senior radiologists. Fusion/non-fusion was classified by visual evaluation of the A-P and lateral views in forced flexion/extension of the cervical spine and by measuring the mobility between the fused vertebrae. MRI of 20 TM cases at 2 years was successfully used to assess the decompression of the neural structures, but was not helpful in determining fusion/non-fusion. Pain intensity in the neck, arms and pelvis/hip were rated by patients on a visual analog scale (VAS) and neck function was rated using the Neck Disability Index (NDI) the day before surgery and 4, 12 and 24 months postoperatively. Follow-ups at 12 and 24 months were performed by an unbiased observer, when patients also assessed their global outcome. Fusion rate in the SR group was 92%, and in the TM group 69% (P < 0.05). The accuracy of the measurements was calculated to be 2.4 degrees . Operating time was shorter for fusion with TM compared with autograft; mean times were 100 min (SD 18) and 123 min (SD 23

  20. Evaluation of a High Concentrated Contrast Media Injection Protocol in Combination with Low Tube Current for Dose Reduction in Coronary Computed Tomography Angiography: A Randomized, Two-center Prospective Study.

    PubMed

    Sun, Yibo; Hua, Yanqing; Wang, Mingpeng; Mao, Dingbiao; Jin, Xiu; Li, Cheng; Shi, Kailei; Xu, Jianrong

    2017-08-08

    The study aimed to prospectively evaluate the radiation dose reduction potential and image quality (IQ) of a high-concentration contrast media (HCCM) injection protocol in combination with a low tube current (mAs) in coronary computed tomography angiography. Eighty-one consecutive patients (mean age: 62 years; 34 females; body mass index: 18-31) were included and randomized-assigned into two groups. All computed tomography (CT) examinations were performed in two groups with the same tube voltage (100 kV), flow rate of contrast medium (5.0 mL/s), and iodine dose (22.8 g). An automatic mAs and low concentration contrast medium (300 mgI/mL) were used in group A, whereas effective mAs was reduced by a factor 0.6 along with HCCM (400 mgI/mL) in group B. Radiation dose was assessed (CT dose index [CTDIvol] and dose length product), and vessel-based objective IQ for various regions of interest (enhancement, noise, signal-to-noise ratio, and contrast-to-noise ratio), subjective IQ, noise, and motion artifacts were analyzed overall and vessel-based with a 5-point Likert scale. The CT attenuation of coronary arteries and image noise in group B were significantly higher than those in group A (ranges: 507.5-548.1 Hounsfield units vs 407.5-444.5 Hounsfield units; and 20.3 ± 8.6 vs 17.7 ± 8.0) (P ≤ 0.0166). There was no significant difference between the two groups in signal-to-noise ratio, contrast-to-noise ratio, and subjective IQ of coronary arteries (29.4-31.7, 30.0-37.0, and medium score of 5 in group A vs 29.4-32.4, 27.7-36.3, and medium score of 5 in group B, respectively, P ≥ 0.1859). Both mean CTDIvol and dose length product in group B were 58% of those of group A. HCCM combined with low tube current allows dose reduction in coronary computed tomography angiography and does not compromise IQ. Copyright © 2017 The Association of University Radiologists. Published by Elsevier Inc. All rights reserved.

  1. [Periprostatic anaesthesic infiltration for prostatic biopsy: a prospective, randomized, double blind and placebo-controlled study].

    PubMed

    Valero, Gonzalo; González, E U Roxana

    2005-06-01

    A prospective, randomized, double blind and placebo-controlled study to evaluate the effectiveness of periprostatic infiltration with lidocaine to reduce pain of prostatic biopsy. In a thirteen months period of time, 115 patients were randomized to receive 10 ml of lidocaine 1% (n=60) or saline (n=55). Evaluating the pain with visual analogue scale (0-10), the first group referred average pain of 3.83 and the second group of 6.87, being this difference clearly significant (p<0.005). There were not complications from anesthesic puncture. The periprostatic infiltration is easy to perform without complications and it is effective in reducing the pain of this procedure. It should be used as a routine procedure in prostatic biopsy.

  2. Reducing mucus production after urinary reconstruction: a prospective randomized trial.

    PubMed

    N'Dow, J; Robson, C N; Matthews, J N; Neal, D E; Pearson, J P

    2001-05-01

    After transposition into the urinary tract, intestinal segments continue to produce mucus. We determine the effectiveness of muco-regulatory drugs, including N-acetylcysteine, aspirin and ranitidine, in reducing mucus secretion and urine viscosity in patients with transposed segments. Our trial was a prospective randomized, double-blind placebo controlled crossover study involving 12 patients who underwent ileal conduit and 31 who underwent bladder reconstruction. Each treatment lasted 3 weeks with a 2-week washout. Pretreatment and posttreatment 24-hour urine samples were analyzed for mucin and viscosity after papain digestion, sodium dodecyl sulfate-polyacrylamide gel electrophoresis and periodic acid-Schiff assay. A disease specific questionnaire and SF-36 quality of life survey were completed. According to the questionnaire, mucus production did not decrease with time in 67% of patients. Mucin comprised 3% of the total nondialyzable material in urine (65 mg./24-hour for ileal conduit and 60 mg./24-hour for bladder reconstruction). Analysis of questionnaires and laboratory results failed to demonstrate any benefit of taking muco-regulatory agents compared with placebo. The use of N-acetylcysteine, aspirin and ranitidine did not result in a reduction in mucin production, urine viscosity or improvement in quality of life.

  3. Blood glucose and schizophrenia: a systematic review of prospective randomized clinical trials.

    PubMed

    Bushe, Chris J; Leonard, Brian E

    2007-11-01

    Most of the data evaluating the potential relationship between diabetes, schizophrenia, and anti-psychotics currently derive from retrospective analysis. Relevant confounders of such data include screening and selection bias. Prospective data collected from randomized controlled trials may reduce such biases. As no single trial has glucose comparisons as a primary endpoint, we undertook a systematic review of available data. Embase, HealthStar, MEDLINE, Pre-MEDLINE, and PsycINFO databases were searched online for relevant articles. Abstracts from major congresses held between January 2000 and April 2006 were included. Search terms included all currently available antipsychotics: olanzapine, risperidone, clozapine, quetiapine, ziprasidone, aripiprazole, haloperidol, chlorpromazine, and zotepine. Prospective clinical trials involving schizophrenia patients with no stated previous glucose abnormalities randomly assigned to cohorts receiving active or placebo comparator antipsychotic medications were included with no restrictions on study length. 16 studies were from peer-reviewed publications, 4 were from posters at major congresses, and 2 were available only on Internet-based sites. Glucose parameters reported included fasting and random glucose and glycosylated hemoglobin. Data reported included mean changes and categorical reports of abnormal levels. Data were available in 6329 patients from 22 trials. The most common comparator agents were aripiprazole and olanzapine in 4 studies including 1432 patients. 14 studies reported fasting and 9 studies reported nonfasting data. 15 studies were a minimum of 5 months, with 8 studies of at least 1 year's duration. No consistent significant glucose differences were found between any comparator antipsychotics or placebo in any trial. In contrast to some of the retrospective data, an analysis of prospective data from randomized clinical trials showed no consistent significant differences in the incidence of treatment

  4. Brachiobasilic versus brachiocephalic arteriovenous fistula: a prospective randomized study.

    PubMed

    Koksoy, Cuneyt; Demirci, Rojbin Karakoyun; Balci, Deniz; Solak, Tuba; Köse, S Kenan

    2009-01-01

    The most recent Kidney Disease Outcomes Quality Initiative (KDOQI) guidelines recommend that the order of preference for arteriovenous fistula (AVF) placement is the radial-cephalic primary AVF, followed by the secondary brachiocephalic (BC) and, if either of these is not viable, then brachiobasilic (BB) AVF should be fashioned. However, there is limited prospective data comparing technical and clinical outcomes of these two approaches. The purpose of our study was to compare outcome, patency, and complication rates in these two autogenous upper arm AV accesses. Between December 2003 and and January 2007, patients (61 male, 39 female) who have lost more distal AVFs were enrolled in the study. After preoperative duplex mapping, patients with patent both basilic and cephalic veins greater than 3 mm of diameter were randomized into BCAVF and BBAVF groups, each group consisting of 50 patients. All procedures were performed under local anesthesia as one-stage procedures. Follow-up data were prospectively collected. Kaplan-Meier analysis was used to calculate primary and secondary patency rates. Univariate and multivariate Cox-regression analysis was used to find risks for the occurrence of thrombosis. Baseline demographics, clinical characteristics, and preoperative history dialysis access were comparable between groups with the exception of the fact that mean caliber of the basilic veins were larger (4.51 +/- 0.93 mm vs 3.90 +/- 0.1 mm; P = .002). The mean duration of operation was significantly shorter in the BC group compared with the BB group (P < .001). There was no significant difference in the thirty day mortality, wound complications, 24 hour thrombosis, postoperative hemorrhage, maturation, and time to maturation between the groups. Mean follow-up was 43.2 +/- 1.8 months. Primary patency at 1 and 3 years of follow-up was 87% and 81% for the BC group and 86% and 73% for the BB group (P = .7) Secondary patency at one and three year follow-up was 87% and 70% for

  5. Oncology E-Learning for Undergraduate. A Prospective Randomized Controlled Trial.

    PubMed

    da Costa Vieira, René Aloisio; Lopes, Ana Helena; Sarri, Almir José; Benedetti, Zuleica Caulada; de Oliveira, Cleyton Zanardo

    2016-01-14

    The e-learning education is a promising method, but there are few prospective randomized publications in oncology. The purpose of this study was to assess the level of retention of information in oncology from undergraduate students of physiotherapy. A prospective, controlled, randomized, crossover study, 72 undergraduate students of physiotherapy, from the second to fourth years, were randomized to perform a course of physiotherapy in oncology (PHO) using traditional classroom or e-learning. Students were offered the same content of the subject. The teacher in the traditional classroom model and the e-learning students used the Articulate® software. The course tackled the main issues related to PHO, and it was divided into six modules, 18 lessons, evaluated by 126 questions. A diagnosis evaluation was performed previous to the course and after every module. The sample consisted of 67 students, allocated in groups A (n = 35) and B (n = 32), and the distribution was homogeneous between the groups. Evaluating the correct answers, we observed a limited score in the pre-test (average grade 44.6 %), which has significant (p < 0.001) improvement in post-test evaluation (average grade 73.9 %). The correct pre-test (p = 0.556) and post-test (p = 0.729) evaluation and the retention of information (p = 0.408) were not different between the two groups. The course in PHO allowed significant acquisition of knowledge to undergraduate students, but the level of information retention was statistically similar between the traditional classroom form and the e-learning, a fact that encourages the use of e-learning in oncology.

  6. A Prospective Evaluation of Helical Tomotherapy

    SciTech Connect

    Bauman, Glenn ||. E-mail: glenn.bauman@lhsc.on.ca; Yartsev, Slav; Rodrigues, George ||; Lewis, Craig; Hammond, Alex; Perera, Francisco; Ash, Robert, Dar, A. Rashid |; Venkatesan, Varagur M. |; Yu, Edward; Lock, Michael; Battista, Jerry; Van Dyk, Jake ||; Baily, Laura; Coad, Terry C; Trenka, Kris C.; Warr, Barbara; Kron, Tomas

    2007-06-01

    Purpose: To report results from two clinical trials evaluating helical tomotherapy (HT). Methods and Materials: Patients were enrolled in one of two prospective trials of HT (one for palliative and one for radical treatment). Both an HT plan and a companion three-dimensional conformal radiotherapy (3D-CRT) plan were generated. Pretreatment megavoltage computed tomography was used for daily image guidance. Results: From September 2004 to January 2006, a total of 61 sites in 60 patients were treated. In all but one case, a clinically acceptable tomotherapy plan for treatment was generated. Helical tomotherapy plans were subjectively equivalent or superior to 3D-CRT in 95% of plans. Helical tomotherapy was deemed equivalent or superior in two thirds of dose-volume point comparisons. In cases of inferiority, differences were either clinically insignificant and/or reflected deliberate tradeoffs to optimize the HT plan. Overall imaging and treatment time (median) was 27 min (range, 16-91 min). According to a patient questionnaire, 78% of patients were satisfied to very satisfied with the treatment process. Conclusions: Helical tomotherapy demonstrated clear advantages over conventional 3D-CRT in this diverse patient group. The prospective trials were helpful in deploying this technology in a busy clinical setting.

  7. Quantitative framework for prospective motion correction evaluation.

    PubMed

    Pannetier, Nicolas A; Stavrinos, Theano; Ng, Peter; Herbst, Michael; Zaitsev, Maxim; Young, Karl; Matson, Gerald; Schuff, Norbert

    2016-02-01

    Establishing a framework to evaluate performances of prospective motion correction (PMC) MRI considering motion variability between MRI scans. A framework was developed to obtain quantitative comparisons between different motion correction setups, considering that varying intrinsic motion patterns between acquisitions can induce bias. Intrinsic motion was considered by replaying in a phantom experiment the recorded motion trajectories from subjects. T1-weighted MRI on five volunteers and two different marker fixations (mouth guard and nose bridge fixations) were used to test the framework. Two metrics were investigated to quantify the improvement of the image quality with PMC. Motion patterns vary between subjects as well as between repeated scans within a subject. This variability can be approximated by replaying the motion in a distinct phantom experiment and used as a covariate in models comparing motion corrections. We show that considering the intrinsic motion alters the statistical significance in comparing marker fixations. As an example, two marker fixations, a mouth guard and a nose bridge, were evaluated in terms of their effectiveness for PMC. A mouth guard achieved better PMC performance. Intrinsic motion patterns can bias comparisons between PMC configurations and must be considered for robust evaluations. A framework for evaluating intrinsic motion patterns in PMC is presented. © 2015 Wiley Periodicals, Inc.

  8. Quantitative framework for prospective motion correction evaluation

    PubMed Central

    Pannetier, Nicolas; Stavrinos, Theano; Ng, Peter; Herbst, Michael; Zaitsev, Maxim; Young, Karl; Matson, Gerald; Schuff, Norbert

    2014-01-01

    Purpose Establishing a framework to evaluate performances of prospective motion correction (PMC) MRI considering motion variability between MRI scans. Method A framework was developed to obtain quantitative comparisons between different motion correction setups, considering that varying intrinsic motion patterns between acquisitions can induce bias. Intrinsic motion was considered by replaying in a phantom experiment the recorded motion trajectories from subjects. T1-weighted MRI on five volunteers and two different marker fixations (mouth guard and nose bridge fixations) were used to test the framework. Two metrics were investigated to quantify the improvement of the image quality with PMC. Results Motion patterns vary between subjects as well as between repeated scans within a subject. This variability can be approximated by replaying the motion in a distinct phantom experiment and used as a covariate in models comparing motion corrections. We show that considering the intrinsic motion alters the statistical significance in comparing marker fixations. As an example, two marker fixations, a mouth guard and a nose bridge, were evaluated in terms of their effectiveness for PMC. A mouth guard achieved better PMC performance. Conclusion Intrinsic motion patterns can bias comparisons between PMC configurations and must be considered for robust evaluations. A framework for evaluating intrinsic motion patterns in PMC is presented. PMID:25761550

  9. Antireflux Versus Conventional Plastic Stent in Malignant Biliary Obstruction: A Prospective Randomized Study.

    PubMed

    Vihervaara, Hanna; Grönroos, Juha M; Hurme, Saija; Gullichsen, Risto; Salminen, Paulina

    2017-01-01

    Endoscopic stents are used to relieve obstructive jaundice. The purpose of this prospective randomized study was to compare the patency of antireflux and conventional plastic biliary stent in relieving distal malignant biliary obstruction. All jaundiced patients admitted to hospital with suspected unresectable malignant distal biliary stricture between October 2009 and September 2010 were evaluated for the study. Eligible patients were randomized either to antireflux or conventional plastic stent arms. The primary endpoint was stent patency and the follow-up was continued either until the stent was occluded or until 6 months after the stent placement. At an interim analysis, antireflux stents (ARSs; n = 6) had a significantly shorter median patency of 34 (8-49) days compared with the conventional stent (n = 7) patency of 167 (38-214) days (P = .0003). Based on these results, the study was terminated due to ethical concerns. According to these results, the use of this ARS is not recommended.

  10. Multicenter prospective evaluation of dogs with trauma.

    PubMed

    Hall, Kelly E; Holowaychuk, Marie K; Sharp, Claire R; Reineke, Erica

    2014-02-01

    To determine hospital admission variables for dogs with trauma including values determined with scoring systems (animal trauma triage [ATT], modified Glasgow coma scale [MGCS], and acute patient physiologic and laboratory evaluation [APPLE] scores) and the usefulness of such variables for the prediction of outcome (death vs survival to hospital discharge). Prospective, multicenter, cohort study. 315 client-owned dogs. By use of a Web-based data capture system, trained personnel prospectively recorded admission ATT, MGCS, and APPLE scores; clinical and laboratory data; and outcome (death vs survival to discharge) for dogs with trauma at 4 veterinary teaching hospitals during an 8-week period. Cause of injury was most commonly blunt trauma (173/315 [54.9%]) followed by penetrating trauma (107/315 [34.0%]), or was unknown (35/315 [11.1%]). Of the 315 dogs, 285 (90.5%) survived to hospital discharge. When 16 dogs euthanized because of cost were excluded, dogs with blunt trauma were more likely to survive, compared with dogs with penetrating trauma (OR, 8.5). The ATT (OR, 2.0) and MGCS (OR, 0.47) scores and blood lactate concentration (OR, 1.5) at the time of hospital admission were predictive of outcome. Surgical procedures were performed for 157 (49.8%) dogs; surgery was associated with survival to discharge (OR, 7.1). Results indicated ATT and MGCS scores were useful for prediction of outcome for dogs evaluated because of trauma. Penetrating trauma, low blood lactate concentration, and performance of surgical procedures were predictive of survival to hospital discharge. The methods enabled collection of data for a large number of dogs in a short time.

  11. Central venous catheterization: a prospective, randomized, double-blind study.

    PubMed

    Mer, Mervyn; Duse, Adriano Gianmaria; Galpin, Jacqueline Suzanne; Richards, Guy Antony

    2009-02-01

    Central venous catheters (CVCs) are extensively used worldwide. Mechanical, infectious and thrombotic complications are well described with their use and may be associated with prolonged hospitalization, increased medical costs and mortality. CVCs account for an estimated 90% of all catheter-related bloodstream infections (CRBSI) and a host of risk factors for CVC-related infections have been documented. The duration of use of CVCs remains controversial and the length of time such devices can safely be left in place has not been fully and objectively addressed in the critically ill patient. Antimicrobial-impregnated catheters have been introduced in an attempt to limit catheter-related infection (CRI) and increase the time that CVCs can safely be left in situ. Recent meta-analyses concluded that antimicrobial-impregnated CVCs appear to be effective in reducing CRI. The authors conducted a prospective, randomized, double-blind study at Johannesburg Hospital over a 4-year period. The study entailed a comparison of standard triple-lumen versus antimicrobial impregnated CVCs on the rate of CRI. Our aim was to determine whether we could safely increase the duration of catheter insertion time from our standard practice of seven days to 14 days, to assess the influence of the antimicrobial impregnated catheter on the incidence of CRI, and to elucidate the epidemiology and risks of CRI. One hundred and eighteen critically ill patients were included in the study which spanned 34 951.5 catheter hours (3.99 catheter years). It was found that antimicrobial catheters did not provide any significant benefit over standard catheters, which the authors feel can safely be left in place for up to 14 days with appropriate infection control measures. The most common source of CRI was the skin. The administration of parenteral nutrition and the site of catheter insertion (internal jugular vein vs subclavian vein) were not noted to be risk factors for CRI. There was no clinical evidence

  12. Prospective safety performance evaluation on construction sites.

    PubMed

    Wu, Xianguo; Liu, Qian; Zhang, Limao; Skibniewski, Miroslaw J; Wang, Yanhong

    2015-05-01

    This paper presents a systematic Structural Equation Modeling (SEM) based approach for Prospective Safety Performance Evaluation (PSPE) on construction sites, with causal relationships and interactions between enablers and the goals of PSPE taken into account. According to a sample of 450 valid questionnaire surveys from 30 Chinese construction enterprises, a SEM model with 26 items included for PSPE in the context of Chinese construction industry is established and then verified through the goodness-of-fit test. Three typical types of construction enterprises, namely the state-owned enterprise, private enterprise and Sino-foreign joint venture, are selected as samples to measure the level of safety performance given the enterprise scale, ownership and business strategy are different. Results provide a full understanding of safety performance practice in the construction industry, and indicate that the level of overall safety performance situation on working sites is rated at least a level of III (Fair) or above. This phenomenon can be explained that the construction industry has gradually matured with the norms, and construction enterprises should improve the level of safety performance as not to be eliminated from the government-led construction industry. The differences existing in the safety performance practice regarding different construction enterprise categories are compared and analyzed according to evaluation results. This research provides insights into cause-effect relationships among safety performance factors and goals, which, in turn, can facilitate the improvement of high safety performance in the construction industry. Copyright © 2015 Elsevier Ltd. All rights reserved.

  13. A Comparative, Prospective and Randomized Evaluation of Roux-en-Y Gastric Bypass With and Without the Silastic Ring: A 2-Year Follow Up Preliminary Report on Weight Loss and Quality of Life.

    PubMed

    Rasera, I; Coelho, T H; Ravelli, M N; Oliveira, M R M; Leite, C V S; Naresse, L E; Henry, M A C A

    2016-04-01

    Currently, Roux-en-Y gastric bypass (RYGB) is one of the most widely used bariatric surgeries. Banding the pouch forms a banded gastric bypass operation, an accepted and frequently used variant. Placing a silastic ring around the pouch to band the gastric bypass operation increases the restriction mechanism. However, the ubiquitous use of the banded gastric bypass remains controversial. One of the controversies is the effect of the silastic ring on patients' perception of their well being after surgery because of the frequency of vomiting. A prospective, blindly randomized, comparative trial was undertaken to resolve this controversy. Four hundred subjects scheduled for gastric bypass surgery were randomized into two arms of the trial, 200 with a silastic ring (WR) and 200 without (NR). After 2-year follow-up, the variables associated with the scores of Bariatric Analysis and Reporting Outcome System (BAROS) were analyzed. The initial median weight (125 kg), BMI (47), and age (36 years) were the same in both the NR and WR groups. The median excess weight loss, weight regain, and incidence of vomiting were 71, 10.5, and 7.75%, respectively, in the NR group vs. 75.4 and 1.1, and 24.4% in the WR group. The mean QOL score was 79% in the NR group vs. 80% in the WR group. After 2-year follow-up, silastic ring placement in the RYGB resulted in greater weight loss and weight stability and a threefold greater incidence of vomiting. There was no difference in the scores in the quality of life analysis.

  14. Randomized prospective study evaluating tenofovir disoproxil fumarate prophylaxis against hepatitis B virus reactivation in anti-HBc-positive patients with rituximab-based regimens to treat hematologic malignancies: The Preblin study

    PubMed Central

    Buti, María; Manzano, María L.; Morillas, Rosa M.; García-Retortillo, Montserrat; Martín, Leticia; Prieto, Martín; Gutiérrez, María L.; Suárez, Emilio; Gómez Rubio, Mariano; López, Javier; Castillo, Pilar; Rodríguez, Manuel; Zozaya, José M.; Simón, Miguel A.; Morano, Luis E.; Calleja, José L.; Esteban, Rafael

    2017-01-01

    Background Hepatitis B virus (HBV) reactivation in patients with resolved HBV infection (HBsAg negative, antiHBc positive) is uncommon, but potentially fatal. The role of HBV prophylaxis in this setting is uncertain. The aim of this study was to compare the efficacy of tenofovir disoproxil fumarate (TDF) prophylaxis versus close monitoring in antiHBc-positive, HBsAg-negative patients under treatment with rituximab (RTX)-based regimens for hematologic malignancy. Methods PREBLIN is a phase IV, randomized, prospective, open-label, multicenter, parallel-group trial conducted in 17 hospitals throughout Spain. Anti-HBc-positive, HBsAg-negative patients with undetectable HBV DNA were randomized to receive TDF 300 mg once daily (Group I) or observation (Group II). The primary endpoint was the percentage of patients showing HBV reactivation during 18 months following initiation of RTX treatment. Patients with detectable HBV DNA (Group III) received the same dose of TDF and were analyzed together with Group I to investigate TDF safety. Results Sixty-one patients were enrolled in the study, 33 in the TDF treatment group and 28 in the observation group. By ITT analysis, HBV reactivation was 0% (0/33) in the study group and 10.7% (3/28) in the observation group (p = 0.091). None of the patients in either group showed significant differences in liver function parameters between baseline and the last follow-up sample. TDF was generally well tolerated and there were no severe treatment-related adverse events. Conclusion In patients with hematological malignancy and resolved hepatitis B infection receiving RTX-based regimens, HBV reactivation did not occur in patients given TDF prophylaxis. PMID:28898281

  15. 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

  16. Day 2 versus day 3 embryo transfer in poor responders: a prospective randomized trial.

    PubMed

    Shahine, Lora K; Milki, Amin A; Westphal, Lynn M; Baker, Valerie L; Behr, Barry; Lathi, Ruth B

    2011-01-01

    Day 2 embryo transfer has been suggested as a method to improve pregnancy rates in poor responders compared with day 3 transfer. Our prospective randomized controlled trial does not show a difference in outcomes based on day of embryo transfer.

  17. Resting heart rate variability after yogic training and swimming: A prospective randomized comparative trial.

    PubMed

    Sawane, Manish Vinayak; Gupta, Shilpa Sharad

    2015-01-01

    Resting heart rate variability (HRV) is a measure of the modulation of autonomic nervous system (ANS) at rest. Increased HRV achieved by the exercise is good for the cardiovascular health. However, prospective studies with comparison of the effects of yogic exercises and those of other endurance exercises like walking, running, and swimming on resting HRV are conspicuous by their absence. Study was designed to assess and compare the effects of yogic training and swimming on resting HRV in normal healthy young volunteers. Study was conducted in Department of Physiology in a medical college. Study design was prospective randomized comparative trial. One hundred sedentary volunteers were randomly ascribed to either yoga or swimming group. Baseline recordings of digital electrocardiogram were done for all the subjects in cohorts of 10. After yoga training and swimming for 12 weeks, evaluation for resting HRV was done again. Percentage change for each parameter with yoga and swimming was compared using unpaired t-test for data with normal distribution and using Mann-Whitney U test for data without normal distribution. Most of the HRV parameters improved statistically significantly by both modalities of exercise. However, some of the HRV parameters showed statistically better improvement with yoga as compared to swimming. Practicing yoga seems to be the mode of exercise with better improvement in autonomic functions as suggested by resting HRV.

  18. Resting heart rate variability after yogic training and swimming: A prospective randomized comparative trial

    PubMed Central

    Sawane, Manish Vinayak; Gupta, Shilpa Sharad

    2015-01-01

    Context: Resting heart rate variability (HRV) is a measure of the modulation of autonomic nervous system (ANS) at rest. Increased HRV achieved by the exercise is good for the cardiovascular health. However, prospective studies with comparison of the effects of yogic exercises and those of other endurance exercises like walking, running, and swimming on resting HRV are conspicuous by their absence. Aims: Study was designed to assess and compare the effects of yogic training and swimming on resting HRV in normal healthy young volunteers. Settings and Design: Study was conducted in Department of Physiology in a medical college. Study design was prospective randomized comparative trial. Subjects and Methods: One hundred sedentary volunteers were randomly ascribed to either yoga or swimming group. Baseline recordings of digital electrocardiogram were done for all the subjects in cohorts of 10. After yoga training and swimming for 12 weeks, evaluation for resting HRV was done again. Statistical Analysis Used: Percentage change for each parameter with yoga and swimming was compared using unpaired t-test for data with normal distribution and using Mann-Whitney U test for data without normal distribution. Results: Most of the HRV parameters improved statistically significantly by both modalities of exercise. However, some of the HRV parameters showed statistically better improvement with yoga as compared to swimming. Conclusion: Practicing yoga seems to be the mode of exercise with better improvement in autonomic functions as suggested by resting HRV. PMID:26170587

  19. Closed Suction Drainage Has No Benefits in Anterior Hip Arthroplasty: A Prospective, Randomized Trial.

    PubMed

    Suarez, Juan C; McNamara, Colin A; Barksdale, Leticia C; Calvo, Cecilia; Szubski, Caleb R; Patel, Preetesh D

    2016-09-01

    Many studies have challenged routine drain placement in patients undergoing total hip arthroplasty. Some studies suggest increased transfusion rate with the use of closed suction drains. The use of tranexamic acid to control surgical bleeding and aspirin for venous thromboembolism prophylaxis has gained popularity. No study has evaluated the use of drains in patients undergoing direct anterior total hip arthroplasty under these conditions. We performed a prospective, randomized study in patients undergoing direct anterior total hip arthroplasty to evaluate whether closed suction drain placement provides any clinical benefit. Patients randomly assigned to the control group had closed suctions drains placed; patients randomly assigned to the treatment group had no drains placed. The primary outcome measures were hematoma formation, wound complications, and transfusion rates. The secondary outcome measures were estimated blood loss, decrease in hemoglobin and hematocrit levels, total hemoglobin loss, calculated blood loss, hidden blood loss, and total length of hospital stay. Differences in outcomes between groups were considered to be significant at P ≤ .05. There were no significant differences between groups in transfusion rate (P = .49), postoperative decrease in hemoglobin levels (P = .95), average calculated blood loss (P = .65), complications (P = .49), or length of hospital stay (P = .14). There was no hematoma formation observed in either group. Our study showed no clinical benefit or disadvantage to closed suction drainage in anterior hip arthroplasty with the concomitant use of tranexamic acid for surgical hemostasis and aspirin for venous thromboembolism prophylaxis. Copyright © 2016 Elsevier Inc. All rights reserved.

  20. Clinical impact of 8 prospective, randomized, multicenter glaucoma trials.

    PubMed

    Panarelli, Joseph F; Banitt, Michael R; Sidoti, Paul A; Budenz, Donald L; Singh, Kuldev

    2015-01-01

    To determine the impact of 8 multicenter randomized clinical trials (RCTs) on glaucoma practice. An electronic survey was distributed to the members of the American Glaucoma Society (AGS). Each participant was asked 2 study-specific questions and 1 standard question common to all 8 RCTs assessing the study's impact on clinical practice. RCTs included in the survey were the Advanced Glaucoma Intervention Study (AGIS), Collaborative Initial Glaucoma Treatment Study (CIGTS), Collaborative Normal Tension Glaucoma (CNTG) Study, European Glaucoma Prevention Study (EGPS), Early Manifest Glaucoma Trial (EMGT), Glaucoma Laser Trial (GLT), Ocular Hypertension Treatment Study (OHTS), and Tube Versus Trabeculectomy (TVT) Study. A 5-point Likert scale was used for rating all responses. The practice setting and duration of glaucoma practice was determined for all AGS members who responded. A total of 206 (23.0%) of 894 AGS members participated in the survey. Among those who responded, 46.4% were self classified as academic practitioners and 53.6% worked in a private practice setting. Mean Likert scores for the standard question evaluating the overall impact of the RCT were OHTS 4.47, CNTG Study 4.13, AGIS 3.78, TVT Study 3.53, EMGT 3.48, CIGTS 3.44, GLT 3.39, and 2.69 EGPS. Substantial differences were observed in the clinical impact of several RCTs in glaucoma. The reported impact of each study likely reflects several factors including study timing, design, conduct, and interpretation of results.

  1. Ultrasonic scalpel for gastric cancer surgery: a prospective randomized study.

    PubMed

    Inoue, Kentaro; Nakane, Yasushi; Michiura, Taku; Yamada, Masanori; Mukaide, Hiromi; Fukui, Junichi; Miki, Hirokazu; Ueyama, Yosuke; Nakatake, Richi; Tokuhara, Katsuji; Iwamoto, Shigeyoshi; Yanagimoto, Hiroaki; Toyokawa, Hideyoshi; Satoi, Sohei; Kwon, A-Hon

    2012-10-01

    The aim of the study was to evaluate the potential advantages of the ultrasonic scalpel compared with the conventional technique in gastric cancer surgery. Patients with resectable adenocarcinoma of the stomach were randomly assigned to ultrasonic scalpel or conventional technique. We used the HARMONIC FOCUS (Ethicon Endo-Surgery, Inc.) as ultrasonic scalpel. Between February 2010 and December 2010, 60 patients with resectable gastric cancer were enrolled into the study. Operative time was significantly shorter with the ultrasonic arm than with the conventional arm (median 238.5 vs. 300.5 min; P = 0.0004). Blood loss was also significantly lower in the ultrasonic arm than in the conventional arm (median 351.0 vs. 569.5 ml; P = 0.016). Clavien-Dindo grades of postoperative complications were similar in the two groups. From a questionnaire survey of operators, the ultrasonic scalpel significantly reduced the stress of lymph node dissection (3.67 vs. 2.87; P = 0.0006). However, in assisting surgeons, the contributions to surgery, study, and technical improvement of the ultrasonic group were lower than in the conventional group. This study shows that the ultrasonic scalpel is a reliable and safe tool for open gastric cancer surgery.

  2. Calcium intake and risk of cardiovascular disease: a review of prospective studies and randomized clinical trials.

    PubMed

    Wang, Lu; Manson, JoAnn E; Sesso, Howard D

    2012-04-01

    The potential effects of inadequate or excessive calcium supply on cardiovascular disease (CVD) are receiving growing attention. We review experimental, epidemiologic, and clinical evidence regarding the role of calcium intake in the development of CVD in adults. In vitro and in vivo laboratory studies have shown that calcium may affect the risk of developing CVD through multiple mechanisms including blood cholesterol, insulin secretion and sensitivity, vasodilation, inflammatory profile, thrombosis, obesity, and vascular calcification. A number of prospective epidemiologic studies have examined the relationship between dietary calcium intake and CVD incidence or mortality in middle-aged and older adults. The results were inconsistent, and the pooled data do not strongly support a significant effect of greater dietary calcium intake on the risk of coronary artery disease (CAD) or stroke. Only a few prospective studies have examined calcium supplement use in association with risk of CVD. The pooled data show no significant benefits of calcium supplement use in reducing the risk of CAD or stroke. No randomized clinical trial has specifically tested the effect of calcium supplementation on CVD as its primary endpoint. Secondary analyses in existing trials to date suggest a neutral effect of calcium (with or without vitamin D) supplements on CVD events, but do not allow for a definitive conclusion. A large percentage of Americans, particularly older adults, fail to meet the US recommendations for optimal calcium intake and are encouraged to increase daily calcium consumption. More prospective cohort studies and large-scale randomized trials are needed to further evaluate the risks or benefits of calcium supplementation on CVD endpoints as the primary pre-specified outcome.

  3. Prospective, randomized, placebo-controlled trial evaluating the efficacy and safety of propofol sedation by anesthesiologists and gastroenterologist-led teams using computer-assisted personalized sedation during upper and lower gastrointestinal endoscopy.

    PubMed

    Kashiwagi, Kazuhiro; Hosoe, Naoki; Takahashi, Keiji; Nishino, Haruo; Miyachi, Hideyuki; Kudo, Shin-Ei; Martin, James F; Ogata, Haruhiko

    2016-09-01

    No randomized controlled studies comparing propofol versus no sedation have been reported. Comparative data demonstrating the efficacy and safety of propofol sedation by anesthesiologists (ANES), and gastroenterologist-led teams (GLT) using computer-assisted personalized sedation (CAPS), during routine gastrointestinal (GI) endoscopy in Japan do not exist. We aimed to demonstrate the safety and efficacy of propofol sedation versus no sedation (PLCB) when propofol is given by ANES or GLT, during routine GI endoscopy. Two hundred and seventy two American Society of Anesthesiologists (ASA) class I or II adults were prospectively enrolled in this multicenter study and randomized into three groups (PLCB, ANES, GLT). Ability to maintain moderate sedation, defined as MOAA/S scores of 2-4 for ≥50% of all MOAA/S measurements from scope-in to scope-out, was the primary endpoint. Secondary endpoints included patient (PSSI) and clinician (CSSI) satisfaction. Proportion of subjects maintained in moderate sedation by ANES (88.1%) and GLT (94.5%) was significantly higher than PLCB (21.6%; P < 0.001); there was no difference between the ANES and GLT groups (P = 0.116). Mean PSSI scores for subjects sedated by ANES (81.2 ± 12.5) and GLT (80.8 ± 14.1) were significantly higher than PLCB (65.3 ± 19.7; P < 0.001) and mean CSSI scores were also significantly higher in both active treatment groups (75.5 ± 10.2, 77.9 ± 10.3) than PLCB (60.8 ± 18.6; P < 0.001). Moderate sedation can be achieved and maintained with propofol, improving both patient and physician satisfaction, when propofol is given by an anesthesiologist or a gastroenterologist-led team using CAPS. © 2016 Japan Gastroenterological Endoscopy Society.

  4. Results of a prospective randomized trial using DTIC and interferon as adjuvant therapy for stage I malignant melanoma.

    PubMed

    Kerin, M J; Gillen, P; Monson, J R; Wilkie, J; Keane, F B; Tanner, W A

    1995-10-01

    This prospective randomized trial evaluated the effect of DTIC and interferon as adjuvant therapy for high risk stage 1 malignant melanoma in 26 patients. Both groups were well matched for depth of disease, site of melanoma and other prognostic criteria. Like other studies the findings of 2.6 times increased relative risk of mortality in the treatment arm do not support a rationale for adjuvant immuno-chemotherapy even in patients at high risk of recurrence.

  5. MIOTIC study: a prospective, multicenter, randomized study to evaluate the long-term efficacy of mobile phone-based Internet of Things in the management of patients with stable COPD.

    PubMed

    Zhang, Jing; Song, Yuan-Lin; Bai, Chun-Xue

    2013-01-01

    Chronic obstructive pulmonary disease (COPD) is a common disease that leads to huge economic and social burden. Efficient and effective management of stable COPD is essential to improve quality of life and reduce medical expenditure. The Internet of Things (IoT), a recent breakthrough in communication technology, seems promising in improving health care delivery, but its potential strengths in COPD management remain poorly understood. We have developed a mobile phone-based IoT (mIoT) platform and initiated a randomized, multicenter, controlled trial entitled the 'MIOTIC study' to investigate the influence of mIoT among stable COPD patients. In the MIOTIC study, at least 600 patients with stable GOLD group C or D COPD and with a history of at least two moderate-to-severe exacerbations within the previous year will be randomly allocated to the control group, which receives routine follow-up, or the intervention group, which receives mIoT management. Endpoints of the study include (1) frequency and severity of acute exacerbation; (2) symptomatic evaluation; (3) pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1) and FEV1/forced vital capacity (FVC) measurement; (4) exercise capacity; and (5) direct medical cost per year. Results from this study should provide direct evidence for the suitability of mIoT in stable COPD patient management.

  6. MIOTIC study: a prospective, multicenter, randomized study to evaluate the long-term efficacy of mobile phone-based Internet of Things in the management of patients with stable COPD

    PubMed Central

    Zhang, Jing; Song, Yuan-lin; Bai, Chun-xue

    2013-01-01

    Chronic obstructive pulmonary disease (COPD) is a common disease that leads to huge economic and social burden. Efficient and effective management of stable COPD is essential to improve quality of life and reduce medical expenditure. The Internet of Things (IoT), a recent breakthrough in communication technology, seems promising in improving health care delivery, but its potential strengths in COPD management remain poorly understood. We have developed a mobile phone-based IoT (mIoT) platform and initiated a randomized, multicenter, controlled trial entitled the ‘MIOTIC study’ to investigate the influence of mIoT among stable COPD patients. In the MIOTIC study, at least 600 patients with stable GOLD group C or D COPD and with a history of at least two moderate-to-severe exacerbations within the previous year will be randomly allocated to the control group, which receives routine follow-up, or the intervention group, which receives mIoT management. Endpoints of the study include (1) frequency and severity of acute exacerbation; (2) symptomatic evaluation; (3) pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1) and FEV1/forced vital capacity (FVC) measurement; (4) exercise capacity; and (5) direct medical cost per year. Results from this study should provide direct evidence for the suitability of mIoT in stable COPD patient management. PMID:24082784

  7. Harmonic Scalpel versus Conventional Haemostasis in Neck Dissection: A Prospective Randomized Study

    PubMed Central

    Ferri, Emanuele; Armato, Enrico; Spinato, Giacomo; Lunghi, Marcello; Tirelli, Giancarlo; Spinato, Roberto

    2013-01-01

    Purpose. The aim of this prospective randomized trial was to compare operative factors, postoperative outcomes, and surgical complications of neck dissection (ND) when using the harmonic scalpel (HS) versus conventional haemostasis (CH) (classic technique of tying and knots, resorbable ligature, and bipolar diathermy). Materials and methods. Sixty-one patients who underwent ND with primary head and neck cancer (HNSCC) resection were enrolled in this study and were randomized into two homogeneous groups: CH (conventional haemostasis with classic technique of tying and knots, resorbable ligature, and bipolar diathermy) and HS (haemostasis with harmonic scalpel). Outcomes of the study included operative time, intraoperative blood loss, drainage volume, postoperative pain, hospital stay, and incidence of intraoperative and postoperative complications. Results. The use of the HS reduced significantly the operating time, the intraoperative blood loss, the postoperative pain, and the volume of drainage. No significant difference was observed in mean hospital stay and perioperative, and postoperative complications. Conclusion. The HS is a reliable and safe tool for reducing intraoperative blood loss, operative time, volume of drainage and postoperative pain in patients undergoing ND for HNSCC. Multicenter randomized studies need to be done to confirm the advantages of this technique and to evaluate the cost-benefit ratio. PMID:24490063

  8. A prospective, randomized controlled study of computer-assisted learning in parasitology.

    PubMed

    Shomaker, T Samuel; Ricks, Daniel J; Hale, Devon C

    2002-05-01

    To compare, using a prospective, randomized controlled study, three methods of teaching a medical school parasitology course: computer-based instruction, traditional lecture-based instruction, and a combination of computer-based and lecture-based instruction. A single class of the University of Utah School of Medicine was randomized into three study groups for the second-year parasitology course. The computer group (n = 29) used a locally developed interactive parasitology computer program; the lecture group (n = 32) had traditional lectures, and the combined group (n = 33) used both the computer program and lectures. Students' knowledge was assessed using a pretest, a final examination, and a posttest administered four months after the course. Students also used logs to track the amounts of time they spent studying. Their impressions and course evaluations were collected using a standardized course-evaluation form. The groups' scores on the pretest, final examination, and posttest were not statistically significantly different. Students in the computer group averaged 26.8 hours of studying over the two-week course compared with 32.1 hours in the lecture group and 32.7 hours in the combined group. The difference in study times between the computer and combined groups yielded a significant p value of 0.036. Students were generally positive about the course and the computer program. Students can learn parasitology from computer-based instruction as effectively as from traditional lecture-based instruction, and they can do so in less time.

  9. Acupuncture for posttraumatic stress disorder: a systematic review of randomized controlled trials and prospective clinical trials.

    PubMed

    Kim, Young-Dae; Heo, In; Shin, Byung-Cheul; Crawford, Cindy; Kang, Hyung-Won; Lim, Jung-Hwa

    2013-01-01

    To evaluate the current evidence for effectiveness of acupuncture for posttraumatic stress disorder (PTSD) in the form of a systematic review, a systematic literature search was conducted in 23 electronic databases. Grey literature was also searched. The key search terms were "acupuncture" and "PTSD." No language restrictions were imposed. We included all randomized or prospective clinical trials that evaluated acupuncture and its variants against a waitlist, sham acupuncture, conventional therapy control for PTSD, or without control. Four randomized controlled trials (RCTs) and 2 uncontrolled clinical trials (UCTs) out of 136 articles in total were systematically reviewed. One high-quality RCT reported that acupuncture was superior to waitlist control and therapeutic effects of acupuncture and cognitive-behavioral therapy (CBT) were similar based on the effect sizes. One RCT showed no statistical difference between acupuncture and selective serotonin reuptake inhibitors (SSRIs). One RCT reported a favorable effect of acupoint stimulation plus CBT against CBT alone. A meta-analysis of acupuncture plus moxibustion versus SSRI favored acupuncture plus moxibustion in three outcomes. This systematic review and meta-analysis suggest that the evidence of effectiveness of acupuncture for PTSD is encouraging but not cogent. Further qualified trials are needed to confirm whether acupuncture is effective for PTSD.

  10. Tramadol versus codeine/acetaminophen after pediatric tonsillectomy: A prospective, double-blinded, randomized controlled trial.

    PubMed

    Friedrichsdorf, Stefan J; Postier, Andrea C; Foster, Laurie Pane; Lander, Timothy A; Tibesar, Robert J; Lu, Yi; Sidman, James D

    2015-01-01

    Tonsillectomy is one of the most common pediatric surgical procedures performed in the United States. The postoperative period can be particularly painful, and there is currently no consensus on an optimal analgesic regimen. The objective of this study was to evaluate efficacy and safety of the single drug tramadol versus codeine/acetaminophen post-tonsillectomy. Prospective, double-blinded, randomized controlled trial. Large, Midwestern US pediatric hospital. Eighty-four children aged 4-15 years who underwent a tonsillectomy (with or without adenoidectomy) procedure were randomized and 74 were included in the analysis. Group 1 received liquid codeine/acetaminophen for 10 days post-tonsillectomy (5 days scheduled, followed by 5 days as-needed). Group 2 received liquid tramadol for 10 days post-tonsillectomy (5 days scheduled, followed by 5 days as-needed). Efficacy and side effects were evaluated using a 10-day take-home diary that was completed by parents. Children in both study arms reported adequate post-tonsillectomy pain management without significant differences between groups in pain scores. Oversedation was significantly higher on the day of surgery in the codeine/acetaminophen group, and itching was experienced by significantly more children in the tramadol group during the postoperative period. As part of multimodal analgesia, scheduled plus as-needed tramadol may be considered for children in the postoperative setting due to its analgesic properties, low potential for side effects, and good safety profile.

  11. Contribution of Geophysical Prospecting to Geohazard Evaluation

    SciTech Connect

    Nicolich, Rinaldo

    2006-03-23

    The physical properties of the subsoil are studied using geophysical methods. These studies are always indirect, such as gravimetric, magnetometric, magnetotelluric or reflection-refraction seismic surveys and are often combined to obtain more accurate and reliable results. With these tools the oil industry commonly investigates the sedimentary basins to localize structures that may favor the accumulation of hydrocarbons. Above all, seismic prospecting allow the understanding of the underground geology, defining boundaries of the geological formations as well as mechanical and physical properties of the rocks. New cutting-edge techniques allow high quality data to be obtained in almost all geological contexts and make reflection seismic the most powerful tool in subsurface observations. The seismic method was utilized in geothermal resources investigation, research of water strategic resources, volcanic risks assessment, etc. The refraction method was the first to be used in the exploration of oil reservoirs. At present the industry employs mainly refraction seismics to study shallow formations. Conversely, university researchers have applied wide-angle reflection-refraction surveys to localize deep crustal interfaces analyzing the high amplitudes of the wide-angle reflections and the velocities obtained from the refracted signals. Moho discontinuity and velocity distribution within the crust were mapped out, indicating thickness and boundary conditions in different geological settings. The maps have been used in the analysis of geodynamical behavior and of active movements within the crust, useful for seismotectonic investigations. The further addition of the seismic reflection imaging, with deep penetration and long transects, completed multidisciplinary programs to unravel the structure of the crust with clear seismic images and models. High-resolution application of seismic has a central role in the identification and characterization of seismotectonic and

  12. The influence of a humectant-rich mixture on normalz skin barrier function and on once- and twice-daily treatment of foot xerosis. A prospective, randomized, evaluator-blind, bilateral and untreated-control study.

    PubMed

    Lodén, Marie; von Scheele, Johan; Michelson, Sophie

    2013-11-01

    Moisturizers are often used to overcome dry skin conditions. However, cosmetic moisturizers may lack in efficiency and may also deteriorate skin barrier function. The objective of this study was to generate data on a new humectant-rich formulation (15% alfahydroxy acids and 15% urea) in the treatment of normal skin as well as in dry feet with hyperkeratosis and cracked skin with fissures. Changes in permeability and effectiveness of the product after once- and twice-daily applications to the feet will be monitored. The study was randomized, bilateral, controlled and evaluator-blind. The first part of the study included 12 healthy volunteers and the second part 50 patients with hyperkeratotic feet. The changes in the skin was evaluated by an expert, the patients and using non-invasive biophysical measurements of skin barrier function (transepidermal water loss, TEWL), erythema, thickness (ultrasound) and hydration (conductance). The humectant-rich formulation increased skin hydration, removed scales and reduced thickness of hyperkeratotic skin. Skin barrier function was improved in normal skin, but no changes in TEWL were noted in the feet. No difference between once and twice-daily applications was found. Some smarting and stinging was noted. The humectant-rich formulation efficiently relieved the xerosis on the feet without inducing any weakening of the skin barrier function. Instead the normal skin became more resistant to external insults by the treatment. © 2013 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  13. A Multicenter, Prospective, Randomized, Double-blind Study to Evaluate the Safety and Efficacy of Saroglitazar 2 and 4 mg Compared to Pioglitazone 45 mg in Diabetic Dyslipidemia (PRESS V).

    PubMed

    Pai, Vikas; Paneerselvam, A; Mukhopadhyay, Satinath; Bhansali, Anil; Kamath, Dinesh; Shankar, V; Gambhire, Dhiraj; Jani, Rajendrakumar H; Joshi, Shashank; Patel, Pankaj

    2014-01-01

    Dual PPARα/γ can improve both metabolic effects and minimized the side effects caused by either PPARα or PPARγ agonist. The PRESS V study was aimed to evaluate the safety, tolerability, and efficacy of saroglitazar 2 mg and 4 mg capsules (Lipaglyn™; Zydus Code: ZYH1) as compared to high dose pioglitazone in patients with diabetic dyslipidemia. In this 26-week double-blind, parallel arm, phase 3 study patients with hypertriglyceridemia with type 2 diabetes mellitus (BMI > 23 kg/m(2); hypertriglyceridemia: TG > 200 to 400 mg/dL; glycosylated hemoglobin [HbA1c] >7 to 9%) were enrolled from 14 sites in India. After 2 weeks of lifestyle modification, 122 patients were randomized double-blind to 24-week treatment with the study drugs (saroglitazar 2 mg or 4 mg or pioglitazone 45 mg once daily) in a 1:1:1 ratio. The primary end point was change in plasma triglyceride level at week 24. The secondary end points were change in lipid profile and fasting plasma glucose at week 24. Patients who received study medication and had undergone at least 1 postbaseline efficacy evaluation were included in the efficacy analysis. All randomized patients who received at least a single dose were included for safety evaluation. The efficacy analysis included 109 patients (n = 37 in saroglitazar 2 mg; n = 39 in saroglitazar 4 mg; n = 33 in pioglitazone). Saroglitazar 2 mg and 4 mg significantly reduced (P < .001) plasma triglyceride from baseline by 26.4% (absolute change ± SD: -78.2 ± 81.98 mg/dL) and 45% (absolute change ± SD -115.4 ± 68.11 mg/dL), respectively, as compared to pioglitazone -15.5% (absolute change ± SD: -33.3 ± 162.41 mg/dL) at week 24. Saroglitazar 4 mg treatment also demonstrated marked decrease in low-density lipoprotein (5%), very-low-density lipoprotein (45.5%), total cholesterol (7.7%), and apolipoprotein-B (10.9%). Saroglitazar treatment was generally safe and well tolerated. No serious adverse events were reported in saroglitazar treatment arm and no

  14. A prospective, randomized, double-blind, placebo-controlled parallel-group dual site trial to evaluate the effects of a Bacillus coagulans-based product on functional intestinal gas symptoms

    PubMed Central

    2009-01-01

    Background This randomized double blind placebo controlled dual site clinical trial compared a probiotic dietary supplement to placebo regarding effects on gastrointestinal symptoms in adults with post-prandial intestinal gas-related symptoms (abdominal pain, distention, flatulence) but no gastrointestinal (GI) diagnoses to explain the symptoms. Methods Sixty-one adults were enrolled (age 36.5 ± 12.6 years; height 165.1 ± 9.2 cm; weight 75.4 ± 17.3 kg) and randomized to either Digestive Advantage™ Gas Defense Formula - (GanedenBC30 Bacillus coagulans GBI-30, 6086): n = 30; or Placebo: n = 31. Study subjects were evaluated every two weeks over a four-week period using validated questionnaires and standard biochemical safety testing. Outcome criteria of interest included change from baseline in Gastrointestinal Symptom Rating Scale (GSRS) abdominal pain, abdominal distention, flatus, and the Severity of Dyspepsia Assessment (SODA) bloating and gas subscores over four weeks of product use. Results Measured against the placebo, subjects in the probiotic group achieved significant improvements in GSRS abdominal pain subscore (p = 0.046) and the GSRS total score (p = 0.048), with a strong trend for improvement on the GSRS abdominal distension subscore (p = 0.061). A strong placebo effect was evident which could explain the lack of statistical significant differences between the groups for many of the efficacy variables. Conclusion In conclusion, the Bacillus coagulans-based product was effective in improving the quality of life and reducing gastrointestinal symptoms in adults with post prandial intestinal gas-related symptoms and no GI diagnoses. Trial Registration ClinicalTrials.gov Identifier: NCT00881322 PMID:19922649

  15. Nonstented versus routine stented ureteroscopic holmium laser lithotripsy: a prospective randomized trial.

    PubMed

    Shao, Yi; Zhuo, Jian; Sun, Xiao-Wen; Wen, Wei; Liu, Hai-Tao; Xia, Shu-Jie

    2008-10-01

    We conducted a prospective, randomized study to evaluate whether postoperative ureteral stenting is necessary after ureteroscopic holmium laser lithotripsy. A total of 115 consecutive patients with distal or middle ureteral calculi amenable to ureteroscopic holmium laser lithotripsy were prospectively randomized into stented group (n = 58) and nonstented group (n = 57). The stent was routinely placed in the treated ureter for 2 weeks. The outcomes were measured with postoperative patient symptoms, stone-free rates, early and late postoperative complications, and cost-effectiveness. The postoperative symptoms were measured with Ureteral Stent Symptom Questionnaire (USSQ). All patients completed a 12-week follow-up. There was no significant difference between two groups with respect to the patient age, stone size, stone location and mean operative time. According to the USSQ, the symptoms of the stented group were significantly worse compared to the nonstented group (P = 0.0001). In the stented group, two patients had high fever for 1 week after the operation, stent migration was found in two patients, and the stents had to be removed earlier in five patients because of severe pain or hematuria. The cost of the stented group was significantly higher than the nonstented group. The stone-free rate was 100% in both groups. No hydronephrosis or ureteral stricture was detected by intravenous pyelogram in the 12th week postoperative follow-up. In conclusion, we believe that routine stenting after ureteroscopic intracorporeal lithotripsy with the holmium laser is not necessary as long as the procedure is uncomplicated for distal or middle ureteral calculis less than 2 cm.

  16. Height and Breast Cancer Risk: Evidence From Prospective Studies and Mendelian Randomization

    PubMed Central

    Zhang, Ben; Shu, Xiao-Ou; Delahanty, Ryan J.; Zeng, Chenjie; Michailidou, Kyriaki; Bolla, Manjeet K.; Wang, Qin; Dennis, Joe; Wen, Wanqing; Long, Jirong; Li, Chun; Dunning, Alison M.; Chang-Claude, Jenny; Shah, Mitul; Perkins, Barbara J.; Czene, Kamila; Darabi, Hatef; Eriksson, Mikael; Bojesen, Stig E.; Nordestgaard, Børge G.; Nielsen, Sune F.; Flyger, Henrik; Lambrechts, Diether; Neven, Patrick; Wildiers, Hans; Floris, Giuseppe; Schmidt, Marjanka K.; Rookus, Matti A.; van den Hurk, Katja; de Kort, Wim L. A. M.; Couch, Fergus J.; Olson, Janet E.; Hallberg, Emily; Vachon, Celine; Rudolph, Anja; Seibold, Petra; Flesch-Janys, Dieter; Peto, Julian; dos-Santos-Silva, Isabel; Fletcher, Olivia; Johnson, Nichola; Nevanlinna, Heli; Muranen, Taru A.; Aittomäki, Kristiina; Blomqvist, Carl; Li, Jingmei; Humphreys, Keith; Brand, Judith; Guénel, Pascal; Truong, Thérèse; Cordina-Duverger, Emilie; Menegaux, Florence; Burwinkel, Barbara; Marme, Frederik; Yang, Rongxi; Surowy, Harald; Benitez, Javier; Zamora, M. Pilar; Perez, Jose I. A.; Cox, Angela; Cross, Simon S.; Reed, Malcolm W. R.; Andrulis, Irene L.; Knight, Julia A.; Glendon, Gord; Tchatchou, Sandrine; Sawyer, Elinor J.; Tomlinson, Ian; Kerin, Michael J.; Miller, Nicola; Chenevix-Trench, Georgia; Haiman, Christopher A.; Henderson, Brian E.; Schumacher, Fredrick; Marchand, Loic Le; Lindblom, Annika; Margolin, Sara; Hooning, Maartje J.; Martens, John W. M.; Tilanus-Linthorst, Madeleine M. A.; Collée, J. Margriet; Hopper, John L.; Southey, Melissa C.; Tsimiklis, Helen; Apicella, Carmel; Slager, Susan; Toland, Amanda E.; Ambrosone, Christine B.; Yannoukakos, Drakoulis; Giles, Graham G.; Milne, Roger L.; McLean, Catriona; Fasching, Peter A.; Haeberle, Lothar; Ekici, Arif B.; Beckmann, Matthias W.; Brenner, Hermann; Dieffenbach, Aida Karina; Arndt, Volker; Stegmaier, Christa; Swerdlow, Anthony J.; Ashworth, Alan; Orr, Nick; Jones, Michael; Figueroa, Jonine; Garcia-Closas, Montserrat; Brinton, Louise; Lissowska, Jolanta; Dumont, Martine; Winqvist, Robert; Pylkäs, Katri; Jukkola-Vuorinen, Arja; Grip, Mervi; Brauch, Hiltrud; Brüning, Thomas; Ko, Yon-Dschun; Peterlongo, Paolo; Manoukian, Siranoush; Bonanni, Bernardo; Radice, Paolo; Bogdanova, Natalia; Antonenkova, Natalia; Dörk, Thilo; Mannermaa, Arto; Kataja, Vesa; Kosma, Veli-Matti; Hartikainen, Jaana M.; Devilee, Peter; Seynaeve, Caroline; Van Asperen, Christi J.; Jakubowska, Anna; Lubiński, Jan; Jaworska-Bieniek, Katarzyna; Durda, Katarzyna; Hamann, Ute; Torres, Diana; Schmutzler, Rita K.; Neuhausen, Susan L.; Anton-Culver, Hoda; Kristensen, Vessela N.; Grenaker Alnæs, Grethe I.; Pierce, Brandon L.; Kraft, Peter; Peters, Ulrike; Lindstrom, Sara; Seminara, Daniela; Burgess, Stephen; Ahsan, Habibul; Whittemore, Alice S.; John, Esther M.; Gammon, Marilie D.; Malone, Kathleen E.; Tessier, Daniel C.; Vincent, Daniel; Bacot, Francois; Luccarini, Craig; Baynes, Caroline; Ahmed, Shahana; Maranian, Mel; Healey, Catherine S.; González-Neira, Anna; Pita, Guillermo; Alonso, M. Rosario; Álvarez, Nuria; Herrero, Daniel; Pharoah, Paul D. P.; Simard, Jacques; Hall, Per; Hunter, David J.; Easton, Douglas F.

