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Sample records for prospective randomized controlled

  1. 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

  2. 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

  3. 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.

  4. 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

  5. [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.

  6. 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

  7. 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

  8. 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.

  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. 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.

  11. 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.

  12. 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.

  13. 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

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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

  1. 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

    compromising the quality of the surgical field. Level 1, prospective randomized controlled trial.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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

  8. 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.

  9. Cocktail sedation containing propofol versus conventional sedation for ERCP: a prospective, randomized controlled study.

    PubMed

    Angsuwatcharakon, Phonthep; Rerknimitr, Rungsun; Ridtitid, Wiriyaporn; Kongkam, Pradermchai; Poonyathawon, Sahadol; Ponauthai, Yuwadee; Sumdin, Sakolkan; Kullavanijaya, Pinit

    2012-08-09

    ERCP practically requires moderate to deep sedation controlled by a combination of benzodiazepine and opiod. Propofol as a sole agent may cause oversedation. A combination (cocktail) of infused propofol, meperidine, and midazolam can reduce the dosage of propofol and we hypothesized that it might decrease the risk of oversedation. We prospectively compare the efficacy, recovery time, patient satisfactory, and side effects between cocktail and conventional sedations in patients undergoing ERCP. ERCP patients were randomized into 2 groups; the cocktail group (n = 103) and the controls (n = 102). For induction, a combination of 25 mg of meperidine and 2.5 mg of midazolam were administered in both groups. In the cocktail group, a bolus dose of propofol 1 mg/kg was administered and continuously infused. In the controls, 25 mg of meperidine or 2.5 mg/kg of midazolam were titrated to maintain the level of sedation. In the cocktail group, the average administration rate of propofol was 6.2 mg/kg/hr. In the control group; average weight base dosage of meperidine and midazolam were 1.03 mg/kg and 0.12 mg/kg, respectively. Recovery times and patients' satisfaction scores in the cocktail and control groups were 9.67 minutes and 12.89 minutes (P = 0.045), 93.1and 87.6 (P <0.001), respectively. Desaturation rates in the cocktail and conventional groups were 58.3% and 31.4% (P <0.001), respectively. All desaturations were corrected with temporary oxygen supplementation without the need for scope removal. Cocktail sedation containing propofol provides faster recovery time and better patients' satisfaction for patients undergoing ERCP. However, mild degree of desaturation may still develop. ClinicalTrials.gov, NCT01540084.

  10. 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

  11. 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

  12. 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.

  13. [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.

  14. 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.

  15. 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.

  16. 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.

  17. 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

  18. 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

  19. 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

  20. 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.

  1. Vapocoolant Spray Versus Lidocaine Infiltration for Radial Artery Cannulation: A Prospective, Randomized, Controlled Clinical Trial.

    PubMed

    Rüsch, Dirk; Koch, Tilo; Seel, Florian; Eberhart, Leopold

    2017-02-01

    Local infiltration with lidocaine is a frequently used measure to prevent pain during arterial cannulation. Its administration is associated with pain. Vapocoolants like ethyl chloride or alkanes also affect rapid-onset anesthesia. However, their administration causes less discomfort compared with administration of lidocaine. The effectiveness of vapocoolants in mitigating discomfort associated with arterial cannulation never has been studied. The authors therefore compared vapocoolant with lidocaine for reducing discomfort caused by arterial cannulation. Prospective, randomized, controlled study. University hospital, single center. One hundred sixty adult patients requiring arterial cannulation before induction of general anesthesia for cardiac surgery or carotid endarterectomy. Patients received either lidocaine infiltration or vapocoolant spray prior to arterial cannulation. Overall discomfort resulting from the whole procedure (applying local/topical anesthesia followed by arterial puncture) was rated on a 0 to 10 numerical rating scale. Puncture failure rate and time required for the intervention also were recorded. One hundred forty-three patients were included in the per-protocol analysis. Mean pain scores in the vapocoolant group were 3.4 (±1.58) compared with 4.5 (±2.29) in the lidocaine group (difference 1.1±0.33; p = 0.032; Mann-Whitney U-test). The higher puncture failure rate in the lidocaine group (n = 11 v 4) was not significant (p = 0.06; Fisher's exact test). The time required for the intervention was longer in the lidocaine group (138±44 s v 128±44 s; p = 0.019; Mann-Whitney U-test). Vapocoolant spray is an alternative to lidocaine infiltration to mitigate discomfort associated with arterial cannulation. Copyright © 2017 Elsevier Inc. All rights reserved.

  2. 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

  3. [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

  4. [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

  5. [Impact of target energy intake on outcomes in septic patients : a prospective randomized controlled trial].

    PubMed

    Liu, Zhaohui; Su, Lei; Liao, Yinguang; Liu, Zhifeng; Liu, Junling

    2014-03-01

    To observe the impact of the diverse caloric energy intake on the outcomes and occurrence rate of complications in septic patients. A prospective single-blind randomized controlled trial was conducted. 158 cases of septic patients in intensive care unit (ICU) were enrolled and randomly assigned to three groups according to their different target value of nutrition: group A [measurements of resting energy expenditure ( MREE) <90% J , B ( MREE 90%-110%) and C ( MREE > 110%). The caloric intake, mechanical ventilation duration ( MVD),nosocomial infection rate, 28-day and 60-day mortality were analyzed. Daily energy intake in 7 days after ICU admission was as follows: the difference in target value of nutrition ( kJ/d: 7 075.0 ± 1 046.5, 5 667.8 ± 1 908.8,4 428.8 ± 1 377.8), calory intake ( k]/d: 4 671.6 ± 1 205.6, 5 655.3 ± 1 373.0, 6 053.0 ± 1 557.2), enteral nutrition value ( kJ/d: 2 051.1 ± 1 046.5, 3 980.9 ± 1 586.5, 5 337.1 ± 2 921.8) and average intake rate [ ( 66.0 ± 15.8 )% ,( 100.0 ± 5.7 )% , ( 134.0 ± 19.7)% J, and they were statistically significant difference among A, B, C groups (all P<0.05 ). The parenteral nutrition in group C were much higher than that in group A and group B ( kJ/d: 2 055.3 ± 273.4vs. 427.0 ± 273.4, 473.0 ± 332.0, both P<0.05 ). The calories provided by glucose and diprivan were similar among three groups. The MVD and ICU stay were shorter in group B than that in groups A and C [ MVD (days): 8.4 ± 6.3 vs.11.0 ± 8.2, 17.8 ± 13.0, P>0.05 and P<0.05; ICU stay (days): 11.0 ± 6.4 vs. 14.9 ± 9.6, 17.8 ± 13.0, respectively,P>0.05 and P<0.05]. The total hospital stay (days: 32.0 ± 22.5, 26.8 ± 7.0, 30.4 ± 21.4) and nosocomial infection rate [ 91.1% ( 51156) , 84.0% ( 42/50) , 90.4% ( 4 7/52) J were similar among A, B, C groups (all P>0.05). There was no difference in survival rate at 28 days among three groups as shown by the Kaplan-Meier survival curve ( F=3.145,P=0.076 ). The survival rate at 60 days showed a tendency

  6. 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.

  7. A multifaceted prospective memory intervention to improve medication adherence: design of a randomized control trial.

    PubMed

    Insel, Kathleen C; Einstein, Gilles O; Morrow, Daniel G; Hepworth, Joseph T

    2013-01-01

    Adherence to prescribed antihypertensive agents is critical because control of elevated blood pressure is the single most important way to prevent stroke and other end organ damage. Unfortunately, nonadherence remains a significant problem. Previous interventions designed to improve adherence have demonstrated only small benefits of strategies that target single facets such as understanding medication directions. The intervention described here is informed by prospective memory theory and performance of older adults in laboratory-based paradigms and uses a comprehensive, multifaceted approach to improve adherence. It incorporates multiple strategies designed to support key components of prospective remembering involved in taking medication. The intervention is delivered by nurses in the home with an education control group for comparison. Differences between groups in overall adherence following the intervention and 6 months later will be tested. Systolic and diastolic blood pressure levels also will be examined between groups and as they relate to adherence. Intra-individual regression is planned to examine change in adherence over time and its predictors. Finally, we will examine the association between executive function/working memory and adherence, predicting that adherence will be related to executive/working memory in the control group but not in the intervention group.

  8. Can visual distraction decrease the dose of patient-controlled sedation required during colonoscopy? A prospective randomized controlled trial.

    PubMed

    Lee, D W H; Chan, A C W; Wong, S K H; Fung, T M K; Li, A C N; Chan, S K C; Mui, L M; Ng, E K W; Chung, S C S

    2004-03-01

    We previously demonstrated that audio distraction using relaxation music could lead to a decrease in the dose of sedative medication required and improve patient satisfaction during colonoscopy. This prospective randomized controlled trial was designed to test the hypotheses that visual distraction may also decrease the requirement for sedatives and that audio and visual distraction may have additive beneficial effects when used in combination. 165 consecutive patients who underwent elective colonoscopy were randomly allocated into three groups to receive different modes of sedation: group 1 received visual distraction and patient-controlled sedation (PCS); group 2 received audiovisual distraction and PCS; group 3 received PCS alone. A mixture of propofol and alfentanil, delivered by a Graseby 3300 PCA pump, was used for PCS in these groups. Each bolus of PCS delivered 4.8 mg propofol and 12 micro g alfentanil. Measured outcomes included the dose of PCS used, complications, recovery time, pain score, satisfaction score, and willingness to use the same mode of sedation if the procedure were to be repeated. Eight patients were excluded after randomization. The mean+/-SD dose of propofol used in group 2 (0.81 mg/kg +/- 0.49) was significantly less than the dose used in group 1 (1.17 mg/kg +/- 0.81) and that used in group 3 (1.18 mg/kg +/- 0.60) ( P < 0.01, one-way analysis of variance). The mean +/- SD pain score was also lower in group 2 (5.1 +/- 2.5), compared with the pain scores in group 1 (6.2 +/- 2.2) and group 3 (7.0 +/- 2.4) ( P < 0.01, one-way analysis of variance). The mean +/- SD satisfaction score was higher in groups 1 (8.2 +/- 2.4)) and 2 (8.4 +/- 2.4), compared with the score in group 3 (6.1 +/- 2.9) ( P < 0.01, one-way analysis of variance). A majority of patients in groups 1 (73 %) and 2 (85 %) said that they would be willing to use the same mode of sedation again, compared with only 53 % in group 3 ( P < 0.01, chi-squared test). Visual distraction

  9. 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

  10. 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.

  11. 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

  12. Sleep quality in patients with xerostomia: a prospective and randomized case-control study.

    PubMed

    Lopez-Jornet, Pia; Lucero Berdugo, Maira; Fernandez-Pujante, Alba; C, Castillo Felipe; Lavella C, Zamora; A, Pons-Fuster; J, Silvestre Rangil; Silvestre, Francisco Javier

    2016-01-01

    Objectives To investigate sleep quality, anxiety/depression and quality-of-life in patients with xerostomia. Materials and methods This prospective, observational, cross-sectional study was conducted among a group of xerostomia patients (n = 30) compared with 30 matched control subjects. The following evaluation scales were used to assess the psychological profile of each patient: the Hospital Anxiety and Depression Scale, the Oral Health Impact Profile-14 (OHIP-14), the Xerostomia Inventory, the Pittsburgh Sleep Quality Index (PSQI) and the Epworth Sleepiness Scale (ESS). Results The PSQI obtained 5.3 3 ± 1.78 for patients with xerostomia compared with 4.26 ± 1.01 for control subjects (p = 0.006); ESS obtained 5.7 ± 2.1 for test patients vs 4.4 0 ± 1 for control subjects (p = 0.010). Statistical regression analysis showed that xerostomia was significantly associated with depression (p = 0.027). Conclusions Patients with xerostomia exhibited significant decreases in sleep quality compared with control subjects.

  13. A prospective randomized controlled trial of two different sedation sequences for third molar removal in adults.

    PubMed

    Khader, Ruba; Oreadi, Daniel; Finkelman, Matthew; Jarmoc, Marcin; Chaudhary, Sanjeet; Schumann, Roman; Rosenberg, Morton

    2015-02-01

    In oral and maxillofacial outpatient surgery, sedation techniques are an important component in patient management for a wide variety of surgical procedures. Fentanyl and midazolam are commonly used sedatives with different mechanisms of action and specific analgesic or amnestic properties. This study examined whether the order of their administration would affect a patient's pain perception or procedural vital signs. After institutional review board approval and written informed consent, a prospective, randomized, parallel-group clinical trial was conducted in patients who planned to undergo removal of at least 2 third molars under intravenous moderate sedation. Patients were randomly assigned to 1 of 2 groups. The fentanyl-first group received fentanyl and then midazolam; the midazolam-first group received midazolam and then fentanyl. Recollection of the intraoperative pain score was assessed 24 hours after surgery using the Wong-Baker FACES pain scale. The Mann-Whitney U test was used to assess for the presence of a statistically significant difference between the 2 groups. Statistically significant differences in procedural vital sign fluctuations were examined using the t test. Patients' satisfaction with the procedure was assessed and intergroup comparisons were made. Sixty-six patients were enrolled, 1 of whom did not complete the study. Recollected procedural pain scores at 24 hours after surgery were not statistically different between groups. Median scores on the Wong-Baker FACES pain scale for the 2 groups were 2.0 (interquartile range, 3.1) for the fentanyl-first group and 1.5 (interquartile range, 2.5) for the midazolam-first group (P = .333). There was no statistical difference in the change in vital signs from baseline to 2 surgical end points in the 2 groups. In addition, patient satisfaction with the procedure did not statistically differ between the 2 groups. In this study, selective sequencing of midazolam or fentanyl during an intravenous

  14. Sweet Sixteen: The Prospective Clinical Trials of John L. Cameron, MD-The Clinician-Scientist: From Alternate-Allocation to Randomized Controlled Trials.

    PubMed

    Yeo, Charles J

    2017-09-15

    : The era of randomized controlled trials was ushered in by the British epidemiologist-statistician Austin Bradford Hill, with his work on the use of streptomycin in patients with tuberculosis. John L. Cameron, can be linked to 16 prospective clinical trials over his career thus far, starting with alternate-allocation trials and transitioning to prospective, randomized, placebo-controlled trials. These trials studied various topics in surgery-from pancreatitis to surgical site infections, to drain trials, a trial in Crohn disease and multiple trials in pancreatic surgery and cancer. Herein are described the "sweet sixteen" prospective clinical trials of Dr Cameron.

  15. Treating major depression with yoga: A prospective, randomized, controlled pilot trial.

    PubMed

    Prathikanti, Sudha; Rivera, Renee; Cochran, Ashly; Tungol, Jose Gabriel; Fayazmanesh, Nima; Weinmann, Eva

    2017-01-01

    Conventional pharmacotherapies and psychotherapies for major depression are associated with limited adherence to care and relatively low remission rates. Yoga may offer an alternative treatment option, but rigorous studies are few. This randomized controlled trial with blinded outcome assessors examined an 8-week hatha yoga intervention as mono-therapy for mild-to-moderate major depression. Investigators recruited 38 adults in San Francisco meeting criteria for major depression of mild-to-moderate severity, per structured psychiatric interview and scores of 14-28 on Beck Depression Inventory-II (BDI). At screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy, herbal or nutraceutical mood therapies, or mind-body practices were excluded. Participants were 68% female, with mean age 43.4 years (SD = 14.8, range = 22-72), and mean BDI score 22.4 (SD = 4.5). Twenty participants were randomized to 90-minute hatha yoga practice groups twice weekly for 8 weeks. Eighteen participants were randomized to 90-minute attention control education groups twice weekly for 8 weeks. Certified yoga instructors delivered both interventions at a university clinic. Primary outcome was depression severity, measured by BDI scores every 2 weeks from baseline to 8 weeks. Secondary outcomes were self-efficacy and self-esteem, measured by scores on the General Self-Efficacy Scale (GSES) and Rosenberg Self-Esteem Scale (RSES) at baseline and at 8 weeks. In intent-to-treat analysis, yoga participants exhibited significantly greater 8-week decline in BDI scores than controls (p-value = 0.034). In sub-analyses of participants completing final 8-week measures, yoga participants were more likely to achieve remission, defined per final BDI score ≤ 9 (p-value = 0.018). Effect size of yoga in reducing BDI scores was large, per Cohen's d = -0.96 [95%CI, -1.81 to -0.12]. Intervention groups did not differ significantly in 8-week change scores for either the GSES or RSES. In

  16. Treating major depression with yoga: A prospective, randomized, controlled pilot trial

    PubMed Central

    Rivera, Renee; Cochran, Ashly; Tungol, Jose Gabriel; Fayazmanesh, Nima; Weinmann, Eva

    2017-01-01

    Background Conventional pharmacotherapies and psychotherapies for major depression are associated with limited adherence to care and relatively low remission rates. Yoga may offer an alternative treatment option, but rigorous studies are few. This randomized controlled trial with blinded outcome assessors examined an 8-week hatha yoga intervention as mono-therapy for mild-to-moderate major depression. Methods Investigators recruited 38 adults in San Francisco meeting criteria for major depression of mild-to-moderate severity, per structured psychiatric interview and scores of 14–28 on Beck Depression Inventory-II (BDI). At screening, individuals engaged in psychotherapy, antidepressant pharmacotherapy, herbal or nutraceutical mood therapies, or mind-body practices were excluded. Participants were 68% female, with mean age 43.4 years (SD = 14.8, range = 22–72), and mean BDI score 22.4 (SD = 4.5). Twenty participants were randomized to 90-minute hatha yoga practice groups twice weekly for 8 weeks. Eighteen participants were randomized to 90-minute attention control education groups twice weekly for 8 weeks. Certified yoga instructors delivered both interventions at a university clinic. Primary outcome was depression severity, measured by BDI scores every 2 weeks from baseline to 8 weeks. Secondary outcomes were self-efficacy and self-esteem, measured by scores on the General Self-Efficacy Scale (GSES) and Rosenberg Self-Esteem Scale (RSES) at baseline and at 8 weeks. Results In intent-to-treat analysis, yoga participants exhibited significantly greater 8-week decline in BDI scores than controls (p-value = 0.034). In sub-analyses of participants completing final 8-week measures, yoga participants were more likely to achieve remission, defined per final BDI score ≤ 9 (p-value = 0.018). Effect size of yoga in reducing BDI scores was large, per Cohen’s d = -0.96 [95%CI, -1.81 to -0.12]. Intervention groups did not differ significantly in 8-week change scores for

  17. Multimodal pain management in total knee arthroplasty: a prospective randomized controlled trial.

    PubMed

    Lamplot, Joseph D; Wagner, Eric R; Manning, David W

    2014-02-01

    We analyze the effects of a multimodal analgesic regimen on postoperative pain, function, adverse effects and satisfaction compared to patient-controlled analgesia (PCA). Thirty-six patients undergoing TKA were randomized to receive either (1) periarticular injection before wound closure (30cc 0.5% bupivacaine, 10mg MSO4, 15 mg ketorolac) and multimodal analgesics (oxycodone, tramadol, ketorolac; narcotics as needed) or (2) hydromorphone PCA. Preoperative and postoperative data were collected for VAS pain scores, time to physical therapy milestones, hospital stay length, patient satisfaction, narcotic consumption and medication-related adverse effects. The multimodal group had lower VAS scores, fewer adverse effects, lower narcotic usage, higher satisfaction scores and earlier times to physical therapy milestones. Multimodal pain management protocol decreases narcotic usage, improves pain scores, increases satisfaction and enhances early recovery. Copyright © 2014 Elsevier Inc. All rights reserved.

  18. In utero Repair of Myelomeningocele: Rationale, Initial Clinical Experience and a Randomized Controlled Prospective Clinical Trial

    PubMed Central

    Danzer, Enrico; Flake, Alan W.

    2008-01-01

    Myelomeningocele (MMC), one of the most common congenital malformations, can result in severe lifelong disabilities, including paraplegia, hydrocephalus, Arnold-Chiari II malformation, incontinence, sexual dysfunction, skeletal deformations, and mental impairment. MMC was the first nonlethal anomaly to be treated by fetal surgery. Studies in animals provide compelling evidence that the primary cause of the neurological deficit associated with MMC is not simply incomplete neurulation but rather chronic mechanical injury and amniotic-fluid-induced chemical trauma that progressively damage the exposed neural tissue during gestation. Initial results suggest that the surgical repair of MMC before 25 weeks of gestation may preserve neurological function, reverse the hindbrain herniation of the Arnold-Chiari II malformation, and obviate the need for postnatal placement of a ventriculoperitoneal shunt. As it is currently unknown whether fetal surgery for MMC is truly beneficial compared to standard postnatal care, a randomized, controlled clinical trial has been initiated within the United States. PMID:22479081

  19. Written Educational Material Relieves Anxiety after Endoscopic Biopsy: A Prospective Randomized Controlled Study.

    PubMed

    Kim, Hae Won; Jung, Da Hyun; Youn, Young Hoon; Kim, Jie-Hyun; Kim, Jae Jin; Park, Hyo Jin

    2016-02-01

    Patients who undergo endoscopic biopsy suffer anxiety until results are confirmed. This study assesses the effects of written educational material on the anxiety level of patients following endoscopic biopsy. This study was a randomized controlled study trial with 83 patients divided into the following three groups: a biopsy group given written educational material prepared by our institution following the biopsy (intervention group, n=28), a biopsy group without written material (biopsy only group, n=25), and a control group without biopsy (control group, n=30). The anxiety level of each patient was evaluated three times using Spielberger's State-Trait Anxiety Inventory (STAI): for baseline at the first visit to our institution, at the day of endoscopy, one day later, and one week after the procedure. We compared baseline characteristics, STAI scores at each visit, and differences in STAI scores among the three groups. No difference was found in STAI score among groups at baseline and before and after the endoscopic procedure. However, the STAI-state score of the intervention group was slightly lower than biopsy only group one day post-procedure (40.3 ± 7.7 vs. 43.9 ± 7.1, p=0.135). The STAI-state score significantly decreased from pre- to post-procedure only in the intervention group (-2.75 ± 6.1 vs. 0.92 ± 4.0, p<0.027). Use of written educational material for patients having biopsy might lessen their anxiety level.

  20. Transfusion requirements in surgical oncology patients: a prospective, randomized controlled trial.

    PubMed

    de Almeida, Juliano Pinheiro; Vincent, Jean-Louis; Galas, Filomena Regina Barbosa Gomes; de Almeida, Elisangela Pinto Marinho; Fukushima, Julia T; Osawa, Eduardo A; Bergamin, Fabricio; Park, Clarice Lee; Nakamura, Rosana Ely; Fonseca, Silvia M R; Cutait, Guilherme; Alves, Joseane Inacio; Bazan, Mellik; Vieira, Silvia; Sandrini, Ana C Vieira; Palomba, Henrique; Ribeiro, Ulysses; Crippa, Alexandre; Dalloglio, Marcos; Diz, Maria del Pilar Estevez; Kalil Filho, Roberto; Auler, Jose Otavio Costa; Rhodes, Andrew; Hajjar, Ludhmila Abrahao

    2015-01-01

    Several studies have indicated that a restrictive erythrocyte transfusion strategy is as safe as a liberal one in critically ill patients, but there is no clear evidence to support the superiority of any perioperative transfusion strategy in patients with cancer. In a randomized, controlled, parallel-group, double-blind (patients and outcome assessors) superiority trial in the intensive care unit of a tertiary oncology hospital, the authors evaluated whether a restrictive strategy of erythrocyte transfusion (transfusion when hemoglobin concentration <7 g/dl) was superior to a liberal one (transfusion when hemoglobin concentration <9 g/dl) for reducing mortality and severe clinical complications among patients having major cancer surgery. All adult patients with cancer having major abdominal surgery who required postoperative intensive care were included and randomly allocated to treatment with the liberal or the restrictive erythrocyte transfusion strategy. The primary outcome was a composite endpoint of mortality and morbidity. A total of 198 patients were included as follows: 101 in the restrictive group and 97 in the liberal group. The primary composite endpoint occurred in 19.6% (95% CI, 12.9 to 28.6%) of patients in the liberal-strategy group and in 35.6% (27.0 to 45.4%) of patients in the restrictive-strategy group (P = 0.012). Compared with the restrictive strategy, the liberal transfusion strategy was associated with an absolute risk reduction for the composite outcome of 16% (3.8 to 28.2%) and a number needed to treat of 6.2 (3.5 to 26.5). A liberal erythrocyte transfusion strategy with a hemoglobin trigger of 9 g/dl was associated with fewer major postoperative complications in patients having major cancer surgery compared with a restrictive strategy.

  1. Conservative versus surgical management of idiopathic normal pressure hydrocephalus: a prospective double-blind randomized controlled trial: study protocol.

    PubMed

    Toma, Ahmed K; Papadopoulos, Marios C; Stapleton, Simon; Kitchen, Neil D; Watkins, Laurence D

    2012-01-01

    There is no level I evidence to indicate whether placement of a shunt is effective in the management of idiopathic normal pressure hydrocephalus (INPH), because no trial has as yet compared the placement of a shunt versus no shunt in a randomized controlled manner. We started recruiting patients into a prospective double-blind randomized controlled study aiming to provide class I evidence supporting or refuting the role of surgical management in INPH. Inclusion criterion was the diagnosis of probable INPH plus objective improvement of walking speed following 72 h of extended lumbar drainage. Patients with concomitant Alzheimer's disease or vascular dementia were excluded. All patients included in the trial were to have a shunt placed with proGAV(®) adjustable valve. Patients were randomly assigned into two groups: group A was to have the shunt immediately adjusted to function, and group B was to have the shunt valve adjusted to the highest setting for 3 months then adjusted to function. Assessment of gait, cognitive function, and urinary symptoms were done before shunt insertion and at 3 months. Primary end point was to be an improvement in gait. Secondary end points were improvement in mental function or urinary function and incidence of complications. Final results are expected mid 2011.

  2. 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.

  3. Acupuncture in posttonsillectomy pain : A prospective, double-blinded, randomized, controlled trial.

    PubMed

    Dingemann, J; Plewig, B; Baumann, I; Plinkert, P K; Sertel, S

    2017-01-01

    Postoperative swallowing pain is one of the most unpleasant after-effects of tonsillectomy. During recent years, the demand for alternatives to drug-based pain therapy has continued to grow, although the topic has received little research attention until now. A total of 46 patients were randomized into verum acupuncture, control acupuncture, and drug-based treatment groups. All patients received nonsteroidal antirheumatic drugs (NSAIDs). One hour after drug intake, the verum group also received acupuncture according to classical acupuncture rules (S34, S44 and PC5). The control group had acupuncture needles placed at nonspecific acupuncture points in the midaxillary line. Acupuncture was performed by a blinded acupuncturist, who had learnt exclusively these techniques in the run up to the study. Patients were asked to evaluate their pain before, and at intervals of 20 min, 1 h, 2 h, and 3 h after drug intake/acupuncture treatment using a visual analog scale (VAS). The analgesic effect of acupuncture was significant up to 3 hours in the verum group (p < 0.05). The analgesic effect in the control acupuncture group was significant for up to 1 h after acupuncture (p < 0.05). With reference to the time point before acupuncture, the differences between both acupuncture groups and the drug group were significant (p < 0.01) over the whole time. Acupuncture is an effective complement to NSAIDs in the treatment of posttonsillectomy pain. Particularly patients with allergies, drug intolerance, or reduced response to the commonly administered drugs may benefit from acupuncture.

  4. [Acupuncture in posttonsillectomy pain : A prospective double-blind randomized controlled trial. German version].

    PubMed

    Dingemann, J; Plewig, B; Baumann, I; Plinkert, P K; Sertel, S

    2017-08-01

    Postoperative swallowing pain is one of the most unpleasant after-effects of tonsillectomy. During recent years, the demand for alternatives to drug-based pain therapy has continued to grow, although the topic has received little research attention until now. A total of 46 patients were randomized into verum acupuncture, control acupuncture, and drug-based treatment groups. All patients received nonsteroidal antirheumatic drugs (NSAIDs). One hour after drug intake, the verum group also received acupuncture according to classical acupuncture rules (S34, S44 and PC5). The control group had acupuncture needles placed at nonspecific acupuncture points in the midaxillary line. Acupuncture was performed by a blinded acupuncturist, who had learnt exclusively these techniques in the run up to the study. Patients were asked to evaluate their pain before, and at intervals of 20 min, 1 h, 2 h, and 3 h after drug intake/acupuncture treatment using a visual analog scale (VAS). The analgesic effect of acupuncture was significant up to 3 hours in the verum group (p < 0.05). The analgesic effect in the control acupuncture group was significant for up to 1 h after acupuncture (p < 0.05). With reference to the time point before acupuncture, the differences between both acupuncture groups and the drug group were significant (p < 0.01) over the whole time. Acupuncture is an effective complement to NSAIDs in the treatment of posttonsillectomy pain. Particularly patients with allergies, drug intolerance, or reduced response to the commonly administered drugs may benefit from acupuncture.

  5. Intrathecal morphine for postoperative pain control following robot-assisted prostatectomy: a prospective randomized trial.

    PubMed

    Bae, Junyeol; Kim, Hyun-Chang; Hong, Deok Man

    2017-08-01

    Robot-assisted laparoscopic prostatectomy (RALP) is minimally invasive surgery, but also causes moderate to severe pain during the immediate postoperative period. We evaluated the efficacy and safety of intrathecal morphine (ITM) for postoperative pain control in patients undergoing RALP. Thirty patients scheduled for RALP were randomly assigned into one of two groups. In the ITM group (n = 15), postoperative pain was managed using 300 µg intrathecal morphine with intravenous patient-controlled analgesia (IV-PCA). In the IV-PCA group (n = 15), only intravenous patient-controlled analgesia was used. The numerical pain score (NPS; 0 = no pain, 100 = worst pain imaginable), postoperative IV-PCA requirements and opioid-related complications including nausea, vomiting, dizziness, headache and pruritus were compared between the two groups. The NPSs on coughing were 20 (IQR 10-50) in the ITM group and 60 (IQR 40-80) in the IV-PCA group at postoperative 24 h (p = 0.001). The NPSs were significantly lower in the ITM group up to postoperative 24 h. The ITM group showed less morphine consumption at postoperative 24 h in the ITM group than in the IV-PCA group [5 (IQR 3-15) mg vs 17 (IQR 11-24) mg, p = 0.001]. Complications associated with morphine were comparable between the two groups and respiratory depression was not reported in either group. Intrathecal morphine provided more satisfactory analgesia without serious complications during the early postoperative period in patients undergoing RALP.

  6. Early oral refeeding based on hunger in moderate and severe acute pancreatitis: a prospective controlled, randomized clinical trial.

    PubMed

    Zhao, Xian L; Zhu, Shi F; Xue, Gui J; Li, Juan; Liu, Yi L; Wan, Mei H; Huang, Wei; Xia, Qing; Tang, Wen F

    2015-01-01

    Early enteral nutrition is beneficial for acute pancreatitis (AP), but the optimal timing and criteria remain unclear. The aim of this study was to explore the feasibility and safety of early oral refeeding (EORF) based on hunger in patients with moderate or severe AP. In a prospective, single-center, controlled, randomized clinical trial (ChiCTR-TRC-12002994), eligible patients with moderate or severe AP were randomized to either EORF or conventional oral refeeding (CORF). Patients in the EORF group restarted an oral diet when they felt hungry, regardless of laboratory parameters. Those in the CORF group restarted an oral diet only when clinical and laboratory symptoms had resolved. Clinical outcomes were compared between the two groups. In all, 146 eligible patients with moderate or severe AP were included and randomized to the EORF (n = 70) or CORF (n = 76) group. There were eight dropouts after randomization (three in EORF group; five in CORF group). The groups had similar baseline characteristics. The total length of hospitalization (13.7 ± 5.4 d versus 15.7 ± 6.2 d; P = 0.0398) and duration of fasting (8.3 ± 3.9 d versus 10.5 ± 5.1 d; P = 0.0047) were shorter in the EORF group than in the CORF group. There was no difference in the number of adverse events or complications between the two groups. The mean blood glucose level after oral refeeding was higher in the EORF group than in the CORF group (P = 0.0030). This controlled, randomized clinical trial confirmed the effectiveness and feasibility of EORF based on hunger in patients with moderate or severe AP. EORF could shorten the length of hospitalization in patients with moderate or severe AP. Copyright © 2015 The Authors. Published by Elsevier Inc. All rights reserved.

  7. 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

  8. A prospective, single-blind, randomized controlled trial of petroleum jelly/Vaseline for recurrent paediatric epistaxis.

    PubMed

    Loughran, S; Spinou, E; Clement, W A; Cathcart, R; Kubba, H; Geddes, N K

    2004-06-01

    The aim of the study was to determine if petroleum jelly was an effective treatment for paediatric epistaxis. A single-blind, prospective, randomized controlled trial was undertaken in an otolaryngology outpatient clinic of a paediatric hospital from March 2001 to March 2002. A total of 105 children referred with recurrent epistaxis were randomized into the study, 52 into the treatment arm and 53 into the control arm. Children in the treatment arm applied Vaseline twice a day bilaterally for 4 weeks and were monitored for any bleeds for the next 4 weeks. Children in the control arm were simply given an 8-week appointment and the number of bleeds were monitored for the 4 weeks prior to their appointment. The outcome measure was the proportion of children in each group without nosebleeds in the preceding 4 weeks. Both groups were equally distributed in age, duration of symptoms and duration of each bleed. Fourteen of 51 (27.5%) patients of the treatment arm and 18 of 53 (34%) of the control arm did not bleed in the 4 weeks before review (chi-square test, P = 0.472). It can be concluded that Vaseline alone confers no benefit over simple observation in recurrent childhood epistaxis.

  9. 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.