    2015-01-01

    Background: Epidemiological studies have linked adult height with breast cancer risk in women. However, the magnitude of the association, particularly by subtypes of breast cancer, has not been established. Furthermore, the mechanisms of the association remain unclear. Methods: We performed a meta-analysis to investigate associations between height and breast cancer risk using data from 159 prospective cohorts totaling 5216302 women, including 113178 events. In a consortium with individual-level data from 46325 case patients and 42482 control subjects, we conducted a Mendelian randomization analysis using a genetic score that comprised 168 height-associated variants as an instrument. This association was further evaluated in a second consortium using summary statistics data from 16003 case patients and 41335 control subjects. Results: The pooled relative risk of breast cancer was 1.17 (95% confidence interval [CI] = 1.15 to 1.19) per 10cm increase in height in the meta-analysis of prospective studies. In Mendelian randomization analysis, the odds ratio of breast cancer per 10cm increase in genetically predicted height was 1.22 (95% CI = 1.13 to 1.32) in the first consortium and 1.21 (95% CI = 1.05 to 1.39) in the second consortium. The association was found in both premenopausal and postmenopausal women but restricted to hormone receptor–positive breast cancer. Analyses of height-associated variants identified eight new loci associated with breast cancer risk after adjusting for multiple comparisons, including three loci at 1q21.2, DNAJC27, and CCDC91 at genome-wide significance level P < 5×10–8. Conclusions: Our study provides strong evidence that adult height is a risk factor for breast cancer in women and certain genetic factors and biological pathways affecting adult height have an important role in the etiology of breast cancer. PMID:26296642

  17. Prospective Randomized Study of Patients with Insomnia and Mild Sleep Disordered Breathing

    PubMed Central

    Guilleminault, Christian; Davis, Kala; Huynh, Nelly T.

    2008-01-01

    Background: Patients with insomnia may present with mild and often unrecognized obstructive sleep apnea (OSA). Objective: To evaluate both subjective and objective outcomes of patients with complaints of insomnia and mild OSA who receive surgical treatment for OSA versus behavioral treatment with cognitive behavioral therapy for insomnia (CBT-I). Methods: Prospective study with crossover design of 30 patients with complaints of insomnia and mild OSA. Thirty subjects, matched for age and gender, were randomized with stratification to receive either CBT-I or surgical treatment of OSA as primary treatment. Patients were reassessed after completing the initial intervention and reassigned if agreeable to the alternative treatment option and assessed again on completion of both treatment arms. Outcome measures included clinical impression, Epworth Sleepiness Scale (ESS) score, Fatigue Severity Scale (FSS) score, and polysomnography (PSG) results. Results: Surgery resulted in greater improvements in total sleep time (TST), slow wave sleep and REM sleep duration, respiratory disturbance index, apnea-hypopnea index, minimum oxygen saturation, FSS, and ESS. CBT-I also improved TST and resulted in shorter sleep latency. Conclusion: Surgical intervention for the management of patients with complaints of insomnia and mild OSA demonstrated greater improvement in both subjective and objective outcome measures. Initial treatment of underlying OSA in patients with insomnia was more successful in improving insomnia than CBT-I alone. However CBT-I as initial treatment improved TST compared to baseline; following surgical intervention, it had the additional benefit of further increasing TST and helped to control sleep onset difficulties that may be related to conditioning due to unrecognized symptoms of mild OSA. Citation: Guilleminault C; Davis K; Huynh NT. Prospective randomized study of patients with insomnia and mild sleep disordered breathing. SLEEP 2008;31(11):1527–1533 PMID

  18. Clinical and angiographic outcomes after treatment of de novo coronary stenoses with a novel platinum chromium thin-strut stent: primary results of the PERSEUS (Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System) trial.

    PubMed

    Kereiakes, Dean J; Cannon, Louis A; Feldman, Robert L; Popma, Jeffrey J; Magorien, Raymond; Whitbourn, Robert; Dauber, Ira M; Rabinowitz, Abram C; Ball, Michael W; Bertolet, Barry; Kabour, Ameer; Foster, Michael C; Wang, John C; Underwood, Paul; Dawkins, Keith D

    2010-07-20

    The aim of this study was to evaluate the safety and efficacy of the novel platinum chromium TAXUS Element paclitaxel-eluting stent (PES) compared with the TAXUS Express PES (Boston Scientific, Natick, Massachusetts) in treating coronary artery stenoses. The TAXUS Element is a novel thin-strut (81 microm), platinum chromium alloy PES designed to improve radial strength, radiopacity, and deliverability, while safely providing comparable restenosis benefit compared with a previous-generation PES. The PERSEUS (Prospective Evaluation in a Randomized Trial of the Safety and Efficacy of the Use of the TAXUS Element Paclitaxel-Eluting Coronary Stent System) Workhorse (WH) trial is a prospective, randomized (3:1), controlled, multicenter study of the TAXUS Element (vs. TAXUS Express) PES for the treatment of de novo coronary atherosclerotic lesionsor=2.75 to

  19. Silver nitrate versus tetracycline in pleurodesis for malignant pleural effusions; a prospective randomized trial

    PubMed Central

    Tabatabaei, Seyed Abass; Hashemi, Seyed Mozafar; Kamali, Ali

    2015-01-01

    Background: In this study, we aimed to investigate the effectiveness of silver nitrate (SN) versus tetracycline in pleurodesis among patients with malignant pleural effusion (MPE). Methods: In this prospective randomized clinical trial, patients with unilateral MPE candidate for pleurodesis were enrolled. The patients randomly allocated in two groups for receiving 20 mL 0.5% SN or 2.5 g tetracycline diluted in 30 cc normal saline and 0.1% lidocaine, through the chest tube. Patients were followed-up immediately (during 24 h) and 1-month after the procedure for evaluating recurrence of the pleural effusion using chest radiograph. They were clinically evaluated for chest pain and/or dyspnea and fever using a questionnaire that completed by the surgeon. The results were compared with two groups. Results: During this trial, 50 patients with MPE candidate for pleurodesis were selected and randomized into two interventional groups (25 patients in each group). Immediate and late recurrence of pleural effusion after pleurodesis were similar in two groups (P > 0.05). All patients in tetracycline group had fever and chest pain, but in SN group fever and chest pain were reported in 3 (12%) and 12 (48%) of patients, respectively (P < 0.05). Conclusion: SN is at least as effective as tetracycline for MPE treatment. In addition, its side effects were lower than tetracycline. Other advantages of SN are its low cost, availability, and safety. For more accurate results, it is recommended to design further trials with larger sample size and with lower doses of both SN and tetracycline. PMID:26605217

  20. Evaluation of quality of life using a tablet PC-based survey in cancer patients treated with radiotherapy: a multi-institutional prospective randomized crossover comparison of paper and tablet PC-based questionnaires (KROG 12-01).

    PubMed

    Kim, Haeyoung; Park, Hee Chul; Yoon, Sang Min; Kim, Tae Hyun; Kim, Jinsung; Kang, Min Kyu; Jung, Jinhong; Kim, Sang-Won; Yea, Ji Woon; Park, Sung Ho; Park, Young Suk

    2016-10-01

    This study compared a tablet PC questionnaire with a paper method for reliability and patient preferences in the acquisition of patient-reported outcomes (PROs) for patients treated with radiotherapy. By comparing the two modes of PRO administration, we aimed to evaluate the adequacy of using tablet PC questionnaires in future clinical use. Patients were randomized in a crossover study design using two different methods for PRO entry. A group of 89 patients answered a paper questionnaire followed by the tablet PC version, whereas 89 patients in another group completed the tablet PC questionnaire followed by the paper version. Surveys were performed four times per patient throughout the course of the radiotherapy. The Korean versions of the M.D. Anderson Symptom Inventory (MDASI-K) and the Brief Fatigue Inventory (BFI-K) were used. The primary endpoint of our current study was an assessment of patient preference for the survey method. The proportions of patients preferring each mode of questionnaire were evaluated. The proportion of patients who preferred the tablet PC version, paper form, or who had no preference was 52.2, 22.1, and 25.7 %, respectively. More than half of the patients preferred the tablet PC to the paper version in all four surveys. Age, gender, educational status, prior experience of using a tablet PC, and the order of paper to tablet PC administration did not impact patient preferences. Inter-class correlation coefficients (ICCs) between the modes were 0.92 for MDASI-K and 0.94 for BFI-K and ranged from 0.91 to 0.96 on both instruments during the four surveys. A tablet PC-based PRO is an acceptable and reliable method compared with paper-based data collection for Korean patients receiving radiotherapy.

  1. Evaluation of sedative effects of single and repeated doses of 50 mg and 150 mg tolperisone hydrochloride. Results of a prospective, randomized, double-blind, placebo-controlled trial.

    PubMed

    Dulin, J; Kovács, L; Ramm, S; Horvath, F; Ebeling, L; Kohnen, R

    1998-07-01

    Sedative effects of single and repeated doses of 50 mg and 150 mg tolperisone hydrochloride (Mydocalm), a centrally active muscle-relaxing agent, were evaluated in a placebo-controlled double-blind clinical trial. A total of 72 healthy young adults balanced by sex were randomized to receive 50 mg or 150 mg tolperisone hydrochloride or placebo t.i.d. for a period of 8 days. Control examinations were performed in the mornings of days 1 and 8 before intake of the morning dose and at 1.5, 4 and 6 hours postdose. The psychomotoric test battery used in this trial revealed no sedative effects of tolperisone hydrochloride in the given doses at any control examination. Subjective mood ratings quantified by the Welzel Colored Scales were not impaired either. The lack of differences in sedative potentials of tolperisone hydrochloride and placebo was confirmed by tests on differences and by tests on equivalence using 95% CI. The present study substantiates clinical experience and previous clinical trials demonstrating that tolperisone hydrochloride, though being a centrally active muscle relaxant, does not cause any sedation and does not impair reaction times.

  2. Designing a prospective study when randomization is not feasible.

    PubMed

    Linden, Ariel

    2011-06-01

    When conducting a randomized controlled trial (RCT) is unfeasible, the goal is to replicate the randomization process by creating a control group that is essentially equivalent to the treatment group on known pre-intervention characteristics and assume that the remaining unknown characteristics will not bias the results. The strategies proposed in this article are based on the thesis that since only pre-intervention characteristics are used for adjustment, a comparable control group can be established as soon as the participant group is identified. Consequently, outcomes can be observed immediately after launching the initiative rather than waiting until study completion. The benefit is that significant treatment effects can be observed as they occur, or alternatively, the initiative can be cancelled if treatment effects are not attained by a certain time point. Although these methods can never ensure the same level of validity as in an RCT, they are considered robust alternatives when randomization is impractical, and therefore a compelling study design for many commercial initiatives, such as disease management programs, benefit design changes, and pay-for-performance efforts. An obvious constraint is that treated participants must first be identified before suitable controls can be found. The preferred strategy is to enroll the entire treatment group within a narrow time frame. An alternative option is to have periodic enrollment periods with their respective treatment and control cohorts. The concept proposed in this article is intended to offer a robust alternative to the inadequate strategies currently being used in many health care settings where study findings may not be trusted, and thus decision makers remain uninformed as to whether an initiative is worth continuing or cancelled.

  3. A prospective randomized controlled blinded study to evaluate the effect of short-term focused training program in laparoscopy on operating room performance of surgery residents (CTRI /2012/11/003113).

    PubMed

    Bansal, Virinder K; Raveendran, Rahul; Misra, Mahesh C; Bhattacharjee, Hemanga; Rajan, Karthik; Krishna, Asuri; Kumar, Pankaj; Kumar, Subodh

    2014-01-01

    Laparoscopic surgery requires certain specific skills. There have been several attempts to minimize the learning curve with training outside the operation room. Although simulators have been well validated as tools to teach technical skills, their integration into comprehensive curricula is lacking. Several randomized controlled trials and systematic reviews have demonstrated that the technical skills learned on these simulators transfer to the operating room. Currently, however, the integration of these simulated models into formal residency training curricula is lacking. In our institute, we have adopted the Tuebingen Trainer devised by Professor GF Buess from Germany. The purpose of this study was to evaluate the training of surgical residents on an ex vivo phantom model for basic laparoscopic skill acquisition and its transferability to the OR performance. Seventeen general surgery residents were randomized into 2 groups: Laparoscopic Training Group (n = 9, Group A) and Standard Training Group (n = 8, Group B). Group A underwent training in the Minimally Invasive Surgery Training Centre on the porcine phantom model and did 10 laparoscopic cholecystectomies, whereas Group B did not undergo training in the Minimally Invasive Surgery Training Centre. All the participants performed a laparoscopic cholecystectomy in the operation theater in the presence of a consultant who was blinded to the training status of the participants. The performance of the residents in both groups in the operation theater was assessed using GOALS criteria, surgical performance assessment parameters, task-specific checklists, and visual analog scale for gallbladder perforation difficulty and overall competence. The Laparoscopic Training Group had better performance than the Standard Training Group regarding operation time, GOALS criteria, and Task-specific checklists. Although the surgical performance assessments, i.e. cystic duct and artery identification scores, gallbladder perforation

  4. Efficiency of antibacterial suture material in cardiac surgery: a double-blind randomized prospective study.

    PubMed

    Isik, Isil; Selimen, Deniz; Senay, Sahin; Alhan, Cem

    2012-02-01

    Postoperative surgical site infections (SSI) still greatly affect mortality and morbidity in cardiovascular surgery. SSI may be related to the suture material. In this prospective, randomized, controlled, and double-blinded study, the effect of antibacterial suture material on SSI in cardiac surgical patients was investigated. We randomly allocated 510 patients into 2 groups. Antibacterial suture materials were used for wound closure in 170 patients (triclosan-coated suture group), and routine suture materials were used in 340 patients (noncoated suture group). All patients were evaluated for SSI on days 10, 20, and 30 following cardiac surgery. Preoperative risk factors and laboratory findings were comparable for the 2 groups. Sternal infection occurred in 4 (2.4%) of the patients in the triclosan-coated suture group and in 3.5% of the noncoated suture group (P > .05). Leg wound infection occurred in 5 (3.5%) of the patients in the triclosan-coated suture group and in 3.8% of the noncoated suture group (P > .05). Only diabetes mellitus was an independent predictor of SSI. Both noncoated and triclosan-coated suture materials are safe. Larger studies may be needed to show the benefit and cost-effectiveness, if any, of triclosan-coated materials over noncoated materials.

  5. HHH regime for arteritis secondary to TB meningitis: a prospective randomized study.

    PubMed

    Gujjar, Arunodaya R; Srikanth, S G; Umamaheshwara Rao, G S

    2009-01-01

    Tuberculous meningitis (TBM) is a fairly common, debilitating disease and is often complicated by arteritis resulting in brain infarction. Few treatment regimes specifically address this condition. Hypervolemia-hypertension-hemodilution (HHH) regime is known to be effective for treatment of vasospasm complicating subarachnoid hemorrhage. We studied the efficacy of HHH regime in patients with TBM with arteritis using a prospective, randomized study design. Patients diagnosed to have TB meningitis by clinical, CSF, and imaging findings were evaluated for arteritis, which was recognized by presence of focal neurologic deficits with or without corresponding focal hypodensities on brain CT scan. Patients with deficits of < 96 h were randomized to HHH or conservative treatment. All patents received four-first-line anti-TB drugs and Inj.dexamethasone. HHH therapy was administered over 3-9 days. Neurologic status and modified Rankin score were noted serially and at discharge. Seven patients received HHH and 5, conservative treatment. All had hemiparesis with power 0-3/5. Median GCS was worse in HHH group (11 vs. 13). In the HHH group, 6/7 improved in motor power, and 5/7 in sensorium. In the control group, 3/5 improved in motor power and 3/5 in sensorium. Four patients died in each group. HHH therapy is safe and may be beneficial in the management of patients with infective arteritis secondary to TBM. Further study in a larger group with improved monitoring of cerebral circulation is indicated.

  6. Intraarticular lidocaine versus intravenous analgesic for reduction of acute anterior shoulder dislocations. A prospective randomized study.

    PubMed

    Matthews, D E; Roberts, T

    1995-01-01

    We performed a prospective, randomized study to evaluate the use of injected lidocaine as an anesthetic for closed reduction of acute anterior shoulder dislocations. Thirty consecutive patients who presented at the emergency department with acute anterior shoulder dislocations were randomly placed in one of two groups. One group received an intraarticular injection of 20 ml of 1% lidocaine and the other group, intravenous injections of morphine sulfate and midazolam. The groups were compared regarding time of reduction maneuver, difficulty of reduction, subjective pain, complications, and total time spent in the emergency department. The lidocaine provided adequate anesthesia and secondary relief of muscle spasm in 15 of 15 (100%) patients. When compared with the intravenous sedation group, the lidocaine group showed no statistically significant difference in time for reduction maneuver, difficulty of reduction, or subjective pain. The lidocaine group had no complications and had a statistically significant shorter emergency department visit when compared with the intravenous sedation group (mean, 78 minutes versus 186 minutes; P = 0.004). Lidocaine provides excellent anesthesia for patients with uncomplicated anterior shoulder dislocations and can be very beneficial when sedation is contraindicated. Lidocaine injections also proved to be cost effective in our institution, reducing total costs by as much as 62%.

  7. Comparison of Rifaximin and Lactulose for the Treatment of Hepatic Encephalopathy: A Prospective Randomized Study

    PubMed Central

    Paik, Yong-Han; Han, Kwang-Hyub; Song, Kun Hoon; Kim, Myoung Hwan; Moon, Byung Soo; Ahn, Sang Hoon; Lee, Se Joon; Park, Hyo Jin; Lee, Dong Ki; Chon, Chae Yoon; Lee, Sang In; Moon, Young Myoung

    2005-01-01

    Rifaximin has been reported to be effective for the treatment of hepatic encephalopathy (HE) in Europe. However, it is unknown whether Rifaximin is effective for the treatment of HE in Koreans, therefore we conducted a open-label prospective randomized study to evaluate the efficacy of rifaximin versus lactulose in Korean patients. Fifty-four patients with liver cirrhosis and hepatic encephalopathy were enrolled. Thirty-two patients were randomized to receive rifaximin and 22 to receive lactulose both over a 7-day periods. Before and at the end of treatment, gradation of blood ammonia, flapping tremor, mental status, number connection test (NCT) were performed and estimation of HE indexes determined. Both rifaximin and lactulose were effective in the majority of patients (84.4% and 95.4%, respectively, p=0.315). Blood NH3, flapping tremor, mental status, and NCT was significantly improved by rifaximin and lactulose, and the posttreatment levels of these measures were similar for the rifaximin and lactulose-treated groups, as was the HE index (rifaximin group (10.0→4.2, p=0.000); lactulose group (11.3→5.0, p=0.000)). One patient treated with rifaximin complained of abdominal pain, which was easily controlled. There was no episode of renal function impairment in either treatment group. Rifaximin proved to be as safe and as effective as lactulose for the treatment of Korean patients with hepatic encephalopathy. PMID:15988813

  8. Nonoperative treatment of thoracic and lumbar spine fractures: a prospective randomized study of different treatment options.

    PubMed

    Stadhouder, Agnita; Buskens, Erik; Vergroesen, Diederik A; Fidler, Malcolm W; de Nies, Frank; Oner, F C

    2009-09-01

    To evaluate and compare nonoperative treatment methods for traumatic thoracic and lumbar compression fractures and burst fractures. Prospective randomized controlled trial with long-term follow-up. Two general hospitals in the Netherlands. Patients with a traumatic thoracic or lumbar spine fracture, without neurologic damage, with less than 50% loss of height of the anterior column and less than 30% reduction of the spinal canal were included. Patients in the compression group were randomized to physical therapy and postural instructions, a brace for 6 weeks, or a Plaster of Paris cast for 6 or 12 weeks. Patients in the burst group received a brace or a Plaster of Paris cast, both for 12 weeks. Follow-up examinations included radiographs, Visual Analogue Scores for toleration of treatment and persistent pain, and an Oswestry Disability Index at long-term follow-up. There were 133 patients: 108 in the compression group and 25 in the burst group. For compression fractures, physical therapy and brace were considered the most tolerable. Brace therapy scored significantly better on the Visual Analogue Scores for residual pain and on the Oswestry Disability Index. None of the treatments had any significant effect on the residual deformity measurements. For burst fractures, no significant differences were found. Brace treatment with supplementary physical therapy is the treatment of choice for patients with compression fractures of the thoracic and lumbar spine. Furthermore, more than 20% of all patients had moderate or severe back pain at long-term follow-up.

  9. Spacers versus nebulizers in treatment of acute asthma - a prospective randomized study in preschool children.

    PubMed

    Mitselou, Niki; Hedlin, Gunilla; Hederos, Carl-Axel

    2016-12-01

    To compare administration of bronchodilators by nebulizers with delivery by metered dose inhalers (MDIs) with spacers and to evaluate the clinical effect of the treatment of acute asthma in preschool children. A prospective randomized clinical trial in a pediatric emergency department (PED). Preschool children who were admitted for virus induced wheezing or acute asthma exacerbation were randomly allocated to receive bronchodilator treatment by nebulizer or by metered dose inhaler. The accompanying parents completed a questionnaire. The length of stay in the PED and the hospitalization rate were similar and no difference was seen in the parents' view of ease of use and device acceptance. Baseline data were similar for both groups apart from the family history of asthma and atopic disease that was greater in the nebulizer group. No significant differences were seen in heart rate, respiratory rate and oxygen saturation at baseline and after the treatment. According to the parents 40% of the participants had asthma diagnosis though up to 66% had some kind of asthma medication. Our data suggests that MDIs with spacers are at least as effective as nebulizers in the delivery of beta agonists to treat preschool children with virus induced wheezing or acute exacerbations of asthma in the PED. Parents may underestimate the gravity of their children's asthma. It is mandatory to provide adequate information to the staff and parents in order to treat pediatric acute asthma successfully.

  10. Effects of platelet-rich plasma on lateral epicondylitis of the elbow: prospective randomized controlled trial☆

    PubMed Central

    Palacio, Evandro Pereira; Schiavetti, Rafael Ramos; Kanematsu, Maiara; Ikeda, Tiago Moreno; Mizobuchi, Roberto Ryuiti; Galbiatti, José Antônio

    2016-01-01

    Objective To evaluate the effects of platelet-rich plasma (PRP) infiltration in patients with lateral epicondylitis of the elbow, through analysis of the Disabilities of the Arm, Shoulder and Hand (DASH) and Patient-Rated Tennis Elbow Evaluation (PRTEE) questionnaires. Methods Sixty patients with lateral epicondylitis of the elbow were prospectively randomized and evaluated after receiving infiltration of three milliliters of PRP, or 0.5% neocaine, or dexamethasone. For the scoring process, the patients were asked to fill out the DASH and PRTEE questionnaires on three occasions: on the day of infiltration and 90 and 180 days afterwards. Results Around 81.7% of the patients who underwent the treatment presented some improvement of the symptoms. The statistical tests showed that there was evidence that the cure rate was unrelated to the substance applied (p = 0.62). There was also intersection between the confidence intervals of each group, thus demonstrating that the proportions of patients whose symptoms improved were similar in all the groups. Conclusion At a significance level of 5%, there was no evidence that one treatment was more effective than another, when assessed using the DASH and PRTEE questionnaires. PMID:26962506

  11. Open versus laparoscopic appendectomy. A prospective randomized comparison.

    PubMed Central

    Martin, L C; Puente, I; Sosa, J L; Bassin, A; Breslaw, R; McKenney, M G; Ginzburg, E; Sleeman, D

    1995-01-01

    OBJECTIVE: The authors compare open and laparoscopic appendectomy in a randomized fashion with regard to length of operation, complications, hospital stay, and recovery time. METHODS: Adult patients (older than 14 years of age) with the diagnosis of acute appendicitis were randomized to either open or laparoscopic appendectomy over a 9-month period. All patients received preoperative antibiotics. The operative time was calculated as beginning with the incision and ending when the wound was fully closed. Patients that were converted from laparoscopic to open appendectomy were considered a separate group. Return to normal activity and work were determined by questioning during postoperative clinic, telephone, or mailed questionnaire. RESULTS: There was a total of 169 patients randomized, 88 to the open and 81 to the laparoscopic group. The groups were similar demographically. Of the 81 laparoscopic patients, 13 (16%) were converted to open. In the open group, 70 patients (79.5%) had acute appendicitis and 21 (23.9%) had perforative appendicitis. In the laparoscopic group, 62 patients (76.5%) had acute appendicitis and 10 (12.3%) had perforative appendicitis. There was no statistical difference in the return to activity or work between the laparoscopic and open groups. The operative time was significantly longer in the laparoscopic group (102.2 minutes vs. 81.7 minutes, p < 0.01). The hospital stay of 2.2 days in the laparoscopic group and 4.3 days in the open group was statistically (p = 0.007). There was no difference in the hospital stay for those with acute appendicitis (1.89 days vs. 2.61 days, p = 0.067) compared with those with a normal appendix but with pelvic inflammatory disease (1.1 days vs. 2.3 days, p = 0.11). There was a significant difference in patients with perforative appendicitis (1.5 days vs. 9.5 days, p < 0.01). The hospital cost for patients having laparoscopic appendectomy was $6077 and for an open appendectomy $7227 (p = 0.164). There were no

  12. Final Results of the Sunbelt Melanoma Trial: A Multi-Institutional Prospective Randomized Phase III Study Evaluating the Role of Adjuvant High-Dose Interferon Alfa-2b and Completion Lymph Node Dissection for Patients Staged by Sentinel Lymph Node Biopsy

    PubMed Central

    Egger, Michael E.; Edwards, Michael J.; Ross, Merrick I.; Reintgen, Douglas S.; Noyes, R. Dirk; Martin, Robert C.G.; Goydos, James S.; Beitsch, Peter D.; Urist, Marshall M.; Ariyan, Stephan; Sussman, Jeffrey J.; Davidson, B. Scott; Gershenwald, Jeffrey E.; Hagendoorn, Lee J.; Stromberg, Arnold J.; Scoggins, Charles R.

    2016-01-01

    Purpose The Sunbelt Melanoma Trial is a prospective randomized trial evaluating the role of high-dose interferon alfa-2b therapy (HDI) or completion lymph node dissection (CLND) for patients with melanoma staged by sentinel lymph node (SLN) biopsy. Patients and Methods Patients were eligible if they were age 18 to 70 years with primary cutaneous melanoma ≥ 1.0 mm Breslow thickness and underwent SLN biopsy. In Protocol A, patients with a single tumor-positive lymph node after SLN biopsy underwent CLND and were randomly assigned to observation versus HDI. In Protocol B, patients with tumor-negative SLN by standard histopathology and immunohistochemistry underwent molecular staging by reverse transcriptase polymerase chain reaction (RT-PCR). Patients positive by RT-PCR were randomly assigned to observation versus CLND versus CLND+HDI. Primary end points were disease-free survival (DFS) and overall survival (OS). Results In the Protocol A intention-to-treat analysis, there were no significant differences in DFS (hazard ratio, 0.82; P = .45) or OS (hazard ratio, 1.10; P = .68) for patients randomly assigned to HDI versus observation. In the Protocol B intention-to-treat analysis, there were no significant differences in overall DFS (P = .069) or OS (P = .77) across the three randomized treatment arms. Similarly, efficacy analysis (excluding patients who did not receive the assigned treatment) did not demonstrate significant differences in DFS or OS in Protocol A or Protocol B. Median follow-up time was 71 months. Conclusion No survival benefit for adjuvant HDI in patients with a single positive SLN was found. Among patients with tumor-negative SLN by conventional pathology but with melanoma detected in the SLN by RT-PCR, there was no OS benefit for CLND or CLND+HDI. PMID:26858331

  13. Final Results of the Sunbelt Melanoma Trial: A Multi-Institutional Prospective Randomized Phase III Study Evaluating the Role of Adjuvant High-Dose Interferon Alfa-2b and Completion Lymph Node Dissection for Patients Staged by Sentinel Lymph Node Biopsy.

    PubMed

    McMasters, Kelly M; Egger, Michael E; Edwards, Michael J; Ross, Merrick I; Reintgen, Douglas S; Noyes, R Dirk; Martin, Robert C G; Goydos, James S; Beitsch, Peter D; Urist, Marshall M; Ariyan, Stephan; Sussman, Jeffrey J; Davidson, B Scott; Gershenwald, Jeffrey E; Hagendoorn, Lee J; Stromberg, Arnold J; Scoggins, Charles R

    2016-04-01

    The Sunbelt Melanoma Trial is a prospective randomized trial evaluating the role of high-dose interferon alfa-2b therapy (HDI) or completion lymph node dissection (CLND) for patients with melanoma staged by sentinel lymph node (SLN) biopsy. Patients were eligible if they were age 18 to 70 years with primary cutaneous melanoma ≥ 1.0 mm Breslow thickness and underwent SLN biopsy. In Protocol A, patients with a single tumor-positive lymph node after SLN biopsy underwent CLND and were randomly assigned to observation versus HDI. In Protocol B, patients with tumor-negative SLN by standard histopathology and immunohistochemistry underwent molecular staging by reverse transcriptase polymerase chain reaction (RT-PCR). Patients positive by RT-PCR were randomly assigned to observation versus CLND versus CLND+HDI. Primary end points were disease-free survival (DFS) and overall survival (OS). In the Protocol A intention-to-treat analysis, there were no significant differences in DFS (hazard ratio, 0.82; P = .45) or OS (hazard ratio, 1.10; P = .68) for patients randomly assigned to HDI versus observation. In the Protocol B intention-to-treat analysis, there were no significant differences in overall DFS (P = .069) or OS (P = .77) across the three randomized treatment arms. Similarly, efficacy analysis (excluding patients who did not receive the assigned treatment) did not demonstrate significant differences in DFS or OS in Protocol A or Protocol B. Median follow-up time was 71 months. No survival benefit for adjuvant HDI in patients with a single positive SLN was found. Among patients with tumor-negative SLN by conventional pathology but with melanoma detected in the SLN by RT-PCR, there was no OS benefit for CLND or CLND+HDI. © 2016 by American Society of Clinical Oncology.

  14. Long-term results of a prospective randomized trial evaluating G-CSF priming in intensive induction chemotherapy followed by autologous stem cell transplantation in elderly patients with acute myeloid leukemia.

    PubMed

    Bug, Gesine; Koschmieder, Steffen; Krauter, Juergen; Heuser, Michael; Thol, Felicitas; Wiebe, Stefanie; Hofmann, Wolf-Karsten; Klein, Stefan A; Wegener, Gerd; Göhring, Gudrun; Heit, Wolfgang; Hoelzer, Dieter; Ganser, Arnold; Ottmann, Oliver G

    2014-02-01

    Few studies have evaluated granulocyte colony-stimulating factor (G-CSF) priming in elderly patients with intensively treated acute myeloid leukemia (AML), and no data are available for genetically defined AML subgroups. We provide long-term results (median follow-up 7.6 years) of a randomized trial in which 183 patients (median age 67 years) received G-CSF prior to (G-CSF priming) or after two cycles of induction chemotherapy. CR rates with G-CSF priming and G-CSF post-chemotherapy were comparable (57 vs. 67 %, p = 0.153), with overall survival (OS) probabilities of 14 vs. 17 % at 10 years. Induction mortality was significantly higher with G-CSF priming (23 vs. 10 %, p = 0.015), primarily in normal karyotype (NK) AML. In this subgroup, a trend for better relapse-free survival (RFS) was observed with G-CSF priming (44 vs. 22 % at 10 years, p = 0.074) but did not translate into an OS benefit. G-CSF priming had no impact on AML with FLT3-ITD and NPM mutations and did not improve outcome in patients with adverse cytogenetics. In a landmark analysis, late consolidation with autologous stem cell transplantation or a second consolidation cycle significantly improved RFS compared with one consolidation cycle (21.0 vs. 12.8 months, p = 0.046). Future studies on G-CSF priming should be restricted to NK AML and used only in post-remission therapy.

  15. Capsule endoscopy and bowel preparation with oral sodium phosphate: a prospective randomized controlled trial.

    PubMed

    Lapalus, Marie-George; Ben Soussan, Emmanuel; Saurin, Jean-Christophe; Favre, Olivier; D'Halluin, Pierre Nicolas; Coumaros, Dimitri; Gaudric, Marianne; Fumex, Fabien; Antonietti, Michel; Gaudin, Jean-Louis; Jacob, Philippe; Heresbach, Denis; Pilichos, Charalambos; Fan, Rong; Mozer, Marianne; Heyries, Laurent; Dumortier, Jerome; Ponchon, Thierry

    2008-06-01

    Capsule endoscopy (CE) is the first procedure to explore the small bowel in obscure GI bleeding (OGB). To evaluate the role of bowel preparation with oral sodium phosphate (NaP) in this indication. A prospective multicenter, controlled, randomized, blind study. A total of 129 patients with the diagnosis of OGB were included and were randomized into 2 groups (group A [n = 64] and group B [n = 63]). In group A, a CE was performed after an 8-hour fasting period. In group B, patients were asked to drink 2 doses of 45 mL NaP before swallowing the capsule. The quality of the images was assessed at 5 different locations of the small bowel. Bowel cleanliness and visibility were evaluated by using 2 scoring systems, which included assessing the presence of bubbles, liquid, and the rate of visibility. A total of 127 patients (53 men; mean age 56.9 years, range 19-90 years) were analyzed for the preparation and detection of lesions (2 patients were not able to swallow the capsule). No difference was observed for cleanliness and visibility between the 2 groups at any of the small-bowel segments; no difference was found for gastric transit time (39.8 minutes vs 35.7 minutes, P = .63), small-bowel transit time (257.5 minutes vs 248.6 minutes, P = .59), and the detection of lesions (35.9% vs 42.8%, P = .54). The evaluation of bowel cleanliness was based on subjective features. The results of the present study, despite a significant number of limitations, did not support that small-bowel preparation with oral NaP can be recommended for CE exploration in patients with OGB.

  16. Design, rationale, and baseline demographics of SEARCH I: a prospective cluster-randomized study

    PubMed Central

    Albers, Frank; Shaikh, Asif; Iqbal, Ahmar

    2012-01-01

    Questionnaires are available to identify patients at risk for several chronic diseases, including COPD, but are infrequently utilized in primary care. COPD is often underdiagnosed, while at the same time the US Preventive Services Task Force recommends against spirometric screening for COPD in asymptomatic adults. Use of a symptom-based questionnaire and subsequent handheld spirometric device depending on the answers to the questionnaire is a promising approach to identify patients at risk for COPD. Screening, Evaluating and Assessing Rate CHanges of diagnosing respiratory conditions in primary care 1 (SEARCH I) was a prospective cluster-randomized study in 168 US primary care practices evaluating the effect of the COPD-Population Screener (COPD-PS™) questionnaire. The effect of this questionnaire alone or sequentially with the handheld copd-6TM device was evaluated on new diagnoses of COPD and on respiratory diagnostic practice patterns (including referrals for pulmonary function testing, referrals to pulmonologists, new diagnoses of COPD, and new respiratory medication prescriptions). Participating practices entered a total of 9704 consecutive consenting subjects aged ≥ 40 years attending primary care clinics. Study arm results were compared for new COPD diagnosis rates between usual care and (1) COPD-PS plus copd-6 and (2) COPD-PS alone. A cluster-randomization design allowed comparison of the intervention effects at the practice level instead of individuals being the subjects of the intervention. Regional principal investigators controlled the flow of study information to sub-investigators at participating practices to reduce observation bias (Hawthorne effect). The results of SEARCH I, to be published subsequently, will provide insight into the real world utility of the COPD-PS as well as two-stage COPD case finding with COPD-PS and copd-6. PMID:22848157

  17. Treatment of Bell palsy with prednisone: a prospective, randomized study.

    PubMed

    Wolf, S M; Wagner, J H; Davidson, S; Forsythe, A

    1978-02-01

    Two hundred thirty-nine patients with Bell palsy were randomly distributed into prednisone-treated and control groups. Patients were followed until complete recovery or for 1 year. In the steroid-treated and control groups, respectively, incomplete recovery of facial strength occurred in 12 percent and 20 percent; motor synkinesis in 9 percent and 15 percent; autonomic synkinesis in 1 percent and 10 percent; and electromyographic evidence of severe denervation in 9 percent and 17 percent. The differences reached statistical significance only for autonomic synkinesis. In the total series recovery of facial strength was incomplete in 16 percent. Residual weakness was mild in 14 percent and moderate in 2 percent. No patient remained with severe weakness. Age, hyperacusis, and severity of the initial palsy were associated with an increased risk of poor outcome.

  18. Revised GH and cortisol cut-points for the glucagon stimulation test in the evaluation of GH and hypothalamic-pituitary-adrenal axes in adults: results from a prospective randomized multicenter study.

    PubMed

    Hamrahian, Amir H; Yuen, Kevin C J; Gordon, Murray B; Pulaski-Liebert, Karen J; Bena, James; Biller, Beverly M K

    2016-06-01

    Recent studies suggest using lower GH cut-points for the glucagon stimulation test (GST) in diagnosing adult GH deficiency (GHD), especially in obese patients. There are limited data on evaluating GH and hypothalamic-pituitary-adrenal (HPA) axes using weight-based dosing for the GST. To define GH and cortisol cut-points to diagnose adult GHD and secondary adrenal insufficiency (SAI) using the GST, and to compare fixed-dose (FD: 1 or 1.5 mg in patients >90 kg) with weight-based dosing (WB: 0.03 mg/kg). Response to the insulin tolerance test (ITT) was considered the gold standard, using GH and cortisol cut-points of ≥3 ng/ml and ≥18 µg/dL, respectively. 28 Patients with hypothalamic-pituitary disease and 1-2 (n = 14) or ≥3 (n = 14) pituitary hormone deficiencies, and 14 control subjects matched for age, sex, estrogen status and body mass index (BMI) underwent the ITT, FD- and WB-GST in random order. Age, sex ratio and BMI were comparable between the three groups. The best GH cut-point for diagnosis of GHD was 1.0 (92 % sensitivity, 100 % specificity) and 2.0 ng/mL (96 % sensitivity and 100 % specificity) for FD- and WB-GST, respectively. Age negatively correlated with peak GH during FD-GST (r = -0.32, P = 0.04), but not WB-GST. The best cortisol cut-point for diagnosis of SAI was 8.8 µg/dL (92 % sensitivity, 100 % specificity) and 11.2 µg/dL (92 % sensitivity and 100 % specificity) for FD-GST and WB-GST, respectively. Nausea was the most common side effect, and one patient had a seizure during the FD-GST. The GST correctly classified GHD using GH cut-points of 1 ng/ml for FD-GST and 2 ng/ml for WB-GST, hence using 3 ng/ml as the GH cut-point will misclassify some GH-sufficient adults. The GST may also be an acceptable alternative to the ITT for evaluating the HPA axis utilizing cortisol cut-points of 9 µg/dL for FD-GST and 11 µg/dL for WB-GST.

  19. Percutaneous tracheostomy: Ciaglia Blue Rhino versus Griggs' Guide Wire Dilating Forceps. A prospective randomized trial.

    PubMed

    Añón, J M; Escuela, M P; Gómez, V; Moreno, A; López, J; Díaz, R; Montejo, J C; Sirgo, G; Hernández, G; Martínez, R

    2004-04-01

    Percutaneous tracheostomy (PT) has gained widespread acceptance to control the airway in patients requiring prolonged mechanical ventilation. Since 1985, new techniques for PT have been described. It was the aim of this investigation to compare two different PT techniques: the Ciaglia Blue Rhino (CBR) and the Guide Wire Dilating Forceps (GWDF). A prospective randomized trial was performed in four intensive care units. After informed consent, 53 consecutive patients were randomized to undergo CBR or GWDF. Procedural complications were evaluated and specific symptoms of the upper airway tract in survivors were assessed. Twenty-seven patients were randomly assigned to CBR and 26 to GWDF. Patients mean ages were 62.7 +/- 15.8 years and 62.2 +/- 18.3, respectively. Mean APACHE II scores were 20.6 +/- 6.8 and 21.2 +/- 7.2, respectively. Median duration of the procedure was 7 min (range: 4-17 min) with GWDF and 9 min (range: 5-32 min) with CBR (P = 0.16). Seven patients in the group undergoing GWDF had complications (desaturation: two; mild bleeding: one; infected stoma: one; inability to complete the procedure: three). Two patients had complications in the group undergoing CBR (mild bleeding) (P = 0.07). Survivors were followed up after discharge. Three patients (all of them having undergone GWDF) were symptomatic (two with mild hoarseness and one with a persistent foreign body sensation), but laryngotracheoscopy was negative. Our results show no differences between both techniques regarding surgical duration or procedural complications. Late symptoms were encountered in three patients undergoing GWDF, however, laryngotracheoscopy failed to document anatomical or functional abnormalities.

  20. Prospective Evaluation of Acupuncture as Treatment for Glaucoma.

    PubMed

    Law, Simon K; Lowe, Starrie; Law, Samuel M; Giaconi, JoAnn A; Coleman, Anne L; Caprioli, Joseph

    2015-08-01

    To evaluate acupuncture as treatment for glaucoma. Prospective double-masked randomized crossover study. setting: Clinical practice. One eye per patient with primary open-angle glaucoma and stable intraocular pressure (IOP). Patients were randomized to receive 1 acupuncture series (12 sessions with either eye-related [eye-points] or non-eye-related [non-eye-points] acupoints) and then crossed over to receive the other series. IOP, blood pressure (BP), heart rate (HR), best-corrected visual acuity (BCVA), visual field (VF), optic disc and peripapillary retinal nerve fiber layer (RNFL) measurements, compliance, and adverse reactions. Probability to detect 3 mm Hg IOP difference between series was 90%. Twenty-two patients volunteered and 11 (50.0%) completed the study; 8 (36.4%) did not complete treatment owing to changes of health, moving away, lack of transportation, or family crisis; and 3(13.6%) were withdrawn owing to needle sensitivity or IOP elevation (8 mm Hg) in the contralateral eye. After an acupuncture session, mean IOP increased slightly with both eye-points (from 12.9 ± 1.8 mm Hg to 13.6 ± 2.0 mm Hg, P = .019) and non-eye-points (from 13.0 ± 1.5 mm Hg to 13.5 ± 1.7 mm Hg, P = .073) series. HR, diurnal IOP, and BCVA showed no statistically significant changes after 12 sessions of either series. Systolic and diastolic BP were reduced after 12 sessions of non-eye-points series (P = .040, P = .002, respectively). Optic disc, RNFL, and VF showed no statistically significant changes. Acupuncture has no overall effect on diurnal IOP or BCVA but may temporally increase the IOP immediately after a treatment session. BP is lowered by acupuncture with non-eye-points, but not with eye-points. Compliance and adverse event rates were low. Copyright © 2015 Elsevier Inc. All rights reserved.

  1. A prospective, randomized therapeutic trial for schistosomal specific nephropathy.

    PubMed

    Sobh, M A; Moustafa, F E; Sally, S M; Foda, M A; Deelder, A M; Ghoneim, M A

    1989-11-01

    In this work 26 patients with schistosomal specific nephropathy were randomly distributed among three groups. Group I cases were given anti-schistosomal drugs (oxamniquine and praziquantel), group II cases were given anti-schistosomal drugs plus prednisolone, and group III cases were given anti-schistosomal drugs plus cyclosporine. The schistosomal specificity of kidney lesions was assessed by detecting the schistosomal specific antigens (CAA and CCA) and antibodies deposited in the renal glomeruli of these patients. Patients who had another etiologic cause which may explain their kidney disease were not admitted to this study. After initiation of the treatment, patients were followed up every other week in the outpatient clinic for 12 months. Follow-up showed complete remission of proteinuria in two cases in group II (duration of remission was 4 and 8 months) and in one case in group III (duration of remission was 6 months) but in none in group I. Partial remission was observed in one case in group I, in three cases in group II and in one case in group III. During the observation period, improvement in kidney function was observed in two cases in group II but deterioration in kidney function was observed in one case in group I and in one other case in group III. We conclude that in patients with schistosomal nephropathy, none of the tried therapeutic regimens produce regression of the disease if given to patients with established disease.

  2. Morphine and hydromorphone epidural analgesia. A prospective, randomized comparison.

    PubMed

    Chaplan, S R; Duncan, S R; Brodsky, J B; Brose, W G

    1992-12-01

    Because evidence from uncontrolled, unblinded studies suggested fewer side effects from epidural hydromorphone than from epidural morphine, we employed a randomized, blinded study design to compare the side effects of lumbar epidural morphine and hydromorphone in 55 adult, non-obstetric patients undergoing major surgical procedures. A bolus dose of epidural study drug was given at least 1 h prior to the conclusion of surgery, followed by a continuous infusion of the same drug for two postoperative days. Infusions were titrated to patient comfort. Visual analog scale (VAS) pain scores, VAS sedation scores, and subjective ratings of nausea and pruritus were assessed twice daily. The two treatments provided equivalent analgesia. Sedation scores and prevalence of nausea did not differ significantly between groups. Prevalence of pruritus, however, differed significantly on postoperative day 1, with moderate to severe pruritus reported by 44.4% of patients in the morphine group versus 11.5% in the hydromorphone group (P < .01). On post-operative day 2, reports of pruritus by patients receiving morphine remained higher than those among the hydromorphone-treated subjects, although this difference was no longer statistically significant (32% vs. 16.7%, P = .18). We conclude that lumbar epidural morphine and hydromorphone afford comparable analgesia, but the occurrence of moderate to severe pruritus on the first postoperative day is reduced by the use of hydromorphone.

  3. Membrane versus centrifuge-based therapeutic plasma exchange: a randomized prospective crossover study.

    PubMed

    Hafer, Carsten; Golla, Paulina; Gericke, Marion; Eden, Gabriele; Beutel, Gernot; Schmidt, Julius J; Schmidt, Bernhard M W; De Reys, Stef; Kielstein, Jan T

    2016-01-01

    Therapeutic plasma exchange (TPE) is either performed using a highly permeable filter with standard multifunctional renal replacement equipment (mTPE) or a centrifugation device (cTPE). Although both techniques are well established in clinical practice, performance of these two modes of TPE was never compared in a prospective randomized fashion. Thus we aimed to compare two commercially available therapeutic apheresis systems: mTPE (Octonova with Plasmaflo filter) and cTPE (Spectra Optia apheresis system). Twenty-one patients (age 51.6 ± 13.5 years; 10 F/11 M; BMI 25.1 ± 5.0 kg/m(2)) were enrolled in this randomized, prospective, paired, crossover study performed in the Hannover Medical School, Germany. First treatment (either mTPE or cTPE) was chosen by an online randomization list. The primary endpoints were plasma removal efficiency with 1.2× of the total plasma volume exchanged. Secondary endpoints were total amount of plasma substances removed, such as IgG and fibrinogen. Further, the treatment effect on platelet count and complications were evaluated. Despite a comparable volume of the processed plasma, mTPE treatment time was 10.5 % longer than cTPE treatment time (p < 0.05), resulting in a 10 % lower plasma removal rate of the mTPE treatment. Both treatments were comparable in terms of decrease in median (IQR) IgG [pre-mTPE 5.34 (3.48-8.37), post-mTPE 1.96 (1.43-2.84) g/L; pre-cTPE 5.88 (3.42-8.84), post-cTPE 1.89 (1.21-3.52) g/L]. Also the median (IQR) amount of IgG removed in mTPE [13.14 (7.42-16.10) g] was not different from the cTPE treatment [9.30 (6.26-15.69) g]. This was also true for IgM removal. Platelet loss during mTPE was nearly twice as much as with cTPE (15 ± 9 versus 7 ± 9 %, p < 0.05). Although the centrifugal procedures were conducted using flow rates that could easily be obtained using peripheral access, plasma removal efficiency was significantly higher and treatment time was significantly lower in cTPE as compared to mTPE. Despite

  4. A prospective randomized study of three expanded polytetrafluoroethylene (PTFE) grafts as small arterial substitutes.

    PubMed Central

    Hastings, O M; Jain, K M; Hobson, R W; Swan, K G

    1978-01-01

    A prospective, double-blind, randomized study was performed to determine the relative patency rate of polytetrafluoroethylene (PTFE) grafts, Gore-Tex, Impra, and a Surgikos prototype PTFE graft. The 48 grafts (40 x 4 mm) replaced excised segments of femoral arteries in adult mongrel dogs, whose mean weight was 20.6 +/- 0.9 kg; the grafts were removed after 12 weeks. Sterile technique and antibiotic therapy were included in the study. Anticoagulation was not employed. Anastomoses were performed with 6 = 0 polypropylene. Angiographic assessment of each anastomosis was made at surgery and prior to sacrifice. Patency was assessed daily by palpation and Doppler flow signals, as well as angiographically, prior to sacrifice. The overall patency rate was 62.5%. There were no statistically significant differences in patency rates among the three groups (Gore-Tex, 56%; Impra, 75%, Surgikos, 56%). Histologic evaluation revealed incomplete neointima formation and significant pannus formation in all three types of grafts without any significant discernible difference among them. The results suggest that further experimental evaluation of PTFE, as a small vessel substitute, is indicated prior to its use clinically in preference to autogenous vein. Images Fig. 1. Fig. 2. Fig. 3. Fig. 4. Fig. 5. Fig. 6. PMID:367297

  5. Glenoumeral dislocation: a prospective randomized study comparing spazo and kocher maneuvers

    PubMed Central

    Rezende, Bruno da Rocha Moreira; de Almeida, José Inácio; de Sousa, Uriel Jaime; Bomfim, Leônidas de Souza; Ferreira, Mário Soares

    2015-01-01

    OBJECTIVE: To evaluate and to compare the Spaso and Kocher reduction maneuvers in terms of efficiency, time of reduction, facileness, pain, discomfort to the patient, complications and risks, besides promoting the comparison between the two maneuvers, aiming to ground the emergency conduct. METHODS: A prospective study with 105 patients with acute shoulder dislocations were enrolled in the study between February 2011 and September 2012. The patients were randomized into two groups and they were submitted to the reduction of dislocation using the Spaso maneuver (group A) or the Kocher technique (group B) by first, second or third-year orthopedic surgery residents from our service. The results were evaluated and compared. RESULTS: There was no statistically significant difference between the two groups in terms of age, gender, timing of reduction, number of precedent episodes and complications after reduction. However, reduction was achieved in more cases using the Spaso method than it was among the Kocher group, as well as the mean duration of the reduction maneuver and discomfort were shorter in the group A patients. CONCLUSIONS: Both methods presented good results in terms of dislocation reduction and low complications rates. Nevertheless, the Spaso maneuver was more efficient, fast and easily applicable in comparison with Kocher's method. Level of Evidence I, Therapeutic. PMID:26327800

  6. Prospective randomized comparison of toxicity of two prophylactic regimens of cotrimoxazole in leukemic children.

    PubMed

    Aricò, M; Molinari, E; Bacchella, L; DeAmici, M; Raiteri, E; Burgio, G R

    1992-01-01

    Cotrimoxazole is currently used for Pneumocystis carinii pneumonia prophylaxis in leukemic children. The former regimen of continuous administration was recently replaced by intermittent administration. The antifolic activity of cotrimoxazole could theoretically enhance that of methotrexate, also administered to leukemic children. We report on a prospective, randomized study to compare two different regimens--continuous vs. 3 days a week--of cotrimoxazole prophylaxis. The aim of the study was to evaluate the toxicity, assuming that both regimens are equally effective to prevent P. carinii pneumonia. Seventy-seven leukemic children were enrolled; 67 were evaluable, 35 from arm A (continuous), 32 from arm B (intermittent cotrimoxazole administration). The conclusion was that long-term maintenance chemotherapy with antimetabolites produced lower levels of folate but normal levels of vitamin B12 in leukemic children. This pattern did not vary between the continuous and the 3-days-a-week administration of cotrimoxazole prophylaxis. Thus it seems hypothesizable that the antimetabolic activity of methotrexate alone exceeds that of cotrimoxazole.

  7. Validation of an Automated Safety Surveillance System with Prospective, Randomized Trial Data

    PubMed Central

    Matheny, Michael E.; Morrow, David A.; Ohno-Machado, Lucila; Cannon, Christopher P.; Sabatine, Marc S.; Resnic, Frederic S.

    2009-01-01

    Objective We sought to validate three methods for automated safety monitoring by evaluating clinical trials with elevated adverse events. Methods An automated outcomes surveillance system was used to retrospectively analyze data from two randomized, TIMI multi-center trials. Trial A was stopped early due to elevated 30 day mortality rates in the intervention arm. Trial B was not stopped early, but there was transient concern regarding 30 day intracranial hemorrhage rates. We compared Statistical Process Control (SPC), Logistic Regression Risk Adjusted SPC (LR-SPC), and Bayesian Updating Statistic (BUS) methods with a standard prospective two-arm event rate analysis. Each method compares observed event rates to alerting boundaries established with previously collected data. In this evaluation, the control arms approximated prior data, and the intervention arms approximated the observed data. Results Trial A experienced elevated 30 day mortality rates beginning 7 months after the start of the trial and continuing until termination at month 14. Trial B did not experience elevated major bleeding rates. Combining the alerting performance of each method across both trials resulted in sensitivities and specificities of 100% and 85% for SPC, 0% and 100% for BUS, 100% and 93% for both LR-SPC models, respectively. Conclusion Both SPC and LR-SPC methods correctly identified the majority of months during which the cumulative event rates were elevated in Trial A, but were susceptible to false positive alerts in Trial B. The BUS method did not result in any alerts in either Trial and requires revision. PMID:19015285

  8. Using adhesive glue to repair first degree perineal tears: a prospective randomized controlled trial.

    PubMed

    Feigenberg, Tomer; Maor-Sagie, Esther; Zivi, Einat; Abu-Dia, Mushira; Ben-Meir, Assaf; Sela, Hen Y; Ezra, Yossef

    2014-01-01

    Our objective was to evaluate the effectiveness of adhesive glue in repairing first degree perineal tears. We conducted a noninferiority prospective, randomized, controlled trial comparing adhesive glue with traditional suturing. Each case was evaluated immediately after birth and after the puerperium. The two-sample t-test and the Mann-Whitney nonparametric test were applied to compare quantitative variables between the treatment groups. The chi-squared test and Fisher's exact test were used to assess the association between qualitative variables. A total of 102 women participated, 28 in the suture arm and 74 in the adhesive glue arm. While cosmetic and functional results of adhesive glue use were not inferior to suturing, the use of adhesive glue was associated with a shorter procedure, less need for local anesthetic, less pain, and greater satisfaction. Our results suggest a novel approach for the repair of common postpartum first degree lacerations. The use of adhesive glue achieves cosmetic and functional results equal to traditional suturing and offers some immediate advantages for the patient. While further clinical trials are needed to validate our results, it is important to inform obstetrician of the possible use of adhesive glue in these very common clinical scenarios. This trial is registered with NCT00746707.

  9. Using Adhesive Glue to Repair First Degree Perineal Tears: A Prospective Randomized Controlled Trial

    PubMed Central

    Maor-Sagie, Esther; Zivi, Einat; Abu-Dia, Mushira; Ben-Meir, Assaf; Sela, Hen Y.; Ezra, Yossef

    2014-01-01

    Our objective was to evaluate the effectiveness of adhesive glue in repairing first degree perineal tears. We conducted a noninferiority prospective, randomized, controlled trial comparing adhesive glue with traditional suturing. Each case was evaluated immediately after birth and after the puerperium. The two-sample t-test and the Mann-Whitney nonparametric test were applied to compare quantitative variables between the treatment groups. The chi-squared test and Fisher's exact test were used to assess the association between qualitative variables. A total of 102 women participated, 28 in the suture arm and 74 in the adhesive glue arm. While cosmetic and functional results of adhesive glue use were not inferior to suturing, the use of adhesive glue was associated with a shorter procedure, less need for local anesthetic, less pain, and greater satisfaction. Our results suggest a novel approach for the repair of common postpartum first degree lacerations. The use of adhesive glue achieves cosmetic and functional results equal to traditional suturing and offers some immediate advantages for the patient. While further clinical trials are needed to validate our results, it is important to inform obstetrician of the possible use of adhesive glue in these very common clinical scenarios. This trial is registered with NCT00746707. PMID:25089271

  10. Double-blind prospective randomized study comparing polyethylene glycol to lactulose for bowel preparation in colonoscopy.

    PubMed

    Menacho, Aline Moraes; Reimann, Adriano; Hirata, Lie Mara; Ganzerella, Caroline; Ivano, Flavio Heuta; Sugisawa, Ricardo

    2014-01-01

    Colonoscopy is the most frequent exam used to evaluate colonic mucosa, allowing the diagnosis and treatment of many diseases. The appropriate bowel preparation is indispensable for the realization of colonoscopy. Therefore, it is necessary the use of laxative medications, preferentially by oral administration. To compare two medications used in bowel preparation in adult patients going to ambulatory colonoscopy and to analyze the patients' profile. A double-blind prospective study with 200 patients, randomized in two groups: one that received polyethilene glycol and another that received lactulose. The patients answered to questionnaires to data compilation, as tolerance, symptoms and complications related to preparation. Besides, it was also evaluated the prepare efficacy related to the presence of fecal residue. Intestinal habit alterations and abdominal pain were the main reasons to realize the exams and hypertension was the most prevalent comorbidity. Ten percent of the ones who received lactulose didn't get to finish the preparation and 50% considered the taste "bad, but tolerable". The most common subjective symptom after the medication was nausea, especially after lactulose. During the exam, most of the patients who used lactulose had a "light discomfort" and the ones who used polyethilene glycol considered the discomfort as "tolerable". The quality of the preparation was good in 75%, undependable of the medication that was used. Polyethilene glycol was more tolerable when compared to lactulose, without difference on the quality of the preparation.

  11. DOUBLE-BLIND PROSPECTIVE RANDOMIZED STUDY COMPARING POLYETHYLENE GLYCOL TO LACTULOSE FOR BOWEL PREPARATION IN COLONOSCOPY

    PubMed Central

    MENACHO, Aline Moraes; REIMANN, Adriano; HIRATA, Lie Mara; GANZERELLA, Caroline; IVANO, Flavio Heuta; SUGISAWA, Ricardo

    2014-01-01

    Background Colonoscopy is the most frequent exam used to evaluate colonic mucosa, allowing the diagnosis and treatment of many diseases. The appropriate bowel preparation is indispensable for the realization of colonoscopy. Therefore, it is necessary the use of laxative medications, preferentially by oral administration. Aim To compare two medications used in bowel preparation in adult patients going to ambulatory colonoscopy and to analyze the patients' profile. Methods A double-blind prospective study with 200 patients, randomized in two groups: one that received polyethilene glycol and another that received lactulose. The patients answered to questionnaires to data compilation, as tolerance, symptoms and complications related to preparation. Besides, it was also evaluated the prepare efficacy related to the presence of fecal residue. Results Intestinal habit alterations and abdominal pain were the main reasons to realize the exams and hypertension was the most prevalent comorbidity. Ten percent of the ones who received lactulose didn't get to finish the preparation and 50% considered the taste "bad, but tolerable". The most common subjective symptom after the medication was nausea, especially after lactulose. During the exam, most of the patients who used lactulose had a "light discomfort" and the ones who used polyethilene glycol considered the discomfort as "tolerable". The quality of the preparation was good in 75%, undependable of the medication that was used. Conclusion Polyethilene glycol was more tolerable when compared to lactulose, without difference on the quality of the preparation. PMID:24676290

  12. A prospective randomized trial comparing open versus laparoscopic appendectomy.

    PubMed Central

    Frazee, R C; Roberts, J W; Symmonds, R E; Snyder, S K; Hendricks, J C; Smith, R W; Custer, M D; Harrison, J B

    1994-01-01

    OBJECTIVE: The authors determined whether there was an advantage to laparoscopic appendectomy when compared with open appendectomy. SUMMARY/BACKGROUND DATA: The advantages of laparoscopic appendectomy versus open appendectomy were questioned because the recovery from open appendectomy is brief. METHODS: From January 15, 1992 through January 15, 1993, 75 patients older than 9 years were entered into a study randomizing the choice of operation to either the open or the laparoscopic technique. Statistical comparisons were performed using the Wilcoxon test. RESULTS: Thirty-seven patients were assigned to the open appendectomy group and 38 patients were assigned to the laparoscopic appendectomy group. Two patients were converted intraoperatively from laparoscopic appendectomies to open procedures. Thirty-one patients (81%) in the open group had acute appendicitis, as did 32 patients (84%) in the laparoscopic group. Mean duration of surgery was 65 minutes for open appendectomy and 87 minutes for laparoscopic appendectomy (p < 0.001). There were no statistically significant differences in length of hospitalization, interval until resumption of a regular diet, or morbidity. Duration of both parenteral and oral analgesic use favored laparoscopic appendectomy (2.0 days versus 1.2 days, and 8.0 days versus 5.4 days, p < 0.05). All patients were instructed to return to full activities by 2 weeks postoperatively. This occurred at an average of 25 days for the open appendectomy group versus 14 days for the laparoscopic appendectomy group (p < 0.001). CONCLUSIONS: Patients who underwent laparoscopic appendectomies have a shorter duration of analgesic use and return to full activities sooner postoperatively when compared with patients who underwent open appendectomies. The authors consider laparoscopic appendectomy to be the procedure of choice in patients with acute appendicitis. PMID:8203983

  13. Evaluating the Effectiveness of Developmental Mathematics by Embedding a Randomized Experiment within a Regression Discontinuity Design

    ERIC Educational Resources Information Center

    Moss, Brian G.; Yeaton, William H.; Lloyd, Jane E.

    2014-01-01

    Using a novel design approach, a randomized experiment (RE) was embedded within a regression discontinuity (RD) design (R-RE-D) to evaluate the impact of developmental mathematics at a large midwestern college ("n" = 2,122). Within a region of uncertainty near the cut-score, estimates of benefit from a prospective RE were closely…

  14. Evaluating the Effectiveness of Developmental Mathematics by Embedding a Randomized Experiment within a Regression Discontinuity Design

    ERIC Educational Resources Information Center

    Moss, Brian G.; Yeaton, William H.; Lloyd, Jane E.

    2014-01-01

    Using a novel design approach, a randomized experiment (RE) was embedded within a regression discontinuity (RD) design (R-RE-D) to evaluate the impact of developmental mathematics at a large midwestern college ("n" = 2,122). Within a region of uncertainty near the cut-score, estimates of benefit from a prospective RE were closely…

  15. Patient-matched instruments versus standard instrumentation in total knee arthroplasty: a prospective randomized study.

    PubMed

    Molicnik, Andrej; Naranda, Jakob; Dolinar, Drago

    2015-12-01

    Optimal positioning of implants and restoration of neutral mechanical axis are two primary surgical goals in total knee arthroplasty (TKA). Despite modern instruments and improved surgical techniques, malalignment remains an important cause of early failure after TKA. The aim of this prospective randomized study was to compare the value of a new patient-matched instrument system (PMI) (Signature(TM); Biomet, Inc, Warsaw, Indiana) to that of standard TKA surgical instrumentation (STD) in terms of coronal mechanical alignment, time of operation and blood loss. A total of 38 patients waiting for primary TKA were enrolled and randomized into two groups (19 PMI and 19 STD). Magnetic resonance imaging was performed in all patients in the PMI group, and specific instruments for the femur and tibia were designed preoperatively. All patients were operated on using the standard medial parapatellar approach with no use of tourniquet. Mechanical axis, time for the operation, and blood loss were evaluated. Patients in both groups had comparable age, body mass index, preoperative mechanical axis, Knee Society Score, and level of hemoglobin. Postoperative results showed that the PMI group fell significantly closer to neutral mechanical axis (STD: 2.7 ± 1.7, PMI: 1.7 ± 0.9; P = 0.013) with no outliers and a reduced time for the operation. There was no difference in the evaluation blood loss. The use of PMI can contribute in achieving better mechanical axis with reduction in outliers and decreased operation time. Due to small differences between PMI and standard instruments, additional research are needed to confirm these preliminary results, and to discover potential benefits and functional improvements in the long-term outcome.

  16. Proof Construction and Evaluation Practices of Prospective Mathematics Educators

    ERIC Educational Resources Information Center

    Imamoglu, Yesim; Togrol, Aysenur Yontar

    2015-01-01

    This study was conducted with 93 freshmen and 82 senior prospective mathematicians and mathematics teachers in order to investigate how they construct and evaluate proofs and whether there are any significant differences in their proof construction (with respect to department and grade) and proof evaluation (with respect to department)…

  17. Feeding premature infants while low umbilical artery catheters are in place: a prospective, randomized trial.

    PubMed

    Davey, A M; Wagner, C L; Cox, C; Kendig, J W

    1994-05-01

    The objective of this prospective, randomized clinical trial was to test the hypothesis that there is no difference in the frequency of feeding problems and necrotizing enterocolitis between a group of premature infants who received early enteral feedings while low umbilical artery catheters (LUACs) were in place, and a late group who were not fed until 24 hours after removal of LUACs. Twenty-nine premature infants (born at 28.5 +/- 3.0 SD weeks of gestational age) who were in stable condition received early enteral feedings at a median of 2 days while a LUAC was in place; 31 infants (born at 28.6 +/- 2.7 SD weeks of gestational age) received late enteral feedings at a median of 5 days of age, 24 hours after the removal of the LUAC. Feeding complications and interventions and nutritional characteristics were recorded prospectively. There were no differences in the baseline perinatal characteristics of the two groups. The incidence of gastric residua and the incidence of abdominal distention were the same in both groups. The early feeding group had significantly fewer percutaneous central venous catheters, evaluations for sepsis, and episodes of receiving nothing by mouth while a gastric suction tube was in place. Infants in the early group received parenteral alimentation-lipid emulsion infusions for a median of 13 days versus 30 days for the late-fed group (p = 0.0028 by Wilcoxon test). There were two cases of necrotizing enterocolitis in the early group versus four cases in the late group. Premature infants in stable condition who receive enteral feedings while LUACs are in place do not have an increased incidence of feeding problems compared with infants who do not receive enteral feedings until 24 hours after removal of LUACs.

  18. Social Media and Peer-Reviewed Medical Journal Readership: A Randomized Prospective Controlled Trial.

    PubMed

    Hawkins, C Matthew; Hunter, Makeba; Kolenic, Giselle E; Carlos, Ruth C

    2017-05-01

    To prospectively evaluate the impact of increasing levels of social media engagement on page visits and web-link clicks for content published in the Journal of the American College of Radiology. A three-arm prospective trial was designed using a control group, a basic Twitter intervention group (using only the Journal's @JACRJournal Twitter account), and an enhanced Twitter intervention group (using the personal Twitter accounts of editorial board members and trainees). Overall, 428 articles published between June 2013 and July 2015 were randomly assigned to the three groups. Article-specific tweets for both intervention arms were sent between September 14, 2015, and October 28, 2015. Primary end points included article-specific weekly and monthly page visits on the journal's Elsevier website (Amsterdam, Netherlands). For the two intervention groups, additional end points included 7-day and 30-day Twitter link clicks. Weekly page visits for the enhanced Twitter arm (mean 18.2; 95% confidence interval [CI] 15.6-20.7) were significantly higher when compared with the weekly page visits for the control arm (mean 7.6; 95% CI 1.7-13.6). However, there was no demonstrable increase in weekly page visits (mean 9.4; 95% CI 7.4-11.5) for the basic Twitter arm compared with the control arm. No intervention effects over control, regardless of Twitter arm assignment, were demonstrated for monthly page visits. The enhanced Twitter intervention resulted in a statistically significant increase in both 7-day and 30-day Twitter link clicks compared with the basic Twitter intervention group. An organized social media strategy, with focused social media activity from editorial board members, increased engagement with content published in a peer-reviewed radiology journal. Copyright © 2016 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  19. Fibrin sealant reduces pain after tonsillectomy: prospective randomized study.

    PubMed

    Vaiman, Michael; Krakovski, Daniel; Gavriel, Haim

    2006-07-01

    Postsurgical pain in adults following tonsillectomy with fibrin sealant or electrocoagulation was assessed by surface electromyography (sEMG), a dysphagia severity rating scale (DSRS), and a visual analog scale (VAS) pain For group 1 (n = 40), hemostasis was achieved by fibrin sealant spraying to the tonsillar fossae. For group 2 (n = 40), hemostasis was achieved by bipolar or needle point electrocautery. The timing of single swallowing and continuous drinking and the mean electrical activity of the masseter, infrahyoid, and submental-submandibular muscles were compared with a normative database during 30 days and with DSRS and VAS scores. Electrical activity of the masseter and infrahyoid muscles was significantly higher in both groups in comparison with the normative database (p < .05 to p < .005), whereas timing was less affected. The combined sEMG, DSRS, and VAS assessment showed that tonsillectomy ended with sealant causes less pain than electrocoagulation (p < .05). The DSRS score data were in strong positive correlation with the sEMG records, whereas the VAS pain score was less informative. The combined sEMG and pain score data indicate that the electrocautery hemostatic technique is more painful and traumatic than the sealant technique. Surface electromyography of swallowing is a simple, reliable evaluation method for postsurgical odynophagia complaints and might be used as an objective tool for pain assessment.

  20. Cigarette Smoking and Military Deployment: A Prospective Evaluation

    DTIC Science & Technology

    2007-04-10

    H 3 w a A © ARTICLE IN PRESSResearch Articles igarette Smoking and Military Deployment Prospective Evaluation esa Smith, MPH, PhD, Margaret A.K...2005;73:713–9. 8. Boos CJ, Croft AM. Smoking rates in the staff of a military field hospital before and after wartime deployment. J R Soc Med 2004;97:20...Military Deployment: A Prospective Evaluation 6. AUTHORS Besa Smith, MPH; Margaret A. K. Ryan, MD, MPH; Deborah L. Wingard, PhD; Thomas L. Patterson

  1. Results of a randomized, prospective clinical trial evaluating metronomic chemotherapy in nonmetastatic patients with high-grade, operable osteosarcomas of the extremities: A report from the Latin American Group of Osteosarcoma Treatment.

    PubMed

    Senerchia, Andreza A; Macedo, Carla Renata; Ferman, Sima; Scopinaro, Marcelo; Cacciavillano, Walter; Boldrini, Erica; Lins de Moraes, Vera Lúcia; Rey, Guadalupe; de Oliveira, Claudia T; Castillo, Luis; Almeida, Maria Tereza; Borsato, Maria Luisa; Lima, Eduardo; Lustosa, Daniel; Barreto, José Henrique; El-Jaick, Tatiana; Aguiar, Simone; Brunetto, Algemir; Greggiani, Lauro; Cogo-Moreira, Hugo; Atallah, Alvaro; Petrilli, Antonio Sergio

    2017-05-15

    Metronomic chemotherapy (MC) consists of the administration of a low dose of chemotherapy on a daily or weekly basis without a long break to achieve an antitumoral effect through an antiangiogenic effect or stimulation of the immune system. The potential effect of MC with continuous oral cyclophosphamide and methotrexate in patients with high-grade operable osteosarcomas (OSTs) of the extremities was investigated. Patients with high-grade OSTs who were 30 years old or younger were eligible for registration at diagnosis. Eligibility for randomization included 1) nonmetastatic disease and 2) complete resection of the primary tumor. The study design included a backbone of 10 weeks of preoperative therapy with methotrexate, adriamycin, and platinum (MAP). After surgery, patients were randomized between 2 arms to complete 31 weeks of MAP or receive 73 weeks of MC after MAP. The primary endpoint was event-free survival (EFS) from randomization. There were 422 nonmetastatic patients registered (May 2006 to July 2013) from 27 sites in 3 countries (Brazil, Argentina and Uruguay), and 296 were randomized to MAP plus MC (n = 139) or MAP alone (n = 157). At 5 years, the EFS cumulative proportions surviving in the MAP-MC group and the MAP-alone group were 61% (standard error [SE], 0.5%) and 64% (SE, 0.5%), respectively, and they were not statistically different (Wilcoxon [Gehan] statistic = 0.724; P =.395). The multivariate analysis showed that necrosis grades 1 and 2, tumor size, and amputation were associated with shorter EFS. According to the current follow-up, EFS with MAP plus MC is not statistically superior to EFS with MAP alone in patients with high-grade, resectable OSTs of the extremities. Cancer 2017;123:1003-10. © 2016 American Cancer Society. © 2016 American Cancer Society.

  2. Visibility of surgical site marking: a prospective randomized trial of two skin preparation solutions.

    PubMed

    Thakkar, Savyasachi C; Mears, Simon C

    2012-01-18

    An important component of the surgical time-out is to confirm surgical site skin markings to prevent wrong-site surgery. Different skin preparation solutions may have variable effects on the visibility of site markings after application. We performed a prospective randomized clinical trial to quantitatively and qualitatively evaluate the visibility of surgical site markings after the use of two commonly available skin preparation solutions. We enrolled twenty patients undergoing primary total hip arthroplasty at our institution. Preoperatively, a black permanent marker was used to mark the skin of each patient with a random combination of three letters, underlined by a single black line, and with the surgeon's initials. Patients were randomly selected to receive a chlorhexidine-based or an iodine-based skin preparation according to manufacturer guidelines. The skin markings were photographed digitally, before and after the application of solution. The photographs made after the application of solution were assessed quantitatively, by calculating the contrast (marker to skin) before and after the application of the solutions, and qualitatively by ten orthopaedic surgeons to identify the random initials and to recognize skin markings. The mean change in contrast level after application of the chlorhexidine-based solution was significantly greater than that after application of the iodine-based solution (mean and standard deviation, 59.8 ± 15.7 U versus 14.9 ± 11.4 U, respectively; p < 0.0001). Surgeons were an average of twenty-two times less likely (95% confidence interval, eight to sixty-eight) to judge markings as acceptable for site identification after preparation with the chlorhexidine-based solution than after preparation with the iodine-based solution. When examining individual letters, the surgeons correctly identified 296 of 300 letters in the group prepared with the iodine-based solution and 209 of 300 letters in the group prepared with the chlorhexidine

  3. Competency Evaluations of Prospective Special Education Teachers.

    ERIC Educational Resources Information Center

    Cellucci, Philomena M. C.; Ragland, G. G.

    A study was undertaken to consider existing, as well as hitherto untried methods, to measure competencies of student teachers in the special education fields and to assess the effectiveness of teacher training programs. The survey, conducted at a university in the Southeast, compared the self-evaluations of 32 undergraduate special education…

  4. 3-Year Randomized Controlled Prospective Clinical Trial on Different CAD-CAM Implant Abutments.

    PubMed

    Ferrari, Marco; Tricarico, Maria Gabriella; Cagidiaco, Maria Crysanti; Vichi, Alessandro; Gherlone, Enrico Felice; Zarone, Fernando; Sorrentino, Roberto

    2016-12-01

    Zirconia abutments were introduced to restore esthetic regions and showed sufficient stability to support implant restorations. Nonetheless, to date the observation periods are shorter than those of titanium abutments. To assess the survival of implant crowns supported by computer aided design-computer aided manufacturing (CAD-CAM) abutments after 3 years. Fifty-six patients were selected for this prospective clinical study. Each patient received at least 1 titanium implant for a total of 89 fixtures. A two-stage surgical technique and no additional soft or hard tissue graft were used. The implants were randomly divided into 3 groups receiving different CAD-CAM abutments: titanium, titanium nitride, and zirconia. Zirconia or metal-ceramic crowns were used as final restorations. Cementation was the baseline and the restorations were checked after 6 months, 1, 2, and 3 years, assessing any mechanical complication. Statistical analyses were performed to evaluate the 3-year success rates. Five failures were reported in the zirconia group; all the failed restorations showed fractures of the abutment connection. Four failures occurred in posterior regions and one more occurred while screwing the abutment. Titanium and titanium nitride abutments had significantly higher 3-year success rates than zirconia abutments (p < .05). Atlantis titanium and titanium nitride abutments showed optimal clinical performances after 3 years. Conversely, Atlantis zirconia abutments should be avoided to restore posterior regions. © 2016 Wiley Periodicals, Inc.

  5. Polycystic ovary syndrome treated with laparoscopic ovarian drilling with a harmonic scalpel. A prospective, randomized study.

    PubMed

    Takeuchi, Shigeto; Futamura, Noritaka; Takubo, Shinichirou; Noda, Naomi; Minoura, Hiroyuki; Toyoda, Nagayasu

    2002-10-01

    To evaluate the endocrinologic profile and reproductive outcome after laparoscopic drilling using a harmonic scalpel for polycystic ovarian syndrome (PCOS) in clomiphene-resistant infertile women. We performed a prospective, randomized study of 34 infertile women with PCOS. Group A (17 women) underwent laparoscopic ovarian drilling using a harmonic scalpel laser. Group B (control group, 17 women) underwent laparoscopic ovarian drilling using a neodymium-yttrium-aluminum-garnet laser. Change in the hormonal profile after surgery, ovulation rate and pregnancy rate were compared between groups A and B. LH and testosterone serum levels and the LH-FSH ratio showed a statistically significant reduction after surgery, and the spontaneous ovulation rate was 94% in both groups. The cumulative pregnancy rates within two years of follow-up were 77% in group A and 60% in group B. Laparoscopic ovarian drilling using a harmonic scalpel is an effective treatment for PCOS in clomiphene-resistant, anovulatory women: it results in ovulation and conception without major complications.

  6. A prospective randomized trial of lafutidine vs rabeprazole on post-ESD gastric ulcers

    PubMed Central

    Ohya, Tomohiko Richard; Endo, Hiroki; Kawagoe, Kei; Yanagawa, Tatsuro; Hanawa, Katsuhiro; Ohata, Ken; Asayama, Masako; Hisatomi, Kantaro; Teratani, Takuma; Gunji, Toshiaki; Sato, Hajime; Matsuhashi, Nobuyuki

    2010-01-01

    AIM: To compare the effects of rabeprazole and lafutidine on post-endoscopic submucosal dissection (ESD) gastric ulcers. METHODS: Patients with gastric tumors indicated for ESD were prospectively studied. After ESD, all patients were treated with intravenous omeprazole for the first 3 d. Patients were then randomly assigned to oral lafutidine or rabeprazole. Ulcer size, ulcer size reduction rate, and ulcer stage were evaluated 4 wk later. Occurrence of complication was monitored throughout the 4-wk period. RESULTS: Sixty five patients were enrolled in the study, and 60 patients were subjected to the final analysis. In the lafutidine group (30 lesions in 29 patients), initial and 4-wk post-ESD ulcer sizes were 33.3 ± 9.2 and 10.5 ± 4.8 mm, respectively. In the rabeprazole group (34 lesions in 31 patients), the values were 34.7 ± 11.3 and 11.8 ± 6.7 mm, respectively. Ulcer size reduction rates in lafutidine and rabeprazole groups were 32.3% and 33.5%, respectively (P = 0.974). Ulcer stage 4 wk post-ESD did not differ significantly between the two groups (P = 0.868). Two cases in the rabeprazole group and no cases in the lafutidine group developed ulcer bleeding during the oral dose period, although the difference of bleeding rate between the two groups was not statistically significant (P = 0.157). CONCLUSION: Lafutidine and rabeprazole have equivalent therapeutic effects on post-ESD gastric ulcers. PMID:21160677

  7. Similar effectiveness of the open versus endoscopic technique for carpal tunnel syndrome: a prospective randomized trial.

    PubMed

    Gümüştaş, Seyit Ali; Ekmekçi, Burcu; Tosun, Haci Bayram; Orak, Mehmet Müfit; Bekler, Halil İbrahim

    2015-12-01

    This prospective randomized study aims at evaluating the electrophysiological results of endoscopic and open carpal ligament release in patients with carpal tunnel syndrome. Included in the study were 41 patients diagnosed with carpal tunnel syndrome (21 hands in the endoscopic group and 20 hands in the open group). The Boston questionnaire was administered preoperatively and postoperatively to the patients, and their functional capacities and symptom severities were recorded. Physical examination was carried out preoperatively and in the postoperative sixth month. Demographic data and preoperative Boston symptomatic and functional scores were similar between both groups. A significant improvement was obtained in the Boston symptomatic and functional scores of both groups, but no significant difference was found between the groups in terms of improvement in the symptomatic and the functional scores. A significant shortening in median nerve motor distal latency and an increase in the velocity of sensory conductions were determined in both groups in the postoperative electromyography, but no difference was found between them in terms of improvement in the electromyography values. It was shown both clinically and electrophysiologically that endoscopic carpal tunnel surgery was as effective as open surgery as a treatment method for carpal tunnel syndrome.

  8. Quality of life after kidney transplantation. A prospective, randomized comparison of cyclosporine and conventional immunosuppressive therapy.

    PubMed

    Simmons, R G; Abress, L; Anderson, C R

    1988-02-01

    The aim of this research is to compare the quality of life after kidney transplantation for patients treated with cyclosporine versus conventional immunosuppressive therapy. This evaluation assumes particular importance given the high cost of cyclosporine, the resistance of the government to cover these costs, and the absence in some series (including this one) of significant differences in patient and kidney survival. This study is based on a randomized, stratified, prospective trial and concentrates on nondiabetic patients from ages 19 to 56 at 1-year posttransplant. Patients on cyclosporine show significant advantages in physical, emotional, and social well-being. Differences for 5 out of 10 indicators of quality of life were significant at the P less than or equal to .05 level. Significant differences are found on health satisfaction, happiness measures, indices of overall life satisfaction and well-being, perceived adjustment of the family, and female (not male) vocational rehabilitation. The fewer number of episodes of rejection and infection are, in part, responsible for these advantages in quality of life for cyclosporine patients.

  9. Intrathecal Versus Intravenous Morphine in Minimally Invasive Posterior Lumbar Fusion: A Blinded Randomized Comparative Prospective Study.

    PubMed

    Araimo Morselli, Fabio Silvio Mario; Zuccarini, Francesco; Caporlingua, Federico; Scarpa, Ilaria; Imperiale, Carmela; Caporlingua, Alessandro; De Biase, Lorenzo; Tordiglione, Paolo

    2017-03-01

    A blinded, randomized, comparative prospective study. The aim of this study was to compare the use of intrathecal morphine to endovenous morphine on postoperative pain after posterior lumbar surgery. Intrathecal morphine can provide significant safe analgesia for at least 12 hours and up to 24 hours in patients undergoing major surgery. Its dosages have been decreasing in the last 30 years, but currently, the optimal dose remains unknown. As of today, there are no studies comparing the efficacy and the side effects of this technique with intravenous morphine administration after minimally invasive lumbar fusion surgery. We randomized and compared two groups of 25 patients, who were given either 100 μg intrathecal (ITM group) or 5 ± 2 mg intravenous morphine delivered intravenously for 24 hours at 2 mL/h (IVM group) after minimally invasive posterior lumbar fusion. VAS score at 0, 6, 12, 24 hours, mobilization out of bed at 6 hours, hospitalization duration and complications as lower limbs paresthesia, urinary retention at 6 and 12 hours, nausea, vomit, itch, and constipation were evaluated. Data showed a lower VAS score, a reduction of constipation, lower limbs paresthesia, or urinary retention at 12 hours in ITM rather than in the IVM group. None suffered of vomit, itch, or nausea in both groups. Urinary retention was observed more frequently in ITM group at 6 hours. Patients of ITM group were mobilized out bed earlier than those from IVM group. A low dosage of intrathecal morphine is safe and effective after minimally invasive lumbar fusion surgery. The reduction of pain in the study group permitted a shorter hospitalization and earlier mobilization out of bed, augmenting patients' comfort. 2.

  10. New ultrasonic dissector versus conventional hemostasis in thyroid surgery: a randomized prospective study.

    PubMed

    Sista, Federico; Schietroma, Mario; Ruscitti, Cristina; De Santis, Giuseppe; De Vita, Fabiola; Carlei, Francesco; Amicucci, Gianfranco

    2012-04-01

    The ultrasonic dissector (UD) is an instrument that uses vibration to coagulate and cut tissue simultaneously. The main advantage of a UD instrument compared with a standard electrosurgical device is represented by minimal lateral thermic tissue damage allowing a wide application in thyroid surgery. A new UD (NUD), with a tip smaller than 5 mm, might enable a more precise dissection near vital structures such as parathyroid glands and recurrent laryngeal nerve. To evaluate the NUD during thyroid surgery, a prospective randomized study was performed using the new device versus traditional procedures. Two hundred sixty-one patients underwent various thyroid surgical procedures; they were randomly assigned (130 in the NUD group and 131 in the conventional hemostasis [CH] group). The two surgical groups were compared in age, sex, diagnosis, thyroid size, operative time, drainage volume during the first 24-48 hours after surgery, and complications (hypoparathyroidism, damage of the recurrent laryngeal nerve, and postoperative pain). The two groups were similar regarding age, sex, numbers of lobectomies and total thyroidectomies, and numbers of focal and diffuse pathologies. Mean ± standard deviation operative time was shorter in the NUD group compared with the CH group for both lobectomy (70 ± 21 minutes versus 99 ± 27 minutes; P<.01) and total thyroidectomy (91 ± 37 minutes versus 121 ± 42 minutes; P=.01) procedures. No difference was found regarding the amount of drainage volume for different procedures (P=not significant). Postoperative transient (P=.01) and definitive (P=.01) hypoparathyroidism occurred more frequently in the CH group than in the NUD group. There was a significant difference regarding the transient damage of the recurrent laryngeal nerve: 7 patients (5.3%) in the NUD group and 13 patients (9.8%) in the CH group (P=.01). There was no difference regarding definitive damage to the recurrent laryngeal nerve and pain. This NUD may reduce the rate of

  11. Effect of cryotherapy after elbow arthrolysis: a prospective, single-blinded, randomized controlled study.

    PubMed

    Yu, Shi-yang; Chen, Shuai; Yan, He-de; Fan, Cun-yi

    2015-01-01

    To investigate the effect of cryotherapy after elbow arthrolysis on elbow pain, blood loss, analgesic consumption, range of motion, and long-term elbow function. Prospective, single-blinded, randomized controlled study. University hospital. Patients (N=59; 27 women, 32 men) who received elbow arthrolysis. Patients were randomly assigned into a cryotherapy group (n=31, cryotherapy plus standard care) or a control group (n=28, standard care). Elbow pain at rest and in motion were measured using a visual analog scale (VAS) on postoperative day (POD) 1 to POD 7 and at 2 weeks and 3 months after surgery. Blood loss and analgesic consumption were recorded postoperatively. Elbow range of motion (ROM) was measured before surgery and on POD 1, POD 7, and 3 months after surgery. The Mayo Elbow Performance Score (MEPS) was evaluated preoperatively and 3 months postoperatively. VAS scores were significantly lower in the cryotherapy group during the first 7 PODs, both at rest and in motion (P<.05). There were no significant differences between the 2 groups in VAS scores at 2 weeks and 3 months after surgery. Less sufentanil was consumed by the cryotherapy group than the control group for pain relief (P<.01). No significant differences were found in blood loss, ROM, and MEPS between the 2 groups (P>.05). Cryotherapy is effective in relieving pain and reducing analgesic consumption for patients received elbow arthrolysis. The application of cryotherapy will not affect blood loss, ROM, or elbow function. Copyright © 2015 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  12. Physical therapy after prophylactic mastectomy with breast reconstruction: a prospective randomized study.

    PubMed

    Unukovych, Dmytro; Johansson, Hemming; Johansson, Elizabeth; Arver, Brita; Liljegren, Annelie; Brandberg, Yvonne

    2014-08-01

    The rate of prophylactic mastectomies (PM) is increasing. Patients generally report high levels of health related quality of life and satisfaction after the procedure, whereas body image perception and sexuality may be negatively affected. The aim of the study was to evaluate the interest in physical therapy as a means of improving body image and sexuality in women after PM. Patients undergoing PM at Karolinska University Hospital between 2006 and 2010 were eligible. The following patient-reported outcome measures were used at study baseline and 2 years postoperatively: the body image scale (BIS), the sexual activity questionnaire (SAQ), the short-form health survey (SF-36), the hospital anxiety and depression scale (HAD), and a study specific "pain/motion/sensation scale". Out of 125 patients invited to participate in this prospective randomized study, 43 (34%) consented and were randomized into the intervention (n = 24, 56%) or control (n = 19, 44%) groups. There were no statistically significant between-group differences found with respect to BIS, SAQ, SF-36, HAD, and "pain/motion/sensation". Two years postoperatively, more than half of the patients in both groups reported problems like feeling less attractive, less sexually attractive, their body feeling less whole, and being dissatisfied with their body. A majority marked a decreased sensation in breast area. The interest in a physiotherapy intervention was limited among women who had undergone PM. The intervention did not show any substantial effects. A large proportion of patients reported specific body image related and pain/motion/sensation problems postoperatively. Copyright © 2014 Elsevier Ltd. All rights reserved.

  13. Suction vs water seal after pulmonary resection: a randomized prospective study.

    PubMed

    Marshall, M Blair; Deeb, Maher E; Bleier, Joshua I S; Kucharczuk, John C; Friedberg, Joseph S; Kaiser, Larry R; Shrager, Joseph B

    2002-03-01

    To evaluate whether suction or water seal is superior in the management of chest tubes after pulmonary resection. A prospective, randomized, controlled trial. After an initial, brief period of suction, patients were randomized to water seal or - 20 cm H(2)O suction. University hospital. Sixty-eight patients who underwent wedge resection, segmentectomy, or lobectomy were included in the study. Those patients who underwent reoperative surgery or lung volume reduction surgery were excluded. There were 34 patients in each group. The two groups were evenly matched for age, sex, operation performed, severity of lung disease, and nutritional status. Fifteen patients in each group (44%) had an air leak at the completion of surgery. The duration of the air leak was shorter in the water seal group than in the suction group (mean +/- SEM, 1.50 +/- 0.32 days vs 3.27 +/- 0.80 days, respectively; p = 0.05). The mean times to removal of chest tubes were 3.33 +/- 0.35 days in the water seal group and 5.47 +/- 0.98 days in the suction group (p = 0.06). The length of stapled parenchyma was measured for each patient and averaged 24.9 cm for the water seal group and 18.5 cm for the suction group (p = 0.18). When corrected for the length of staple lines, the duration of air leaks and days with chest tube were dramatically lower in the water seal group (p = 0.02 and p = 0.02, respectively). Placing chest tubes on water seal after a brief period of suction after pulmonary resection shortens the duration of the air leak and likely decreases the time that the chest tubes remain in place. Adoption of this practice may result in lower morbidity and lower hospital costs.

  14. A Prospective, Randomized, Double-Blind Study of Coblation versus Dissection Tonsillectomy in Adult Patients.

    PubMed

    Rakesh, Singh; Anand, T S; Payal, Garg; Pranjal, Kulshreshtha

    2012-09-01

    This randomized double blind study was conducted prospectively to determine whether coblation tonsillectomy fared better than the conventional dissection method in terms of postoperative pain, bleeding, and rapidity of healing in adult Indian patients undergoing tonsillectomy. Sixty adult patients undergoing tonsillectomy for benign indications were randomized to have one tonsil removed by subcapsular radiofrequency ablation method and the other by conventional dissection method. The operative time and blood loss was noted for each side. Patients were evaluated at 6, 12, 24, 48, 72 h and then on 7th and 20th postoperative day for postoperative pain (by visual analog scale), bleeding, and tonsillar fossa healing. Statistical comparison was done using appropriate tests. The two groups were demographically matched. It took longer to perform the coblation procedure (15 vs 11 min) (P > 0.05). The operative blood loss on the radiofrequency side was 11 ml, vs 34 ml on the conventional side (P = 0.009). 77% patients said that the coblation side was less painful for the overall 20-day recovery period. There were significant differences seen at 6, 12, 24, 48, and 72 h in terms of postoperative pain scores. Beyond that, the pain was consistently less on the coblation side, but the difference was not significant. There was no case of reactionary or secondary hemorrhage in either arm. The healing took longer on the radiofrequency side. Coblation tonsillectomy is an easy to learn technique with significantly reduced operative blood loss and postoperative pain. Longer operative times maybe further reduced with experience.

  15. Wu-Ling-San formula prophylaxis against recurrent calcium oxalate nephrolithiasis - a prospective randomized controlled trial.

    PubMed

    Lin, Eugene; Ho, Lin; Lin, Mao-Sheng; Huang, Min-Ho; Chen, Wen-Chi

    2013-01-01

    Wu-Ling-San (WLS) formula has been proved to prevent calcium oxalate nephrolithiasis both in vitro and in vivo. This is the first prospective, randomized and placebo-controlled clinical trial of WLS in calcium oxalate nephrolithiasis prevention. All patients who enrolled were asked to drink enough fluid to urinate at least 2 L daily during the study period. A 24-hour urine collection was performed to establish the baseline levels of multiple urinary parameters before taking the medicine. The patients were randomized and divided into two groups. The medication group took 2 gm WLS formula three times daily for 1 month. The control group took 2 gm placebo three times daily for 1 month. A 24-hour urine collection was performed to evaluate multiple urinary and serum parameters from all patients during the study period. A total of 39 patients were enrolled and 28 patients completed the study. Fourteen patients were allocated to WLS group and 14 patients to placebo group. After treatment, the mean urine output level increased to 2796.4 ± 525.7 ml/day (percentage of change, 13.9 %) in the WLS formula group. With placebo therapy, the mean decreased slightly to 2521.4 ± 762.7ml/day (percentage of change, -5.7 %). The percentage of change was significantly different between the two groups (independent t-test, P=0.02). No patient complained of side effects, such as fatigue, dizziness, musculoskeletal symptoms, or gastrointestinal disturbance. WLS formula is a promising adjunct to surgical and medical management of kidney stones. Active therapy with WLS formula has a positive effect on diuresis without leading to electrolyte imbalance.

  16. Tribulus terrestris versus placebo in the treatment of erectile dysfunction: A prospective, randomized, double blind study.

    PubMed

    Santos, C A; Reis, L O; Destro-Saade, R; Luiza-Reis, A; Fregonesi, A

    2014-05-01

    To evaluate the possible effects of Tribulus terrestris herbal medicine in the erectile dysfunction treatment and to quantify its potential impact on serum testosterone levels. Prospective, randomized, double-blind and placebo-controlled study including thirty healthy men selected from 100 patients who presented themselves spontaneously complaining of erectile dysfunction, ≥ 40 years of age, nonsmokers, not undergoing treatment for prostate cancer or erectile dysfunction, no dyslipidemia, no phosphodiesterase inhibitor use, no hormonal manipulation and, if present hypertension and/or diabetes mellitus should be controlled. International Index of Erectile Function (IIEF-5) and serum testosterone were obtained before randomization and after 30 days of study. Patients were randomized into two groups of fifteen subjects each. The study group received 800 mg of Tribulus terrestris, divided into two doses per day for thirty days and the control group received placebo administered in the same way. The groups were statistically equivalent in all aspects evaluated. The mean (SD) age was 60 (9.4) and 62.9 (7.9), P = .36 for intervention and placebo groups, respectively. Before treatment, the intervention group showed mean IIEF-5 of 13.2 (5-21) and mean total testosterone 417.1 ng/dl (270.7-548.4 ng/dl); the placebo group showed mean IIEF-5 of 11.6 (6-21) and mean total testosterone 442.7 ng/dl (301-609.1 ng/dl). After treatment, the intervention group showed mean IIEF-5 of 15.3 (5-21) and mean total testosterone 409.3 ng/dl (216.9-760.8 ng/dl); the placebo group showed mean IIEF-5 of 13.7 (6-21) and mean total testosterone 466.3 ng/dl (264.3-934.3 ng/dl). The time factor caused statistically significant changes in both groups for IIEF-5 only (P = .0004), however, there was no difference between the two groups (P = .7914). At the dose and interval studied, Tribulus terrestris was not more effective than placebo on improving symptoms of erectile dysfunction or serum total

  17. An Open Label, Randomized, Comparative, Parallel Group, Multicenter, Prospective, Interventional, Clinical Study to Evaluate Efficacy and Safety of “AHPL/AYTOP/0113” in Comparison with “Framycetin Sulphate Cream” in Acute Wounds

    PubMed Central

    Nipanikar, Sanjay U; Gajare, Kamalakar V; Vaidya, Vidyadhar G; Kamthe, Amol B; Upasani, Sachin A; Kumbhar, Vidyadhar S

    2017-01-01

    Objectives: The main objective of the present study was to assess efficacy and safety of AHPL/AYTOP/0113 cream, a polyherbal formulation in comparison with Framycetin sulphate cream in acute wounds. Methodology: It was an open label, randomized, comparative, parallel group and multi-center clinical study. Total 47 subjects were randomly assigned to Group-A (AHPL/AYTOP/0113 cream) and 42 subjects were randomly assigned to Group-B (Framycetin sulphate cream). All the subjects were advised to apply study drug, thrice daily for 21 days or up to complete wound healing (whichever was earlier). All the subjects were called for follow up on days 2, 4, 7, 10, 14, 17 and 21 or up to the day of complete wound healing. Data describing quantitative measures are expressed as mean ± SD. Comparison of variables representing categorical data was performed using Chi-square test. Results: Group-A subjects took significantly less (P < 0.05) i.e., (mean) 7.77 days than (mean) 9.87 days of Group-B subjects for wound healing. At the end of the study, statistically significant better (P < 0.05) results were observed in Group-A than Group-B in mean wound surface area, wound healing parameters and pain associated with wound. Excellent overall efficacy and tolerability was observed in subjects of both the groups. No adverse event or adverse drug reaction was noted in any subject of both the groups. Conclusion: AHPL/AYTOP/0113 cream proved to be superior to Framycetin sulphate cream in healing of acute wounds. PMID:28867855

  18. A Randomized Prospective Comparison of Patient-Assessed Satisfaction and Clinical Outcomes with Radioactive Seed Localization versus Wire Localization.

    PubMed

    Bloomquist, Erica V; Ajkay, Nicolas; Patil, Sujata; Collett, Abigail E; Frazier, Thomas G; Barrio, Andrea V

    2016-01-01

    Radioactive seed localization (RSL) has emerged as an alternative to wire localization (WL) in patients with nonpalpable breast cancer. Few studies have prospectively evaluated patient satisfaction and outcomes with RSL. We report the results of a randomized trial comparing RSL to WL in our community hospital. We prospectively enrolled 135 patients with nonpalpable breast cancer between 2011 and 2014. Patients were randomized to RSL or WL. Patients rated the pain and the convenience of the localization on a 5-point Likert scale. Characteristics and outcomes were compared between groups. Of 135 patients enrolled, 10 were excluded (benign pathology, palpable cancer, mastectomy, and previous ipsilateral cancer) resulting in 125 patients. Seventy patients (56%) were randomized to RSL and 55 (44%) to WL. Fewer patients in the RSL group reported moderate to severe pain during the localization procedure compared to the WL group (12% versus 26%, respectively, p = 0.058). The overall convenience of the procedure was rated as very good to excellent in 85% of RSL patients compared to 44% of WL patients (p < 0.0001). There was no difference between the volume of the main specimen (p = 0.67), volume of the first surgery (p = 0.67), or rate of positive margins (p = 0.53) between groups. RSL resulted in less severe pain and higher convenience compared to WL, with comparable excision volume and positive margin rates. High patient satisfaction with RSL provides another incentive for surgeons to strongly consider RSL as an alternative to WL.

  19. Platelet-rich plasma enhances bone union in posterolateral lumbar fusion: A prospective randomized controlled trial.

    PubMed

    Kubota, Go; Kamoda, Hiroto; Orita, Sumihisa; Yamauchi, Kazuyo; Sakuma, Yoshihiro; Oikawa, Yasuhiro; Inage, Kazuhide; Sainoh, Takeshi; Sato, Jun; Ito, Michihiro; Yamashita, Masaomi; Nakamura, Junichi; Suzuki, Takane; Takahashi, Kazuhisa; Ohtori, Seiji

    2017-07-20

    Platelet-rich plasma (PRP) accelerates bone union in vivo in a rodent model of spinal fusion surgery. However, PRP's effect on bone union after spinal surgery remains unclear. The objective of this study was to evaluate the efficacy of PRP after posterolateral lumbar fusion (PLF) surgery. Single-center prospective randomized controlled clinical trial with 2-year follow-up. The patient sample included a total 62 patients (31 patients in the PRP group or 31 patients in the control group). The outcome measures included the bone fusion rate, the area of bone fusion mass, the duration of bone fusion, and the clinical score using the visual analog scale (VAS). We randomized 62 patients who underwent one- or two-level instrumented PLF for lumbar degenerative spondylosis with instability to either the PRP (31 patients) or the control (31 patients) groups. Platelet-rich plasma-treated patients underwent surgery using an autograft bone chip (local bone), and PRP was prepared from patient blood samples immediately before surgery; patients from the control group underwent PLF without PRP treatment. We assessed platelet counts and growth factor concentrations in PRP prepared immediately before surgery. The duration of bone union, the postoperative bone fusion rate, and the area of fusion mass were assessed using plain radiography every 3 months after surgery and by computed tomography at 12 or 24 months. The duration of bone fusion and the clinical scores for low back pain, leg pain, and leg numbness before and 3, 6, 12, and 24 months after surgery were evaluated using VAS. Data from 50 patients with complete data were included. The bone union rate at the final follow-up was significantly higher in the PRP group (94%) than in the control group (74%) (p=.002). The area of fusion mass was significantly higher in the PRP group (572 mm(2)) than in the control group (367 mm(2)) (p=.02). The mean period necessary for union was 7.8 months in the PRP group and 9.8 months in the

  20. 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.

  1. Navigation of total knee arthroplasty: rotation of components and clinical results in a prospectively randomized study

    PubMed Central

    2011-01-01

    Background Navigation was introduced into total knee arthroplasty (TKA) to improve accuracy of component position, function and survival of implants. This study was designed to assess the outcome of navigated TKA in comparison with conventional implantation with the focus on rotational component position and clinical mid-term results. Methods In a prospectively randomized single-blinded approach, 90 patients with primary gonarthrosis were assigned to three different groups. Thirty patients each were assigned to NexGen LPS without and with navigation (groups 1 and 2), and 30 patients to navigation with the Stryker Scorpio PS (group 3). The navigation system used was the imageless Stryker KneeTrac, version 1.0. Clinical outcome was assessed by a blinded observer applying the Knee Society Score (KSS) and a visual analogue scale (VAS) for pain. CT scans and radiographs were conducted prior to and 12 weeks after index surgery. Results Seventy-nine patients were available for clinical evaluation at 3 ± 0.4 years follow-up. Four implants had to be revised for early loosening or infection (4.4%). Four patients had died and three patients were not able to follow the invitation for clinical assessment. Functional results in the KSS were significantly lower after navigated TKA. Operation time and incisions with navigation were significantly longer. Significantly less radiological outliers with navigation were found for coronal alignment of the femur, only. Conclusion In this series, no beneficial effect for navigation in TKA could be shown assessing clinical data, as functional results in the presented series seemed to be lower after first generation navigated TKA. The clinical mid- to long-term value of navigation remains to be evaluated in larger patient series or meta-analyses at longer follow-up. Trial registration number DRKS 00000430 PMID:21235810

  2. [Resorbable rods and screws for fixation of ankle fractures. A randomized clinical prospective study].

    PubMed

    Springer, M A; van Binsbergen, E A; Patka, P; Bakker, F C; Haarman, H J

    1998-05-01

    A prospective randomized clinical trial was performed to evaluate the use of self-reinforced absorbable composites (Biofix) in the fixation of ankle fractures. The aim of this study was to demonstrate that fixation with Biofix rods and screws is as good as the standard A.O. fixation. The benefits of Biofix rods and screws are: a reduction in costs since no secondary operation is needed, prevention of stress-shielding and thereby diminishing the risk of bone porosity. Patients aged between 16 and 75 years old with closed, non-comminuted fractures of the lateral and/or medial malleolus and dislocation of the fracture fragments greater than 2 mm were included in the study. 22 patients were treated with Biofix rods and screws and the control group of 19 patients with a standard technique. After 3, 6 and 12 months, rontgenograms were taken. At the same time functional results were evaluated following the criteria of Olerud and Molander. Two patients were withdrawn from the trial for non-medical reasons. 22 patients (12 from the Biofix group, 10 from the AO group) operated two or more years ago were contacted to see if any complications had occurred since they were last seen. In 4 cases a Biofix screw broke down just beneath the head during insertion. This did not result in an insufficient fixation of the fracture. There were no early post-operative complications. The functional and rontgenological results in both groups were equal. In three cases a sterile sinus developed at the site of screw insertion. Biofix rods and screws, made of polylactic acid, are a good alternative for the fixation of fractures of the ankle. The use of resorbable fracture fixation material has the advantage that a second operation to remove osteosynthesis material is not necessary. The long term results are good. There is, however, a possibility of development of tissue reaction to the resorbable material.

  3. Minimizing tourniquet pressure in pediatric anterior cruciate ligament reconstructive surgery: a blinded, prospective randomized controlled trial.

    PubMed

    Reilly, Christopher W; McEwen, James A; Leveille, Lise; Perdios, Angeliki; Mulpuri, Kishore

    2009-01-01

    Tourniquet cuff pressures in pediatric patients are commonly set at standard pressures. Recent evidence on adult subjects has shown that safer and more effective cuff pressures can be achieved by measuring limb occlusion pressure (LOP) and using a wide contour cuff. There is little evidence validating these techniques in children. The primary objective of this study was to evaluate if a difference in tourniquet cuff pressure can be achieved in a pediatric population using a wide contour cuff in conjunction with measured LOP when compared with a standard cuff and pressure. Subjects aged 10 to 17 years that underwent anterior cruciate ligament repair were included and randomized into either the control group or the experimental LOP group using variable block randomization. The tourniquet cuff was inflated to 300 mm Hg in the control group or to the recommended tourniquet pressure based on LOP measurement in the LOP group. The surgeon was blinded to cuff selection, application, and pressure throughout the surgical procedure. Immediately after the surgical procedure, the surgeon rated the quality of the bloodless field on a visual analog scale. This study was powered as an effectiveness trial, and intention to treat analysis was used. After a planned interim analysis at midpoint, complete data were recorded for 11 (control group) and 10 (LOP group) patients. The quality of the surgical field was not different between the groups (P = 0.053). There was a statistically significant difference in the mean cuff pressure between the control (300 mm Hg) and the LOP (151 mm Hg) groups (P < 0.001). We ran the same analysis comparing the LOP data with the hypothetical control data of 250 mm Hg, and our results remained statistically significant (P < 0.001). The use of an automatic LOP measurement with the use of wide contour cuffs can significantly reduce mean tourniquet cuff pressures in pediatric patients compared with the typical practice of 300 or 250 mm Hg without

  4. Randomized, multicenter, phase II study of CO-101 versus gemcitabine in patients with metastatic pancreatic ductal adenocarcinoma: including a prospective evaluation of the role of hENT1 in gemcitabine or CO-101 sensitivity.

    PubMed

    Poplin, Elizabeth; Wasan, Harpreet; Rolfe, Lindsey; Raponi, Mitch; Ikdahl, Tone; Bondarenko, Ihor; Davidenko, Irina; Bondar, Volodymyr; Garin, August; Boeck, Stefan; Ormanns, Steffen; Heinemann, Volker; Bassi, Claudio; Evans, T R Jeffrey; Andersson, Roland; Hahn, Hejin; Picozzi, Vince; Dicker, Adam; Mann, Elaina; Voong, Cynthia; Kaur, Paramjit; Isaacson, Jeff; Allen, Andrew

    2013-12-10

    Gemcitabine requires transporter proteins to cross cell membranes. Low expression of human equilibrative nucleoside transporter-1 (hENT1) may result in gemcitabine resistance in pancreatic ductal adenocarcinoma (PDAC). CO-101, a lipid-drug conjugate of gemcitabine, was rationally designed to enter cells independently of hENT1. We conducted a randomized controlled trial to determine whether CO-101 improved survival versus gemcitabine in patients with metastatic PDAC (mPDAC) with low hENT1. The study also tested the hypothesis that gemcitabine is more active in patients with mPDAC tumors with high versus low hENT1 expression. Patients were randomly assigned to CO-101 or gemcitabine, after providing a metastasis sample for blinded hENT1 assessment. An immunohistochemistry test measuring tumor hENT1 was developed. To dichotomize the population, an hENT1 cutoff value was defined using primary PDAC samples from an adjuvant trial, and a high/low cutoff was applied. The primary end point was overall survival (OS) in the low hENT1 subgroup. Of 367 patients enrolled, hENT1 status was measured in 358 patients (97.5%). Two hundred thirty-two (64.8%) of 358 patients were hENT1 low. There was no difference in OS between treatments in the low hENT1 subgroup or overall, with hazard ratios (HRs) of 0.994 (95% CI, 0.746 to 1.326) and 1.072 (95% CI, 0.856 to 1.344), respectively. The toxicity profiles in both arms were similar. Within the gemcitabine arm, there was no difference in survival between the high and low hENT1 subgroups (HR, 1.147; 95% CI, 0.809 to 1.626). CO-101 is not superior to gemcitabine in patients with mPDAC and low tumor hENT1. Metastasis hENT1 expression did not predict gemcitabine outcome.

  5. Randomized, Double-Blind Phase II Trial With Prospective Classification by ATM Protein Level to Evaluate the Efficacy and Tolerability of Olaparib Plus Paclitaxel in Patients With Recurrent or Metastatic Gastric Cancer.

    PubMed

    Bang, Yung-Jue; Im, Seock-Ah; Lee, Keun-Wook; Cho, Jae Yong; Song, Eun-Kee; Lee, Kyung Hee; Kim, Yeul Hong; Park, Joon Oh; Chun, Hoo Geun; Zang, Dae Young; Fielding, Anitra; Rowbottom, Jacqui; Hodgson, Darren; O'Connor, Mark J; Yin, Xiaolu; Kim, Woo Ho

    2015-11-20

    Gastric cancer cell lines, particularly those with low levels of ataxia telangiectasia mutated (ATM), a key activator of DNA damage response, are sensitive to the poly (ADP-ribose) polymerase inhibitor olaparib. We compared the efficacy of olaparib plus paclitaxel (olaparib/paclitaxel) with paclitaxel alone in patients with recurrent or metastatic gastric cancer and assessed whether low ATM expression is predictive of improved clinical outcome for olaparib/paclitaxel. In this phase II, double-blind study (Study 39; NCT01063517), patients were randomly assigned to oral olaparib 100 mg twice per day (tablets) plus paclitaxel (80 mg/m(2) per day intravenously on days 1, 8, and 15 of every 28-day cycle) or placebo plus paclitaxel (placebo/paclitaxel), followed by maintenance monotherapy with olaparib (200 mg twice per day) or placebo. The study population was enriched to 50% for patients with low or undetectable ATM levels (ATMlow). Primary end point was progression-free survival (PFS). One hundred twenty-three of 124 randomly assigned patients received treatment (olaparib/paclitaxel, n = 61; placebo/paclitaxel, n = 62). The screening prevalence of ATMlow patients was 14%. Olaparib/paclitaxel did not lead to a significant improvement in PFS versus placebo/paclitaxel (overall population: hazard ratio [HR], 0.80; median PFS, 3.91 v 3.55 months, respectively; ATMlow population: HR, 0.74; median PFS, 5.29 v 3.68 months, respectively). However, olaparib/paclitaxel significantly improved overall survival (OS) versus placebo/paclitaxel in both the overall population (HR, 0.56; 80% CI, 0.41 to 0.75; P = .005; median OS, 13.1 v 8.3 months, respectively) and the ATMlow population (HR, 0.35; 80% CI, 0.22 to 0.56; P = .002; median OS, not reached v 8.2 months, respectively). Olaparib/paclitaxel was generally well tolerated, with no unexpected safety findings. Olaparib/paclitaxel is active in the treatment of patients with metastatic gastric cancer, with a greater OS benefit in

  6. I-ONE therapy in patients undergoing total knee arthroplasty: a prospective, randomized and controlled study

    PubMed Central

    2012-01-01

    Background Total knee arthroplasty (TKA) is often associated with a severe local inflammatory reaction which, unless controlled, leads to persistent pain up to one year after surgery. Standard and accelerated rehabilitation protocols are currently being implemented after TKA, but no consensus exists regarding the long-term effects. Biophysical stimulation with pulsed electromagnetic fields (PEMFs) has been demonstrated to exert an anti-inflammatory effect, to promote early functional recovery and to maintain a positive long-term effect in patients undergoing joint arthroscopy. The aim of this study was to evaluate whether PEMFs can be used to limit the pain and enhance patient recovery after TKA. Methods A prospective, randomized, controlled study in 30 patients undergoing TKA was conducted. Patients were randomized into experimental PEMFs or a control group. Patients in the experimental group were instructed to use I-ONE stimulator 4hours/day for 60days. Postoperatively, all patients received the same rehabilitation program. Treatment outcome was assessed using the Knee Society Score, SF-36 Health-Survey and VAS. Patients were evaluated pre-operatively and one, two, six and 12 months after TKA. Joint swelling and Non Steroidal Anti Inflammatory Drug (NSAID) consumption were recorded. Comparisons between the two groups were carried out using a two-tail heteroschedastic Student’s t-test. Analysis of variance for each individual subject during the study was performed using ANOVA for multiple comparisons, applied on each group, and a Dunnet post hoc test. A p value < 0.05 was considered statistically significant. Results Pre-operatively, no differences were observed between groups in terms of age, sex, weight, height, Knee-Score, VAS, SF-36 and joint swelling, with the exception of the Functional Score. The Knee-Score, SF-36 and VAS demonstrated significantly positive outcomes in the I-ONE stimulated group compared with the controls at follow-ups. In the I

  7. Comparative Evaluation of Anesthetic Efficacy of 2% Lidocaine, 4% Articaine, and 0.5% Bupivacaine on Inferior Alveolar Nerve Block in Patients with Symptomatic Irreversible Pulpitis: A Prospective, Randomized, Double-blind Clinical Trial.

    PubMed

    Aggarwal, Vivek; Singla, Mamta; Miglani, Sanjay

    2017-01-01

    To compare the anesthetic efficacy of 1.8 mL of 2% lidocaine with 1:200,000 epinephrine, 4% articaine with 1:100,000 epinephrine, and 0.5% bupivacaine with 1:200,000 epinephrine on producing inferior alveolar nerve block (IANB) in patients with symptomatic irreversible pulpitis. A total of 91 adult patients who were actively experiencing mandibular molar pain were involved in this study. The patients were randomly divided into three groups on the basis of the anesthetic solution used. The first group received IANB with 1.8 mL of 2% lidocaine with 1:200,000 epinephrine, the second group received IANB with 4% articaine with 1:100,000 epinephrine, and the third group received IANB with 0.5% bupivacaine with 1:200,000 epinephrine. After 15 minutes of IANB, conventional endodontic access preparation was started. The pain during the treatment was noted on a Heft-Parker visual analog scale (HP VAS). The primary outcome measure was anesthetic success, and anesthesia was considered successful if the patient reported no pain or weak/mild pain (HP VAS score < 55 mm) during endodontic treatment (pulp access and canal preparation procedures). The data were analyzed with one-way analysis of variance and chi-square test. The anesthetic success rates of 2% lidocaine, 4% articaine, and 0.5% bupivacaine were 23%, 33%, and 17%, respectively. The differences were statistically insignificant (P > .05). The 2% lidocaine solution used for IANB had similar success rates when compared with 4% articaine and 0.5% bupivacaine.

  8. Comparison of two purification products of shankha bhasma: A prospective randomized control trial

    PubMed Central

    Ranade, Manjiri; Chary, Dingari Laxmana

    2013-01-01

    Background: Shankha bhasma is widely used in the treatment of gastroesophageal reflux disease (GERD) patients. Aim: To compare the efficacy of two purification methods of shankha bhasma in relieving GERD symptoms. In method A, purification was done with lemon juice and method B with sour gruel. Materials and Methods: Patients with heartburn since at least four days/week but who did undergo endoscopy to assess esophageal mucosa could participate. In this single-phase, single-center, prospective, randomized control trial, the patients were randomized to receive either shankha bhasma purified by method A or by method B. The primary efficacy variable was the proportion of patients with resolution of heartburn at week 4 and week 8. Design: Single-phase, single-center, prospective, randomized control trial in a hospital setting. Results: Of the total 70 patients who received samples A and B in a randomized double-blind manner, 65% of the patients showed resolution of symptoms in sample A and 28% in sample B at the end of four weeks, whereas, 71% of the patients showed resolution of symptoms in sample A and 31% in sample B at the end of eight weeks; P value was statistically significant for resolution of symptoms (P <0.005). Conclusion: Purification of shankha bhasma by lemon juice method is better than sour gruel method in terms of clinical outcome in GERD patients and is hence recommended. PMID:23633854

  9. Comparison of two purification products of shankha bhasma: A prospective randomized control trial.

    PubMed

    Ranade, Manjiri; Chary, Dingari Laxmana

    2013-01-01

    Shankha bhasma is widely used in the treatment of gastroesophageal reflux disease (GERD) patients. To compare the efficacy of two purification methods of shankha bhasma in relieving GERD symptoms. In method A, purification was done with lemon juice and method B with sour gruel. Patients with heartburn since at least four days/week but who did undergo endoscopy to assess esophageal mucosa could participate. In this single-phase, single-center, prospective, randomized control trial, the patients were randomized to receive either shankha bhasma purified by method A or by method B. The primary efficacy variable was the proportion of patients with resolution of heartburn at week 4 and week 8. Single-phase, single-center, prospective, randomized control trial in a hospital setting. Of the total 70 patients who received samples A and B in a randomized double-blind manner, 65% of the patients showed resolution of symptoms in sample A and 28% in sample B at the end of four weeks, whereas, 71% of the patients showed resolution of symptoms in sample A and 31% in sample B at the end of eight weeks; P value was statistically significant for resolution of symptoms (P <0.005). Purification of shankha bhasma by lemon juice method is better than sour gruel method in terms of clinical outcome in GERD patients and is hence recommended.

  10. [The PreFord Study. A prospective cohort study to evaluate the risk of a cardiovascular event (overall-collective) as well as a prospective, randomized, controlled, multicentre clinical intervention study (high-risk-collective) on primary prevention of cardiovascular diseases in the Ford Motor Company employees in Germany].

    PubMed

    Gysan, D B; Latsch, J; Bjarnason-Wehrens, B; Albus, C; Falkowski, G; Herold, G; Mey, E; Heinzler, R; Montiel, G; Schneider, C A; Stützer, H; Türk, S; Weisbrod, M; Predel, H G

    2004-02-01

    The PreFord Study is a multicenter prospective cohort study to evaluate guideline based risk management on primary prevention of cardiovascular diseases. Furthermore a randomised controlled trial (RCT) will be designed to analyse the effect of a special intervention program. 40,000 employees of the Ford Motor Company, Visteon Company and Deutz Company in Germany will be included, monitored for ten years and the following primary endpoints will be investigated: 1. evaluation and comparison of established and newly developed risk-scores, 2. the relative impact of single and combined cardiovascular risk factors on cardiovascular diseases, 3. the influence of a novel occupationally integrated ambulant rehabilitation program in combination with a guideline oriented optimal drug therapy within a high risk group on the primary endpoint: risk reduction by, 4. the influence of this intervention on secondary endpoints: death, myocardial infarction and stroke, combined appearance of angina pectoris and hospitalisation, occurrence of cerebral circulatory disorder and hospitalisation, occurrence of peripheral occlusive arterial disease and hospitalisation and single cardiovascular risk factors and cost-benefit-analysis. Beginning with an cross sectional study there will be a systemic screening of cardiovascular risk profiles, of anthropometric data and different lifestyle-factors. Based on these data participants will be differentiated into three risk-groups according to the risk score of the European Society of Cardiology (risk of a lethal primary acute cardiovascular event: I < or = 1%; II > 1-< 5% and III > or = 5%). In the following longitudinal study different strategies will be applied: Group I: low risk (< 0.5% per year): repetition of the investigation after five and ten years. Group II: middle risk, (0.6% to 1.4% per year), repetition of the investigation every two years, instruction of the patients general practitioner (GP) with respect to a risk factor oriented and

  11. [Caudal epidural steroid injection in the treatment of chronic discogenic low back pain. Comparative, prospective and randomized study].

    PubMed

    Cervera-Irimia, J; Tomé-Bermejo, F

    2013-01-01

    There is no consensus on the treatment of chronic low back pain of disc origin in the medical literature. The few prospective, randomized, controlled studies evaluating the effectiveness of caudal epidural steroid injections (CESI) have obtained contradictory results. The aim of this study is to evaluate the efficacy of CEI in reducing pain and improving the associated disability. This is a prospective, randomized, case-control study of a group of 46 patients with chronic low back disc pain. Patients were randomly allocated into 2 groups to either receive fluoroscopy guided CESI (CESI-group), or oral non-steroidal anti-inflammatory drugs (NSAID-group). All patients were clinically evaluated at 4, 12, and 24 weeks, and according to the indications of the Spanish Society for Study of Diseases of the Spine (GEER). Lumbar pain, measured by the visual analog scale (VAS) and the Oswestry Low Back Pain Disability Questionnaire (ODQ), did not improve significantly during follow-up in any of the two study groups (P>.05). Younger patients, women, patients with shorter duration of symptoms, low physical job demand, without leg pain, and sport-active, included in CESI-group showed a trend towards better results, but none reached statistical significance (P>.05). The present study has not demonstrated the superiority of CESI over NSAIDs in treating chronic low back pain of disc origin. While CESI could show some improvement in patients with degenerative lumbar disc disease, we consider it should be used with caution, informing patients about realistic expectations on the success of treatment. Copyright © 2013 SECOT. Published by Elsevier Espana. All rights reserved.