  10. The effect of laser epilation on recurrence and satisfaction in patients with sacrococcygeal pilonidal disease: a prospective randomized controlled trial

    PubMed Central

    Demircan, Firat; Akbulut, Sami; Yavuz, Ridvan; Agtas, Huseyin; Karabulut, Koray; Yagmur, Yusuf

    2015-01-01

    Background: The primary aim of this prospective study was to investigate the effects of laser epilation on patient satisfaction and recurrence in patients who underwent pilonidal sinus surgery. Method: Sixty patients scheduled for pilonidal sinus surgery in our clinic between 2011 and 2012 were enrolled in this prospective randomized controlled study. Patients were divided in two groups of 30 patients each. Only the Karydakis flap reconstruction technique was performed in the first group. Two sessions of laser epilation were applied in the second group in addition to Karydakis flap reconstruction. The patients in the second group underwent laser epilation 2 weeks before and 3 weeks after the surgery for a total of 2 times in a private office. Results: There were no statistically significant differences between the groups in terms of age, gender, smoking usage, ASA Score, duration of patient’s complaints, BMI and hospital stay. There were no statistically significant differences between the groups in terms of surgical site infection, wound separation, abscess formation at the any time postoperatively. There were statistically significant differences between the two groups in the first week post operation considering the VAS pain score (P<0.03) and VAS satisfaction score (P<0.01). While there were statistically significant differences between the two groups in the first month post operation considering the VAS pain score (P<0.0001), there were no statistically significant differences between the groups in terms of VAS satisfaction score in the first and three month postoperatively. In the telephone interviews done 1 year after the surgery, recurrence were detected in 4% of first group and in 20% of second group. Recurrence rates were significantly higher in the second group (P=0.045). Conclusion: Our results show that laser epilation does not reduce the relapse rates in pilonidal sinus surgery, as expected. It is obvious that prospective randomized studies need to

  11. 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

  12. 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.

  13. Idiopathic facial paralysis: a randomized, prospective, and controlled study using single-dose prednisone versus acyclovir three times daily.

    PubMed

    De Diego, J I; Prim, M P; De Sarriá, M J; Madero, R; Gavilán, J

    1998-04-01

    In a prospective, controlled, and randomized study, we compared the outcome of 101 Bell's palsy patients treated with acyclovir (54 patients) or prednisone (47 patients). The acyclovir dosage was 2400 mg (800 mg three times a day) for 10 days, and prednisone was given as a single daily dose of 1 mg/kg of body weight for 10 days and tapered to 0 over the next 6 days. Minimum follow-up was 3 months in all patients. Patients in the prednisone group had better clinical recovery than those treated with acyclovir. Less degree of neural degeneration was observed in the prednisone group compared with acyclovir patients. The incidence of sequelae was the same in both groups. According to these results, in a 10-day treatment cycle acyclovir given 800 mg three times is not as useful as prednisone given 1 mg/kg of body weight once a day in patients with idiopathic facial nerve paralysis.

  14. Is Electrocautery of Patella Useful in Patella Non-Resurfacing Total Knee Arthroplasty?: A Prospective Randomized Controlled Study.

    PubMed

    Kwon, Sae Kwang; Nguku, Levis; Han, Chang Dong; Koh, Yong-Gon; Kim, Dong-Wook; Park, Kwan Kyu

    2015-12-01

    There is controversy over the need for electrocauterization of the patella in non-resurfacing total knee arthroplasty (TKA). We investigated whether this procedure is beneficial through a prospective randomized controlled trial. Fifty patients who underwent electrocautery were compared with 50 patients who did not undergo this procedure. We determined cartilage status, preoperative and postoperative American Knee Society (AKS) score, the Western Ontario and McMaster Universities score (WOMAC) and the Patellofemoral (PF) scores for a minimum of 5 years. The two groups did not differ significantly in demographics, intraoperative cartilage status, or preoperative or postoperative outcomes. No complications were detected in either group. We found no benefits of electrocautery of the patella in patellar non-resurfacing TKA up to 5 years. Copyright © 2015 Elsevier Inc. All rights reserved.

  15. Synergistic Effect of Intravenous Ibuprofen and Hydromorphone for Postoperative Pain: Prospective Randomized Controlled Trial.

    PubMed

    Oh, Eunjung; Ahn, Hyun Joo; Sim, Woo Seog; Lee, Jin Young

    2016-07-01

    An intravenous form of ibuprofen has recently been approved by the Food and Drug Administration (FDA) and reports are rare on its co-administration with opioids. We researched whether an intravenous ibuprofen-hydromorphone combination is synergistic, additive, or infra-additive on postoperative pain. A parallel-group, 1:1:1 allocation, randomized, double-blind controlled trial. University teaching hospital in Korea. Ninety patients, undergoing breast surgery, were divided into one of the 3 groups (I, H, IH groups). Positive analgesic efficacy was defined as a numeric rating scale (NRS) 1.1), dose reduction index (DRI, a measure of how much the dose of each drug in a combination can be reduced), and isobologram were used to define the nature of their interaction. One way ANOVA, Kruskal Wallis test, and Chi square test, significance level P < 0.05. The median effective doses (ED50) of ibuprofen and hydromorphone were 1,447 mg and 1.5 mg, respectively. The median ED50 of the combination was ibuprofen 71 mg and hydromorphone 0.3 mg. Ibuprofen and hydromorphone showed a strong synergy (CI 0.2, DRI 20 and 5 for ibuprofen and hydromorphone at ED50). Analgesic efficacy was observed during post-anesthesia care unit (PACU) period only. The combination of intravenous ibuprofen and hydromorphone produces a strong synergistic analgesia on postoperative pain.

  16. Prepackaged central line kits reduce procedural mistakes during central line insertion: a randomized controlled prospective trial.

    PubMed

    Fenik, Yelena; Celebi, Nora; Wagner, Robert; Nikendei, Christoph; Lund, Frederike; Zipfel, Stephan; Riessen, Reimer; Weyrich, Peter

    2013-04-30

    Central line catheter insertion is a complex procedure with a high cognitive load for novices. Providing a prepackaged all-inclusive kit is a simple measure that may reduce the cognitive load. We assessed whether the use of prepackaged all-inclusive central line insertion kits reduces procedural mistakes during central line catheter insertion by novices. Thirty final year medical students and recently qualified physicians were randomized into two equal groups. One group used a prepackaged all-inclusive kit and the other used a standard kit containing only the central vein catheter and all other separately packaged components provided in a materials cart. The procedure was videotaped and analyzed by two blinded raters using a checklist. Both groups performed central line catheter insertion on a manikin, assisted by nursing students. The prepackaged kit group outperformed the standard kit group in four of the five quality indicators: procedure duration (26:26 ± 3:50 min vs. 31:27 ± 5:57 min, p = .01); major technical mistakes (3.1 ± 1.4 vs. 4.8 ± 2.6, p = .03); minor technical mistakes (5.2 ± 1.7 vs. 8.0 ± 3.2, p = .01); and correct steps (83 ± 5% vs. 75 ± 11%, p = .02). The difference for breaches of aseptic technique (1.2 ± 0.8 vs. 3.0 ± 3.6, p = .06) was not statistically significant. Prepackaged all-inclusive kits for novices improved the procedure quality and saved staff time resources in a controlled simulation environment. Future studies are needed to address whether central line kits also improve patient safety in hospital settings.

  17. Effects of Aromatherapy Massage on Pregnant Women's Stress and Immune Function: A Longitudinal, Prospective, Randomized Controlled Trial.

    PubMed

    Chen, Pao-Ju; Chou, Cheng-Chen; Yang, Luke; Tsai, Yu-Lun; Chang, Yue-Cune; Liaw, Jen-Jiuan

    2017-08-07

    This study's aims are to examine the effects of aromatherapy massage on women's stress and immune function during pregnancy. This longitudinal, prospective, randomized controlled trial recruited 52 healthy pregnant women from a prenatal clinic in Taipei using convenience sampling. The participants were randomly assigned to the intervention (n = 24) or control (n = 28) group using Clinstat block randomization. The intervention group received 70 min of aromatherapy massage with 2% lavender essential oil every other week (10 times in total) for 20 weeks; the control group received only routine prenatal care. In both groups, participants' salivary cortisol and immunoglobulin A (IgA) levels were collected before and after the intervention group received aromatherapy massage (every month from 16 to 36 weeks gestation) and were analyzed using enzyme-linked immunosorbent assay. The pregnant women in the intervention group had lower salivary cortisol (p < 0.001) and higher IgA (p < 0.001) levels immediately after aromatherapy massage than those in the control group, which did not receive massage treatment. Comparing the long-term effects of aromatherapy massage on salivary IgA levels between groups at different times, the study found that the pretest salivary IgA levels at 32 (p = 0.002) and 36 (p < 0.001) weeks gestational age (GA) were significantly higher than the pretest IgA at 16 weeks GA (baseline). This study presented evidence that aromatherapy massage could significantly decrease stress and enhance immune function in pregnant women. The findings can guide clinicians or midwives in providing aromatherapy massage to women throughout the pregnancy.

  18. 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.

  19. Cardiac shock wave therapy for chronic refractory angina pectoris. A prospective placebo-controlled randomized trial.

    PubMed

    Schmid, Jean-Paul; Capoferri, Mauro; Wahl, Andreas; Eshtehardi, Parham; Hess, Otto Martin

    2013-06-01

    Cardiac shock wave therapy (CSWT) delivered to the myocardium increases capillary density and regional myocardial blood flow in animal experiments. In addition, nonenzymatic nitric oxide production and the upregulation of vascular growth factor's mRNA by CSWT have been described. The aim of the study was therefore to test its potential to relieve symptoms in patients with chronic stable angina pectoris. Twenty-one patients (mean age 68.2 ± 8.3 years, 19 males) with chronic refractory angina pectoris and evidence of inducible myocardial ischemia during MIBI-SPECT imaging, were randomized into a treatment (n = 11) and a placebo arm (n = 10). The region of exercise-induced ischemia was treated with echocardiographic guidance during nine sessions over a period of 3 months. One session of CSWT consisted of 200 shots/spot (9--12 spots/session) with an energy intensity of 0.09 mJ/mm(2) . In the control group acoustic simulation was performed without energy application. Medication was kept unchanged during the whole treatment period. In the treatment group, symptoms improved in 9/11 patients, and the ischemic threshold, determined by cardiopulmonary exercise stress testing, increased from 80 ± 28 to 95 ± 28 W (P= 0.036). In the placebo arm, only 2/10 patients reported an improvement and the ischemic threshold remained unchanged (98 ± 23 to 107 ± 23 W; P= 0.141). The items "physical functioning" (P= 0.043), "general health perception" (P= 0.046), and "vitality" (P= 0.035) of the SF-36 questionnaire significantly improved in the treatment arm, whereas in the placebo arm, no significant change was noted. Neither arrhythmias, troponin rise nor complications were observed during treatment. This placebo controlled trial shows a significant improvement in symptoms, quality of life parameters and ischemic threshold during exercise in patients with chronic refractory angina pectoris treated with CSWT. Thus, CSWT represents a new option for the treatment of patients with

  20. Effectiveness of pit and fissure sealants bonded with different adhesive systems: a prospective randomized controlled trial.

    PubMed

    Erbas Unverdi, Gizem; Atac, Stephan Atilla; Cehreli, Zafer Cavit

    2016-11-30

    To evaluate and compare the clinical retention of a resin-based fissure sealant placed with an intermediate layer of etch-and-rinse (ER) or self-etch (SE) adhesives. Two hundred twenty-eight sealants were placed in 57 children with previously unsealed, caries-free permanent first molars, employing a split-mouth design. The teeth were randomized into four groups (n = 57 teeth/groups) according to the adhesive system placed under the tested sealant (Delton FS+; Dentsply). Group 1 (control): no bonding agent (conventional acid-etch sealant); group 2: prior enamel etch + ER adhesive (XP Bond; Dentsply); group 3: SE adhesive (Clearfil SE Bond; Kuraray) without prior etching; and group 4: prior enamel etch + SE adhesive (Clearfil SE Bond). Clinical assessments were performed according to modified USPHS criteria at 1, 3, 6, 12, 18, and 24 months. The data were analyzed statistically using Fisher's Exact test, the Kaplan-Meier analysis, and the Log-rank test. At 24 months, sealants bonded with XP Bond and Clearfil SE Bond with prior enamel etching showed similar retention rates (p > 0.05), and these rates were significantly better than the rates of the conventional sealant and Clearfil-SE groups (p < 0.05). There was no significant difference between the retention rates of the latter two groups (p > 0.05). The cumulative survival rates on palatal/buccal surfaces showed similar outcomes as with occlusal surfaces: XP Bond (94%), Clearfil SE Bond + acid-etch (94%), conventional sealant (52%), and Clearfil SE Bond only (37%). Application of the tested ER adhesive and the SE adhesive with enamel etching significantly improved the clinical retention of Delton-FS over the 24-month period. The use of a resin-based fissure sealant placed with ER or SE adhesive with prior acid-etching yielded better retention than the conventional sealant over the 24-month period.

  1. Analysis of Factors Affecting Successful Clinical Trial Enrollment in the Context of Three Prospective, Randomized, Controlled Trials.

    PubMed

    Logan, Jennifer K; Tang, Chad; Liao, Zhongxing; Lee, J Jack; Heymach, John V; Swisher, Stephen G; Welsh, James W; Zhang, Jianjun; Lin, Steven H; Gomez, Daniel R

    2017-03-15

    Challenges can arise when attempting to maximize patient enrollment in clinical trials. There have been limited studies focusing on the barriers to enrollment and the efficacy of alternative study design to improve accrual. We analyzed barriers to clinical trial enrollment, particularly the influence of timing, in context of three prospective, randomized oncology trials where one arm was considered more aggressive than the other. From June 2011 to March 2015, patients who were enrolled on 3 prospective institutional protocols (an oligometastatic non-small cell lung cancer [NSCLC] trial and 2 proton vs intensity modulated radiation therapy trials in NSCLC and esophageal cancer) were screened for protocol eligibility. Eligible candidates were approached about trial participation, and patient characteristics (age, sex, T/N categorization) were recorded along with details surrounding trial presentation (appointment number). Fisher's exact test, Student's t tests, and multivariate analysis were performed to assess differences between enrolled and refusal patients. A total of 309 eligible patients were approached about trial enrollment. The enrollment success rate during this time span was 52% (n=160 patients). Enrolled patients were more likely to be presented trial information at an earlier appointment (oligometastatic protocol: 5 vs 3 appointments [P<.001]; NSCLC protocol: 4 vs 3 appointments [P=.0018]; esophageal protocol: 3 vs 2 appointments [P=.0086]). No other factors or patient characteristics significantly affected enrollment success rate. Improvement in enrollment rates for randomized control trials is possible, even in difficult accrual settings. Earlier presentation of trial information to patients is the most influential factor for success and may help overcome accrual barriers without compromising trial design. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. The Complex Sleep Apnea Resolution Study: A Prospective Randomized Controlled Trial of Continuous Positive Airway Pressure Versus Adaptive Servoventilation Therapy

    PubMed Central

    Morgenthaler, Timothy I.; Kuzniar, Tomasz J.; Wolfe, Lisa F.; Willes, Leslee; McLain, William C.; Goldberg, Rochelle

    2014-01-01

    outcomes. Clinical Trials: Clinicaltrials.Gov NCT00915499 Citation: Morgenthaler TI, Kuzniar TJ, Wolfe LF, Willes L, McLain WC, Goldberg R. The complex sleep apnea resolution study: a prospective randomized controlled trial of continuous positive airway pressure versus adaptive servoventilation therapy. SLEEP 2014;37(5):927-934. PMID:24790271

  3. Can low-intensity extracorporeal shockwave therapy improve erectile dysfunction? A prospective, randomized, double-blind, placebo-controlled study.

    PubMed

    Olsen, Anne B; Persiani, Marie; Boie, Sidsel; Hanna, Milad; Lund, Lars

    2015-01-01

    The aim of this study was to investigate whether low-intensity extracorporeal shockwave therapy (LI-ESWT) can be used as a treatment for men with erectile dysfunction of organic origin. This prospective, randomized, blinded, placebo-controlled study included 112 men unable to have intercourse either with or without medication. Erectile dysfunction was assessed at screening and 5, 12 and 24 weeks after treatment. Assessment was performed by interview and using the Erection Hardness Scale (EHS) and the International Index of Erectile Function (IIEF-15) questionnaire. The men were randomly assigned either to LI-ESWT (n = 51, active group) or placebo (n = 54, placebo group). They received five treatments over 5 weeks. Both the participants and the doctors were blinded to the treatment. After 10 weeks, the placebo group received active treatment (active placebo group). Twenty-nine men (57%, active group) were able to obtain an erection after treatment and to have sexual intercourse without the use of medication. In the placebo group, only five men (9%) showed similar results (p = 0.0001). The EHS after 5 weeks showed that men in the active group experienced a significant improvement in their erectile dysfunction, but no significant result was found with the use of the IIEF - Erectile Function domain. This placebo-controlled study over 5 weeks shows that 57% of the men who suffered from erectile dysfunction had an effect from LI-ESWT. After 24 weeks, seven (19%, active group) and nine (23%, active placebo group) men were still able to have intercourse without medication. This study shows a possible cure in some patients, but more research, longer follow-up in the placebo group and an international multicentre randomized study are needed.

  4. [A prospective, randomized, double-blinded control study on comparison of tramadol, clonidine and dexmedetomidine for post spinal anesthesia shivering].

    PubMed

    Venkatraman, Rajagopalan; Karthik, Krishnamoorthy; Pushparani, Anand; Mahalakshmi, Annadurai

    2017-05-22

    Shivering, a common intraoperative problem under spinal anesthesia increases the oxygen consumption considerably and is uncomfortable and distressing to the patient, anesthesiologist as well as surgeon. The present study was designed to explore the effectiveness of tramadol, clonidine and dexmedetomidine in the treatment of post spinal anesthesia shivering and to look for their adverse effects. This prospective, randomized, double blinded control study was done on 90 patients who developed shivering under spinal anesthesia. They were randomly allocated into three groups with Group T receiving tramadol 1mg.kg(-1), Group C getting clonidine 1mcg.kg(-1) and Group D patients receiving dexmedetomidine 0.5mcg.kg(-1). The time taken to control shivering, recurrence rate, hemodynamic variables, sedation score and adverse effects were observed. Dexmedetomidine was faster in the control of shivering in 5.7±0.79minutes (min) whereas tramadol took 6.76±0.93min and clonidine was slower with 9.43±0.93min. The recurrence rate was much lower in the dexmedetomidine group with 3.3% than for clonidine (10%) and tramadol (23.3%) group. The sedation achieved with dexmedetomidine was better than clonidine and tramadol. The tramadol group had more cases of vomiting (four) and dexmedetomidine group had six cases of hypotension and two cases of bradycardia. Two of the clonidine patients encountered bradycardia and hypotension. Dexmedetomidine is better than tramadol and clonidine in the control of shivering because of its faster onset and less recurrence rate. Though complications are encountered in the dexmedetomidine group, they are treatable. Copyright © 2016 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

  5. Effectiveness and safety of Chinese massage therapy (Tui Na) on post-stroke spasticity: a prospective multicenter randomized controlled trial.

    PubMed

    Yang, Yu-Jie; Zhang, Jun; Hou, Ying; Jiang, Bao-Yin; Pan, Hua-Fei; Wang, Jian; Zhong, Da-Yong; Guo, Hai-Ying; Zhu, Yi; Cheng, Jie

    2017-07-01

    To evaluate the effectiveness and safety of Chinese massage therapy (Tui Na) for patients with post-stroke spasticity. A prospective, multicenter, blinded, randomized, placebo-controlled intervention trial. A total of 90 patients with post-stroke spasticity were randomly assigned to the experimental (Tui Na therapy) group ( n = 45) or control (placebo Tui Na therapy) group ( n = 45). Participants in the experimental group received Tui Na therapy, while those in the control group received placebo-Tai Na (gentle rubbing) for 20-25 minutes per limb, once per day, five days per week for a total of four weeks. All participants in both groups received conventional rehabilitation. The Modified Ashworth Scale, the Fugl-Meyer Assessment and the Modified Barthel Index were used to assess the severity of spasticity, motor function of limbs and activities of daily living, respectively. Assessments were performed at baseline, at four weeks and at three months. Tui Na group had a significantly greater reduction in Modified Ashworth Scale in only four muscle groups than the control did (elbow flexors, P = 0.026; wrist flexors, P = 0.005; knee flexors, P = 0.023; knee extensors, P = 0.017). Improvements were sustained at three months follow-up. There was no significant difference between the two groups in Fugl-Meyer Assessment ( P = 0.503) and Modified Barthel Index ( P = 0.544). No adverse reaction was recorded in any of the cases mentioned at all study sites. Tui Na might be a safe and effective treatment to reduce post-stroke spasticity of several muscle groups.

  6. PONV in Ambulatory surgery: A comparison between Ramosetron and Ondansetron: a prospective, double-blinded, and randomized controlled study

    PubMed Central

    Banerjee, Debasis; Das, Anjan; Majumdar, Saikat; Mandal, Rahul Deb; Dutta, Soumyadip; Mukherjee, Anindya; Chakraborty, Aparna; Chattopadhyay, Sandip

    2014-01-01

    Background: postoperative nausea and vomiting (PONV) frequently hampers implementation of ambulatory surgery in spite of so many antiemetic drugs and regimens. Aims: the study was carried out to compare the efficacy of Ramosetron and Ondansetron in preventing PONV after ambulatory surgery. Setting and Design: it was a prospective, double blinded, and randomized controlled study. Methods: 124 adult patients of either sex, aged 25-55, of ASA physical status I and II, scheduled for day care surgery, were randomly allocated into Group A [(n=62) receiving (IV) Ondansetron (4 mg)] and Group B [(n=62) receiving IV Ramosetron (0.3 mg)] prior to the induction of general anesthesia in a double-blind manner. Episodes of PONV were noted at 0.5, 1, 2, 4 h, 6, 12, and 18 h postoperatively. Statistical Analysis and Results: statistically significant difference between Groups A and B (P <0.05) was found showing that Ramosetron was superior to Ondansetron as antiemetic both regarding frequency and severity. Conclusion: it was evident that preoperative prophylactic administration of single dose IV Ramosetron (0.3 mg) has better efficacy than single dose IV Ondansetron (4 mg) in reducing the episodes of PONV over 18 h postoperatively in patients undergoing day-care surgery under general anesthesia. PMID:24665236

  7. 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.

  8. 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.

  9. 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.

  10. [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.

  11. 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.

  12. [A prospective, randomized, controlled clinical study of Huai Qi Huang granules in treatment of childhood primary nephrotic syndrome].

    PubMed

    Geng, Hai-Yun; Cao, Li; Wang, Wei; Chen, Da-Kun; Chen, Chao-Ying; Chu, Mei; Ji, Li-Na; Wang, Jing-Jing; Tu, Juan; Li, Jian-Guo; Li, Hua-Rong; Du, Pei-Wei

    2015-01-01

    To study the efficacy of Huai Qi Huang granules in the treatment of childhood primary nephrotic syndrome. Between July 2009 and December 2011, patients who were admitted and diagnosed for the first time as childhood primary nephrotic syndrome were randomized into a treatment group (Huai Qi Huang granules plus glucocorticoid; n=23) and a control group (glucocorticoid alone; n=19) for a prospective study. The two groups were compared for regression time of edema, time to urinary protein clearance, relapse rate, incidence of infection, dosage of glucocorticoid, and humoral and cellular immunological indicators. There were no significant differences in regression time of edema, time to urinary protein clearance, and relapse rate between the treatment and control groups (P>0.05). The treatment group had significantly lower incidence of infection and daily dose of glucocorticoid (at month 6) than the control group (P<0.05). Humoral and cellular immunological indicators showed no significant differences between the two groups (P>0.05). No Huai Qi Huang-related adverse events were observed in this study. Huai Qi Huang granules treatment can reduce the dose of glucocorticoid and the incidence of infection in children with primary nephrotic syndrome and has a favourable safety.

  13. Effects of epidural lidocaine analgesia on labor and delivery: A randomized, prospective, controlled trial

    PubMed Central

    Nafisi, Shahram

    2006-01-01

    Background Whether epidural analgesia for labor prolongs the active-first and second labor stages and increases the risk of vacuum-assisted delivery is a controversial topic. Our study was conducted to answer the question: does lumbar epidural analgesia with lidocaine affect the progress of labor in our obstetric population? Method 395 healthy, nulliparous women, at term, presented in spontaneous labor with a singleton vertex presentation. These patients were randomized to receive analgesia either, epidural with bolus doses of 1% lidocaine or intravenous, with meperidine 25 to 50 mg when their cervix was dilated to 4 centimeters. The duration of the active-first and second stages of labor and the neonatal apgar scores were recorded, in each patient. The total number of vacuum-assisted and cesarean deliveries were also measured. Results 197 women were randomized to the epidural group. 198 women were randomized to the single-dose intravenous meperidine group. There was no statistical difference in rates of vacuum-assisted delivery rate. Cesarean deliveries, as a consequence of fetal bradycardia or dystocia, did not differ significantly between the groups. Differences in the duration of the active-first and the second stages of labor were not statistically significant. The number of newborns with 1-min and 5-min Apgar scores less than 7, did not differ significantly between both analgesia groups. Conclusion Epidural analgesia with 1% lidocaine does not prolong the active-first and second stages of labor and does not increase vacuum-assisted or cesarean delivery rate. PMID:17176461

  14. 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.

  15. Ebeltoft project: baseline data from a five-year randomized, controlled, prospective health promotion study in a Danish population.

    PubMed Central

    Lauritzen, T; Leboeuf-Yde, C; Lunde, I M; Nielsen, K D

    1995-01-01

    BACKGROUND. There is increasing political pressure on the medical profession to approach welfare diseases, such as coronary heart disease and diabetes, through prevention. General practitioners are required to offer regular health checks to healthy people, in spite of the lack of scientific evidence for the universal need, usefulness and side effects of such an intervention. Randomized controlled trials are needed. AIM. A study was carried out to investigate people's interest in participating in health checks and in discussions about health with their own general practitioner, participants' health status, the proportion who received health advice following health checks, and the lifestyle goals they set following discussion with their general practitioner. This study reports the baseline data from a five-year randomized, controlled, prospective, population-based study in general practices in Ebeltoft, Denmark. METHOD. All general practitioners from the four practices in Ebeltoft and a random sample of 2000 people aged between 30 and 50 years were invited to participate. Participants were randomly divided into three groups--one control group and two intervention groups. One intervention group were given a health check which included being screened for cardiovascular risk factors, lung and liver function, fitness, sight and hearing and an optional test for the human immunodeficiency virus (HIV); this group received written feedback from the general practitioner. The other intervention group were also given a health check and written feedback; in addition, they were given the opportunity to attend their general practitioner to discuss preventive health. RESULTS. A total of 1370 people participated in the study (69% response rate). Health advice was given to 76% of 905 participants following health checks. Almost all of the 456 participants (96%) who were offered the opportunity of discussing their health with their general practitioner took up the offer; 64% of the

  16. Bipolar Versus Unipolar Temporary Epicardial Ventricular Pacing Leads Use in Congenital Heart Disease: A Prospective Randomized Controlled Study.

    PubMed

    Mohari, Nivedita; Starr, Joanne P; Gates, Richard N; Domico, Michele B; Batra, Anjan S

    2016-05-01

    To compare the pacing parameters of unipolar versus bipolar temporary ventricular epicardial pacing leads. Prospective Randomized Unblinded Controlled Study. Fifty patients undergoing surgery for congenital heart disease who were anticipated to require temporary ventricular pacing leads were recruited preoperatively: 25 patients were randomized to receive unipolar temporary ventricular epicardial pacing leads; the remaining 25 were randomized to receive bipolar temporary ventricular epicardial leads. The baseline characteristics of the groups were similar. The pacing parameters were measured daily for up to first seven postoperative days (PODs) with the day of surgery recorded as POD 0. On the day of insertion, the mean pacing and sensing thresholds were similar for both unipolar and bipolar leads. Thresholds progressively deteriorated with each subsequent POD. By POD 4, the mean ± standard deviation pacing threshold of ventricular bipolar lead was 2.87 ± 0.37 mA compared with 5.6 ± 0.85 mA for the unipolar leads (P = 0.005). The decrease in sensing threshold of the unipolar ventricular pacing leads was significantly more than that of bipolar leads (by POD 5, 5.7 ± 2.64 vs 10.33 ± 2.8, P = 0.01). Our study shows that the bipolar leads (Medtronic 6495, Medtronic Inc., Minneapolis, MN, USA) have superior sensing and pacing thresholds in the ventricular position in patients undergoing surgery for congenital heart disease when compared to the unipolar leads (Medical Concepts Europe VF608ABB, Medical Concepts Europe Inc., Buffalo, NY, USA). ©2016 Wiley Periodicals, Inc.

  17. 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

  18. Treatment of obesity with extension of sleep duration: a randomized, prospective, controlled trial.

    PubMed

    Cizza, Giovanni; Marincola, Paula; Mattingly, Megan; Williams, Lyda; Mitler, Merrill; Skarulis, Monica; Csako, Gyorgy

    2010-06-01

    The prevalence of chronic sleep deprivation is increasing in modern societies with negative health consequences. Recently, an association between short sleep and obesity has been reported. To assess the feasibility of increasing sleep duration to a healthy length (approximately 7(1/2) h) and to determine the effect of sleep extension on body weight. To examine the long-term effects of sleep extension on endocrine (leptin and ghrelin) and immune (cytokines) parameters, the prevalence of metabolic syndrome, body composition, psychomotor vigilance, mood, and quality of life. One hundred-fifty obese participants who usually sleep less than 6(1/2) h, are being randomized at a 2:1 ratio to either an Intervention or to a Comparison Group. They are stratified by age (above and below 35) and the presence or absence of metabolic syndrome. During the first 12 months (Efficacy Phase) of the study, participants are evaluated at bi-monthly intervals: the Intervention Group is coached to increase sleep by at least 30-60 min/night, while the Comparison Group maintains baseline sleep duration. In the second (Effectiveness) phase, participants converge into the same group and are asked to increase (Comparison Group) or maintain (Intervention Group) sleep duration and are evaluated at 6-month intervals for an additional 3 years. Non-pharmacological and behavior-based interventions are being utilized to increase sleep duration. Endocrine, metabolic, and psychological effects are monitored. The sleep, energy expenditure, and caloric intake are assessed by activity monitors and food recall questionnaires. At yearly intervals, body composition, abdominal fat, and basal metabolic rate are measured by dual energy X-ray absorptiometry (DXA), computerized tomography (CT), and indirect calorimetry, respectively. As of January 2010, 109 participants had been randomized, 64 to the Intervention Group and 45 to the Comparison Group (76% women, 62% minorities, average age: 40.8 years; BMI: 38.5 kg

  19. Prospective randomized controlled trial comparing 1- versus 7-day manipulation following collagenase injection for dupuytren contracture.

    PubMed

    Mickelson, Dayne T; Noland, Shelley S; Watt, Andrew J; Kollitz, Kathleen M; Vedder, Nicholas B; Huang, Jerry I

    2014-10-01

    To compare the efficacy, tolerance, and safety of manual manipulation at day 7 to day 1 following collagenase Clostridium histolyticum (CCH) injection for Dupuytren contracture. Eligible patients were randomized to manipulation at day 1 versus day 7 following CCH injection. Preinjection, premanipulation, postmanipulation, and 30-day follow-up metacarpophalangeal (MCP) and proximal interphalangeal (PIP) joint contractures were measured. Pain scores were recorded at each time point. Data were stratified per cohort based on primary joint treated (MCP vs PIP). Means were compared using paired and unpaired t-tests. Forty-three patients with 46 digits were eligible and were randomized to 1-day (22 digits) and 7-day (24 digits) manipulation. For MCP joints, there were no significant differences in flexion contractures between 1- and 7-day cohorts for initial (47° vs 46°), postmanipulation (0° vs 2°), or 30-day follow-up (1° vs 2°) measurements. Premanipulation, the residual contracture was significantly lower in the 7-day group (23° vs 40°). For PIP joints, there were no significant differences between 1- and 7-day cohorts for initial (63° vs 62°), premanipulation (56° vs 52°), postmanipulation (13° vs 15°), or 30-day (14° vs 16°) measurements. There were no significant differences in pain or skin tears between the 2 groups. No flexor tendon ruptures were observed. The effectiveness of CCH in achieving correction of Dupuytren contractures was preserved when manipulation was performed on day 7, with no differences in correction, pain, or skin tears. These data suggest that manipulation can be scheduled at the convenience of the patient and surgeon within the first 7 days after injection. Therapeutic I. Copyright © 2014 American Society for Surgery of the Hand. Published by Elsevier Inc. All rights reserved.

  20. 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

  1. Does Visceral Osteopathic Treatment Accelerate Meconium Passage in Very Low Birth Weight Infants?- A Prospective Randomized Controlled Trial

    PubMed Central

    Haiden, Nadja; Pimpel, Birgit; Kreissl, Alexandra; Jilma, Bernd; Berger, Angelika

    2015-01-01

    Background To determine whether the complementary approach of visceral manipulative osteopathic treatment accelerates complete meconium excretion and improves feeding tolerance in very low birth weight infants. Methods This study was a prospective, randomized, controlled trial in premature infants with a birth weight <1500 g and a gestational age <32 weeks who received a visceral osteopathic treatment 3 times during their first week of life or no treatment. Results Passage of the last meconium occurred after a median of 7.5 days (95% confidence interval: 6–9 days, n = 21) in the intervention group and after 6 days (95% confidence interval: 5-9 days, n = 20,) in the control group (p = 0.11). However, osteopathic treatment was associated with a 8 day longer time to full enteral feedings (p = 0.02), and a 34 day longer hospital stay (Median = 66 vs. 100 days i.e.; p=0.14). Osteopathic treatment was tolerated well and no adverse events were observed. Conclusions Visceral osteopathic treatment of the abdomen did not accelerate meconium excretion in VLBW (very low birth weight)-infants. However infants in the osteopathic group had a longer time to full enteral feedings and a longer hospital stay, which could represent adverse effects. Based on our trial results, we cannot recommend visceral osteopathic techniques in VLBW-infants. Trial registration Clinical trials.gov: NCT02140710 PMID:25875011

  2. Effect of mode of hydrocortisone administration on glycemic control in patients with septic shock: a prospective randomized trial.

    PubMed

    Loisa, Pekka; Parviainen, Ilkka; Tenhunen, Jyrki; Hovilehto, Seppo; Ruokonen, Esko

    2007-01-01

    Low-dose hydrocortisone treatment is widely accepted therapy for the treatment of vasopressor-dependent septic shock. The question of whether corticosteroids should be given to septic shock patients by continuous or by bolus infusion is still unanswered. Hydrocortisone induces hyperglycemia and it is possible that continuous hydrocortisone infusion would reduce the fluctuations in blood glucose levels and that tight blood glucose control could be better achieved with this approach. In this prospective randomized study, we compared the blood glucose profiles, insulin requirements, amount of nursing workload needed, and shock reversal in 48 septic shock patients who received hydrocortisone treatment either by bolus or by continuous infusion with equivalent dose (200 mg/day). Duration of hydrocortisone treatment was five days. The mean blood glucose levels were similar in the two groups, but the number of hyperglycemic episodes was significantly higher in those patients who received bolus therapy (15.7 +/- 8.5 versus 10.5 +/- 8.6 episodes per patient, p = 0.039). Also, more changes in insulin infusion rate were needed to maintain strict normoglycemia in the bolus group (4.7 +/- 2.2 versus 3.4 +/- 1.9 adjustments per patient per day, p = 0.038). Hypoglycemic episodes were rare in both groups. No difference was seen in shock reversal. Strict normoglycemia is more easily achieved if the hydrocortisone therapy is given to septic shock patients by continuous infusion. This approach also reduces nursing workload needed to maintain tight blood glucose control.

  3. 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.

  4. A prospective randomized controlled trial on the efficacy of noninvasive ventilation in severe acute asthma.

    PubMed

    Gupta, Dheeraj; Nath, Alok; Agarwal, Ritesh; Behera, Digamber

    2010-05-01

    Noninvasive ventilation (NIV) is an emerging modality in the management of patients with acute respiratory failure. However, its role in severe acute asthma is not well defined. Evaluate the efficacy of NIV in severe acute asthma. Patients with severe acute asthma were randomized to receive either standard medical therapy or NIV in addition to medical therapy. The primary outcomes were improvement in forced expiratory volume in the first second (FEV1), intensive care unit (ICU) stay, and hospital stay. The secondary outcomes were rate of improvement in respiratory rate, blood pH, ratio of PaO2 to fraction of inspired oxygen (F(I)O2), PaCO2, requirement for inhaled medications, and failure of primary therapy. Fifty-three patients with severe acute asthma (42 females and 11 males, mean +/- SD age 44 +/- 15 y, FEV1 < 30% of predicted) were randomized to NIV (n = 28) or standard medical therapy (n = 25). The baseline variables were similar in the 2 groups except for the mean duration of asthma, which was shorter in the standard-medical-therapy group. The median inspiratory and expiratory airway pressures applied were 12 cm H2O and 5 cm H2O, respectively. There was a significant improvement in respiratory rate, FEV1, and PaO2/F(I)O2 (but not pH or PaCO2) in both the groups, but no significant difference between the 2 groups. The number of patients who had a > or = 50% improvement in FEV1 at 1, 2, and 4 hours was nonsignificantly greater in the NIV arm. ICU and hospital stay was significantly shorter in the NIV group. The mean dose of inhaled bronchodilator was significantly less in the NIV group. There were 4 instances of standard-medical-therapy failure, and all those patients improved with NIV. Two patients in the NIV arm required invasive ventilation. There was no mortality in either of the arms. In patients with severe acute asthma, the addition of NIV to standard medical therapy probably accelerates the improvement in lung function, decreases the inhaled

  5. Cardiovascular effects of dietary salt intake in aged healthy cats: a 2-year prospective randomized, blinded, and controlled study.

    PubMed

    Chetboul, Valérie; Reynolds, Brice Stéphane; Trehiou-Sechi, Emilie; Nguyen, Patrick; Concordet, Didier; Sampedrano, Carolina Carlos; Testault, Isabelle; Elliott, Jonathan; Abadie, Jérôme; Biourge, Vincent; Lefebvre, Hervé Pierre

    2014-01-01

    High salt dry expanded diets are commercially available for cats to increase water intake and urine volume, as part of the prevention or treatment of naturally occurring urinary stone formation (calcium oxalates and struvites). However, chronic high salt intake may have potential cardiovascular adverse effects in both humans, especially in aging individuals, and several animal models. The objective of this prospective, randomized, blinded, and controlled study was to assess the long-term cardiovascular effects of high salt intake in healthy aged cats. Twenty healthy neutered cats (10.1 ± 2.4 years) were randomly allocated into 2 matched groups. One group was fed a high salt diet (3.1 g/Mcal sodium, 5.5 g/Mcal chloride) and the other group a control diet of same composition except for salt content (1.0 g/Mcal sodium, 2.2 g/Mcal chloride). Clinical examination, systolic and diastolic arterial blood pressure measurements, standard transthoracic echocardiography and conventional Doppler examinations were repeatedly performed on non-sedated cats by trained observers before and over 24 months after diet implementation. Radial and longitudinal velocities of the left ventricular free wall and the interventricular septum were also assessed in systole and diastole using 2-dimensional color tissue Doppler imaging. Statistics were performed using a general linear model. No significant effect of dietary salt intake was observed on systolic and diastolic arterial blood pressure values. Out of the 33 tested imaging variables, the only one affected by dietary salt intake was the radial early on late diastolic velocity ratio assessed in the endocardium of the left ventricular free wall, statistically lower in the high salt diet group at 12 months only (P = 0.044). In conclusion, in this study involving healthy aged cats, chronic high dietary salt intake was not associated with an increased risk of systemic arterial hypertension and myocardial dysfunction, as observed in some

  6. Does preparation of children before MRI reduce the need for anesthesia? Prospective randomized control trial.

    PubMed

    Rothman, Sarah; Gonen, Anat; Vodonos, Alina; Novack, Victor; Shelef, Ilan

    2016-10-01

    Magnetic resonance imaging has been recognized for years as the safest and most precise imaging method, particularly for children. The accuracy of MRI depends on avoidance of patient movement during the study. This may be difficult for children and may require anesthesia. We evaluated an introductory instruction program as an assistive tool in performing MRI without anesthesia. In one institution, 121 children were randomized to undergo full interactive pre-MRI instruction (n=64), which included an instructional booklet, movie and simulator practice, or partial instruction (n=57), comprised of the booklet only. All researchers and health care professionals involved, except for the one who instructed the families, were masked to the group allocation. Parents' anxiety, according to the Spielberger state anxiety inventory, was measured. Median age was 7.4 years (range: 5 years-16 years). Anesthesia was required for fewer children who received full compared to partial instruction: 17 (27%) vs. 27 (47%), P≤0.02. The median anxiety level prior to instruction was higher than the median level after instruction, for both the partial and full instruction groups. Instruction including simulator practice was associated with a decreased need for anesthesia among children undergoing MRI scans.

  7. Carboprost Versus Oxytocin for Active Management of Third Stage of Labor: A Prospective Randomized Control Study.

    PubMed

    Sunil Kumar, K S; Shyam, Sundar; Batakurki, Pavitra

    2016-10-01

    Postpartum hemorrhage is the single largest and leading cause of maternal morbidity and mortality not only in developing countries but also in developed countries. The present study is an attempt to evaluate the scope of using prophylactic intramuscular carboprost tromethamine 125 μg in comparison with intramuscular oxytocin 10 units for the active management of third stage of labor. Two hundred pregnant women at term with spontaneous onset of labor were included in the study and were randomly divided into 2 groups of 100 women each. Group A and group B were given injection oxytocin 10 units and injection carboprost tromethamine 125 μg intramuscularly, respectively, at the time of delivery of anterior shoulder. The main outcome measures with respect to third stage of labor were: duration, blood loss by volume, difference in hemoglobin, need for additional oxytocics and side effects. Subjects who received carboprost tromethamine 125 μg showed a significant reduction in duration of third stage of labor (p < 0.05) and blood loss (p < 0.01) when compared to the subjects who received oxytocin 10 units. Likelihood of occurrence of postpartum hemorrhage was reduced without significant side effects except for diarrhea. Additional need for other uterotonics after carboprost was significantly less compared to oxytocin. Intramuscular carboprost 125 μg is a better cost-effective alternative as compared to 10 units intramuscular oxytocin in active management of third stage of labor.

  8. [Prevention of intrauterine adhesion with auto-crosslinked hyaluronic acid gel: a prospective, randomized, controlled clinical study].

    PubMed

    Xiao, Songshu; Wan, Yajun; Zou, Fangjun; Ye, Mingzhu; Deng, Henan; Ma, Jiezhi; Wei, Yingying; Tan, Chen; Xue, Min

    2015-01-01

    To evaluate the efficacy and safety of auto-crosslinked hyaluronic acid (HA) gel for preventing intrauterine adhesion (IUA) after hysteroscopic adhesiolysis. A prospective, randomized, double blinded and controlled clinical trial (level I) was performed. According to American Fertility Society (AFS) scoring system, 120 patients (treatment group: 60 cases, control group: 60 cases) with moderate to severe IUA were enrolled. Upon completion of adhesiolysis, a Foley balloon catheter was first introduced into the uterine cavity and then 3 ml of auto-crosslinked HA gel for patients in the treatment group; patients in the control group, however, only received Foley balloon catheter. Second-look hysteroscopic examination was performed to all patients at 3 months postoperatively for evaluation of IUA. Primary endpoint was the reduction rate of IUA at 3 months after surgery. The secondary endpoints include total AFS score, score of each individual AFS category. At 3 months after surgery, auto-crosslinked HA gel resulted in significantly higher effective rate for reduction of adhesion, the effective rate were 76% (42/55) and 48% (27/56) respectively (P = 0.000 9); the total AFS score of treatment group was 2.1 ± 1.1, and significantly lower than that of control group (3.7 ± 2.5, P = 0.000 8). Application of auto-crosslinked HA gel after surgery significantly enhanced the improvement for each individual patient with regard to their adhesive type and menstrual pattern (P = 0.037 8, P = 0.000 4). The treatment group had significantly lower proportion of patients with moderate to severe adhesive stages than that of control group [13% (7/55) versus 38% (21/56), P = 0.000 6]. No adverse events and complications were observed. Auto-crosslinked HA gel coule be able to reduce IUA, decrease adhesion severity, and improve menopause postoperatively. This absorbable auto-crosslinked HA gel is proposed as a barrier for preventing IUA after intrauterine procedures.

  9. Acupuncture for nasal congestion: a prospective, randomized, double-blind, placebo-controlled clinical pilot study.

    PubMed

    Sertel, Serkan; Bergmann, Zazie; Ratzlaff, Kerstin; Baumann, Ingo; Greten, Henry Johannes; Plinkert, Peter Karl

    2009-01-01

    Nasal congestion is one of the most common complaints dealt with in otorhinolaryngology. Side effects of decongestants are frequently seen in patients with chronic nasal congestion. This leads to an increasing demand of alternative treatments such as acupuncture. Future studies on acupuncture should aim at objectifying effects by both physical measuring and double blinding. Therefore, we were interested in whether these effects can potentially be measured as increase in nasal airflow (NAF) in ventus ("wind") disease of traditional Chinese medicine (TCM). Twenty-four patients with a history of nasal congestion due to hypertrophic inferior turbinates or chronic sinusitis without polyposis were additionally diagnosed according to the Heidelberg model of TCM. They were asked to score the severity of their nasal congestion on a visual analog scale (VAS). The acupuncturist was blinded according to the Heidelberg blinding assay. NAF was measured by using active anterior rhinomanometry (ARM). Specific verum acupoints according to the Chinese medical diagnosis were tested against nonspecific control acupoints. VAS and NAF were scored and measured before and 15 and 30 minutes after acupuncture. Control acupuncture showed a significant improvement in VAS and a deterioration of NAF. Verum acupuncture showed highly significant improvements in VAS and NAF. In addition, verum acupuncture improved NAF and VAS significantly over time. Our control and verum acupoints fulfill the condition of a control and verum treatment, respectively. Measuring NAF by RRM and scoring VAS are possible and reflect acupuncture effects in vivo.

  10. Prospective randomized controlled trial comparing laser lithotripsy with pneumatic lithotripsy in miniperc for renal calculi.

    PubMed

    Ganesamoni, Raguram; Sabnis, Ravindra B; Mishra, Shashikant; Parekh, Narendra; Ganpule, Arvind; Vyas, Jigish B; Jagtap, Jitendra; Desai, Mahesh

    2013-12-01

    The energy source used for stone fragmentation is important in miniperc. In this study, we compared the stone fragmentation characteristics and outcomes of laser lithotripsy and pneumatic lithotripsy in miniperc for renal calculi. After Institutional Review Board approval, 60 patients undergoing miniperc for renal calculi of 15 to 30 mm were equally randomized to laser and pneumatic lithotripsy groups. Miniperc was performed using 16.5F Karl Storz miniperc sheath and a 12F nephroscope. Laser lithotripsy was performed using a 550-μm laser fiber and 30 W laser with variable settings according to the need. Pneumatic lithotripsy was performed using the EMS Swiss lithoclast. Patient demographics, stone characteristics, intraoperative parameters, and postoperative outcomes were analyzed. The baseline patient demographics and stone characteristics were similar in both groups. The total operative time (P = 0.433) and fragmentation time (P=0.101) were similar between the groups. The surgeon assessed that the Likert score (1 to 5) for fragmentation was similar in both groups (2.1 ± 0.8 vs 1.9 ± 0.9, P=0.313). Stone migration was lower with the laser (1.3 ± 0.5 vs 1.7 ± 0.8, P=0.043), and fragment removal was easier with the laser (1.1 ± 0.3 vs 1.7 ± 1.1, P=0.011). The need for fragment retrieval using a basket was significantly more in the pneumatic lithotripsy group (10% vs 37%, P=0.002). The hemoglobin drop, complication rates, auxiliary procedures, postoperative pain, and stone clearance rates were similar between the groups (P>0.2). Both laser lithotripsy and pneumatic lithotripsy are equally safe and efficient stone fragmentation modalities in miniperc. Laser lithotripsy is associated with lower stone migration and easier retrieval of the smaller fragments it produces.

  11. Regenerative Endodontics Versus Apexification in Immature Permanent Teeth with Apical Periodontitis: A Prospective Randomized Controlled Study.

    PubMed

    Lin, Jiacheng; Zeng, Qian; Wei, Xi; Zhao, Wei; Cui, Minyi; Gu, Jing; Lu, Jiaxuan; Yang, Maobin; Ling, Junqi

    2017-08-29

    The aim of the study was to compare the outcomes of regenerative endodontic treatment (RET) and apexification on immature permanent teeth with pulp necrosis and apical periodontitis. A total of 118 patients (118 teeth) were recruited and randomly assigned to either RET or apexification treatment. Each treatment group was divided into 2 subgroups according to the etiology: dens evaginatus or trauma. Clinical symptoms and complications were recorded, and cone-beam computed tomographic imaging with a limited field of view was used to measure the change of root length, root thickness, and apical foramen size at the 12-month follow-up. The t test/rank sum test and Fisher exact test were applied to compare the change of root morphology between RET and apexification. One hundred three of 118 cases were completed at the 12-month follow-up. The survival rate was 100% for both treatment groups. All cases were asymptomatic with apical healing. The RET group showed a significant increase in root length and root thickness compared with the apexification group (P < .05). In the RET group, the cases caused by dens evaginatus achieved increased root length and root thickness compared with those caused by trauma (P < .05). RET and apexification achieved a comparable outcome in regard to the resolution of symptoms and apical healing. RET showed a better outcome than apexification regarding increased root thickness and root length. The etiology had an impact on the outcome of RET. Dens evaginatus cases showed better prognoses than trauma cases after RET. Copyright © 2017 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  12. Value of a Community-Based Medication Management Review Service in Jordan: A Prospective Randomized Controlled Study.

    PubMed

    Basheti, Iman A; Tadros, Odate K I; Aburuz, Salah

    2016-10-01

    To assess the impact of a medication management review (MMR) service on treatment-related problems (TRPs) and certain clinical outcomes in outpatients. Prospective randomized controlled study. Two community pharmacies in Amman, Jordan. A total of 160 people who visited the two community pharmacies between September 2009 and June 2010. Patients were randomized into two groups: intervention (82 patients) and control (78 patients) groups. The clinical pharmacist conducted a baseline assessment MMR for patients in both groups to determine the prevalence and type of TRPs; however, recommendations regarding the identified TRPs were only submitted to the physicians of patients in the intervention group. All patients were followed for an average of 3.39 months after their baseline visit to the pharmacy. The impact of the MMR service for the intervention group was assessed by evaluating the outcomes of the recommendations submitted by the clinical pharmacist to resolve the identified TRPs, physicians' acceptance of the recommended interventions, and the effect of the intervention on certain clinical outcomes: blood glucose levels, blood pressure, and triglyceride levels. Follow-up assessment of the control group included evaluating the outcomes of the identified TRPs (identified and corrected by physicians without any input from the clinical pharmacist) and comparing glucose level, blood pressure, and triglyceride-level results with baseline values. No significant differences in mean number of medical conditions (3.7 vs 3.42, p=0.134), mean number of medications (4.51 vs 4.96, p=0.135), or mean number of TRPs per patient (5.55 vs 5.17, p=0.42) were observed at baseline in the intervention group versus the control group. Follow-up results revealed a high acceptance rate of recommendations by the physicians (94%). Regarding outcomes of TRPs, almost 70% of the identified TRPs in the intervention group were resolved or improved compared with 2% in the control group (p<0

  13. [A prospective multicenter randomized controlled clinical study on the efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution].

    PubMed

    Lu, Quan

    2010-03-01

    To evaluate efficacy and safety of Guaifenesin compound pseudoephedrine hydrochloride oral solution for the treatment of cough, expectoration, nasal congestion and runny nose in children. This was a prospective multicenter randomized single-blind, parallel-controlled clinical study. A total of 10 centers participated in this study, the actual number of cases in line with the program was 412, of whom 205 cases in trial group were treated with Guaifenesin compound pseudoephedrine hydrochloride oral solution, and 207 cases in control group with ambroxol hydrochloride oral solution, treatment of both groups persisted for 7 days. The improvement rate of each single symptom and the combined symptoms and the overall effective rate were compared between the two groups. The adverse drug reactions and compliance were assessed as well. The treatment of both groups showed efficacy. Except sputum stickiness, the improvement of all symptoms in trial group was superior to that in the control group on the 3rd day after treatment (P < 0.05) and except nasal congestion, the efficacy in all the other symptoms of trial group was better than that in the control group as well on the 7th day (P < 0.01). The improvement rate for combined symptoms of Guaifenesin compound pseudoephedrine hydrochloride oral solution was 82.9% and the overall efficacy rate was 89.3%. Guaifenesin compound Pseudoephedrine hydrochloride oral solution had higher compliance and its adverse event rate was merely 0.92%. Guaifenesin compound pseudoephedrine hydrochloride oral solution showed significant efficacy and safety in children for treatment of cough, expectoration, nasal congestion and runny nose caused by common cold or acute tracheobronchitis.

  14. 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.

  15. 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

  16. 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.

  17. 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

  18. 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

  19. 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.

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

    PubMed

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

    2016-03-01

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

  1. Comparison of Incidence of hypoxia during modified rapid sequence induction and an alternative technique: a prospective randomized controlled trial

    PubMed Central

    Sun, Ji; Li, Xing-Huan; Zuo, Yun-Xia

    2015-01-01

    Background: We evaluated the effects and safety of an alternative technique for rapid sequence intubation in children predicting to have high risk of pulmonary aspiration in this prospective, randomized, placebo-controlled study. Methods: One hundred sixty-five children predicting to have high risk of pulmonary aspiration were randomly allocated to spontaneous breathing maintained induction and intubation group (Group S) and the modified rapid sequence group (Group C). The primary outcome was the incidence of hypoxemia around the intubation period, which was defined as SpO2<90% at any time during the induction and 10 min after the endotracheal intubation. Secondary outcomes included the incidence of pulmonary aspiration, gastroesophageal reflux and other major adverse events associated with the induction and intubation. Results: There were no differences in the incidence of hypoxemia around the intubation period between Group C and Group S; 25.9% vs. 14.8% (P=0.079). The incidence of severe hypoxemia appeared higher in Group C than Group S but not statistical significance, 6.2% vs. 2.5% (P=0.246). Simultaneously, gastroesophageal reflux (upper esophageal pH≤4) was detected in 4.93% children in Group C and 2.47% in group S, which was not significantly different between the two groups (P=0.552). There were no witnessed aspirations in all subjects. Conclusion: Sevoflurane based deep sedation with spontaneous respiration maintained technique is not superior to modified rapid sequence induction but can be an alternative technique for anesthesia induction for those predicting to have high risk of aspiration in children. PMID:26629138

  2. 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

  3. Efficacy and safety of pamidronate in Modic type 1 changes: study protocol for a prospective randomized controlled clinical trial

    PubMed Central

    2014-01-01

    Background Erosive degenerative disc disease, also known as Modic type 1 changes, is usually characterized by low back pain with an inflammatory pain pattern, as seen in spondyloarthropathies. Intravenous pamidronate has proven to be effective in patients with ankylosing spondylitis who are refractory to nonsteroidal antiinflammatory drugs, and in painful bone diseases in general, such as Paget’s disease, fibrous dysplasia or vertebral fractures. We therefore hypothesize that pamidronate would be effective in treating low back pain associated with Modic type 1 changes. Methods/Design This study, called PEPTIDE (short for the French title “Etude Prospective sur l’Efficacité et la tolérance du PamidronaTe dans les dIscopathies Degeneratives Erosives”), will be a double-blind, randomized, placebo-controlled, parallel group, phase two clinical trial. A total of 48 patients will be recruited. These patients will be randomly assigned to one of the two groups, with 24 patients in each group: one group will be given pamidronate and the other a placebo. Pamidronate will be administered at a dose of 90 mg per day for two days consecutively, and every patient, irrespective of treatment group, will be given paracetamol to maintain blinding by preventing drug-induced fever. The primary outcome measure is a between-group difference of 30 points on a 100 mm Visual Analogue Scale (VAS) at three months. Secondary outcome measures are improvement in functional status and the drug’s safety. Primary and secondary outcome measures will be assessed at each visit (inclusion, at six weeks, three months, and six months). If the primary goal is not attained, the patient will be offered a rigid or semi-rigid back brace, irrespective of the treatment group. Discussion To date, only local treatments, for example intradiscal corticosteroid therapy, lumbar arthrodesis or back braces have been studied in randomized, controlled trials, with controversial results. This trial is

  4. The effects of parental presence in the postanesthetic care unit on children's postoperative behavior: a prospective, randomized, controlled study.

    PubMed

    Lardner, David R; Dick, Bruce D; Crawford, Susan

    2010-04-01

    The effects on children of parental presence in the postanesthesia care unit (PACU) have not been extensively studied. The few published studies are retrospective, nonrandomized, or lack adequate controls. They suggest that parental presence in the PACU decreases crying and negative behavior change postoperatively. We performed this prospective, randomized, controlled study to determine whether the presence of a parent affected crying behaviors in the PACU and behavior change 2 weeks postoperatively. Randomly selected patients, aged 2.0 to 8 years 11 months, ASA physical status I or II, and scheduled for elective outpatient surgery with an anticipated PACU stay of >10 minutes were randomly assigned to the parent present group (n = 150) or parent absent group (n = 150) in the PACU. All parents underwent the same preparation program. Reunification occurred once children's eyes had opened for the parent present group. In the PACU, crying was scored each minute after eye opening using a 5-point scale. Negative behavior change 2 weeks after discharge was determined using the Post Hospitalization Behavior Questionnaire. Because the anesthesia technique to be used was not determined a priori, data on the technique used were collected to ensure that groups were similar. Multiple and logistic regression techniques were used to determine predictors of crying in the PACU and behavior change 2 weeks postoperatively. Parental presence in the PACU made no difference in crying in the PACU. Negative behavior change 2 weeks postoperatively occurred more frequently in the parent absent group than the parent present group (45.8% vs 29.3%; P = 0.007). Multiple regression identified the following significant factors as predictive of larger proportion of time spent crying in the PACU (R(2) = 0.256, F[5, 273] = 15.66, P < 0.001): age <5 years (P < 0.001) and higher Children's Hospital of Eastern Ontario Pain Scale score at 15 minutes after arrival in day surgery (P < 0.001). Parental

  5. Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial.

    PubMed

    Hannemann, Pascal; Göttgens, Kevin W A; van Wely, Bob J; Kolkman, Karel A; Werre, Andries J; Poeze, Martijn; Brink, Peter R G

    2011-05-06

    The scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%), non-union (5-21%) and early osteo-arthritis (up to 32%) which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences.Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid. This is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning).Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory.Study parameters are clinical consolidation, radiological consolidation evaluated by CT-scanning, functional

  6. 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

  7. CT-guided liver biopsy with electromagnetic tracking: results from a single-center prospective randomized controlled trial.

    PubMed

    Kim, Edward; Ward, Thomas J; Patel, Rahul S; Fischman, Aaron M; Nowakowski, Scott; Lookstein, Robert A

    2014-12-01

    The purpose of this study is to evaluate the effectiveness of electromagnetic tracking in assisting CT-guided liver biopsies. This was a single-center prospective randomized controlled trial comparing nonfluoroscopic CT-guided liver biopsy using an advance-and-scan technique with and without electromagnetic tracking. Fifty patients with a liver lesion referred for biopsy (women, 52%; mean age, 59.7 years; mean lesion size, 3.6 cm) were enrolled in the study and were randomly assigned to either arm. The primary and secondary objectives were to assess and quantify differences in the number of intraprocedural scans, cumulative effective radiation dose, number of needle manipulations, and procedure time from skin-stick to the target lesion with and without assistance. Electromagnetic tracking significantly decreased the number of scans, effective radiation dose, number of manipulations per procedure, and time from skin-stick to the target lesion. The ratio of the number of scans (electromagnetic tracking to control) was 0.55 (95% CI, 0.42-0.73; p<0.0001). The mean difference in effective radiation dose (electromagnetic tracking-control) was -4.7 mSv (95% CI, -7.01 to -2.44 mSv; p=0.0001), and the median difference was -5.1 mSv (95% CI, -7.01 to -3.56 mSv; p<0.0001). The ratio of the number of manipulations (electromagnetic tracking to control) was 0.36 (95% CI, 0.24-0.54; p<0.0001). The mean difference for the time from skin-stick to the target lesion was -247.6 seconds (95% CI, -394.34 to -100.83 seconds; p=0.0014) and the median difference was -253.0 seconds (95% CI, -325.00 to -124.00 seconds; p=0.0001). Electromagnetic tracking assistance has the potential to decrease the number of intraprocedural CT scans and needle manipulations and to reduce patient radiation dose during CT-guided liver biopsy.

  8. Use of cryo-banked oocytes in an ovum donation programme: a prospective, randomized, controlled, clinical trial.

    PubMed

    Cobo, Ana; Meseguer, Marcos; Remohí, José; Pellicer, Antonio

    2010-09-01

    An efficient oocyte cryopreservation method is mandatory to establish a successful egg-banking programme. Although there are increasing reports showing good clinical outcomes after oocyte cryopreservation, there is still a lack of large controlled studies evaluating the effectiveness of oocyte cryo-banking. In this study, we aimed to compare the outcome of vitrified-banked oocytes with the gold standard procedure of employing fresh oocytes. A randomized, prospective, triple-blind, single-centre, parallel-group controlled-clinical trial (NCT00785993), including 600 recipients (alpha = 0.05 and power of 80% for sample-size calculation) selected among 1032 eligible patients from November 2008 to September 2009, was designed to compare the outcome of vitrified-banked oocytes with the gold standard procedure of employing fresh oocytes. The study was designed to establish the superiority of the ongoing pregnancy rate (OPR) of fresh oocytes over that of vitrified oocytes, by performing a likelihood ratio test in a logistic regression analysis expressed as odds ratio (OR) with 95% confidence interval (CI). A limit of 0.66 for OR of vitrified versus fresh groups was defined to set up a possible conversion from superiority to non-inferiority. Randomization was performed 1:1 based on a computer randomization list in vitrification (n = 300) or fresh groups (n = 300). The primary end-point was the OPR per randomized patient i.e. intention-to-treat population (ITT). Secondary end-points were clinical pregnancy (CPR), implantation (IR) and fertilization rates, respectively. Additionally, embryo developmental characteristics were recorded. There were no differences in donor ovarian stimulation parameters, demographic baseline characteristics for donors and recipients, ovum donation indications or male factor distribution between groups (NS). The OPR per ITT was 43.7 and 41.7% in the vitrification and fresh groups, respectively. The OR of OPR was 0.921 in favour of the

  9. Perioperative ketorolac in high risk breast cancer patients. Rationale, feasibility and methodology of a prospective randomized placebo-controlled trial.

    PubMed

    Forget, Patrice; Berlière, Martine; van Maanen, Aline; Duhoux, Francois P; Machiels, Jean-Pascal; Coulie, Pierre G; Bouche, Gauthier; De Kock, Marc

    2013-10-01

    Ketorolac, a NSAID routinely used during surgery proposed to have anticancer effects, is a promising way to improve postoperative oncological outcome. This effect may be particularly prominent in patients with elevated preoperative inflammatory scores, like the neutrophil:lymphocyte ratio. In this paper, we describe the rationale, the preliminary analyses in our patients, the feasibility and the methodology of a prospective randomized trial called "Ketorolac in Breast Cancer trial" (KBCt) (NCT01806259). Copyright © 2013 Elsevier Ltd. All rights reserved.

  10. Therapeutic comparison between treatments for Vulvar Lichen Sclerosus: study protocol of a randomized prospective and controlled trial.

    PubMed

    Belotto, Renata A; Chavantes, Maria Cristina; Tardivo, João Paulo; Euzébio Dos Santos, Roberto; Fernandes, Raquel Civolani Marques; Horliana, Anna Carolina Ratto Tempestini; Pavani, Christiane; Teixeira da Silva, Daniela Fátima

    2017-08-10

    Vulvar lichen sclerosus (VLS) is a lymphocyte-mediated disease of unknown etiology that can cause intense itching as well stenosis, hindering the evacuation and urination. It can also limit the sex life due to severe local pruritus, pain and dyspareunia (pain during sexual intercourse). The standard treatment for this disease is the use of topical corticosteroids to reduce the clinical symptoms and to try to increase disease-free intervals. Photodynamic therapy (PDT), a treatment that associates a light radiation with a photosensitizing agent and photobiomodulation (PBM) are therapies that can promote effective immunomodulatory responses at the application site by means of photophysical and photochemical phenomena from the molecular to the systemic level, which promote their use in chronic dermatoses. The aim is to compare the effects of PDT, PBM, and topical corticosteroid in VLS evaluating clinical, histological, immunohistochemical and spectroscopic responses. The study is prospective, randomized and controlled, in a population of 60 women with histological diagnoses of VLS. There will be 3 treatments groups: PDT, PBM and topical corticosteroid (control group), where will be allocated by randomization 20 patients in each one. The clinical course will be monitored by measuring local temperature, itching, atrophy, and the area of the lesion. Histologically, the slides will be classified and will have the ordering of collagen fibers quantified. Immunohistochemical analysis will be done using the markers IFN-γ, TGF-β, CD4, CD8, IL-1, p53 and Ki-67. Finally, the spectroscopic evaluation will be done by reflectance. Descriptive and inferential statistical analyses will be conducted to compare the groups and make associations between different responses. The study is an open-label for patients with active symptomatic disease with a period of 1 year follow-up to determine the rate of recurrence in each groups. The immunological effects of PDT and PBM are described by

  11. A prospective randomized controlled trial assessing the efficacy of adjunctive hyperbaric oxygen therapy in the treatment of hidradenitis suppurativa.

    PubMed

    Yildiz, Hamza; Senol, Levent; Ercan, Erdinc; Bilgili, Memet Ersan; Karabudak Abuaf, Ozlem

    2016-02-01

    Hyperbaric oxygen therapy (HBOT) appears to enhance wound healing, increase bactericidal activity, and act synergistically with a number of antibiotics. The aim of this study was to evaluate the efficacy of HBOT as an adjunctive therapy in patients with hidradenitis suppurativa (HS) treated with a combination of systemic rifampicin and clindamycin. The study was a prospective, single-center, single-dose, open-label, randomized controlled clinical study of HBOT in patients with moderate to severe HS. Efficacy was measured by modified Sartorius score (SS), HS Severity Index (HSSI), Dermatology Life Quality Index (DLQI), and a visual analog scale (VAS) before treatment and after the completion of 4 and 10 weeks of treatment. Erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP) levels were also measured. Forty-three patients were enrolled in the study. More patients in the HBOT than in the control group showed a decrease of ≥50% from baseline parameters at week 10 for SS (100%), HSSI (100%), DLQI (95.5%), VAS (100%), ESR (100%), and CRP (72.7%). Clinically and statistically significant improvements from baseline were observed at 4 and 10 weeks in HSSI (P = 0.009 at both), SS (P = 0.021 at both), and DLQI (P = 0.044 at week 4, P = 0.009 at week 10). Adjunctive HBOT was considered to be effective in significantly improving antibiotic treatment of HS. The treatment was well tolerated, and no unexpected safety issues were identified.

  12. Tranexamic Acid Reduces Blood Loss and Transfusion in Patients Undergoing Total Knee Arthroplasty without Tourniquet: A Prospective Randomized Controlled Trial

    PubMed Central

    Bidolegui, Fernando; Arce, Guillermo; Lugones, Alfonso; Pereira, Sebastián; Vindver, Gabriel

    2014-01-01

    Introduction : Blood loss during and after total knee arthroplasty (TKA) can lead to substantial morbidity and the need for blood transfusions. There are several methods to minimize blood loss and to decrease transfusion rates in patients undergoing TKA. Tranexamic acid is an antifibrinolytic agent with known efficacy for achieving these goals. Currently, many surgeons are performing TKA without the use of tourniquet. Consequently, the aim of the study is to evaluate whether tranexamic acid reduces blood loss during and after TKA without the adjunctive use of above-the-knee tourniquet. Methods : We performed a prospective randomized controlled trial (1:1 fashion) on the use of tranexamic acid versus placebo in 50 patients undergoing TKA (without tourniquet). The treatment group received two (preoperative and postoperative) 15 mg/kg doses. The primary endpoint was blood transfusion rate. We collected data about demographic and procedural characteristics, hemoglobin and hematocrit values, drain blood loss at 24 hours as well as adverse events. Results : There were no transfusions in the treatment group, whereas 32% of the control group required transfusion (p<0.01). The treatment group had higher hematocrit and hemoglobin levels at 24, 48 and 72 hours after surgery (all p<0.01) and lower drain loss at 24hours (363.4±141 vs 626±260ml, p=<0,001). There were no in-hospital or six-month thromboembolic complications. Discussion : A double-dose of tranexamic acid was safe and effective, reducing blood loss and preventing the need of blood transfusion in patients undergoing TKA without above-the-need tourniquet. PMID:25132872

  13. Effect of Continuous Motion Parameter Feedback on Laparoscopic Simulation Training: A Prospective Randomized Controlled Trial on Skill Acquisition and Retention.