  12. Postprocessing for quantum random-number generators: Entropy evaluation and randomness extraction

    NASA Astrophysics Data System (ADS)

    Ma, Xiongfeng; Xu, Feihu; Xu, He; Tan, Xiaoqing; Qi, Bing; Lo, Hoi-Kwong

    2013-06-01

    Quantum random-number generators (QRNGs) can offer a means to generate information-theoretically provable random numbers, in principle. In practice, unfortunately, the quantum randomness is inevitably mixed with classical randomness due to classical noises. To distill this quantum randomness, one needs to quantify the randomness of the source and apply a randomness extractor. Here, we propose a generic framework for evaluating quantum randomness of real-life QRNGs by min-entropy, and apply it to two different existing quantum random-number systems in the literature. Moreover, we provide a guideline of QRNG data postprocessing for which we implement two information-theoretically provable randomness extractors: Toeplitz-hashing extractor and Trevisan's extractor.

  13. A Prospective Randomized Trial of Moderately Strenuous Aerobic Exercise After an Implantable Cardioverter Defibrillator (ICD)

    PubMed Central

    Dougherty, Cynthia M.; Glenny, Robb W.; Burr, Robert L.; Flo ARNP, Gayle L.; Kudenchuk, Peter J.

    2015-01-01

    Background Despite its salutary effects on health, aerobic exercise is often avoided after receipt of an implantable cardioverter-defibrillator (ICD) because of fears that exercise may provoke acute arrhythmias. We prospectively evaluated the effects of a home aerobic exercise training and maintenance program (EX) on aerobic performance, ICD shocks and hospitalizations exclusively in ICD recipients. Methods and Results One hundred sixty (124 men, 36 women) were randomized who had an ICD for primary (43%) or secondary (57%) prevention to EX or usual care (UC). The primary outcome was peak oxygen consumption (peakVO2), measured with cardiopulmonary exercise testing at baseline, 8 and 24 weeks. EX consisted of 8 weeks of home walking 1 hour/day, 5 days/week at 60-80% of heart rate reserve, followed by 16 weeks of maintenance home walking for 150 minutes/week. Adherence to EX was determined from exercise logs, ambulatory HR recordings of exercise, and weekly telephone contacts. UC received no exercise directives and were monitored by monthly telephone contact. Adverse events were identified by ICD interrogations, patient reports and medical records. ICD recipients averaged 55±12 years and mean ejection fraction of 40.6±15.7, all were taking beta blocker medications. EX significantly increased peakVO2 ml/kg/min (EX 26.7±7.0; UC 23.9±6.6, p=0.002) at 8 weeks, which persisted during maintenance exercise at 24 weeks (EX 26.9±7,7; UC 23.4±6.0, p<0.001). ICD shocks were infrequent (EX=4 vs UC=8), with no differences in hospitalizations or deaths between groups. Conclusions Prescribed home exercise is safe and significantly improves cardiovascular performance in ICD recipients without causing shocks or hospitalizations. PMID:25792557

  14. Backfill for iliac-crest donor sites: a prospective, randomized study of coralline hydroxyapatite.

    PubMed

    Bojescul, John A; Polly, David W; Kuklo, Timothy R; Allen, Thomas W; Wieand, Kay E

    2005-08-01

    We report on a prospective randomized study of coralline hydroxyapatite (CH) used as backfill for iliac-crest donor sites. Autogenous iliac-crest bone graft is routinely harvested for spinal fusion. Donor-site morbidity is underappreciated; the presumption is that donor sites regenerate. In this study, we assessed the biological viability of the backfill CH (Pro OsteonTM Implant 500 Hydroxyapatite Bone Void Filler; Interpore, Irvine, Calif) and compared donor-site morbidity after harvest. Twelve patients (11 men, 1 woman) were enrolled: 5 in the backfill group and 7 in the no-backfill group. As part of routine evaluations done preoperatively and 6 weeks, 3 months, 6 months, and 1 year postoperatively, plain radiographs and computed tomography (CT) scans were used to assess bone ingrowth, and technetium bone scans were used to assess biological activity. Postoperative pain analysis was also done. Ten patients (9 men, 1 woman) completed the study. Of the 4 completers in the backfill group, 3 (75%) showed bony ingrowth on plain radiographs and CT scans at 1 year; the fourth patient showed bony ingrowth only on plain radiographs. All 4 patients showed biological activity on bone scans and reported mild pain to no pain. Of the 6 completers in the no-backfill group, 1 (17%) showed bony ingrowth on plain radiographs and CT scans. No patient showed biological activity on bone scans at 1 year. CH aids in iliac-crest healing after bone-graft harvesting by acting as a biological osteoconductive matrix. Postoperative pain at the bone-graft site is potentially reduced. More studies of larger numbers of patients are needed to assess the true long-term benefits of this material in a clinical setting.

  15. The Addition of Dexmedetomidine to Analgesia for Patients After Abdominal Operations: A Prospective Randomized Clinical Trial.

    PubMed

    Cheng, Minhua; Shi, Jialiang; Gao, Tao; Shen, Juanhong; Zhao, Chenyan; Xi, Fengchan; Li, Weiqin; Li, Qiurong; Yu, Wenkui

    2017-01-01

    Postoperative pain and anxiety are two common factors influencing patient's recovery. Benefits and safety in the use of sedative agents after abdominal operations to improve recovery are not well known. The present study is to evaluate the efficacy and safety of dexmedetomidine use in this population. A prospective randomized controlled trial of 145 patients undergoing abdominal operations was conducted in the Surgical Intensive Care Unit of Jinling Hospital between October and December 2015. Thirty-two patients were excluded, and 113 were included and divided into the experimental group (59 patients) receiving dexmedetomidine and analgesics for 72 h after abdominal operations, and the control group (54 patients) receiving only analgesics. Postoperative pain, inflammatory response, recovery of gastrointestinal function, adverse events, and sedation level were analyzed. Pain scores, assessed by Prince Henry Pain Scale (PHPS), in the experimental group were significantly lower than in the control group on the first (1.53 vs. 2.07, p ≤ 0.01), second (1.07 vs. 1.63, p ≤ 0.01), and third day (1.08 vs. 1.82, p = 0.01). Time to defecation was 0.60 days shorter in the experimental group than the control group (2.51 vs. 3.11, p = 0.01). There was no significant difference between inflammatory responses in the two groups (p > 0.05). Both groups had similar blood pressure, heart rate, prevalence of bradycardia, and hypotension requiring interventions (p > 0.05). The addition of dexmedetomidine to analgesia after abdominal operations is safe and could enhance gastrointestinal function recovery and pain control when monitored carefully. The capacity of dexmedetomidine to attenuate inflammatory responses requires further investigation.

  16. Synthetic porous ceramic compared with autograft in scoliosis surgery. A prospective, randomized study of 341 patients.

    PubMed

    Ransford, A O; Morley, T; Edgar, M A; Webb, P; Passuti, N; Chopin, D; Morin, C; Michel, F; Garin, C; Pries, D

    1998-01-01

    We have evaluated the use of a synthetic porous ceramic (Triosite) as a substitute for bone graft in posterior spinal fusion for idiopathic scoliosis. In a prospective, randomised study 341 patients at five hospitals in the UK and France were randomly allocated either to autograft from the iliac crest or rib segments (171) or to receive Triosite blocks (170). All patients were assessed after operation and at 3, 6, 12 and 18 months. The two groups were similar with regard to all demographic and baseline variables, but the 184 treated in France (54%) had Cotrel-Dubouset instrumentation and the 157 treated in the UK usually had Harrington-Luque implants. In the Triosite group the average Cobb angle of the upper curve was 56 degrees, corrected to 24 degrees (57%). At 18 months, the average was 26 degrees (3% loss). In the autograft group the average preoperative upper curve of 53 degrees was corrected to 21 degrees (60%). At 18 months the mean curve was 25 degrees (8% loss). Pain levels after operation were similar in the two groups, being mild in most cases. In the Triosite group only three patients had problems of wound healing, but in the autograft group, 14 patients had delayed healing, infection or haematoma in the spinal wound. In addition, 15 autograft patients had pain at the donor site at three months. Seven had infections, two had haematoma and four had delayed healing. The haematological and serum biochemistry results showed no abnormal trends and no significant differences between the groups. There were no adverse events related to the graft material and no evidence of allergenicity. Our results suggest that Triosite synthetic porous ceramic is a safe and effective substitute for autograft in these patients. Histological findings on biopsy indicate that Triosite provides a favourable scaffolding for the formation of new bone and is gradually incorporated into the fusion mass.

  17. A prospective randomized study in 20 patients undergoing bilateral TKA comparing midline incision to anterolateral incision.

    PubMed

    Maniar, Rajesh N; Singhi, Tushar; Nanivadekar, Arun; Maniar, Parul R; Singh, Jaivardhan

    2017-02-11

    Lateral flap numbness is a known side-effect of midline skin incision in total knee arthroplasty (TKA) and a cause of patient dissatisfaction. Anterolateral incision is an alternative approach which preserves the infrapatellar branches of the saphenous nerve and avoids numbness. Studies have compared both incisions, but in different patients. However, different patients may assess the same sensory deficit dissimilarly, because of individual variations in anatomy and healing responses. We compared the two incisions in the same patient at the same time, using an anterolateral incision on one knee and a midline incision on the other knee in simultaneous bilateral TKA. Other surgical steps including medial arthrotomy were idential. We also correlated subjective and objective findings. Twenty patients were prospectively randomized. Sensory loss and skin healing were assessed at 6, 12 and 52 weeks. Subjective preference for the knee with less numbness was charted on Wald's Sequential Probability Ratio Test. Sensation scores for touch, vibration, static and moving two-point discrimination were measured. Scar healing was evaluated using the Patient and Observer Scar Assessment Scale (POSAS). Functional scores were measured. A statistically significant difference favoring knees with anterolateral incision was observed in patient preference at all assessment points and this correlated with sensation scores. A statistically significant difference was observed in POSAS score favoring knees with anterolateral incision at 6 and 12 weeks which became statistically insignificant at 1 year. Functional scores remained comparable. We recommend anterolateral incision as a safe and effective method to circumvent the problem of lateral flap numbness with midline incision. I.

  18. Fast-track rehabilitation following video-assisted pulmonary sublobar wedge resection: A prospective randomized study

    PubMed Central

    Asteriou, Christos; Lazopoulos, Achilleas; Rallis, Thomas; Gogakos, Apostolos S; Paliouras, Dimitrios; Barbetakis, Nikolaos

    2016-01-01

    BACKGROUND: Postoperative morbidity and inhospital length of stay are considered major determinants of total health care expenditure associated with thoracic operations. The aim of this study was to prospectively evaluate the role of video-assisted thoracic surgery (VATS) compared to mini-muscle-sparing thoracotomy in facilitating early recovery and hospital discharge after pulmonary sublobar wedge resections. PATIENTS AND METHODS: A total number of 120 patients undergoing elective pulmonary sublobar wedge resection were randomly assigned to VATS (n = 60) or mini-muscle-sparing thoracotomy (n = 60). The primary endpoint was time to hospital discharge. Postoperative complications, cardiopulmonary morbidity and 30-day mortality served as secondary endpoints. RESULTS: Patients' baseline demographic and clinical data did not differ among study arms as well as the number of pulmonary segments resected and the morphology of the nodular lesions. Total hospital stay was significantly shorter in patients assigned to the thoracoscopic technique as opposed to those who were operated using the mini-muscle-sparing thoracotomy approach (4 ± 0.6 versus 4.4 ± 0.6 days respectively, P = 0.006). Multivariate analysis revealed that VATS approach was inversely associated with longer inhospital stay whereas the number of resected segments was positively associated with an increased duration of hospitalization. Patients in the VATS group were less likely to develop atelectasis (≥1 lobe) compared to those who underwent thoracotomy (0% versus 6.7% respectively, P = 0.042). Kaplan-Meier analysis revealed similar 30-day mortality rates in both study arms (Log-rank P = 0.560). CONCLUSION: VATS was associated with shorter duration of hospitalization positively affecting the patients' quality of life and satisfaction. Significant suppression of the total cost of recovery after thoracoscopic pulmonary resections is expected. PMID:27279390

  19. Rib approximation without intercostal nerve compression reduces post-thoracotomy pain: a prospective randomized study.

    PubMed

    Bayram, Ahmet Sami; Ozcan, Metin; Kaya, Fatma Nur; Gebitekin, Cengiz

    2011-04-01

    One of the most important considerations in the care of thoracic surgery patients is the control of pain, which leads to increased morbidity and relevant mortality. Between February and May 2009, 60 patients undergoing full muscle-sparing posterior minithoracotomy were prospectively randomized into two groups, according to the thoracotomy closure techniques. In the first group (group A), two holes were drilled into the sixth rib using a hand perforator, and sutures were passed through the holes in the sixth rib and were circled from the upper edge of the fifth rib, thereby compressing the intercostal nerve underneath the fifth rib. In the second group (group B), the intercostal muscle underneath the fifth rib was partially dissected along with the intercostal nerve, corresponding to the holes on the sixth rib. Two 1/0 polyglactin (Vicyrl) sutures were passed through the holes in the sixth rib and above the intercostal nerve. There were 30 patients in each group. The visual analog score, observer verbal ranking scale (OVRS) scores for pain, and Ramsay sedation scores were used to follow-up on postoperative analgesia and sedation. The von Frey hair test was used to evaluate hyperalgesia of the patients. The patients in group B had lower visual analog scores at rest and during coughing. The patients in group B had lower OVRS scores than group A patients. The groups were not statistically different in terms of the Ramsay sedation scores and von Frey hair tests. Thoracotomy closure by a technique that avoids intercostal nerve compression significantly decreases post-thoracotomy pain. Copyright © 2010 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.

  20. Mechanical labor induction in the obese population: a secondary analysis of a prospective randomized trial.

    PubMed

    Anabusi, Saja; Mei-Dan, Elad; Hallak, Mordechai; Walfisch, Asnat

    2016-01-01

    The objective of this study was to estimate the influence of maternal body mass index (BMI) on progress and outcomes of labor induction using mechanical devices. This study was a secondary analysis of data collected during the Cook Catheter vs. Foley Catheter study, a series of prospective randomized trials of women requiring cervical ripening for labor induction. The duration, characteristics, and outcomes of labor were analyzed after stratification by BMI categories. Outcomes assessed included time from device insertion to delivery, successful ripening, cesarean delivery rates, and any maternal and neonatal adverse events. One hundred and eighty-one patients were stratified according to BMI categories, with 102 study participants classified as normal weight (BMI ≤30) and 79 as obese (BMI >30). Maternal satisfaction from the induction process was significantly lower in the obese group compared to the normal weight group (5.95 ± 3.14 vs. 7.58 ± 2.7, respectively, in a 1-10 scale, p = 0.009). The cesarean delivery rate was similar in the normal weight and the obese groups (17.6 vs. 25.3 %, respectively, p = 0.27). No statistical differences were found in all other outcomes evaluated, including a sub-analysis of the different mechanical devices. During the process of mechanical cervical ripening, maternal satisfaction, but not objective obstetrical parameters, was influenced by increased maternal BMI. The trial is registered at ClinicalTrials.gov, no: NCT00604487. Trial registry name is "Induction of Labor in Patients with Unfavorable Cervical Conditions."

  1. Black cohosh and fluoxetine in the treatment of postmenopausal symptoms: a prospective, randomized trial.

    PubMed

    Oktem, Mesut; Eroglu, Derya; Karahan, Hilal B; Taskintuna, Nilgun; Kuscu, Esra; Zeyneloglu, Hulusi B

    2007-01-01

    The objective of this study was to evaluate the efficacy of fluoxetine and black cohosh in the treatment of women with postmenopausal symptoms. A total of 120 healthy women with menopausal symptoms were recruited to this prospective study with a follow-up period of 6 mo. They were randomly assigned to 1 of 2 groups and were treated with fluoxetine or black cohosh. After entry into the study, patients were examined at the first, second, third, and sixth months of the treatment period. The women kept diaries in which they reported the daily number and intensity of hot flushes and night sweats. In addition, at the beginning and end of the third month, they completed questionnaires consisting of a modified Kupperman Index, Beck's Depression Scale, and a RAND-36 Quality-of-Life Questionnaire. Statistically significant differences were noted in the Kupperman Index and Beck's Depression Scale at the end of the third month in both groups compared with baseline values. In the black cohosh group, the Kupperman Index decreased significantly compared with that in the fluoxetine group by the end of the third month. On the other hand, in the fluoxetine group, Beck's Depression Scale decreased significantly compared with that in the black cohosh group. Monthly scores for hot flushes and night sweats decreased significantly in both groups; however, black cohosh reduced monthly scores for hot flushes and night sweats to a greater extent than did fluoxetine. At the end of the sixth month of treatment, black cohosh reduced the hot flush score by 85%, compared with a 62% result for fluoxetine. By the sixth month of the study, 40 women had discontinued the study--20 (33%) in the fluoxetine group and 20 (33%) in the black cohosh group. Compared with fluoxetine, black cohosh is more effective for treating hot flushes and night sweats. On the other hand, fluoxetine is more effective in improvements shown on Beck's Depression Scale.

  2. Effects of zoledronate on the radiation-induced collagen breakdown: a prospective randomized clinical trial.

    PubMed

    Gierloff, M; Reutemann, M; Gülses, A; Niehoff, P; Wiltfang, J; Açil, Y

    2015-06-01

    A negative side effect of therapeutic irradiation is the radiation-induced bone loss which can lead, in long term, to pathological fractures. Until today, the detailed mechanism is unknown. If osteoclasts would mainly contribute to the pathological bone loss, bisphosphonates could potentially counteract the osteolytic process and possibly help to prevent long-term complications. The aim of this study was to evaluate the effect of zoledronic acid on the early radiation-induced degradation of bone collagen fibrils by monitoring the urinary excretion of hydroxylysylpyridinoline and lysylpyridinoline under radiotherapy. A total of 40 patients with skeletal metastases were assigned for a local radiotherapy and bisphosphonate treatment. The patients were prospectively randomized into two treatment groups: group A (n = 20) received the first zoledronate administration after and group B (n = 20) prior to the radiotherapy. Urine samples were collected from each patient on the first day, in the middle, and on the last day of the radiation therapy. Measurement of the bone metabolites hydroxylysylpyridinoline and lysylpyridinoline was performed by high-performance liquid chromatography. Statistical analysis was performed using the Mann-Whitney U test. The hydroxylysylpyridinoline and lysylpyridinoline excretion decreased significantly in the combined bisphosphonate and radiotherapy group (p = 0.02, p = 0.08). No significant change of the hydroxylysylpyridinoline and lysylpyridinoline excretion was determined in the patients that received solely irradiation. The results indicate the ability of zoledronate to prevent the early radiation-induced bone collagen degradation suggesting that the radiation-induced bone loss is mainly caused by osteoclastic bone resorption rather than by a direct radiation-induced damage.

  3. Glare disability and spherical aberration with five foldable intraocular lenses: a prospective randomized study.

    PubMed

    Casprini, Fabrizio; Balestrazzi, Angelo; Tosi, Gian Marco; Miracco, Flavia; Martone, Gianluca; Cevenini, Gabriele; Caporossi, Aldo

    2005-02-01

    To compare differences in subjective glare and spherical aberration between five foldable intraocular lenses (IOLs) made of different materials and to different designs. This prospective study comprised 175 cataract patients who underwent phacoemulsification and were randomized to receive one of five types of foldable IOL (AcrySof MA30BA, Alcon; Sensar AR40, AMO; AcrySof SA30AL, Alcon; Sensar AR40e, AMO, and Tecnis Z9000, Pharmacia & Upjohn). All patients received a questionnaire investigating the incidence of subjective photic phenomena. Two months postoperatively, we collected data regarding subjective glare and evaluated pupil size, visual acuity and wavefront aberration of the cornea and eye. With regard to difficulty in performing ordinary activities under different light conditions and light and dark adaptation, the difference between the groups was not significant (p > 0.05, chi-squared test). With respect to difficulty in driving at night, the MA30BA group had a significant higher incidence of photic phenomena than the SA30AL, AR40e and Z9000 groups (p < 0.05, chi-squared test). Wavefront measurements revealed a significant difference between the Z9000, AR40e and SA30AL groups, which showed the lowest values, and the MA30BA group, which showed the highest value (p < 0.05, anova with Tamhane posthoc test). New generation IOLs such as the Pharmacia Z9000, AMO AR40e and AcrySof SA30AL have a lower incidence of glare and spherical aberrations; however, their impact on future IOL design should be conditioned by further data, especially regarding posterior capsule opacification.

  4. Prospective randomized study of patients with insomnia and mild sleep disordered breathing.

    PubMed

    Guilleminault, Christian; Davis, Kala; Huynh, Nelly T

    2008-11-01

    Patients with insomnia may present with mild and often unrecognized obstructive sleep apnea (OSA). To evaluate both subjective and objective outcomes of patients with complaints of insomnia and mild OSA who receive surgical treatment for OSA versus behavioral treatment with cognitive behavioral therapy for insomnia (CBT-I). Prospective study with crossover design of 30 patients with complaints of insomnia and mild OSA. Thirty subjects, matched for age and gender, were randomized with stratification to receive either CBT-I or surgical treatment of OSA as primary treatment. Patients were reassessed after completing the initial intervention and reassigned if agreeable to the alternative treatment option and assessed again on completion of both treatment arms. Outcome measures included clinical impression, Epworth Sleepiness Scale (ESS) score, Fatigue Severity Scale (FSS) score, and polysomnography (PSG) results. Surgery resulted in greater improvements in total sleep time (TST), slow wave sleep and REM sleep duration, respiratory disturbance index, apnea-hypopnea index, minimum oxygen saturation, FSS, and ESS. CBT-I also improved TST and resulted in shorter sleep latency. Surgical intervention for the management of patients with complaints of insomnia and mild OSA demonstrated greater improvement in both subjective and objective outcome measures. Initial treatment of underlying OSA in patients with insomnia was more successful in improving insomnia than CBT-I alone. However CBT-I as initial treatment improved TST compared to baseline; following surgical intervention, it had the additional benefit of further increasing TST and helped to control sleep onset difficulties that may be related to conditioning due to unrecognized symptoms of mild OSA.

  5. Use of resterilized polypropylene mesh in inguinal hernia repair: a prospective, randomized study.

    PubMed

    Cingi, Asim; Manukyan, Manuk N; Güllüoğlu, Bahadir M; Barlas, Afşar; Yeğen, Cumhur; Yalin, Rifat; Yilmaz, Nuray; Aktan, A Ozdemir

    2005-12-01

    Inguinal hernia repair consumes considerable health-care resources worldwide. Open mesh repairs are commonly used and the feasibility of using a resterilized mesh, which is a general practice in certain countries, has not been evaluated. In this randomized prospective study, original and resterilized meshes were used in two groups of patients with unilateral inguinal hernia. Microbiologic changes, textile mechanical properties, overall complication rates, and cost-effectiveness of resterilized mesh were investigated. A time period of 3 years was determined for patient enrollment to this pilot feasibility study, with the goal of 100 patients in each group. Ninety-one patients were enrolled in the original group and 93 in the resterilized mesh group. Median followup was 735 and 739 days and calculated interquartile ranges were 454 and 513 days, respectively. Average tensile strength of the original polypropylene mesh changed slightly with resterilization, as maximum load decreased from a mean of 66.6 to 58.2 N/cm. Overall complication rates were similar in the two groups. The 6.6% infection rate in the original mesh group was not statistically different from the 7.5% rate in the resterilized group (p = 0.80, relative risk = 0.88, 95% confidence interval, 0.31-2.51). There was only one recurrence in the original mesh group in the 21st month. Use of a resterilized mesh decreased the overall cost of operation by decreasing the cost of mesh from 15.9% to 8.3% of the total amount. Use of a resterilized mesh for inguinal hernia repair is feasible without considerable changes in infection and recurrence rates.

  6. Early Aqueous Suppressant Therapy on Hypertensive Phase Following Glaucoma Drainage Device Procedure: A Randomized Prospective Trial.

    PubMed

    Law, Simon K; Kornmann, Helen L; Giaconi, JoAnn A; Kwong, Allen; Tran, Eric; Caprioli, Joseph

    2016-03-01

    To prospectively evaluate the effect of early aqueous suppression (therapy) on hypertensive phase (HP) and intraocular pressure (IOP) control after implantation of silicone Ahmed glaucoma valve (AGV). Patients who underwent AGV implantation were randomized to initiate therapy (including β-blockers, α-agonists, or carbonic anhydrase inhibitors) when postoperative IOP>10 mm Hg (low-IOP initiation group) or >17 mm Hg (moderate-IOP initiation group). HP was defined as an IOP>21 mm Hg during the first 6 postoperative months, after an initial IOP reduction to <22 mm Hg in the first postoperative week. Primary outcome measures included the occurrence of HP and IOP control. Fifty-two eyes (50 patients) underwent AGV implantation. Average follow-up was 21.9±10.7 months. HP was observed in 21 eyes (40.4%) with average peak IOP of 30±8 mm Hg, onset at 32±30 days, and duration of 15±32 days. One year postoperatively, those eyes with HP had higher IOP than eyes that did not develop HP (15.1±5.2, 11.4±4.3, respectively; P=0.021) and required more additional glaucoma surgeries (28.6%, 3.2%, respectively; P=0.013). The peak IOP at week 3 postoperatively in the low-IOP initiation group (26 eyes) was significantly lower than in the moderate-IOP initiation group (26 eyes; 15.7±3.6, 20.6±8.9, respectively; P=0.012). Eyes with therapy started after HP onset had significantly higher postoperative IOP from 2 to 4 months. Therapy initiated before the development of HP was not associated with a higher complication rate. Aqueous suppression initiated in the early postoperative period while IOPs were still in the low-teens and was able to reduce the incidence of IOP spike associated with the HP without an increased complication rate.

  7. Laparoscopic total extraperitoneal repair under spinal anesthesia versus general anesthesia: a randomized prospective study

    PubMed Central

    Donmez, Turgut; Erdem, Vuslat Muslu; Sunamak, Oguzhan; Erdem, Duygu Ayfer; Avaroglu, Huseyin Imam

    2016-01-01

    Background Laparoscopic total extraperitoneal (TEP) inguinal hernia repair is a well-known approach to inguinal hernia repair that is usually performed under general anesthesia (GA). To date, no reports compare the efficacy of spinal anesthesia (SA) with that of GA for laparoscopic hernia repairs. The purpose of this study was to compare the surgical outcome of TEP inguinal hernia repair performed when the patient was treated under SA with that performed under GA. Materials and methods Between July 2015 and July 2016, 50 patients were prospectively randomized to either the GA TEP group (Group I) or the SA TEP group (Group II). Propofol, fentanyl, rocuronium, sevoflurane, and tracheal intubation were used for GA. Hyperbaric bupivacaine (15 mg) and fentanyl (10 µg) were used for SA to achieve a sensorial level of T3. Intraoperative events related to SA, operative and anesthesia times, postoperative complications, and pain scores were recorded. Each patient was asked to evaluate the anesthetic technique by using a direct questionnaire filled in 3 months after the operation. Results All the procedures were completed by the allocated method of anesthesia as there were no conversions from SA to GA. Pain was significantly less for 1 h (P<0.0001) and 4 h (P=0.002) after the procedure for the SA and GA groups, respectively. There was no difference between the two groups regarding complications, hospital stay, recovery, or surgery time. Generally, patients were more satisfied with SA than GA (P<0.020). Conclusion TEP inguinal hernia repair can be safely performed under SA, and SA was associated with less postoperative pain, better recovery, and better patient satisfaction than GA. PMID:27822053

  8. Safety and efficacy comparison of minocycline microgranules vs lymecycline in the treatment of mild to moderate acne: randomized, evaluator-blinded, parallel, and prospective clinical trial for 8 weeks.

    PubMed

    Ocampo-Candiani, Jorge; Velazquez-Arenas, Luis Leobardo; de la Fuente-Garcia, Alberto; Trevino-Gomezharper, Carlos; Berber, Arturo

    2014-06-01

    Minocycline and lymecycline are used in the treatment of acne, but there is not enough evidence to support superior efficacy of one of them. 170 participants from 14 to 34 years old with mild to moderate facial acne vulgaris were recruited. 84 had 100 mg of minocycline in a single daily dose for 8 weeks and 86 had 300 mg of lymecycline in a single daily dose for 8 weeks. Participants were evaluated at baseline, week 4 and week 8. 65 minocycline and 60 lymecycline patients were evaluable. The last observation carried forward for the count of non-inflammatory lesions changed from 37.5 ± 17.8 to 37.7 ± 17.8 in the minocycline group and from 36.9 ± 15.5 to 33.4 ± 19.3 in the lymecycline group (no significant changes); corresponding changes in inflammatory lesions were from 19.4 ± 12.4 to 12.2 ± 10.0 in the minocycline group and from 20.1 ± 11.3 to 12.6 ± 8.4 in lymecycline group (P< 0.05 comparing baseline vs. final in both groups). Porphyrin counts varied from 899.5 ± 613.9 to 233.5 ± 219.5 in the minocycline group and from 956.9 ± 661.8 to 411.8 ± 411.5 in the lymecycline group (P<0.05 between the groups at study end). 36 (42.9%) patients receiving minocycline suffered 55 adverse events (22 of them gastrointestinal), while 28 (33.3%) lymecycline patients had 37 adverse events (15 of them gastrointestinal). One patient in the lymecycline group withdrew the study due to gastritis, and one more patient in the same group experienced eosinophilia. There were no differences between the groups in non-inflammatory and inflammatory lesion counts, and in the safety profile. Treatment with minocycline induced statistically significant decrease in facial porphyrin counts compared to the group treated with lymecycline (ClinicalTrials.gov number, NCT00988026).

  9. 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.

  10. Testing the prospective evaluation of a new healthcare system

    PubMed Central

    Planitz, Birgit; Sanderson, Penelope; Freeman, Clinton; Xiao, Tania; Botea, Adi; Orihuela, Cristina Beltran

    2012-01-01

    Research into health ICT adoption suggests that the failure to understand the clinical workplace has been a major contributing factor to the failure of many computer-based clinical systems. We suggest that clinicians and administrators need methods for envisioning future use when adopting new ICT. This paper presents and evaluates a six-stage “prospective evaluation” model that clinicians can use when assessing the impact of a new electronic patient information system on a Specialist Outpatients Department (SOPD). The prospective evaluation model encompasses normative, descriptive, formative and projective approaches. We show that this combination helped health informaticians to make reasonably accurate predictions for technology adoption at the SOPD. We suggest some refinements, however, to improve the scope and accuracy of predictions. PMID:23304347

  11. Dexmedetomidine in Postoperative Analgesia in Patients Undergoing Hysterectomy: A CONSORT-Prospective, Randomized, Controlled Trial.

    PubMed

    Ren, Chunguang; Chi, Meiying; Zhang, Yanwei; Zhang, Zongwang; Qi, Feng; Liu, Zhong

    2015-08-01

    Both dexmedetomidine and sufentanil modulate spinal analgesia by different mechanisms, and yet no human studies are available on their combination for analgesia during the first 72 hours after abdominal hysterectomy.This CONSORT-prospective, randomized, double-blinded, controlled trial sought to evaluate the safety and efficacy of the combination of dexmedetomidine and sufentanil in intravenous patient-controlled analgesia (PCA) for 72 hours after abdominal hysterectomy.Ninety women undergoing total abdominal hysterectomy were divided into 3 equal groups that received sufentanil (Group C; 0.02 μg/kg/h), sufentanil plus dexmedetomidine (Group D1; 0.02 μg/kg/h, each), or sufentanil (0.02 μg/kg/h) plus dexmedetomidine (0.05 μg/kg/h) (Group D2) for 72 hours after surgery in this double-blinded, randomized study. The primary outcome measure was the postoperative sufentanil consumption, whereas the secondary outcome measures were pain intensity (visual analogue scale), requirement of narcotic drugs during the operation, level of sedation, Bruggrmann comfort scale, and concerning adverse effects.The postoperative sufentanil consumption was significantly lower in Groups D1 and D2 than in Group C during the observation period (P < 0.05), but lower in Group D2 than in Group D1 at 24, 48, and 72 hours after surgery (P < 0.05). The heart rate after intubation and incision was lower in Groups D1 and D2 than in Group C (P < 0.05). On arrival at the recovery room, Groups D1 and D2 had lower mean blood pressure than Group C (P < 0.05). The intraoperative requirement of sevoflurane was 30% lesser in Groups D1 and D2 than in Group C. The sedation levels were greater in Groups D1 and D2 during the first hour (P < 0.05). Compared with Groups C and D1, Group D2 showed lower levels of the overall incidence of nausea and vomiting (P < 0.05).Among the tested PCA options, the addition of dexmedetomidine (0.05 μg/kg/h) and sufentanil (0.02

  12. A Prospective Randomized Study Comparing the Interference Screw and Suture Anchor Techniques for Biceps Tenodesis.

    PubMed

    Park, Ji Soon; Kim, Sae Hoon; Jung, Ho Jin; Lee, Ye Hyun; Oh, Joo Han

    2017-02-01

    Several methods are used to perform biceps tenodesis in patients with superior labrum-biceps complex (SLBC) lesions accompanied by a rotator cuff tear. However, limited clinical data are available regarding the best technique in terms of clinical and anatomic outcomes. To compare the clinical and anatomic outcomes of the interference screw (IS) and suture anchor (SA) fixation techniques for biceps tenodesis performed along with arthroscopic rotator cuff repair. Randomized controlled trial; Level of evidence, 2. A total of 80 patients who underwent arthroscopic rotator cuff repair with SLBC lesions were prospectively enrolled and randomly divided according to the tenodesis method: the IS and SA groups. Functional outcomes were evaluated with the visual analog scale (VAS) for pain, American Shoulder and Elbow Surgeons (ASES) score, Simple Shoulder Test (SST), Constant score, Korean Shoulder Score (KSS), and long head of the biceps (LHB) score at least 2 years after surgery. The anatomic status of tenodesis was estimated using magnetic resonance imaging or ultrasonography, and the anatomic failure of tenodesis was determined when the biceps tendon was not traced in the intertubercular groove directly from the insertion site of the IS or SA. Thirty-three patients in the IS group and 34 in the SA group were monitored for more than 2 years. All postoperative functional scores improved significantly compared with the preoperative scores (all P < .001) and were not significantly different between the groups, including the LHB score (all P > .05). Nine anatomic failures of tenodesis were observed: 7 in the IS group and 2 in the SA group ( P = .083). In a multivariate analysis using logistic regression, IS fixation ( P = .003) and a higher (ie, more physically demanding) work level ( P = .022) were factors associated with the anatomic failure of tenodesis significantly. In patients with tenodesis failure, the LHB score ( P = .049) and the degree of Popeye deformity by the

  13. A comparative prospective randomized clinical study of MTA and IRM as root-end filling materials in single-rooted teeth in endodontic surgery.

    PubMed

    Lindeboom, Jerome A H; Frenken, Joost W F H; Kroon, Frans H M; van den Akker, Hans P

    2005-10-01

    Randomized clinical prospective study to evaluate the application of MTA and IRM as retrograde sealers in surgical endodontics. One hundred single-rooted teeth were surgically treated. After randomization, MTA or IRM was used as a retrosealer. Radiographs were taken 1 week, 3 months, and 1 year postoperatively. Assessment was performed by 2 independent assessors 1 year after surgery. Both treatment groups were homogeneous in their composition, and clinical features and radiographic findings were classified according to Rud's classification. Complete healing was observed in 64% of the MTA-treated teeth vs 50% of the IRM-treated teeth. Incomplete healing was seen in 28% (MTA) vs 36% (IRM), and unsatisfactory in 6% (MTA) vs 14% (IRM). Only 1 failure was seen (MTA). No statistically significant differences were found between the 2 retrofilling materials. As root-end filling materials in this clinical prospective randomized design on single rooted teeth, MTA and IRM had the same clinical effectiveness.

  14. A Prospective Randomized Controlled Trial of an Interpersonal Violence Prevention Program With a Mexican American Community

    PubMed Central

    Kelly, Patricia J.; Lesser, Janna; Cheng, An-Lin; Osóos-Sánchez, Manuel; Martinez, Elisabeth; Pineda, Daniel; Mancha, Juan

    2014-01-01

    Using methods of community-based participatory research, a prospective randomized controlled trial of a violence prevention program based on Latino cultural values was implemented with elementary school children in a Mexican American community. Community members participated in intervention program selection, implementation, and data collection. High-risk students who participated in the program had greater nonviolent self-efficacy and demonstrated greater endorsement of program values than did high-risk students in the control group. This collaborative partnership was able to combine community-based participatory research with a rigorous study design and provide sustained benefit to community partners. PMID:20531101

  15. Safety of fondaparinux for prevention of postoperative venous thromboembolism in urological malignancy: A prospective randomized clinical trial.

    PubMed

    Hata, Kenichi; Kimura, Takahiro; Tsuzuki, Shunsuke; Ishii, Gen; Kido, Masahito; Yamamoto, Toshihiro; Sasaki, Hiroshi; Miki, Jun; Yamada, Hiroki; Furuta, Akira; Miki, Kenta; Egawa, Shin

    2016-11-01

    To prospectively evaluate the safety of postoperative fondaparinux in comparison with low molecular weight heparin in patients undergoing uro-oncological surgery. The present study was a prospective, single-blind, non-inferiority randomized trial. A total of 359 patients undergoing surgery for urological malignancy were enrolled from January 2011 to December 2012. A total of 298 of these patients (fondaparinux group, 152; low molecular weight heparin group, 146) were evaluable for the intention-to-treat-analysis. Patients were randomly assigned to low-dose unfractionated heparin, 5000 units twice daily until postoperative day 1 plus either fondaparinux 2.5 mg once daily or low molecular weight heparin 2000 units twice daily until postoperative day 5. The primary end-point was postoperative bleeding as by independent review, and the study was powered to show the non-inferiority of fondaparinux versus low molecular weight heparin. The other adverse events were evaluated. D-dimer and soluble fibrin monomer complex levels were measured perioperatively. Bleeding occurred in 21 patients (12 in the fondaparinux group and 9 in low molecular weight heparin group, respectively). No significant differences were detected in the incidence of postoperative bleeding and the other adverse events between the two groups. The D-dimer was elevated on postoperative day 1 in one patient (16.6 μg/mL). In another patient, the soluble fibrin monomer complex was elevated (109 μg/mL). Fondaparinux is non-inferior to low molecular weight heparin with respect to risk of bleeding. The favorable safety profile of fondparinux supports its prophylactic use as an alternative to low molecular weight heparin after surgery for urological malignancy. © 2016 The Japanese Urological Association.

  16. Barbed versus standard sutures for closure in total knee arthroplasty: a multicenter prospective randomized trial.

    PubMed

    Gililland, Jeremy M; Anderson, Lucas A; Barney, Jacob K; Ross, Hunter L; Pelt, Christopher E; Peters, Christopher L

    2014-09-01

    Barbed suture has been associated with improved closure efficiency and safety in TKA in prior studies. We performed a multicenter randomized controlled trial to determine the efficiency and safety of this technology in TKA. We prospectively randomized 411 patients undergoing primary TKA to either barbed running (n=191) or knotted interrupted suture closure (n=203). Closure time was measured intra-operatively. Cost analysis was based on suture and OR time costs. Closure time was shorter with barbed suture (9.8 vs. 14.5 min, p<0.001). Total closure cost was less with barbed suture ($324 vs. $419, p<0.001). Early complications and outcomes were similar between groups. The use of barbed suture in TKA is associated with shorter closure time, lower cost and similar outcomes and complications when compared with standard sutures. Published by Elsevier Inc.

  17. Prospective randomized study of viscous lidocaine versus benzocaine in a GI cocktail for dyspepsia.

    PubMed

    Vilke, Gary M; Jin, Albert; Davis, Daniel P; Chan, Theodore C

    2004-07-01

    We hypothesized that Benzocaine (Hurricaine) would work as quickly and effectively as viscous Lidocaine in this preparation. This was a prospective randomized, single-blinded comparison between Benzocaine and Lidocaine as the topical anesthetic in a gastrointestinal (GI) cocktail. Patients 18 years or older were approached for participation when a GI cocktail was ordered by the Emergency Physician. Patients were randomized to equivalent doses of either Benzocaine or viscous Lidocaine in addition to 30 cc of Maalox and 10 cc of Donnatal. Assessment using a visual analog pain scale occurred at time intervals of 0, 5, 15, and 30 min. Eighty-two patients were enrolled (44 to Benzocaine, 38 to viscous Lidocaine), with each group having a statistically significant improvement in pain (p < 0.001). There were no statistical differences between the Benzocaine and viscous Lidocaine groups in terms of the relief of symptoms at each of the assessment times. There were no adverse outcomes in either group.

  18. Prospect evaluation as a function of numeracy and probability denominator.

    PubMed

    Millroth, Philip; Juslin, Peter

    2015-05-01

    This study examines how numeracy and probability denominator (a direct-ratio probability, a relative frequency with denominator 100, a relative frequency with denominator 10,000) affect the evaluation of prospects in an expected-value based pricing task. We expected that numeracy would affect the results due to differences in the linearity of number perception and the susceptibility to denominator neglect with different probability formats. An analysis with functional measurement verified that participants integrated value and probability into an expected value. However, a significant interaction between numeracy and probability format and subsequent analyses of the parameters of cumulative prospect theory showed that the manipulation of probability denominator changed participants' psychophysical response to probability and value. Standard methods in decision research may thus confound people's genuine risk attitude with their numerical capacities and the probability format used.

  19. Intensive insulin therapy in severely burned pediatric patients: a prospective randomized trial.

    PubMed

    Jeschke, Marc G; Kulp, Gabriela A; Kraft, Robert; Finnerty, Celeste C; Mlcak, Ron; Lee, Jong O; Herndon, David N

    2010-08-01

    Hyperglycemia and insulin resistance have been shown to increase morbidity and mortality in severely burned patients, and glycemic control appears essential to improve clinical outcomes. However, to date no prospective randomized study exists that determines whether intensive insulin therapy is associated with improved post-burn morbidity and mortality. To determine whether intensive insulin therapy is associated with improved post-burn morbidity. A total of 239 severely burned pediatric patients with burns over greater than 30% of their total body surface area were randomized (block randomization 1:3) to intensive insulin treatment (n = 60) or control (n = 179). Demographics, clinical outcomes, sepsis, glucose metabolism, organ function, and inflammatory, acute-phase, and hypermetabolic responses were determined. Demographics were similar in both groups. Intensive insulin treatment significantly decreased the incidence of infections and sepsis compared with controls (P < 0.05). Furthermore, intensive insulin therapy improved organ function as indicated by improved serum markers, DENVER2 scores, and ultrasound (P < 0.05). Intensive insulin therapy alleviated post-burn insulin resistance and the vast catabolic response of the body (P < 0.05). Intensive insulin treatment dampened inflammatory and acute-phase responses by deceasing IL-6 and acute-phase proteins compared with controls (P < 0.05). Mortality was 4% in the intensive insulin therapy group and 11% in the control group (P = 0.14). In this prospective randomized clinical trial, we showed that intensive insulin therapy improves post-burn morbidity. Clinical trial registered with www.clinicaltrials.gov (NCT00673309).

  20. [Assessment of nociceptive suppression in laparoscopic postoperative status: prospective, randomized and comparative study with a control group].

    PubMed

    Jaime, A; Hernández-Favela, P; Zamora, R; Nava, E; Barroso, G; Kably, A

    2001-08-01

    In recent years endoscopic surgery has became a highly demanded procedure because it is an easy method for diagnosis and treatment in gynecological field. Post-operative pain is considered as a condition in the morbidity status. The objective of this study was to evaluate the nociceptive suppression in laparoscopic surgery. A prospective randomized trial was performed in order to evaluate this condition. A total of 45 patients were included. Three groups were randomized using two different anesthetics applied in the cult-de-sac and uterine-bladder union. Group A (n-15) received bupivacaine, group B (n = 15) ropivacaine and group C (control) saline solution was instilled. The pain was scored using the visual analog scale as same as blood pressure and heart rate in a 15 minute intervals in the recovery room. For study design there were no differences in age, weight, height and body mass index (EMI). The surgical and anesthetic times were similar among groups. However there were significant differences when pain was evaluated. For a less toxic effects and good preventive analgesia we recommend to use ropivacaine in the postoperative status.

  1. A comparative, prospective, and randomized study of two conservative treatment protocols for first-episode lateral ankle ligament injuries.

    PubMed

    Prado, Marcelo Pires; Mendes, Alberto Abussamra Moreira; Amodio, Daniel Tasseto; Camanho, Gilberto Luis; Smyth, Niall A; Fernandes, Tulio Diniz

    2014-03-01

    The objective of this study was to investigate functional results, the amount of time that patients missed from regular working activities, and the incidence of residual mechanical ankle instability following conservative treatment of a first episode of severe lateral ankle ligament sprain (with articular instability). This prospective and randomized study included 186 patients with severe lateral ankle ligament injuries, who were randomly assigned into 2 conservative treatment groups. In group A, participants were treated with a walking boot with weight-bearing allowed, pain management, ice, and elevation with restricted joint mobilization for 3 weeks. In group B, patients were treated with a functional brace for 3 weeks. After this period, patients from both groups were placed in a short, functional brace for an additional 3 weeks, during which they also started a rehabilitation program. No statistically significant difference was found in pain intensity score between the 2 groups; however, functional evaluations based on the AOFAS ankle and hindfoot score system showed a statistically significant improvement in the group treated with the functional brace. In addition, the average recovery period necessary for patients of group B to resume their duties was shorter than that for patients in group A. No significant difference was detected in residual mechanical ankle instability between the 2 groups. Patients with severe lateral ankle ligament lesions treated with a functional brace were shown to exhibit somewhat better results than those treated with a walking boot, and both methods presented a very low incidence of residual chronic instability. We found adequate conservative treatment was sufficient to reestablish ankle stability and that functional treatment had a marginally better clinical short-term outcome with a shorter average recovery period. Level I, prospective randomized study.

  2. Durability of the next-generation flexible fiberoptic ureteroscopes: a randomized prospective multi-institutional clinical trial.

    PubMed

    Knudsen, Bodo; Miyaoka, Ricardo; Shah, Ketul; Holden, Timothy; Turk, Thomas M T; Pedro, Renato N; Kriedberg, Carly; Hinck, Bryan; Ortiz-Alvarado, Omar; Monga, Manoj

    2010-03-01

    To evaluate the durability of 4 next-generation flexible ureteroscopes in a randomized, multi-institutional, prospective study. Patients at 3 institutions were randomized to 1 of 4 flexible ureteroscopes: the Wolf Viper, Olympus URF-P5, Gyrus-ACMI DUR-8 Elite (DUR-8E), and Stryker FlexVision U-500. Each center used 1 scope from each manufacturer until it needed major repair (primary endpoint). Intraoperative data included total time of use, number of scope insertions through an access sheath, working time in the lower pole, number of insertions and total time for accessory instrumentation in the working channel, number of laser insertions through the working channel, and total laser energy used. A total of 175 patients were randomized. The DUR-8E experienced early catastrophic failure (< or = 10 cases) at all 3 sites; however, this also occurred at 1 site each for the Stryker and Wolf scopes. The DUR-8E required major repair after the fewest average number of cases (5.3), the lowest average total time of usage (108 minutes), the fewest insertions through an access sheath (20.3), the shortest duration of laser firing (31.3 minutes), and the shortest instrument in the working channel time (224.7 minutes). As such, due to variation in durability within manufacturers, no differences could be demonstrated. Visibility ratings for the Wolf iper were significantly better than the DUR-8E (P = .034) and the Flexvision (P = .038). The Wolf Viper, Olympus URF-P5, and Stryker Flexvision U-500 flexible ureteroscopes seem comparable with regard to durability. However, larger prospective registry-based studies are needed to document significant differences between them. 2010 Elsevier Inc. All rights reserved.

  3. A Randomized Prospective Comparison of Patient-Assessed Satisfaction and Clinical Outcomes with Radioactive Seed Localization Versus Wire Localization

    PubMed Central

    Bloomquist, Erica V.; Ajkay, Nicolas; Patil, Sujata; Collett, Abigail E.; Frazier, Thomas G.; Barrio, Andrea V.

    2015-01-01

    Background Radioactive seed localization (RSL) has emerged as an alternative to wire localization (WL) in patients with non-palpable breast cancer. Few studies have prospectively evaluated patient satisfaction and outcomes with RSL. We report the results of a randomized trial comparing RSL to WL in our community hospital. Materials and Methods We prospectively enrolled 135 patients with non-palpable breast cancer between 2011 and 2014. Patients were randomized to RSL or WL. Patients rated the pain and the convenience of the localization on a 5-point Likert scale. Characteristics and outcomes were compared between groups. Results Of 135 patients enrolled, 10 were excluded (benign pathology, palpable cancer, mastectomy and previous ipsilateral cancer) resulting in 125 patients. Seventy patients (56%) were randomized to RSL and 55 (44%) to WL. Fewer patients in the RSL group reported moderate to severe pain during the localization procedure compared to the WL group (12% versus 26%, respectively, p=0.058). The overall convenience of the procedure was rated as very good to excellent in 85% of RSL patients compared to 44% of WL patients (p<0.0001). There was no difference between the volume of the main specimen (p=0.67), volume of the first surgery (p=0.67), or rate of positive margins (p=0.53) between groups. Conclusions RSL resulted in less severe pain and higher convenience compared to WL, with comparable excision volume and positive margin rates. High patient satisfaction with RSL provides another incentive for surgeons to strongly consider RSL as an alternative to WL. PMID:26696461

  4. A randomized prospective comparison of intermittent methotrexate, methotrexate with leucovorin, and a methotrexate combination in head and neck cancer.

    PubMed

    DeConti, R C; Schoenfeld, D

    1981-09-01

    A randomized prospective clinical trial involved 259 cases of advanced recurrent Stage III and IV epidermoid cancers of the head and neck. The cases were randomized among three treatment programs evaluating two dose schedules and a combination treatment of methotrexate. The treatments consisted of: weekly methotrexate, biweekly methotrexate with leucovorin rescue (ML), and biweekly ML combined with cyclophosphamide and cytosine arabinoside (MLCC). Equivalent overall drug-related toxicity was produced with a 5% drug-related fatality rate. Methotrexate alone produced significantly more skin and mucosal toxicity, and the combination (MLCC) resulted in more hematologic toxicity than other treatments. Complete and partial objective responses were achieved in 26%, 24%, and 18% by each treatment. Methotrexate alone produced a median duration of response and 105 days compared with 42 and 49 days from the other treatments. Duration of response was significantly longer and survival was better in the methotrexate-alone group. Response was markedly stage dependent; 40% of Stage III patients achieved response, whereas only 17% of Stage IV patients responded. Presence of visceral metastases decreased response rates and the likelihood of response was particularly compromised by pulmonary metastatic spread; only seven of 54 such patients responded. Decreased survival was related to non-ambulatory performance status, disease-free intervals of less than one year and weight loss. Survival differences between Stage III and IV patients could not be shown. This study demonstrates the therapeutic superiority of weekly i.v. treatment with methotrexate but failed to support claims of an improved therapeutic index for high-dose methotrexate with leucovorin rescue. As the only randomized prospective clinical trial of chemotherapy in advanced head and neck cancer, this study reinforces the weekly i.v. schedule of methotrexate as the standard against which other drug schedules and drug

  5. Laparoendoscopic single-site versus conventional laparoscopic total extraperitoneal hernia repair: a prospective randomized clinical trial.

    PubMed

    Tsai, Yao-Chou; Ho, Chen-Hsun; Tai, Huai-Ching; Chung, Shiu-Dong; Chueh, Shih-Chieh

    2013-12-01

    This study aimed to compare laparoendoscopic single-site (LESS) total extraperitoneal (TEP) repair with conventional laparoscopic TEP repair for the treatment of inguinal hernias. To date, no other studies have compared the LESS and conventional laparoscopic TEP approaches for the treatment of inguinal hernia in a prospective randomized study setting. For this study, 100 patients undergoing inguinal hernia repair were prospectively randomized into either the LESS TEP group or the conventional laparoscopic TEP group. Pre-, intra-, and postoperative factors were recorded. The primary end point was postoperative pain. The patients were interviewed at outpatient clinics at 1 week, 3 months, and 6 months postoperatively. The demographic data were comparable between the two groups. The median operative time was longer in the LESS TEP group (63.5 min) than in the conventional TEP group (50.5 min) (p = 0.001). No conversion was performed in either group. The mean pain score 2 h postoperatively during rest was significantly higher in the conventional TEP group than in the LESS TEP group (3.9 vs. 2.6; p = 0.02). The postoperative results were comparable between the groups in terms of analgesic requirements, systemic stress responses, complications, and postoperative convalescence. The LESS TEP technique is associated with a longer operative time but offers the minor benefit of a reduction in immediate postoperative pain.

  6. Lidocaine versus mepivacaine in sedated pediatric dental patients: randomized, prospective clinical study.

    PubMed

    Çalış, Aylin Sipahi; Cagiran, Esra; Efeoglu, Candan; Ak, Aslı Topaloglu; Koca, Huseyın

    2014-01-01

    Dental anxiety is usually seen in the pediatric patients. specially in the case of minor oral surgical procedures and exodontia, cooperation of the patients and their families with the dentist will lead to superior treatment outcomes. Pain control is important in dentistry. The aim of this randomized prospective clinical study is to compare the local anaesthetic and haemodynamic effects of 2% lidocaine (Group 1) and 3% mepivacaine (Group 2) in sedated pediatric patients undergoing primary tooth extraction. 60 pediatric patients undergoing sedation for elective primary tooth extraction was prospectively included in the study in a randomized fashion. Inclusion and exclusion criteria were assigned. Patients were given premedication via oral route. Local anesthesia was achieved before extraction(s). There were no significant differences between the groups in patient demographics, number of teeth extracted, duration of the operation and time from the end of the procedure to discharge (p ≥ 0.05). FLACC pain scale scores were not statistically significant between the groups, except at 20 minutes post-operatively when the score is significantly lower in Group 2 (p=0.029). Prevention of pain during dental procedures can nurture the relationship of the patient and dentist. Tooth extraction under sedation in pediatric patients could be safe with both local anesthetics.

  7. Laparoscopic versus open adhesiolysis for small bowel obstruction - a multicenter, prospective, randomized, controlled trial

    PubMed Central

    2014-01-01

    Background Laparoscopic adhesiolysis is emerging as an alternative for open surgery in adhesive small bowel obstruction. Retrospective studies suggest that laparoscopic approach shortens hospital stay and reduces complications in these patients. However, no prospective, randomized, controlled trials comparing laparoscopy to open surgery have been published. Methods/Design This is a multicenter, prospective, open label, randomized, controlled trial comparing laparoscopic adhesiolysis to open surgery in patients with computed-tomography diagnosed adhesive small bowel obstruction that is not resolving with conservative management. The primary study endpoint is the length of postoperative hospital stay in days. Sample size was estimated based on preliminary retrospective cohort, which suggested that 102 patients would provide 80% power to detect a difference of 2.5 days in the length of postoperative hospital stay with significance level of 0.05. Secondary endpoints include passage of stool, commencement of enteral nutrition, 30-day mortality, complications, postoperative pain, and the length of sick leave. Tertiary endpoints consist of the rate of ventral hernia and the recurrence of small bowel obstruction during long-term follow-up. Long-term follow-up by letter or telephone interview will take place at 1, 5, and 10 years. Discussion To the best of our knowledge, this trial is the first one aiming to provide level Ib evidence to assess the use of laparoscopy in the treatment of adhesive small bowel obstruction. Trial registration ClinicalTrials.gov identifier: NCT01867528. Date of registration May 26th 2013. PMID:25306234

  8. Evaluation of a Geothermal Prospect Using a Stochastic Joint Inversion Algorithm

    NASA Astrophysics Data System (ADS)

    Tompson, A. F.; Mellors, R. J.; Ramirez, A.; Dyer, K.; Yang, X.; Trainor-Guitton, W.; Wagoner, J. L.

    2013-12-01

    A stochastic joint inverse algorithm to analyze diverse geophysical and hydrologic data for a geothermal prospect is developed. The purpose is to improve prospect evaluation by finding an ensemble of hydrothermal flow models that are most consistent with multiple types of data sets. The staged approach combines Bayesian inference within a Markov Chain Monte Carlo (MCMC) global search algorithm. The method is highly flexible and capable of accommodating multiple and diverse datasets as a means to maximize the utility of all available data to understand system behavior. An initial application is made at a geothermal prospect located near Superstition Mountain in the western Salton Trough in California. Readily available data include three thermal gradient exploration boreholes, borehole resistivity logs, magnetotelluric and gravity geophysical surveys, surface heat flux measurements, and other nearby hydrologic and geologic information. Initial estimates of uncertainty in structural or parametric characteristics of the prospect are used to drive large numbers of simulations of hydrothermal fluid flow and related geophysical processes using random realizations of the conceptual geothermal system. Uncertainty in the results is represented within a ranked subset of model realizations that best match all available data within a specified norm or tolerance. Statistical (posterior) characteristics of these solutions reflect reductions in the perceived (prior) uncertainties. This work was performed under the auspices of the U.S. Department of Energy by Lawrence Livermore National Laboratory under Contract DE-AC52-07NA27344. LLNL-ABS-641792.

  9. A prospective, randomized study of empirical antifungal therapy for the treatment of chemotherapy-induced febrile neutropenia in children.

    PubMed

    Caselli, Désirée; Cesaro, Simone; Ziino, Ottavio; Ragusa, Pietro; Pontillo, Alfredo; Pegoraro, Anna; Santoro, Nicola; Zanazzo, Giulio; Poggi, Vincenzo; Giacchino, Mareva; Livadiotti, Susanna; Melchionda, Fraia; Chiodi, Marcello; Aricò, Maurizio

    2012-07-01

    Given that the rationale for empirical antifungal therapy in neutropenic children is limited and based on adult patient data, we performed a prospective, randomized, controlled trial that evaluated 110 neutropenic children with persistent fever. Those at high risk for invasive fungal infections (IFI) received caspofungin (Arm C) or liposomal amphotericinB (Arm B); those with a lower risk were randomized to receive Arm B, C, or no antifungal treatment (Arm A). Complete response to empirical antifungal therapy was achieved in 90/104 patients (86·5%): 48/56 at high risk (85·7%) [88·0% in Arm B; 83·9% in Arm C (P = 0·72)], and 42/48 at low risk (87·5%) [87·5% in control Arm A, 80·0% Arm B, 94·1% Arm C; (P = 0·41)]. None of the variables tested by multiple logistic regression analysis showed a significant effect on the probability to achieve complete response. IFI was diagnosed in nine patients (8·2%, 95% confidence interval, 3·8-15·0). This randomized controlled study showed that empirical antifungal therapy was of no advantage in terms of survival without fever and IFI in patients aged <18 years and defined with low risk of IFI. Higher risk patients, including those with relapsed cancer, appear to be the target for empirical antifungal therapy during protracted febrile neutropenia.

  10. Design and application of nickel-titanium olecranon memory connector in treatment of olecranon fractures: a prospective randomized controlled trial.

    PubMed

    Chen, Xiao; Liu, Peng; Zhu, Xiaofei; Cao, Liehu; Zhang, Chuncai; Su, Jiacan

    2013-06-01

    We carried out this study to test the efficacy of the olecranon memory connector (OMC) in olecranon fractures. We designed a prospective randomised controlled trial involving 40 cases of olecranon fractures. From May 2004 to December 2009, 40 patients with olecranon fractures were randomly assigned into two groups. Twenty patients were treated with OMC, while another 20 patients were fixed with locking plates in our hospital. The DASH score, MEP score, range of motion and radiographs were used to evaluate the postoperative elbow function and complications. For MEP score, OMC was better than the locking plate; for DASH score, complication rate, and range of elbow motion, the two methods presented no significant difference. The study showed that OMC could be an effective alternative to treat olecranon fractures.