    PubMed

    Buescher, Julian Frederik; Mehdorn, Anne-Sophie; Neumann, Philipp-Alexander; Becker, Felix; Eichelmann, Ann-Kathrin; Pankratius, Ulrich; Bahde, Ralf; Foell, Daniel; Senninger, Norbert; Rijcken, Emile

    2017-08-29

    To investigate the effect of motion parameter feedback on laparoscopic basic skill acquisition and retention during a standardized box training curriculum. A Lap-X Hybrid laparoscopic simulator was designed to provide individual and continuous motion parameter feedback in a dry box trainer setting. In a prospective controlled trial, surgical novices were randomized into 2 groups (regular box group, n = 18, and Hybrid group, n = 18) to undergo an identical 5-day training program. In each group, 7 standardized tasks on laparoscopic basic skills were completed twice a day on 4 consecutive days in fixed pairs. Additionally, each participant performed a simulated standard laparoscopic cholecystectomy before (day 1) and after training (day 5) on a LAP Mentor II virtual reality (VR) trainer, allowing an independent control of skill progress in both groups. A follow-up assessment of skill retention was performed after 6 weeks with repetition of both the box tasks and VR cholecystectomy. Muenster University Hospital Training Center, Muenster, Germany. Medical students without previous surgical experience. Laparoscopic skills in both groups improved significantly during the training period, measured by the overall task performance time. The 6 week follow-up showed comparable skill retention in both groups. Evaluation of the VR cholecystectomies demonstrated significant decrease of operation time (p < 0.01), path length of the left and right instrument, and the number of movements of the left and right instruments for the Hybrid group (all p < 0.001), compared to the box group. Similar results were found at the assessment of skill retention. Simulation training on both trainers enables reliable acquisition of laparoscopic basic skills. Furthermore, individual and continuous motion feedback improves laparoscopic skill enhancement significantly in several aspects. Thus, training systems with feedback of motion parameters should be considered to achieve long-term improvement of

  14. Continuous Ropivacaine Subfascial Wound Infusion Compared With Intrathecal Morphine for Postcesarean Analgesia: A Prospective, Randomized Controlled, Double-Blind Study.

    PubMed

    Lalmand, Manon; Wilwerth, Madeleine; Fils, Jean-François; Van der Linden, Philippe

    2017-09-01

    After cesarean delivery, postoperative pain management allows early rehabilitation and helps prevent postpartum depression and chronic pain. Our present prospective, randomized controlled, double-blind study assessed the duration and effect of intrathecal analgesia and continuous ropivacaine wound infiltration versus a control group after cesarean delivery. The primary outcome was analgesia duration, defined as time to first morphine request. Secondary outcomes were cumulative postoperative morphine consumption, number of patients who did not require IV morphine, incidence of adverse effects, and time to first ambulation. A total of 192 full-term parturients undergoing elective cesarean delivery were randomly allocated into 3 groups (control, morphine, and catheter). All patients received spinal anesthesia with 10 mg bupivacaine 0.5% hyperbaric bupivacaine (2 mL) + 5 μg of sufentanil (1 mL) and a multiholed catheter inserted into the wound. In the control group, NaCl 0.9% was administered intrathecally (0.1 mL) and through the catheter. The morphine group received 100 μg morphine (0.1 mL) intrathecally and NaCl 0.9% infused through the wound catheter. The catheter group received 0.1 mL NaCl 0.9% intrathecally and ropivacaine 0.2% infused in the catheter. Each patient received a 15-mL bolus of the dedicated solution through the catheter, which was connected to an elastomeric pump infusor delivering the same solution at a rate of 10 mL/h for 30 hours. All patients also received multimodal analgesia including acetaminophen and diclofenac. Analgesia duration was defined as the time from spinal injection (T0) to first IV morphine requirement (T1) administered via a patient-controlled IV analgesia pump. Statistical data analyses included use of the Kruskal-Wallis rank-sum test followed by the post hoc Tukey test and χ test. The duration of postoperative analgesia was increased with intrathecal morphine (380 minutes; 215-1527) and ropivacaine wound infusion (351

  15. Cardiovascular Effects of Dietary Salt Intake in Aged Healthy Cats: A 2-Year Prospective Randomized, Blinded, and Controlled Study

    PubMed Central

    Chetboul, Valérie; Reynolds, Brice Stéphane; Trehiou-Sechi, Emilie; Nguyen, Patrick; Concordet, Didier; Sampedrano, Carolina Carlos; Testault, Isabelle; Elliott, Jonathan; Abadie, Jérôme; Biourge, Vincent; Lefebvre, Hervé Pierre

    2014-01-01

    High salt dry expanded diets are commercially available for cats to increase water intake and urine volume, as part of the prevention or treatment of naturally occurring urinary stone formation (calcium oxalates and struvites). However, chronic high salt intake may have potential cardiovascular adverse effects in both humans, especially in aging individuals, and several animal models. The objective of this prospective, randomized, blinded, and controlled study was to assess the long-term cardiovascular effects of high salt intake in healthy aged cats. Twenty healthy neutered cats (10.1±2.4 years) were randomly allocated into 2 matched groups. One group was fed a high salt diet (3.1 g/Mcal sodium, 5.5 g/Mcal chloride) and the other group a control diet of same composition except for salt content (1.0 g/Mcal sodium, 2.2 g/Mcal chloride). Clinical examination, systolic and diastolic arterial blood pressure measurements, standard transthoracic echocardiography and conventional Doppler examinations were repeatedly performed on non-sedated cats by trained observers before and over 24 months after diet implementation. Radial and longitudinal velocities of the left ventricular free wall and the interventricular septum were also assessed in systole and diastole using 2-dimensional color tissue Doppler imaging. Statistics were performed using a general linear model. No significant effect of dietary salt intake was observed on systolic and diastolic arterial blood pressure values. Out of the 33 tested imaging variables, the only one affected by dietary salt intake was the radial early on late diastolic velocity ratio assessed in the endocardium of the left ventricular free wall, statistically lower in the high salt diet group at 12 months only (P = 0.044). In conclusion, in this study involving healthy aged cats, chronic high dietary salt intake was not associated with an increased risk of systemic arterial hypertension and myocardial dysfunction, as observed in some

  16. Nonnutritive sweeteners and cardiometabolic health: a systematic review and meta-analysis of randomized controlled trials and prospective cohort studies.

    PubMed

    Azad, Meghan B; Abou-Setta, Ahmed M; Chauhan, Bhupendrasinh F; Rabbani, Rasheda; Lys, Justin; Copstein, Leslie; Mann, Amrinder; Jeyaraman, Maya M; Reid, Ashleigh E; Fiander, Michelle; MacKay, Dylan S; McGavock, Jon; Wicklow, Brandy; Zarychanski, Ryan

    2017-07-17

    Nonnutritive sweeteners, such as aspartame, sucralose and stevioside, are widely consumed, yet their long-term health impact is uncertain. We synthesized evidence from prospective studies to determine whether routine consumption of non-nutritive sweeteners was associated with long-term adverse cardiometabolic effects. We searched MEDLINE, Embase and Cochrane Library (inception to January 2016) for randomized controlled trials (RCTs) that evaluated interventions for nonnutritive sweeteners and prospective cohort studies that reported on consumption of non-nutritive sweeteners among adults and adolescents. The primary outcome was body mass index (BMI). Secondary outcomes included weight, obesity and other cardiometabolic end points. From 11 774 citations, we included 7 trials (1003 participants; median follow-up 6 mo) and 30 cohort studies (405 907 participants; median follow-up 10 yr). In the included RCTs, nonnutritive sweeteners had no significant effect on BMI (mean difference -0.37 kg/m(2); 95% confidence interval [CI] -1.10 to 0.36; I(2) 9%; 242 participants). In the included cohort studies, consumption of nonnutritive sweeteners was associated with a modest increase in BMI (mean correlation 0.05, 95% CI 0.03 to 0.06; I(2) 0%; 21 256 participants). Data from RCTs showed no consistent effects of nonnutritive sweeteners on other measures of body composition and reported no further secondary outcomes. In the cohort studies, consumption of nonnutritive sweeteners was associated with increases in weight and waist circumference, and higher incidence of obesity, hypertension, metabolic syndrome, type 2 diabetes and cardiovascular events. Publication bias was indicated for studies with diabetes as an outcome. Evidence from RCTs does not clearly support the intended benefits of nonnutritive sweeteners for weight management, and observational data suggest that routine intake of nonnutritive sweeteners may be associated with increased BMI and cardiometabolic risk. Further

  17. Erectile dysfunction and hormonal imbalance in morbidly obese male is reversed after gastric bypass surgery: a prospective randomized controlled trial.

    PubMed

    Reis, L O; Favaro, W J; Barreiro, G C; de Oliveira, L C; Chaim, E A; Fregonesi, A; Ferreira, U

    2010-10-01

    The effects of weight loss on erectile function and hormones have not been well studied. The aim of this study was to measure the degree to which sexual function and in particular erectile function and hormonal environment change after substantial weight loss, surgically and non-surgically induced in the morbidly obese male in a prospective randomized long-term controlled trial. Furthermore, how surgery makes a difference when treating morbidly obese men was envisaged in this context. We prospectively studied 20 morbidly obese men for 24 months, divided into two groups: group A included 10 patients who underwent life style modifications (exercise and diet) for 4 months and subsequently gastric bypass, and another 10 patients in group B were kept on weekly follow-up. None of the men were taking phosphodiesterase type-5 inhibitors. All patients underwent International Index of Erectile Function (IIEF)-5 questionnaire, serum oestradiol, prolactin (PRL), luteinizing (LH) and follicle-stimulating (FSH) hormones, free and total testosterone (FT and TT) at baseline (time 0), surgery - 4 months latter baseline (time 1) and final evaluation - 24 months (time 2). From times 0 to 1, group A presented a mean body mass index (BMI) reduction of 12.6 (p < 0.0001), whereas group B, 2.1 (p > 0.05). The BMI reductions between times 0 and 2 were 24.7 (p < 0.0001) and 0.7 (p > 0.05) for groups A and B respectively. BMI average between the two groups was similar at time 0 (p = 0.2142), and different at times 1 (p = 0.0033) and 2 (p < 0.0006). Increase in IIEF-5 score (p = 0.0469), TT (p = 0.0349) and FSH levels (p = 0.0025), and reduction in PRL level (p < 0.0001) were observed in group A from times 0 to 2 and 1 to 2. There were no changes from times 0 to 1. Comparing groups A and B at time 2, IIEF-5, TT and FT increased significantly in group A (p = 0.0224, 0.0043 and 0.0149 respectively). Surgery-induced weight loss increased erectile function quality measured by IIEF-5 questionnaire

  18. Nonnutritive sweeteners and cardiometabolic health: a systematic review and meta-analysis of randomized controlled trials and prospective cohort studies

    PubMed Central

    Azad, Meghan B.; Abou-Setta, Ahmed M.; Chauhan, Bhupendrasinh F.; Rabbani, Rasheda; Lys, Justin; Copstein, Leslie; Mann, Amrinder; Jeyaraman, Maya M.; Reid, Ashleigh E.; Fiander, Michelle; MacKay, Dylan S.; McGavock, Jon; Wicklow, Brandy; Zarychanski, Ryan

    2017-01-01

    BACKGROUND Nonnutritive sweeteners, such as aspartame, sucralose and stevioside, are widely consumed, yet their long-term health impact is uncertain. We synthesized evidence from prospective studies to determine whether routine consumption of non-nutritive sweeteners was associated with long-term adverse cardiometabolic effects. METHODS We searched MEDLINE, Embase and Cochrane Library (inception to January 2016) for randomized controlled trials (RCTs) that evaluated interventions for nonnutritive sweeteners and prospective cohort studies that reported on consumption of non-nutritive sweeteners among adults and adolescents. The primary outcome was body mass index (BMI). Secondary outcomes included weight, obesity and other cardiometabolic end points. RESULTS From 11 774 citations, we included 7 trials (1003 participants; median follow-up 6 mo) and 30 cohort studies (405 907 participants; median follow-up 10 yr). In the included RCTs, nonnutritive sweeteners had no significant effect on BMI (mean difference −0.37 kg/m2; 95% confidence interval [CI] −1.10 to 0.36; I2 9%; 242 participants). In the included cohort studies, consumption of nonnutritive sweeteners was associated with a modest increase in BMI (mean correlation 0.05, 95% CI 0.03 to 0.06; I2 0%; 21 256 participants). Data from RCTs showed no consistent effects of nonnutritive sweeteners on other measures of body composition and reported no further secondary outcomes. In the cohort studies, consumption of nonnutritive sweeteners was associated with increases in weight and waist circumference, and higher incidence of obesity, hypertension, metabolic syndrome, type 2 diabetes and cardiovascular events. Publication bias was indicated for studies with diabetes as an outcome. INTERPRETATION Evidence from RCTs does not clearly support the intended benefits of nonnutritive sweeteners for weight management, and observational data suggest that routine intake of nonnutritive sweeteners may be associated with

  19. Tramadol vs dexmedetomidine for emergence agitation control in pediatric patients undergoing adenotonsillectomy with sevoflurane anesthesia: prospective randomized controlled clinical study.

    PubMed

    Bedirli, Nurdan; Akçabay, Mehmet; Emik, Ulku

    2017-03-11

    This study was designed to compare the efficacy of an intraoperative single dose administration of tramadol and dexmedetomidine on hemodynamics and postoperative recovery profile including pain, sedation, emerge reactions in pediatric patients undergoing adenotonsillectomy with sevoflurane anesthesia. Seventy-seven patient, aged 2-12, undergoing adenotonsillectomy with sevoflurane anesthesia was enrolled in this study. Patients were randomly assigned to receive either intravenous 2 mg/kg tramadol (Group T; n = 39) or 1 μg/kg dexmedetomidine (Group D; n = 38) after intubation. Heart rates (HR), mean arterial pressure (MAP) were recorded before induction, at induction and every 5 min after induction. Observational pain scores (OPS), pediatric anesthesia emergence delirium (PAED) scores, percentage of patients with OPS ≥ 4 or PAED scale items 4 or 5 with an intensity of 3 or 4, and Ramsay sedation scores (RSS) were recorded on arrival to the postoperative care unit (PACU) and at 5, 10, 15, 30, 45, 60 min. Extubation time and time to reach Alderete score > 9 were recorded. Dexmedetomidine significantly decreased the HR and MAP 10 and 15 min after induction; increased the RSS 15, 30 and 45 min after arrival to PACU. OPS and PAED scores and percentage of patients with OPS ≥ 4 or PAED scale items 4 or 5 with an intensity of 3 or 4 in both groups did not show any significant difference. Extubation time and time to have Alderete score > 9 was significantly longer in Group D. Both tramadol and dexmedetomidine were effective for controlling pain and emergence agitation. When compared with tramadol intraoperative hypotension, bradycardia and prolonged sedation were problems related with dexmedetomidine administration. Retrospectively registered, registration number: ISRCTN89326952 registration date: 14.07.2016.

  20. Non-randomized controlled prospective study on perioperative levels of stress and dysautonomia during dental implant surgery.

    PubMed

    Morino, Miyuki; Masaki, Chihiro; Seo, Yoshinori; Mukai, Chisato; Mukaibo, Taro; Kondo, Yusuke; Shiiba, Shunji; Nakamoto, Tetsuji; Hosokawa, Ryuji

    2014-07-01

    The purpose of this study was to compare pre- and postoperative autonomic activities and changes in salivary stress biomarkers between patients who received only local anesthesia and those who received local anesthesia together with intravenous sedation in dental implant surgery. A total of 21 patients were enrolled in this non-randomized controlled prospective study; 7 subjects underwent implant surgery under local anesthesia with intravenous sedation and 14 subjects underwent surgery under only local anesthesia. Stress was evaluated by measuring salivary levels of chromogranin A (CgA) and a spectral analysis of heart rate variability (HRV) at baseline (on a day other than the day of surgery), 1h preoperatively, and 1h postoperatively. HRV analysis yields low- (LF) and high-frequency (HF) components, the LF/HF ratio, and the component coefficient of variance (CCV[HF]), which provide indices of sympathetic and parasympathetic regulatory activity. CgA levels were significantly higher (p<0.05) at baseline in patients who received sedation than those who did not, but CgA levels did not differ prior to surgery. Also, the values of most parameters, including LF, HF, LF/HF (L/H), and CCV(HF), did not significantly differ between groups or among the three time points. Only ΔL/H and ΔCCV(HF) were significantly lower (p<0.05) at 1h preoperatively in patients who received sedation than those who received only local anesthesia. CgA levels were high in both groups immediately before surgery, and thus CgA values immediately before surgery may not be a reliable indicator of the need for intravenous sedation. Also, spectral analysis of HRV, especially ΔL/H and ΔCCV(HF), could be useful for assessing tension and anxiety. Copyright © 2014. Published by Elsevier Ltd.

  1. The short-term efficacy of laser, brace, and ultrasound treatment in lateral epicondylitis: a prospective, randomized, controlled trial.

    PubMed

    Oken, Oznur; Kahraman, Yaşar; Ayhan, Figen; Canpolat, Sabahat; Yorgancioglu, Z Rezan; Oken, O Fuad

    2008-01-01

    The aims of this study were to evaluate the effects of low-level laser therapy (LLLT) and to compare these with the effects of brace or ultrasound (US) treatment in tennis elbow. The study design used was a prospective and randomized, controlled, single-blind trial. Fifty-eight outpatients with lateral epicondylitis (9 men, 49 women) were included in the trial. The patients were divided into three groups: 1) brace group-brace plus exercise, 2) ultrasound group-US plus exercise, and 3) laser group-LLLT plus exercise. Patients in the brace group used a lateral counterforce brace for three weeks, US plus hot pack in the ultrasound group, and laser plus hot pack in the LLLT group. In addition, all patients were given progressive stretching and strengthening exercise programs. Grip strength and pain severity were evaluated with visual analog scale (VAS) at baseline, at the second week of treatment, and at the sixth week of treatment. VAS improved significantly in all groups after the treatment and in the ultrasound and laser groups at the sixth week (p<0.05). Grip strength of the affected hand increased only in the laser group after treatment, but was not changed at the sixth week. There were no significant differences between the groups on VAS and grip strength at baseline and at follow-up assessments. The results show that, in patients with lateral epicondylitis, a brace has a shorter beneficial effect than US and laser therapy in reducing pain, and that laser therapy is more effective than the brace and US treatment in improving grip strength.

  2. Pimecrolimus cream 1% in erosive oral lichen planus--a prospective randomized double-blind vehicle-controlled study.

    PubMed

    Volz, T; Caroli, U; Lüdtke, H; Bräutigam, M; Kohler-Späth, H; Röcken, M; Biedermann, T

    2008-09-01

    Erosive oral lichen planus (EOLP) is a T-cell mediated inflammatory disease leading to severe pain and impairment. As current therapies are of limited efficacy, application of calcineurin inhibitors is considered to be a potential option. To investigate the efficacy of pimecrolimus cream 1% (Elidel) compared with vehicle cream in the treatment of EOLP. Twenty patients were enrolled in a prospective, double-blind, randomized, vehicle-controlled trial and assigned to either pimecrolimus or vehicle group. Study medication was applied for 30 days followed by 30 days of observation without therapy. In case of unresponsiveness, treatment was continued for 30 days with open-label pimecrolimus. EOLP was monitored on days 0, 30 and 60. Safety was assessed by patient documentation, measurement of pimecrolimus levels and blood counts. Within 30 days erosions cleared completely in seven of 10 patients treated with pimecrolimus and in two of 10 patients treated with vehicle. The clinical EOLP 'composite score' including mucosal erosions and pain sensation was significantly reduced in the pimecrolimus-treated group compared with vehicle (P = 0.025). In the three of 10 patients not responding to pimecrolimus, EOLP cleared after an additional 30 days of treatment with pimecrolimus. Following termination of the therapy, sustained remission of EOLP was detected in 83% of patients demonstrating long-lasting effects of pimecrolimus treatment. No severe adverse events were observed. In five patients pimecrolimus blood levels were detected, all of which stayed below 4 ng mL(-1). Pimecrolimus cream 1% effectively treats EOLP with long-lasting therapeutic effects and is therefore a promising therapeutic option for EOLP.

  3. A Pilot Prospective Randomized Control Trial Comparing Exercises Using Videogame Therapy to Standard Physical Therapy: 6 Months Follow-Up.

    PubMed

    Parry, Ingrid; Painting, Lynda; Bagley, Anita; Kawada, Jason; Molitor, Fred; Sen, Soman; Greenhalgh, David G; Palmieri, Tina L

    2015-01-01

    Commercially available, interactive videogames that use body movements for interaction are used clinically in burn rehabilitation and have been shown to facilitate functional range of motion (ROM) but their efficacy with burn patients has not yet been proven. The purpose of this pilot randomized control study was to prospectively compare planar and functional ROM, compliance, pain, enjoyment, and exertion in pediatric burn patients receiving two types of rehabilitation therapy. Seventeen school-aged children with 31 affected limbs who demonstrated limited shoulder ROM from burn injury were randomized to receive exercises using either standard therapy ROM activities (ST) or interactive videogame therapy (VGT). Patients received 3 weeks of the designated therapy intervention twice daily. They were then given a corresponding home program of the same type of therapy to perform regularly for 6 months. Standard goniometry and three-dimensional motion analysis during functional tasks were used to assess ROM. Measures were taken at baseline, 3 weeks, 3 months, and 6 months. Pain was measured before and after each treatment session during the 3-week intervention. There was no difference in compliance, enjoyment, or exertion between the groups. Patients in both the ST and VGT groups showed significant improvement in shoulder flexion (P < .001), shoulder abduction (P <.001), shoulder external rotation (P = .01), and elbow flexion (P = .004) ROM from baseline to 6 months as measured with goniometry. Subjects also showed significant gains in elbow flexion (P = .04) during hand to head and shoulder flexion (P = .04) during high reach. There was no difference in ROM gains between the groups. Within group comparison showed that the VGT group had significantly more recovery of ROM during the first 3 weeks than any other timeframe in the study, whereas ST had most gains at 3 months. There was a significant difference between the groups in the subjects' pain response. ST subjects

  4. Erythropoietin improves long-term neurological outcome in acute ischemic stroke patients: a randomized, prospective, placebo-controlled clinical trial.

    PubMed

    Tsai, Tzu-Hsien; Lu, Cheng-Hsien; Wallace, Christopher Glenn; Chang, Wen-Neng; Chen, Shu-Feng; Huang, Chi-Ren; Tsai, Nai-Wen; Lan, Min-Yu; Sung, Pei-Hsun; Liu, Chu-Feng; Yip, Hon-Kan

    2015-02-25

    Mortality and disability following ischemic stroke (IS) remains unacceptably high with respect to the conventional therapies. This study tested the effect of erythropoietin (EPO) on long-term neurological outcome in patients after acute IS. This study aimed to evaluate the safety and efficacy of two consecutive doses of EPO (5,000 IU/dose, subcutaneously administered at 48 hours and 72 hours after acute IS) on improving the 90-day combined endpoint of recurrent stroke or death that has been previously reported. A secondary objective was to evaluate the long-term (that is, five years) outcome of patients who received EPO. This was a prospective, randomized, placebo-controlled trial that was conducted between October 2008 and March 2010 in a tertiary referral center. IS stroke patients who were eligible for EPO therapy were enrolled into the study. The results showed that long-term recurrent stroke and mortality did not differ between group 1 (placebo-control; n = 71) and group 2 (EPO-treated; n = 71). Long-term Barthel index of <35 (defining a severe neurological deficit) was lower in group 2 than group 1 (P = 0.007). Multiple-stepwise logistic-regression analysis showed that EPO therapy was significantly and independently predictive of freedom from a Barthel index of <35 (P = 0.029). Long-term major adverse neurological event (MANE; defined as: death, recurrent stroke, or long-term Barthel index < 35) was lower in group 2 than group 1 (P = 0.04). Log-Rank test showed that MANE-free rate was higher in group 2 than group 1 (P = 0.031). Multiple-stepwise Cox-regression analysis showed that EPO therapy and higher Barthel Index at day 90 were independently predictive of freedom from long-term MANE (all P <0.04). EPO therapy significantly improved long-term neurological outcomes in patients after IS. ISRCTN71371114 . Registered 10 October 2008.

  5. Randomized prospective double-blind placebo-controlled study of dextrose prolotherapy for knee osteoarthritis with or without ACL laxity.

    PubMed

    Reeves, K D; Hassanein, K

    2000-03-01

    Use of prolotherapy (injection of growth factors or growth factor stimulators). Determine the effects of dextrose prolotherapy on knee osteoarthritis with or without anterior cruciate ligament (ACL) laxity. Prospective randomized double-blind placebo-controlled trial. Outpatient physical medicine clinic. Six months or more of pain along with either grade 2 or more joint narrowing or grade 2 or more osteophytic change in any knee compartment. A total of 38 knees were completely void of cartilage radiographically in at least 1 compartment. Three bimonthly injections of 9 cc of either 10% dextrose and .075% lidocaine in bacteriostatic water (active solution) versus an identical control solution absent 10% dextrose. The dextrose-treated joints then received 3 further bimonthly injections of 10% dextrose in open-label fashion. Visual analogue scale for pain and swelling, frequency of leg buckling, goniometrically measured flexion, radiographic measures of joint narrowing and osteophytosis, and KT1000-measured anterior displacement difference (ADD). All knees: Hotelling multivariate analysis of paired observations between 0 and 6 months for pain, swelling, buckling episodes, and knee flexion range revealed significantly more benefit from the dextrose injection (P = .015). By 12 months (6 injections) the dextrose-treated knees improved in pain (44% decrease), swelling complaints (63% decrease), knee buckling frequency (85% decrease), and in flexion range (14 degree increase). Analysis of blinded radiographic readings of 0- and 12-month films revealed stability of all radiographic variables except for 2 variables which improved with statistical significance. (Lateral patellofemoral cartilage thickness [P = .019] and distal femur width in mm [P = .021]. Knees with ACL laxity: 6-month (3 injection) data revealed no significant improvement. However, Hotelling multivariate analysis of paired values at 0 and 12 months for pain, swelling, joint flexion, and joint laxity in the

  6. Portable Video Media Versus Standard Verbal Communication in Surgical Information Delivery to Nurses: A Prospective Multicenter, Randomized Controlled Crossover Trial.

    PubMed

    Kam, Jonathan; Ainsworth, Hannah; Handmer, Marcus; Louie-Johnsun, Mark; Winter, Matthew

    2016-10-01

    Continuing education of health professionals is important for delivery of quality health care. Surgical nurses are often required to understand surgical procedures. Nurses need to be aware of the expected outcomes and recognize potential complications of such procedures during their daily work. Traditional educational methods, such as conferences and tutorials or informal education at the bedside, have many drawbacks for delivery of this information in a universal, standardized, and timely manner. The rapid uptake of portable media devices makes portable video media (PVM) a potential alternative to current educational methods. To compare PVM to standard verbal communication (SVC) for surgical information delivery and educational training for nurses and evaluate its impact on knowledge acquisition and participant satisfaction. Prospective, multicenter, randomized controlled crossover trial. Two hospitals: Gosford District Hospital and Wyong Hospital. Seventy-two nursing staff (36 at each site). Information delivery via PVM--7-minute video compared to information delivered via SVC. Knowledge acquisition was measured by a 32-point questionnaire, and satisfaction with the method of education delivery was measured using the validated Client Satisfaction Questionnaire (CSQ-8). Knowledge acquisition was higher via PVM compared to SVC 25.9 (95% confidence interval [CI] 25.2-26.6) versus 24.3 (95% CI 23.5-25.1), p = .004. Participant satisfaction was higher with PVM 29.5 (95% CI 28.3-30.7) versus 26.5 (95% CI 25.1-27.9), p = .003. Following information delivery via SVC, participants had a 6% increase in knowledge scores, 24.3 (95% CI 23.5-25.1) versus 25.7 (95% CI 24.9-26.5) p = .001, and a 13% increase in satisfaction scores, 26.5 (95% CI 25.1-27.9) versus 29.9 (95% CI 28.8-31.0) p < .001, when they crossed-over to information delivery via PVM. PVM provides a novel method for providing education to nurses that improves knowledge retention and satisfaction with the

  7. Perfluorocarbon-associated gas exchange (partial liquid ventilation) in respiratory distress syndrome: a prospective, randomized, controlled study.

    PubMed

    Leach, C L; Fuhrman, B P; Morin, F C; Rath, M G

    1993-09-01

    To determine the efficacy of perfluorocarbon-associated gas exchange (partial liquid ventilation) in respiratory distress syndrome. Prospective, randomized, controlled study. State University of New York at Buffalo, School of Medicine and Biomedical Sciences. Eleven premature lambs with respiratory distress syndrome, delivered by cesarean section. Five lambs were supported by conventional mechanical ventilation alone. Six lambs were switched to perfluorocarbon-associated gas exchange after 60 to 90 mins of conventional mechanical ventilation. Perfluorocarbon-associated gas exchange was accomplished by instilling a volume of liquid perfluorocarbon equivalent to normal functional residual capacity (30 mL/kg) into the trachea, performing 3 to 4 mins of tidal liquid ventilation, and, at end-expiration, with liquid functional residual capacity of 30 mL/kg remaining in the lung, reconnecting the animal to the volume ventilator for gas tidal volumes. Serial arterial blood gases and lung mechanics were measured. While receiving conventional ventilation, all animals developed progressive hypoxemia, hypercarbia, and acidosis. However, in the perfluorocarbon-associated gas exchange group, within 5 mins of the initiation of perfluorocarbon-associated gas exchange, mean PaO2 increased four-fold, from 59 +/- 6 torr (7.9 +/- 0.8 kPa) during conventional ventilation to 250 +/- 28 torr (33.3 +/- 3.7 kPa; p < .05) during perfluorocarbon-associated gas exchange, and this increase was sustained at 60 mins of perfluorocarbon-associated gas exchange (268 +/- 38 torr; 35.7 +/- 5.1 kPa; p < .05). Mean PaCO2 decreased progressively from 62 +/- 4 torr (8.3 +/- 0.5 kPa) during conventional ventilation to 38 +/- 3.3 torr (5.1 +/- 0.4 kPa) at 60 mins of perfluorocarbon-associated gas exchange (p < .05). Mean pH concomitantly increased. Dynamic compliance increased three-fold within 15 mins of instituting perfluorocarbon-associated gas exchange, from 0.31 +/- 0.02 mL/cm H2O during conventional

  8. Adjunctive atropine versus metoclopramide: can we reduce ketamine-associated vomiting in young children? a prospective, randomized, open, controlled study.

    PubMed

    Lee, Ji Sook; Jeon, Woo Chan; Park, Eun Jung; Min, Young Gi; Jung, Yoon Seok; Kim, Gi Woon; Choi, Sang Cheon

    2012-10-01

    Pediatric procedural sedation and analgesia (PPSA) with ketamine administration occurs commonly in the emergency department (ED). Although ketamine-associated vomiting (KAV) is a less serious complication of ketamine administration, it seems to be cumbersome and not uncommon. The authors evaluated the incidence of KAV and the prophylactic effect of adjunctive atropine and metoclopramide in children receiving ketamine sedation in the ED setting. This prospective, randomized, open, controlled study was conducted in children receiving ketamine sedation in the ED of a university-affiliated, tertiary hospital with 85,000 ED visits, including 32,000 pediatric patients from October 2010 to September 2011. The primary outcome was a measure of the incidence of KAV in the ED and after discharge according to the adjunctive drug administered. Secondary outcome measures included the time to resumption of a normal diet after ketamine sedation. Of the 1,883 children administered ketamine for primary wound repair during the study period, a convenience sample of 338 patients aged 4 months to 5 years was enrolled. The incidences of KAV were 28.4% in the ketamine alone group, 27.9% in the ketamine with adjunctive atropine group, and 31.2% in the ketamine with adjunctive metoclopramide group (p = 0.86). The vomiting rate after discharge was 9.2% in the ketamine alone group. The nothing-by-mouth (NPO) status before sedation did not influence the incidence of KAV in any of the groups. Mean times to resumption of normal diet after ketamine administration were 7 hours 59 minutes in the ketamine alone group, 7 hours 35 minutes in the ketamine with atropine group, and 8 hours 1 minute in the ketamine with metoclopramide group (p = 0.64).  In this study, a high rate (28.4%) of KAV was observed, consistent with prior reports using the intramuscular (IM) route. However, the authors were unable to reduce KAV using adjunctive atropine or metoclopramide. Parents or

  9. To determine the effect of metoclopramide on gastric emptying in severe head injuries: a prospective, randomized, controlled clinical trial.

    PubMed

    Marino, L V; Kiratu, E M; French, S; Nathoo, N

    2003-02-01

    To determine the effect of 8-hourly administration of 10 mg intravenous metoclopramide, over a 48-h period on gastric emptying in severe head injury (SHI), 22 patients were prospectively randomized (Glasgow Coma Score of 3-8) to receive 2 ml of intravenous metoclopramide or 2 ml of 5% saline 8-hourly for 48 h. Baseline and serial blood paracetamol absorption assays were performed at time (t) = 0, 15, 30, 45, 60, 90 and 120 min on day 0 and day 2. The area under the curve between the day 0 and day 2 was used to measure the degree of gastric emptying. In SHI, sequential doses of metoclopramide did not appear to improve gastric motility within subject comparisons (p = 0.65) and between subject comparisons (placebo p = 0.4 and drug p = 0.12). Metoclopramide has no significant prokinetic effect on gastric emptying in SHI patients when given in the early postinjury period.

  10. In Vivo Performance of Moderately Crosslinked, Thermally Treated Polyethylene in a Prospective Randomized Controlled Primary Total Knee Arthroplasty Trial.

    PubMed

    Kindsfater, Kirk A; Pomeroy, Donald; Clark, Charles R; Gruen, Thomas A; Murphy, Jeff; Himden, Sam

    2015-08-01

    Cross-linked bearings have been developed for use in total knee arthroplasty that exhibit improved wear properties, but at the expense of a decrease in mechanical strength of the cross-linked material. Adoption has been slow due to fears of mechanical failure secondary to this alteration in mechanical properties. This prospective, randomized study compared mid-term survivorship, clinical and radiographic results of a conventional polyethylene (GVF) to a cross-linked polyethylene (XLK) in total knee prostheses of the same design. At minimum 5-year follow-up there was no difference in survivorship, clinical performance or radiographic findings between the groups. There were no revisions for polyethylene wear, osteolysis or tibial insert dissociation. Most importantly, there were no revisions for mechanical failure or fracture of the polyethylene bearing in either group.

  11. Transepithelial Versus Epithelium-Off Corneal Collagen Cross-Linking for Progressive Keratoconus: A Prospective Randomized Controlled Trial.

    PubMed

    Al Fayez, Mashhoor F; Alfayez, Salman; Alfayez, Yasmin

    2015-10-01

    To compare the safety and efficacy of transepithelial with epithelium-off corneal cross-linking for progressive keratoconus. In a prospective clinical trial, 70 patients with progressive keratoconus were randomized to undergo corneal cross-linking with intact epithelium (n = 34) or after deepithelialization (n = 36). The main outcome measure was a change in the maximum K reading (K(max)). With 3-year follow-up, K(max) decreased in the epithelium-off group with a mean of 2.4 D and no patient showed evidence of progression. In the transepithelial group, K(max) increased by a mean of 1.1 D, and 20 patients (55%) showed progression of keratoconus. In this study, epithelium-off was significantly more effective than transepithelial corneal cross-linking in halting the progression of keratoconus (P < 0.0001).

  12. Analysis of Postoperative Thoracolumbar Spine Infections in a Prospective Randomized Controlled Trial Using the Centers for Disease Control Surgical Site Infection Criteria

    PubMed Central

    Takemoto, Richelle C.; Lonner, Baron S.; Andres, Tate M.; Park, Justin J.; Ricart-Hoffiz, Pedro A.; Bendo, John A.; Goldstein, Jeffrey A.; Spivak, Jeffrey M.; Errico, Thomas J.

    2016-01-01

    Introduction Wound infections following spinal surgery place a high toll on both the patient and the healthcare system. Although several large series studies have examined the incidence and distribution of spinal wound infection, the applicability of these studies varies greatly since nearly every study is either retrospective and/or lacks standard inclusion criteria for defining surgical site infection. To address this void, we present results from prospectively gathered thoracolumbar spine surgery data for which the Centers for Disease Control (CDC) criteria were stringently applied to define a surgical site infection (SSI). Methods A prospective randomized trial of 314 patients who underwent multilevel thoracolumbar spinal surgery with instrumentation followed by postoperative drain placement was completed (Takemoto et al., 2015). The trial consisted of two antibiotic arms: one for 24-hours, and the other for the duration of the drain; no differences were found between the arms. All infections meeting CDC criteria for SSI were included. Results A total of 40 infections met CDC criteria for SSI, for an overall incidence of 12.7%. Of these, 20 (50%) were culture-positive. The most common organism was Staphylococcus aureus (4 total: methicillin-sensitive=2; methicillin-resistant=2), followed by coagulase-negative Staphylococcus (3 cases), Propionibacterium acnes and Escherichia coli (2 cases each). Six infections grew multiple organisms, most commonly involving coagulase-negative staphylococcus and enterococcus. Conclusions Our findings indicate that thoracolumbar SSI occurs at the higher end of the range cited in the literature (2-13%), which is largely based on retrospective data not subjected to the inclusivity of SSI as defined by the CDC. The three most common organisms in our analysis (S. aureus, P. acnes, E. coli) are consistent with previous reports. Staphylococcus aureus continues to be the most common causative organism and continued vigilance and

  13. Antiemetic effects of midazolam added to fentanyl-ropivacaine patient-controlled epidural analgesia after subtotal gastrectomy: A prospective, randomized, double-blind, controlled trial

    PubMed Central

    Kim, Sioh; Seo, Jeongwon; Jeon, Younghoon

    2010-01-01

    Background: Nausea and vomiting are frequent adverse effects of patient-controlled epidural analgesia (PCEA) with opioids. Objective: This study was designed to assess the antiemetic effect of midazolam added to fentanyl—ropivacaine PCEA. Methods: In a prospective, randomized, double-blind, controlled trial, smoking patients with gastric cancer undergoing elective subtotal gastrectomy were evenly allocated to 1 of 2 treatment groups to manage postoperative pain: 0.2% ropivacaine mixed with fentanyl 4 μg/mL and midazolam 0.2 mg/mL (test group) or 0.2% ropivacaine mixed with fentanyl 4 μg/mL (control group). The PCEA infusion was set to deliver 4 μL/h of the study solution, with a bolus of 2 mL per demand and a 15-minute lockout time. The incidence of postoperative nausea and vomiting (PONV), pain intensity, sedation score, usage of rescue analgesia and rescue antiemetic, respiratory depression, urinary retention, and pruritus were recorded at 2, 6, 12, 24, 48, and 72 hours after surgery. Total infused volume of PCEA at 72 hours after surgery was measured. Results: A total of 60 patients were approached and randomized to treatment. No patients were excluded by exclusion criteria and all enrolled patients completed this study. Incidence of nausea (7% vs 33%; P = 0.02) in the test group was significantly lower than in the control group. The overall frequency of PONV in the test group was significantly less than that of the control group (7% vs 40%; P = 0.006). In addition, the mean (SD) infused volume of PCEA in the test group was significantly lower than that in the control group (392.3 [68.9] vs 351.2 [49.8] mL; P = 0.01). However, there were no significant differences in pain intensity, usage of rescue antiemetics and rescue analgesics, and mild pruritus between groups. No patient reported moderate or severe sedation, respiratory depression, or hypoxemia. In addition, there were no severe adverse events. Conclusions: Midazolam added to fentanyl-ropivacaine PCEA

  14. 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.

  15. Lack of efficacy of manual therapy in children and adolescents with suspected cervicogenic headache: results of a prospective, randomized, placebo-controlled, and blinded trial.

    PubMed

    Borusiak, Peter; Biedermann, Heiner; Bosserhoff, Stephanie; Opp, Joachim

    2010-02-01

    Clinical trials concerning cervical spine manipulation and mobilization in children and adolescents with cervicogenic headache are lacking. We performed a multicenter, prospective, randomized, placebo-controlled, and blinded trial in 52 children and adolescents (21 boys, 31 girls) aged 7-15. After prospective baseline documentation for 2 months patients were either assigned to placebo or true manipulation with another 2-month follow-up. Main outcome measures were defined as: percentage of days with headache, total duration of headache, days with school absence due to headache, consume of analgesics, intensity of headache. We did not find a significant difference comparing the groups with placebo and true manipulation with respect to the defined main outcome measures. We were not able to show an efficacy of cervical spine manipulation in 52 children and adolescents.

  16. Radiation-induced proctosigmoiditis. Prospective, randomized, double-blind controlled trial of oral sulfasalazine plus rectal steroids versus rectal sucralfate

    SciTech Connect

    Kochhar, R.; Patel, F.; Dhar, A.; Sharma, S.C.; Ayyagari, S.; Aggarwal, R.; Goenka, M.K.; Gupta, B.D.; Mehta, S.K. )

    1991-01-01

    In a prospective study, 37 consecutive patients with radiation-induced proctosigmoiditis were randomized to receive a four-week course of either 3.0 g oral sulfasalazine plus 20 mg twice daily rectal prednisolone enemas (group I, N = 18) or 2.0 g twice daily rectal sucralfate enemas plus oral placebo (group II, N = 19). The two groups were comparable with respect to demographic features, duration of symptoms, and clinical and endoscopic staging of the disease. Fifteen patients in group I and 17 in group II completed the trial. At four weeks, both groups showed significant clinical improvement (P less than 0.01 for group I and P less than 0.001 for group II) and endoscopic healing (P less than 0.01 for group I and P less than 0.001 for group II). When the two groups were compared, sucralfate enemas showed a significantly better response as assessed clinically (P less than 0.05), although endoscopically the response was not statistically different (P greater than 0.05). We conclude that both treatment regimens are effective in the management of radiation proctitis. Sucralfate enemas give a better clinical response, are tolerated better, and because of the lower cost should be the preferred mode of short-term treatment.

  17. Comparison of dexmedetomidine and propofol for conscious sedation in inguinal hernia repair: A prospective, randomized, controlled trial.

    PubMed

    Wang, Hong-Mei; Shi, Xiao-Yu; Qin, Xia-Rong; Zhou, Jia-Li; Xia, Yan-Fei

    2017-04-01

    Objective The ideal agents for conscious sedation during ambulatory inguinal hernia repair are still unclear. We aimed to compare the analgesic, sedative, haemodynamic, and side effects of dexmedetomidine with those of propofol in combination with fentanyl for conscious sedation in patients undergoing inguinal hernia repair. Methods Eighty patients undergoing unilateral inguinal hernia repair were prospectively randomized to receive either dexmedetomidine (n = 40) or propofol (n = 40). Dexmedetomidine and propofol dosages were adjusted to maintain the targeted level of sedation. Results After administration of sedative drugs, patients who received dexmedetomidine had a significantly lower heart rate. The intraoperative requirement of fentanyl was significantly lower in patients who received dexmedetomidine compared with patients who received propofol. Administration of dexmedetomidine was associated with a reduced postoperative pain score, longer time for onset of sedation, and a slightly longer recovery time. No serious adverse events occurred in either group. The patients' overall satisfaction score was comparable between the two groups. Conclusion Dexmedetomidine is an effective adjuvant when co-administered with fentanyl for conscious sedation in patients who undergo inguinal hernia repair. Administration of dexmedetomidine decreases the requirement of fentanyl and the pain score, but slightly prolongs the time to sedation and recovery.

  18. 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.

  19. Corticosteroid Injection for the Treatment of Morton's Neuroma: A Prospective, Double-Blinded, Randomized, Placebo-Controlled Trial.

    PubMed

    Lizano-Díez, Xavier; Ginés-Cespedosa, Alberto; Alentorn-Geli, Eduard; Pérez-Prieto, Daniel; González-Lucena, Gemma; Gamba, Carlo; de Zabala, Santiago; Solano-López, Alberto; Rigol-Ramón, Pau

    2017-09-01

    The effectiveness of corticosteroid injection for the treatment of Morton's neuroma is unclear. In addition, most of the studies related to it are case-control or retrospective case series. The purpose of this study was to compare the effectiveness between corticosteroid injection associated with local anesthetic and local anesthetic alone (placebo control group) for the treatment of Morton's neuroma. Forty-one patients with a diagnosis of Morton's neuroma were randomized to receive 3 injections of either a corticosteroid plus a local anesthetic or a local anesthetic alone. The patients and the researcher who collected data were blinded to the treatment groups. The visual analog scale for pain and the American Orthopaedic Foot & Ankle Score (metatarsophalangeal/interphalangeal score) were obtained at baseline, after each injection, and at 3 and 6 months after the last injection. There were no significant between-group differences in terms of pain and function improvement at 3 and 6 months after treatment completion in comparison with baseline values. At the end of the study, 17 (48.5%) patients requested surgical excision of the neuroma: 7 (44%) in the experimental group and 10 (53%) in the control group ( P = 1.0). The injection of a corticosteroid plus a local anesthetic was not superior to a local anesthetic alone in terms of pain and function improvement in patients with Morton's neuroma. Level I, randomized controlled trial.

  20. The complex sleep apnea resolution study: a prospective randomized controlled trial of continuous positive airway pressure versus adaptive servoventilation therapy.

    PubMed

    Morgenthaler, Timothy I; Kuzniar, Tomasz J; Wolfe, Lisa F; Willes, Leslee; McLain, William C; Goldberg, Rochelle

    2014-05-01

    Prior studies show that adaptive servoventilation (ASV) is initially more effective than continuous positive airway pressure (CPAP) for patients with complex sleep apnea syndrome (CompSAS), but choosing therapies has been controversial because residual central breathing events may resolve over time in many patients receiving chronic CPAP therapy. We conducted a multicenter, randomized, prospective trial comparing clinical and polysomnographic outcomes over prolonged treatment of patients with CompSAS, with CPAP versus ASV. Qualifying participants meeting criteria for CompSAS were randomized to optimized CPAP or ASV treatment. Clinical and polysomnographic data were obtained at baseline and after 90 days of therapy. We randomized 66 participants (33 to each treatment). At baseline, the diagnostic apnea-hypopnea index (AHI) was 37.7 ± 27.8 (central apnea index [CAI] = 3.2 ± 5.8) and best CPAP AHI was 37.0 ± 24.9 (CAI 29.7 ± 25.0). After second-night treatment titration, the AHI was 4.7 ± 8.1 (CAI = 1.1 ± 3.7) on ASV and 14.1 ± 20.7 (CAI = 8.8 ± 16.3) on CPAP (P ≤ 0.0003). At 90 days, the ASV versus CPAP AHI was 4.4 ± 9.6 versus 9.9 ± 11.1 (P = 0.0024) and CAI was 0.7 ± 3.4 versus 4.8 ± 6.4 (P < 0.0001), respectively. In the intention-to-treat analysis, success (AHI < 10) at 90 days of therapy was achieved in 89.7% versus 64.5% of participants treated with ASV and CPAP, respectively (P = 0.0214). Compliance and changes in Epworth Sleepiness Scale and Sleep Apnea Quality of Life Index were not significantly different between treatment groups. Adaptive servoventilation (ASV) was more reliably effective than CPAP in relieving complex sleep apnea syndrome. While two thirds of participants experienced success with CPAP, approximately 90% experienced success with ASV. Because both methods produced similar symptomatic changes, it is unclear if this polysomnographic effectiveness may translate into other desired outcomes. Clinicaltrials.Gov NCT00915499.

  1. Replication of a Prospective Randomized Controlled Trial of Resource Facilitation to Improve Return to Work and School After Brain Injury.

    PubMed

    Trexler, Lance E; Parrott, Devan R; Malec, James F

    2016-02-01

    To determine the extent to which previous findings on the effectiveness of resource facilitation to impact return to work and school could be replicated. Randomized controlled trial. Outpatient rehabilitation clinic. Outpatients with acquired brain injury (N=44). Fifteen months of resource facilitation services. A revised version of the Vocational Independence Scale and the Mayo-Portland Adaptability Inventory-4 Participation Index. Participants randomized to the resource facilitation group demonstrated a significant advantage in terms of rate and timing of return to productive community-based work relative to control participants. When examining only return to competitive work (and not return to school), 69% of the resource facilitation group was able to return compared with 50% of the control participants. Analyses of measures of participation in household and community activities revealed that both groups improved significantly over the 15-month study period, but no significant advantage for either group was demonstrated. This study replicates the positive impact of resource facilitation in improving productive community-based activity, including competitive employment and volunteering in the community. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  2. The efficacy of cefazolin in reducing surgical site infection in laparoscopic cholecystectomy: a prospective randomized double-blind controlled trial.

    PubMed

    Ruangsin, Sakchai; Laohawiriyakamol, Supparerk; Sunpaweravong, Somkiat; Mahattanobon, Somrit

    2015-04-01

    A prophylactic antibiotic is recommended in open cholecystectomy surgeries, but in laparoscopic cholecystectomies such prophylaxis is controversial. Recent reviews have not found conclusive evidence that routine prophylaxis, especially in low risk patients, is effective. This clinical trial was undertaken to evaluate the efficacy of cefazolin in reducing surgical site infection SSI in laparoscopic cholecystectomies in a sample not screened for high or low risk patients. A randomized double-blind controlled trial was conducted in a single university hospital. Scheduled cholecystectomy patients without selection for patient risk factors were randomized into two groups. Pre-operatively, group A patients received a placebo of 10 ml isotonic sodium chloride, and group B patients received 1 g of cefazolin as a prophylactic antibiotic. All patients underwent a standard laparoscopic cholecystectomy, and were followed up for at least 30 days. Two hundred ninety-nine patients were randomized (149 in group A and 150 in group B). SSI occurred in seven patients (2.34 %), five (1.67 %) in the placebo group, and two (0.67 %) in the prophylactic antibiotic group. The difference was not statistically significant (p value = 0.512), and no specific risk factors for post-operative infection were identified. A single dose of preoperative prophylactic cefazolin has no significant benefit in reducing the incidence of SSI in laparoscopic cholecystectomy. Whether or not to use a prophylactic depends on the individual patient, and the consideration of the attending surgeon.

  3. Effects of alveolar recruitment on arterial oxygenation in patients after cardiac surgery: a prospective, randomized, controlled clinical trial.

    PubMed

    Minkovich, Leonid; Djaiani, George; Katznelson, Rita; Day, Fergal; Fedorko, Ludwik; Tan, Jens; Carroll, Jo; Cheng, Davy; Karski, Jacek

    2007-06-01

    Pulmonary atelectasis and hypoxemia remain considerable problems after cardiac surgery. The objective of this study was to determine the efficacy of consecutive vital capacity maneuvers (C-VCMs) to improve oxygenation in patients after cardiac surgery. Randomized, controlled clinical trial. Tertiary referral teaching center. Ninety-five patients requiring elective cardiac surgery with cardiopulmonary bypass (CPB). Patients were randomly allocated to either C-VCM or control groups. In the C-VCM group, lung inflation at pressure of 35 cmH(2)O was sustained for 15 seconds before separation from CPB and at 30 cmH(2)O for 5 seconds after admission to the intensive care unit (ICU). The primary outcome was the ratio of arterial oxygen tension to inspired oxygen fraction measured at the following predetermined time intervals: after induction of anesthesia, 15 minutes after separation from CPB, after admission to the ICU, after 3 hours of positive-pressure ventilation, after extubation, and before ICU discharge. C-VCM resulted in better arterial oxygenation extending from the immediate postoperative period to approximately 24 hours after surgery at the time of ICU discharge. There were no significant adverse events related to C-VCM application. C-VCM is an effective method to reduce hypoxemia associated with the formation of atelectasis after cardiac surgery with CPB.

  4. Effect of biofeedback and deep oscillation on Raynaud's phenomenon secondary to systemic sclerosis: results of a controlled prospective randomized clinical trial.

    PubMed

    Sporbeck, Birte; Mathiske-Schmidt, Kirsten; Jahr, Silke; Huscher, Dörte; Becker, Mike; Riemekasten, Gabriela; Taufmann, Ines; Burmester, Gerd-Rüdiger; Pögel, Stephanie; Reisshauer, Anett

    2012-05-01

    Our aim was to evaluate the effect of deep oscillation and biofeedback on Raynaud's phenomenon (RP) secondary to systemic sclerosis (SSc). A prospective randomized study was performed in SSc patients receiving either deep oscillation (n = 10) or biofeedback (n = 8) thrice a week for 4 weeks, or patients were randomized into the waiting group untreated for vasculopathy (n = 10) in time of running the study interventions. Biofeedback resulted in an improvement of RP as determined by score reduction of visual analogue scale compared with patients of the control group (P < 0.05), whereas deep oscillation revealed a tendency for improvement (P = 0.055). The study underlines the beneficial role of physiotherapy for the treatment of SSc-related RP.

  5. Alveolar ridge preservation using autogenous tooth graft versus beta-tricalcium phosphate alloplast: A randomized, controlled, prospective, clinical pilot study

    PubMed Central

    Joshi, Chaitanya Pradeep; Dani, Nitin Hemchandra; Khedkar, Smita Uday

    2016-01-01

    Background: A randomized, prospective clinical, radiographical, and histological study was conducted to evaluate healing after alveolar ridge preservation technique using two different graft materials, namely, a novel autogenous graft material i. e., autogenous tooth graft (ATG) and beta-tricalcium phosphate (β-TCP) alloplast. Materials and Methods: Fifteen patients undergoing extraction of at least three teeth were selected. Atraumatic extractions were performed. Of the three extraction sockets, one was grafted with ATG, other with β-TCP, and the third was left ungrafted. Cone-beam computed tomography scans were taken immediately after grafting and 4 months postoperatively to check the changes in alveolar crest height and width at all the sites. Three patients in whom implant placement was done after complete healing; bone samples were harvested using a 3 mm diameter trephine during osteotomy preparation from both the ridge preserved sites and studied histologically. Results: There was a statistically significant difference when the changes in width and height of alveolar crest were compared within all the three groups (P < 0.05). Among three sites, ATG-grafted sites showed the most superior results with a minimal reduction in alveolar crest height and width. Histological analysis also showed the same trend with more new bone formation at ATG-grafted sites as compared to β-TCP-grafted sites. Conclusion: Postextraction, ridge preservation leads to more predictable maintenance of alveolar ridge height and width. ATG as compared to β-TCP provided superior results. Based on this, we conclude that ATG material can serve as a better alternative to conventional bone graft materials. PMID:28298826

  6. Effect of diaper cream and wet wipes on skin barrier properties in infants: a prospective randomized controlled trial.

    PubMed

    Garcia Bartels, Natalie; Lünnemann, Lena; Stroux, Andrea; Kottner, Jan; Serrano, José; Blume-Peytavi, Ulrike

    2014-01-01

    The effect of different diaper care procedures on skin barrier function in infants has been minimally investigated and may be assessed using objective methods. In a single-center, prospective trial, 89 healthy 9-month-old infants (±8 wks) were randomly assigned to three diaper care regimens: group I used water-moistened washcloths at diaper changes (n = 30), group II additionally applied diaper cream twice daily (n = 28), and group III used wet wipes and diaper cream twice daily (n = 31). Transepidermal water loss (TEWL), skin hydration (SCH), skin pH, interleukin 1α (IL-1α) levels, and microbiologic colonization were measured in diapered skin (upper outer quadrant of the buttocks), nondiapered skin (upper leg), and if diaper dermatitis (DD) occurred, using the most affected skin area at day 1 and weeks 4 and 8. Skin condition was assessed utilizing a neonatal skin condition score and diaper rash grade. On diapered skin, SCH decreased in groups II and III, whereas TEWL values were reduced in group II only. Skin pH increased in groups II and III. In general, SCH, skin pH, and IL-1α levels were higher in healthy diapered skin than in nondiapered skin. The incidence and course of DD was comparable in all groups. Areas with DD had greater TEWL and skin pH than unaffected skin areas. Infants who received diaper cream had lower SCH and TEWL and higher pH levels in the diapered area than on nondiapered skin. No correlation with the occurrence of DD was found.

  7. The efficacy of peritubal analgesic infiltration in postoperative pain following percutaneous nephrolithotomy - A prospective randomized controlled study.

    PubMed

    Lojanapiwat, Bannakij; Chureemas, Tanarit; Kittirattarakarn, Pruit

    2015-01-01

    To study the efficacy of peritubal infiltration in postoperative pain following percutaneous nephrolithotomy in general PCNL patients and PCNL patients with supracostal renal access. A total of 105 PCNL patients were randomized into two groups, 53 patients receiving peritubal analgesic infiltration (study group) and 52 patients as the control group. Of these patients, supracostal access was performed in 22 patients of study group and 23 patients of control group. The study group received peritubal injection with 10mL of bupivacain. Postoperative pain as the primary outcome was assessed by using visual analogue scale at 1, 4, 12, 24 and 48 hours postoperatively. The secondary outcomes were the total postoperative morphine usage in 24 hours and time of the first analgesic demand. The average VAS pain at 1 and 4 hours after the operation in the study group were significant lower in the control group (P≤ 0.001 and 0.026). Doses of morphine usage for controlling postoperative pain and the first analgesic demand were significantly lower and longer in study group. Among patients submitted to supracostal access, the average VAS pain at 1 hour after operation in the study group was lower (P=0.018). Doses of morphine usage for controlling postoperative pain also was lower in the study group (P=0.012). The peritubal local anesthetic infiltration is effective in alleviating immediate postoperative pain after percutaneous nephrolithotomy even with supracostal access.

  8. The efficacy of peritubal analgesic infiltration in postoperative pain following percutaneous nephrolithotomy – A prospective randomized controlled study

    PubMed Central

    Lojanapiwat, Bannakij; Chureemas, Tanarit; Kittirattarakarn, Pruit

    2015-01-01

    ABSTRACT Objective: To study the efficacy of peritubal infiltration in postoperative pain following percutaneous nephrolithotomy in general PCNL patients and PCNL patients with supracostal renal access. Patients and Methods: A total of 105 PCNL patients were randomized into two groups, 53 patients receiving peritubal analgesic infiltration (study group) and 52 patients as the control group. Of these patients, supracostal access was performed in 22 patients of study group and 23 patients of control group. The study group received peritubal injection with 10mL of bupivacain. Postoperative pain as the primary outcome was assessed by using visual analogue scale at 1, 4, 12, 24 and 48 hours postoperatively. The secondary outcomes were the total postoperative morphine usage in 24 hours and time of the first analgesic demand. Results: The average VAS pain at 1 and 4 hours after the operation in the study group were significant lower in the control group (P≤0.001 and 0.026). Doses of morphine usage for controlling postoperative pain and the first analgesic demand were significantly lower and longer in study group. Among patients submitted to supracostal access, the average VAS pain at 1 hour after operation in the study group was lower (P=0.018). Doses of morphine usage for controlling postoperative pain also was lower in the study group (P=0.012). Conclusion: The peritubal local anesthetic infiltration is effective in alleviating immediate postoperative pain after percutaneous nephrolithotomy even with supracostal access. PMID:26689520

  9. BOTULINUM TOXIN A INDUCED PARALYSIS OF THE LATERAL ABDOMINAL WALL AFTER DAMAGE CONTROL LAPAROTOMY: A MULTIINSTITUTIONAL, PROSPECTIVE, RANDOMIZED, PLACEBO CONTROLLED PILOT STUDY

    PubMed Central

    Zielinski, Martin D.; Kuntz, Melissa; Zhang, Xiaoming; Zagar, Abigail E.; Khasawneh, Mohammad A.; Zendejas, Benjamin; Polites, Stephanie F.; Ferrara, Michael; Harmsen, William S.; Ballman, Karla S.; Park, Myung S.; Schiller, Henry J.; Dries, David; Jenkins, Donald H.

    2015-01-01

    INTRODUCTION Damage control laparotomy (DCL) is a life-saving operation used in critically ill patients; however, interval primary fascial closure remains a challenge. We hypothesized that flaccid paralysis of the lateral abdominal wall musculature induced by Botulinum Toxin A (BTX), would improve of rates of primary fascial closure, decrease duration of hospital stay (LOS), and enhance pain control. METHODS Consenting adults who had undergone a DCL at two institutions were prospectively randomized to receive ultrasound-guided injections of their external oblique, internal oblique, and transversus abdominus muscles with either BTX (150cc, 2units/cc) or placebo (150cc 0.9%NaCl). Patients were excluded if they had a BMI>50, remained unstable or coagulopathic, were home O2 dependent or had an existing neuromuscular disorder. Outcomes were assessed in a double-blinded manner. Univariate and Kaplan Meier estimates of cumulative probability of abdominal closure were performed. RESULTS We randomized 46 patients (24 BTX, 22 placebo). There were no significant differences in demographics, comorbidities, and physiological status. Injections were performed on average 1.8 ± 2.8 days after DCL (range 0-14). The 10-day cumulative probability of primary fascial closure was similar between groups: 96% for BTX (95% CI 72%-99%) and 93% for placebo (95% CI 61%-99%); HR =1.0 (95% CI 0.5-1.8). No difference between BTX and placebo groups was observed for LOS (37 vs 26 days, p=0.30) or intensive care unit stay (17 vs 11 days, p=0.27). There was no difference in median morphine equivalents following DCL. The overall complication rate was similar (63% vs 68%, p=0.69), with 2 deaths in the placebo group and 0 in the BTX group. No BTX or injection procedure complications were observed. CONCLUSION Use of BTX after DCL was safe but did not appear to affect primary fascial closure, LOS, or pain modulation after DCL. Given higher than expected rates of primary fascial closure, type II error

  10. Botulinum toxin A-induced paralysis of the lateral abdominal wall after damage-control laparotomy: A multi-institutional, prospective, randomized, placebo-controlled pilot study.

    PubMed

    Zielinski, Martin D; Kuntz, Melissa; Zhang, Xiaoming; Zagar, Abigail E; Khasawneh, Mohammad A; Zendejas, Benjamin; Polites, Stephanie F; Ferrara, Michael; Harmsen, William Scott; Ballman, Karla S; Park, Myung S; Schiller, Henry J; Dries, David; Jenkins, Donald H

    2016-02-01

    Damage-control laparotomy (DCL) is a lifesaving operation used in critically ill patients; however, interval primary fascial closure remains a challenge. We hypothesized that flaccid paralysis of the lateral abdominal wall musculature induced by botulinum toxin A (BTX) would improve rates of primary fascial closure, decrease duration of hospital stay, and enhance pain control. Consenting adults who had undergone a DCL at two institutions were prospectively randomized to receive ultrasound-guided injections of their external oblique, internal oblique, and transversus abdominus muscles with either BTX (150 mL, 2 U/mL) or placebo (150-mL 0.9% NaCl). Patients were excluded if they had a body mass index of greater than 50, remained unstable or coagulopathic, were home O2 dependent, or had an existing neuromuscular disorder. Outcomes were assessed in a double-blinded manner. Univariate and Kaplan-Meier estimates of cumulative probability of abdominal closure were performed. We randomized 46 patients (24 BTX, 22 placebo). There were no significant differences in demographics, comorbidities, and physiologic status. Injections were performed on average 1.8 ± 2.8 days (range, 0-14 days) after DCL. The 10-day cumulative probability of primary fascial closure was similar between groups: 96% for BTX (95% confidence interval [CI], 72-99%) and 93% for placebo (95% CI, 61-99%) (HR, 1.0; 95% CI, 0.5-1.8). No difference between BTX and placebo groups was observed for hospital length of stay (37 days vs. 26 days, p = 0.30) or intensive care unit length of stay (17 days vs. 11 days, p = 0.27). There was no difference in median morphine equivalents following DCL. The overall complication rate was similar (63% vs. 68%, p = 0.69), with two deaths in the placebo group and none in the BTX group. No BTX or injection procedure complications were observed. The use of BTX after DCL was safe but did not seem to affect primary fascial closure, hospital length of stay, or pain modulation after

  11. 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

  12. Efficacy of fluoride varnish for preventing white spot lesions and gingivitis during orthodontic treatment with fixed appliances-a prospective randomized controlled trial.

    PubMed

    Kirschneck, Christian; Christl, Jan-Joachim; Reicheneder, Claudia; Proff, Peter

    2016-12-01

    The development of white spot lesions around orthodontic brackets and gingivitis is a common problem during orthodontic treatment with fixed appliances. This prospective randomized double-blind controlled clinical trial investigated the preventive efficacy of a one-time application of two commonly used fluoride varnishes in patients with low to moderate caries risk. Ninety adolescent orthodontic patients with a low to moderate caries risk were prospectively randomized to three groups of 30 patients each: (1) standardized dental hygiene with fluoride toothpaste and one-time application of placebo varnish (control) or (2) of elmex® fluid or (3) of Fluor Protector S on all dental surfaces at the start of fixed therapy. The extent of enamel demineralization and gingivitis was determined with the ICDAS and the gingivitis index (GI) at baseline and after 4, 12, and 20 weeks. Each treatment group showed a significant increase of the ICDAS index, but not of the GI over the course of time with no significant intergroup differences detectable. A one-time application of fluoride varnish at the start of orthodontic treatment did not provide any additional preventive advantage over sufficient dental hygiene with fluoride toothpaste with regard to formation of white spots and gingivitis in patients with a low to moderate caries risk. In dental practice, patients often receive an application of fluoride varnish at the start of orthodontic treatment with fixed appliances. However, the efficacy of this procedure is still unclear.

  13. Does Extended-Release Liposomal Bupivacaine Better Control Pain Than Bupivacaine After Total Knee Arthroplasty (TKA)? A Prospective, Randomized Clinical Trial.

    PubMed

    Schroer, William C; Diesfeld, Paul G; LeMarr, Angela R; Morton, Diane J; Reedy, Mary E

    2015-09-01

    Liposomal bupivacaine periarticular injection (PAI) offers sustained bupivacaine release after TKA, but few prospective independent studies exist. In this prospective, blinded study, liposomal bupivacaine was randomized against bupivacaine and incorporated into a comprehensive multimodal pain management protocol. 111 primary TKAs were randomized to receive PAI: 58 patients received 266 mg (20cc) liposomal bupivacaine mixed with 75 mg (30cc) 0.25% bupivacaine, and 53 patients received 150 mg (60cc) 0.25% bupivacaine. Visual analog pain scores and narcotic use were determined. No pain score differences occurred between study and control patients: Day 1: 4.5/4.6 (P=0.73); Day 2: 4.4/4.8 (P=0.27); or Day 3: 3.5/3.7 (P=0.58). Narcotic use was similar during hospitalization, 51.8/54.2 (P=0.34). The study medication costs $285, and the control medication costs $2.80. This finding does not justify the routine use of liposomal bupivacaine.

  14. Magnetic field therapy in patients with cytostatics‐induced polyneuropathy: A prospective randomized placebo‐controlled phase‐III study

    PubMed Central

    von Hehn, Ulrike; Mikus, Eberhard; Dertinger, Hermann; Geiger, Georg

    2016-01-01

    No causal treatment for chemotherapy‐induced peripheral neuropathy (CIPN) is known. Therefore, there is an urgent need to develop a therapy for CIPN. Only scarce clinical data are available concerning magnetic field therapy (MFT) in this context. We conducted a unicentric, randomized, double‐blind, placebo‐controlled phase‐III trial of an MFT device versus placebo. In this study, we randomized 44 patients with CIPN to two treatment groups, where 21 patients were treated with MFT (Group 1) and 23 patients received placebo (Group 2). We evaluated the efficacy of MFT at baseline (T1), after 3 weeks of study treatment (T2), and after 3 months of study treatment (T3). The primary endpoint was nerve conduction velocity (NCV), while secondary endpoints were the Common Toxicity Criteria (CTCAE) score and the Pain Detect End Score at T3. Seventeen of the patients in Group 1 and 14 patients in Group 2 completed the respective study treatment. The primary endpoint, significant improvement of NCV at T3, was achieved by MFT (P = 0.015), particularly for sensory neurotoxicity of the peroneal nerve. Also, in respect to the secondary endpoints, significant improvement (P = 0.04) was achieved in terms of the patients’ subjectively perceived neurotoxicity (CTCAE score), but not of neuropathic pain (P = 0.11). From data in the randomized study presented here, a positive effect on the reduction of neurotoxicity can be assumed for the MFT device. Patients with sensory neurotoxicity in the lower limbs, especially, should therefore be offered this therapy. Bioelectromagnetics. 38:85–94, 2017. © 2016 The Authors. Bioelectromagnetics published by Wiley Periodicals, Inc. PMID:27657350

  15. Robot-assisted Versus Laparoscopic Surgery for Rectal Cancer: A Phase II Open Label Prospective Randomized Controlled Trial.