  11. [Stabilizing splint versus relaxing appliances in the treatment of myofacial pain. Preliminary results of a prospective randomized study].

    PubMed

    Siegert, R; Gundlach, K K

    1989-11-01

    Both stabilizing splints and relaxing appliances have been recommended for the treatment of myofacial pain. It was the goal of the present study to compare the therapeutic effect of these two types of appliances. 26 patients with myofacial pain, whose symptoms were not overshadowed by arthropathy and in whom previous physiotherapy had failed to bring about sufficient pain relief, were divided into two prospectively randomized groups. They received either a stabilizing splint or a relaxing appliance. The therapeutic effect was assessed with the aid of the patients' subjective reports and the Helkimo indices. In spite of the small number of patients the statistical evaluation of the results showed stabilizing splints to be significantly (p less than 0.03) superior to relaxing appliances in the treatment of myofacial pain.

  12. New technology for the division of short gastric vessels during laparoscopic Nissen fundoplication. A prospective randomized trial.

    PubMed

    Laycock, W S; Trus, T L; Hunter, J G

    1996-01-01

    Division of the short gastric vessels (SGV) is a standard component of laparoscopic Nissen fundoplications (LNF) at our institution. This study compares our original method of vessel control, multifire clip applier (MCA) and sharp division, to the Ultracision Harmonic Scalpel LCS (LCS). Twenty consecutive patients were evaluated in a randomized prospective fashion. Times for SGV division and estimated blood loss (EBL) were recorded. Cost data represent patient charges for use of either the MCA or LCS and the charge for operative time. Use of the LCS produced a significant reduction in the time required for SGV division and in the charges to the patient. [table: see text] We feel it is important to divide the SGV in all LNFs, and LCS use can result in significant savings of time and money.

  13. Using Vascular Quality Initiative as a Platform for Organizing Multicenter, Prospective, Randomized Clinical Trials: OVERPAR Trial

    PubMed Central

    Eslami, Mohammad H.; Doros, Gheorghe; Goodney, Philip P.; Elderup-Jorgenson, Jens; Cronenwett, Jack L.; Malikova, Marina; Farber, Alik

    2014-01-01

    Background We describe the organization of a prospective, randomized, multicenter trial comparing the effectiveness of open popliteal artery aneurysm repair (OPAR) and endovascular popliteal artery aneurysm repair (EPAR) of asymptomatic popliteal artery aneurysms (PAAs) as an example for how to use the Vascular Quality Initiative (VQI) framework. Given that many centers participate in the VQI, this model can be used to perform multicenters’ prospective trials on very modest budget. Methods VQI prospectively collects data on many vascular procedures. These data include many important perioperative, intraoperative, and postoperative details regarding both patients and their procedures. We describe a study where minimal changes to the collected data by participating centers can provide level-1 evidence regarding a significant clinical question. Data will be collected using modified VQI forms within the existing VQI data reporting structure. We plan to enroll 148 patients with asymptomatic PAAs into the open and endovascular surgery cohorts. Patients from participating VQI centers will be randomized 1:1 to either OPAR or EPAR and will be followed for an average of 2.5 years. Our primary hypothesis is that major adverse limb event–free survival is lower in the EPAR cohort and that EPAR is associated with more secondary interventions, improved quality of life, and decreased length of stay. The budget for this trial is fixed at $10,000/year for the course of the study, and the trial is judged to be feasible because of the functionality of the VQI platform. Conclusions Using the existing VQI infrastructure, Open versus Endovascular Repair of Popliteal Artery Aneurysm will provide level 1 data for PAA treatment on a modest budget. The proposed trial has an adequately powered comparative design that will use objective performance goals to describe limb-related morbidity and procedural reintervention rates. PMID:25311746

  14. [Mucosa advancement flap anoplasty in treatment of chronic anal fissures: a prospective, multicenter, randomized controlled trial].

    PubMed

    Wang, Zhen-yi; Liu, Hua; Sun, Jian-hua; Mao, Xu-ming; Xu, Wei-xiang; Wu, Ying-ge; Zhang, Hai-yan; Zhu, Li-juan; Jin, Wei; Wu, Jiong; Li, Ying; Wu, Chuang; Jiang, Zai-long; Shi, Li; Li, Yan; Dong, Wei

    2011-04-01

    Anal fissure is one of the most common anal-rectum diseases, and approximately 10 percent patients with chronic anal fissure ultimately receive surgery. Relieving postoperative pain and protecting functions of the sphincter are central issues for coloproctologists. To evaluate the efficacy and safety of anoplasty in the treatment of chronic anal fissures. In this prospective, multicenter, randomized controlled trial, 120 adult patients with chronic anal fissure were referred from Department of Coloproctology of Yueyang Hospital of Integrated Traditional Chinese Medicine Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine and Shanghai Municipal Hospital of Traditional Chinese Medicine. The patients were enrolled from January 2009 to April 2010 and randomly divided into study (mucosa advancement flap anoplasty, abbreviated as anoplasty) group and control (fissurectomy) group. The two groups were assessed separately, and the main outcome measures were observed for 2 weeks, with a short-term follow-up for 6 weeks. Degree of pain, haemorrhage and anal canal pressure were observed and recorded preoperatively, and on the third day, the fourteenth day and the sixth week postoperatively. The wound healing time was also recorded. Surgical complications of the two groups were recorded and compared on the third day and the sixth week postoperatively. The curative effects associated with the surgery were analyzed on the fourteenth day and the sixth week after surgery and the therapeutic results were evaluated. Three patients were dropped out due to the early discharge from hospital and losing connection (1 in study group and 2 in control group). Overall the surgery showed that the anoplasty group had better results than the fissurectomy group in the curative effect on the sixth week after operation (P<0.05). Time of wound healing in the anoplasty group was (17.22 ± 4

  15. Efficacy of direct arthroscopy-guided suprascapular nerve block after arthroscopic rotator cuff repair: a prospective randomized study.

    PubMed

    Lee, Jae Jun; Yoo, Yon-Sik; Hwang, Jung-Taek; Kim, Do-Young; Jeon, Seong-Jae; Hwang, Sung Mi; Jang, Ji Su

    2015-02-01

    The purpose of this study was to evaluate the outcomes of arthroscopy-guided direct suprascapular nerve block performed after arthroscopic rotator cuff repair. In the present prospective, randomized, double-blinded clinical study, 30 patients were divided into two groups: 15 patients (group I) were treated with arthroscopy-guided suprascapular nerve block using 10 mL 0.5 % ropivacaine with 1:200,000 epinephrine, and 15 patients (group II) were treated with placebo using 10 mL 0.9 % saline after arthroscopic rotator cuff repair. Patient pain levels were measured using the visual analog scale (VAS) at 1, 3, 6, 12, 18, and 24 h post-operatively. Additionally, the number of boluses and total amount of fentanyl dispensed by patient-controlled analgesia administration during the 24-h post-operative period were evaluated. VAS scores did not differ significantly between groups I and II during the 24-h post-operative period, but mean fentanyl bolus consumption was significantly less in group I compared with group II (p = 0.015). Arthroscopy-guided suprascapular nerve block at the end of a rotator cuff repair was safe and less time-consuming than expected. Although this procedure did not significantly reduce the post-operative pain, the post-operative need for fentanyl boluses as analgesia was reduced significantly, and it would be beneficial if this procedure involved a sensory branch of axillary nerve block or was performed at the beginning of the arthroscopic procedure. Prospective, randomized, double-blinded clinical trial, Level I.

  16. Cardiac catheterization laboratory inpatient forecast tool: a prospective evaluation.

    PubMed

    Toerper, Matthew F; Flanagan, Eleni; Siddiqui, Sauleh; Appelbaum, Jeff; Kasper, Edward K; Levin, Scott

    2016-04-01

    To develop and prospectively evaluate a web-based tool that forecasts the daily bed need for admissions from the cardiac catheterization laboratory using routinely available clinical data within electronic medical records (EMRs). The forecast model was derived using a 13-month retrospective cohort of 6384 catheterization patients. Predictor variables such as demographics, scheduled procedures, and clinical indicators mined from free-text notes were input to a multivariable logistic regression model that predicted the probability of inpatient admission. The model was embedded into a web-based application connected to the local EMR system and used to support bed management decisions. After implementation, the tool was prospectively evaluated for accuracy on a 13-month test cohort of 7029 catheterization patients. The forecast model predicted admission with an area under the receiver operating characteristic curve of 0.722. Daily aggregate forecasts were accurate to within one bed for 70.3% of days and within three beds for 97.5% of days during the prospective evaluation period. The web-based application housing the forecast model was used by cardiology providers in practice to estimate daily admissions from the catheterization laboratory. The forecast model identified older age, male gender, invasive procedures, coronary artery bypass grafts, and a history of congestive heart failure as qualities indicating a patient was at increased risk for admission. Diagnostic procedures and less acute clinical indicators decreased patients' risk of admission. Despite the site-specific limitations of the model, these findings were supported by the literature. Data-driven predictive analytics may be used to accurately forecast daily demand for inpatient beds for cardiac catheterization patients. Connecting these analytics to EMR data sources has the potential to provide advanced operational decision support. © The Author 2015. Published by Oxford University Press on behalf of the

  17. Efficacy of exercise and ultrasound in patients with lumbar spinal stenosis: a prospective randomized controlled trial.

    PubMed

    Goren, Ahmet; Yildiz, Necmettin; Topuz, Oya; Findikoglu, Gulin; Ardic, Fusun

    2010-07-01

    To assess the effectiveness of therapeutic exercises alone and in combination with a single physical agent - ultrasound - in patients with lumbar spinal stenosis. Randomized, prospective, controlled trial. Department of Physical Medicine and Rehabilitation, University Hospital. Forty-five patients presenting with symptoms of neurological claudication and magnetic resonance image-proven lumbar spinal stenosis were assigned to one of three groups: ultrasound plus exercise group (group 1, n =15), sham ultrasound plus exercise group (group 2, n= 15) and no exercise - no treatment group (control group, n = 15). Stretching and strengthening exercises for lumbar, abdominal, leg muscles as well as low-intensity cycling exercises were given as therapeutic exercises. Ultrasound was applied with 1 mHz, 1.5 W/cm(2) intensity, in continuous mode on the back muscle for 10 minutes in group 1 while ultrasound on/off mode was applied in group 2. Before and after a three-week period, all subjects were evaluated by pain, disability, functional capacity and consumption of analgesic. Thirty-two of the participants were women and 13 were men, with an average age of 53.2 +/- 12.68 years (range 25-82 years). After a three-week treatment period, leg pain decreased in group 1 (-1.47 +/- 3.02) and group 2 (-2.47 +/- 3.75) compared with the control group (P<0.05). Disability score decreased in group 1 (-3.94 +/- 7.20) and group 2 (-7.80 +/- 10.26) compared with control group (P<0.05). We did not find any statistically significant difference between groups 1 and 2 (P>0.05). The amount of analgesic consumption is significantly less in the group with ultrasound application compared to that in the control group (P<0.05). The results of our study suggest that therapeutic exercises are effective for pain and disability in patients with lumbar spinal stenosis and that addition of ultrasound to exercise therapy lowers the analgesic intake substantially.

  18. Use of Play Therapy in Nursing Process: A Prospective Randomized Controlled Study.

    PubMed

    Sezici, Emel; Ocakci, Ayse Ferda; Kadioglu, Hasibe

    2017-03-01

    Play therapy is a nursing intervention employed in multidisciplinary approaches to develop the social, emotional, and behavioral skills of children. In this study, we aim to determine the effects of play therapy on the social, emotional, and behavioral skills of pre-school children through the nursing process. A single-blind, prospective, randomized controlled study was undertaken. The design, conduct, and reporting of this study adhere to the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The participants included 4- to 5-year-old kindergarten children with no oral or aural disabilities and parents who agreed to participate in the study. The Pre-school Child and Family Identification Form and Social Competence and the Behavior Evaluation Scale were used to gather data. Games in the play therapy literature about nursing diagnoses (fear, social disturbance, impaired social interactions, ineffective coping, anxiety), which were determined after the preliminary test, constituted the application of the study. There was no difference in the average scores of the children in the experimental and control groups in their Anger-Aggression (AA), Social Competence (SC), and Anxiety-Withdrawal (AW) scores beforehand (t = 0.015, p = .988; t = 0.084, p = .933; t = 0.214, p = .831, respectively). The difference between the average AA and SC scores in the post-test (t = 2.041, p = .045; t = 2.692, p = .009, respectively), and the retests were statistically significant in AA and SC average scores in the experimental and control groups (t = 4.538, p = .000; t = 4.693; p = .000, respectively). In AW average scores, no statistical difference was found in the post-test (t = 0.700, p = .486), whereas in the retest, a significant difference was identified (t = 5.839, p = .000). Play therapy helped pre-school children to improve their social, emotional, and behavioral skills. It also provided benefits for the children to decrease their fear and anxiety levels, to improve

  19. Effect of Head Position on Intraocular Pressure During Lumbar Spine Fusion: A Randomized, Prospective Study.

    PubMed

    Emery, Sanford E; Daffner, Scott D; France, John C; Ellison, Matthew; Grose, Brian W; Hobbs, Gerald R; Clovis, Nina B

    2015-11-18

    Ischemic optic neuropathy resulting in visual loss is a rare but devastating complication of spine surgery. Elevated intraocular pressure (IOP) results in decreased perfusion and possibly ischemic optic neuropathy. We performed a randomized, prospective trial to evaluate the effect of head positioning on IOP during lumbar spine fusion. The study included fifty-two patients treated at one institution. Inclusion criteria were a lumbar spine fusion and an age of eighteen to eighty years. Exclusion criteria were a diagnosis of tumor, infection, or traumatic injury or a history of eye disease, ocular surgery, cervical spine surgery, chronic neck pain, or cervical stenosis. The control group underwent the surgery with the head in neutral and the face parallel to the level operating room table whereas, in the experimental group, the neck was extended so that the face had a 10° angle of inclination in relation to the table. IOP measurements were recorded along with the corresponding blood pressure and PCO2 values at the same time points. The primary outcome measure was the change in intraocular pressure (ΔIOP, defined as the maximum IOP minus the initial IOP). Analysis of covariance (ANCOVA) was used for categorical risk factors, and regression analysis was used for continuous risk factors. The mean ΔIOP, corrected for duration of surgery, was significantly (p = 0.0074) lower in the group treated with the head elevated than it was in the group treated with the head in neutral (difference between the two groups, 4.53 mm Hg [95% confidence interval, 1.29 to 7.79 mm Hg]). No patient sustained visual loss or any cervical-spine-related complications. Head elevation for adult lumbar spine fusion performed with the patient prone resulted in significantly lower IOP measurements than those seen when the operation was done with the patient's head in neutral. As lower IOP correlates with increased optic nerve perfusion, this intervention could mitigate the risk of perioperative

  20. Air-filled vs water-filled intragastric balloon: a prospective randomized study.

    PubMed

    Giardiello, Cristiano; Borrelli, Alessandro; Silvestri, Eufemia; Antognozzi, Valentina; Iodice, Giuseppe; Lorenzo, Michele

    2012-12-01

    The positioning of an intragastric saline-filled balloon has been developed as temporary and reversible therapeutic option for treatment of morbid obesity. Recently, an air-filled balloon was also developed. The aim of this study is to prospectively compare these two devices in terms of weight loss parameters, safety, and tolerance. Sixty patients were randomized into two groups: group A (Bioenterics Intragastric Balloon-BIB; n = 30; 20 F/10 M, mean age 36.7 ± 10.9; mean BMI 46.5 ± 5.9) and group B (Endobag-Heliosphere; n = 30; 20 F/10 M, mean age 37.8 ± 10.6; mean BMI 46.1 ± 5.6). All patients of both groups were sedated with midazolam (5 mg) + Propofol (2 mg/kg i.v.). The Heliosphere Bag was air-filled with 950 ml while BIB® was inflated with 500 ml of saline and 10 ml of methylene blue. Percentage of excess weight loss (%EWL) and body mass index (BMI) were evaluated. Student t test, Fisher exact test, and χ(2) test were used for statistical analysis. Similar weight loss parameters were observed in patients treated with liquid or air-filled balloon at time of removal: mean BMI was 40.8 ± 6.2 and 41.9 ± 6.5(p = ns), and mean %EWL was 20 ± 12 and 18 ± 14 (p = ns) in groups A and B, respectively. Significant longer extraction time, with high patient discomfort, was observed in group B due to difficult passage through the cardia and the lower pharynx. Air-filled balloon can be another valid therapeutic option in the temporary treatment of obesity, but at this time, the quality of the device must be improved to ameliorate the patient compliance at removal and avoid the spontaneous deflations.

  1. Prospective evaluation of a pediatric inpatient early warning scoring system.

    PubMed

    Tucker, Karen M; Brewer, Tracy L; Baker, Rachel B; Demeritt, Brenda; Vossmeyer, Michael T

    2009-04-01

    The present study evaluated the use of the Pediatric Early Warning Score (PEWS) for detecting clinical deterioration among hospitalized children. A prospective, descriptive study design was used. The tool was used to score 2,979 patients admitted to a single medical unit of a pediatric hospital over a 12-month period. PEWS discriminated between children who required transfer to the pediatric intensive care unit and those who did not require transfer (area under the curve = 0.89, 95% CI = 0.84-0.94, p < .001). The PEWS tool was found to be a reliable and valid scoring system to identify children at risk for clinical deterioration.

  2. Is hypothermia in the victim of major trauma protective or harmful? A randomized, prospective study.

    PubMed Central

    Gentilello, L M; Jurkovich, G J; Stark, M S; Hassantash, S A; O'Keefe, G E

    1997-01-01

    OBJECTIVE: The purpose of this randomized, prospective clinical trial was to determine whether hypothermia during resuscitation is protective or harmful to critically injured trauma patients. SUMMARY BACKGROUND DATA: Hypothermia has both protective and harmful clinical effects. Retrospective studies show higher mortality in patients with hypothermia; however, hypothermia is more common in more severely injured patients, which makes it difficult to determine whether hypothermia contributes to mortality independently of injury severity. There are no randomized, prospective treatment studies to assess hypothermia's impact as an independent variable. METHODS: Fifty-seven hypothermic (T < or = 34.5 C), critically injured patients requiring a pulmonary artery catheter were randomized to a rapid rewarming protocol using continuous arteriovenous rewarming (CAVR) or to a standard rewarming (SR) control group. The primary outcome of interest was first 24-hour blood product and fluid resuscitation requirements. Other comparative analyses included coagulation assays, hemodynamic and oxygen transport measurements, length of stay, and mortality. RESULTS: The two groups were well matched for demographic and injury severity characteristics. CAVR rewarmed significantly faster than did SR (p < 0.01), producing two groups with different amounts of hypothermia exposure. The patients who underwent CAVR required less fluid during resuscitation to the same hemodynamic goals (24,702 mL vs. 32,540 mL, p = 0.05) and were significantly more likely to rewarm (p = 0.002). Only 2 (7%) of 29 patients who underwent CAVR failed to warm to 36 C and both died, whereas 12 (43%) of 28 patients who underwent SR failed to reach 36 C, and all 12 died. Patients who underwent CAVR had significantly less early mortality (p = 0.047). CONCLUSION: Hypothermia increases fluid requirements and independently increases acute mortality after major trauma. PMID:9351712

  3. Comparison of Suction Versus Nonsuction Drainage After Lung Resections: A Prospective Randomized Trial.

    PubMed

    Gocyk, Wojciech; Kużdżał, Jarosław; Włodarczyk, Janusz; Grochowski, Zbigniew; Gil, Tomasz; Warmus, Janusz; Kocoń, Piotr; Talar, Piotr; Obarski, Piotr; Trybalski, Łukasz

    2016-10-01

    Sufficiently large, prospective randomized trials comparing suction drainage and nonsuction drainage are lacking. The aim of the present study was to compare the effects of suction drainage and nonsuction drainage on the postoperative course in patients who have undergone lung resection. This prospective, randomized trial included patients undergoing different types of lung resections. On the day of surgery, suction drainage at -20 cm H2O was used. On the morning of the first postoperative day, patients, in whom the pulmonary parenchyma was fully reexpanded, were randomized in the ratio of 1:1. Patients assigned to group A continued with suction drainage, while those assigned to group B underwent nonsuction drainage. The study included 254 patients, with 127 patients in each group. The drainage volumes were 1098.8 mL and 814.4 mL in groups A and B, respectively (p = 0.0014). The times to chest tube removal were 5.61 days and 4.49 days in groups A and B, respectively (p = 0.0014). Prolonged air leakage occurred in 5.55% of patients in group A and in 0.7% of patients in group B (p = 0.032), and asymptomatic residual air spaces were noted in 0.8% of patients in group A and 9.4% of patients in group B (p = 0.0018). Nonsuction drainage is more effective than suction drainage with regard to drainage volume, drainage duration, and incidence of persistent air leakage. However, it is associated with a higher incidence of asymptomatic residual air spaces. Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  4. A prospective, randomized, single-blinded controlled trial on biodegradable synthetic polyurethane foam as a packing material after septoplasty.

    PubMed

    Kim, Yoo Suk; Kim, Young Hoon; Kim, Na Hyun; Kim, Si Hong; Kim, Kyung Rok; Kim, Kyung-Su

    2011-01-01

    We evaluated synthetic polyurethane foam (SPF; Polyganics BV, Groningen, The Netherlands) as a packing material used after septoplasty compared with Merocel (Medtronic Xomed Surgical Products, Jacksonville, FL) in the aspects of clinical efficacy and the subjective severity of symptoms. A prospective, randomized, single-blinded controlled study was performed in 64 patients who had undergone septoplasty. The patients were randomized to receive Merocel or SPF after septoplasty. Assessments of clinical efficacy on bleeding and pain were done and subjective symptoms related to packing materials were evaluated using questionnaires quantified by the visual analog scale. There was no difference in repacking or additional packing due to postoperative bleeding, bleeding and/or septal hematoma on the removal of packing, and the mucosal condition after packing removal during postoperative period between the Merocel and SPF groups. Bleeding and pain during packing removal was significantly lower in patients with SPF packing. Also, in the SPF group, patient's general satisfaction and willingness to reuse the material were higher compared with the Merocel group. SPF is as suitable as Merocel to be used after septoplasty with beneficial effects on bleeding and pain at packing removal.

  5. Laparoscopic versus open gastrectomy for gastric cancer, a multicenter prospectively randomized controlled trial (LOGICA-trial).

    PubMed

    Haverkamp, Leonie; Brenkman, Hylke J F; Seesing, Maarten F J; Gisbertz, Suzanne S; van Berge Henegouwen, Mark I; Luyer, Misha D P; Nieuwenhuijzen, Grard A P; Wijnhoven, Bas P L; van Lanschot, Jan J B; de Steur, Wobbe O; Hartgrink, Henk H; Stoot, Jan H M B; Hulsewé, Karel W E; Spillenaar Bilgen, Ernst J; Rütter, Jeroen E; Kouwenhoven, Ewout A; van Det, Marc J; van der Peet, Donald L; Daams, Freek; Draaisma, Werner A; Broeders, Ivo A M J; van Stel, Henk F; Lacle, Miangela M; Ruurda, Jelle P; van Hillegersberg, Richard

    2015-07-29

    For gastric cancer patients, surgical resection with en-bloc lymphadenectomy is the cornerstone of curative treatment. Open gastrectomy has long been the preferred surgical approach worldwide. However, this procedure is associated with considerable morbidity. Several meta-analyses have shown an advantage in short-term outcomes of laparoscopic gastrectomy compared to open procedures, with similar oncologic outcomes. However, it remains unclear whether the results of these Asian studies can be extrapolated to the Western population. In this trial from the Netherlands, patients with resectable gastric cancer will be randomized to laparoscopic or open gastrectomy. The study is a non-blinded, multicenter, prospectively randomized controlled superiority trial. Patients (≥18 years) with histologically proven, surgically resectable (cT1-4a, N0-3b, M0) gastric adenocarcinoma and European Clinical Oncology Group performance status 0, 1 or 2 are eligible to participate in the study after obtaining informed consent. Patients (n = 210) will be included in one of the ten participating Dutch centers and are randomized to either laparoscopic or open gastrectomy. The primary outcome is postoperative hospital stay (days). Secondary outcome parameters include postoperative morbidity and mortality, oncologic outcomes, readmissions, quality of life and cost-effectiveness. In this randomized controlled trial laparoscopic and open gastrectomy are compared in patients with resectable gastric cancer. It is expected that laparoscopic gastrectomy will result in a faster recovery of the patient and a shorter hospital stay. Secondly, it is expected that laparoscopic gastrectomy will be associated with a lower postoperative morbidity, less readmissions, higher cost-effectiveness, better postoperative quality of life, but with similar mortality and oncologic outcomes, compared to open gastrectomy. The study started on 1 December 2014. Inclusion and follow-up will take 3 and 5

  6. Implant supported dental rehabilitation following segmental mandibular reconstruction- quality of life outcomes of a prospective randomized trial.

    PubMed

    Kumar, Vinay V; Jacob, P C; Ebenezer, Supriya; Kuriakose, Moni A; Kekatpure, Vikram; Baliarsing, Amresh S; Al-Nawas, Bilal; Wagner, Wilfried

    2016-07-01

    The primary objective of this study was to assess the difference in quality of life (QoL) in patients with dental rehabilitation using two or four implant-supported overdentures following segmental mandibulectomy defect reconstruction with fibula free flap. This prospective, parallel designed, randomized clinical study was conducted with a 1:1 ratio. At baseline, all participants already had fibula flap reconstruction for segmental defects of the mandible and rehabilitation with conventional (non-implant supported) removable partial dentures. The participants were then randomized into two groups. Group I received implant supported overdentures on two implants, and Group II received four implants. QoL outcomes were evaluated using standardized questionnaires (EORTC_QLQ c30, H&N35, OHIP, DSI). Outcomes of treatment were evaluated at 6 months (T1) and 1 year (T2) following rehabilitation. A total of 52 patients were randomized into two treatment groups (26 each). After accounting for the loss to lack of follow-up, 22 patients in Group I and 24 patients in Group II were evaluated for QoL at the end of the study. There was a significant improvement in QoL with implant-assisted dental rehabilitation. However there were no significant differences in QoL between the two-implant and four-implant groups. Implant-supported removable overdentures improve QoL outcomes in patients with reconstructed mandibles. This study showed no significant difference in QoL outcomes in patients with two- or four-implant supported removable prostheses. Copyright © 2016 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  7. CT detector evaluation with complex random backgrounds

    NASA Astrophysics Data System (ADS)

    Fan, Helen; Barrett, Harrison H.

    2012-02-01

    Modern computed tomography (CT) uses detector arrays consisting of large numbers of photodiodes with scintil- lator crystals. The number of pixels in the array can play an important role in system performance. Considerable research has been performed on signal detection in flat backgrounds under various conditions, but little has been done with complex, random backgrounds in CT; our work investigates in particular the effect of the number of detector elements on signal detection by a channelized Hotelling observer in a complex background. For this project, a simulated three-dimensional phantom is generated with its attenuation equal to that of water. The phantom contains a smaller central section with random variations to simulate random anatomical structures. Cone-beam projections of the phantom are acquired at different angles and used to calculate the covariance matrix of the raw projection data. Laguerre-Gauss channels are used to reduce the dimensionality of each 2D projection and hence the size of the covariance matrix, but the covariance is still a function of two projection angles. A strong cross-channel correlation is observed as a function of the difference between the angles. A signal with known location and size is used, and the performance of the observer is calculated from the channel outputs at multiple projection angles. A contrast-detail diagram is computed for different variables such as signal size, number of incident x-ray photons, pixel size, etc. At a fixed observer signal-to-noise ratio (SNR), the contrast required to detect a signal increases dramatically as the signal size decreases.

  8. Methadone versus morphine for treatment of neonatal abstinence syndrome: a prospective randomized clinical trial.

    PubMed

    Brown, M S; Hayes, M J; Thornton, L M

    2015-04-01

    Compare duration of treatment of neonatal abstinence syndrome between methadone and morphine. A prospective, double-masked, randomized trial at a single site. Randomization of methadone or morphine was stratified for maternal treatment with methadone or buprenorphine. Inclusion criteria were (i) maternal treatment with prescribed methadone or buprenorphine, (ii) withdrawal treatment criteria, (iii) adjusted gestational age ⩾35(0/7) weeks and (iv) medically stable. Primary outcome was length of opioid treatment. From January 2011 through October 2012, 78 infants were eligible for the study: 41 methadone-exposed and 37 buprenorphine-exposed. Consent was obtained from 31 mothers, 13/41 (32%) methadone-treated and 18/37 (49%) buprenorphine-treated. Length of opioid treatment was significantly shorter for methadone than morphine treatment, median 14 versus 21 days (P=0.008). Methadone had a shorter length of neonatal withdrawal treatment compared with morphine. Owing to the smaller sample size and single site, a larger randomized study is needed.

  9. Erythropoietin therapy after allogeneic hematopoietic cell transplantation: a prospective, randomized trial.

    PubMed

    Jaspers, Aurélie; Baron, Frédéric; Willems, Evelyne; Seidel, Laurence; Hafraoui, Kaoutar; Vanstraelen, Gaetan; Bonnet, Christophe; Beguin, Yves

    2014-07-03

    We conducted a prospective randomized trial to assess hemoglobin (Hb) response to recombinant human erythropoietin (rhEPO) therapy after hematopoietic cell transplantation (HCT). Patients (N = 131) were randomized (1:1) between no treatment (control arm) or erythropoietin at 500 U/kg per week (EPO arm). Patients were also stratified into 3 cohorts: patients undergoing myeloablative HCT with rhEPO to start on day (D)28, patients given nonmyeloablative HCT (NMHCT) with rhEPO to start on D28, and patients also given NMHCT but with rhEPO to start on D0. The proportion of complete correctors (ie, Hb ≥13 g/dL) before D126 posttransplant was 8.1% in the control arm (median not reached) and 63.1% in the EPO arm (median, 90 days) (P < .001). Hb levels were higher and transfusion requirements decreased (P < .001) in the EPO arm, but not during the first month in the nonmyeloablative cohort starting rhEPO on D0. There was no difference in rates of thromboembolic events or other complications between the 2 arms. This is the first randomized trial to demonstrate that rhEPO therapy hastens erythroid recovery and decreases transfusion requirements when started one month after allogeneic HCT. There was no benefit to start rhEPO earlier after NMHCT.

  10. A randomized prospective comparison between intrauterine insemination and fallopian sperm perfusion for the treatment of infertility.

    PubMed

    Karande, V C; Rao, R; Pratt, D E; Balin, M; Levrant, S; Morris, R; Dudkeiwicz, A; Gleicher, N

    1995-09-01

    To determine if the pregnancy rates (PRs) in infertile women could be improved with fallopian sperm perfusion in comparison with IUI. Randomized prospective analysis. Academically affiliated infertility center. Consecutive patients undergoing controlled ovarian hyperstimulation (COH). After hCG administration, patients were randomized to either IUI or fallopian sperm perfusion. Pregnancy rates with the two treatment modalities. Of 240 COH cycles, those randomized to IUI included 44 clomiphene citrate (CC) (group I) and 76 gonadotropin (group III) cycles. Patients receiving fallopian sperm perfusion included 44 cycles of CC (group II) and 76 cycles of gonadotropin (group IV) treatment. The overall PRs per cycle (10.8% versus 10.8%) were similar for IUI and fallopian sperm perfusion, respectively. The PRs were also similar when compared for ovulation induction with CC (6.8% versus 9.1%) and gonadotropins (13.2% versus 11.8%). We conclude that fallopian sperm perfusion offers no advantage over IUI. Because the process of fallopian sperm perfusion is more time consuming and more costly (because of increased media usage), fallopian sperm perfusion does not seem indicated as a routine infertility therapy and should not replace IUI.

  11. Hyperbaric Oxygen Therapy Can Improve Post Concussion Syndrome Years after Mild Traumatic Brain Injury - Randomized Prospective Trial

    PubMed Central

    Fishlev, Gregori; Bechor, Yair; Volkov, Olga; Bergan, Jacob; Friedman, Mony; Hoofien, Dan; Shlamkovitch, Nathan; Ben-Jacob, Eshel; Efrati, Shai

    2013-01-01

    Background Traumatic brain injury (TBI) is the leading cause of death and disability in the US. Approximately 70-90% of the TBI cases are classified as mild, and up to 25% of them will not recover and suffer chronic neurocognitive impairments. The main pathology in these cases involves diffuse brain injuries, which are hard to detect by anatomical imaging yet noticeable in metabolic imaging. The current study tested the effectiveness of Hyperbaric Oxygen Therapy (HBOT) in improving brain function and quality of life in mTBI patients suffering chronic neurocognitive impairments. Methods and Findings The trial population included 56 mTBI patients 1–5 years after injury with prolonged post-concussion syndrome (PCS). The HBOT effect was evaluated by means of prospective, randomized, crossover controlled trial: the patients were randomly assigned to treated or crossover groups. Patients in the treated group were evaluated at baseline and following 40 HBOT sessions; patients in the crossover group were evaluated three times: at baseline, following a 2-month control period of no treatment, and following subsequent 2-months of 40 HBOT sessions. The HBOT protocol included 40 treatment sessions (5 days/week), 60 minutes each, with 100% oxygen at 1.5 ATA. “Mindstreams” was used for cognitive evaluations, quality of life (QOL) was evaluated by the EQ-5D, and changes in brain activity were assessed by SPECT imaging. Significant improvements were demonstrated in cognitive function and QOL in both groups following HBOT but no significant improvement was observed following the control period. SPECT imaging revealed elevated brain activity in good agreement with the cognitive improvements. Conclusions HBOT can induce neuroplasticity leading to repair of chronically impaired brain functions and improved quality of life in mTBI patients with prolonged PCS at late chronic stage. Trial Registration ClinicalTrials.gov NCT00715052 PMID:24260334

  12. Continuous postoperative blood glucose monitoring and control by artificial pancreas in patients having pancreatic resection: a prospective randomized clinical trial.

    PubMed

    Okabayashi, Takehiro; Nishimori, Isao; Yamashita, Koichi; Sugimoto, Takeki; Maeda, Hiromichi; Yatabe, Tomoaki; Kohsaki, Takuhiro; Kobayashi, Michiya; Hanazaki, Kazuhiro

    2009-10-01

    To evaluate a closed-loop system providing continuous monitoring and strict control of perioperative blood glucose following pancreatic resection. Prospective, randomized clinical trial. Thirty patients who had pancreatic resection for pancreatic neoplasm. Patients were prospectively randomized. Perioperative blood glucose levels were continuously monitored using an artificial endocrine pancreas (STG-22). Glucose levels were controlled using either the sliding scale method (sliding scale group, n = 13) or the artificial pancreas (artificial pancreas group, n = 17). Incidence of severe hypoglycemia (<40 mg/dL) during the intensive care period following pancreatic resection in patients monitored with the artificial pancreas. The secondary outcome measure was the total amount of insulin required for glycemic control in the first 18 hours after pancreatic resection in each patient group. In the sliding scale group, postoperative blood glucose levels rose initially before reaching a plateau of approximately 200 mg/dL between 4 and 6 hours after pancreatectomy. The levels remained high for 18 hours postoperatively. In the artificial pancreas group, blood glucose levels reduced steadily, reaching the target zone (80-110 mg/dL) by 6 hours after surgery. The total insulin dose administered per patient during the first postoperative 18 hours was significantly higher in the artificial pancreas group (mean [SD], 107 [109] IU) than the sliding scale group (8 [6] IU; P < .01). Neither group showed hypoglycemia. Perioperative use of an artificial endocrine pancreas to control pancreatogenic diabetes after pancreatic resection is an easy and effective way to maintain near-normal blood glucose levels. The artificial pancreas shows promise for use as insulin treatment for patients with pancreatogenic diabetes after pancreatic resection.

  13. Nd:YAG laser versus polidocanol injection for palliation of esophageal malignancy: a prospective, randomized study.

    PubMed

    Angelini, G; Pasini, A F; Ederle, A; Castagnini, A; Talamini, G; Bulighin, G

    1991-01-01

    Palliation is often the only treatment that can be offered to patients affected by esophageal malignancy. This prospective study was carried out in order to compare two endoscopic palliative treatments: Nd:YAG laser and local injection of 3% polidocanol. We randomized 34 patients with inoperable malignancies to one of the two treatments. After the first course, 88.8% of the patients in the laser group and 81.5% in the polidocanol group were able to swallow a normal oral caloric intake. Only one major complication (esophageal perforation) was observed (polidocanol group) and was successfully treated with endoscopic placement of a prosthesis. We believe that both techniques are safe and effective for the palliation of esophageal malignant strictures but that polidocanol injection is cheap, simple, and more widely available.

  14. Total hip arthroplasty using imageless computer-assisted hip navigation: a prospective randomized study.

    PubMed

    Lass, Richard; Kubista, Bernd; Olischar, Boris; Frantal, Sophie; Windhager, Reinhard; Giurea, Alexander

    2014-04-01

    In a prospective randomized study of two groups of 65 patients each, we compared the acetabular component position when using the imageless navigation system compared to the freehand conventional technique for cementless total hip arthroplasty. The position of the component was determined postoperatively on computed tomographic scans of the pelvis. There was no significant difference for postoperative mean inclination (P = 0.29), but a significant difference for mean postoperative acetabular component anteversion (P = 0.007), for mean deviation of the postoperative anteversion from the target position of 15° (P = 0.02) and for the outliers regarding inclination (P = 0.02) and anteversion (P < 0.05) between the computer-assisted and the freehand-placement group. Our results demonstrate the importance of imageless navigation for the accurate positioning of the acetabular component.

  15. Comparison between lengthening over nail and conventional Ilizarov lengthening: a prospective randomized clinical study.

    PubMed

    El-Husseini, Timour F; Ghaly, Nabil A M; Mahran, Mahmoud A; Al Kersh, Mohamed Ahmed; Emara, Khaled M

    2013-08-01

    The aim of this study is to compare lengthening over an intramedullary nail to the conventional Ilizarov method with regard to percentage length increase, external fixation index, consolidation index and incidence of complications. This is a prospective randomized controlled study. Thirty-one limbs in 28 patients were included in the study; 15 were lengthened over an intramedullary nail, and 16 limbs were lengthened conventionally. The mean duration of external fixation in the lengthening over nail group was 52.2 days compared to 180.4 days in the conventional group. There was higher incidence of complications in the conventional method group. In comparison with conventional Ilizarov lengthening, lengthening over an intramedullary nail offers a shorter period of external fixation and fewer complications overall, but there is a high incidence of deep intramedullary infection which is serious.

  16. Prospective randomized comparison of cefepime and cefotaxime for treatment of bacterial meningitis in infants and children.

    PubMed Central

    Sáez-Llorens, X; Castaño, E; García, R; Báez, C; Pérez, M; Tejeira, F; McCracken, G H

    1995-01-01

    Ninety infants and children were prospectively randomized to receive cefepime (n = 43) or cefotaxime (n = 47) for therapy of bacterial meningitis. The two treatment groups were comparable in terms of age, duration of illness before enrollment, history of seizures, clinical status on admission, and etiology. Six (7%) patients died--two treated with cefepime and four treated with cefotaxime. Clinical response, cerebrospinal fluid sterilization, development of complications, antibiotic toxicity, and hospital stay were similar for the two treatment regimens. Concentrations of cefepime in cerebrospinal fluid varied from 55 to 95 times greater than the maximal MIC required by the causative pathogens. Audiologic and/or neurologic sequelae were found in 16% of the cefepime-treated patients and 15% of the cefotaxime-treated patients examined 2 to 6 months after discharge. We conclude that cefepime is safe and therapeutically equivalent to cefotaxime for management of bacterial meningitis in infants and children. PMID:7785999

  17. Prospective randomized comparison of cefepime and cefotaxime for treatment of bacterial meningitis in infants and children.

    PubMed

    Sáez-Llorens, X; Castaño, E; García, R; Báez, C; Pérez, M; Tejeira, F; McCracken, G H

    1995-04-01

    Ninety infants and children were prospectively randomized to receive cefepime (n = 43) or cefotaxime (n = 47) for therapy of bacterial meningitis. The two treatment groups were comparable in terms of age, duration of illness before enrollment, history of seizures, clinical status on admission, and etiology. Six (7%) patients died--two treated with cefepime and four treated with cefotaxime. Clinical response, cerebrospinal fluid sterilization, development of complications, antibiotic toxicity, and hospital stay were similar for the two treatment regimens. Concentrations of cefepime in cerebrospinal fluid varied from 55 to 95 times greater than the maximal MIC required by the causative pathogens. Audiologic and/or neurologic sequelae were found in 16% of the cefepime-treated patients and 15% of the cefotaxime-treated patients examined 2 to 6 months after discharge. We conclude that cefepime is safe and therapeutically equivalent to cefotaxime for management of bacterial meningitis in infants and children.

  18. Prospective randomized clinical study of arterial pumps used for routine on pump coronary bypass grafting.

    PubMed

    Keyser, Andreas; Hilker, Michael K; Diez, Claudius; Philipp, Alois; Foltan, Maik; Schmid, Christof

    2011-05-01

    In a number of studies, centrifugal blood pumps--in comparison with roller pumps--have been shown to attenuate trauma to blood components. Nevertheless, the impact of these results on the postoperative course needs to be discussed controversially. In a prospective randomized study, 240 consecutive adult patients underwent elective myocardial revascularization with cardiopulmonary bypass employing five different pumps (Roller, Avecor, Sarns, Rotaflow, Bio-Medicus). We analyzed clinical course, blood loss, damage of blood components, and impairment of the hemostatic system. The study population was homogenous with respect to age, gender, myocardial function, and operative data. No differences were found with respect to time of ventilation, duration of intensive care stay, hospitalization, and laboratory data. The choice of arterial pump during standard extracorporeal bypass for elective coronary artery bypass grafting is no matter of concern.

  19. Carvedilol prospective randomized cumulative survival (COPERNICUS) trial: carvedilol in severe heart failure.

    PubMed

    Fowler, Michael B

    2004-05-06

    The impact of carvedilol on the survival of patients with severe heart failure was examined in the Carvedilol Prospective Randomized Cumulative Survival (COPERNICUS) trial. The trial recruited 2,289 patients with symptoms at rest or on minimal exertion despite therapy with angiotensin-converting enzyme inhibitors and a left ventricular ejection fraction of < or = 0.25. After an average follow-up period of 10.4 months, mortality was reduced by 34% in the carvedilol group. Carvedilol also reduced the number of days spent in the hospital for any cause by 27% and the number of days spent in the hospital for heart failure by 40%. Patients in the carvedilol group felt better and were less likely to have a serious adverse event. The benefits of carvedilol appeared early and were detected during the up-titration period.

  20. A prospective double blind randomized controlled study on the use of ethanol locks in HPN patients.

    PubMed

    Salonen, Bradley R; Bonnes, Sara L; Vallumsetla, Nishanth; Varayil, Jithinraj Edakkanambeth; Mundi, Manpreet S; Hurt, Ryan T

    2017-05-17

    Ethanol lock therapy (ELT) has been shown to reduce the rate of catheter-related bloodstream infection (CRBSI) in high-risk home parenteral nutrition (HPN) patients. The aim of this study was to determine whether ELT therapy for all patients newly started on HPN would reduce the incidence of CRBSI. This study was a prospective, double-blind, randomized controlled trial that was carried out from July 2014 to April 2016. The study participants were patients newly started on HPN, and they were randomly assigned to either treatment with ELT or our current standard of care with saline heparin locks. The primary outcome was occurrence of CRBSI. Thirty eight patients that were newly started on HPN were randomized to either treatment with ELT (n = 18) or to our current standard of care with heparin locks (n = 20). Four patients in the ELT group and one patient in the control arm had a CRBSI (p = 0.17). No significant adverse side effects were noted during the study. This study did not show improvement in the rate of CRBSI with ELT in all patients started on HPN. ELT therapy may be most helpful to reduce in CRBSI in high-risk HPN patients, but further studies with a randomized control trial design of high-risk patients are needed to further clarify this important issue in HPN patients. The study was registered at clinicaltrials.gov prior to patient enrollment (NCT02227329). Copyright © 2017 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  1. Prospective Randomized Controlled Trial of Liberal Vs Restricted Perioperative Fluid Management in Patients Undergoing Pancreatectomy.

    PubMed

    Grant, Florence; Brennan, Murray F; Allen, Peter J; DeMatteo, Ronald P; Kingham, T Peter; D'Angelica, Michael; Fischer, Mary E; Gonen, Mithat; Zhang, Hao; Jarnagin, William R

    2016-10-01

    The aim of this study is to examine, by a prospective randomized controlled trial, the influence of liberal (LIB) vs restricted (RES) perioperative fluid administration on morbidity following pancreatectomy. Randomized controlled trials in patients undergoing major intra-abdominal surgery have challenged the historical use of LIB fluid administration, suggesting that a more restricted regimen may be associated with fewer postoperative complications. Patients scheduled to undergo pancreatic resection were consented for randomization to a LIB (n = 164) or RES (n = 166) perioperative fluid regimen. Sample size was designed with 80% power to decrease Grade 3 complications from 35% to 21%. Between July 2009 and July 2015, we randomized 330 patients undergoing pancreaticoduodenectomy (PD, n = 218), central (n = 16), or distal pancreatectomy (DP, n = 96). Patients were equally distributed for all demographic and intraoperative characteristics. Intraoperatively, LIB patients received crystalloid 12 mL/kg/h and RES patients 6 mL/kg/h. Cumulative crystalloid given (median, range, mL) days 0 to 3 was LIB: 12,252 (6600 to 21,365), RES 7808 (2700 to 16,274) P < 0.0001. Sixty-day mortality was 2 of 330 (0.6%). Median operative time for PD was 227 minutes (105 to 462) and DP 150 (44 to 323). Grade 3 complications occurred in 20% of LIB and 27% of RES patients (P = 0.6). Median length of stay was 7 and 5 days for PD and DP, respectively, in both arms. In a high volume institution, major perioperative complications from pancreatic resection were not significantly influenced by fluid regimens that differed approximately 1.6-fold.

  2. A multimodal approach for postoperative pain management after lumbar decompression surgery: a prospective, randomized study.

    PubMed

    Garcia, Ryan Michael; Cassinelli, Ezequiel H; Messerschmitt, Patrick J; Furey, Christopher G; Bohlman, Henry H

    2013-08-01

    A prospective and randomized study. The objective of this study was to assess the efficacy of a novel multimodal analgesic regimen in reducing postoperative pain and intravenous morphine requirements after primary multilevel lumbar decompression surgery. The use of opioid medications after surgery can lead to incomplete analgesia and may cause undesired side effects such as respiratory depression, somnolence, urinary retention, and nausea. Multimodal (opioid and nonopioid combination) analgesia may be an effective alternative to morphine administration leading to improved postoperative analgesia with diminished side effects. After Institutional Review Board approval, 22 patients who underwent a primary multilevel lumbar decompression procedure were randomly assigned to receive either only intravenous morphine or a multimodal (celecoxib, pregabalin, extended release oxycodone) analgesic regimen. Postoperatively, all patients were allowed to receive intravenous morphine on an as needed basis. Intravenous morphine requirements were then recorded immediately postoperative, at 6, 12, 24 hours, and the total requirement before discharge. Patient postoperative pain levels were determined using the visual analog pain scale and were documented at 0, 4, 8, 12, 16, 24, and 36 hours postoperative. There were no significant differences in available patient demographics, intraoperative blood loss, or postoperative hemovac drain output between study groups. Total postoperative intravenous morphine requirements in addition to morphine requirements at all predetermined time points were less in patients randomized to receive the multimodal analgesic regimen. Visual analog pain scores were lower at all postoperative time points in patients randomized to receive the multimodal analgesic regimen. Time to solid food was significantly less in the multimodal group. There were no major identifiable postoperative complications in either treatment group. Opioid and nonopioid analgesic

  3. Prospective Randomized Comparison Between Transperitoneal Laparoscopic Pyeloplasty and Retroperitoneoscopic Pyeloplasty for Primary Ureteropelvic Junction Obstruction

    PubMed Central

    Singh, Vishwajeet; Gupta, Dheeraj Kumar; Kumar, Vikas; Pandey, Mohit; Akhtar, Asif

    2014-01-01

    Background and Objectives: To compare laparoscopic transperitoneal versus retroperitoneoscopic pyeloplasty for primary ureteropelvic junction obstruction in a prospective randomized manner and assess overall results with long-term follow-up. Methods: In this prospective study, from 2008 to 2012, 112 cases of primary ureteropelvic junction obstruction were randomized in a 1:1 ratio into 2 groups. Group I included patients who underwent transperitoneal laparoscopic pyeloplasty, and group II consisted of patients who underwent retroperitoneoscopic laparoscopic pyeloplasty. Demographic and clinical characteristics and postoperative and operative data were collected and analyzed. The statistical analysis was performed with the Fisher exact test, χ2 test, and Mann-Whitney U test for independent groups, and P < .05 was considered statistically significant. Results: The total operative time and intracorporeal suturing time were significantly higher in group II than in group I (P < .001). The visual analog scale score for pain on postoperative day 1 and the requirement for tramadol were significantly higher in group I than in group II (P = .004). The hospital stay and the rate of temporary ileus were significantly greater (P < .036 and P < .02, respectively) in group I than in group II. The success rate of transperitoneal laparoscopic pyeloplasty versus retroperitoneoscopic laparoscopic pyeloplasty was 96.4% versus 96.6% with a mean follow-up period of 30.75 ± 4.85 months versus 30.99 ± 5.59 months (P < .88). Conclusion: Transperitoneal laparoscopic pyeloplasty is associated with significantly greater postoperative pain, a higher tramadol dose, a higher rate of ileus, and a longer hospital stay in comparison with retroperitoneoscopic laparoscopic pyeloplasty. Although the operative time for retroperitoneoscopic laparoscopic pyeloplasty is significantly longer, the success rate remains the same for both procedures. PMID:25392671

  4. Laparoscopic versus open appendectomy: a prospective randomized trial of 81 patients

    PubMed Central

    Hart, Richard; Rajgopal, Chellapa; Plewes, Arthur; Sweeney, John; Davies, Ward; Gray, Daryl; Taylor, Brian

    1996-01-01

    Objective To compare the efficacy of laparoscopic appendectomy (LA) and open appendectomy (OA) in the treatment of acute appendicitis. Design A prospective randomized trial. Setting A university teaching hospital. Patients Eighty-one patients with a diagnosis of acute appendicitis were prospectively randomized to undergo either LA or OA. The two groups were matched for age and sex. Interventions LA or OA. Main Outcome Measures Number of days in hospital and time to full recovery. Results The mean hospital stay for LA was 3.23 days compared with 3.03 days for OA (p < 0.001). The mean number of narcotic injections required for patients in the LA group was 4.05 compared with 5.58 for patients in the OA group (p < 0.001). The mean time to complete recovery for patients in the LA group was 9.0 days compared with 16.2 days for patients in the OA group (p < 0.001). The mean operative time for LA was 73.8 minutes compared with 45.0 minutes for OA (p < 0.001). Three patients in the LA group had intra-abdominal abscesses (p > 0.25). No significant difference in wound infection rates was demonstrated (p > 0.05). Similarly, pain scores at 7 and 28 days showed no significant difference (p > 0.05). Conclusions With LA significantly fewer narcotic injections are required and there is a more rapid return to normal activities. LA takes longer to perform and was associated with three intra-abdominal abscesses. In cases of simple acute appendicitis the hospital stay for LA is significantly shorter. PMID:8956810

  5. Clinical Outcomes Comparing Capsular Repair vs. No Repair Following Hip Arthroscopy: A Prospective, Randomized, Control Study

    PubMed Central

    Sugarman, Etan P.; Birns, Michael E.; Fishman, Matthew; Patel, Deepan N.; Goldsmith, Laura; Greene, Renee Shirley; Banffy, Michael B.

    2017-01-01

    Objectives: As hip arthroscopy procedures become more common there is increasing concern of iatrogenic instability from excessive capsulotomy during surgery. As a result, greater attention is being focused preserving hip capsule integrity following surgery. To date, there are no large scale prospective blinded studies that address whether capsular closure has any detrimental effect on outcomes. Our goal is to evaluate outcomes in patients undergoing interportal capsulotomy repair compared to outcomes when not repairing the capsule. The purpose of this study is to demonstrate a clinical/functional difference at 1 & 2 year follow up between patients who undergo capsular repair vs no repair following hip arthroscopy. Our hypothesis is that restoration of normal capsular anatomy with interportal repair will achieve similar clinical outcomes as the “no repair” group without functional deficits from over-constraint. Methods: Adult patients were recruited from November 2013 to July 2015 who were scheduled to undergo hip arthroscopy for femoral acetabular. Subjects were randomized into either the capsular repair (CR) or no repair (NR) groups. Standard AP/Dunn view radiographs were evaluated and alpha angle (AA) /center-edge (CEA) angle measurements were performed for all patients preoperatively. All patients underwent standard hip arthroscopy with labral repair +/- CAM/pincer lesion resection. Primary clinical outcomes were measured via the Hip Outcome Score Activities of Daily Living (HOS-ADL) and Sport-Specific (HOS-SS) subscales at 3 months, 6 months and 1 year. Secondary outcome measures included the modified Harris Hip Score (mHHS), visual analog scale (VAS), the international hip outcome tool (iHOT-12), and the Veterans RAND 12 Item Health Survey (VR-12) scores. Results: A total of 56 patients were included in this study (30 male, 26 females) with a mean age of 33 years. Follow up was available for 49 patients at 6 months, 41 patients at 1 year and 26 patients at

  6. Efficacy of IP6 + inositol in the treatment of breast cancer patients receiving chemotherapy: prospective, randomized, pilot clinical study

    PubMed Central

    2010-01-01

    Background Prospective, randomized, pilot clinical study was conducted to evaluate the beneficial effects of inositol hexaphosphate (IP6) + Inositol in breast cancer patients treated with adjuvant therapy. Patients and methods Patients with invasive ductal breast cancer where polychemotherapy was indicated were monitored in the period from 2005-2007. Fourteen patients in the same stage of ductal invasive breast cancer were involved in the study, divided in two randomized groups. One group was subjected to take IP6 + Inositol while the other group was taking placebo. In both groups of patients the same laboratory parameters were monitored. When the treatment was finished, all patients have filled questionnaires QLQ C30 and QLQ-BR23 to determine the quality of life. Results Patients receiving chemotherapy, along with IP6 + Inositol did not have cytopenia, drop in leukocyte and platelet counts. Red blood cell counts and tumor markers were unaltered in both groups. However, patients who took IP6 + Inositol had significantly better quality of life (p = 0.05) and functional status (p = 0.0003) and were able to perform their daily activities. Conclusion IP6 + Inositol as an adjunctive therapy is valuable help in ameliorating the side effects and preserving quality of life among the patients treated with chemotherapy. PMID:20152024

  7. Efficacy of IP6 + inositol in the treatment of breast cancer patients receiving chemotherapy: prospective, randomized, pilot clinical study.

    PubMed

    Bacić, Ivan; Druzijanić, Nikica; Karlo, Robert; Skifić, Ivan; Jagić, Stjepan

    2010-02-12

    Prospective, randomized, pilot clinical study was conducted to evaluate the beneficial effects of inositol hexaphosphate (IP6) + Inositol in breast cancer patients treated with adjuvant therapy. Patients with invasive ductal breast cancer where polychemotherapy was indicated were monitored in the period from 2005-2007. Fourteen patients in the same stage of ductal invasive breast cancer were involved in the study, divided in two randomized groups. One group was subjected to take IP6 + Inositol while the other group was taking placebo. In both groups of patients the same laboratory parameters were monitored. When the treatment was finished, all patients have filled questionnaires QLQ C30 and QLQ-BR23 to determine the quality of life. Patients receiving chemotherapy, along with IP6 + Inositol did not have cytopenia, drop in leukocyte and platelet counts. Red blood cell counts and tumor markers were unaltered in both groups. However, patients who took IP6 + Inositol had significantly better quality of life (p = 0.05) and functional status (p = 0.0003) and were able to perform their daily activities. IP6 + Inositol as an adjunctive therapy is valuable help in ameliorating the side effects and preserving quality of life among the patients treated with chemotherapy.

  8. Pulmonary complications following major head and neck surgery with tracheostomy: a prospective, randomized, controlled trial of prophylactic antibiotics.

    PubMed

    Ong, Soo-Kim; Morton, Randall P; Kolbe, John; Whitlock, Ralph M L; McIvor, Nicholas P

    2004-09-01

    To test the hypothesis that extended postoperative antibiotic cover would reduce the incidence of pulmonary complications in patients undergoing major head and neck surgery with tracheostomy. A prospective, randomized, controlled trial was carried out to determine the efficacy of an extended course (5 days) of intravenous amoxicillin-clavulanic acid in reducing the rate of atelectasis and pulmonary infections postoperatively. Other possible risk factors that might predispose to pulmonary complications were also evaluated. Tertiary referral center for head and neck surgery. Consecutive patients younger than 80 years with planned surgery for carcinoma of the oral cavity, pharynx, or larynx were enrolled. Patients with diabetes, those who had received antibiotics within 1 week before surgery, and those with preexisting pulmonary disease were excluded. Patients were randomly assigned no antibiotics or a 5-day course of intravenous amoxicillin-clavulanic acid postoperatively. The development of pulmonary complications (pulmonary infection or atelectasis). Eighty-six patients were enrolled; 73 patients met the criteria for analysis. Thirty-four (47%) developed pulmonary complications; 29 (40%) had a pulmonary infection. An extended course of antibiotics did not reduce the rate of pulmonary infections (P =.57). Positive risk factors for a pulmonary infection were presence of preoperative obstructive lung function and postoperative atelectasis. An extended course of antibiotics did not prevent the development of postoperative pulmonary infections in patients undergoing major head and neck surgery with tracheostomy. Poor pulmonary function and postoperative atelectasis emerged as significant risk factors for pulmonary infection.

  9. Immunologic and infectious consequences of immediate versus delayed umbilical cord clamping in premature infants: a prospective, randomized, controlled study.

    PubMed

    Kugelman, Amir; Borenstein-Levin, Liron; Kessel, Aharon; Riskin, Arieh; Toubi, Elias; Bader, David

    2009-01-01

    To evaluate the immunologic and infectious consequences of delayed versus immediate cord clamping in premature infants (<35 weeks) during the neonatal period. This was a prospective, masked, randomized, controlled, single-center study. Prior to delivery 35 infants were randomly assigned to immediate cord clamping (ICC) at 5-10 s and 30 infants to delayed cord clamping (DCC), at 30-45 s (14 and 15 infants in each group were <1500 g, respectively). Neonatal characteristics of the ICC and DCC groups were comparable. There was no significant difference between the ICC and DCC groups in the complement or in the immunoglobulin levels. All were within the normal range for age. All infectious parameters (events of sepsis or "rule-out sepsis", days of antibiotic therapy, and number of antibiotic courses during hospitalization and infections within the first month of life in cases of earlier discharge) were comparable in both groups. Similar results were found in the subgroup of infants <1500 g. Gender analysis showed only modest differences. Delayed compared to immediate cord clamping did not affect the immunologic or the infectious status of infants born at <35 weeks during the neonatal period.