    PubMed

    Kim, Min Jung; Park, Sung Chan; Park, Ji Won; Chang, Hee Jin; Kim, Dae Yong; Nam, Byung-Ho; Sohn, Dae Kyung; Oh, Jae Hwan

    2017-05-25

    The phase II randomized controlled trial aimed to compare the outcomes of robot-assisted surgery with those of laparoscopic surgery in the patients with rectal cancer. The feasibility of robot-assisted surgery over laparoscopic surgery for rectal cancer has not been established yet. Between February 21, 2012 and March 11, 2015, patients with rectal cancer (cT1-3NxM0) were enrolled. Patients were randomized 1:1 to either robot-assisted or laparoscopic surgery, and stratified per sex and administration of preoperative chemoradiotherapy. The primary outcome was the quality of total mesorectal excision (TME) specimen. Secondary outcomes were the circumferential and distal resection margins, the number of harvested lymph nodes, morbidity, bowel function recovery, and quality of life. A total of 163 patients were randomly assigned to the robot-assisted (n = 81) and laparoscopic (n = 82) surgery groups, and 139 patients were eligible for the analyses (73 vs 66, respectively). One patient (1.2%) in the robot-assisted group was converted to open surgery. The TME quality did not differ between the robot-assisted and laparoscopic groups (80.3% vs 78.1% complete TME, respectively; 18.2% vs 21.9% nearly complete TME, respectively; P = 0.599). The resection margins, number of harvested lymph nodes, morbidity, and bowel function recovery also were not significantly different. On analyzing quality of life, scores of the European Organization for Research and Treatment of Cancer Quality of Life (EORTC QLQ C30) and EORTC QLQ CR38 were similar in the 2 groups, but in the EORTC QLQ CR 38 questionnaire, sexual function 12 months postoperatively was better in the robot-assisted group than in the laparoscopic group (P = 0.03). Robot-assisted surgery in rectal cancer showed TME quality comparable with that of laparoscopic surgery, and it demonstrated similar postoperative morbidity, bowel function recovery, and quality of life.

  16. Wound infiltration with bupivacaine and intramuscular diclofenac reduces postoperative tramadol consumption in patients undergoing radical retropubic prostatectomy: a prospective, double-blind, placebo-controlled, randomized study.

    PubMed

    Bilgin, Tugsan Egemen; Bozlu, Murat; Atici, Sebnem; Cayan, Selahittin; Tasdelen, Bahar

    2011-12-01

    To assess the impact of wound infiltration with bupivacaine and i.m. diclofenac administration on patient-controlled analgesia (PCA) tramadol consumptions and postoperative pain in patients who underwent radical retropubic prostatectomy (RRP) under general anesthesia. Previous studies have found only limited or no benefits of local anesthetics for postoperative opioid consumption and pain relief after RRP. In this prospective, double-blind, placebo-controlled, randomized trial, 96 men who underwent RRP were randomized into 2 groups. Each group (n = 48) received either wound infiltration with 0.5% bupivacaine during surgical closure and i.m. 75 mg diclofenac (group BD) or wound infiltration with saline during surgical closure and i.m. saline (group P). PCA with i.v. tramadol was used for postoperative analgesia. PCA tramadol consumptions and pain scores were collected at 1, 2, 6, 12, and 24 hours postoperatively. The mean cumulative tramadol consumption was significantly lower in group BD (184.43 ± 38.58 mg) compared with group P (269.52 ± 52.46) at 24 hours (P <.001). The pain scores were significantly lower in group BD compared with group P (P <.05). The number of patients who required rescue antiemetic and analgesic was lower in group BD than in group P, revealing a significant difference (P <.05). Patients' satisfaction scores were significantly higher in group BD than in group P (P <.001). This prospective, double-blind, placebo-controlled, randomized study demonstrated that wound infiltration with bupivacaine during surgical closure combined with i.m. diclofenac administration might decrease in 24 hours with PCA tramadol consumption in patients who underwent RRP under general anesthesia. Copyright © 2011 Elsevier Inc. All rights reserved.

  17. Effect of Shenzhu Guanxin Recipe () on patients with angina pectoris after percutaneous coronary intervention: A prospective, randomized controlled trial.

    PubMed

    Xu, Dan-Ping; Wu, Huan-Lin; Lan, Tao-Hua; Wang, Xia; Sheng, Xiao-Gang; Lin, Yu; Li, Song; Zheng, Chao-Yang

    2015-06-01

    To evaluate the efficacy and safety of a combination therapy using Chinese medicine (CM) Shenzhu Guanxin Recipe (, SGR) and standard Western medicine treatment (SWMT) in patients with angina pectoris after percutaneous coronary intervention (PCI). Double-blind randomized controlled trial was used in this experimental procedure. One hundred and eighty-seven patients with coronary heart disease receiving SWMT after PCI were randomly assigned to the treatment (SGR) and control (placebo) groups. Outcome measures including angina pectoris score (APS), CM symptom score, and Seattle Angina Questionnaire (SAQ) score were evaluated in 1, 2, 3 and 12 months, and the death rate, restenosis and other emergency treatments were observed. The mixed-effects models were employed for the data analysis. In the treatment group, a larger within-treatment effect size (d=1.74) was found, with a 76.7% reduction in APS from pretreatment to 12-month follow-up assessment compared with the control group (d=0.83, 53.8% symptom reduction); betweentreatment (BT) effect size was d=0.66. CM symptom scores included an 18.3% reduction in the treatment group (d=0.46), and a 16.1% decrease in the control group (d=0.31); d=0.62 for BT effect size. In regard to scores of SAQ, the BT effect size of cognition level of disease was larger in the treatment group (d=0.63), followed by the level of body limitation of activity (d=0.62), condition of angina pectoris attacks (d=0.55), satisfaction level of treatments (d=0.31), and steady state of angina pectoris (d=0.30). Two cardiovascular related deaths and one incidental death were recorded in the control and treatment groups, respectively. No significant difference in any cardiovascular event (including death toll, frequency of cardiovascular hospitalization or emergency room visits) was found between the two groups. The combination therapy of SGR and SWMT is effective and safe in patients with angina pectoris after PCI when compared with SWMT alone.

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

    PubMed

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

    2017-04-01

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

  19. Impact of maternal diet during pregnancy and breastfeeding on infant metabolic programming: a prospective randomized controlled study.

    PubMed

    Aaltonen, J; Ojala, T; Laitinen, K; Poussa, T; Ozanne, S; Isolauri, E

    2011-01-01

    To evaluate the impact of maternal diet and intensive dietary counselling during pregnancy and breastfeeding on the infant's metabolic status. At the first trimester of pregnancy, 256 women were randomized into a control/placebo group and two dietary counselling groups (diet/probiotics and diet/placebo). The counselling, with double-blind randomization to probiotics (Lactobacillus rhamnosus GG and Bifidobacterium lactis) or placebo, targeted excessive saturated fat and low fibre consumption. Maternal diet was evaluated repeatedly during pregnancy and postpartum by means of 3 days' food diaries. Metabolic markers, serum 32-33 split and intact proinsulin, leptin/adiponectin ratio, skinfold thickness and waist circumference were measured of 194 healthy infants at the age of 6 months, and the high levels were taken to mirror adverse metabolic status. The proportion of infants with a high 32-33 split proinsulin was significantly lower in dietary counselling with probiotics (n = 6/62, 9.7%) or placebo (n = 7/69, 10.1%) compared with the control/placebo group (n = 17/63, 27.0%). The high split proinsulin was associated with larger skinfold thickness, waist circumference and higher leptin/adiponectin ratio in the infants (P < 0.05). With respect to maternal diet during pregnancy, the highest and lowest tertiles of fat intake increased the infant's risk of high split proinsulin, whereas those of butter associated correspondingly with the infant's waist circumference. Further, breastfed infants showed a reduced risk of high split proinsulin and leptin/adiponectin ratio compared with formula-fed infants. Modification of maternal diet during pregnancy and breastfeeding may benefit infant metabolic health. High split proinsulin reflects adverse metabolic status in infancy, which can be improved by early dietary counselling.

  20. Effects of Breast Shielding during Heart Imaging on DNA Double-Strand-Break Levels: A Prospective Randomized Controlled Trial.

    PubMed

    Cheezum, Michael K; Redon, Christophe E; Burrell, Allison S; Kaviratne, Anthony S; Bindeman, Jody; Maeda, Daisuke; Balmakhtar, Houria; Pezel, Ashly; Wisniewski, Piotr; Delacruz, Panfilo; Nguyen, Binh; Bonner, William M; Villines, Todd C

    2016-10-01

    Purpose To examine the effect of breast shielding on blood lymphocyte deoxyribonucleic acid (DNA) double-strand-break levels resulting from in vivo radiation and ex vivo radiation at breast-tissue level, and the effect of breast shielding on image quality. Materials and Methods The study was approved by institutional review and commpliant with HIPAA guidelines. Adult women who underwent 64-section coronary computed tomographic (CT) angiography and who provided informed consent were prospectively randomized to the use (n = 50) or absence (n = 51) of bismuth breast shields. Peripheral blood samples were obtained before and 30 minutes after in vivo radiation during CT angiography to compare DNA double-strand-break levels by γ-H2AX immunofluorescence in blood lymphocytes. To estimate DNA double-strand-break induction at breast-tissue level, a blood sample was taped to the sternum for ex vivo radiation with or without shielding. Data were analyzed by linear regression and independent sample t tests. Results Breast shielding had no effect on DNA double-strand-break levels from ex vivo radiation of blood samples under shields at breast-tissue level (unadjusted regression: β = .08; P = .43 versus no shielding), or in vivo radiation of circulating lymphocytes (β = -.07; P = .50). Predictors of increased DNA double-strand-break levels included total radiation dose, increasing tube potential, and tube current (P < .05). With current radiation exposures (median, 3.4 mSv), breast shielding yielded a 33% increase in image noise and 19% decrease in the rate of excellent quality ratings. Conclusion Among women who underwent coronary CT angiography, breast shielding had no effect on DNA double-strand-break levels in blood lymphocytes exposed to in vivo radiation, or ex vivo radiation at breast-tissue level. At present relatively low radiation exposures, breast shielding contributed to an increase in image noise and a decline in image quality. The findings support efforts to

  1. 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.

  2. Biodegradable magnesium-based screw clinically equivalent to titanium screw in hallux valgus surgery: short term results of the first prospective, randomized, controlled clinical pilot study

    PubMed Central

    2013-01-01

    Purpose Nondegradable steel-and titanium-based implants are commonly used in orthopedic surgery. Although they provide maximal stability, they are also associated with interference on imaging modalities, may induce stress shielding, and additional explantation procedures may be necessary. Alternatively, degradable polymer implants are mechanically weaker and induce foreign body reactions. Degradable magnesium-based stents are currently being investigated in clinical trials for use in cardiovascular medicine. The magnesium alloy MgYREZr demonstrates good biocompatibility and osteoconductive properties. The aim of this prospective, randomized, clinical pilot trial was to determine if magnesium-based MgYREZr screws are equivalent to standard titanium screws for fixation during chevron osteotomy in patients with a mild hallux valgus. Methods Patients (n=26) were randomly assigned to undergo osteosynthesis using either titanium or degradable magnesium-based implants of the same design. The 6 month follow-up period included clinical, laboratory, and radiographic assessments. Results No significant differences were found in terms of the American Orthopaedic Foot and Ankle Society (AOFAS) score for hallux, visual analog scale for pain assessment, or range of motion (ROM) of the first metatarsophalangeal joint (MTPJ). No foreign body reactions, osteolysis, or systemic inflammatory reactions were detected. The groups were not significantly different in terms of radiographic or laboratory results. Conclusion The radiographic and clinical results of this prospective controlled study demonstrate that degradable magnesium-based screws are equivalent to titanium screws for the treatment of mild hallux valgus deformities. PMID:23819489

  3. Intravenous paracetamol for relief of pain during transrectal-ultrasound-guided biopsy of the prostate: A prospective, randomized, double-blind, placebo-controlled study.

    PubMed

    Kilic, Ozcan; Akand, Murat; Kulaksizoglu, Haluk; Haliloglu, Ahmet H; Tanidik, Seher; Piskin, Mehmet M; Yurdakul, Talat

    2015-11-01

    Transrectal-ultrasound-guided prostate biopsy (TRUS-PBx) is the standard procedure for diagnosing prostate cancer. The procedure does cause some pain and discomfort; therefore, an adequate analgesia is necessary to ensure patient comfort, which can also facilitate good-quality results. This prospective, randomized, double-blinded, placebo-controlled study aimed to determine if intravenous (IV) paracetamol can reduce the severity of pain associated with TRUS-PBx. The study included 104 patients, scheduled to undergo TRUS-PBx with a suspicion of prostate cancer, that were prospectively randomized to receive either IV paracetamol (paracetamol group) or placebo (placebo group) 30 minutes prior to TRUS-PBx. All patients had 12 standardized biopsy samples taken. Pain was measured using a 10-point visual analog pain scale during probe insertion, during the biopsy procedure, and 1 hour postbiopsy. All biopsies were performed by the same urologist, whereas a different urologist administered the visual analog pain scale. There were not any significant differences in age, prostate-specific antigen level, or prostate volume between the two groups. The pain scores were significantly lower during probe insertion, biopsy procedure, and 1 hour postbiopsy in the paracetamol group than in the placebo group. In conclusion, the IV administration of paracetamol significantly reduced the severity of pain associated with TRUS-PBx. Copyright © 2015. Published by Elsevier Taiwan.

  4. Silver sucrose octasulfate nasal applications and wound healing after endoscopic sinus surgery: a prospective, randomized, double-blind, placebo-controlled study.

    PubMed

    Ottaviano, Giancarlo; Blandamura, Stella; Fasanaro, Elena; Favaretto, Niccolo'; Andrea, Lovato; Giacomelli, Luciano; Bartolini, Andrea; Staffieri, Claudia; Marchese-Ragona, Rosario; Marioni, Gino; Staffieri, Alberto

    2015-01-01

    The aim of the present prospective, randomized, double-blind, and placebo-controlled investigation (approved by the Ethical Committee of Padova University Hospital [Italy]) was to assess the effect of a nasal gel containing a combination of silver sucrose octasulfate and potassium sucrose octasulfate (Silsos gel® [SG]) in wound healing after endoscopic sinus surgery (ESS) for chronic rhinosinusitis in terms of: nasal symptoms (SNOT22), endoscopic appearance of the sinonasal mucosa (Lund-Kennedy score), nasal air flow (anterior active rhinomanometry), evidence of mucosal inflammatory processes (nasal cytology and histology), and microbiological growth. Thirty-four patients with chronic rhinosinusitis were randomized on a 1:1 ratio to receive after ESS either SG or placebo (contained only the excipients [carbopol and propylene glycol] in the same concentrations as in SG). Judging from the present prospective investigation on patients who underwent ESS for chronic rhinosinusitis, treatment with SG seems to enable a significantly faster improvement in specific symptoms (assessed on the validated SNOT22 scale) than placebo. Patients treated with SG also had a quicker improvement in the endoscopic appearance of their nasal mucosa after ESS than patients treated with placebo. These endoscopic improvements in the SG group were also confirmed at the long-term follow-up, while the same did not apply to the placebo-treated group. Copyright © 2015 Elsevier Inc. All rights reserved.

  5. A randomized, controlled prospective trial of zolpidem and haloperidol for use as sleeping agents in pediatric burn patients.

    PubMed

    Armour, Alexis; Gottschlich, Michele M; Khoury, Jane; Warden, Glenn D; Kagan, Richard J

    2008-01-01

    Children with burn injuries often require hospital treatment where they are subjected to stimuli likely to produce sleep deprivation. Previously demonstrated sleep fragmentation and significantly reduced sleep stage 3/4 and rapid eye movement in this population led to a search for sleep-enhancing interventions. The purpose of this study was to evaluate the effects of selected therapeutic interventions on sleep architecture. Forty patients with a mean (+/-SEM) age of 9.4 +/- 0.7 years, mean total burn surface area of 50.1 +/- 2.9% and full thickness burns of 43.2 +/- 3.6% were randomly assigned to one of two treatment regimens using a blinded crossover design. Continuous polysomnographic recordings were obtained for six study periods. Each patient alternately received zolpidem one week and haloperidol the next, with the first monitored night conducted without medication. Zolpidem minimally increased the proportion of 3/4 and rapid eye movement sleep (0.81 +/- 0.16 vs 0.61 +/- 0.10 hrs, P = .02) but not total sleep time (4.8 +/- 0.3 vs 4.3 +/- 0.3 hrs on control nights, P = .1). Haloperidol significantly increased total sleep (5.3 +/- 0.3 vs 4.3 +/- 0.3 hrs on control nights, P = .02) and stage 2 sleep (3.3 +/- 0.3 vs 2.4 +/- 0.2 hrs, P = .001) compared with control nights. Both drugs slightly improved average sleep and wake period duration compared with control nights. Although sleep was somewhat improved by each test drug, there were no statistically significant differences between the drugs. Additional studies are needed to identify methods for improving restorative sleep postburn.

  6. A CONTROLLED RESUSCITATION STRATEGY IS FEASIBLE AND SAFE IN HYPOTENSIVE TRAUMA PATIENTS: RESULTS OF A PROSPECTIVE RANDOMIZED PILOT TRIAL

    PubMed Central

    Schreiber, Martin A.; Meier, Eric N.; Tisherman, Samuel A.; Kerby, Jeffrey D.; Newgard, Craig D.; Brasel, Karen; Egan, Debra; Witham, William; Williams, Carolyn; Daya, Mohamud; Beeson, Jeff; McCully, Belinda H.; Wheeler, Stephen; Kannas, Delores; May, Susanne; McKnight, Barbara; Hoyt, David B.

    2015-01-01

    BACKGROUND Optimal resuscitation of hypotensive trauma patients has not been defined. This trial was performed to assess the feasibility and safety of controlled resuscitation (CR) versus standard resuscitation (SR) in hypotensive trauma patients. METHODS Patients were enrolled and randomized in the out-of-hospital setting. 19 EMS systems in the Resuscitation Outcome Consortium participated. Eligible patients had an out-of-hospital systolic blood pressure (SBP) ≤ 90 mmHg. CR patients received 250 cc of fluid if they had no radial pulse or a SBP < 70 mmHg and additional 250 cc boluses to maintain a radial pulse or a SBP ≥ 70 mmHg. SR group patients received 2 liters initially and additional fluid as needed to maintain a SBP ≥ 110 mmHg. The crystalloid protocol was maintained until hemorrhage control or 2 hours after hospital arrival. RESULTS 192 patients were randomized (97 CR and 95 SR). The CR and SR groups were similar at baseline. Average crystalloid volume administered during the study period was 1.0 liter (SD 1.5) in the CR group and 2.0 liters (SD 1.4) in the SR group, a difference of 1.0 liter (95% CI: 0.6 to 1.4). ICU-free days, ventilator-free days, renal injury and renal failure did not differ between groups. At 24 hours after admission, there were 5 deaths (5%) in the CR group and 14 (15%) in the SR group (adjusted odds ratio 0.39 [95% CI: 0.12, 1.26]). Among patients with blunt trauma, 24-hour mortality was 3% (CR) and 18% (SR) with an adjusted OR of 0.17 (0.03, 0.92). There was no difference among patients with penetrating trauma: 9% vs 9%, adjusted OR 1.93 (0.19, 19.17). CONCLUSION Controlled resuscitation is achievable in out-of-hospital and hospital settings and may offer an early survival advantage in blunt trauma. A large-scale, Phase III trial to examine its effects on survival and other clinical outcomes is warranted. PMID:25807399

  7. Auricular Acupressure Reduces Anxiety Levels and Improves Outcomes of in Vitro Fertilization: A Prospective, Randomized and Controlled Study

    PubMed Central

    Qu, Fan; Zhang, Dan; Chen, Lu-Ting; Wang, Fang-Fang; Pan, Jie-Xue; Zhu, Yi-Min; Ma, Chun-Mei; Huang, Yi-Ting; Ye, Xiao-Qun; Sun, Sai-Jun; Zheng, Wen-Jun; Zhang, Run-Ju; Xu, Jian; Xing, Lan-Feng; Huang, He-Feng

    2014-01-01

    The study was to explore whether auricular acupressure (AA) can relieve anxiety during the period from trans-vaginal oocyte retrieval to the embryo transfer in IVF treatment and whether AA can improve the outcomes of IVF. 305 infertile patients with tubal blockage who were referred for IVF were included. The women were randomized into a control group with 102 cases, a Sham-AA group with 102 cases and an AA group with 101 cases. The anxiety levels were rated with Spielberger's State Trait Anxiety Inventory and the Amsterdam Preoperative Anxiety and Information Scale. Data of clinical pregnancy rate (CPR), implantation rate (IR) and live birth rate (LBR) were obtained. The levels of neuropeptide Y (NPY) and transforming growth factor alpha (TGF-alpha) in the follicular fluids were detected with ELISA. After treatment, in AA group, the levels of state anxiety, preoperative anxiety and need-for-information were significantly lower, whereas CPR, IR, LBR and NPY levels in the follicular fluids were markedly higher than Sham-AA group and control group. We concluded that AA could help to reduce anxiety levels associated with IVF and improves the outcomes of IVF partly through increasing the levels of NPY in the follicular fluids. PMID:24848522

  8. The analgesic efficacy of intravenous lidocaine infusion after laparoscopic fundoplication: a prospective, randomized, double-blind, placebo-controlled trial.

    PubMed

    Dale, Gregory J; Phillips, Stephanie; Falk, Gregory L

    2016-01-01

    This study aimed to determine if intravenous lidocaine infusion reduces postoperative pain intensity following laparoscopic fundoplication surgery and to also validate the safety of intravenous lidocaine at the dose tested. This was an equally randomized, double-blind, placebo-controlled, parallel-group, single center trial. Adult patients undergoing laparoscopic fundoplication were recruited. The intervention group received 1 mg/kg intravenous lidocaine bolus prior to induction of anesthesia, then an intravenous infusion at 2 mg/kg/h for 24 hours. The primary outcome was pain, measured using a numeric rating scale for 30 hours postoperatively. Secondary outcomes were nausea and vomiting, opioid requirements, adverse events, serum lidocaine concentration, and length of hospital stay. The study was terminated after an interim analysis of 24 patients showed evidence of futility. There was no difference in postoperative pain scores (lidocaine versus control, mean ± standard deviation) at rest (2.0 ± 2.7 vs 2.1 ± 2.4, P=0.286) or with movement (2.0 ± 2.6 vs 2.6 ± 2.7, P=0.487). Three adverse events occurred in the lidocaine group (25% of patients). Intravenous lidocaine did not provide clinically significant analgesia to patients undergoing laparoscopic fundoplication. The serum lidocaine concentration of patients who experienced adverse events were within the therapeutic range. This trial cannot confirm the safety of intravenous lidocaine at the dose tested.

  9. The analgesic efficacy of intravenous lidocaine infusion after laparoscopic fundoplication: a prospective, randomized, double-blind, placebo-controlled trial

    PubMed Central

    Dale, Gregory J; Phillips, Stephanie; Falk, Gregory L

    2016-01-01

    This study aimed to determine if intravenous lidocaine infusion reduces postoperative pain intensity following laparoscopic fundoplication surgery and to also validate the safety of intravenous lidocaine at the dose tested. This was an equally randomized, double-blind, placebo-controlled, parallel-group, single center trial. Adult patients undergoing laparoscopic fundoplication were recruited. The intervention group received 1 mg/kg intravenous lidocaine bolus prior to induction of anesthesia, then an intravenous infusion at 2 mg/kg/h for 24 hours. The primary outcome was pain, measured using a numeric rating scale for 30 hours postoperatively. Secondary outcomes were nausea and vomiting, opioid requirements, adverse events, serum lidocaine concentration, and length of hospital stay. The study was terminated after an interim analysis of 24 patients showed evidence of futility. There was no difference in postoperative pain scores (lidocaine versus control, mean ± standard deviation) at rest (2.0 ± 2.7 vs 2.1 ± 2.4, P=0.286) or with movement (2.0 ± 2.6 vs 2.6 ± 2.7, P=0.487). Three adverse events occurred in the lidocaine group (25% of patients). Intravenous lidocaine did not provide clinically significant analgesia to patients undergoing laparoscopic fundoplication. The serum lidocaine concentration of patients who experienced adverse events were within the therapeutic range. This trial cannot confirm the safety of intravenous lidocaine at the dose tested. PMID:27980437

  10. Auricular acupressure reduces anxiety levels and improves outcomes of in vitro fertilization: a prospective, randomized and controlled study.

    PubMed

    Qu, Fan; Zhang, Dan; Chen, Lu-Ting; Wang, Fang-Fang; Pan, Jie-Xue; Zhu, Yi-Min; Ma, Chun-Mei; Huang, Yi-Ting; Ye, Xiao-Qun; Sun, Sai-Jun; Zheng, Wen-Jun; Zhang, Run-Ju; Xu, Jian; Xing, Lan-Feng; Huang, He-Feng

    2014-05-22

    The study was to explore whether auricular acupressure (AA) can relieve anxiety during the period from trans-vaginal oocyte retrieval to the embryo transfer in IVF treatment and whether AA can improve the outcomes of IVF. 305 infertile patients with tubal blockage who were referred for IVF were included. The women were randomized into a control group with 102 cases, a Sham-AA group with 102 cases and an AA group with 101 cases. The anxiety levels were rated with Spielberger's State Trait Anxiety Inventory and the Amsterdam Preoperative Anxiety and Information Scale. Data of clinical pregnancy rate (CPR), implantation rate (IR) and live birth rate (LBR) were obtained. The levels of neuropeptide Y (NPY) and transforming growth factor alpha (TGF-alpha) in the follicular fluids were detected with ELISA. After treatment, in AA group, the levels of state anxiety, preoperative anxiety and need-for-information were significantly lower, whereas CPR, IR, LBR and NPY levels in the follicular fluids were markedly higher than Sham-AA group and control group. We concluded that AA could help to reduce anxiety levels associated with IVF and improves the outcomes of IVF partly through increasing the levels of NPY in the follicular fluids.

  11. Hemodynamic Consequences of Malignant Ascites in Epithelial Ovarian Cancer Surgery*: A Prospective Substudy of a Randomized Controlled Trial.

    PubMed

    Hunsicker, Oliver; Fotopoulou, Christina; Pietzner, Klaus; Koch, Mandy; Krannich, Alexander; Sehouli, Jalid; Spies, Claudia; Feldheiser, Aarne

    2015-12-01

    Malignant ascites (MA) is most commonly observed in patients scheduled for epithelial ovarian cancer (EOC) surgery and is supposed as a major risk factor promoting perioperative hemodynamic deterioration. We aimed to assess the hemodynamic consequences of MA on systemic circulation in patients undergoing cytoreductive EOC surgery.This study is a predefined post-hoc analysis of a randomized controlled pilot trial comparing intravenous solutions within a goal-directed algorithm to optimize hemodynamic therapy in patients undergoing cytoreductive EOC surgery. Ascites was used to stratify the EOC patients prior to randomization in the main study. We analyzed 2 groups according to the amount of ascites (NLAS: none or low ascites [<500 mL] vs HAS: high ascites group [>500 mL]). Differences in hemodynamic variables with respect to time were analyzed using nonparametric analysis for longitudinal data and multivariate generalized estimating equation adjusting the analysis for the randomized study groups of the main study.A total of 31 patients in the NLAS and 16 patients in the HAS group were analyzed. Although cardiac output was not different between groups suggesting a similar circulatory blood flow, the HAS group revealed higher heart rates and lower stroke volumes during surgery. There were no differences in pressure-based hemodynamic variables. In the HAS group, fluid demands, reflected by the time to reindication of a fluid challenge after preload optimization, increased steadily, whereas stroke volume could not be maintained at baseline resulting in hemodynamic instability after 1.5 h of surgery. In contrast, in the NLAS group fluid demands were stable and stroke volume could be maintained during surgery. Clinically relevant associations of the type of fluid replacement with hemodynamic consequences were particularly observed in the HAS group, in which transfusion of fresh frozen plasma (FFP) was associated to an improved circulatory flow and reduced

  12. Symptomatic improvement with gluten restriction in irritable bowel syndrome: a prospective, randomized, double blinded placebo controlled trial

    PubMed Central

    Pawar, Sunil V; Gambhire, Pravir A; Jain, Samit S; Surude, Ravindra G; Shah, Vinaya B; Contractor, Qais Q; Rathi, Pravin M

    2016-01-01

    Background/Aims The existence of non-celiac gluten sensitivity has been debated. Indeed, the intestinal and extra-intestinal symptoms of many patients with irritable bowel syndrome (IBS) but without celiac disease or wheat allergy have been shown to improve on a gluten-free diet. Therefore, this study set out to evaluate the effects of gluten on IBS symptoms. Methods We performed a double-blind randomized placebo-controlled rechallenge trial in a tertiary care hospital with IBS patients who fulfilled the Rome III criteria. Patients with celiac disease and wheat allergy were appropriately excluded. The participants were administered a gluten-free diet for 4 weeks and were asked to complete a symptom-based questionnaire to assess their overall symptoms, abdominal pain, bloating, wind, and tiredness on the visual analog scale (0-100) at the baseline and every week thereafter. The participants who showed improvement were randomly assigned to one of two groups to receive either a placebo (gluten-free breads) or gluten (whole cereal breads) as a rechallenge for the next 4 weeks. Results In line with the protocol analysis, 60 patients completed the study. The overall symptom score on the visual analog scale was significantly different between the two groups (P<0.05). Moreover, the patients in the gluten intervention group scored significantly higher in terms of abdominal pain, bloating, and tiredness (P<0.05), and their symptoms worsened within 1 week of the rechallenge. Conclusions A gluten diet may worsen the symptoms of IBS patients. Therefore, some form of gluten sensitivity other than celiac disease exists in some of them, and patients with IBS may benefit from gluten restrictions. PMID:27799885

  13. Performance of zirconia ceramic cantilever fixed dental prostheses: 3-year results from a prospective, randomized, controlled pilot study.

    PubMed

    Zenthöfer, Andreas; Ohlmann, Brigitte; Rammelsberg, Peter; Bömicke, Wolfgang

    2015-07-01

    Little is known about the clinical performance of ceramic cantilever fixed dental prostheses on natural teeth. The purpose of this randomized controlled pilot study was to evaluate the clinical performance of ceramic and metal ceramic cantilever fixed dental prostheses (CFDPs) after 3 years of service. Twenty-one participants were randomly allocated to 2 treatment groups. Participants in the ceramic (ZC) group (n=11) each received 1 CFDP made of yttria-stabilized, tetragonal zirconia polycrystal; the others (n=10) were fitted with a metal ceramic (MC) CFDP. All CFDPs were retained by 2 complete crown abutments and replaced 1 tooth. The clinical target variables were survival, incidence of complications, probing pocket depth (PPD), probing attachment level (PAL), plaque index (PI), gingival index (GI), and esthetic performance as rated by the participants. The United States Public Health Service (USPHS) criteria were used to evaluate chipping, retention, color, marginal integrity, and secondary caries. Descriptive statistics and nonparametric analyses were applied to the target variables in the 2 groups. The esthetic performance of the CFDPs was also visualized by using a pyramid comparison. The overall survival of the CFDPs was 100% in both groups. During the 3-year study, 6 clinically relevant complications requiring aftercare were observed among 5 participants (4 in the ZC group and 2 in the MC group). Changes in the PI, GI, PPD, and PAL of the abutment teeth were similar for both groups (P>.05). The participants regarded the esthetic performance of ZC-CFDPs and MC-CFDPs as satisfactory. Within the 3-year observation period, the clinical performance of MC-FDPs and ZC-FDPs was acceptable. More extensive research with larger sample sizes is encouraged, however, to confirm the evaluation of the survival of Y-TZP hand-veneered cantilever FPDs. Copyright © 2015 Editorial Council for the Journal of Prosthetic Dentistry. Published by Elsevier Inc. All rights reserved.

  14. Symptomatic improvement with gluten restriction in irritable bowel syndrome: a prospective, randomized, double blinded placebo controlled trial.

    PubMed

    Zanwar, Vinay G; Pawar, Sunil V; Gambhire, Pravir A; Jain, Samit S; Surude, Ravindra G; Shah, Vinaya B; Contractor, Qais Q; Rathi, Pravin M

    2016-10-01

    The existence of non-celiac gluten sensitivity has been debated. Indeed, the intestinal and extra-intestinal symptoms of many patients with irritable bowel syndrome (IBS) but without celiac disease or wheat allergy have been shown to improve on a gluten-free diet. Therefore, this study set out to evaluate the effects of gluten on IBS symptoms. We performed a double-blind randomized placebo-controlled rechallenge trial in a tertiary care hospital with IBS patients who fulfilled the Rome III criteria. Patients with celiac disease and wheat allergy were appropriately excluded. The participants were administered a gluten-free diet for 4 weeks and were asked to complete a symptom-based questionnaire to assess their overall symptoms, abdominal pain, bloating, wind, and tiredness on the visual analog scale (0-100) at the baseline and every week thereafter. The participants who showed improvement were randomly assigned to one of two groups to receive either a placebo (gluten-free breads) or gluten (whole cereal breads) as a rechallenge for the next 4 weeks. In line with the protocol analysis, 60 patients completed the study. The overall symptom score on the visual analog scale was significantly different between the two groups (P<0.05). Moreover, the patients in the gluten intervention group scored significantly higher in terms of abdominal pain, bloating, and tiredness (P<0.05), and their symptoms worsened within 1 week of the rechallenge. A gluten diet may worsen the symptoms of IBS patients. Therefore, some form of gluten sensitivity other than celiac disease exists in some of them, and patients with IBS may benefit from gluten restrictions.

  15. Efficacy and safety of deep transcranial magnetic stimulation for major depression: a prospective multicenter randomized controlled trial

    PubMed Central

    Levkovitz, Yechiel; Isserles, Moshe; Padberg, Frank; Lisanby, Sarah H; Bystritsky, Alexander; Xia, Guohua; Tendler, Aron; Daskalakis, Zafiris J; Winston, Jaron L; Dannon, Pinhas; Hafez, Hisham M; Reti, Irving M; Morales, Oscar G; Schlaepfer, Thomas E; Hollander, Eric; Berman, Joshua A; Husain, Mustafa M; Sofer, Uzi; Stein, Ahava; Adler, Shmulik; Deutsch, Lisa; Deutsch, Frederic; Roth, Yiftach; George, Mark S; Zangen, Abraham

    2015-01-01

    Major depressive disorder (MDD) is a prevalent and disabling condition, and many patients do not respond to available treatments. Deep transcranial magnetic stimulation (dTMS) is a new technology allowing non-surgical stimulation of relatively deep brain areas. This is the first double-blind randomized controlled multicenter study evaluating the efficacy and safety of dTMS in MDD. We recruited 212 MDD outpatients, aged 22–68 years, who had either failed one to four antidepressant trials or not tolerated at least two antidepressant treatments during the current episode. They were randomly assigned to monotherapy with active or sham dTMS. Twenty sessions of dTMS (18 Hz over the prefrontal cortex) were applied during 4 weeks acutely, and then biweekly for 12 weeks. Primary and secondary efficacy endpoints were the change in the Hamilton Depression Rating Scale (HDRS-21) score and response/remission rates at week 5, respectively. dTMS induced a 6.39 point improvement in HDRS-21 scores, while a 3.28 point improvement was observed in the sham group (p+0.008), resulting in a 0.76 effect size. Response and remission rates were higher in the dTMS than in the sham group (response: 38.4 vs. 21.4%, p+0.013; remission: 32.6 vs. 14.6%, p+0.005). These differences between active and sham treatment were stable during the 12-week maintenance phase. dTMS was associated with few and minor side effects apart from one seizure in a patient where a protocol violation occurred. These results suggest that dTMS constitutes a novel intervention in MDD, which is efficacious and safe in patients not responding to antidepressant medications, and whose effect remains stable over 3 months of maintenance treatment. PMID:25655160

  16. Efficacy of 10% sucralfate ointment after anal fistulotomy: A prospective, double-blind, randomized, placebo-controlled trial.

    PubMed

    Alvandipour, Mina; Ala, Shahram; Tavakoli, Hasan; Yazdani Charati, Jamshid; Shiva, Afshin

    2016-12-01

    The most frequent problems after anal fistulotomy are pain, bleeding, and delayed or impaired wound healing. Topical Sucralfate preparation has been used to treat a wide variety of wounds. In this study, we investigate effects of 10% sucralfate ointment on wound healing and postoperative pain after fistulotomy. A total of 41 patients undergoing anorectal fistulotomy were included in this randomized, blinded, controlled trial and were randomly allocated to either sucralfate ointment (every 12 h) or placebo. The patients were visited weekly for up to 5 weeks. The intensity of pain and the wound healing were assessed. The sucralfate group had significantly less pain at rest (1.92 ± 0.88 vs 2.96 ± 0.98; P = 0.002) and on defecation (1.68 ± 0.92 vs 3.08 ± 1.12; p < 0.001) than the placebo group from 1st to 5th post-operative visits. Complete wound healing was achieved after 8.15 ± 1 weeks in placebo group versus 5.9 ± 0.8 weeks in sucralfate group (p < 0.001). There were no significant differences in the frequencies of postoperative complications between the two groups. Compared with placebo, sucralfate ointment reduced postoperative pain at rest and on defecation and improves wound healing in patients undergoing fistulotomy. Copyright © 2016 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  17. Short-Term Outcome After Arthroscopic Bursectomy Debridement of Rotator Cuff Calcific Tendonopathy With and Without Subacromial Decompression: A Prospective Randomized Controlled Trial.

    PubMed

    Clement, Nicholas D; Watts, Adam C; Phillips, Christine; McBirnie, Julie M

    2015-09-01

    To conduct a prospective randomized controlled trial to assess whether arthroscopic bursectomy and debridement of the calcific deposit, with or without subacromial decompression, influences the functional outcome of patients with calcific tendonitis. During a 4-year period, 80 patients were recruited who presented to the study center with refractory calcific tendonitis of the shoulder. Forty patients were randomized to have a subacromial decompression, and 40 were randomized not to have a subacromial decompression in combination with bursectomy and arthroscopic removal of the calcific deposit. All surgery was performed by one surgeon who was blinded to the functional assessment of the patients. Patient demographics, body mass index (BMI), and length of symptoms were recorded at the time of randomization. Patients were asked to complete a pain visual analog score (VAS), short form (SF-12), disability arm shoulder and hand (DASH), and Constant score (CS) preoperatively and at 1 year postoperatively. There were 21 male and 59 female patients with a mean age of 49 (range, 32 to 75) years. The mean time of follow-up was 13 (range, 12 to 15) months. There were no significant differences in gender, age, BMI, length of symptoms, or preoperative outcome measures assessed between the groups. Overall, for both groups there was a significant improvement in the pain VAS (P < .001), DASH (P < .001), and CS (P < .001) at 1 year compared with preoperative scores. There were no significant differences demonstrated between the groups for improvement in the pain VAS (P = .57), DASH (P = .93), SF-12 physical component score (P = .58), or CS (P = .27) at 1 year. This study has demonstrated that the short-term functional outcome of patients with calcific tendonitis after arthroscopic bursectomy and debridement of the calcific deposit is not influenced if performed in combination with or without a subacromial decompression. Level I therapeutic study, randomized controlled trial

  18. Prospective molecular marker analyses of EGFR and KRAS from a randomized, placebo-controlled study of erlotinib maintenance therapy in advanced non-small-cell lung cancer.

    PubMed

    Brugger, Wolfram; Triller, Nadja; Blasinska-Morawiec, Maria; Curescu, Stefan; Sakalauskas, Raimundas; Manikhas, Georgy Moiseevich; Mazieres, Julien; Whittom, Renaud; Ward, Carol; Mayne, Karen; Trunzer, Kerstin; Cappuzzo, Federico

    2011-11-01

    The phase III, randomized, placebo-controlled Sequential Tarceva in Unresectable NSCLC (SATURN; BO18192) study found that erlotinib maintenance therapy extended progression-free survival (PFS) and overall survival in patients with advanced non-small-cell lung cancer (NSCLC) who had nonprogressive disease following first-line platinum-doublet chemotherapy. This study included prospective analysis of the prognostic and predictive value of several biomarkers. Mandatory diagnostic tumor specimens were collected before initiating first-line chemotherapy and were tested for epidermal growth factor receptor (EGFR) protein expression by using immunohistochemistry (IHC), EGFR gene copy number by using fluorescent in situ hybridization (FISH), and EGFR and KRAS mutations by using DNA sequencing. An EGFR CA simple sequence repeat in intron 1 (CA-SSR1) polymorphism was evaluated in blood. All 889 randomly assigned patients provided tumor samples. EGFR IHC, EGFR FISH, KRAS mutation, and EGFR CA-SSR1 repeat length status were not predictive for erlotinib efficacy. A profound predictive effect on PFS of erlotinib relative to placebo was observed in the EGFR mutation-positive subgroup (hazard ratio [HR], 0.10; P < .001). Significant PFS benefits were also observed with erlotinib in the wild-type EGFR subgroup (HR, 0.78; P = .0185). KRAS mutation status was a significant negative prognostic factor for PFS. This large prospective biomarker study found that patients with activating EGFR mutations derive the greatest PFS benefit from erlotinib maintenance therapy. No other biomarkers were predictive for outcomes with erlotinib, although the study was not powered for clinical outcomes in biomarker subgroups other than EGFR IHC-positive [corrected]. KRAS mutations were prognostic for reduced PFS. The study demonstrated the feasibility of prospective tissue collection for biomarker analyses in NSCLC.

  19. Tenoxicam 20 mg or 40 mg after thoracotomy: a prospective, randomized, double-blind, placebo-controlled study.

    PubMed

    Merry, A F; Sidebotham, D A; Middleton, N G; Calder, M V; Webster, C S

    2002-04-01

    Forty-five adults undergoing thoracotomy were randomized to receive placebo, tenoxicam 20 mg or tenoxicam 40 mg IV during chest wall closure. All patients received intraoperative fentanyl and intercostal blocks followed by morphine by patient-controlled analgesia. Patient numbers 13 to 45 also received thoracic epidural analgesia by continuous infusion of bupivacaine 0.125%, patient numbers 25 to 45 having fentanyl 2 microg/ml added to the epidural infusion. Efficacy parameters and adverse reactions were assessed over the first 24 hours postoperatively. On a 100 mm visual analogue scale, mean (SD) pain at rest (adjusted area under curve for hours 1 to 24) was 25.8 (12.5), 17.4 (14.8) and 16.5 (13.3) mm for groups receiving placebo, 20 mg and 40 mg tenoxicam, respectively (ANOVA: P<0.05). There were no significant differences between study groups postoperatively in pain on coughing, opioid consumption, blood gas measurements, nausea, vomiting, sedation, blood loss, haemoglobin or serum creatinine. One patient in each tenoxicam group reported epigastric pain, rated moderate. These data support the inclusion of tenoxicam 20 mg IV in the management of pain at rest for patients undergoing thoracotomy, but do not show additional benefit for a higher dose.

  20. Endoscopic versus transcranial procurement of allograft tympano-ossicular systems: a prospective double-blind randomized controlled audit.

    PubMed

    Caremans, Jeroen; Hamans, Evert; Muylle, Ludo; Van de Heyning, Paul; Van Rompaey, Vincent

    2016-06-01

    Allograft tympano-ossicular systems (ATOS) have proven their use over many decades in tympanoplasty and reconstruction after resection of cholesteatoma. The transcranial bone plug technique has been used in the past 50 years to procure en bloc ATOS (tympanic membrane with malleus, incus and stapes attached). Recently, our group reported the feasibility of the endoscopic procurement technique. The aim of this study was to assess whether clinical outcome is equivalent in ATOS acquired by using the endoscopic procurement technique compared to ATOS acquired by using the transcranial technique. A double-blind randomized controlled audit was performed in a tertiary referral center in patients that underwent allograft tympanoplasty because of chronic otitis media with and without cholesteatoma. Allograft epithelialisation was evaluated at the short-term postoperative visit by microscopic examination. Failures were reported if reperforation was observed. Fifty patients underwent allograft tympanoplasty: 34 received endoscopically procured ATOS and 16 received transcranially procured ATOS. One failed case was observed, in the endoscopic procurement group. We did not observe a statistically significant difference between the two groups in failure rate. This study demonstrates equivalence of the clinical outcome of allograft tympanoplasty using either endoscopic or transcranial procured ATOS and therefore indicates that the endoscopic technique can be considered the new standard procurement technique. Especially because the endoscopic procurement technique has several advantages compared to the former transcranial procurement technique: it avoids risk of prion transmission and it is faster while lacking any noticeable incision.

  1. Role of silicone derivative plus onion extract gel in presternal hypertrophic scar protection: a prospective randomized, double blinded, controlled trial.

    PubMed

    Jenwitheesuk, Kamonwan; Surakunprapha, Palakorn; Jenwitheesuk, Kriangsak; Kuptarnond, Chusak; Prathanee, Sompop; Intanoo, Worawit

    2012-08-01

    Use of silicone derivative and onion extract had been reported in the prevention of hypertrophic scarring. Our experience showed the preventive use of silicone derivative plus onion extract gel on hypertrophic scars after median sternotomy. In a randomized, double blinded, placebo-controlled study, 60 patients after median sternotomy incisions were separated into two groups. All patients were treated either with silicone derivative plus onion extract gel (Cybele(®) scagel) or placebo gel twice daily for a total treatment period of 12 weeks. During each visit, pain and itching scores were graded by the patients and scar characteristics were observed by surgeons using the Vancouver scar scale. Pain and itch score values from patients' who applied silicone derivative plus onion extract gel was less than another group (P < 0·05). Pigmentation was significantly different between two groups (P < 0·05) and the reduction of scores on vascularity, pliability, height in treated group was not superior to the untreated group. No adverse events were reported by any of the patients. A silicone derivative plus onion extract gel is safe and effective for the preventing the hypertrophic scarring after median sternotomy. © 2011 The Authors. © 2011 Blackwell Publishing Ltd and Medicalhelplines.com Inc.

  2. Are postoperative intravenous antibiotics necessary after bimaxillary orthognathic surgery? A prospective, randomized, double-blind, placebo-controlled clinical trial.

    PubMed

    Tan, S K; Lo, J; Zwahlen, R A

    2011-12-01

    Postoperative antibiotic prophylaxis is often administered intravenously, despite an increased morbidity rate compared with oral application. This study investigates whether a postoperative oral antibiotic regimen is as effective as incorporation of intravenous antibiotics after bimaxillary orthognathic surgery. 42 patients who underwent bimaxillary orthognathic surgery between December 2008 and May 2010 were randomly allocated to 2 placebo-controlled postoperative antibiotic prophylaxis groups. Group 1 received oral amoxicillin 500mg three times daily; group 2 received intravenous ampicillin 1g four times daily, during the first two postoperative days. Both groups subsequently took oral amoxicillin for three more days. Clinically, the infection rate was assessed in both study groups for a period of 6 weeks after the surgery. 9 patients (21.4%) developed infection. No adverse drug event was detected. No significant difference (p=0.45) was detected in the infection rate between group 1 (3/21) and group 2 (6/21). Age, type of surgical procedures, duration of the operative procedure, surgical procedure-related events, blood loss, and blood transfusion were all found not related to infection (p>0.05). Administration of more cost-effective oral antibiotic prophylaxis, which causes less comorbidity, can be considered to be safe in bimaxillary orthognathic surgery with segmentalizations. Copyright © 2011 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  3. Flavonoids mixture (diosmin, troxerutin, hesperidin) in the treatment of acute hemorrhoidal disease: a prospective, randomized, triple-blind, controlled trial.

    PubMed

    Giannini, I; Amato, A; Basso, L; Tricomi, N; Marranci, M; Pecorella, G; Tafuri, S; Pennisi, D; Altomare, D F

    2015-06-01

    The role of a mixture of phlebotonics in the treatment of acute hemorrhoid crisis is investigated to test their efficacy. One hundred and thirty-four consecutive patients with an acute hemorrhoidal crisis recruited in five colorectal units entered the study. Sixty-six of them were randomized to receive a mixture of diosmin, troxerutin and hesperidin (group A), and 68 a placebo (group B). The main symptoms, the use of oral painkillers and the Bristol scale score were recorded at each scheduled visit and compared using both Student's t test for independent samples and the ANOVA models for repeated measures. The presence of edema, prolapse and thrombosis were also recorded and compared using the Chi-square test. Furthermore, the trend of proportions during the time of the evaluations was assessed by the Chi-square test for linear trend. Pain, bleeding and the proportion of patients who reported persistence of edema and thrombosis decreased significantly after 12 days of treatment in group A. After 6 days, the number of paracetamol tablets taken by patients in group A was significantly lower than the amount of flavonoid mixture. The use of a mixture of diosmin, troxerutin and hesperidin is a safe and effective mean of managing symptoms of acute hemorrhoidal disease. Furthermore, in patients receiving treatment, there was faster control and lower persistence of edema and thrombosis.

  4. [Effects of three-stage rehabilitation treatment on acute cerebrovascular diseases: a prospective, randomized, controlled, multicenter study].

    PubMed

    Zhang, Tong; Li, Li-lin; Bi, Sheng; Mei, Yuan-wu; Xie, Rui-man; Luo, Zu-ming; Wang, De-sheng; Wang, Wei-zhi; Wang, Ning-hua; Jia, Jian-ping; Tan, Lan; Ding, Xin-sheng; Cui, Li-ying; Wang, De-xin; Hu, Xue-qiang; Niu, Zhu

    2004-12-02

    To evaluate the effect of tertiary rehabilitation treatment on acute cerebrovascular diseases. Fifteen tertiary rehabilitation networks were set up throughout the country. 1078 patients with acute cerebrovascular diseases were randomly divided into 2 groups: rehabilitation group and control group, out of which 19 patients died, 157 dropped out, and 7 successive evaluations were completed in 902 patients that. 439 of the remaining 902 patients in the rehabilitation group, 266 males and 173 females, aged 61 +/- 11, 278 cases with cerebral infarction and 161 with cerebral hemorrhage, received routine treatment and early rehabilitation for 28 days in the ward of neurology, and then went home and received community rehabilitation for 6 months or underwent specialized reinforcement training for 2 months and after that went home and received community rehabilitation for 4 months. The 463 patients in the control group, 281 males and 182 females, aged 60 +/- 11, 291 of which with cerebral infarction and 172 with cerebral hemorrhage, received only routine treatment and early rehabilitation for 28 days in the ward of neurology, and then went home to conduct rehabilitation training by themselves or their family members for 6 months. Evaluation was conducted 7 times, with National Institutes of Health Stroke Scale (NIHSS), Fugl-Meyer motor function scale, Barthel index, SF-36 scale, Lowenstein occupational therapy cognitive assessment (LOTCA), Westen aphasia battery, Hamilton depression scale, and modified Ashworth spasm scale, one week after the onset and by the ends of 1, 2, 3, 4, 5, and 6 months after the onset respectively. The scores of clinical neurological impairment, Fugl-Meyer scores, SF-36 scores, incidence of PSD, and modified Ashworth scores (for upper and lower limbs) were lower, and LOTCA scores and Barthel indexes were higher at different time points in the rehabilitation group than in the control group; and the differences were statistically significant since

  5. Intravenous Lidocaine for Effective Pain Relief After a Laparoscopic Colectomy: A Prospective, Randomized, Double-Blind, Placebo-Controlled Study

    PubMed Central

    Ahn, EunJin; Kang, Hyun; Choi, Geun Joo; Park, Yong Hee; Yang, So Young; Kim, Beom Gyu; Choi, Seung Won

    2015-01-01

    A perioperative intravenous lidocaine infusion has been reported to decrease postoperative pain. The goal of this study was to evaluate the effectiveness of intravenous lidocaine in reducing postoperative pain for laparoscopic colectomy patients. Fifty-five patients scheduled for an elective laparoscopic colectomy were randomly assigned to 2 groups. Group L received an intravenous bolus injection of lidocaine 1.5 mg/kg before intubation, followed by 2 mg/kg/h continuous infusion during the operation. Group C received the same dosage of saline at the same time. Postoperative pain was assessed at 2, 4, 8, 12, 24, and 48 hours after surgery by using the visual analog scale (VAS). Fentanyl consumption by patient-controlled plus investigator-controlled rescue administration and the total number of button pushes were measured at 2, 4, 8, 12, 24, and 48 hours after surgery. In addition, C-reactive protein (CRP) levels were checked on the operation day and postoperative days 1, 2, 3, and 5. VAS scores were significantly lower in group L than group C until 24 hours after surgery. Fentanyl consumption was lower in group L than group C until 12 hours after surgery. Moreover, additional fentanyl injections and the total number of button pushes appeared to be lower in group L than group C (P < 0.05). The CRP level tended to be lower in group L than group C, especially on postoperative day1 and 2 and appeared to be statistically significant. The satisfaction score was higher in group L than group C (P = 0.024). Intravenous lidocaine infusion during an operation reduces pain after a laparoscopic colectomy. PMID:25785316

  6. Intravenous lidocaine for effective pain relief after a laparoscopic colectomy: a prospective, randomized, double-blind, placebo-controlled study.

    PubMed

    Ahn, EunJin; Kang, Hyun; Choi, Geun Joo; Park, Yong Hee; Yang, So Young; Kim, Beom Gyu; Choi, Seung Won

    2015-03-01

    A perioperative intravenous lidocaine infusion has been reported to decrease postoperative pain. The goal of this study was to evaluate the effectiveness of intravenous lidocaine in reducing postoperative pain for laparoscopic colectomy patients. Fifty-five patients scheduled for an elective laparoscopic colectomy were randomly assigned to 2 groups. Group L received an intravenous bolus injection of lidocaine 1.5 mg/kg before intubation, followed by 2 mg/kg/h continuous infusion during the operation. Group C received the same dosage of saline at the same time. Postoperative pain was assessed at 2, 4, 8, 12, 24, and 48 hours after surgery by using the visual analog scale (VAS). Fentanyl consumption by patient-controlled plus investigator-controlled rescue administration and the total number of button pushes were measured at 2, 4, 8, 12, 24, and 48 hours after surgery. In addition, C-reactive protein (CRP) levels were checked on the operation day and postoperative days 1, 2, 3, and 5. VAS scores were significantly lower in group L than group C until 24 hours after surgery. Fentanyl consumption was lower in group L than group C until 12 hours after surgery. Moreover, additional fentanyl injections and the total number of button pushes appeared to be lower in group L than group C (P < 0.05). The CRP level tended to be lower in group L than group C, especially on postoperative day 1 and 2 and appeared to be statistically significant. The satisfaction score was higher in group L than group C (P = 0.024). Intravenous lidocaine infusion during an operation reduces pain after a laparoscopic colectomy.

  7. Bupivacaine Versus Liposomal Bupivacaine for Postoperative Pain Control after Augmentation Mammaplasty: A Prospective, Randomized, Double-Blind Trial.

    PubMed

    Nadeau, Meghan H; Saraswat, Anju; Vasko, Alexander; Elliott, John O; Vasko, Susan D

    2016-02-01

    The long-acting preparation of bupivacaine, liposomal bupivacaine (EXPAREL, Pacira Pharmaceuticals, Inc., San Diego, CA), was approved by the Food and Drug Administration in October 2011 and has been shown to be safe in breast augmentation. It remains to be established if liposomal bupivacaine provides superior pain control in this setting. This study compares liposomal bupivacaine and standard bupivacaine for postoperative pain control. Thirty-four patients undergoing cosmetic primary subpectoral breast augmentation were recruited. Each patient was treated with bupivacaine in one implant pocket and liposomal bupivacaine in the other prior to closure in a randomized fashion. Both patient and surgeon were blinded. A brief pain inventory was administered by telephone every 12 h up to 72 h postoperatively. Liposomal bupivacaine demonstrated a statistically significantly lower pain score at the 12, 36, and 48 h time points in the worst pain category, at the 24, 36, 48, and 60 h time points in the least pain category, at the 12, 24, 36, 48, 60, and 72 h time points in the average pain category, and at the 24, 48, and 72 h time points in the pain rated at the time of the survey. These differences, however, were small, ranging from 0.08 to 0.98 using a 10-point pain scale. When asked if the additional charge for the liposomal bupivacaine would have been worth the benefit, 70% of the patients surveyed said "no." Although there is a statistically significant decrease in postoperative pain with the use of liposomal bupivacaine, this may not translate to an appreciable clinical benefit that justifies the additional cost. LEVEL OF EVIDENCE 3: Therapeutic. © 2015 The American Society for Aesthetic Plastic Surgery, Inc. Reprints and permission: journals.permissions@oup.com.

  8. Virtual reality robotic surgery warm-up improves task performance in a dry laboratory environment: a prospective randomized controlled study.

    PubMed

    Lendvay, Thomas S; Brand, Timothy C; White, Lee; Kowalewski, Timothy; Jonnadula, Saikiran; Mercer, Laina D; Khorsand, Derek; Andros, Justin; Hannaford, Blake; Satava, Richard M

    2013-06-01

    Preoperative simulation warm-up has been shown to improve performance and reduce errors in novice and experienced surgeons, yet existing studies have only investigated conventional laparoscopy. We hypothesized that a brief virtual reality (VR) robotic warm-up would enhance robotic task performance and reduce errors. In a 2-center randomized trial, 51 residents and experienced minimally invasive surgery faculty in General Surgery, Urology, and Gynecology underwent a validated robotic surgery proficiency curriculum on a VR robotic simulator and on the da Vinci surgical robot (Intuitive Surgical Inc). Once they successfully achieved performance benchmarks, surgeons were randomized to either receive a 3- to 5-minute VR simulator warm-up or read a leisure book for 10 minutes before performing similar and dissimilar (intracorporeal suturing) robotic surgery tasks. The primary outcomes compared were task time, tool path length, economy of motion, technical, and cognitive errors. Task time (-29.29 seconds, p = 0.001; 95% CI, -47.03 to -11.56), path length (-79.87 mm; p = 0.014; 95% CI, -144.48 to -15.25), and cognitive errors were reduced in the warm-up group compared with the control group for similar tasks. Global technical errors in intracorporeal suturing (0.32; p = 0.020; 95% CI, 0.06-0.59) were reduced after the dissimilar VR task. When surgeons were stratified by earlier robotic and laparoscopic clinical experience, the more experienced surgeons (n = 17) demonstrated significant improvements from warm-up in task time (-53.5 seconds; p = 0.001; 95% CI, -83.9 to -23.0) and economy of motion (0.63 mm/s; p = 0.007; 95% CI, 0.18-1.09), and improvement in these metrics was not statistically significantly appreciated in the less-experienced cohort (n = 34). We observed significant performance improvement and error reduction rates among surgeons of varying experience after VR warm-up for basic robotic surgery tasks. In addition, the VR warm-up reduced errors on

  9. Virtual Reality Robotic Surgery Warm-Up Improves Task Performance in a Dry Lab Environment: A Prospective Randomized Controlled Study

    PubMed Central

    Lendvay, Thomas S.; Brand, Timothy C.; White, Lee; Kowalewski, Timothy; Jonnadula, Saikiran; Mercer, Laina; Khorsand, Derek; Andros, Justin; Hannaford, Blake; Satava, Richard M.

    2014-01-01

    Background Pre-operative simulation “warm-up” has been shown to improve performance and reduce errors in novice and experienced surgeons, yet existing studies have only investigated conventional laparoscopy. We hypothesized a brief virtual reality (VR) robotic warm-up would enhance robotic task performance and reduce errors. Study Design In a two-center randomized trial, fifty-one residents and experienced minimally invasive surgery faculty in General Surgery, Urology, and Gynecology underwent a validated robotic surgery proficiency curriculum on a VR robotic simulator and on the da Vinci surgical robot. Once successfully achieving performance benchmarks, surgeons were randomized to either receive a 3-5 minute VR simulator warm-up or read a leisure book for 10 minutes prior to performing similar and dissimilar (intracorporeal suturing) robotic surgery tasks. The primary outcomes compared were task time, tool path length, economy of motion, technical and cognitive errors. Results Task time (-29.29sec, p=0.001, 95%CI-47.03,-11.56), path length (-79.87mm, p=0.014, 95%CI -144.48,-15.25), and cognitive errors were reduced in the warm-up group compared to the control group for similar tasks. Global technical errors in intracorporeal suturing (0.32, p=0.020, 95%CI 0.06,0.59) were reduced after the dissimilar VR task. When surgeons were stratified by prior robotic and laparoscopic clinical experience, the more experienced surgeons(n=17) demonstrated significant improvements from warm-up in task time (-53.5sec, p=0.001, 95%CI -83.9,-23.0) and economy of motion (0.63mm/sec, p=0.007, 95%CI 0.18,1.09), whereas improvement in these metrics was not statistically significantly appreciated in the less experienced cohort(n=34). Conclusions We observed a significant performance improvement and error reduction rate among surgeons of varying experience after VR warm-up for basic robotic surgery tasks. In addition, the VR warm-up reduced errors on a more complex task (robotic

  10. Comparing parecoxib and ketorolac as preemptive analgesia in patients undergoing posterior lumbar spinal fusion: a prospective randomized double-blinded placebo-controlled trial.

    PubMed

    Siribumrungwong, Koopong; Cheewakidakarn, Julin; Tangtrakulwanich, Boonsin; Nimmaanrat, Sasikaan

    2015-03-18

    Poor postoperative pain control is frequently associated with complications and delayed discharge from a hospital. Preemptive analgesia is one of the methods suggested for reducing postoperative pain. Opioids are effective for pain control, but there known addictive properties make physicians cautious about using them. Parecoxib and ketorolac are potent non-opioid NSAIDs that are attractive alternative drugs to opioids to avoid opioid-related side effects. However, there are no good head-to-head comparisons between these two drugs in the aspect of preemptive analgesic effects in lumbar spinal fusion surgery. This study aimed to compare the efficacy in terms of postoperative pain control and safety of parecoxib with ketorolac as preemptive analgesia in posterior lumbar spinal fusion patients. A prospective, double-blinded randomized controlled trial was carried out in patients undergoing posterior lumbar spinal fusion, who were randomized into 3 groups (n = 32). Parecoxib, ketorolac or a placebo was given to each patient via injection around 30 minutes prior to incision. The efficacy of postoperative pain control was assessed by a verbal numerical rating score (0-10). And various postoperative things were monitored for analysis, such as total opioid consumption, complications, and estimated blood loss. Both the ketorolac and parecoxib groups showed significantly better early postoperative pain reduction at the postanesthesia care unit (PACU) than the control group (p < 0.05). There were no differences between the pain scores of ketorolac and parecoxib at any time points. Complications and bleeding were not significantly different between all three groups. Preemptive analgesia using both ketorolac and parecoxib showed a significantly better early postoperative pain control in the PACU than the control group in patients undergoing lumbar spinal fusion. ClinicalTrials.gov NCT01859585. Registered 15 May 2013.

  11. Clinical Benefits of an Adherence Monitoring Program in the Management of Secondary Hyperparathyroidism with Cinacalcet: Results of a Prospective Randomized Controlled Study

    PubMed Central

    Forni Ogna, Valentina; Pruijm, Menno; Zweiacker, Carole; Wuerzner, Grégoire; Tousset, Eric; Burnier, Michel

    2013-01-01

    Background/Aims. One of the causes of uncontrolled secondary hyperparathyroidism (sHPT) is patient's poor drug adherence. We evaluated the clinical benefits of an integrated care approach on the control of sHPT by cinacalcet. Methods. Prospective, randomized, controlled, multicenter, open-label study. Fifty hemodialysis patients on a stable dose of cinacalcet were randomized to an integrated care approach (IC) or usual care approach (UC). In the IC group, cinacalcet adherence was monitored using an electronic system. Results were discussed with the patients in motivational interviews, and drug prescription adapted accordingly. In the UC group, drug adherence was monitored, but results were not available. Results. At six months, 84% of patients in the IC group achieved recommended iPTH targets versus 55% in the UC group (P = 0.04). The mean cinacalcet taking adherence improved by 10.8% in the IC group and declined by 5.3% in the UC group (P = 0.02). Concomitantly, the mean dose of cinacalcet was reduced by 7.2 mg/day in the IC group and increased by 6.4 mg/day in the UC group (P = 0.03). Conclusions. The use of a drug adherence monitoring program in the management of sHPT in hemodialysis patients receiving cinacalcet improves drug adherence and iPTH control and allows a reduction in the dose of cinacalcet. PMID:23971019

  12. Effect of adjusted cuff pressure of endotracheal tube during thyroidectomy on postoperative airway complications: prospective, randomized, and controlled trial.

    PubMed

    Ryu, Jung-Hee; Han, Sun-Sook; Do, Sang-Hwan; Lee, Jung-Min; Lee, Sang-Chul; Choi, Eun-Soo

    2013-04-01

    Postoperative sore throat (POST) is a common complaint after general anesthesia, especially following thyroidectomy. We examined the effect of adjusting the endotracheal tube cuff pressure during thyroidectomy on the incidence of airway complications. Ninety patients scheduled for elective thyroidectomy were randomized into two groups: control (group A, n = 45) and experimental (group B, n = 45). All patients underwent total intravenous anesthesia with propofol and remifentanil. In group A, the cuff pressure was set to 25 cm H2O initially and then monitored continuously without adjustment during thyroidectomy. In group B, the cuff pressure was maintained at approximately 25 cm H2O throughout the operation. The incidences and the severity of POST, hoarseness, dysphagia, and cough were recorded at 2 and 24 h postoperatively. Cuff pressures in group A changed significantly over time (P < 0.05) and were higher than those of group B during thyroidectomy (P < 0.05). The incidences of POST were lower in group B than in group A at 2 and 24 h postoperatively (P < 0.05), and there was a significant difference in the severity of POST at 2 h postoperatively between the two groups. There were no differences in the incidences of hoarseness, dysphagia, and cough between the two study groups (P > 0.05). Adjusting the endotracheal cuff pressure during thyroidectomy decreased the incidence and degree of POST. Intraoperative monitoring and adjustment of the cuff pressure can reduce POST in patients undergoing thyroidectomy.

  13. A Prospective Cohort Study of Influences on Externalizing Behaviors Across Childhood: Results From a Nurse Home Visiting Randomized Controlled Trial.

    PubMed

    Enoch, Mary-Anne; Kitzman, Harriet; Smith, Joyce A; Anson, Elizabeth; Hodgkinson, Colin A; Goldman, David; Olds, David L

    2016-05-01

    This study investigated genetic and environmental influences on behavior in a cohort of 600 children followed prenatally to 18 years. A randomized controlled trial of prenatal/infancy nurse home visits (NHV) was conducted in 600 predominantly African American mothers and their firstborn children from Memphis, TN. Mothers were assessed in pregnancy for mental health (MH), self-efficacy, and mastery. Mothers reported longitudinally on smoking and alcohol/drug use. The functional polymorphisms SLC6A4 5-HTTLPR, FKBP5 rs1360780 and DRD2/ANKK1 rs1800497 were genotyped together with 186 ancestry informative markers. Composite externalizing disorders (ED) continuous total scores from the mother-report Achenbach Child Behavior Checklist were included as dependent variables in regression analyses for time points 2, 6, 12, and 18 years. Behaviors at younger ages strongly predicted later behaviors (p < .0001). Children whose mothers had high self-efficacy and had received NHV were better behaved at age 2 years. Poorer maternal MH adversely influenced ED up to 12 years, but at age 18 years, maternal mastery exerted a strong, positive effect (p = .0001). Maternal smoking was associated with worse ED at 6 and 18 years. Main and interactive effects of genetic polymorphisms varied across childhood: FKBP5 rs1360780 up to age 6, 5-HTTLPR from 6 to 12, and DRD2/ANKK1 rs1800497 from 2 to 18 years. Our study suggests that maternal MH and resilience measured in pregnancy have long-lasting effects on child behavior. Maternal smoking across childhood and genetic factors also play a role. NHV had a positive effect on early behavior. Our findings have implications for prevention of pathological behaviors in adulthood. Clinical trial registration information-Age-17 Follow-Up of Home Visiting Intervention; http://clinicaltrials.gov/; NCT00708695. Published by Elsevier Inc.