  10. Does transcutaneous electric acupoint stimulation improve the quality of recovery after thyroidectomy? A prospective randomized controlled trial

    PubMed Central

    Chen, Yanqing; Yang, Yang; Yao, Yusheng; Dai, Dongsheng; Qian, Bin; Liu, Pingping

    2015-01-01

    Background: We evaluated the effects of transcutaneous electric acupoint stimulation (TEAS) on the postoperative quality of recovery after thyroidectomy with general anesthesia in this prospective, randomized, double-blind, placebo-controlled study. Methods: Eight-four American Society of Anesthesiologists physical status (ASA) I or II patients undergoing thyroidectomy were randomly allocated to TEAS or control groups. The primary outcome was the quality of recovery, which was assessed on the day before surgery and 24 h after surgery using the Quality of Recovery 40 questionnaire (QoR-40). Secondary outcomes included the incidence of postoperative nausea and vomiting (PONV), postoperative pain intensity, duration of post anesthesia care unit (PACU) stay and patient’s satisfaction. Results: Global QoR-40 score at 24 h after surgery was higher in the TEAS group (median [interquartile range], 183 [172-190]) compared with the control group (168 [154-183]) (P < 0.001). Compared with the control group, postoperative pain intensity and the cumulative number of opioids administered was lower in the TEAS group patients (P < 0.001). TEAS reduced the incidence of PONV and dizziness (P = 0.001), as well as the duration of PACU stay (P < 0.001). Simultaneously, the patient’s satisfaction scores were higher in the TEAS group (P = 0.002). Conclusion: Preoperative TEAS enhances the quality of recovery, postoperative analgesia and patient’s satisfaction, alleviates postoperative side effects and accelerates discharge after general anesthesia for thyroidectomy. PMID:26550304

  11. Prone versus Modified Supine Position in Percutaneous Nephrolithotomy: a Prospective Randomized Study

    PubMed Central

    Wang, Yanbo; Wang, Yan; Yao, Yunming; Xu, Ning; Zhang, Haifeng; Chen, Qihui; Lu, Zhihua; Hu, Jinghai; Wang, Xiaoqing; Lu, Ji; Hao, Yuanyuan; Jiang, Fengming; Hou, Yuchuan; Wang, Chunxi

    2013-01-01

    Objective: To perform a prospective randomized trial comparing the efficacy and safety of percutaneous nephrolithotomy (PCNL) in the prone and modified supine positions. Methods: Between August 2010 and August 2011, 102 patients with renal calculi and 20 patients with ureteral calculi were randomized to undergo fluoroscopy and ultrasound-guided PCNL procedures in the prone or modified supine position. Baseline characteristics, puncture position, numbers of punctures, operation time, stone free rate, loss of blood, hospital stay and second phase PCNL were compared in the two groups. Results: There were no significant differences in gender, age, body mass index, stone location, stone size and the presence of hydronephrosis between the two groups. The rate of second PCNL was significantly higher and the stone clearance rate was significantly lower in the modified supine than in the prone position group. Mean operation time was significantly lower in the prone than in the modified supine position group (78 min vs 88 min, P<0.05). There were no significant differences in rates of rib and calyx puncture, numbers of punctures, mean blood loss, and mean hospital stay between the two groups. Conclusions: Both the prone and modified supine positions are effective and safe for PCNL. Operation time was longer in the modified supine group, and patients undergoing PCNL in the modified supine position more frequently required a second operation due to a lower stone clearance rate. PMID:24046526

  12. Prone versus modified supine position in percutaneous nephrolithotomy: a prospective randomized study.

    PubMed

    Wang, Yanbo; Wang, Yan; Yao, Yunming; Xu, Ning; Zhang, Haifeng; Chen, Qihui; Lu, Zhihua; Hu, Jinghai; Wang, Xiaoqing; Lu, Ji; Hao, Yuanyuan; Jiang, Fengming; Hou, Yuchuan; Wang, Chunxi

    2013-01-01

    To perform a prospective randomized trial comparing the efficacy and safety of percutaneous nephrolithotomy (PCNL) in the prone and modified supine positions. Between August 2010 and August 2011, 102 patients with renal calculi and 20 patients with ureteral calculi were randomized to undergo fluoroscopy and ultrasound-guided PCNL procedures in the prone or modified supine position. Baseline characteristics, puncture position, numbers of punctures, operation time, stone free rate, loss of blood, hospital stay and second phase PCNL were compared in the two groups. There were no significant differences in gender, age, body mass index, stone location, stone size and the presence of hydronephrosis between the two groups. The rate of second PCNL was significantly higher and the stone clearance rate was significantly lower in the modified supine than in the prone position group. Mean operation time was significantly lower in the prone than in the modified supine position group (78 min vs 88 min, P<0.05). There were no significant differences in rates of rib and calyx puncture, numbers of punctures, mean blood loss, and mean hospital stay between the two groups. Both the prone and modified supine positions are effective and safe for PCNL. Operation time was longer in the modified supine group, and patients undergoing PCNL in the modified supine position more frequently required a second operation due to a lower stone clearance rate.

  13. Protocol versus ad libitum feeds after laparoscopic pyloromyotomy: a prospective randomized trial.

    PubMed

    Adibe, Obinna O; Iqbal, Corey W; Sharp, Susan W; Juang, David; Snyder, Charles L; Holcomb, George W; Ostlie, Daniel J; St Peter, Shawn D

    2014-01-01

    We conducted a prospective, randomized trial comparing protocol to ad libitum (ad lib) feeding after laparoscopic pyloromyotomy. Infants undergoing laparoscopic pyloromyotomy were randomized to protocol versus ad lib feeding strategies. The protocol started with Pedialyte® two hours post-operative. This was repeated by another round of Pedialyte®, then two rounds of half-strength formula or breast milk, followed by two rounds of full strength formula or breast milk, followed by the home feeding regimen, at which time the patient was discharged if feeding well. The ad lib group was allowed formula or breast milk two hours after the operation and considered for discharge after tolerating three consecutive feeds. The primary outcome variable was the length of postoperative hospitalization. One hundred fifty infants were enrolled between January 2010 and December 2011. There were no differences in patient characteristics at presentation. While the ad lib group reached goal feeds sooner than the protocol group, this did not translate into a difference in duration of postoperative hospitalization. There were more patients with emesis in the ad lib group after goal feeding was reached, but no difference in readmissions. Ad lib feeding allows patients to reach goal feeds more rapidly than protocol feeding following laparoscopic pyloromyotomy. However, this goal is usually reached beyond discharge hours, resulting in a similar duration of hospitalization. © 2014.

  14. Peyton's four-step approach for teaching complex spinal manipulation techniques - a prospective randomized trial.

    PubMed

    Gradl-Dietsch, Gertraud; Lübke, Cavan; Horst, Klemens; Simon, Melanie; Modabber, Ali; Sönmez, Tolga T; Münker, Ralf; Nebelung, Sven; Knobe, Matthias

    2016-11-03

    The objectives of this prospective randomized trial were to assess the impact of Peyton's four-step approach on the acquisition of complex psychomotor skills and to examine the influence of gender on learning outcomes. We randomly assigned 95 third to fifth year medical students to an intervention group which received instructions according to Peyton (PG) or a control group, which received conventional teaching (CG). Both groups attended four sessions on the principles of manual therapy and specific manipulative and diagnostic techniques for the spine. We assessed differences in theoretical knowledge (multiple choice (MC) exam) and practical skills (Objective Structured Practical Examination (OSPE)) with respect to type of intervention and gender. Participants took a second OSPE 6 months after completion of the course. There were no differences between groups with respect to the MC exam. Students in the PG group scored significantly higher in the OSPE. Gender had no additional impact. Results of the second OSPE showed a significant decline in competency regardless of gender and type of intervention. Peyton's approach is superior to standard instruction for teaching complex spinal manipulation skills regardless of gender. Skills retention was equally low for both techniques.

  15. Is alcohol required for effective pancreatic cyst ablation? The prospective randomized CHARM trial pilot study

    PubMed Central

    Moyer, Matthew T.; Dye, Charles E.; Sharzehi, Setareh; Ancrile, Brooke; Mathew, Abraham; McGarrity, Thomas J.; Gusani, Niraj; Yee, Nelson; Wong, Joyce; Levenick, John; Dougherty-Hamod, Brandy; Mathers, Bradley

    2016-01-01

    Background and study aims: In this study, we aim to determine the safety and feasibility of an alcohol-free approach to pancreatic cyst ablation using a chemotherapeutic ablation cocktail. Patients and methods: In this prospective, randomized, double-blinded pilot study, 10 patients with known mucinous type pancreatic cysts underwent endoscopic ultrasound (EUS)-guided fine needle aspiration and then lavage with either 80 % ethanol or normal saline. Both groups were then treated with a cocktail of paclitaxel and gemcitabine. Primary outcomes were reduction in cyst volume and rates of complications. Results: At 6 months, patients randomized to the alcohol arm had an 89 % average volume reduction, with a 91 % reduction noted in the alcohol-free arm. Complete ablation was achieved in 67 % of patients in the alcohol-free arm at both 6 and 12 months, whereas the alcohol group recorded complete ablation rates of 50 % and 75 % at 6 and 12 months, respectively. One patient in the alcohol arm developed acute pancreatitis (20 %) with no adverse events in the alcohol-free arm. Conclusions: This study revealed similar ablation rates between the alcohol ablation group and the alcohol-free arm and demonstrates the safety and feasibility of an alcohol-free ablation protocol. This pilot study suggests that alcohol may not be required for effective cyst ablation. PMID:27227122

  16. [Bipolar versus monopolar transurethral resection of the prostate: a prospective randomized study].

    PubMed

    Ghozzi, S; Ghorbel, J; Ben Ali, M; Dridi, M; Maarouf, J; Khiari, R; Ben Rais, N

    2014-02-01

    To compare bipolar with standard monopolar transurethral resection of the prostate (TURP). A prospectively randomized study was conducted between January 2010 and September 2011. Primary end points studied were efficacy (maximum flow rate [Qmax], International Prostate Symptom Score) and safety (adverse events, decline in postoperative serum sodium [Na+] and haemoglobin [Hb] levels). Secondary end points were operation time and duration of irrigation, catheterization, and hospitalization. Sixty consecutive patients were randomized and completed the study, with 29 patients in the monopolar TURP group and 31 in the TURIS group. At baseline, the two groups were comparable in age, prostate volume, mean prostate-specific antigen value, International Prostate Symptom Score, and they had at least 12 months of follow-up. Declines in the mean postoperative serum Na+ for bipolar and monopolar TURP groups were 1.2 and 8.7 mmol/L, respectively. However, there was no statistical difference in the decline in postoperative Hb between the two groups. The mean catheterization time was 26.6 and 52 hours in the bipolar and standard groups, respectively. This difference was statistically significant as was the difference in the time to hospital discharge. The IPSS and Qmax improvements were comparable between the two groups at 12 months of follow-up. No clinically relevant differences in short-term efficacy are existed between the two techniques, but bipolar TURP is preferable due to a more favorable safety profile and shorter catheterization duration. Copyright © 2013 Elsevier Masson SAS. All rights reserved.

  17. Focus Harmonic Scalpel Compared to Conventional Haemostasis in Open Total Thyroidectomy: A Prospective Randomized Trial

    PubMed Central

    Ferri, Emanuele; Armato, Enrico; Spinato, Giacomo; Spinato, Roberto

    2011-01-01

    The aim of this prospective randomized trial was to compare operative factors, postoperative outcomes and surgical complications of open total thyroidectomy when using the Harmonic Scalpel (HS) versus Conventional Haemostasis (CH). Methods. 100 consecutive patients underwent open total thyroidectomy were randomized into two groups: group CH (Conventional Haemostasis) and group HS (Harmonic Scalpel). We recorded the following: age, sex, pathology, thyroid volume, haemostatic technique, operative time, drainage volume, thyroid weight, postoperative pain, postoperative complications, and hospital stay. The results were analyzed using the Student's t test and χ2 test. Results. No significant difference was found between the two groups concerning mean thyroid weight and mean hospital stay. The mean operative time was significantly shorter in the HS group. The total drainage fluid volume was lower in HS group. Two (4%) transient recurrent laryngeal nerve palsies were observed in CH group and no one (0%) in the HS group. Postoperative transient hypocalcemia occurred more frequently in the CH group. HS group experienced significantly less postoperative pain at 24 and 48 hours. Conclusions. In patients undergoing thyroidectomy, HS is a reliable and safe tool. Comparing with CH techniques, its use reduces operative times, postoperative pain, drainage volume and transient hypocalcemia. PMID:22187563

  18. OPEN DRAINAGE VERSUS PERCUTANEOUS DRAINAGE IN THE TREATMENT OF TROPICAL PYOMYOSITIS. PROSPECTIVE AND RANDOMIZED STUDY

    PubMed Central

    Palacio, Evandro Pereira; Rizzi, Nívea Gitahy; Reinas, Gustavo Serra; Júnior, Melvis Michiuti; Júnior, Alcides Durigan; Mizobuchi, Roberto Ryuiti; Yanasse, Ricardo Hideki; da Silva, Marcos Vinícius Muriano; Branco, Rodrigo Borsatto; Galbiatti, José Antônio

    2015-01-01

    Objective: To compare the results from treating tropical pyomyositis through percutaneous drainage of abscesses versus open surgical drainage of abscesses, by means of a randomized prospective study. Methods: Twenty-five patients with tropical pyomyositis (Chiedozi grade II) were included in this study. They were randomized into two groups: group A (n = 13), treated with antibiotics and open drainage of the abscesses; and group B (n = 12), treated with antibiotics and percutaneous drainage of the abscesses. Results: The mean age was 35.3 years (± 19.2) in group A and 30.1 years (± 9) in group B (p = 0.41). There were eight female patients (61.5%) and five male patients (38.5%) in group A; in group B, three were female (25%) and nine were male (75%) (p = 0.11). Staphylococcus aureus was the microorganism most frequently found (72%). The mean hospital stay in group A was 12.7 days (± 2.3), and in group B, 10.6 days (± 1.6) (p = 0.01). The mean duration of antibiotic use in group A was 12.2 days (± 2.3), and in group B, 10.1 days (± 1.5) (p = 0.02). Conclusion: Percutaneous drainage of the abscesses, in association with antibiotic therapy, is an efficient treatment method for tropical pyomyositis grade II, with shorter antibiotic use and hospital stay for patients. PMID:27022550

  19. 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.

  20. 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.

  1. Antibiotic use in post-adenotonsillectomy morbidity: a randomized prospective study.

    PubMed

    Guerra, Marja Michelin; Garcia, Eduardo; Pilan, Renata Ribeiro de Mendonça; Rapoport, Priscila Bogar; Campanholo, Caio Barbosa; Martinelli, Eli Onivaldo

    2008-01-01

    Tonsillectomy with or without adenoidectomy still is one of the most commonly performed surgical procedures in the world, mostly in the pediatric population. to study the impact of amoxicillin for 7 days in post-adenotonsillectomy recovery, comparing results with a control group. prospective, randomized, controlled study with 120 patients. the patients were randomized according to surgery time to receive 7 days of amoxicillin associated with pain killers, or analgesic alone. During the first week of postoperative, we assessed the level of pain, oral intake acceptance, nausea and vomits, fever and return to daily activities. It was only in the fourth post-operative day that the group receiving antibiotic agents showed a statistically significant difference as far as pain is concerned. There was no difference between the two groups for other data analyzed. considering the results from our study and reviewing the literature on the use of antibiotic agents, we agree that there is no improvement in patient recovery after adenotonsillectomy with the use of amoxicillin for 7 days in the postoperative.

  2. Single-Level Degenerative Cervical Disc Disease and Driving Disability: Results from a Prospective, Randomized Trial

    PubMed Central

    Kelly, Michael P.; Mitchell, M. David; Hacker, Robert J.; Riew, K. Daniel; Sasso, Rick C.

    2013-01-01

    Study Design Post hoc analysis of prospective, randomized trial. Objective To investigate the disability associated with driving and single-level degenerative, cervical disc disease and to investigate the effect of surgery on driving disability. Methods Post hoc analysis of data obtained from three sites participating in a multicenter, randomized, controlled trial comparing cervical disc arthroplasty (TDA) with anterior cervical discectomy and fusion (ACDF). The driving subscale of the Neck Disability Index (NDI) was analyzed for all patients. A dichotomous severity score was created from the NDI. Statistical comparisons were made within and between groups. Results Two-year follow-up was available for 118/135 (87%) patients. One half of the study population (49.6%) reported moderate or severe preoperative driving difficulty. This disability associated with driving was similar among the two groups (ACDF: 2.5 ± 1.1, TDA: 2.6 ± 1.0, p = 0.646). The majority of patients showed improvement, with no or little driving disability, at the sixth postoperative week (ACDF: 75%, TDA: 90%, p = 0.073). At no follow-up point did a difference exist between groups according to the severity index. Conclusions Many patients suffering from radiculopathy or myelopathy from cervical disc disease are limited in their ability to operate an automobile. Following anterior cervical spine surgery, most patients are able to return to comfortable driving at 6 weeks. PMID:24436875

  3. Minimal vs extensive esophageal mobilization during laparoscopic fundoplication: a prospective randomized trial

    PubMed Central

    St. Peter, Shawn D.; Barnhart, Douglas C.; Ostlie, Daniel J.; Tsao, KuoJen; Leys, Charles M.; Sharp, Susan W.; Bartle, Donna; Morgan, Tracey; Harmon, Carroll M.; Georgeson, Keith E.; Holcomb, George W.

    2011-01-01

    Purpose Laparoscopic Nissen fundoplication has been traditionally performed with extensive esophageal dissection to create 2 to 3 cm of intraabdominal esophagus. Retrospective data have suggested that minimal esophageal mobilization may reduce the risk of postoperative herniation of the wrap into the lower mediastinum. To compare complete esophageal dissection to leaving the phrenoesophageal attachment intact, we conducted a 2-center, prospective, randomized trial. Methods After obtaining permission/assent, patients were randomized to circumferential division of the phrenoesophageal attachments (MAX) or minimal mobilization with no violation of the phrenoesophageal membrane (MIN). A contrast study was performed at 1 year. The primary outcome variable was postoperative wrap herniation. Results One hundred seventy-seven patients were enrolled in the study (MIN, n = 90; MAX, n = 87) from February 2006 to May 2008. There were no differences in demographics or operative time. Contrast studies were performed in 64 MIN and 71 MAX patients, respectively. The transmigration rate was 30% in the MAX group compared with 7.8% in the MIN group (P = .002). The reoperation rate was 18.4% in the MAX group and 3.3% in the MIN group (P = .006) Conclusions Minimal esophageal mobilization during laparoscopic fundoplication decreases postoperative wrap transmigration and the need for a redo operation. PMID:21238659

  4. Efficacy of intravenous dexamethasone to reduce incidence of postoperative sore throat: A prospective randomized controlled trial

    PubMed Central

    Bagchi, Dipanjan; Mandal, Mohan Chandra; Das, Sabyasachi; Sahoo, Tirtha; Basu, Sekhar Ranjan; Sarkar, Sanhita

    2012-01-01

    Background: Sore throat and hoarseness are common complications of endotracheal intubation. It may be very distressing for the patient and may lead to sleep disturbances and unpleasant memories. Materials and Methods: This prospective double-blinded randomized control trial was aimed to determine the efficacy of prophylactic intravenous dexamethasone to reduce the incidence of postoperative sore throat at 1 hour after tracheal extubation. Ninety six patients of either sex aged between 18 to 60 years scheduled for elective surgeries needing general anesthesia with endotracheal intubation, were randomly allocated into two groups A and B. The patients received either intravenous 0.2 mg/kg dexamethasone (group A, n = 48) or normal saline (group B, n = 47) just before induction. Trachea was intubated with appropriate size disposable endotracheal tubes for securing the airway. Follow up for the incidence of sore throat, cough and hoarseness was done at 1, 6 and 24 hours post-extubation. Results: At 1 hour post-extubation, the incidence of sore throat in the control group was 48.9% compared with 18.8% in the dexamethasone group (P<0.002). Conclusions: Prophylactic intravenous dexamethasone in a dose of 0.2 mg/kg can reduce the incidence of postoperative sore throat at 1 hour post-extubation by around 30%, with the efficacy being around 60%. PMID:23225928

  5. A prospective, randomized, double-blind, multicenter study comparing remifentanil with fentanyl in mechanically ventilated patients.

    PubMed

    Spies, Claudia; Macguill, Martin; Heymann, Anja; Ganea, Christina; Krahne, Daniel; Assman, Angelika; Kosiek, Heinrich-Rudolf; Scholtz, Kathrin; Wernecke, Klaus-Dieter; Martin, Jörg

    2011-03-01

    To compare the quality of analgesia provided by a remifentanil-based analgesia regime with that provided by a fentanyl-based regime in critically ill patients. This was a registered, prospective, two-center, randomized, triple-blind study involving adult medical and surgical patients requiring mechanical ventilation (MV) for more than 24 h. Patients were randomized to either remifentanil infusion or a fentanyl infusion for a maximum of 30 days. Sedation was provided using propofol (and/or midazolam if required). Primary outcome was the proportion of patients in each group maintaining a target analgesia score at all time points. Secondary outcomes included duration of MV, discharge times, and morbidity. At planned interim analysis (n = 60), 50% of remifentanil patients (n = 28) and 63% of fentanyl patients (n = 32) had maintained target analgesia scores at all time points (p = 0.44). There were no significant differences between the groups with respect to mean duration of ventilation (135 vs. 165 h, p = 0.80), duration of hospital stay, morbidity, or weaning. Interim analysis strongly suggested futility and the trial was stopped. The use of remifentanil-based analgesia in critically ill patients was not superior regarding the achievement and maintenance of sufficient analgesia compared with fentanyl-based analgesia.

  6. Antibiotic prophylaxis at urinary catheter removal prevents urinary tract infections: a prospective randomized trial.

    PubMed

    Pfefferkorn, Urs; Lea, Sanlav; Moldenhauer, Jörg; Peterli, Ralph; von Flüe, Markus; Ackermann, Christoph

    2009-04-01

    To assess whether antibiotic prophylaxis at urinary catheter removal reduces the rate of urinary tract infections. Urinary tract infections are among the most common nosocomial infections. Antibiotic prophylaxis at urinary catheter removal is used as a measure to prevent them, albeit without supporting evidence. A prospective randomized study enrolled 239 patients undergoing elective abdominal surgery, who were randomized either for receiving 3 doses of trimethoprim-sulfamethoxazole at urinary catheter removal, or not. Urinary tract infections were diagnosed according to Center of Disease Control definitions. Urinary cultures were obtained before and 3 days after catheter removal. Subjective symptoms were assessed by an independent study-blind urologist. Patients who received antibiotic prophylaxis showed significantly fewer urinary tract infections (5/103, 4.9%) than those without prophylaxis (22/102, 21.6%), P < 0.001. The absolute risk reduction for the occurrence of a urinary tract infection was 16.7%; the relative risk reduction was 77.5%, and the number needed to treat was 6. Patients with antibiotic prophylaxis also had less significant bacteriuria 3 days after catheter removal (17/103, 16.5%) than those without (42/102, 41.2%), P < 0.001. Antibiotic prophylaxis with trimethoprim-sulfamethoxazole on urinary catheter removal significantly reduces the rate of symptomatic urinary tract infections and bacteriuria in patients undergoing abdominal surgery with perioperative transurethral urinary catheters.

  7. Laparoscopic versus open cholecystectomy in cirrhotic patients: a prospective randomized study.

    PubMed

    El-Awadi, Saleh; El-Nakeeb, Ayman; Youssef, Tamer; Fikry, Amir; Abd El-Hamed, Tito M; Ghazy, Hosam; Foda, Elyamany; Farid, Mohamed

    2009-02-01

    Improved laparoscopic experience and techniques have made laparoscopic cholecystectomy (LC) feasible options in cirrhotic patients. This study was designed to compare the risk and benefits of open cholecystectomy (OC) versus LC in compensated cirrhosis. A randomized prospective study, in the period from October 2002 till December 2006, where 110 cirrhotic patients with symptomatic gallstone were randomly divided into OC group (55 patients) and LC group (55 patients). There was no operative mortality. In LC group 4 (7.33%) patients were converted to OC. Mean surgical time was significantly longer in OC group than LC group (96.13+17.35 min versus 76.13+15.12) P<0.05, associated with significantly higher intraoperative bleeding in OC group (P<0.01), necessitating blood transfusions to 7 (12.72%) patients in OC group. The time to resume diet was 18.36+8.18 h in LC group which is significantly earlier than in OC group 47.84+14.6h P<0.005. Hospital stay was significantly longer in OC group than LC group (6+1.74 days versus 1.87+1.11 days) P<0.01 with low postoperative morbidity. LC in cirrhotics is still complicated and highly difficult which associates with significant morbidity compared with that of patients without cirrhosis. However, it offers lower morbidity, shorter operative time; early resume dieting with less need for blood transfusion and reducing hospital stay than OC.

  8. Repair or observe moderate ischemic mitral regurgitation during coronary artery bypass grafting? Prospective randomized multicenter data

    PubMed Central

    Gulack, Brian C.; Englum, Brian R.; Castleberry, Anthony W.; Daneshmand, Mani A.; Perrault, Louis P.

    2015-01-01

    Ischemic mitral regurgitation (MR) is a common occurrence following myocardial infarction and its presence is associated with poor outcomes. The optimal treatment of ischemic MR is a matter of debate, especially for patients with moderate MR severity. Some authors advocate for isolated coronary artery bypass grafting (CABG) for patients with moderate MR, maintaining that reverse ventricular remodeling will reduce MR grade and its associated mortality risk, while others argue that a concomitant mitral valve repair (MVR) or replacement is superior. The Cardiothoracic Surgical Trials Network (CTSN) recently published the 1-year results of the Surgical Treatment of Moderate Ischemic Mitral Regurgitation study, a multicenter, randomized, controlled trial investigating the impact of MVR in addition to CABG compared to CABG alone in the treatment of moderate ischemic MR. Here, we have reviewed previous observational and prospective studies investigating moderate ischemic MR treatment as well as the results of the current CTSN randomized trial. Furthermore, we have summarized the current state of the available evidence and preview potential new information that will become available with planned subgroup analyses and further follow-up of enrolled patients in the recently completed CTSN trial. PMID:26309829

  9. One-day nasogastric tube decompression after distal gastrectomy: a prospective randomized study.

    PubMed

    Kimura, Yutaka; Yano, Hiroshi; Iwazawa, Takashi; Fujita, Junya; Fujita, Shoichiro; Yamamoto, Kazuyoshi; Yasuda, Takushi

    2017-09-01

    Many surgeons in Japan use 1-day nasogastric tube (NGT) decompression after gastrectomy as a standard procedure. This prospective randomized study aimed to define whether 1-day NGT decompression is necessary after distal gastrectomy. The subjects were 233 patients with gastric cancer, randomized into two groups immediately after distal gastrectomy: one group received 1-day NGT decompression (NGT group, n = 119) and the other did not (no-NGT group, n = 114). The primary outcome measure was postoperative surgery-related and respiratory complications, whereas secondary measures were the postoperative course to recovery and patient complaints. The incidence of surgery-related complications did not differ significantly between the NGT and no-NGT groups (21.0 and 19.2%, respectively; p = 0.87). The rate of respiratory complications was 6.7% in the NGT group and 7.0% in the no-NGT group (p > 0.99). The time to passage of first flatus and the postoperative hospital stay did not differ between the groups. Twenty-five patients in the NGT group and none in the no-NGT group complained of nasopharyngeal discomfort (p < 0.0001). Considering the physical discomfort caused by the NGT, we believe that routine 1-day NGT decompression is unnecessary after distal gastrectomy.

  10. Acupuncture accelerates recovery after general anesthesia: a prospective randomized controlled trial.

    PubMed

    Gemma, Marco; Nicelli, Elisa; Gioia, Luigi; Moizo, Elena; Beretta, Luigi; Calvi, Maria Rosa

    2015-03-01

    Acupuncture anesthesia was created in the 1950's in China and continues to be used there today during most major surgeries. It is widely used in China for such complex operations as brain, heart, and abdominal surgery. It is popular in China because it is economical, practical, and beneficial to the patients. With acupuncture anesthesia there is less bleeding during surgery and there is also quicker post-operative recovery. This randomized prospective study aims at comparing the effect of two acupoints (Yongquan, KI1 and Renzhong, DU26) with sham acupuncture and no acupuncture on the time to recovery of consciousness after general anesthesia by means of the Bispectral Index monitor (BIS). This is a prospective randomized controlled study. We randomly assigned 50 patients to 5 groups during recovery from surgical anesthesia. Four groups had acupuncture on KI1 (group A), DU26 (groups B), both KI1 and DU26 (group C), and sham points (group D), and one had no acupuncture (group E). Bispectral Index (BIS), time to spontaneous eye opening, time to tracheal extubation, and time to following commands were measured as the main outcome measures. Time to spontaneous eye opening differed among groups (P=0.002), as well as time to tracheal extubation (P<0.000 1) and time to following commands (P=0.000 6). BIS values differed significantly among groups both 5 and 10 min after the end of anesthesia (P<0.000 1 and P=0.000 4, respectively). BIS values of groups D and E were lower than those of the other groups and those of group C were higher. The same pattern was observed also 15 and 30 min after the end of anesthesia, although the difference among groups was not significant at these time points (P=0.164 and P=0.104, respectively). Acupuncture on DU26 and KI1 accelerates recovery of consciousness after general anesthesia. Moreover, a possible synergistic effect of DU26 and KI1 is suggested. This issue may play a role in the optimization of operating room management and raise

  11. MI Paste Plus to prevent demineralization in orthodontic patients: a prospective randomized controlled trial.

    PubMed

    Robertson, Michael A; Kau, Chung How; English, Jeryl D; Lee, Robert P; Powers, John; Nguyen, Jennifer T

    2011-11-01

    Enamel demineralization is a problem in orthodontics. Fluoride is partially effective in addressing this problem, but additional treatment options are needed. The objective of this prospective randomized controlled trial was to determine the effectiveness of a new product, MI Paste Plus (GC America, Alsip, Ill), in the prevention or reduction of white spot lesions in orthodontic patients. Sixty patients who were undergoing routine orthodontic treatment were recruited for this prospective randomized clinical trial. A double-blind method of randomization was used to determine whether each patient received the MI Paste Plus or a placebo paste (Tom's of Maine, Salisbury, United Kingdom). Each patient was asked to administer the paste by using a fluoride tray for a minimum of 3 to 5 minutes each day at night after brushing. Photographic records obtained in a light-controlled environment were used to record the presence or absence of white spot lesions in both groups. The enamel decalcification index was used to determine the number of white spot lesions per surface at each time interval. Patients were followed at 4-week intervals for 3 months. A scoring system from 0 to 6 was used to determine the level of caries or cavitations. This system was also used for each tooth at each time interval. Fifty patients (26 using MI Paste Plus, 24 using the placebo paste) completed the study. The enamel decalcification index scores for all surfaces were 271 and 135 at the start of treatment and 126 and 258 at the end of treatment for the MI Paste Plus and placebo paste groups, respectively. The enamel decalcification index scores in the MI Paste Plus group reduced by 53.5%, whereas the placebo group increased by 91.1% during the study period. A 3-way analysis of variance (ANOVA) was done for the average enamel decalcification index scores. The surface type, the product/time interactions, and the product/surface interactions of the mean enamel decalcification index scores were

  12. Irrigation versus suction alone during laparoscopic appendectomy for perforated appendicitis: a prospective randomized trial.

    PubMed

    St Peter, Shawn D; Adibe, Obinna O; Iqbal, Corey W; Fike, Frankie B; Sharp, Susan W; Juang, David; Lanning, David; Murphy, J Patrick; Andrews, Walter S; Sharp, Ronald J; Snyder, Charles L; Holcomb, George W; Ostlie, Daniel J

    2012-10-01

    The efficacy of irrigating the peritoneal cavity during appendectomy for perforated appendicitis has been debated extensively. To date, prospective comparative data are lacking. Therefore, we conducted a prospective, randomized trial comparing peritoneal irrigation to suction alone during laparoscopic appendectomy in children. Children younger than 18 years with perforated appendicitis were randomized to peritoneal irrigation with a minimum of 500 mL normal saline, or suction only during laparoscopic appendectomy. Perforation was defined as a hole in the appendix or fecalith in the abdomen. The primary outcome variable was postoperative abscess. Using a power of 0.8 and alpha of 0.05, a sample size of 220 patients was calculated. A battery-powered laparoscopic suction/irrigator was used in all cases. Pre- and postoperative management was controlled. Data were analyzed on an intention-to-treat basis. A total of 220 patients were enrolled between December 2008 and July 2011. There were no differences in patient characteristics at presentation. There was no difference in abscess rate, which was 19.1% with suction only and 18.3% with irrigation (P = 1.0). Duration of hospitalization was 5.5 ± 3.0 with suction only and 5.4 ± 2.7 days with group (P = 0.93). Mean hospital charges was $48.1K in both groups (P = 0.97). Mean operative time was 38.7 ± 14.9 minutes with suction only and 42.8 ± 16.7 minutes with irrigation (P = 0.056). Irrigation was felt to be necessary in one case (0.9%) randomized to suction only. In the patients who developed an abscess, there was no difference in duration of hospitalization, days of intravenous antibiotics, duration of home health care, or abscess-related charges. There is no advantage to irrigation of the peritoneal cavity over suction alone during laparoscopic appendectomy for perforated appendicitis. The study was registered with clinicaltrials.gov at the inception of enrollment (NCT00981136).

  13. Chaotic cryptographic scheme and its randomness evaluation

    NASA Astrophysics Data System (ADS)

    Stoyanov, B. P.

    2012-10-01

    We propose a new cryptographic scheme based on the Lorenz chaos attractor and 32 bit bent Boolean function. We evaluated the keystream generated by the scheme with batteries of the NIST statistical tests. We also applied a number of statistical analysis techniques, such as calculating histograms, correlations between two adjacent pixels, information entropy, and differential resistance, all refer to images encrypted by the proposed system. The results of the analysis show that the new cryptographic scheme ensures a secure way for sending digital data with potential applications in real-time image encryption.

  14. Removal of diminutive colorectal polyps: A prospective randomized clinical trial between cold snare polypectomy and hot forceps biopsy

    PubMed Central

    Komeda, Yoriaki; Kashida, Hiroshi; Sakurai, Toshiharu; Tribonias, George; Okamoto, Kazuki; Kono, Masashi; Yamada, Mitsunari; Adachi, Teppei; Mine, Hiromasa; Nagai, Tomoyuki; Asakuma, Yutaka; Hagiwara, Satoru; Matsui, Shigenaga; Watanabe, Tomohiro; Kitano, Masayuki; Chikugo, Takaaki; Chiba, Yasutaka; Kudo, Masatoshi

    2017-01-01

    AIM To compare the efficacy and safety of cold snare polypectomy (CSP) and hot forceps biopsy (HFB) for diminutive colorectal polyps. METHODS This prospective, randomized single-center clinical trial included consecutive patients ≥ 20 years of age with diminutive colorectal polyps 3-5 mm from December 2014 to October 2015. The primary outcome measures were en-bloc resection (endoscopic evaluation) and complete resection rates (pathological evaluation). The secondary outcome measures were the immediate bleeding or immediate perforation rate after polypectomy, delayed bleeding or delayed perforation rate after polypectomy, use of clipping for bleeding or perforation, and polyp retrieval rate. Prophylactic clipping after polyp removal wasn’t routinely performed. RESULTS Two hundred eight patients were randomized into the CSP (102), HFB (106) and 283 polyps were evaluated (CSP: 148, HFB: 135). The en-bloc resection rate was significantly higher with CSP than with HFB [99.3% (147/148) vs 80.0% (108/135), P < 0.0001]. The complete resection rate was significantly higher with CSP than with HFB [80.4% (119/148) vs 47.4% (64/135), P < 0.0001]. The immediate bleeding rate was similar between the groups [8.6% (13/148) vs 8.1% (11/135), P = 1.000], and endoscopic hemostasis with hemoclips was successful in all cases. No cases of perforation or delayed bleeding occurred. The rate of severe tissue injury to the pathological specimen was higher HFB than CSP [52.6% (71/135) vs 1.3% (2/148), P < 0.0001]. Polyp retrieval failure was encountered CSP (7), HFB (2). CONCLUSION CSP is more effective than HFB for resecting diminutive polyps. Further long-term follow-up study is required. PMID:28127206

  15. Carbon dioxide insufflation compared with air insufflation in double-balloon enteroscopy: a prospective, randomized, double-blind trial.

    PubMed

    Hirai, Fumihito; Beppu, Takahiro; Nishimura, Taku; Takatsu, Noritaka; Ashizuka, Shinya; Seki, Takehiko; Hisabe, Takashi; Nagahama, Takashi; Yao, Kenshi; Matsui, Toshiyuki; Beppu, Tsuyoshi; Nakashima, Rikiya; Inada, Naomi; Tajiri, Eriko; Mitsuru, Hideko; Shigematsu, Hideko

    2011-04-01

    Few studies have evaluated the degree of pain, the amount of retained gas, and the safety of carbon dioxide (CO(2)) insufflation in patients undergoing double-balloon enteroscopy (DBE). To clarify the usefulness and safety of CO(2) insufflation during DBE. Single-center, prospective, randomized, double-blind, controlled trial. University hospital. Forty eligible patients with small-bowel disease for whom DBE was indicated were randomized to a CO(2) insufflation (CO(2)) group or an air insufflation (air) group by means of sealed envelopes. DBE with insufflation of CO(2) or air. Efficacy evaluation was based on the degree of pain as assessed by use of a visual analog scale (VAS) and the amount of residual gas retention within the small and large bowels on radiography. The safety of CO(2) insufflation was evaluated by arterial blood gas analysis. Significantly fewer patients in the CO(2) group had severe pain of ≥ 50 mm on the VAS during DBE than in the air group (P = .02). Significantly less gas was retained in the small bowel just after and at 3 hours after DBE in the CO(2) group than in the air group (P = .003, P = .01, respectively). There was significantly less residual gas retention in the large bowel at 3 hours after DBE in the CO(2) group than in the air group (P = .02). There was no significant difference in pre-DBE and post-DBE partial pressure of oxygen in the blood (PaO(2)) and partial pressure of carbon dioxide in the blood (PaCO(2)) between groups. Small sample size. CO(2) insufflation is a safe and useful procedure when performed during DBE. Copyright © 2011 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

  16. Virtual cystoscopy (pneumo-cystoscopy)—Its utility in the prospective evaluation of bladder tumor

    PubMed Central

    Singh, Iqbal; Mehrotra, Gopesh; Jaura, Maninder S.; Agarwal, Vivek; Tandon, Anupama; Joshi, Mohit

    2012-01-01

    Aim: To evaluate the role of virtual cystoscopy (VC) comparing it with cystopanendoscopy (CPE) for detecting bladder tumor(s). Material and Methods: Ethical clearance was obtained from the Institutional ethics committee. After an informed consent 30 patients fulfilling the inclusion criteria were enrolled in the prospective non-randomized clinical study and were evaluated as per protocol with VC performed by a qualified radiologist who was blinded to the findings of CPE performed by a qualified urologist. The results so obtained were analyzed using appropriate statistical tools. Results: The mean age of the patients was 56 years. Sensitivity of VC in detecting bladder lesions was 92%. However, when axial images were also interpreted along with VC, the sensitivity increased to 96% for detecting bladder lesions. The specificity of VC with axial CT was 40% in respect of detecting bladder lesions. VC with axial CT was 85.7% sensitive in identifying multiple bladder tumors. There were no complications on account of performing VC. Minor problems were encountered with VC and CPE in 16.7% and 13.3% patients respectively. Conclusions: VC with axial CT is 96% sensitive in detecting bladder lesions and 85.7% sensitive in detecting the multiplicity of the tumors. VC may be a useful complementary diagnostic tool for the workup of select patients with suspected bladder lesions. However, larger randomized controlled studies are needed to better define the precise clinical and diagnostic role of VC in routine practice. Settings and Design: Prospective Clinical Comparative Non Randomized Clinical Study. PMID:22919131

  17. Prospective, randomized assessment of the acquisition, maintenance, and loss of laparoscopic skills.

    PubMed

    Gallagher, Anthony G; Jordan-Black, Julie Anne; O'Sullivan, Gerald C

    2012-08-01

    Laparoscopic skills are difficult to learn. We, therefore, assessed the factors involved in skill acquisition, maintenance, and loss in 2 prospective, randomized studies. In study 1, 24 laparoscopic novices were randomly assigned to a control condition who performed the laparoscopic assessment task; Massed condition who trained on virtual reality (VR) simulation during 1 day or Interval condition who had the same amount of VR training distributed over 3 consecutive days. All groups also completed a novel laparoscopic box-trainer task on 5 consecutive days. In study 2, 16 laparoscopic novices were randomly assigned to a Practice or a No-practice condition. All subjects were required to train on a VR simulation curriculum for the same duration and skill attainment level. The week after completion of training, subjects in the Practice condition were allowed 1 complete practice trial on the simulator. Both groups completed the same tasks 2 weeks after completion of the training. In study 1, the Interval trained group showed the fastest rate of learning and on completion of training significantly outperformed both the Massed and Control groups (P < 0.0001). In study 2, both groups showed significant skills improvement from training trial T1 to T3 (P < 0.0001). The subjects in the Practice group maintained or improved their skills at 1 week but those in the No practice group showed significant decline of skills at 2 weeks after training completion (P < 0.0001). Laparoscopic skills are optimally acquired on an Interval training schedule. They significantly decline with 2 weeks of nonuse.

  18. Endoscopic versus microscopic type 1 tympanoplasty in the same patients: a prospective randomized controlled trial.

    PubMed

    Kaya, Isa; Sezgin, Baha; Sergin, Demet; Ozturk, Arin; Eraslan, Sevinc; Gode, Sercan; Bilgen, Cem; Kirazli, Tayfun

    2017-07-01

    The aim of this study was to compare the audiologic outcomes of the patients who underwent endoscopy on one ear and microscopic tympanoplasty on the other, and to investigate the operative time, graft success, postoperative pain and health status. This prospective randomized controlled study was carried out in Ege University ENT Department between February 2015 and September 2016. The patients who had bilateral chronic otitis media, normal middle ear mucosa and a hearing loss difference of 10 dB or less between the two ears randomly underwent microscopic tympanoplasty in one ear and endoscopic tympanoplasty in the contralateral ear, with 6-month intervals. 13 patients were included in the study with a mean age of 36.17 ± 3.61 years (range 17-53 years, 7 female, 6 male). The improvement in air-bone gap for groups 1 (endoscopic) and 2 (microscopic) was 9.48 ± 5.23 and 9.89 ± 2.79 dB, respectively. The duration of the surgery in group 1 was significantly lower than that in group 2 (p < 0.01). VAS scores were 2.15 ± 0.37 and 3.76 ± 1.64 cm for groups 1 and 2, respectively (p = 0.006). The endoscopic approach for type 1 tympanoplasty offers shorter surgery time, better health status and lower postoperative pain than microscopic surgery. In addition, endoscopic surgery offers comparable improvement in air-bone gap and similar graft success. The endoscopic approach has comparable audiological and morphological graft outcomes with the microscopic one. The endoscopic approach yielded better health and pain status for the same patients. Level of evidence This is an individual randomized controlled trial. The level of evidence is 1b.

  19. Vestibular rehabilitation in elderly patients with central vestibular dysfunction: a prospective, randomized pilot study.

    PubMed

    Marioni, Gino; Fermo, Salvatore; Lionello, Marco; Fasanaro, Elena; Giacomelli, Luciano; Zanon, Stefania; Staffieri, Claudia; Dall'Igna, Franco; Manzato, Enzo; Staffieri, Alberto

    2013-12-01

    For the vestibular system, aging is associated with degenerated otoconia and loss of hair cells, vestibular afferents, and cells in the vestibular nuclei. Further neurodegenerative processes involve cortical, extrapyramidal motor, and cerebellar structures. Dizziness is quite common in the elderly, limiting their mobility and activities. The role of vestibular rehabilitation in these patients is controversial. The present prospective, randomized, preliminary investigation aimed to compare the effect of a 6-week posturography-assisted vestibular rehabilitation protocol (30 min a week) combined with a home-based exercise program (group A, 14 randomly assigned elderly patients) with the same home-based exercise program alone (group B, 14 randomly assigned elderly patients) for treating dizziness due to central vestibular dysfunction in elderly patients. The outcomes were analyzed using the 25-item Dizziness Handicap Inventory (DHI) and computerized posturography. After rehabilitation, group A scored significantly better in the DHI for the functional (p = 0.0016) and emotional (p = 0.01) domains and total score (p = 0.001); only the emotional domain improved significantly in group B (p = 0.038). Group A improved significantly in some posturographic parameters in the motor tests (reaction time, movement velocity, and endpoint excursion), while group B experienced more limited improvements. Our preliminary results with a program of posturography-assisted vestibular rehabilitation, and home-based exercises are more promising than with home-based exercises alone. A new study on a larger series of elderly patients with central vestibular dysfunctions is currently underway at Padova University, considering the effect of a protocol involving rehabilitation with computerized posturography alone and the relationship between outcomes and the duration of rehabilitation programs.

  20. Randomized, Prospective Study of the Impact of a Sleep Health Program on Firefighter Injury and Disability.

    PubMed

    Sullivan, Jason P; O'Brien, Conor S; Barger, Laura K; Rajaratnam, Shantha M W; Czeisler, Charles A; Lockley, Steven W

    2017-01-01

    Firefighters' schedules include extended shifts and long work weeks which cause sleep deficiency and circadian rhythm disruption. Many firefighters also suffer from undiagnosed sleep disorders, exacerbating fatigue. We tested the hypothesis that a workplace-based Sleep Health Program (SHP) incorporating sleep health education and sleep disorders screening would improve firefighter health and safety compared to standard practice. Prospective station-level randomized, field-based intervention. US fire department. 1189 firefighters. Sleep health education, questionnaire-based sleep disorders screening, and sleep clinic referrals for respondents who screened positive for a sleep disorder. Firefighters were randomized by station. Using departmental records, in an intention-to-treat analysis, firefighters assigned to intervention stations which participated in education sessions and had the opportunity to complete sleep disorders screening reported 46% fewer disability days than those assigned to control stations (1.4 ± 5.9 vs. 2.6 ± 8.5 days/firefighter, respectively; p = .003). There were no significant differences in departmental injury or motor vehicle crash rates between the groups. In post hoc analysis accounting for intervention exposure, firefighters who attended education sessions were 24% less likely to file at least one injury report during the study than those who did not attend, regardless of randomization (OR [95% CI] 0.76 [0.60, 0.98]; χ2 = 4.56; p = .033). There were no significant changes pre- versus post-study in self-reported sleep or sleepiness in those who participated in the intervention. A firefighter workplace-based SHP providing sleep health education and sleep disorders screening opportunity can reduce injuries and work loss due to disability in firefighters.

  1. PLATINUM China: a prospective, randomized investigation of the platinum chromium everolimus-eluting stent in de novo coronary artery lesions.

    PubMed

    Gao, Runlin; Han, Yaling; Yang, Yuejin; Zhang, Jian; Hou, Yuqing; Wang, Haichang; Li, Hui; Fang, Quan; Yu, Bo; Xu, Bo; Allocco, Dominic J; Dawkins, Keith D

    2015-03-01

    The PLATINUM China clinical trial evaluated the safety and effectiveness of the thin-strut, everolimus-eluting, platinum-chromium PROMUS™ Element™ stent (PtCr-EES) (Boston Scientific, Marlborough, MA) for the treatment of patients in China. Clinical outcomes from the PtCr-EES have not been evaluated in patients from China, nor has it been directly compared with the second-generation stainless steel paclitaxel-eluting TAXUS Liberté stent (PES) in a randomized head-to-head trial. Methods In this prospective, multicenter, single-blind, superiority trial, patients with a single de novo atherosclerotic coronary artery lesion were randomized 1:3 to receive either the PES or PtCr-EES. The primary endpoint was in-stent late loss at 9 months. Among 127 PES and 373 PtCr-EES patients (71.2% male; mean age 57.3 years), the primary endpoint of 9-month in-stent late loss was 0.40 ± 0.45 mm for PES versus 0.11 ± 0.36 mm for PtCr-EES (P < 0.001). In-stent % diameter stenosis was 22.20 ± 16.00% for PES versus 11.06 ± 13.86% for PtCr-EES (P < 0.001) at 9 months. The 1-year rate of death/MI was 1.6% (2/127) for PES versus 0% (0/371) for PtCr-EES (P = 0.06) and target vessel revascularization was 4.7% (6/127) for PES versus 2.7% (10/371) for PtCr-EES (P = 0.26). No stent thromboses occurred at 12 months in either group. In the largest prospective angiographic evaluation conducted to date with this stent, the PROMUS Element PtCr-EES was superior to the TAXUS Liberté PES for the primary endpoint of late loss at 9 months, with low rates of clinical events at 1 year. Clinical follow-up will continue to 2 years. © 2015 Wiley Periodicals, Inc.

  2. Evaluating the effects of GP remuneration: problems and prospects.

    PubMed

    Scott, A; Hall, J

    1995-03-01

    General practice reform is occurring in a number of countries. Little is known, however, of the effects of remunerating general practitioners on the costs and outcomes of care. Valuable lessons can be learned for the scope and design of future research, however, from the existing literature on the effects of general practioner (GP) remuneration. The objectives of this paper are to highlight some of the problems and pitfalls that should be avoided in any further research on the effects of GP remuneration and to identify the main issues for future research. Eighteen studies of the effects of GP remuneration have been reviewed, with a focus on the methods used. Eight studies addressed the effect of changes in the level of remuneration, three evaluated the effect of special payments and bonuses and seven assessed the effects of different remuneration systems. Although there are often practical constraints on the choice of study design, crude 'before and after' analyses and the use of aggregate data should be avoided in favour of prospective evaluations using consultation-based data. The studies reviewed did not evaluate the effects of remuneration on patient welfare and were characterised by the omission of major confounding variables and an inability to generalise to other settings. These issues present a considerable challenge to researchers, GPs and policy makers.

  3. Treatment of chronic antibody mediated rejection with intravenous immunoglobulins and rituximab: a multicenter, prospective, randomized, double blind clinical trial.

    PubMed

    Moreso, Francesc; Crespo, Marta; Ruiz, Juan C; Torres, Armando; Gutierrez-Dalmau, Alex; Osuna, Antonio; Perelló, Manel; Pascual, Julio; Torres, Irina B; Redondo-Pachón, Dolores; Rodrigo, Emilio; Lopez-Hoyos, Marcos; Seron, Daniel

    2017-09-26

    There are no approved treatments for chronic antibody mediated rejection (ABMR). We conducted a multicenter, prospective, randomized, placebo-controlled, double blind clinical trial to evaluate efficacy and safety of intravenous immunoglobulins (IVIG) combined with rituximab (RTX) (EudraCT 2010-023746-67). Patients with transplant glomerulopathy and anti-HLA donor-specific antibodies (DSA) were eligible. Patients with estimated glomerular filtration rate (eGFR) < 20 mL/min/1.73m(2) and/or severe interstitial fibrosis/tubular atrophy were excluded. Patients were randomized to receive IVIG (4 doses of 0.5 g/kg) and RTX (375 mg/m(2) ) or a wrapped isovolumetric saline infusion. Primary efficacy variable was the decline of eGFR at one year. Secondary efficacy variables included evolution of proteinuria, renal lesions and DSA at one year. The planned sample size was 25 patients per group. During 2012-2015, twenty-five patients were randomized (13 to the treatment and 12 to the placebo group). The planned patient enrollment was not achieved because of budgetary constraints and slow patient recruitment. There were no differences between the treatment and placebo groups in eGFR decline (-4.2±14.4 vs. -6.6±12.0 mL/min/1.73 m(2,) p-value=0.475), increase of proteinuria (+0.9±2.1 vs. +0.9±2.1 g/day, p-value=0.378), Banff scores at one year and MFI of the immunodominant DSA. Safety was similar between groups. These data suggest that the combination of IVIG and RTX is not useful in patients displaying transplant glomerulopathy and DSA. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  4. A Randomized, Prospective, Double-Blind, Placebo-Controlled Trial of Terlipressin for Type 1 Hepatorenal Syndrome

    PubMed Central

    SANYAL, ARUN J.; BOYER, THOMAS; GARCIA–TSAO, GUADALUPE; REGENSTEIN, FREDERICK; ROSSARO, LORENZO; APPENRODT, BEATE; BLEI, ANDRES; GÜLBERG, VEIT; SIGAL, SAMUEL; TEUBER, PETER

    2013-01-01

    Background & Aims Hepatorenal syndrome (HRS) type 1 is a progressive functional renal failure in subjects with advanced liver disease. The aim of this study was to evaluate the efficacy and safety of terlipressin, a systemic arterial vasoconstrictor, for cirrhosis type 1 HRS. Methods A prospective, randomized, double-blind, placebo-controlled clinical trial of terlipressin was performed. Subjects with type 1 HRS were randomized to terlipressin (1 mg intravenously every 6 hours) or placebo plus albumin in both groups. The dose was doubled on day 4 if the serum creatinine (SCr) level did not decrease by 30% of baseline. Treatment was continued to day 14 unless treatment success, death, dialysis, or transplantation occurred. Treatment success was defined by a decrease in SCr level to ≤1.5 mg/dL for at least 48 hours by day 14 without dialysis, death, or relapse of HRS type 1. Results Fifty-six subjects were randomized to each arm. Treatment success with terlipressin was double that with placebo (25% vs 12.5%, P = .093). SCr level improved from baseline to day 14 on terlipressin (−0.7 mg/dL) as compared with placebo (0 mg/dL), P < .009. Terlipressin was superior to placebo for HRS reversal (34% vs 13%, P= .008), defined by decrease in SCr level ≤1.5 mg/dL. Overall and transplantation-free survival was similar between study groups; HRS reversal significantly improved survival at day 180. One nonfatal myocardial infarction occurred with terlipressin, but the total adverse event rate was similar to placebo. Conclusions Terlipressin is an effective treatment to improve renal function in HRS type 1. PMID:18471513

  5. 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.

  6. Effect of radial shock wave therapy for carpal tunnel syndrome: A prospective randomized, double-blind, placebo-controlled trial.

    PubMed

    Wu, Yung-Tsan; Ke, Ming-Jen; Chou, Yu-Ching; Chang, Chih-Ya; Lin, Ching-Yueh; Li, Tsung-Ying; Shih, Feng-Mei; Chen, Liang-Cheng

    2016-06-01

    Three recent studies demonstrated the positive effect of extracorporeal shock wave therapy (ESWT) for treating carpal tunnel syndrome (CTS). However, none have entirely proved the effects of ESWT on CTS because all studies had a small sample size and lacked a placebo-controlled design. Moreover, radial ESWT (rESWT) has not been used to treat CTS. We conducted a prospective randomized, controlled, double-blinded study to assess the effect of rESWT for treating CTS. Thirty-four enrolled patients (40 wrists) were randomized into intervention and control groups (20 wrists in each). Participants in the intervention group underwent three sessions of rESWT with nightly splinting, whereas those in the control group underwent sham rESWT with nightly splinting. The primary outcome was visual analog scale (VAS), whereas the secondary outcomes included the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. Evaluations were performed before treatment and at 1, 4, 8, and 12 weeks after the third rESWT session. A significantly greater improvement in the VAS, BCTQ scores, and CSA of the median nerve was noted in the intervention group throughout the study as compared to the control group (except for BCTQ severity at week 12 and CSA at weeks 1 and 4) (p < 0.05). This is the first study to assess rESWT in a randomized placebo-controlled trial and demonstrate that rESWT is a safe and effective method for relieving pain and disability in patients with CTS. © 2015 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 34:977-984, 2016.

  7. Comparison of Early Total Thyroidectomy with Antithyroid Treatment in Patients with Moderate-Severe Graves' Orbitopathy: A Randomized Prospective Trial

    PubMed Central

    Erdoğan, Murat Faik; Demir, Özgür; Ersoy, Reyhan Ünlü; Gül, Kamile; Aydoğan, Berna İmge; Üç, Ziynet Alphan; Mete, Türkan; Ertek, Sibel; Ünlütürk, Uğur; Çakır, Bekir; Aral, Yalçın; Güler, Serdar; Güllü, Sevim; Çorapçıoğlu, Demet; Dağdelen, Selçuk; Erdoğan, Gürbüz

    2016-01-01

    Background The optimal therapeutic choice for Graves' hyperthyroidism in the presence of moderate-severe Graves' orbitopathy (GO) remains controversial. Objectives We aimed to compare GO course in patients with moderate-severe GO treated with early total thyroidectomy (TTx) versus antithyroid drug (ATD) regimens, in a prospective, randomized manner. Methods Forty-two patients with moderate-severe GO were enrolled. A total of 4.5 g of pulse corticosteroids were given intravenously to all patients before randomization. Patients in the first group were given TTx, whereas patients in the second group were treated with ATDs. TSH was kept between 0.4 and 1 mIU/l. The clinical course of GO was evaluated with proptosis, lid aperture, clinical activity score (CAS), and diplopia. Results Eighteen and 24 patients were randomized to the TTx and ATD groups, respectively. Thyroid autoantibodies decreased significantly, and there were significant improvements in proptosis, lid aperture, and CAS in the TTx group. While in the ATD group the decrement in thyroid autoantibodies was not significant, there were significant improvements in proptosis and CAS. When the TTx group was compared with the ATD group, anti-TPO, anti-Tg, and TSH-receptor antibodies were significantly decreased in the TTx group (p < 0.01), but there was no significant difference with respect to proptosis, lid aperture, CAS, and diplopia between the two groups during a median (min.-max.) follow-up period of 60 months (36-72). Conclusion Although no definitive conclusions could be drawn from the study, mainly due to limited power, early TTx and the ATD treatment regimens, followed by intravenous pulse corticosteroid therapy, seemed to be equally effective on the course of GO in this relatively small group of patients with moderate-severe GO during a median (min.-max.) follow-up period of 60 months (36-72). PMID:27493884

  8. Using Randomized Controlled Trials to Evaluate Interventions for Releasing Prisoners

    ERIC Educational Resources Information Center

    Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia

    2016-01-01

    Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…

  9. Using Randomized Controlled Trials to Evaluate Interventions for Releasing Prisoners

    ERIC Educational Resources Information Center

    Pettus-Davis, Carrie; Howard, Matthew Owen; Dunnigan, Allison; Scheyett, Anna M.; Roberts-Lewis, Amelia

    2016-01-01

    Randomized controlled trials (RCTs) are rarely used to evaluate social and behavioral interventions designed for releasing prisoners. Objective: We use a pilot RCT of a social support intervention (Support Matters) as a case example to discuss obstacles and strategies for conducting RCT intervention evaluations that span prison and community…

  10. Intravaginal Misoprostol for Cervical Ripening and Labor Induction in Nulliparous Women: A Double-blinded, Prospective Randomized Controlled Study.

    PubMed

    Zhang, Yu; Zhu, Hao-Ping; Fan, Jian-Xia; Yu, Hong; Sun, Li-Zhou; Chen, Lian; Chang, Qing; Zhao, Nai-Qing; Di, Wen

    2015-10-20

    In China, no multicenter double-blinded prospective randomized controlled study on labor induction has been conducted till now. This study is to evaluate the efficacy and safety of intravaginal accurate 25-μg misoprostol tablets for cervical ripening and labor induction in term pregnancy in nulliparous women. This was a double-blinded, prospective randomized controlled study including nulliparous women from 6 university hospitals across China. Subjects were randomized into misoprostol or placebo group with the sample size ratio set to 7:2. Intravaginal 25-μg misoprostol or placebo was applied at an interval of 4 h (repeated up to 3 times) for labor induction. Primary outcome measures were the incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h. Safety assessments included the incidences of maternal morbidity and adverse fetal/neonatal outcomes. A total of 173 women for misoprostol group and 49 women for placebo were analyzed. The incidence of cumulative Bishop score increases ≥3 within 12 h or vaginal delivery within 24 h was higher in the misoprostol group than in the placebo (64.2% vs. 22.5%, relative risk [RR]: 2.9, 95% confidence interval [CI]: 1.4-6.0). The incidence of onset of labor within 24 h was significantly higher in the misoprostol group than in the placebo group (48.0% vs. 18.4%, RR: 2.6, 95% CI: 1.2-5.7); and the induction-onset of labor interval was significantly shorter in the misoprostol group (P = 0.0003). However, there were no significant differences in the median process time of vaginal labor (6.4 vs. 6.8 h; P = 0.695), incidence (39.3% vs. 49.0%, RR: 0.8, 95% CI: 0.4-1.5) and indications (P = 0.683) of cesarean section deliveries, and frequencies of maternal, fetal/neonatal adverse events between the groups. Intravaginal misoprostol 25 μg every 4 h is efficacious and safe in labor induction and cervical ripening.

  11. Mono- versus polyaxial locking plates in distal femur fractures: a prospective randomized multicentre clinical trial.

    PubMed

    Hanschen, Marc; Aschenbrenner, Ina M; Fehske, Kai; Kirchhoff, Sonja; Keil, Leonhard; Holzapfel, Boris M; Winkler, Sebastian; Fuechtmeier, Bernd; Neugebauer, Rainer; Luehrs, Sven; Liener, Ulrich; Biberthaler, Peter

    2014-04-01

    Treatment of complex fractures of the distal femur utilizing monoaxial locking plates (e.g. Less Invasive Stabilisation System, LISS®, Synthes) is considered to be superior to conventional plating systems. Due to the limitation that the thread forces the screw into pre-determined positions, modifications have been made to allow screw positioning within a range of 30° (Non Contact Bridging, NCB®-DF, Zimmer). For the first time, this multicenter prospective randomized clinical trial (RCT) investigates the outcome of LISS® vs. NCB®-DF treatment following complex fractures of the distal femur. Since June 2008, 27 patients with a fracture of the distal femur (AO ASIF 33-A-C and periprosthetic fractures) were enrolled in this study by four university trauma centres in southern Germany. Clinical (e.g. range of motion, Oxford knee score, Tegner score) and radiological (e.g. axis deviation, secondary loss of realignment) follow-ups were conducted one and six weeks, as well as three, six, and 12 months after the operation. This study comprises data of 27 patients (8 male, 19 female; 15 NCB®-DF, 12 LISS®). Polyaxial osteosynthesis using the NCB® system tended to result in better functional knee scores and a higher range of motion. Interestingly, fracture union tended to be more rapid using the polyaxial plating system. We present the analysis of a multicenter prospective RCT to compare the monoaxial LISS® vs. the polyaxial NCB®-DF treatment following complex fractures of the distal femur. NCB®-DF treatment tended to result in better functional and radiological outcomes than LISS® treatment. Level I.

  12. Functional parameters before and after parathyroidectomy: a prospective, randomized long-term trial on different rat strains.

    PubMed

    Hasse, C; Brune, M; Lorenz, W; Barth, P; Metzler, W; Breves, G; Sitter, H

    2004-07-01

    For clinical controls before and after parathyroidectomy and for evaluation of the function of transplants of parathyroid tissue, it is necessary to establish standard values of relevant laboratory parameters for donor and recipient animals as well as for different types of nutrition. Since no such data are yet available, it was the purpose to define such standards. In a prospective randomized trial on 400 rats of the Dark Agouti (DA) and Lewis strain, different functional laboratory parameters such as total calcium, intact parathyroid hormone, phosphate, 1.25-dihydroxyvitamin D, and alkaline phosphatase were measured under a standard and low calcium diet over a period of 40 weeks. Two hundred of these animals underwent a parathyroidectomy four weeks after the beginning of the study and specimens were evaluated histologically. For all eight different study groups normal values could be defined within tight limits for parameters which describe the function of the parathyroid gland or elements of calcium metabolism under different conditions. The optimal conditions for a transplantation model of parathyroid glands were established. Lewis-rats were identified as the ideal donor and DA rats as the better recipient animals. These data can serve as reference values for future studies on transplantation of the parathyroid without immunosuppression.

  13. A large, prospective, randomized, open-label, multicentre study of corticosteroid withdrawal in SPK transplantation: a 3-year report.

    PubMed

    Nakache, Richard; Malaise, Jacques; Van Ophem, Dominique

    2005-05-01

    Simultaneous pancreas-kidney (SPK) transplantation is the treatment of choice for selected diabetic patients. Corticosteroids are an important element of immunosuppressive protocols, but their long-term use has detrimental effects on patients' health, necessitating eventual discontinuation. This prospective study evaluated the safety and feasibility of corticosteroid withdrawal in 205 SPK transplant recipients randomized to immunosuppressive treatment with either tacrolimus and mycophenolate mofetil (MMF) (n = 103) or cyclosporin microemulsion (ME) and MMF (n = 102). Corticosteroid withdrawal was successful in the majority of in-study patients (66% tacrolimus, 73% cyclosporin-ME). Compared with out-of-study patients or those continuing corticosteroid therapy, in-study patients withdrawn from corticosteroids experienced fewer pancreas or kidney graft losses, fewer episodes of acute rejection and were less likely to be withdrawn from the study. Acute rejection occurred after corticosteroid withdrawal in two patients who had a previous rejection and in five patients who were rejection-free before corticosteroid withdrawal. No rejection episodes were associated with graft loss or immediate serious consequences. Overall, corticosteroid withdrawal was achieved with an increase in the dose of both MMF and tacrolimus. A long-term survey of corticosteroid withdrawal in SPK transplantation with multifactorial analyses is necessary to confirm these early results and to evaluate the positive effects on glucose metabolism and hypertension.

  14. Additional Targeted Biopsy in Clinically Suspected Prostate Cancer: Prospective Randomized Comparison between Contrast-Enhanced Ultrasound and Sonoelastography Guidance.

    PubMed

    Koh, Jieun; Jung, Dae Chul; Oh, Young Taik; Yoo, Moon Gyu; Noh, Songmi; Han, Kyung Hwa; Rha, Koon-Ho; Choi, Young Deuk; Hong, Sung Joon

    2015-11-01

    Our aim was to improve the detection of prostate cancer by evaluating whether contrast-enhanced ultrasound (CEUS) or sonoelastography (SE) is more helpful in guiding targeted biopsy (TB) performed before systematic biopsy (SB). A total of 52 patients suspected of having prostate cancer were prospectively included and randomly assigned to either the CEUS or SE group. Different, independent radiologists performed TB and twelve-core SB. Within each group, cancer detection rates based on core number were compared between SB and TB. We evaluated the effect of TB on core-based cancer detection rates between the CEUS and SE groups. Cancer detection was higher in overall TB cores 16.4% (28/171) than SB cores 11.4% (71/624) in both groups. In the SE group, TB cores revealed higher cancer detection than did SB cores from 4.49% (14/312) to 12.86% (9/70) (p = 0.01). Compared with CEUS, SE may improve detection rates when considering additional TB guidance methods.

  15. Intrapleural Fibrinolysis with Urokinase Versus Alteplase in Complicated Parapneumonic Pleural Effusions and Empyemas: A Prospective Randomized Study.

    PubMed

    Alemán, Carmen; Porcel, José M; Alegre, José; Ruiz, Eva; Bielsa, Silvia; Andreu, Jordi; Deu, Maria; Suñé, Pilar; Martínez-Sogués, Mireia; López, Iker; Pallisa, Esther; Schoenenberger, Joan Antoni; Bruno Montoro, J; de Sevilla, Tomás Fernández

    2015-12-01

    Pleurofibrinolysis has been reported to be potentially beneficial in the management of complicated parapneumonic effusions (CPPE) and empyemas in the adult population. Prospective, controlled, randomized, and double-blind study, to evaluate intrapleural alteplase 10 mg (initially 20 mg was considered but bleeding events forced dose reduction) versus 100,000 UI urokinase every 24 h for a maximum of 6 days in patients with CPPE or empyemas. The primary aim was to evaluate the success rate of each fibrinolytic agent at 3 and 6 days. Success of therapy was defined as the presence of both clinical and radiological improvement, making additional fibrinolytic doses unnecessary, and eventually leading to resolution. Secondary outcomes included the safety profile of intrapleural fibrinolytics, referral for surgery, length of hospital stay, and mortality. A total of 99 patients were included, of whom 51 received alteplase and 48 urokinase. Success rates for urokinase and alteplase at 3 and 6 days were not significantly different, but when only the subgroup of CPPE was considered, urokinase resulted in a high proportion of cures. There were no differences in mortality or surgical need (overall, 3 %). Five (28 %) patients receiving 20 mg of alteplase and 4 (12 %) receiving 10 mg presented serious bleeding events. If intrapleural fibrinolytics are intended to be used, urokinase may be more effective than alteplase in patients with non-purulent CPPE and have a lower rate of adverse events.

  16. Central venous access for haemodialysis: prospective evaluation of possible complications.

    PubMed

    de Andrade, Denise; Ferreira, Viviane

    2007-02-01

    The combination of chronic renal insufficiency and haemodialysis represents a challenge for health professionals. Chronic renal insufficiency patients undergoing haemodialysis treatment through a temporary double-lumen catheter were prospectively studied in order to identify the type and frequency of local and systemic complications. A six-month period was established with a view to the inclusion of new cases. Data were acquired through interviews, clinical assessment and patient records, and entered into a Microsoft Excel database through a double entry system and exported to the Statistical Package Social Sciences software. Sixty-four patients were evaluated prospectively, of which thirty-eight (59.4%) were men and 35 (54.7%) required catheter insertion for immediate treatment. During the study period, 145 catheters were inserted, ranging from 1 to 7 implants per patient, 29 (45.3%) were single insertions and 127 (87.6%) catheters were inserted into the jugular vein. The catheters were left in place for an average of 30 days. Forty-one (64%) presented inadequate functioning, after about 26 days. A febrile state occurred in 24 (37.5%) patients after 34 days, secretion at the catheter entry site in 27 (42.2% after 26 days and bloodstream infection was encountered in 34(53%) after 34 days. Of the 61 blood culture samples, thirty (49%) were positive for Staphylococcus aureus that was the microorganism most frequently isolated. The findings indicate worrying aspects such as the catheters permanence time, exposing patients to different complications, including infection. Furthermore, inadequate catheter functioning leads to inefficient haemodialysis treatment. Knowledge about complications allows for systematic care planning, prevention and control actions.

  17. Delayed cord clamping with and without cord stripping: a prospective randomized trial of preterm neonates.

    PubMed

    Krueger, Margaret S; Eyal, Fabien G; Peevy, Keith J; Hamm, Charles R; Whitehurst, Richard M; Lewis, David F

    2015-03-01

    Autologous blood transfusion from the placenta to the neonate at birth has been proven beneficial. Transfusion can be accomplished by either delayed cord clamping or cord stripping. Both are equally effective in previous randomized trials. We hypothesized that combining these 2 techniques would further improve outcomes in preterm neonates. This was a prospective randomized trial for singleton deliveries with estimated gestational ages between 22 and 31 6/7 weeks. The control protocol required a 30-second delayed cord clamping, whereas the test protocol instructed a concurrent cord stripping during the delay. The primary outcome was initial fetal hematocrit. We also examined secondary outcomes of neonatal mortality, length of time on the ventilator, days to discharge, peak bilirubin, number of phototherapy days, and neonatal complication rates. Of the 67 patients analyzed, 32 were randomized to the control arm and 35 were randomized to the test arm. The gestational ages and fetal weights were similar between the arms. Mean hematocrit of the control arm was 47.75%, and the mean hematocrit for the test arm was 47.71% (P = .98). These results were stratified by gestational age, revealing the infants less than 28 weeks had an average hematocrit of 41.2% in the control arm and 44.7% in the test arm (P = .12). In the infants with gestational ages of 28 weeks or longer, the control arm had an average hematocrit of 52.9%, which was higher than the test arm, which averaged 49.5% (P = .04). The control arm received an average of 1.53 blood transfusions, whereas the test arm received 0.97 (P = .33). The control arm had 3 neonatal deaths, and the test arm had none (P = .10). The average number of days until discharge was 71.2 for the control arm and 67.8 for the test arm (P = .66). The average number of days on the ventilator was 4.86 for the control arm and 3.06 for the test arm (P = .34). Adding cord stripping to the delayed cord clamp does not result in an increased

  18. Prospective Randomized Comparison of Chemoembolization with Doxorubicin-Eluting Beads and Bland Embolization with BeadBlock for Hepatocellular Carcinoma

    SciTech Connect

    Malagari, Katerina; Pomoni, Mary; Kelekis, Alexis; Pomoni, Anastasia; Dourakis, Spyros; Spyridopoulos, Themis; Moschouris, Hippokratis; Emmanouil, Emmanouil; Rizos, Spyros; Kelekis, Dimitrios

    2010-06-15

    The purpose of this study was to evaluate the added role of a chemotherapeutic in transarterial chemoembolization (TACE) of intermediate-stage hepatocellular carcinoma (HCC). The issue is of major importance since, as suggested by recent evidence, hypoxia or incomplete devascularization of the tumor is a potent stimulator of angiogenesis, and there are not many papers supplying level one evidence confirming the value of a chemotherapeutic. The hypothesis was that since drug-eluting bead (DEB)-TACE is standardized and reproducible, a comparison with bland TACE can readily reveal the potential value of the chemotherapeutic. Two groups were randomized in this prospective study: group A (n = 41) was treated with doxorubicin DEB-TACE, and group B (n = 43) with bland embolization. Patients were randomized for tumor diameter. Patients were embolized at set time intervals (2 months), with a maximum of three embolizations. Tumor response was evaluated using the EASL criteria and {alpha}-fetoprotein levels. At 6 months a complete response was seen in 11 patients (26.8%) in the DEB-TACE group and in 6 patients (14%) in the bland embolization group; a partial response was achieved in 19 patients (46.3%) and 18 (41.9%) patients in the DEB-TACE and bland embolization groups, respectively. Recurrences at 9 and 12 months were higher for bland embolization (78.3% vs. 45.7%) at 12 months. Time to progression (TTP) was longer for the DEB-TACE group (42.4 {+-} 9.5 and 36.2 {+-} 9.0 weeks), at a statistically significant level (p = 0.008). In conclusion, DEB-TACE presents a better local response, fewer recurrences, and a longer TTP than bland embolization with BeadBlock. However, survival benefit and bland embolization with smaller particles must be addressed in future papers to better assess the clinical value.

  19. 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.

  20. Effectiveness of high-intensity laser therapy and splinting in lateral epicondylitis; a prospective, randomized, controlled study.

    PubMed

    Dundar, Umit; Turkmen, Utku; Toktas, Hasan; Ulasli, Alper Murat; Solak, Ozlem

    2015-04-01

    Lateral epicondylitis (LE) is a common disorder that causes pain on the outside of the elbow, as well as pain and weakness during gripping. In this prospective, randomized, controlled, assessor-blinded trial, we planned to investigate the effects of high-intensity laser therapy (HILT) in patients with LE and to compare these results with those of a brace and placebo HILT. Patients were randomly assigned to three treatment groups. The first group was treated with HILT. The second group (sham therapy group) received placebo HILT, while the third group (brace group) used the lateral counterforce brace for LE. The patients were assessed for grip strength, pain, disability, and quality of life. Outcome measurements and ultrasonographic examination of the patients were performed before treatment (week 0) and after treatment (after 4 and 12 weeks). HILT and brace groups showed significant improvements for most evaluation parameters (pain scores, grip strength, disability scores, and several subparts of the short-form 36 health survey (physical function, role limitations due to physical functioning, bodily pain, general health, and vitality)) after treatment (after 4 and 12 weeks). However, the improvements in evaluation parameters of the patients with LE in HILT and brace groups were not reflected to ultrasonographic findings. Furthermore, comparison of the percentage changes of the parameters after treatment relative to pretreatment values did not show a significant difference between HILT and brace groups. We conclude that HILT and splinting are effective physical therapy modalities for patients with LE in reducing pain and improving disability, quality of life, and grip strength.

  1. Dyslipidemia in HIV-positive patients: a randomized, controlled, prospective study on ezetimibe+fenofibrate versus pravastatin monotherapy

    PubMed Central

    Grandi, Anna M; Nicolini, Eleonora; Rizzi, Laura; Caputo, Sara; Annoni, Filippo; Cremona, Anna M; Marchesi, Chiara; Guasti, Luigina; Maresca, Andrea M; Grossi, Paolo

    2014-01-01

    Introduction We designed a randomized, controlled prospective study aimed at comparing efficacy and tolerability of ezetimibe+fenofibrate treatment versus pravastatin monotherapy in dyslipidemic HIV-positive (HIV+) patients treated with protease inhibitors (PIs). Methods We consecutively enrolled 42 HIV+ dyslipidemic patients on stable PIs therapy (LDL cholesterol >130 mg/dl or triglycerides 200–500 mg/dl with non-HDL cholesterol >160 mg/dl). After basal evaluation, patients were randomized to a six-month treatment with ezetimibe 10 mg/day+fenofibrate 200 mg/day or with pravastatin 40 mg/day. Both at the basal evaluation and after the six-month treatment, the patients underwent blood tests for lipid parameters, and muscle and liver enzymes. Results At baseline, the two groups (21 patients each) were similar with regards to gender, age, BMI, blood pressure and virologic and metabolic parameters. After the six-month therapy, total cholesterol, LDL cholesterol and non-HDL cholesterol decreased significantly (p<0.01) in both groups. high-density lipoprotein (HDL) cholesterol increased (44±10 to 53±12 mg/dl, p<0.005) and triglycerides decreased (from 265±118 mg/dl to 149±37 mg/dl, p<0.001) in the ezetimibe+fenofibrate group, whereas both parameters remained unchanged in the pravastatin group. Mean values of creatine kinase (CK), alanine aminotransferase and aspartate aminotransferase were unchanged in both groups; only one patient in the pravastatin group stopped the treatment after two months, due to increased CK. Conclusions In dyslipidemic HIV+ patients on PI therapy, the association of ezetimibe+fenofibrate is more effective than pravastatin monotherapy in improving lipid profile and is also well tolerated. PMID:25148829

  2. Significance of patient-controlled sedation during colonoscopy. Results from a prospective randomized controlled study.

    PubMed

    Crepeau, Thomas; Poincloux, Laurent; Bonny, Corinne; Lighetto, Sylvie; Jaffeux, Patricia; Artigue, Fabrice; Walleckx, Pierre; Bazin, Jean Etienne; Dapoigny, Michel; Bommelaer, Gilles

    2005-11-01

    In France, general anesthesia is given to more than 90% of patients undergoing colonoscopy although in several countries sedation is limited to intolerant patients. This study was carried out to determine whether Patient-Controlled Sedation (PCS) could provide a lighter sedation than general anesthesia adapted to the patient's individual requirement. Patients aged from 18 to 80 scheduled for elective colonoscopy were prospectively randomized to receive either standard sedation (control group) or patient-controlled-sedation (PCS). In the control group, patients received a continuous infusion of propofol. Patients in the PCS group were connected to an infusion pump containing propofol and self-administered 20-mg boluses as often as they required. An anesthetist was present throughout the procedure. Patient satisfaction measured on a visual analog scale four hours after colonoscopy was the main outcome criterion. From December 2002 to September 2003, 402 patients underwent elective colonoscopy, 173 of them were eligible and were asked to participate in the study. Seventy-two gave their informed consent and were prospectively randomized. The patients' mean satisfaction scores were not statistically different between the two groups: 84.7 mm (PCS group) vs. 91.5 mm (control group); P = 0.24. Mean doses of propofol (60 mg vs. 248 mg; P <0.001), depth of sedation and time before discharge (1.75 hours vs. 4.45 hours) were significantly lower for patients in the PCS group; nine of them (25.7%) did not use the pump and had total colonoscopy without sedation. There were no statistically significant differences between the two groups regarding total duration of colonoscopy (19.4 min (PCS) vs. 18 min (control)) difficulty and therapeutic procedures (biopsy or polypectomy). Two weeks after the procedure, 96.5% of patients in the PCS group were willing to repeat the examination under the same conditions vs. 72.5% of patients in the control group (P = 0.03). Our results demonstrate

  3. Restrictive versus Standard Fluid Regimen in Elective Minilaparotomy Abdominal Aortic Repair-Prospective Randomized Controlled Trial.

    PubMed

    Piljic, Dragan; Petricevic, Mate; Piljic, Dilista; Ksela, Jus; Robic, Boris; Klokocovnik, Tomislav

    2016-06-01

    Objective Elective minilaparotomy abdominal aortic aneurysm (AAA) repair is associated with a significant number of complications involving respiratory, cardiovascular, gastrointestinal, and central nervous systems, with mortality ranging up to 5%. In our study, we tested the hypothesis that intra- and postoperative intravenous restrictive fluid regimen reduces postoperative morbidity and mortality, and improves the outcome of minilaparotomy AAA repair. Methods From March 2009 to July 2013, 60 patients operated due to AAA were included in a prospective randomized controlled trial (RCT). About the administration of fluid during the operation and in the early postoperative period, all the patients were randomized into two groups: the group of standard fluid administration (S-group, 30 patients) and the group of reduced fluid administration (R-group, 30 patients). The verification of the treatment success was measured by the length of intensive care unit (ICU) stay, duration of hospitalization after the procedure, as well as the number and type of postoperative complications and mortality. This prospective RCT was registered in a publicly accessible database ClinicalTrials.gov with unique Identifier ID: NTC01939652. Results Total fluid administration and administration of blood products were significantly lower in R-group as compared with S-group (2,445.5 mL vs. 3308.7 mL, p = 0.004). Though the number of nonlethal complications was significantly lower in R-group (2 vs. 9 patients, p = 0.042), the difference in lethal complications remained nonsignificant (0 vs. 1 patient, p = ns). The average ICU stay (1.2 vs. 1.97 days, p = 0.003) and duration of postoperative hospital stay (4.33 vs. 6.20 days, p = 0.035 for R-group and S-group, respectively) were found to be significantly shorter in R-group. Conclusion Intra- and postoperative restrictive intravenous fluid regimen in patients undergoing minilaparotomy AAA repair significantly reduces

  4. Radiation therapy for heterotopic ossification prophylaxis acutely after elbow trauma: a prospective randomized study.

    PubMed

    Hamid, Nady; Ashraf, Nomaan; Bosse, Michael J; Connor, Patrick M; Kellam, James F; Sims, Stephen H; Stull, Douglass E; Jeray, Kyle J; Hymes, Robert A; Lowe, Timothy J

    2010-09-01

    Heterotopic ossification around the elbow can result in pain, loss of motion, and impaired function. We hypothesized that a single dose of radiation therapy could be administered safely and acutely after elbow trauma, could decrease the number of elbows that would require surgical excision of heterotopic ossification, and might improve clinical results. A prospective randomized study was conducted at three medical centers. Patients with an intra-articular distal humeral fracture or a fracture-dislocation of the elbow with proximal radial and/or ulnar fractures were enrolled. Patients were randomized to receive either single-fraction radiation therapy of 700 cGy immediately postoperatively (within seventy-two hours) or nothing (the control group). Clinical and radiographic assessment was performed at six weeks, three months, and six months postoperatively. All adverse events and complications were documented prospectively. This study was terminated prior to completion because of an unacceptably high number of adverse events reported in the treatment group. Data were available on forty-five of the forty-eight patients enrolled in this study. When the rate of complications was investigated, a significant difference was detected in the frequency of nonunion between the groups. Of the nine patients who had a nonunion, eight were in the treatment group. The nonunion rate was 38% (eight) of twenty-one patients in the treatment group, which was significantly different from the rate of 4% (one) of twenty-four patients in the control group (p = 0.007). There were no significant differences between the groups with regard to the prevalence of heterotopic ossification, postoperative range of motion, or Mayo Elbow Performance Score noted at the time of study termination. This study demonstrated that postoperative single-fraction radiation therapy, when used acutely after elbow trauma for prophylaxis against heterotopic ossification, may play a role in increasing the rate of

  5. Prospective evaluation of syndesmotic ankle sprains without diastasis.

    PubMed

    Nussbaum, E D; Hosea, T M; Sieler, S D; Incremona, B R; Kessler, D E

    2001-01-01

    Sixty consecutive collegiate athletes with "high" ankle symptoms were prospectively evaluated over a 3-year period in an effort to better define this debilitating ankle injury. All athletes included in this study had tenderness over the distal anterior tibiofibular ligament, tenderness proximally along the interosseous membrane, and functional disability. No study subject had a fracture or frank tibia-fibula diastasis. The severity of the sprain was quantified using the interosseous "tenderness length." A standard rehabilitation protocol was followed by all patients. Athletes returned to competition when they could perform all functional testing without difficulty. Time to return to full competitive activity averaged 13.4 days. The number of days missed from competition was statistically related to the interosseous tenderness length (P = 0.0001) and to positive results on the squeeze test (P = 0.03). Fifty-three of the 60 injured athletes were evaluated at least 6 months after injury. Patients rated their outcomes as good or excellent. Six of the patients experienced occasional ankle pain and stiffness, four patients reported recurrent ankle sprains, and one patient had heterotopic ossification formation.

  6. [Effect of chest physiotherapy in patients undergoing mechanical ventilation: a prospective randomized controlled trial].

    PubMed

    Zeng, Hui; Zhang, Zhen; Gong, Yuan; Chen, Miao

    2017-05-01

    To investigate the effect of chest physiotherapy (CPT) on patients undergoing mechanical ventilation (MV). A prospective randomized controlled trial (RCT) was conducted. Sixty-eight adult patients undergoing invasive MV over 48 hours admitted to intensive care unit (ICU) of Affiliated Hospital of Zunyi Medical College from December 2014 to October 2016 were enrolled, and they were divided into CPT group (n = 37) and control group (n = 31) by random number table. The patients in control group received routine physical therapy; while those in the CPT group received comprehensive CPT including manual lung inflation, vibration expectoration and early functional exercise etc. on the basis of the treatment in control group. Acute physiology and chronic health evaluation II (APACHE II) score and oxygenation index (PaO2/FiO2) before and after the treatment in both two groups were observed as well as the respiratory function and vital signs before and after CPT. The laboratory indicators after treatment, incidence of complications, duration of MV and the length of ICU stay in the two groups were recorded. The incidence of ventilator associated pneumonia (VAP) in the CPT group was significantly lower than that of control group (5.4% vs. 25.8%, P < 0.05), the patients in control group also had atelectasis, deep vein thrombosis and other complications, while no such complications were found in the CPT group. The duration of MV (hours: 77.4±41.0 vs. 133.9±117.2) and the length of ICU stay (hours: 134.4±71.4 vs. 207.4±177.7) in CPT group were significantly shorter than those of the control group (both P < 0.05). There was no significant difference in APACHE II score and PaO2/FiO2 before treatment between the two groups. After treatment for 2 days, the APACHE II score in both groups was gradually decreased, and that in CPT group was more significantly, it was significantly lower than that of control group after treatment for 4 days (8.6±3.9 vs. 12.5±5.3, P < 0.05). The PaO2

  7. A Prospective Randomized Trial to Assess Oral Versus Intravenous Antibiotics for the Treatment of Postoperative Wound Infection After Extremity Fractures (POvIV Study).

    PubMed

    Obremskey, William T; Schmidt, Andrew H; OʼToole, Robert V; DeSanto, Jennifer; Morshed, Saam; Tornetta, Paul; Murray, Clinton K; Jones, Clifford B; Scharfstein, Daniel O; Taylor, Tara J; Carlini, Anthony R; Castillo, Renan C

    2017-04-01

    Patients surgically treated for infection after extremity fractures are typically discharged with a 6- to 12-week antibiotic regimen. Intravenous (IV) antibiotics are associated with significant cost and potential complications of deep vein thrombosis, line clotting, and sepsis. Many of the pathogens that cause musculoskeletal infection have both oral (PO) and IV antibiotic options with adequate bioavailability and antibacterial effect, yet IV antibiotics remain the standard of care absent evidence that PO options are clinically as efficacious. The POvIV study is a prospective, multicenter, randomized trial to compare PO with IV antibiotic therapy in patients with postoperative wound infections after extremity fractures. Patients between the ages of 18 and 84 who have a culture-positive surgical site infection after internal fixation for fracture repair or arthrodesis are approached for this study, and if they provide consent, are randomly assigned to receive either PO or IV antibiotics. Antibiotic selection is based on culture and sensitivity results. Randomization determines the route of administration. Patients are followed for 1 year after study enrollment. This study will be the largest prospective randomized trial to evaluate the safety and effectiveness of PO antibiotic use for treatment of postoperative wound infections. Results will inform clinician decisions on antibiotic delivery in patients with postoperative wound infections.

  8. Voice Disorders in Teacher Students-A Prospective Study and a Randomized Controlled Trial.

    PubMed

    Ohlsson, Ann-Christine; Andersson, Eva M; Södersten, Maria; Simberg, Susanna; Claesson, Silwa; Barregård, Lars

    2016-11-01

    Teachers are at risk of developing voice disorders, but longitudinal studies on voice problems among teachers are lacking. The aim of this randomized trial was to investigate long-term effects of voice education for teacher students with mild voice problems. In addition, vocal health was examined prospectively in a group of students without voice problems. First-semester students answered three questionnaires: one about background factors, one about voice symptoms (Screen6), and the Voice Handicap Index. Students with voice problems according to the questionnaire results were randomized to a voice training group or a control group. At follow-up in the sixth semester, all students answered Screen6 again together with four questions about factors that could have affected vocal health during their teacher education. The training group and the control group also answered the Voice Handicap Index a second time. At follow-up, 400 students remained in the study: 27 in the training group, 54 in the control group, and 319 without voice problems at baseline. Voice problems had decreased somewhat more in the training group than in the control group, but the difference was not statistically significant (P = 0.1). However, subgroup analyses showed significantly larger improvement among the students in the group with complete participation in the training program compared with the group with incomplete participation. Of the 319 students without voice problems at baseline, 14% had developed voice problems. Voice problems often develop in teacher students. Despite extensive dropout, our results support the hypothesis that voice education for teacher students has a preventive effect. Copyright © 2016 The Voice Foundation. Published by Elsevier Inc. All rights reserved.

  9. Early motion for Achilles tendon ruptures: is surgery important? A randomized, prospective study.

    PubMed

    Twaddle, Bruce C; Poon, Peter

    2007-12-01

    Comparisons of surgically and nonsurgically treated Achilles tendon ruptures have demonstrated that those treated with surgery allow earlier motion and tend to show superior results. However, early motion enhances tendon healing with or without surgery and may be the important factor in optimizing outcomes in patients with Achilles tendon rupture. There is no difference in the outcome of acute Achilles tendon rupture treated nonoperatively or operatively if controlled early motion is allowed as part of the rehabilitation program. Randomized, controlled clinical trial; Level of evidence, 1. Patients with acute rupture of the Achilles tendon were randomized to surgery or no surgery, with both groups receiving early motion controlled in a removable orthosis, progressing to full weightbearing at 8 weeks from treatment. Both groups were followed prospectively for 12 months with measurements of range of motion, calf circumference, and the Musculoskeletal Functional Assessment Instrument (MFAI) outcome score; any reruptures and any complications were noted. Both groups were comparable for age and sex. There were no significant differences between the 2 groups in plantar flexion, dorsiflexion, calf circumference, or the MFAI scores measured at 2, 8, 12, 26, or 52 weeks. One patient in each group was noncompliant and required surgical rerepair of the tendon. There were no differences in complications and a similar low number of reruptures in both groups. This study supports early motion as an acceptable form of rehabilitation in both surgically and nonsurgically treated patients with comparable functional results and a low rerupture rate. There appears to be no difference between the 2 groups, suggesting that controlled early motion is the important part of treatment of ruptured Achilles tendon.

  10. Influence of ultra-low dose Aprotinin on thoracic surgical operations: a prospective randomized trial

    PubMed Central

    Apostolakis, Efstratios; Panagopoulos, Nikolaos; Koletsis, Efstratios N; Crockett, James; Stamou-Kouki, Helen; Sourgiadaki, Efrosini; Filos, Kriton; Dougenis, Dimitrios

    2008-01-01

    Background The blood saving effect of aprotinin has been well documented in cardiac surgery. In thoracic surgery, very few recent studies, using rather high doses of aprotinin, have shown a similar result. In a randomized prospective trial, we have tested the influence of aprotinin using an ultra-low dose drug regime. Methods Fifty-nine patients, mean age 58 ± 13.25 years (mean ± SD) undergoing general thoracic procedures were randomized into placebo (Group A) and treatment group (Group B). The group B (n = 29) received 500.000 IU of aprotinin after induction to anesthesia and a repeat dose immediately after chest closure. A detailed protocol with several laboratory parameters was recorded. Patients were transfused when perioperative Ht was less than 26%. Results The two groups were similar in terms of age, gender, diagnosis, pathology, co-morbidity and operations performed. The mean drainage of the first and second postoperative day in group B was significantly reduced (412.6 ± 199.2 vs. 764.3 ± 213.9 ml, p < 0.000, and 248.3 ± 178.5 vs. 455.0 ± 274.6, p < 0.001). Similarly, the need for fresh frozen plasma transfusion was lower in group B, p < 0.035. Both the operation time and the hospital stay were also less for group B but without reaching statistical significance (84.6 ± 35.2 vs 101.2 ± 52.45 min. and 5.8 ± 1.6 vs 7.2 ± 3.6 days respectively, p < 0.064). The overall transfusion rate did not differ significantly. No side effects of aprotinin were noted. Conclusion The perioperative ultra-low dose aprotinin administration was associated with a reduction of total blood losses and blood product requirements. We therefore consider the use of aprotinin safe and effective in major thoracic surgery. PMID:18361800

  11. Effect of nepafenac eye drops on intraocular pressure: a randomized prospective study.

    PubMed

    Dave, Paaraj; Shah, Kuntal; Ramchandani, Bharat; Jain, Rupa

    2014-03-01

    To report the effect of nepafenac (0.1%) eye drops on intraocular pressure in eyes with cataract. Prospective randomized clinical trial. Three hundred and twenty-seven patients with bilateral cataracts in an institutional setting were included. All patients had a baseline intraocular pressure (IOP) ≤ 21 mm Hg without a history of intraocular surgery in the past 3 months. One eye of each individual was randomized to the treatment group, with the other eye acting as a control. Nepafenac (0.1%) eye drops were instilled 3 times a day in the eye that received treatment. Intraocular pressure (IOP) with Goldmann applanation tonometer (GAT) was measured at baseline and at 4 and 8 weeks. Proportion of eyes with an IOP elevation of >4 mm Hg was the main outcome measure. The mean age of the participants was 45.7 ± 4.4 years. Participants included 192 female and 135 male patients. The mean IOP at baseline in the treated and control eyes was, respectively, 13.8 ± 2.5 mm Hg and 13.4 ± 3.0 mm Hg, which reduced to 12.0 ± 2.0 mm Hg and 12.1 ± 1.5 mm Hg, respectively, at the end of 8 weeks. This reduction in IOP in both groups was significant (P < .01). The difference between the IOP in the treated and control eyes at 8 weeks was not statistically significant (P = .34). One eye in the treated group and 2 eyes in the control group had an IOP elevation of >4 mm Hg. Nepafenac eye drops do not increase the IOP. They can possibly be used as an alternative to steroid medications where steroid responsiveness is a concern. Copyright © 2014 Elsevier Inc. All rights reserved.

  12. Triclosan-coated sutures and sternal wound infections: a prospective randomized clinical trial.

    PubMed

    Steingrimsson, S; Thimour-Bergström, L; Roman-Emanuel, C; Scherstén, H; Friberg, Ö; Gudbjartsson, T; Jeppsson, A

    2015-12-01

    Surgical site infection is a common complication following cardiac surgery. Triclosan-coated sutures have been shown to reduce the rate of infections in various surgical wounds, including wounds after vein harvesting in coronary artery bypass grafting patients. Our purpose was to compare the rate of infections in sternotomy wounds closed with triclosan-coated or conventional sutures. A total of 357 patients that underwent coronary artery bypass grafting were included in a prospective randomized double-blind single-center study. The patients were randomized to closure of the sternal wound with either triclosan-coated sutures (Vicryl Plus and Monocryl Plus, Ethicon, Inc., Somerville, NJ, USA) (n = 179) or identical sutures without triclosan (n = 178). Patients were followed up after 30 days (clinical visit) and 60 days (telephone interview). The primary endpoint was the prevalence of sternal wound infection according to the Centers for Disease Control and Prevention (CDC) criteria. The demographics in both groups were comparable, including age, gender, body mass index, and rate of diabetes and smoking. Sternal wound infection was diagnosed in 43 patients; 23 (12.8%) sutured with triclosan-coated sutures compared to 20 (11.2%) sutured without triclosan (p = 0.640). Most infections were superficial (n = 36, 10.1%), while 7 (2.0%) were deep sternal wound infections. There were 16 positive cultures in the triclosan group and 17 in the non-coated suture group (p = 0.842). The most commonly identified main pathogens were Staphylococcus aureus (45.4%) and coagulase-negative staphylococci (36.4%). Skin closure with triclosan-coated sutures did not reduce the rate of sternal wound infection after coronary artery bypass grafting. (clinicaltrials.gov: NCT01212315).

  13. [Randomized prospective study of three different techniques for ultrasound-guided axillary brachial plexus block].

    PubMed

    Ferraro, Leonardo Henirque Cunha; Takeda, Alexandre; Sousa, Paulo César Castello Branco de; Mehlmann, Fernanda Moreira Gomes; Junior, Jorge Kiyoshi Mitsunaga; Falcão, Luiz Fernando Dos Reis

    2017-06-23

    Randomized prospective study comparing two perivascular techniques with the perineural technique for ultrasound-guided axillary brachial plexus block (US-ABPB). The primary objective was to verify if these perivascular techniques are noninferior to the perineural technique. 240 patients were randomized to receive the techniques: below the artery (BA), around the artery (AA) or perineural (PN). The anesthetic volume used was 40mL of 0.375% bupivacaine. All patients received a musculocutaneous nerve blockade with 10mL. In BA technique, 30mL were injected below the axillary artery. In AA technique, 7.5mL were injected at 4 points around the artery. In PN technique, the median, ulnar, and radial nerves were anesthetized with 10mL per nerve. Confidence interval analysis showed that the perivascular techniques studied were not inferior to the perineural technique. The time to perform the blockade was shorter for the BA technique (300.4±78.4sec, 396.5±117.1sec, 487.6±172.6sec, respectively). The PN technique showed a lower latency time (PN - 655.3±348.9sec; BA -1044±389.5sec; AA-932.9±314.5sec), and less total time for the procedure (PN-1132±395.8sec; BA -1346.2±413.4sec; AA 1329.5±344.4sec). TA technique had a higher incidence of vascular puncture (BA - 22.5%; AA - 16.3%; PN - 5%). The perivascular techniques are viable alternatives to perineural technique for US-ABPB. There is a higher incidence of vascular puncture associated with the BA technique. Copyright © 2017. Publicado por Elsevier Editora Ltda.

  14. Syndesmotic fixation in supination-external rotation ankle fractures: a prospective randomized study.

    PubMed

    Pakarinen, Harri J; Flinkkilä, Tapio E; Ohtonen, Pasi P; Hyvönen, Pekka H; Lakovaara, Martti T; Leppilahti, Juhana I; Ristiniemi, Jukka Y

    2011-12-01

    This study was designed to assess whether transfixion of an unstable syndesmosis is necessary in supination-external rotation (Lauge-Hansen SE/Weber B)-type ankle fractures. A prospective study of 140 patients with unilateral Lauge-Hansen supination-external rotation type 4 ankle fractures was done. After bony fixation, the 7.5-Nm standardized external rotation (ER) stress test for both ankles was performed under fluoroscopy. A positive stress examination was defined as a difference of more than 2 mm side-to-side in the tibiotalar or tibiofibular clear spaces on mortise radiographs. If the stress test was positive, the patient was randomized to either syndesmotic transfixion with 3.5-mm tricortical screws or no syndesmotic fixation. Clinical outcome was assessed using the Olerud-Molander scoring system, RAND 36-Item Health Survey, and Visual Analogue Scale (VAS) to measure pain and function after a minimum 1-year of followup. Twenty four (17%) of 140 patients had positive standardized 7.5-Nm ER stress tests after malleolar fixation. The stress view was positive three times on tibiotalar clear space, seven on tibiofibular clear space, and 14 times on both tibiotalar and tibiofibular clear spaces. There was no significant difference between the two randomization groups with regards to Olerud-Molander functional score, VAS scale measuring pain and function, or RAND 36-Item Health Survey pain or physical function at 1 year. Relevant syndesmotic injuries are rare in supination-external rotation ankle fractures, and syndesmotic transfixion with a screw did not influence the functional outcome or pain after the 1-year followup compared with no fixation.

  15. A prospective, randomized study analyzing sartorius transposition following inguinal-femoral lymphadenectomy.

    PubMed

    Judson, Patricia L; Jonson, Amy L; Paley, Pamela J; Bliss, Robin L; Murray, Karuna P; Downs, Levi S; Boente, Matthew P; Argenta, Peter A; Carson, Linda F

    2004-10-01

    Based on the reduced morbidity seen in our retrospective study, we undertook a prospective, randomized trial to determine whether transposition of the sartorius muscle improves post-operative morbidity in women with squamous cell carcinoma of the vulva undergoing inguinal-femoral lymphadenectomy. Patients with squamous carcinoma of the vulva requiring inguinal-femoral lymphadenectomy were randomized to undergo sartorius transposition or not. All patients received perioperative antibiotics, DVT prophylaxis, and closed suction surgical site drainage. Outcomes assessed include wound cellulitis, wound breakdown, lymphocyst formation, lymphedema, and/or rehospitalization. Cohorts were compared using Fisher's exact test. Baseline characteristics were compared using Student's t test or Fischer's exact test as appropriate. Logistic regression was used to assess the impact of sartorius transposition, after adjusting for other factors. From June 1996 to December 2002, 61 patients underwent 99 inguinal-femoral lymphadenectomies, 28 with sartorius transposition, and 33 without. The mean (SD) age for controls and patients undergoing sartorius transposition was 63.5 (15.2) and 73.8 (13.7) years, respectively (P < 0.05). There were no statistically significant differences in BSA, tobacco use, co-morbid medical conditions, past surgical history, medication use, size of incision, duration of surgery, number of positive lymph nodes, pathologic stage, pathologic grade, pre- or postoperative hemoglobin, or length of hospitalization. There were no statistically significant differences in the incidence of wound cellulitis, wound breakdown, lymphedema, or rehospitalization. The incidence of lymphocyst formation was increased in the sartorius transposition group. After adjusting for age, however, the groups appeared similar. Sartorius transposition after inguinal-femoral lymphadenectomy does not reduce postoperative wound morbidity.

  16. A prospective randomized study of the efficacy of "Turning Point," an inpatient violence intervention program.

    PubMed

    Loveland-Jones, Catherine; Ferrer, Lucas; Charles, Scott; Ramsey, Frederick; van Zandt, Andrea; Volgraf, Jill; Santora, Thomas; Pathak, Abhijit; Dujon, Jay; Sjoholm, Lars; Rappold, Joseph; Goldberg, Amy

    2016-11-01

    From 2002 to 2011, there were more than 17,000 shootings in Philadelphia. "Turning Point," Temple University Hospital's inpatient violence intervention program, takes advantage of the teachable moment that occurs after violent injury. In addition to receiving traditional social work services, Turning Point patients watch their trauma bay resuscitation video and a movie about violence, meet with a gunshot wound survivor and an outpatient case manager, and also undergo psychiatric assessment. The purpose of this study was to determine the efficacy of Turning Point in changing attitudes toward guns and violence among victims of penetrating trauma. This prospective randomized study was conducted from January 2012 to January 2014. Patients who sustained a gunshot or stab wound were randomized to standard of care, which involved traditional social work services only, or Turning Point. The Attitudes Toward Guns and Violence Questionnaire was administered to assess attitude change. Analysis was performed with repeated-measures analysis of variance. A p < 0.05 was significant. A total of 80 of a potential 829 patients completed the study (40 standard of care, 40 Turning Point). The most common reason for exclusion was anticipated length of stay being less than 48 hours. The two groups were similar with respect to most demographics. Unlike the standard-of-care group, the Turning Point group demonstrated a 50% reduction in aggressive response to shame, a 29% reduction in comfort with aggression, and a 19% reduction in overall proclivity toward violence. Turning Point is effective in changing attitudes toward guns and violence among victims of penetrating trauma. Longer follow-up is necessary to determine if this program can truly be a turning point in patients' lives. Therapeutic/care management study, level II.

  17. [The benefits of digital chest drainage in pleural decortication in thoracic empyema. Prospective, randomized, control trial].

    PubMed

    Mier, José M; Cortés-Julián, Gildardo; Berrios-Mejía, Juan; Víctor-Valdivia, Zotés

    2017-01-10

    Prolonged air leak after pleural decortication is one of the most frequent complications. The aim of this study is to compare the effects of prolonged air leak between the digital chest drainage (DCD) system and the classic drainage system in patients with empyema class IIB or III (American Thoracic Society classification) in pleural decortication patients. A total of 37 patients were enrolled in a prospective randomized control trial over one year, consisting of 2blinded groups, comparing prolonged air leak as a main outcome, the number of days until removal of chest drain, length of hospital stay and complications as secondary outcomes. The percentage of prolonged air leak was 11% in the DCD group and 5% in the classic group (P=0.581); the mean number of days of air leak was 2.5±1.8 and 2.4±2.2, respectively (P=0.966). The mean number of days until chest tube removal was 4.5±1.8 and 5.1±2.5 (P=0.41), the length of hospital stay was 7.8±3.7 and 8.9±4.0 (P=0.441) and the complication percentages were 4 (22%) and 7 (36%), respectively (P=0.227). In this study, no significant difference was observed when the DCD was compared with the classic system. This was the first randomized clinical trial for this indication; thus, future complementing studies are warranted. Copyright © 2016 Academia Mexicana de Cirugía A.C. All rights reserved.

  18. Prospective randomized clinical trial of aggressive rehabilitation after acute Achilles tendon ruptures repaired with Dresden technique.

    PubMed

    De la Fuente, Carlos; Peña y Lillo, Roberto; Carreño, Gabriel; Marambio, Hugo

    2016-03-01

    Rupture of the Achilles tendon is a common injury during working years. Aggressive rehabilitation may provide better outcomes, but also a greater chance of re-rupture. To determine if aggressive rehabilitation has better clinical outcomes for Achilles tendon function, Triceps surae function, one-leg heel rise capacity and lower complication rate during twelve weeks after percutaneous Achilles tendon repair compared to conventional rehabilitation. Randomized controlled trial. Thirty-nine patients were prospectively randomized. The aggressive group (n=20, 41.4 ± 8.3 years) received rehabilitation from the first day after surgery. The conventional group (n=19, 41.7 ± 10.7 years) rested for 28 days, before rehabilitation started. The statistical parameters were the Achilles tendon rupture score (ATRS), verbal pain scale, time to return to work, pain medication consumption, Achilles tendon strength, dorsiflexion range of motion (RoM), injured-leg calf circumference, calf circumference difference, one-leg heel rise repetition and difference, re-rupture rate, strength deficit rate, and other complication rates. Mixed-ANOVA and Bonferroni's post hoc test were performed for multiple comparisons. Student's t-test was performed for parameters measured on the 12th week. The aggressive group with respect to the conventional group had a higher ATRS; lower verbal pain score; lower pain medication consumption; early return to work; higher Achilles tendon strength; higher one-leg heel rise repetitions; and lower one-leg heel rise difference. The re-rupture rate was 5% and 5%, the strength deficit rate was 42% and 5%, and other complications rate was 11% and 15% in the conventional and aggressive group, respectively. Patients with Dresden repair and aggressive rehabilitation have better clinical outcomes, Achilles tendon function and one-leg heel rise capacity without increasing the postoperative complications rate after 12 weeks compared to rehabilitation with immobilization and

  19. Efficacy of a new hemostatic forceps during gastric endoscopic submucosal dissection: A prospective randomized controlled trial.

    PubMed

    Tanaka, Shinwa; Toyonaga, Takashi; Morita, Yoshinori; Ishida, Tsukasa; Hoshi, Namiko; Grimes, Kevin L; Ohara, Yoshiko; Yoshizaki, Tetsuya; Kawara, Fumiaki; Umegaki, Eiji; Azuma, Takeshi

    2017-04-01

    Currently, endoscopic submucosal dissection (ESD) is a widely accepted standard treatment for early gastric cancer, but one challenging aspect of ESD is hemostasis. We developed a new hemostatic forceps (FD-Y0007) with the aim of achieving more effective hemostasis and investigated the hemostatic ability of the FD-Y0007 during gastric ESD in humans. This study was a prospective randomized controlled trial, which was conducted at a cancer referral center. Sixty-six patients who were scheduled to undergo ESD were enrolled and randomly assigned to either the Coagrasper or the FD-Y0007, which was used for hemostasis throughout the case. The primary end point was the time required to obtain hemostasis, which was measured for the first episode of bleeding during each case. Hemostasis time for the first bleeding episode during ESD was 73.0 s for the Coagrasper and 21.5 s for the FD-Y0007 (P < 0.001). When all episodes of bleeding were included, hemostasis time was 56.8 s in the Coagrasper group and 25.5 s in FD-Y0007group (P < 0.0001). The frequency of adverse events (perforation: 3.4% vs 7.1%; delayed bleeding: 0% vs 0%) was not significantly different between the two groups. Compared with the Coagrasper, the FD-Y0007 efficiently reduces the hemostatic time during gastric ESD with no increase in adverse events. © 2016 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.

  20. Randomized, controlled, prospective trial of the use of a mesh to prevent parastomal hernia.

    PubMed

    Serra-Aracil, Xavier; Bombardo-Junca, Jordi; Moreno-Matias, Juan; Darnell, Anna; Mora-Lopez, Laura; Alcantara-Moral, Manuel; Ayguavives-Garnica, Isidro; Navarro-Soto, Salvador

    2009-04-01

    The prevalence of terminal parastomal hernia (PH) after colostomy placement may be as high as 50%. The effect of the PH may range from discomfort to life-threatening complications. Surgical procedures for repairing PH are difficult to perform and present a high-failure rate. To reduce the incidence of PH by implanting a lightweight mesh in the sublay position. Randomized, controlled, prospective study. Patients were scheduled for permanent end colostomy surgery to treat cancer of the lower third of the rectum, performed by the same colorectal surgery team. An Ultrapro lightweight mesh was inserted in the sublay position in the study group. Using simple randomization, the sample size required was estimated to be 27 per group. Patients were followed-up clinically and radiologically with abdominal computed tomography by an independent clinician and a radiologist who were all blind to the aims of the study, 1 month and every 6 months after surgery. : The groups were homogeneous in terms of their clinical and demographic characteristics. Surgical time and postoperative morbidity were similar in the 2 groups. Mortality was 0. No mesh intolerance was reported. In the clinical follow-up (median: 29 months, range: 13-49), 11/27 (40.7%) hernias were recorded in the control group compared with 4/27 (14.8%) in the study group (P = 0.03). Abdominal computed tomography identified 14/27 (44.4%) hernias in the control group compared with 6/27 (22.2%) in the study group (P = 0.08). Parastomal placement of a mesh reduces the appearance of PH. The technique is safe, well-tolerated, and does not increase morbidity rates.

  1. Highly potent and moderately potent topical steroids are effective in treating phimosis: a prospective randomized study.

    PubMed

    Yang, Stephen Shei Dei; Tsai, Yao Chou; Wu, Chia Chang; Liu, Shih Ping; Wang, Chung Cheng

    2005-04-01

    We report a prospective randomized study comparing the effects of highly potent and moderately potent topical steroids in treating pediatric phimosis. A total of 70 boys 1 to 12 years old with phimosis were randomly assigned to receive topical application of either betamethasone valerate 0.06% (a highly potent steroid) or clobetasone butyrate 0.05% (a moderately potent steroid). Parents of the boys were instructed to retract the foreskin gently without causing pain, and to apply the topical steroids over the stenotic opening of the prepuce twice daily for 4 weeks, then for another 4 weeks if no improvement was achieved. Retractibility of the prepuce was graded from 0 to 5. Response to treatment was arbitrarily defined as improvement in the retractibility score of more than 2 points. Mean treatment and followup periods were 4.3 and 19.1 weeks, respectively. The response rates in boys treated with betamethasone valerate and clobetasone butyrate were 81.3% and 77.4%, respectively (p = 0.63). Mean retractibility score decreased from 3.9 +/- 1.0 to 1.7 +/- 1.1, and 4.2 +/- 1.0 to 1.9 +/- 1.0 in the betamethasone and clobetasone groups, respectively. Both steroids were effective in all age groups. Pretreatment retractibility score did not affect treatment outcomes. No adverse effect was encountered. Highly potent and moderately potent topical steroids are of comparable effectiveness in treating phimosis. A less potent steroid may be considered first to decrease the risk of the potential adverse effects.

  2. Dysphotopsia after temporal versus superior laser peripheral iridotomy: a prospective randomized paired eye trial.

    PubMed

    Vera, Vanessa; Naqi, Abdulla; Belovay, Graham W; Varma, Devesh K; Ahmed, Iqbal Ike K

    2014-05-01

    To determine if the location of neodymium:yttrium-aluminum-garnet laser peripheral iridotomy (LPI) is related to the occurrence of postoperative visual dysphotopsia. Randomized, prospective, single-masked, paired-eye comparative clinical trial. setting: Private subspecialty clinic in Mississauga, Canada. study population: Patients with primary angle closure or primary angle-closure suspects were recruited and randomized to receive LPI temporally in one eye and superiorly in the other. Patients were masked to the location of treatment in each eye. intervention: Temporal or superior LPI. main outcome measures: Occurrence of new-onset linear dysphotopsia. Other visual disturbances also were assessed using a questionnaire before and 1 month after intervention. Secondary outcome measures included eyelid position, laser parameters, and any intraoperative complications. A total of 208 patients were recruited to the study, of which 169 (84%) completed it. New-onset linear dysphotopsia was reported in 18 (10.7%) eyes with superior LPI versus 4 (2.4%) eyes with temporal LPI (P = .002). Eleven eyes (6.5%) with superior LPI reported linear dysphotopsia despite complete eyelid coverage of the iridotomy. No significant differences were found with other visual disturbances between them. There was more pain experienced by the temporal LPI (2.8 ± 2.2 vs 2.1 ± 2.0; P = .001), despite no difference in laser energy or number of shots. Intraoperative rates of hemorrhage were similar (8.9% vs 10.1%; P = .71). Temporal placement of LPI is safe and was found to be less likely to result in linear dysphotopsia as compared with superior placement. Temporal iris therefore may be considered a preferred location for LPI. Copyright © 2014 Elsevier Inc. All rights reserved.

  3. A prospective randomized blister prevention trial assessing paper tape in endurance distances (Pre-TAPED).

    PubMed

    Lipman, Grant S; Ellis, Mark A; Lewis, Erica J; Waite, Brandee L; Lissoway, John; Chan, Garrett K; Krabak, Brian J

    2014-12-01

    Friction foot blisters are a common injury occurring in up to 39% of marathoners, the most common injury in adventure racing, and represent more than 70% of medical visits in multi-stage ultramarathons. The goal of the study was to determine whether paper tape could prevent foot blisters in ultramarathon runners. This prospective randomized trial was undertaken during RacingThePlanet 155-mile (250-km), 7-day self-supported ultramarathons in China, Australia, Egypt, Chile, and Nepal in 2010 and 2011. Paper tape was applied prerace to one randomly selected foot, with the untreated foot acting as the own control. The study end point was development of a hot spot or blister on any location of either foot. One hundred thirty-six participants were enrolled with 90 (66%) having completed data for analysis. There were 36% women, with a mean age of 40 ± 9.4 years (range, 25-40 years) and pack weight of 11 ± 1.8 kg (range, 8-16 kg). All participants developed blisters, with 89% occurring by day 2 and 59% located on the toes. No protective effect was observed by the intervention (47 versus 35; 52% versus 39%; P = .22), with fewer blisters occurring around the tape on the experimental foot than under the tape (23 vs 31; 25.6% versus 34.4%), yet 84% of study participants when queried would choose paper tape for blister prevention in the future. Although paper tape was not found to be significantly protective against blisters, the intervention was well tolerated with high user satisfaction. Copyright © 2014 Wilderness Medical Society. Published by Elsevier Inc. All rights reserved.

  4. Guidewire-assisted transpancreatic sphincterotomy for difficult biliary cannulation: a prospective randomized controlled trial.

    PubMed

    Zang, Jinfeng; Zhang, Chi; Gao, Junye

    2014-10-01

    Precut techniques have been used to facilitate biliary cannulation during difficult endoscopic retrograde cholangiopancreatography. Presently, needle-knife sphincterotomy (NKS) is a commonly used precut technique. Since its first description, transpancreatic sphincterotomy, as an alternative method for bile duct entry when conventional biliary cannulation failed, has been debated on its success rate of cannulation and its complications, such as increased incidence of pancreatitis. Guidewire techniques are another effective method to improve the success rate of selective bile duct cannulation. This is a single-center prospective randomized controlled trial aimed to compare success rate, cannulation time, and complications of guidewire-assisted transpancreatic sphincterotomy (GATS) and NKS for difficult biliary cannulation. Between July 2010 and October 2013, consecutive patients who failed in the standard biliary cannulation were randomly assigned to the GATS and NKS groups. The outcome measures included success rate, cannulation time, and complications. A total of 149 patients were enrolled and analyzed: 73 in the GATS group and 79 in the NKS group. The characteristics of the 2 groups were similar. Bile duct cannulation was successful in 70 patients (95.9%) in the GATS group and 64 (84.2%) in the NKS group (P=0.018). The median cannulation time spent in precut was 193 seconds in the GATS group and 485 seconds in the NKS group (P<0.001). There was no difference between the groups for the incidence of complications, pancreatitis, and hemorrhage (9.6% vs. 10.5%, 6.8% vs. 6.6%, 1.4% vs. 3.9%, respectively). No perforation occurred. GATS compared with NKS increases biliary cannulation rate and requires less cannulation time during difficult biliary access. This technique is not associated with an increased risk for complications. It seems to be an effective and safe alternative for biliary access during difficult endoscopic retrograde cholangiopancreatography.

  5. Selective laser trabeculoplasty versus medical therapy as initial treatment of glaucoma: a prospective, randomized trial.

    PubMed

    Katz, L Jay; Steinmann, William C; Kabir, Azad; Molineaux, Jeanne; Wizov, Sheryl S; Marcellino, George

    2012-09-01

    To compare outcomes of selective laser trabeculoplasty (SLT) with drug therapy for glaucoma patients in a prospective randomized clinical trial. Sixty-nine patients (127 eyes) with open-angle glaucoma or ocular hypertension were randomized to SLT or medical therapy. Target intraocular pressure (IOP) was determined using the Collaborative Initial Glaucoma Treatment Study formula. Patients were treated with SLT (100 applications 360 degrees) or medical therapy (prostaglandin analog). Six visits over 1 year followed initial treatment. If target IOP range was not attained with SLT, additional SLT was the next step, or in the medical arm additional medications were added. IOP; secondary: number of steps. Sixty-nine patients were treated. Data collection terminated with 54 patients reaching 9 to 12-months follow-up. Twenty-nine patients were in the SLT group, 25 patients in the medical group. Baseline mean IOP for all eyes was 24.5 mm Hg in the SLT group, 24.7 mm Hg in the medical group. Mean IOP (both eyes) at last follow-up was 18.2 mm Hg (6.3 mm Hg reduction) in the SLT arm, 17.7 mm Hg (7.0 mm Hg reduction) in the medical arm. By last follow-up, 11% of eyes received additional SLT, 27% required additional medication. There was not a statistically significant difference between the SLT and medication groups. IOP reduction was similar in both arms after 9 to 12-months follow-up. More treatment steps were necessary to maintain target IOP in the medication group, although there was not a statistically significant difference between groups. These results support the option of SLT as a safe and effective initial therapy in open-angle glaucoma or ocular hypertension.

  6. Early rehabilitation for unilateral peripheral vestibular disorders: a prospective, randomized investigation using computerized posturography.

    PubMed

    Marioni, Gino; Fermo, Salvatore; Zanon, Davide; Broi, Nadia; Staffieri, Alberto

    2013-02-01

    Patients with unilateral vestibular lesions have a set of deficits requiring compensation based on the inherent plasticity of the central nervous system. In the 1940s, it was reported that patients with unilateral vestibular dysfunctions who exercised recovered faster than those who did not. The present prospective, randomized investigation aimed to assess the role of a computerized posturography-assisted early vestibular rehabilitation protocol combined with a home-based exercise program in the treatment of patients with unilateral peripheral vestibular disorders occurring 2 weeks previously. Fifteen patients were randomly assigned to a 5-week posturography-assisted vestibular rehabilitation protocol and a home-based exercise program (Group A), while 15 simply awaited spontaneous compensation (Group B). All patients underwent computerized posturography approximately 2 weeks after their vestibular disorder was diagnosed and again after 6 weeks. Ten healthy volunteers were also studied (Group C). After rehabilitation, Group A patients improved significantly in most sensory measures [modified clinical test of sensory organization and balance (mCTSIB)] and motor parameters [limits of stability (LOS)] by comparison with preliminary outcomes, and there were no significant differences in sensory (mCTSIB) and motor (LOS) findings between Group A and the healthy volunteers. At the same time point, several motor (LOS) parameters were still altered in Group B by comparison with the healthy volunteers. These preliminary outcomes support the hypothesis that the compensation achievable after 6 weeks with a customized program of posturography-assisted vestibular rehabilitation and home-based exercises is superior to the results of physiological spontaneous compensation.

  7. Heparin and Protamine Titration Does Not Improve Haemostasis after Cardiac Surgery: A Prospective Randomized Study.

    PubMed

    Radulovic, Vladimir; Laffin, Anna; Hansson, Kenny M; Backlund, Erika; Baghaei, Fariba; Jeppsson, Anders

    2015-01-01

    Bleeding complications are common in cardiac surgery. Perioperative handling of heparin and protamine may influence the haemostasis. We hypothesized that heparin and protamine dosing based on individual titration curves would improve haemostasis in comparison to standard dosing. Sixty patients scheduled for first time elective coronary artery bypass grafting or valve surgery were included in a prospective randomized study. The patients were randomized to heparin and protamine dosing with Hepcon HMS Plus device or to standard weight and activated clotting time (ACT) based dosing. Blood samples were collected before and 10 minutes, 2 hours and 4 hours after cardiopulmonary bypass. Primary endpoint was endogenous thrombin potential in plasma 2 hours after surgery as assessed by calibrated automated thrombography. Secondary endpoints included total heparin and protamine doses, whole blood clot formation (thromboelastometry) and post-operative bleeding volume and transfusions. Heparin effect was assessed by measuring anti-Xa activity. Endogenous thrombin potential and clot formation deteriorated in both groups after surgery without statistically significant intergroup difference. There were no significant differences between the groups in total heparin and protamine doses, heparin effect, or postoperative bleeding and transfusions at any time point. Significant inverse correlations between anti-Xa activity and endogenous thrombin potential were observed 10 min (r = -0.43, p = 0.001), 2 hours (r = -0.66, p<0.001) and 4 hours after surgery (r = -0.58, p<0.001). In conclusion, the results suggest that perioperative heparin and protamine dosing based on individual titration curves does not improve haemostasis after cardiac surgery. Postoperative thrombin generation capacity correlates to residual heparin effect. www.isrctn.com ISRCTN14201041.

  8. Comparison of vascularization of Medpor and Medpor-Plus orbital implants: a prospective, randomized study.

    PubMed

    Naik, Milind N; Murthy, Ramesh K; Honavar, Santosh G

    2007-01-01

    To compare vascularization of porous polyethylene (Medpor) and porous polyethylene with synthetic bone graft particulate (Medpor-Plus) orbital implants following enucleation. Prospective, randomized study involving 10 patients. A standard enucleation procedure was performed, and each patient was randomized to receive either Medpor or Medpor-Plus orbital implant with anterior scleral cap technique. Gadolinium-enhanced, 3-Tesla MRI was performed at 1.5 months, 3 months, and 4.5 months following surgery. Implant vascularization was calculated in axial, coronal, and sagittal planes with manual planimetric method using postcontrast T1-weighted Digital Imaging and Communications in Medicine images. The mean area of implant vascularization at 1.5 months, 3 months, and 4.5 months for Medpor implants was 58%, 70%, and 75%, respectively, and for Medpor-Plus implants was 69%, 76%, and 85%, respectively. The mean vascularization of Medpor-Plus implants was more than Medpor implants at 1.5 months (p = 0.008), 3 months (p = 0.09), and 4.5 months (p = 0.003). The difference between the 2 groups assessed by repeated measures analysis of variance was statistically significant (p < 0.0001). During the mean follow-up of 36.7 months (range, 18-43 months), 1 patient in the Medpor group had implant exposure that responded to scleral patch graft. Implant vascularization is faster with Medpor-Plus implants compared with Medpor implants when assessed by a planimetric method using 3 Tesla MRI. The addition of synthetic bone graft particulate (Novabone) to porous polyethylene may enhance implant vascularization.

  9. Tamsulosin versus tadalafil as a medical expulsive therapy for distal ureteral stones: A prospective randomized study

    PubMed Central

    Shrestha, Anil; Acharya, Ganesh Bhakta; Basnet, Robin Bahadur; Shah, Arvind Kumar; Shrestha, Parash Mani

    2016-01-01

    Purpose This study aimed to compare the safety and efficacy of tamsulosin and tadalafil as medical expulsive therapy for distal ureteral stones. Materials and Methods This prospective randomized study was conducted at the Department of Urology of Bir Hospital over a period of 12 months in patients with distal ureteral stones sized 5 to 10 mm. Patients were randomly divided into 2 groups: group A received tamsulosin 0.4 mg and group B received tadalafil 10 mg at bedtime for 2 weeks. Stone expulsion rate, number of ureteric colic episodes and pain score, analgesic requirements, and adverse drug effects were noted in both groups. Statistical analyses were performed by using Student t-test and chi-square test. Results Altogether 85 patients, 41 in group A and 44 in group B, were enrolled in the study. The patients' average age was 31.72±12.63 years, and the male-to-female ratio was 1.5:1. Demographic profiles, stone size, and baseline investigations were comparable between the 2 groups. The stone expulsion rate was significantly higher in the tadalafil group than in the tamsulosin group (84.1% vs. 61.0%, p=0.017). Although the occurrence of side effects was higher with tadalafil, this difference was not significant (p=0.099). There were no serious adverse effects. Conclusions Tadalafil has a significantly higher stone expulsion rate than tamsulosin when used as a medical expulsive therapy for distal ureteral stones sized 5–10 mm. Both drugs are safe, effective, and well tolerated with minor side effects. PMID:27617317

  10. Intraarterial Lidocaine for Pain Control in Uterine Artery Embolization: A Prospective, Randomized Study.

    PubMed

    Noel-Lamy, Maxime; Tan, Kong T; Simons, Martin E; Sniderman, Kenneth W; Mironov, Oleg; Rajan, Dheeraj K

    2017-01-01

    To assess efficacy of two different techniques of lidocaine injection in the uterine arteries to reduce pain following uterine artery embolization (UAE) for leiomyomas. This prospective randomized single-blinded study was performed with 60 patients enrolled between November 2014 and December 2015 equally randomized to 3 arms. Group A received 10 mL lidocaine 1% (100 mg) mixed with polyvinyl alcohol particles (355-500 μm). Group B received the same dose of lidocaine injected after embolization. Group C was a control group. Pain was assessed on a 100-point visual analog scale at 4, 7, and 24 hours after the procedure. Narcotic agent dose to 24 hours was recorded. Outcomes were examined by analysis of variance and pairwise comparison. Leiomyoma infarction was assessed with magnetic resonance imaging 3 months after the procedure. Technical success rate of UAE was 100%. Mean pain score at 4 hours was significantly lower in the lidocaine groups (group A, 28.6; group B, 35.8) compared with the control group (59.4; P = .001). Pain scores at 7 and 24 hours were not statistically different among the 3 arms. The mean in-hospital narcotic agent dose was significantly lower in both lidocaine groups than in the control group (group A, 8.5 mg [P = .002]; group B, 11.1 mg [P = .03]; group C, 17.4 mg). There were no adverse events related to the use of lidocaine. The number of patients with complete infarction of leiomyomas at 3 months was significantly lower in group A at 38.9% (group B, 77.8%; group C, 75%; P = .0451). Lidocaine injected in the uterine arteries reduced postprocedural pain and narcotic agent dose after UAE. There were more cases of incomplete necrosis when lidocaine was mixed with the particles. Copyright © 2016 SIR. Published by Elsevier Inc. All rights reserved.

  11. Free rehabilitation is safe after isolated meniscus repair: a prospective randomized trial comparing free with restricted rehabilitation regimens.

    PubMed

    Lind, Martin; Nielsen, Torsten; Faunø, Peter; Lund, Bent; Christiansen, Svend Erik

    2013-12-01

    The optimal rehabilitation program after meniscus repair has not been established. Numerous regimens have been suggested as beneficial for meniscus healing, but no controlled trials exist in the literature. The purpose of this prospective randomized trial was to investigate outcome with a free or a restricted rehabilitation regimen after isolated meniscus repair. The hypothesis was that free rehabilitation would result in increased failure of meniscus healing. Randomized controlled clinical trial; Level of evidence, 1. A total of 60 patients were included in this study within 2 to 3 days after meniscus repair. No patients with concomitant ligament reconstruction or cartilage repair surgery were included. Meniscus repair was performed with the all-inside technique; only vertical meniscus lesions close to the capsule were repaired. Patients were randomized to free (n = 32) or restricted (n = 28) rehabilitation. Free rehabilitation consisted of 2 weeks (range of motion [ROM], 0°-90°, no brace) and touch weightbearing, with unrestricted activity and free ROM allowed thereafter. Restricted rehabilitation consisted of 6 weeks of hinged brace use with a gradual increase ROM to 90° and only touch weightbearing during the 6 weeks. Patients were seen for follow-up at 3 months, 1 year, and 2 years. Those patients with joint line pain at the 3-month follow-up underwent MRI scanning to evaluate meniscus healing; a subsequent arthroscopy was performed for final evaluation meniscus healing if the MRI indicated lack of meniscus healing. At follow-up, the Knee Osteoarthritis Outcome Score (KOOS), Tegner function score, pain assessment, and patient satisfaction were used to evaluate outcomes. Eleven patients were lost to follow-up. Repeat arthroscopy in patients with persistent symptoms demonstrated partial healing or lack of healing in 28% and 36% of patients in the free and the restricted rehabilitation groups, respectively (P = .53, nonsignificant). The KOOS and Tegner

  12. Prospective, randomized comparison of castor oil and sodium phosphate preparation for barium enema.

    PubMed

    Apisarnthanarak, Piyaporn; Rotjanaaree, Benjaporn; Komoltri, Chulalak; Charoensak, Aphinya; Apisarnthanarak, Anucha; Hargrove, Narumol Srisuthapan

    2009-02-01

    To compare castor oil and sodium phosphate preparation (Swiff) in patients' satisfaction, efficacy for colon cleanness, side effects, and prices. One hundred patients referred for barium enema were randomized to receive castor oil (n = 50) and sodium phosphate preparation (n = 50). They graded their satisfaction using a 5-point scale (easy, acceptable, slightly difficult, extremely difficult, and unacceptable). The efficacy for colon cleanness was graded by two radiologists using a 5-point scale (excellent, easy for evaluation, acceptable, difficult for evaluation, and unacceptable). Side effects were evaluated by patients' vital signs, total number of bowel frequency, and 10 associated symptoms. Both preparations revealed no difference in patients' satisfaction (p = 0.882) and efficacy of colon cleanness (p = 0.130). Sodium phosphate preparation was more expensive (79 vs. 10 Baht) and caused higher number of bowel frequency (p < 0.001). With a cheaper price, castor oil was comparable with sodium phosphate preparation in patients' satisfaction and efficacy of colon cleanness.

  13. Residual Spinal Cord Compression Following Hemilaminectomy and Mini-Hemilaminectomy in Dogs: A Prospective Randomized Study

    PubMed Central

    Svensson, Gustaf; Simonsson, Ulrika S. H.; Danielsson, Fredrik; Schwarz, Tobias

    2017-01-01

    The aim of this study was to compare the reduction of spinal cord compression after surgical treatment of dogs with acute thoracolumbar intervertebral disc (IVD) extrusion achieved using hemilaminectomy versus mini-hemilaminectomy techniques. This was a prospective randomized study with client-owned dogs presented with acute IVD extrusion that were allocated to surgical treatment using hemilaminectomy (n = 15) or mini-hemilaminectomy (n = 15) techniques. Plain and intravenous-contrast computed tomography was performed pre- and postoperatively. The preoperative minimal cross-sectional dimension of the spinal cord (MDSCpre) and the postoperative minimal cross-sectional dimension of the spinal cord (MDSCpost) were measured at the level of greatest compression. The minimal diameter of the uncompressed spinal cord was measured in a similar way both pre- (MDUSCpre) and postoperatively (MDUSCpost). Dogs in the mini-hemilaminectomy group had significantly greater reduction of compression (RC) (p < 0.01) after surgery compared to dogs in the hemilaminectomy group. The mean RC in the hemilaminectomy group was 34.6% and in the mini-hemilaminectomy group 62.6%. Our results showed a significantly greater reduction of spinal cord compression for mini-hemilaminectomy compared to hemilaminectomy. Additionally, mini-hemilaminectomy could be a preferred method due to its minimal invasiveness and easier access to lateral fenestration. PMID:28386545

  14. Prospective non-randomized study on the use of antibiotic prophylaxis with ciprofloxacin in flexible urethrocystoscopy.

    PubMed

    Cano-García, María Carmen; Casares-Pérez, Rosario; Arrabal-Martín, Miguel; Merino-Salas, Sergio; Arrabal-Polo, Miguel Ángel

    2016-11-01

    The goal of this study is to analyze whether there is a need for antibiotic prophylaxis in this outpatient procedure. Prospective observational non-randomized study including 100 patients divided into two groups: - Group 1: 48 patients receiving 500 mg of ciprofloxacin prophylaxis 1 hour before urethrocystoscopy; - Group 2: 52 patients without antibiotic prophylaxis. Before inclusion of the patients in the study, we checked the absence of urinary tract infection by means of a urinalysis obtained 3 days before the procedure. We analyze: cystoscopy indication, cystoscopy results, presence of comorbidities, urinalysis 7 days after the procedure, and urinary symptoms within 7 days of the procedure. The statistical analysis was performed using SPSS 20.0 and the statistical significance was p=0.05. The average age of patients in group 1 was 66.7±12.4 versus 65.6±10.8 years in group 2 (p=0.6). There are no differences in the percentage of men/women included in the groups. 14% of patients of group 1 and 12% of group 2 presented bacteriuria, without showing any significant differences. In the multivariate study, it is observed that neither age, nor diabetes, smoking, lower urinary tract symptoms, nor immunosuppression are related with the onset of bacteriuria in the groups. We do not consider the use of ciprofloxacin as prophylaxis for flexible cystoscopy is appropriate in this area of health, since it does not reduce the presence of urinary infection or bacteriuria.

  15. Spontaneous labor and elective induction--a prospective randomized study. I. Effects on mother and fetus.

    PubMed

    Tylleskär, J; Finnström, O; Leijon, I; Hedenskog, S; Rydén, G

    1979-01-01

    In a prospective randomized study spontaneous and oxytocin induced labor "for convenience" have been compared with respect to uterine activity, duration of labor, the condition of the fetus and the newborn infant. The study consists of 84 normal patients, of whom 43 were induced at full term by amniotomy and oxytocin infusion using the Cardiff Infusion System Mark II; 41 patients served as controls. No difference in maternal age, number of previous pregnancies and pelvic score one week before the day of delivery were found between the groups. The following parameters were calculated: duration of labor, uterine activity, amount of bleeding in the third stage of labor, number of early and late decelerations as well as number of episodes of bradycardia in the CTG-recordings, birth weight, Apgar score one and five minutes post-delivery and blood gases in mother and child 60 seconds after delivery. No significant differences between the two groups were found. It is concluded that there are no increased risks to mother or fetus compared to normal labor provided that there is cephalic presentation and normal pregnancy, careful selection with respect to the length of pregnancy and the condition of the cervix and that the Cardiff infusion system is used with intrauterine pressure recording and continuous fetal heart monitoring.

  16. [Ambulatory laparoscopic cholecystectomy by minilaparoscopy versus traditional multiport ambulatory laparoscopic cholecystectomy. Prospective randomized trial].

    PubMed

    Planells Roig, Manuel; Arnal Bertomeu, Consuelo; Garcia Espinosa, Rafael; Cervera Delgado, Maria; Carrau Giner, Miguel

    2016-02-01

    Difference analysis of ambulatorization rate, pain, analgesic requirements and daily activities recovery in patients undergoing laparoscopic cholecystectomy with standard multiport access (CLMP) versus a minilaparoscopic, 3mm size, technique. Prospective randomized trial of 40 consecutive patients undergoing laparoscopic cholecystectomy. Comparison criteria included predictive ultrasound factors of difficult cholecystectomy, previous history of complicated biliary disease and demographics. Results are analyzed in terms of ambulatorization rate, pain, analgesic requirements, postoperative recovery, technical difficulty, hemorrhage intensity, overnight stay, readmission rate and total or partial conversion. Both procedures were similar in surgery time, technical score and hemorrhage score. MLC was associated with similar ambulatorization rate, 85%, and over-night stay 15%, with only 15% partial conversion rate. MLC showed less postoperative pain (P=.026), less analgesic consumption (P=.006) and similar DAR (P=.879). MLC is similar to CLMP in terms of ambulatorization with less postoperative pain and analgesic requirements without differences in postoperative recovery. Copyright © 2014 AEC. Publicado por Elsevier España, S.L.U. All rights reserved.

  17. No clinical effect of back schools in an HMO. A randomized prospective trial.

    PubMed

    Berwick, D M; Budman, S; Feldstein, M

    1989-03-01

    In a prospective trial, 222 adults with low-back pain of at least 2 weeks' duration in a Health Maintenance Organization (HMO) were randomly assigned to usual care (UC), a 4-hour back school psychoeducational session (LBS), or the same back school plus a 1-year "compliance package" program designed to encourage appropriate self-management for back pain (CP). Sixty-four percent of LBS and CP subjects attended their back school sessions. Follow-up measurement of pain level (using the Visual Analogue Scale), functional status (using the Sickness Impact Profile), and various other indicators of health status showed no measurable effect of either treatment condition (LBS or CP) compared with UC at 3, 6, 12, and 18 months after entry into the study. Initial disability resolved by 3 months in most patients, and a minority of subjects (10-15%) showed residual or recurrent functional impairment 1 year after entry. Health care utilization tended to be slightly higher after intervention in the CP group. With or without follow-up encouragement, back school instructions given in a single 4-hour session had no measurable impact on the comfort or functional status of the majority of patients with new onset back pain in this HMO.

  18. Prospective randomized controlled trial of resource facilitation on community participation and vocational outcome following brain injury.

    PubMed

    Trexler, Lance E; Trexler, Laura C; Malec, James F; Klyce, Daniel; Parrott, Devan

    2010-01-01

    To examine the impact of resource facilitation (RF) on return to work, participation in home and community activities, and depression. Twenty-two people with acquired brain injury (mean age = 43 years; mean education = 13.3 years). A prospective randomized controlled trial of RF compared with standard care. All participants received standard follow-up services, but participants in the RF group were also assigned a resource facilitator to assist them in returning to work. Participation increased significantly for both groups (F = 60.65, P < .0001), but the interaction between groups and time demonstrated greater improvement for the RF group relative to controls (F = 9.11, P < .007). Also, 64% of the RF group was employed at follow-up compared with 36% of the control group (Wald-Wolfkowitz z = -3.277, P < .0001). No significant differences were found between groups on measures of depression. Resource facilitation services that have a clear focus on return to work may have a substantial impact on participation and unemployment after brain injury.

  19. Why Prospectively Randomized Clinical Trials Have Been Rare in Reproductive Medicine and Will Remain So?

    PubMed

    Gleicher, Norbert; Kushnir, Vitaly A; Barad, David H

    2016-01-01

    There is almost unanimity that modern medicine should be "evidence based." In this context, lack of prospectively randomized clinical trials (RCTs) is widely lamented in reproductive medicine. Some leading voices, indeed, increasingly suggest that only RCT-based clinical conclusions should be integrated into clinical practice, since lower levels of evidence are inadequate. We have argued that reproductive medicine requires special considerations because, like clinical oncology, fertility treatments (especially in older women) are time dependent. Unlike clinical oncology, reproductive medicine, however, does not receive substantial financial research support from government or industry and, at least in the United States, has, therefore, to be primarily funded via patient revenues. Given a 50% chance of receiving placebo, infertility patients are, understandably, reluctant to fund their own RCTs. We here selectively review this subject, contrasting opposing opinions recently published in the literature by a prominent reproductive scientist and one of the world's leading experts on evidence-based medicine. Placing these recent publications into the evolving context of infertility practice, as also addressed in this journal in recent publications, we conclude that objective reasons explain why relatively few RCTs are performed in reproductive medicine and predict that this will not change in the foreseeable future. Reproductive medicine, therefore, has to find ways to develop satisfactory clinical evidence in other ways, satisfying patients' rights to easy access to potentially beneficial medical treatments with low costs and low risks. The RCTs should be reserved for relatively high risk and/or high cost treatments. © The Author(s) 2015.

  20. Alemtuzumab in lung transplantation: an open-label, randomized, prospective single center study.

    PubMed

    Jaksch, P; Ankersmit, J; Scheed, A; Kocher, A; Muraközy, G; Klepetko, W; Lang, G

    2014-08-01

    Induction therapy with alemtuzumab followed by lower maintenance immunosuppression (IS) has been associated with reduced morbidity and mortality in abdominal and heart transplantation (TX). In the current study, alemtuzumab, in combination with reduced levels of maintenance IS, was compared to thymoglobulin in combination with standard IS. Sixty consecutive patients who underwent lung transplantation (LUTX) at a single center were prospectively randomized in two groups: group A received alemtuzumab in conjunction with reduced doses of tacrolimus, steroids and mycophenolate mofetil. Group B received thymoglobulin in association with standard dose IS. Patient and graft survival, freedom from acute cellular rejection (ACR), lymphocytic bronchiolitis, bronchiolitis obliterans syndrome, kidney function, infectious complications and posttransplant lymphoproliferative disorder were analyzed. Alemtuzumab induction therapy resulted in complete the absence of ACR episodes ≥ A2 within the first year post-TX. The difference to thymoglobulin was significant (alemtuzumab 0 vs. ATG 0.33; p = 0.019). All other factors studied did not show any differences between the two groups. Alemtuzumab induction therapy after LUTX in combination with reduced maintenance IS significantly reduces higher-grade rejection rates. This novel therapeutic agent had no impact on survival, infections rates, kidney function and incidence of malignancies. © Copyright 2014 The American Society of Transplantation and the American Society of Transplant Surgeons.

  1. Frequency format diagram and probability chart for breast cancer risk communication: a prospective, randomized trial.

    PubMed

    Ghosh, Karthik; Crawford, Brianna J; Pruthi, Sandhya; Williams, Constance I; Neal, Lonzetta; Sandhu, Nicole P; Johnson, Ruth E; Wahner-Roedler, Dietlind; Britain, Marcia K; Cha, Stephen S; Ghosh, Amit K

    2008-10-20

    Breast cancer risk education enables women make informed decisions regarding their options for screening and risk reduction. We aimed to determine whether patient education regarding breast cancer risk using a bar graph, with or without a frequency format diagram, improved the accuracy of risk perception. We conducted a prospective, randomized trial among women at increased risk for breast cancer. The main outcome measurement was patients' estimation of their breast cancer risk before and after education with a bar graph (BG group) or bar graph plus a frequency format diagram (BG+FF group), which was assessed by previsit and postvisit questionnaires. Of 150 women in the study, 74 were assigned to the BG group and 76 to the BG+FF group. Overall, 72% of women overestimated their risk of breast cancer. The improvement in accuracy of risk perception from the previsit to the postvisit questionnaire (BG group, 19% to 61%; BG+FF group, 13% to 67%) was not significantly different between the 2 groups (P = .10). Among women who inaccurately perceived very high risk (> or = 50% risk), inaccurate risk perception decreased significantly in the BG+FF group (22% to 3%) compared with the BG group (28% to 19%) (P = .004). Breast cancer risk communication using a bar graph plus a frequency format diagram can improve the short-term accuracy of risk perception among women perceiving inaccurately high risk.

  2. [Cervical ripening at term. A randomized and prospective study: Misoprotol versus dinoprostone].

    PubMed

    Trabelsi, Haikel; Mathlouthi, Nabil; Zayen, Sonia; Dhouib, Mohamed; Chaabene, Kaies; Trabelsi, Khaled; Amouri, Habib; Ben Ayed, Belhassen; Guermazi, Mohamed

    2012-05-01

    To compare the efficacy and safety of cervical ripening at term by vaginal Misoprostol and Dinoprostone. We performed a prospective randomized study on cervical ripening with misoprostol and dinoprostone in the third trimester of pregnancy. 300 patients have been divided into two groups: one consisted by 150 patients who received Misoprostol (Cytotec ®) and the second consisted by 150 patients who received Dinoprostone (Prépidil ®). Analysis of our results allowed to reveal: a significant decrease in the time of entry into work for the Misoprostol group (9.08 hours versus 12.51 hours, p = 0.007), a significant reduction delivery time (14.48 hours versus 19.30 hours, p = 0.001). Moreover, the birth rate in the first 24 hours after the first dose was significantly higher in the Misoprostol group (86.7% versus 72.7%, p = 0.003). The use of oxytocin was significantly reduced with Misoprostol (44% versus 58.7%, p = 0.01). The mode of delivery was not influenced by membership in one or other of the two groups. Misoprostol seems an interesting molecule for cervical ripening and labor induction.

  3. Prospective randomized study of oxytocin discontinuation after the active stage of labor is established.

    PubMed

    Ustunyurt, Emin; Ugur, Mustafa; Ustunyurt, Basak Ozlem; Iskender, Tekin Can; Ozkan, Ovgu; Mollamahmutoglu, Leyla

    2007-12-01

    To investigate the effects of discontinuing oxytocin infusion on labor outcomes once the active stage of labor is established. This is a prospective study involving 342 pregnant women who underwent labor induction at our institution. Patients were randomly divided into two groups. In the first group oxytocin was discontinued at the beginning of the active phase of labor, and in the other group, oxytocin was administered until delivery. Duration of the active phase and the second stage of labor were longer in the oxytocin-discontinued group; however, this was not statistically significant. The rate of uterine hyperstimulation was significantly higher in oxytocin-continued group (P < 0.05). The total cesarean delivery rate for the oxytocin-continued group was 6.9%, compared with 4.8% in the oxytocin-discontinued group (P > 0.05). Discontinuing oxytocin infusion once the active stage of labor is established may be an alternative protocol in developing countries where the conditions for fetal monitoring and emergency cesarean section are less available.

  4. Prospective Randomized Trial Comparing the Efficacy of Surgical Preparation Solutions in Hand Surgery.

    PubMed

    Xu, Peter Z; Fowler, John R; Goitz, Robert J

    2017-05-01

    Decontamination of the skin prior to incision is part of the standard of care for any surgical procedure. Previous studies have demonstrated variable efficacy of different surgical preparation solutions based on anatomic location. The purpose of this study is to determine the effectiveness of 3 commonly used surgical preparation solutions in eliminating bacteria from the skin prior to incision for common elective soft tissue hand procedures. A total of 240 patients undergoing clean, elective, soft tissue hand surgery were prospectively randomized to 1 of 3 groups (ChloraPrep, DuraPrep, or Betadine). Prepreparation and postpreparation cultures were obtained adjacent to the surgical incision and neutralization was performed on the obtained specimen. Cultures were held for 14 days and patients followed for 6 weeks postoperatively. Postpreparation cultures were positive in 21 of 80 (26.3%) ChloraPrep patients, 3 of 79 (3.8%) DuraPrep patients, and 1 of 81 (1.2%) Betadine patients ( P < .001). There was no difference in the postpreparation culture rate between DuraPrep and Betadine ( P = 1.000). Duraprep and Betadine were found to be superior to Chloraprep for skin decontamination prior to clean elective soft tissue hand surgery. The bacterial flora of the hand was found to be different from those of the shoulder and spine. The clinical significance of this finding requires clinical consideration because the majority of prepreparation and postpreparation positive cultures were of Bacillus species, which are rarely a cause of postoperative infections.

  5. Pronuclear zygote score following intracytoplasmic injection of hyaluronan-bound spermatozoa: a prospective randomized study.

    PubMed

    Van Den Bergh, Marc Jg; Fahy-Deshe, Mary; Hohl, Michael K

    2009-12-01

    The aim of this study was to determine whether the early stages of embryo development, as assessed by the zygote score (Z-score), could be influenced by the injection of spermatozoa that had been preselected on the basis of their binding to hyaluronic acid (HA). A total of 407 sibling metaphase II oocytes, belonging to 44 different patients, were injected in a prospective randomized way, with either hyaluronic acid bound (HA(+) ) or non-bound (HA(-)) spermatozoa. The fertilization rate (75-70%), the percentage of the different Z-scores (Z 1: 22-24%, Z 2: 22-22.5%, Z 3: 44- 45%, Z 4: 12-8.5%), the mean score of the transferred embryos (3.76 +/- 1.29, 3.78 +/- 1.1) and the number of embryos at the 4-cell stage 45 h after injection (77-76%) were not different between the two groups. The ongoing pregnancy rate in this study (>20 weeks of gestation) was 36.4% per replacement, the implantation rate 28% and the twin pregnancy rate 44% (7/16). Although binding to HA did not apparently influence the Z-score, this agent continues to be used for the immobilization of spermatozoa prior to injection, on the basis that it is a natural product that can easily be metabolized by the oocyte via normal biological mechanisms.

  6. Intermittent antegrade warm versus cold blood cardioplegia: a prospective, randomized study.

    PubMed

    Pelletier, L C; Carrier, M; Leclerc, Y; Cartier, R; Wesolowska, E; Solymoss, B C

    1994-07-01

    A prospective, randomized study was performed in 200 patients undergoing coronary artery bypass grafting to compare the myocardial protection obtained with intermittent antegrade warm versus cold blood cardioplegia. Preoperative and surgical characteristics of the two cohorts were similar. Intermittent antegrade infusion of warm blood cardioplegia failed to achieve sustained electromechanical arrest of the heart in 13%. The only difference in clinical outcomes was the more frequent spontaneous return to sinus rhythm after the unclamping of the aorta in the warm group (88% versus 70%, p = 0.002). Mortality (1% each) and myocardial infarction (2% and 4%) rates were similar. Rates of increase in serum activity of the isoenzyme of creatine kinase (CK-MB), CK-MB mass concentration, and cardiac troponin-T level as well as total release of troponin T were significantly lower in the warm group, and fewer patients in this group had a clinically significant increase in serum CK-MB mass (20% versus 39%, p = 0.005) and troponin T (20% versus 56%, p = 0.00001). Thus, intermittent antegrade warm blood cardioplegia is appropriate and clinically safe; the lower release of biochemical markers of myocardial damage suggests improved protection during first-time coronary artery bypass grafting.

  7. Reliability Evaluation Based on Different Distributions of Random Load

    PubMed Central

    Gao, Peng; Xie, Liyang

    2013-01-01

    The reliability models of the components under the nonstationary random load are developed in this paper. Through the definition of the distribution of the random load, it can be seen that the conventional load-strength interference model is suitable for the calculation of the static reliability of the components, which does not reflect the dynamic change in the reliability and cannot be used to evaluate the dynamic reliability. Therefore, by developing an approach to converting the nonstationary random load into the random load whose pdf is the same at each moment when the random load applies, the reliability model based on the longitudinal distribution is derived. Moreover, through the definition of the transverse standard load and the transverse standard load coefficient, the reliability model based on the transverse distribution is derived. When the occurrence of the random load follows the Poisson process, the dynamic reliability models considering the strength degradation are derived. These models take the correlation between the random load and the strength into consideration. The result shows that the dispersion of the initial strength and that of the transverse standard load coefficient have great influences on the reliability and the hazard rate of the components. PMID:24223504

  8. Effectiveness of bonded and vacuum-formed retainers: A prospective randomized controlled clinical trial.

    PubMed

    O'Rourke, Niamh; Albeedh, Hussein; Sharma, Pratik; Johal, Ama

    2016-09-01

    The objective of this prospective trial was to compare the clinical effectiveness of bonded retainers with vacuum-formed retainers, in terms of maintaining the results of orthodontic treatment in the lower arch up to 18 months post debond. This was a hospital-based, prospective randomized controlled clinical trial in which a total of 82 subjects were randomly allocated using a computer-generated number sequence to 1 of 2 groups, receiving either a vacuum-formed retainer (Essix Ace plastic (120 mm; DENTSPLY Raintree Essix, Sarasota, Fla) or a bonded retainer (0.0175 coaxial archwire (Ortho-Care, UK, Shipley, United Kingdom) bonded in place with Transbond LR (3M United Kingdom, Brachnell, United Kingdom) for the mandibular arch. Each number was placed in an opaque, concealed envelope and chosen randomly by the study subject; this determined the allocation group. Eligibility criteria included patients nearing debond after treatment with 0.022 × 0.028-in slot size preadjusted edgewise fixed orthodontic appliances whose pretreatment records and study models were available to confirm pretreatment labial segment crowding or spacing and who had clinically acceptable alignment at the end of treatment. The main outcome was to investigate the clinical effectiveness of the 2 types of retainers in terms of changes in incisor irregularity at 6 months of retention. The following measurements were recorded at each time point (6, 12, and 18 months) with a digital caliper: Little's irregularity index, intercanine width, intermolar width, arch length, and extraction site opening. Blinding was applicable only at debond because of the permanence of 1 intervention. The 2 groups were well matched with respect to age, sex, clinical characteristics, and treatment plans. There was a statistically significant difference between the groups for changes in Little's irregularity index at 6 months, with the vacuum-formed retainer group showing greater changes than the bonded retainer

  9. Prospective evaluation of pregnant women with hypothyroidism: implications for treatment.

    PubMed

    Neto, Leonardo Vieira; De Almeida, Carla Amaral; Da Costa, Sheila Mamede; Vaisman, Mário

    2007-03-01

    Pregnancy is characterized by a series of maternal hormonal and metabolic changes which can affect thyroid function and the course of thyroid dysfunction in different ways. Moreover, hypothyroidism is also associated with obstetric complications and morbidity to the fetus. The aim of the present study was to evaluate the influence of hypothyroidism during the course of pregnancy and the necessity of adjusting the dose of levothyroxine. We prospectively followed 16 patients with previous diagnosis of hypothyroidism. In ten patients (62.5%) it was necessary to raise the dose of levothyroxine, with a median increase of 20.7%. One pregnancy was complicated by premature amniorrhexis and two by pre-eclampsia. The screening for congenital hypothyroidism was negative in all newborns. We conclude that it is very important to offer screening to high-risk patients who wish to become pregnant. Dose adjustment based on serum levels of thyroid-stimulating hormone (TSH) is essential. In patients in whom TSH is not measured during the first weeks of pregnancy, a good approach could be to increase the dose of replacement therapy by 20-25% to avoid hypothyroidism.

  10. Thrombotic complications of implanted central venous access devices: prospective evaluation.

    PubMed

    Labourey, Jean-Luc; Lacroix, Philippe; Genet, Dominique; Gobeaux, François; Martin, Jean; Venat-Bouvet, Laurence; Lavau-Denes, Sandrine; Maubon, Antoine; Tubiana-Mathieu, Nicole

    2004-05-01

    Implanted venous access devices (IVAD) are routinely used in oncologic patients. Thrombotic complication is a source of morbidity. During one year 246 patients with different solid neoplastic diseases received IVAD for chemotherapy administration. Two hundred forty-nine IVAD were placed percutaneously or by surgical cutdown. IVAD were flushed immediately after implantation with 3-5 mL of heparinized saline (100 U/mL). No monthly flush was required. A prospective evaluation of thrombotic complications was realised. in event of catheter dysfunction and/or clinical symptoms of phlebitis, a catheter opacification and/or a Doppler ultrasonography were performed. Twenty-three catheter dysfunctions were noted, corresponding to 13 catheter occlusions. Twelve patients presented clinical symptoms of phlebitis. Eleven venous thrombosis were diagnosed in this group; 10 by echo-Doppler and one by scanography. A unvaried statistic analysis using Fisher's test was performed to detect risk factors. Two factors were identified: the position of catheter tip above T4 (p < 0.001) and mediastinal or cervical lymph nodes larger than 6 cm (p < 0.001). The first increased the risk of catheter occlusion and the second increased the risk of phlebitis.

  11. Prospective evaluation of luteal phase length and natural fertility.

    PubMed

    Crawford, Natalie M; Pritchard, David A; Herring, Amy H; Steiner, Anne Z

    2017-03-01

    To evaluate the impact of a short luteal phase on fecundity. Prospective time-to-pregnancy cohort study. Not applicable. Women trying to conceive, ages 30-44 years, without known infertility. Daily diaries, ovulation prediction testing, standardized pregnancy testing. Subsequent cycle fecundity. Included in the analysis were 1,635 cycles from 284 women. A short luteal phase (≤11 days including the day of ovulation) occurred in 18% of observed cycles. Mean luteal phase length was 14 days. Significantly more women with a short luteal phase were smokers. After adjustment for age, women with a short luteal phase had 0.82 times the odds of pregnancy in the subsequent cycle immediately following the short luteal phase compared with women without a short luteal phase. Women with a short luteal length in the first observed cycle had significantly lower fertility after the first 6 months of pregnancy attempt, but at 12 months there was no significant difference in cumulative probability of pregnancy. Although an isolated cycle with a short luteal phase may negatively affect short-term fertility, incidence of infertility at 12 months was not significantly higher among these women. NCT01028365. Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  12. Optimizing effectivity of tranexamic acid in bilateral knee arthroplasty - A prospective randomized controlled study.

    PubMed

    Maniar, Rajesh N; Singhi, Tushar; Patil, Aniket; Kumar, Gaurav; Maniar, Parul; Singh, Jaivardhan

    2017-01-01

    Tranexamic acid (TEA) is used in reducing surgical blood loss. Literature shows no optimal regimen recommended for Bilateral Total Knee Arthroplasty (TKA). We evaluated three TEA regimens differing in dosage, timing and mode of administration in bilateral TKA to identify the most effective regimen to reduce blood loss. We prospectively studied three TEA regimens (25 patients each) as follows: (1) two intraoperative, intravenous doses (IOIO), (2) two intraoperative local applications (LALA), and (3) one preoperative plus two intraoperative, intravenous doses (POIOIO). Two independent parameters of drain loss and total blood loss, calculated by the hemoglobin balance method were statistically evaluated. Mean drain loss was least (412.9ml) in the POIOIO group, greatest (607.2ml) in the IOIO group and LALA group in between (579.4ml), with a statistically significant difference among them (p=0.0022). On paired evaluation, the drain loss in the POIOIO group was significantly less as compared to the other two groups, whereas the difference between IOIO and LALA was not significant. Mean total blood loss was least in the POIOIO group (1207ml) and greatest in LALA group (1270ml). The difference among the groups was not statistically significant (p=0.80). There was no incidence of any thromboembolic phenomenon. On correlation with our study on Most Effective Regimen in Unilateral TKA, both results were found to substantiate each other. Copyright © 2016 Elsevier B.V. All rights reserved.

  13. Comparison of two picosecond lasers to a nanosecond laser for treating tattoos: a prospective randomized study on 49 patients.

    PubMed

    Lorgeou, A; Perrillat, Y; Gral, N; Lagrange, S; Lacour, J-P; Passeron, T

    2017-07-31

    Q-switched nanosecond lasers demonstrated their efficacy in treating most types of tattoos, but complete disappearance is not always achieved even after performing numerous laser sessions. Picosecond lasers are supposed to be more efficient in clearing tattoos than nanosecond lasers, but prospective comparative data remain limited. To compare on different types of tattoos the efficacy of a nanosecond laser with two types of picosecond lasers. We conducted a prospective randomized study performed from December 2014 to June 2016 on adult patients with all types of tattoos. The tattoos were divided into two halves of equal size. After randomization, half of the tattoo was treated with a picosecond laser and the other half with a nanosecond laser. The evaluation was performed on standardized pictures performed before treatment and 2 months after the last session, by two physicians, not involved in the treatment, blinded on the type of treatments received. The main end point was a clearance above 75% of the tattoos. A total of 49 patients were included. Professional tattoos represented 85.7%, permanent make-up 8.2% and non-professional tattoo 6.1%. The majority were black or blue and 10.2% were polychromatic. No patient was lost during follow-up. A reduction of 75% or more of the colour intensity was obtained for 33% of the tattoos treated with the picosecond lasers compared to 14% with the nanosecond laser (P = 0.008). An improvement superior to 75% was obtained in 34% monochromic black or blue tattoos with the picosecond lasers compared to 9% for the nanosecond laser. Only one of the five polychromic tattoos achieved more than 75% of improvement with the two types of laser. Our results show a statistically significant superiority of the picosecond lasers compared to the nanosecond laser for tattoo clearance. However, they do not show better efficacy for polychromic tattoos and the difference in terms of side-effects was also minimal with a tendency of picosecond

  14. A randomized prospective trial of a worksite intervention program to increase physical activity.

    PubMed

    Gazmararian, Julie A; Elon, Lisa; Newsome, Kimberly; Schild, Laura; Jacobson, Kara L

    2013-01-01

    To evaluate the effectiveness of addressing multiple barriers to physical activity (PA) using interventions at the workplace. The Physical Activity and Lifestyle Study used a randomized controlled trial in which 60 university departments were randomized into five groups. Large Southeastern university. Physically inactive nonfaculty employees in the participating departments (n = 410) were interviewed five times over 9 months, with 82% completing all surveys. Departments were randomly assigned to (1) control, (2) gym membership, (3) gym + PA education, (4) gym + time during the workday, and (5) gym + education + time. PA intensity and quantity were measured using the 7-day Physical Activity Recall instrument, with PA then classified as the number of days meeting Centers for Disease Control and Prevention guidelines. The outcome was modeled with generalized linear mixed model methodology. There was no significant improvement when a group received gym alone compared to the control (Rate Ratio [RR]) 1.22 [.90, 1.67]). However, gym + education, gym + time, and gym + education + time were significantly better than the control (RR 1.51 [1.15, 1.98], RR 1.46 [1.13, 1.88], RR 1.28 [1.01, 1.62]), with improvements sustained over the 9 months. Among sedentary adults who had access to indoor exercise facilities, addressing environmental and cognitive barriers simultaneously (i.e., time and education) did not encourage more activity than addressing either barrier alone.

  15. Evaluation of neurosensory disturbance following orthognathic surgery: a prospective study.

    PubMed

    Degala, Saikrishna; Shetty, Sujeeth Kumar; Bhanumathi, M

    2015-03-01

    The prospective study was to evaluate the incidence, type of neurosensory disturbance (NSD), grade its severity and monitor its recovery occurring in the lower lip and chin due to damage to inferior alveolar nerve following orthognathic surgery involving mandible. The study included 10 patients who have undergone sagittal split osteotomy, genioplasty, and anterior subapical osteotomy (ASO). All the patients examined preoperatively and post operatively 1 week, 1 and 6 months according to standardized test to clarify the subjective and objective neurosensory status of the injured nerve. Pin prick test, blunt test, two-point discrimator test, brush stoke direction, light touch test, warm and cold test were used bilaterally to lower lip and chin area. Seven patients underwent bilateral sagittal split osteotomy (BSSO) (70 %), one patient had BSSO with genioplasty (10 %), two patients had BSSO with ASO (20 %). During the operation none of the nerves were transectioned, in 60 % of patients nerve was not visible and in 40 % of patients nerve was seen in distal segment. 70 % of patients underwent setback, 30 % of patients underwent advancement. The subjective evaluation of the patients revealed the incidence of 90 % at 1 week, 30 % at 1 month, 20 % at 6 months and 10 % at 1 year post operatively. The altered sensation reported subjectively was hypoesthesia in 50 % of the patients, anaesthesia in 40 % of the patients. There was 100 % recovery in advancement cases and 93.5 % recovery in setback cases. There is a high incidence of NSD of the lower lip and chin after BSSO related to advancement, setback, intraoperative nerve encounter and surgical skill. However, recovery of sensation occurs with increasing frequency during the follow-up period. The clinical neurosensory tests are effective guides to study the neurosensory deficit.

  16. Adjunctive remifentanil infusion in deeply sedated and paralyzed ICU patients during fiberoptic bronchoscopy procedure: a prospective, randomized, controlled study

    PubMed Central

    2012-01-01

    Background Even with an adequate pain assessment, critically ill patients under sedation experience pain during procedures in the intensive care unit (ICU). We evaluated the effects of adjunctive administration of Remifentanil, a short-acting drug, in deeply sedated patient on variation of Bispectral Index (BIS) during a fiberoptic bronchoscopy. Methods A prospective, randomized, blinded, placebo-controlled study was conducted in 18-bed ICU. Patients needing a tracheal fibroscopy under deep sedation (midazolam (0.1 mg/kg per hour) fentanyl (4 μg/kg per hour)) and neuromuscular blocking (atracurium 0.5 mg/kg) were included in the study. A continuous monitoring of BIS, arterial pressure, and heart rate were realized before, during, and after the fiberoptic exam. An adjunctive continuous placebo or Remifentanil infusion was started just before the fiberoptic exam with a target effect-site concentration of 4 ng/ml using a Base Primea pump. Results Mean arterial pressure and heart rates were comparable between the placebo and Remifentanil groups at all times of the procedure. We did not observe differences in the variation of BIS values between the two groups during procedure. We described no change in BIS values relative to the placebo group in this population. Conclusions In deeply sedated and paralyzed patients, receiving analgesic support based on a scale score an additional administration of short-acting analgesic drug, such as Remifentanil, seems not to be necessary for acute pain control. Trial registration NCT00162591. PMID:22800647

  17. Chocolate or orange juice for non-reactive non-stress test (NST) patterns: a randomized prospective controlled study.

    PubMed

    Esin, Sertac; Baser, Eralp; Cakir, Caner; Ustun Tuncal, Gul Nihal; Kucukozkan, Tuncay

    2013-06-01

    The objective of the study was to compare bitter chocolate and orange juice with the control group for non-reactive non-stress test (NST) patterns and for maternal perception of fetal movements. Pregnant women who were followed-up on an outpatient basis and admitted for a NST and had a non-reactive result were randomized prospectively into bitter chocolate, orange juice and control groups. 180 patients were evaluable for the final analysis. Although there was a trend for orange juice group for having higher percentages of reactive NST patterns on control, there was no statistically significant difference between three groups (p = 0.159). Besides this, maternal perception of increased fetal movements was similar between groups (p = 0.755). The control group had lower post-test capillary blood glucose concentrations when compared with chocolate and orange juice groups (p = 0.01) and after post-hoc tests, this difference was found to be between orange juice and control groups. Although orange juice resulted in higher blood glucose levels, this was not synonymous with better NST results on control; in such a way that bitter chocolate, orange juice and no intervention had similar effects on non-reactive NST patterns and also on maternal perception of fetal movements.

  18. Continuous passive motion following total knee replacement: a prospective randomized trial with follow-up to 1 year.

    PubMed

    Leach, W; Reid, J; Murphy, F

    2006-10-01

    We have carried out a prospective randomised, single blind clinical trial to investigate the effect of continuous passive motion on range of knee flexion, lack of extension, pain levels and analgesic use after total knee replacement surgery. 85 subjects were randomly allocated to control or study group. All subjects followed the existing rehabilitation protocol, which permits immediate active range of motion exercises and mobilisation with the study group using continuous passive motion for 1 h, twice a day. Outcome measures employed were range of motion, pain assessed on a visual analogue scale and analgesic use according to the WHO ladder. Blinded evaluation was carried out preoperatively, at time of discharge from hospital, 6 weeks, 6 and 12 months postoperation. No significant difference was observed between groups at all time intervals for each outcome variable using Wilcoxon Rank sum tests. The results substantiate previous findings that short duration continuous passive motion following total knee arthroplasty does not influence outcome of range of motion or reported pain.

  19. Topical steroid application versus circumcision in pediatric patients with phimosis: a prospective randomized placebo controlled clinical trial.

    PubMed

    Esposito, Ciro; Centonze, Antonella; Alicchio, Francesca; Savanelli, Antonio; Settimi, Alessandro

    2008-04-01

    Topical steroids have been advocated as an effective alternative treatment to circumcision in boys with phimosis. We evaluated the effectiveness of topical steroid therapy compared to a placebo neutral cream in 240 patients with phimosis. A prospective study was carried out over a 24-months period, on an out-patient basis on two groups of patients with phimosis. One-hundred twenty patients applied a steroid cream twice a day for 4 weeks, and another group of 120 pts used a placebo cream twice a day for 4 weeks. Patients were assigned to either group by a computer-generated random choice. All patients in our series completed the two treatment periods without interruption. At a median follow-up of 20 months (6-30 months) therapeutic success was obtained in 43.75% (99/240) of cases, independently of the protocol. In particular, therapeutic success was obtained in 65.8% (79/120) of cases in the steroids group and in 16.6% (20/120) of cases in the placebo group, the difference being statistically significant (P < 0.0001, Mann-Withney test). Our study shows that topical steroids represent a good alternative to surgery in case of phimosis. Steroid therapy using monometasone furoate 0.1% in our series gave better results that placebo with an overall efficacy of 65.8%. In patients where a phimotic ring persist after steroid therapy, circumcision is mandatory.

  20. Effect of dietary sodium restriction on body water, blood pressure, and inflammation in hemodialysis patients: a prospective randomized controlled study.

    PubMed

    Rodrigues Telini, Lidiane Silva; de Carvalho Beduschi, Gabriela; Caramori, Jacqueline Costa Teixeira; Castro, João Henrique; Martin, Luis Cuadrado; Barretti, Pasqual

    2014-01-01

    Accumulating evidence suggests an association between body volume overload and inflammation in chronic kidney diseases. The purpose of this study was to evaluate the effect of dietary sodium reduction in body fluid volume, blood pressure (BP), and inflammatory state in hemodialysis (HD) patients. In this prospective controlled study, adult patients on HD for at least 90 days and those with C-reactive protein (CRP) levels ≥ 0.7 mg/dl were randomly allocated into two groups: group A, which included 21 patients treated with 2 g of sodium restriction on their habitual diet; and group B, which included 18 controls. Clinical, inflammatory, biochemical, hematological, and nutritional markers were assessed at baseline and after 8 and 16 weeks. Baseline characteristics were not significantly different between the groups. Group A showed a significant reduction in serum concentrations of CRP, tumor necrosis factor-α, and interleukin-6 during the study period, while BP and extracellular water (ECW) did not change. In group B, there were no changes in serum concentrations of inflammatory markers, BP, and ECW. Dietary sodium restriction is associated with the attenuation of the inflammatory state, without changes in BP and ECW, suggesting inhibition of a salt-induced inflammatory response.

  1. Standardized diaper care regimen: a prospective, randomized pilot study on skin barrier function and epidermal IL-1α in newborns.

    PubMed

    Garcia Bartels, Natalie; Massoudy, Lida; Scheufele, Ramona; Dietz, Ekkehart; Proquitté, Hans; Wauer, Roland; Bertin, Christiane; Serrano, José; Blume-Peytavi, Ulrike

    2012-01-01

    Adaptation of skin barrier function and interleukin-1α (IL-1α) content in diapered and nondiapered skin are poorly characterized in newborns receiving standard skin care. In a monocentric, prospective pilot study 44 healthy, full-term neonates were randomly assigned to skin care with baby wipes (n = 21) or water-moistened washcloth (n = 23) at each diaper change. Transepidermal water loss (TEWL), skin hydration, skin-pH, IL-1α, and epidermal desquamation were measured on days 2, 14, and 28 postpartum. Microbiological colonization was evaluated at baseline and on day 28. Significantly lower TEWL was found on the buttock in the group using baby wipes compared to water. IL-1α and skin hydration significantly increased and pH decreased independent of skin care regimen. IL-1α was significantly higher in diapered skin compared to nondiapered skin. Although skin care with wipes seems to stabilize TEWL better than using water, the skin condition and microbiological colonization were comparable using both cleansing procedures. Increase of epidermal IL-1α may reflect postnatal skin barrier maturation. These data suggest that neither of the two cleansing procedures harms skin barrier maturation within the first four weeks postpartum. Longer observations on larger populations could provide more insight into postnatal skin barrier maturation.

  2. Prospective randomized crossover study of simulation vs. didactics for teaching medical students the assessment and management of critically ill patients.

    PubMed

    McCoy, Christopher Eric; Menchine, Michael; Anderson, Craig; Kollen, Robert; Langdorf, Mark I; Lotfipour, Shahram

    2011-04-01

    Simulation (SIM) allows medical students to manage high-risk/low-frequency cases in an environment without patient risk. However, evidence for the efficacy of SIM-based training remains limited. To compare SIM-based training to traditional didactic lecture (LEC) for teaching medical students to assess and manage critically ill patients with myocardial infarction (MI) and anaphylaxis. Prospective, randomized, non-blinded crossover study of 28 fourth-year medical students. Students were oriented to the human patient simulator, then randomized to SIM or LEC between August and December 2007. The SIM group learned to manage MI using SIM training and the LEC group learned via PowerPoint lecture. All subjects' assessment and management skills were then evaluated during a simulation session of MI. During a second instruction session, the students crossed over and were taught anaphylaxis using the opposite modality and similar assessments were conducted. Completion of critical actions for each case were scored, converted to percentages, and analyzed via signed rank test. Of 28 subjects, 27 performed better when trained with SIM compared with LEC (p < 0.0001). Mean scores were 93% (95% confidence interval [CI] 91-95%) of critical actions completed for SIM and 71% (95% CI 66-76%) for LEC. Absolute increase for simulation was 22% (95% CI 18-26%). For three domains common to MI and anaphylaxis, simulation scores were higher for history (27%, 95% CI 21-38%), physical examination (26%, 95% CI 20-33%), and management (16%, 95% CI 11-21%). SIM training is superior to didactic lecture for teaching fourth-year medical students to assess and manage simulated critically ill MI and anaphylaxis patients. Copyright © 2011 Elsevier Inc. All rights reserved.

  3. Metoclopramide improves the quality of tramadol PCA indistinguishable to morphine PCA: a prospective, randomized, double blind clinical comparison.

    PubMed

    Pang, Weiwu; Liu, Yu-Cheng; Maboudou, Edgard; Chen, Tom Xianxiu; Chois, John M; Liao, Cheng-Chun; Wu, Rick Sai-Chuen

    2013-09-01

    Multimodal analgesia has been effectively used in postoperative pain control. Tramadol can be considered "multimodal" because it has two main mechanisms of action, an opioid agonist and a reuptake inhibitor of norepinephrine and serotonin. Tramadol is not as commonly used as morphine due to the increased incidence of postoperative nausea and vomiting (PONV). As metoclopramide is an antiemetic and an analgesic, it was hypothesized that when added to reduce PONV, metoclopromide may enhance the multimodal feature of tramadol by the analgesic property of metoclopramide. Therefore, the effectiveness of postoperative patient-controlled analgesia (PCA) with morphine was compared against PCA with combination of tramadol and metoclopramide. A prospective, randomized, double blind clinical trial. Academic pain service of a university hospital. Sixty patients undergoing elective total knee arthroplasty with general anesthesia. Sixty patients were randomly divided into Group M and Group T. In a double-blinded fashion, Group M received intraoperative 0.2 mg/kg morphine and postoperative PCA with 1 mg morphine per bolus, whereas Group T received intraoperative tramadol 2.5 mg/kg and postoperative PCA with 20 mg tramadol plus 1 mg metoclopramide per bolus. Lockout interval was 5 minutes in both groups. Pain scale, satisfaction rate, analgesic consumption, PCA demand, and side effects were recorded by a blind investigator. These two groups displayed no statistically significant difference between the items and variables evaluated. This combination provides analgesia equivalent to that of morphine and can be used as an alternative to morphine PCA. Wiley Periodicals, Inc.

  4. Safety and efficacy of vertebroplasty in the treatment of osteoporotic vertebral compression fractures: a prospective multicenter international randomized controlled study

    PubMed Central

    Leali, Paolo Tranquilli; Solla, Federico; Maestretti, Gianluca; Balsano, Massimo; Doria, Carlo

    2016-01-01

    Summary Background Vertebral compression fractures (VCFs) treated non-operatively can diminish function and quality of life, and lead to chronic health effects. The short-term safety and effectiveness of vertebroplasty for symptomatic VCFs are well-documented, but long-term follow-up is needed. Purpose The aim of this paper was to analyse a multicenter international experience of 200 compression fractures treated with percutaneous vertebroplasty (VP) and compare the results of this procedure with the result of 200 patients treated conservatively. To estimate cost-effectiveness of VP compared to conservative care in terms of: pain reduction, quality of life, complications, secondary fractures and mortality. Materials and methods 400 patients have been enrolled in a prospective randomized controlled study with painful VCFs with bone edema on MR imaging, local back pain for 6 weeks or less, osteoporosis and aged 55 years or older; after obtaining informed consent patients are included and randomized for VP or conservative care. Before treatment and at follow-up with regular intervals during 1-year period were administered to patients standard questionnaires addressing: clinical symptoms, pain medication, Visual Analogue Scale (VAS) score for pain, Oswestry Disability Index (ODI) score to evaluate functional activity. Results 200 patients treated with PV compared with 200 patients treated conservatively had significantly better VAS and used less analgesics 1 day after treatment. Twenty-four hours after VP, there was a reduction in pain scores and an improvement in physical functions, whereas remain unchanged in the patients treated conservatively. Conclusions Pain relief and improvement of mobility and function after PV is immediate and significantly better in the short term compared with non-surgical care treatment. PMID:28228788

  5. Use of wide-screen, high-definition monitors for improving adenoma detection: A prospective, randomized, controlled trial.

    PubMed

    Mills, Douglas; Spyratos, Tilemahos; Haider, Ali; Sulo, Suela; Laurie, Timothy

    2016-07-01

    Colonoscopy is sensitive at detecting large polyps; however, a significant polyp miss rate is still recognized. Indicators such as the adenoma detection rate (ADR) and, more recently, the adenoma per colonoscopy rate (APC) are increasingly used to ensure quality in colonoscopy. We carried out a prospective, randomized, controlled study evaluating improvement in adenoma detection between wide-screen, high-definition (WSHD) monitors compared to standard monitors (SD). Patients undergoing screening or surveillance colonoscopy were randomized to a WSHD room or SD. Polyp size, location, shape, and histology were recorded. Right-sided polyps were considered to be those proximal to the splenic flexure. A total of 152 patients were enrolled in the study, with 78 (51.3%) and 74 (48.7%) enrolled in the WSHD and SD groups, respectively. A 10% absolute difference in favor of the WSHD group was noted for the ADR (41% vs 31% patients); however, the difference was statistically not significant. In the WSHD and SD groups, APC of 0.9 ± 1.4 versus 0.7 ± 1.4 (P = 0.49) were noted, respectively. For polyps <5 mm, an ADR of 0.3 ± 0.4 versus 0.2 ± 0.4 (P = 0.34) and APC of 0.5 ± 1.1 versus 0.2 ± 0.5 (P = 0.06) were seen in the WSHD and SD groups. This study shows a trend toward improvement in ADR, with an increase in APC for small adenomas that approaches statistical significance. WSHD monitors are a one-time, low-cost intervention for improving the quality of colonoscopy with potentially favorable outcomes. © 2016 Japan Gastroenterological Endoscopy Society.

  6. Comparative study of intravenous Tramadol versus Ketorolac for preventing postoperative pain after third molar surgery--a prospective randomized study.

    PubMed

    Gopalraju, Prathibha; Lalitha, Ramanujapuram Manikarnike; Prasad, Kavitha; Ranganath, Krishnappa

    2014-07-01

    The aim of this comparative, prospective, randomized, controlled study was to evaluate two different regimens of analgesics: a preoperative intravenous dose of either Tramadol or Ketorolac given 10 min prior to surgery to assess their impact on clinical recovery after third molar surgery. Forty patients requiring surgical extraction of unilateral impacted mandibular third molars similar in position were enrolled in the study. Patients were randomly divided into two groups based on permuting the numbers. Patients in Group 1 and Group 2 were administered either Tramadol 50 mg or Ketorolac 30 mg, intravenously, 10 min prior to surgery. The difference in postoperative pain was assessed by four primary points: pain intensity as measured by a 10 mm visual analogue scale hourly for 12 h, median time to rescue analgesics, number of analgesics consumed and patient's overall 5-point global assessment scale. Throughout the 12 h investigation period, patients treated with Ketorolac reported significantly lower pain intensity scores, significantly longer time to rescue analgesics (Acetaminophen 500 mg) and less intake of postoperative analgesics. In Group 2, 40% of the patient had good overall assessment as compared to Group 1 where only 25% of patients had good overall assessment. The current study shows that pre-emptive use of Inj. Ketorolac 30 mg intravenously can reduce the severity of the postoperative sequelae of asymptomatic impacted mandibular third molar surgery. Copyright © 2013 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

  7. A prospective, randomized study of adjuvant parenteral nutrition in the treatment of sarcomas: results of metabolic and survival studies.

    PubMed

    Shamberger, R C; Brennan, M F; Goodgame, J T; Lowry, S F; Maher, M M; Wesley, R A; Pizzo, P A

    1984-07-01

    A prospective, randomized study was performed to evaluate the