  14. Polylactide-caprolactone composite mesh used for ventral hernia repair: a prospective, randomized, single-blind controlled trial.

    PubMed

    Shen, Ying-Mo; Li, Qi; Chen, Jie; Sun, Li; Chen, Fu-Qiang

    2017-02-23

    Although composite surgical meshes are widely used in laparoscopic repair of ventral hernia, the risk of postoperative complications associated with these type of mesh is relatively high. In this report, we demonstrated the safety as well as the effectiveness of a new composite polypropylene mesh coated with poly Llactidecocaprolactone ε (EasyProsthesTM) for the repair of ventral hernia. This study was a randomized, controlled trial designed to compare EasyProsthes composite mesh (EPM) with ParietexTM Composite (PCO) in patients undergoing laparoscopic ventral hernia repair. Hernia recurrence, chronic pain, seroma formation, intestinal fistula or obstruction, wound or abdominal infection, and viscera adhesion were evaluated. 80 patients who needed repair surgery for primary or secondary ventral hernias were enrolled in this study. Patients were divided into two groups: the EPM group (n=40) and the PCO group (n=40). Patients completed 12 months of followup. Our results revealed that one patient in the EPM group (2.5%) and two patients in the PCO group (5%) developed mesh viscera adhesions after surgery (p=1.000). We had no case of intestinal fistulas or obstruction. Seventeen patients in EPM group (42.5%) and 21 in PCO group (52.2%) developed post surgical seromas in the surgery area (p=0.370). One patient from each group developed postoperative wound infection. There was no case of abdominal infection, chronic pain or hernia recurrence. The incidence of postoperative complications in the EPM group was similar to that observed in the PCO group. We concluded that EPM is a safe and effective method to be used in ventral hernia repair surgeries.

  15. Does moderate-to-high intensity Nordic walking improve functional capacity and pain in fibromyalgia? A prospective randomized controlled trial

    PubMed Central

    2010-01-01

    Introduction The objective of this study was to investigate the effects of moderate-to-high intensity Nordic walking (NW) on functional capacity and pain in fibromyalgia (FM). Methods A total of 67 women with FM were recruited to the study and randomized either to moderate-to-high intensity Nordic Walking (n = 34, age 48 ± 7.8 years) or to a control group engaging in supervised low-intensity walking (LIW, n = 33, age 50 ± 7.6 years). Primary outcomes were the six-minute walk test (6MWT) and the Fibromyalgia Impact Questionnaire Pain scale (FIQ Pain). Secondary outcomes were: exercise heart rate in a submaximal ergometer bicycle test, the FIQ Physical (activity limitations) and the FIQ total score. Results A total of 58 patients completed the post-test. Significantly greater improvement in the 6MWT was found in the NW group (P = 0.009), as compared with the LIW group. No between-group difference was found for the FIQ Pain (P = 0.626). A significantly larger decrease in exercise heart rate (P = 0.020) and significantly improved scores on the FIQ Physical (P = 0.027) were found in the NW group as compared with the LIW group. No between-group difference was found for the change in the FIQ total. The effect sizes were moderate for the above mentioned outcomes. Conclusions Moderate-to-high intensity aerobic exercise by means of Nordic walking twice a week for 15 weeks was found to be a feasible mode of exercise, resulting in improved functional capacity and a decreased level of activity limitations. Pain severity did not change over time during the exercise period. Trial registration Clinicaltrials.gov identifier NCT00643006. PMID:20942911

  16. Water exchange enhanced cecal intubation in potentially difficult colonoscopy. Unsedated patients with prior abdominal or pelvic surgery: a prospective, randomized, controlled trial.

    PubMed

    Luo, Hui; Zhang, Linhui; Liu, Xiaodong; Leung, Felix W; Liu, Zhiguo; Wang, Xiangping; Xue, Ling; Wu, Kaichun; Fan, Daiming; Pan, Yanglin; Guo, Xuegang

    2013-05-01

    Colonoscopy is widely used for management of colorectal diseases. A history of abdominal or pelvic surgery is a well-recognized factor associated with difficult colonoscopy. Although water exchange colonoscopy (WEC) was effective in small groups of male U.S. veterans with such a history, its application in other cultural settings is uncertain. To investigate the application of WEC in such patients. Prospective, randomized, controlled, patient-blinded study. Tertiary-care referral center in China. Outpatients with prior abdominal or pelvic surgery undergoing unsedated diagnostic, screening, or surveillance colonoscopy. Patients were randomized to examination by either WEC or conventional air colonoscopy (AC). Cecal intubation rate. A total of 110 patients were randomized to the WEC (n = 55) or AC (n = 55) group. WEC significantly increased the cecal intubation rate (92.7% vs 76.4%; P = .033). The maximum pain scores (± standard deviation) were 2.1 ± 1.8 (WEC) and 4.6 ± 1.7 (AC), respectively (P < .001). Multivariate analysis showed that the colonoscopy method was the only independent predictor of failed colonoscopy (odds ratio 11.44, 95% confidence interval, 1.35-97.09). A higher proportion of patients examined by WEC would be willing to have a repeat unsedated colonoscopy (90.9% vs 72.7%, P = .013). Single center; unblinded but experienced endoscopists. This randomized, controlled trial confirms that the water exchange method significantly enhanced cecal intubation in potentially difficult colonoscopy in unsedated patients with prior abdominal or pelvic surgery. The lower pain scores and higher proportion accepting repeat of the unsedated option suggest that WEC is promising. It may enhances compliance with colonoscopy in specific populations. ( NCT01485133.). Copyright © 2013 American Society for Gastrointestinal Endoscopy. Published by Mosby, Inc. All rights reserved.

  17. Effectiveness of percutaneous laser disc decompression versus conventional open discectomy in the treatment of lumbar disc herniation; design of a prospective randomized controlled trial

    PubMed Central

    Brouwer, Patrick A; Peul, Wilco C; Brand, Ronald; Arts, Mark P; Koes, Bart W; Berg, Annette A van den; van Buchem, Mark A

    2009-01-01

    Background The usual surgical treatment of refractory sciatica caused by lumbar disc herniation, is open discectomy. Minimally invasive procedures, including percutaneous therapies under local anesthesia, are increasingly gaining attention. One of these treatments is Percutaneous Laser Disc Decompression (PLDD). This treatment can be carried out in an outpatient setting and swift recovery and return to daily routine are suggested. Thus far, no randomized trial into cost-effectiveness of PLDD versus standard surgical procedure has been performed. We present the design of a randomized controlled trial, studying the cost-effectiveness of PLDD versus conventional open discectomy in patients with sciatica from lumbar disc herniation. Methods/design The study is a randomized prospective multi-center trial, in which two treatment strategies are compared in a parallel group design. Patients (age 18–70 years) visiting the neurosurgery department of the participating hospitals, are considered for inclusion in the trial when sciatica due to lumbar disc herniation has lasted more than 8 weeks. Patients with disc herniation smaller than 1/3 of the spinal canal diameter, without concomitant lateral recess stenosis or sequestration, are eligible for participation, and are randomized into one of two treatment arms; either Percutaneous Laser Disc Decompression or conventional discectomy. The functional outcome of the patient, as assessed by the Roland Disability Questionnaire for Sciatica at 8 weeks and 1 year after treatment, is the primary outcome measure. The secondary outcome parameters are recovery as perceived by the patient, leg and back pain, incidence of re-intervention, complications, quality of life, medical consumption, absence of work and secondary costs. Discussion Open discectomy is still considered to be the golden standard in the surgical treatment of lumbar disc herniation. Whether Percutaneous Laser Disc Decompression has at least as much efficacy as the

  18. Iliotibial band autograft versus bone-patella-tendon-bone autograft, a possible alternative for ACL reconstruction: a 15-year prospective randomized controlled trial.

    PubMed

    Stensbirk, Frederik; Thorborg, Kristian; Konradsen, Lars; Jørgensen, Uffe; Hölmich, Per

    2014-09-01

    The long-term results after using the iliotibial band autograft (ITB) in anterior cruciate ligament (ACL) reconstruction are not fully known. If equal in quality to conventional methods, the ITB graft could be a useful alternative as a primary graft, in revision surgery or multi-ligament reconstruction. The purpose is to assess whether the ITB autograft is a long-term reliable alternative to the bone-patella-tendon-bone (BPTB) autograft, using a prospective randomized controlled trial design. From 1995 to 1996, sixty patients scheduled for primary ACL reconstruction were included in a prospective randomized controlled trial. Three senior knee surgeons, experienced in both types of ACL surgery, performed all the operations. A standardized and supervised rehabilitation programme was used for both groups for 6 months. Thirty patients received the ITB reconstruction, and 30 received the BPTB reconstruction. Forty-nine participated at follow-up in 2010 (82%). Primary outcome was the failure rate after ACL reconstruction. Secondary outcomes were knee injury osteoarthritis outcome score (KOOS) [pain, symptoms, Sport/Rec, quality of life (QOL), daily living function], Tegner activity scale, anterior knee pain-score, Lysholm score, Rolimeter laxity, extension deficit, single hop and crossover hop for distance. At 15-year follow-up, no significant difference existed between the groups. Graft failure occurred in 4 ITB subjects (16%) and 3 BPTB subjects (13%). KOOS (Sport/Rec) for the ITB group was 75 and 73 for the BPTB group. The KOOS (QOL) was 72 and 68 for the ITB group and BPTB group, respectively. Similar graft failure rates and KOOS were found when comparing ITB- and BPTB-operated individuals, at 15-year follow-up. The ITB graft had equal long-term clinical results compared to the BPTB graft and is recommended as a reliable alternative autograft for ACL reconstruction. Therapeutic studies, Level I.

  19. Simvastatin effects on androgens, inflammatory mediators, and endogenous pituitary gonadotropins among patients with PCOS undergoing IVF: results from a prospective, randomized, placebo-controlled clinical trial.

    PubMed

    Rashidi, Batool; Abediasl, Jhila; Tehraninejad, Ensiyeh; Rahmanpour, Haleh; Sills, Eric Scott

    2011-08-01

    To evaluate effects of simvastatin on selected biochemical parameters and reproductive outcome among patients with polycystic ovary syndrome (PCOS) who undergo in vitro fertilization (IVF). Patients with PCOS were randomized to receive either oral simvastatin, 20 mg/d (n = 32), or placebo (n = 32) in a prospective, double-blind, randomized clinical trial (NCT 005-75601) in parallel with controlled ovarian hyperstimulation for IVF. All patients were determined to be at average risk for cardiovascular disease, based on high-sensitivity C-reactive protein (hsCRP) measurement at entry. After an 8-week treatment interval concluding at periovulatory human chorionic gonadotropin administration, selected clinical and laboratory parameters were measured. Mean serum total testosterone level decreased by 25% in the simvastatin group, compared to a 10% reduction in the placebo group (P < 0.001). A trend of lower serum luteinizing hormone levels was noted in experimental and control groups (29% vs 22%, respectively), although this difference was not significant (P > 0.05). Neither fasting insulin nor quantitative insulin sensitivity check index were significantly impacted by simvastatin (P > 0.05). As expected, total cholesterol was not modified among placebo patients but was significantly reduced after simvastatin (P = 0.001). In addition, hsCRP and vascular cell adhesion protein-1 were both significantly lower after simvastatin therapy compared to controls (P ≤ 0.005 for both). At study completion, no important change in body mass index was observed in either group (P ≥ 0.60). Although oocyte maturation, fertilization, and clinical pregnancy rates were all higher after simvastatin, none of these improvements were statistically significant. This report presents data from the first prospective, randomized, placebo-controlled clinical investigation of simvastatin in the setting of PCOS and IVF. Simvastatin seems to be compatible with gonadotropin therapy for IVF and can

  20. Effect of Radial Shock Wave Therapy on Spasticity of the Upper Limb in Patients With Chronic Stroke: A Prospective, Randomized, Single Blind, Controlled Trial.

    PubMed

    Li, Tsung-Ying; Chang, Chih-Ya; Chou, Yu-Ching; Chen, Liang-Cheng; Chu, Heng-Yi; Chiang, Shang-Lin; Chang, Shin-Tsu; Wu, Yung-Tsan

    2016-05-01

    Recently, studies have reported that extracorporeal shock wave therapy (ESWT) is a safe, noninvasive, alternative treatment for spasticity. However, the effect of ESWT on spasticity cannot be determined, because most studies to date have enrolled small patient numbers and have lacked placebo-controlled groups and/or long-term follow-up. In addition, whether varying the number of ESWT sessions would affect the duration of the therapeutic effect has not been investigated in a single study. Hence, we performed a prospective, randomized, single blind, placebo-controlled study to investigate the long-term effect of radial ESWT (rESWT) in patients with poststroke spasticity and surveyed the outcome of functional activity.Sixty patients were randomized into 3 groups. Group A patients received 1 session of rESWT per week for 3 consecutive weeks; group B patients received a single session of rESWT; group C patients received one session of sham rESWT per week for 3 consecutive weeks. The primary outcome was Modified Ashworth Scale of hand and wrist, whereas the secondary outcomes were Fugl-Meyer Assessment of hand function and wrist control. Evaluations were performed before the first rESWT treatment and immediately 1, 4, 8, 12, and 16 weeks after the last session of rESWT.Compared to the control group, the significant reduction in spasticity of hand and wrist lasted at least 16 and 8 weeks in group A and B, respectively. Three sessions of rESWT had a longer-lasting effect than one session. Furthermore, the reduction in spasticity after 3 sessions of rESWT may be beneficial for hand function and wrist control and the effect was maintained for 16 and 12 weeks, respectively.rESWT may be valuable in decreasing spasticity of the hand and wrist with accompanying enhancement of wrist control and hand function in chronic stroke patients.

  1. Unique approach to sensorimotor training with a new device combining air cushion with stochastic translations-A prospective randomized controlled clinical trial.

    PubMed

    Mittermaier, Christian; Schindler, Maximilian; Loader, Benjamin; Waldhoer, Thomas; Ambrozy, Clemens; Crevenna, Richard; Pieber, Karin

    2017-02-01

    Sensorimotor training with a wide variety of available devices represents an important component in rehabilitation and prevention of different sports injuries and chronic diseases. The purpose of this study was to evaluate the effects of a sensorimotor training with a newly developed device, which consists of an instable platform moving on an air cushion, providing dynamic balance training by tilting and unanticipated stochastic translations on postural control. Seventy-two healthy young subjects were included in this prospective, randomized, controlled, and observer-blinded study. Balance was objectively assessed by posturography and Functional Reach Test (FRT). Additionally we evaluated the subjective rating of balance. After randomization the sensorimotor training group performed a training program on the new device over a 5-6 week study period. After this time improvement in objective and subjective measurements as a result of training became evident. A significant difference in challenging posturographic parameters (Sensory Organization Test 5: training group 5.32±5.25 vs. control group 1.78±5.05, p=0.006 and Head Shake Sensory Organization Test 5: training group 11.94±8.97 vs. control group 5.41±10.17, p=0.01) as well as a significant difference in the FRT (training group 3.34±3.35cm vs. control group 0.01±2.97cm, p=0.0001) was found. Subjective assessment revealed a significant improvement in the participants' rating of balance and alteration of balance. Subjects showed a high satisfaction with the new training device. Our findings suggest that the newly developed device could be a promising option for sensorimotor training to improve postural control. Copyright © 2016 Elsevier B.V. All rights reserved.

  2. A double-blind, randomized controlled, prospective trial assessing the effectiveness of oral corticoids in the treatment of symptomatic lumbar canal stenosis

    PubMed Central

    2014-01-01

    Background Corticoids have potent anti-inflammatory effects, which may help in relieving pain and dysfunction associated with lumbar canal stenosis. We assessed the effectiveness of a decreasing-dose regimen of oral corticoids in the treatment of lumbar canal stenosis in a prospective, double-blind, randomized, placebo-controlled trial. Results Sixty-one patients with lumbar canal stenosis (50–75 years; canal area < 100 mm2 at L3/L4, L4/L5, and/or L5/S1on magnetic resonance imaging; and claudication within 100 m were electronically randomized to an oral corticoid group (n = 31) or a placebo group (n = 30). The treatment group received 1 mg/kg of oral corticoids daily, with a dose reduction of one-third per week for 3 weeks. Patients and controls were assessed by the Short Form 36 Health Survey, Roland–Morris Questionnaire, 6-min walk test, visual analog scale, and a Likert scale. All instruments showed similar outcomes for the corticoid and placebo groups (P > 0.05). Obese patients exhibited more severe symptoms compared with non-obese patients. L4/L5 stenosis was associated with more severe symptoms compared with stenosis at other levels. Conclusion The oral corticoid regimen used in this study was not effective in the treatment of lumbar canal stenosis. PMID:25099318

  3. Efficacy of lanolin and bovine type I collagen in the treatment of childhood anal fissures: a prospective, randomized, controlled clinical trial.

    PubMed

    Büyükyavuz, Behçet Ilker; Savaş, Cagri; Duman, Levent

    2010-08-01

    We designed an open-labeled, prospective, randomized, controlled clinical trial to test the efficacy of topical lanolin ointment (PureLan) and bovine type I collagen spray (Gelfix) in the treatment of childhood anal fissures. Seventy-one children with acute anal fissure were divided randomly into three groups: group I (control; n = 25), group II (PureLan; n = 28), and group III (Gelfix; n = 18). All children were assigned to have warm sitz baths, topical analgesic creams, and stool softeners. Patients in groups II and III were also treated with topical lanolin ointment and bovine type I collagen, respectively. All children were re-examined 4 weeks later. Complete healing of the anal fissure was observed in 68% of the group I patients, but in 92.9% and 100% of the group II and III patients, respectively. The difference among groups was significant in terms of complete fissure healing (P = 0.003), but the efficacy of topical lanolin ointment and bovine type I collagen spray did not differ significantly (P = 0.078). Our data suggest that topical lanolin ointment and bovine type I collagen spray are effective in the treatment of acute anal fissure in children.

  4. Multicenter prospective, randomized, double-masked, placebo-controlled study of Rheopheresis to treat nonexudative age-related macular degeneration: interim analysis.

    PubMed Central

    Pulido, Jose S

    2002-01-01

    OBJECTIVE: To evaluate the safety and efficacy of Rheopheresis blood filtration to treat intermediate- to late-stage preangiogenic age-related macular degeneration (AMD) with soft drusen. DESIGN: Multicenter, prospective, randomized, double-masked, placebo-controlled clinical trial. PARTICIPANTS: First 43 randomized patients (28 Rheopheresis and 15 placebo-control patients) with available baseline and 3-month postbaseline best corrected visual acuity (BCVA) measurements and intermediate- to late-stage preangiogenic AMD with multiple large soft drusen and elevated serum levels of targeted macromolecules. INTERVENTION: Patients were randomly assigned to receive eight Rheopheresis or eight placebo procedures over 10 weeks. MAIN OUTCOME MEASURES: ETDRS BCVA measurements at baseline, 3, 6, 9, and 12 months postbaseline. RESULTS: In primary eyes, the mean LogMAR line difference between Rheopheresis and placebo-control eyes was 1.6 lines at 12 months postbaseline; the difference was significant throughout the first posttreatment year (P = .0011, repeated measures analysis). Thirteen percent of Rheopheresis compared with 0% of placebo-control eyes had a > or = 3-line improvement in BCVA at 12 months postbaseline. Four percent of Rheopheresis compared with 18% of placebo-control eyes had a > or = 3-line loss in BCVA. The subgroup of patients whose primary eyes had baseline BCVA worse than 20/40 demonstrated a mean LogMAR difference between Rheopheresis and placebo-control eyes equaling 3.0 lines at 12 months postbaseline; the difference was significant throughout the first posttreatment year (P = .0014, repeated measures analysis). Sixteen percent of Rheopheresis compared with 0% of the placebo-control eyes had a > or = 3-line improvement in BCVA at 12 months postbaseline. Five percent of Rheopheresis compared with 29% of placebo-control eyes had a > or = 3-line loss in BCVA. Fifty-eight percent of Rheopheresis eyes improved to 20/40 or better, compared with 14% of placebo-control

  5. Extracorporeal shock wave treatment for non-inflammatory chronic pelvic pain syndrome: a prospective, randomized and sham-controlled study.

    PubMed

    Zeng, Xiao-Yong; Liang, Chen; Ye, Zhang-Qun

    2012-01-01

    Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a clinical syndrome characterized by pain in the perineum, pelvis, suprapubic area, or external genitalia and variable degrees of voiding and ejaculatory disturbance. The analgesic effect of extracorporeal shock wave treatment (ESWT) was an interesting phenomenon with an unclear mechanism discovered by chance in the applications for urolithiasis, on which ESWT has become an increasingly popular therapeutic approach as an alternative option for the treatment of a number of soft tissue complaints. In this study, we aimed to evaluate the feasibility and efficacy of ESWT in non-inflammatory (IIIB) CP/CPPS. Men diagnosed with IIIB CP/CPPS were randomized to either ESWT (group 1, n = 40) or the control (group 2, n = 40). Group 1 received 20 000 shock wave impulses in 10 sessions over a two-week period, whereas group 2 received only a sham procedure. The total scores and sub-domain scores of the National Institutes of Health Chronic Prostatitis Symptom Index (NIH-CPSI) for both groups were assessed at baseline, mid-treatment, end-point, and 4-week and 12-week follow-up visits. The mean total NIH-CPSI score of group 1 was significantly decreased from baseline at all post-treatment time points (P < 0.01 for all). Decreases in pain domain and quality of life (QOL) scores were also significant. In group 2, no significant decreases of total NIH-CPSI score and pain domain score were found at all post-treatment time points. At the end-point of treatment, 71.1% of group 1 exhibited perceptible improvement in total NIH-CPSI compared with 27.0% of group 2 (P < 0.001); additionally, 28.9% of group 1 exhibited clinically significant improvement compared with 10.8% of group 2 (P < 0.01). Moreover, a greater number of patients in group 1 at 4-week and 12-week follow-up were rated as responders (perceptible and clinically significant response) compared with group 2. ESWT exhibits a potentially therapeutic role in the

  6. Urtica dioica for treatment of benign prostatic hyperplasia: a prospective, randomized, double-blind, placebo-controlled, crossover study.

    PubMed

    Safarinejad, Mohammad Reza

    2005-01-01

    To determine the effects of therapy with Urtica dioica for symptomatic relief of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). A 6-month, double-blind, placebo-controlled, randomized, partial crossover, comparative trial of Urtica dioica with placebo in 620 patients was conducted. Patients were evaluated using the International Prostate Symptom Score (IPSS), the maximum urinary flow rate (Qmax), postvoid residual urine volume (PVR), Serum Prostatic- Specific Antigen (PSA), testosterone levels, and prostate size. At the end of 6-month trial, unblinding revealed that patients who initially received the placebo were switched to Urtica dioica. Both groups continued the medication up to 18 months. 558 patients (90%) completed the study (287/305, 91% in the Urtica dioica group, and 271/315, 86% in the placebo group). By intention- to-treat analysis, at the end of 6-month trial, 232 (81%) of 287 patients in the Urtica dioica group reported improved LUTS compared with 43 (16%) of 271 patients in the placebo group (P < 0.001). Both IPSS and Qmax showed greater improvement with drug than with placebo. The IPSS went from 19.8 down to 11.8 with Urtica dioica and from 19.2 to 17.7 with placebo (P = 0.002). Peak flow rates improved by 3.4 mL/s for placebo recipients and by 8.2 mL/s for treated patients (P < 0.05). In Urtica dioica group, PVR decreased from an initial value of 73 to 36 mL (P < 0.05). No appreciable change was seen in the placebo group. Serum PSA and testosterone levels were unchanged in both groups. A modest decrease in prostate size as measured by transrectal ultrasonography (TRUS) was seen in Urtica dioica group (from 40.1 cc initially to 36.3 cc; P < 0.001). There was no change in the prostate volume at the end of study with placebo. At 18-month follow-up, only patients who continued therapy, had a favorable treatment variables value. No side effects were identified in either group. In the present study, Urtica dioica

  7. A prospective, double-blind, randomized controlled trial of the angiotensin-converting enzyme inhibitor Ramipril In Aortic Stenosis (RIAS trial).

    PubMed

    Bull, Sacha; Loudon, Margaret; Francis, Jane M; Joseph, Jubin; Gerry, Stephen; Karamitsos, Theodoros D; Prendergast, Bernard D; Banning, Adrian P; Neubauer, Stefan; Myerson, Saul G

    2015-08-01

    Angiotensin-converting enzyme (ACE) inhibitors improve left ventricular (LV) remodelling and outcome in heart failure and hypertensive heart disease. They may be similarly beneficial in patients with aortic stenosis (AS), but historical safety concerns have limited their use, and no prospective clinical trials exist. We conducted a prospective, randomized, double-blind, placebo-controlled trial in 100 patients with moderate or severe asymptomatic AS to examine the physiological effects of ramipril, particularly LV mass (LVM) regression. Subjects were randomized to ramipril 10 mg daily (n = 50) or placebo (n = 50) for 1 year, and underwent cardiac magnetic resonance, echocardiography, and exercise testing at 0, 6, and 12 months, with follow-up data available in 77 patients. There was a modest but progressive reduction in LVM (the primary end point) in the ramipril group vs. the placebo group (mean change -3.9 vs. +4.5 g, respectively, P = 0.0057). There were also trends towards improvements in myocardial physiology: the ramipril group showed preserved tissue Doppler systolic velocity compared with placebo (+0.0 vs. -0.5 cm/s, P = 0.04), and a slower rate of progression of the AS (valve area 0.0 cm(2) in the ramipril group vs. -0.2 cm(2) in the placebo arm, P = 0.067). There were no significant differences in major adverse cardiac events. ACE inhibition leads to a modest, but progressive reduction in LVM in asymptomatic patients with moderate-severe AS compared with placebo, with trends towards improvements in myocardial physiology and slower progression of valvular stenosis. A larger clinical outcome trial to confirm these findings and explore their clinical relevance is required. © The Author 2015. Published by Oxford University Press on behalf of the European Society of Cardiology.

  8. A Comparison of Two Types of Rabbit Antithymocyte Globulin Induction Therapy in Immunological High-Risk Kidney Recipients: A Prospective Randomized Control Study

    PubMed Central

    Burkhalter, F.; Schaub, S.; Bucher, Ch.; Gürke, L.; Bachmann, A.; Hopfer, H.; Dickenmann, M.; Steiger, J.; Binet, I.

    2016-01-01

    Background Induction treatment with rabbit polyclonal antithymocyte globulins (ATGs) is frequent used in kidney transplant recipients with donorspecific HLA antibodies and shows acceptable outcomes. The two commonly used ATGs, Thymoglobulin and ATG-F have slightly different antigen profile and antibody concentrations. The two compounds have never been directly compared in a prospective trial in immunological high-risk recipients. Therefore we performed a prospective randomized controlled study comparing the two compounds in immunological high-risk kidney recipients in terms of safety and efficacy. Methods Immunological high-risk kidney recipients, defined as the presence of HLA DSA but negative CDC-B and T-cell crossmatches were randomized 1:1 to receive ATG-F or Thymoglobulin. Maintenance immunosuppressive therapy consisted of tacrolimus, mycophenolate mofetil and steroids. Results The per-protocol analysis included 35 patients. There was no immediate infusion reaction observed with both compounds. No PTLD or malignancy occurred during the follow-up in both groups. The incidence of viral and bacterial infections was similar in both groups (p = 0.62). The cumulative incidence of clinical and subclinical antibody mediated allograft rejection as well as T-cell mediated allograft rejection during the first year between ATG-F and Thymoglobulin was similar (35% versus 19%; p = 0.30 and 11% versus 18%; 0.54 respectively). The two-year graft function was similar with a median eGFR of 56 ml/min/1.73m2 (range 21–128) (ATG-F-group) and 51 ml/min/1.73m2 (range 22–132) (Thymo-group) (p = 0.69). Conclusion We found no significant differences between the compared study drugs for induction treatment in immunological high-risk patients regarding safety and efficacy during follow-up with good allograft function at 2 years after transplantation. PMID:27855166

  9. A prospective, double-blind, randomized controlled trial of the angiotensin-converting enzyme inhibitor Ramipril In Aortic Stenosis (RIAS trial)

    PubMed Central

    Bull, Sacha; Loudon, Margaret; Francis, Jane M.; Joseph, Jubin; Gerry, Stephen; Karamitsos, Theodoros D.; Prendergast, Bernard D.; Banning, Adrian P.; Neubauer, Stefan; Myerson, Saul G.

    2015-01-01

    Aims Angiotensin-converting enzyme (ACE) inhibitors improve left ventricular (LV) remodelling and outcome in heart failure and hypertensive heart disease. They may be similarly beneficial in patients with aortic stenosis (AS), but historical safety concerns have limited their use, and no prospective clinical trials exist. Methods and results We conducted a prospective, randomized, double-blind, placebo-controlled trial in 100 patients with moderate or severe asymptomatic AS to examine the physiological effects of ramipril, particularly LV mass (LVM) regression. Subjects were randomized to ramipril 10 mg daily (n = 50) or placebo (n = 50) for 1 year, and underwent cardiac magnetic resonance, echocardiography, and exercise testing at 0, 6, and 12 months, with follow-up data available in 77 patients. There was a modest but progressive reduction in LVM (the primary end point) in the ramipril group vs. the placebo group (mean change −3.9 vs. +4.5 g, respectively, P = 0.0057). There were also trends towards improvements in myocardial physiology: the ramipril group showed preserved tissue Doppler systolic velocity compared with placebo (+0.0 vs. −0.5 cm/s, P = 0.04), and a slower rate of progression of the AS (valve area 0.0 cm2 in the ramipril group vs. −0.2 cm2 in the placebo arm, P = 0.067). There were no significant differences in major adverse cardiac events. Conclusion ACE inhibition leads to a modest, but progressive reduction in LVM in asymptomatic patients with moderate–severe AS compared with placebo, with trends towards improvements in myocardial physiology and slower progression of valvular stenosis. A larger clinical outcome trial to confirm these findings and explore their clinical relevance is required. PMID:25796267

  10. Comparison of effectiveness of different surgical treatments for meralgia paresthetica: Results of a prospective observational study and protocol for a randomized controlled trial.

    PubMed

    de Ruiter, Godard C W; Kloet, Alfred

    2015-07-01

    Various surgical procedures can be applied in the treatment of meralgia paresthetica. The two main ones are neurolysis and neurectomy of the lateral femoral cutaneous nerve. To date, no prospective or randomized controlled trial has compared the effectiveness of these procedures with standardized outcome measures. In this study we present our results for two prospectively followed cohorts and we present the protocol for a double blind randomized controlled trial (RCT). All patients that had an indication for surgical treatment of idiopathic meralgia paresthetica between August 2012 and April 2014 were included in the study. The patient decided on the type of treatment (neurolysis or neurectomy) after informed consent had been given. Primary outcome was measured using the Likert scale obtained 6 weeks after the surgery. Successful pain reduction was defined as Likert 1 or 2. Secondary outcome measures were the Numeric Rating Scale (NRS) and Bothersomeness Index (BSI). In case of neurectomy the BSI for numbness was also obtained. A total of 22 consecutive patients were included: neurolysis was performed in 8 patients and neurectomy in 14 patients (one bilateral case). Successful pain reduction was observed more frequently after neurectomy (93.3%) than after neurolysis (37.5%, P<0.05). Secondary outcome scores (NRS and BSI pain) were also better after neurectomy, although not significantly (respectively P=0.07 and 0.05). Paired analysis of the scores before and after the surgery showed an improvement in both the NRS and BSI after the neurectomy procedure (both P<0.001), while scores were not significantly different before and after the neurolysis procedure. Patient's scores for the BSI numbness after the neurectomy procedure were low (mean 1.4, SD±1.0, range 0-3). The results of our prospective study confirm results previous studies reported in the literature in that the percentage pain relief was better after neurectomy than after neurolysis. A RCT is needed to

  11. Low-calorie sweeteners and body weight and composition: a meta-analysis of randomized controlled trials and prospective cohort studies123

    PubMed Central

    Miller, Paige E; Perez, Vanessa

    2014-01-01

    Background: Replacement of caloric sweeteners with lower- or no-calorie alternatives may facilitate weight loss or weight maintenance by helping to reduce energy intake; however, past research examining low-calorie sweeteners (LCSs) and body weight has produced mixed results. Objective: The objective was to systematically review and quantitatively evaluate randomized controlled trials (RCTs) and prospective cohort studies, separately, that examined the relation between LCSs and body weight and composition. Design: A systematic literature search identified 15 RCTs and 9 prospective cohort studies that examined LCSs from foods or beverages or LCSs consumed as tabletop sweeteners. Meta-analyses generated weighted mean differences in body weight and composition values between the LCS and control groups among RCTs and weighted mean correlations for LCS intake and these parameters among prospective cohort studies. Results: In RCTs, LCSs modestly but significantly reduced all outcomes examined, including body weight (−0.80 kg; 95% CI: −1.17, −0.43), body mass index [BMI (in kg/m2): −0.24; 95% CI: −0.41, −0.07], fat mass (−1.10 kg; 95% CI: −1.77, −0.44), and waist circumference (−0.83 cm; 95% CI: −1.29, −0.37). Among prospective cohort studies, LCS intake was not associated with body weight or fat mass, but was significantly associated with slightly higher BMI (0.03; 95% CI: 0.01, 0.06). Conclusions: The current meta-analysis provides a rigorous evaluation of the scientific evidence on LCSs and body weight and composition. Findings from observational studies showed no association between LCS intake and body weight or fat mass and a small positive association with BMI; however, data from RCTs, which provide the highest quality of evidence for examining the potentially causal effects of LCS intake, indicate that substituting LCS options for their regular-calorie versions results in a modest weight loss and may be a useful dietary tool to improve

  12. Low-calorie sweeteners and body weight and composition: a meta-analysis of randomized controlled trials and prospective cohort studies.

    PubMed

    Miller, Paige E; Perez, Vanessa

    2014-09-01

    Replacement of caloric sweeteners with lower- or no-calorie alternatives may facilitate weight loss or weight maintenance by helping to reduce energy intake; however, past research examining low-calorie sweeteners (LCSs) and body weight has produced mixed results. The objective was to systematically review and quantitatively evaluate randomized controlled trials (RCTs) and prospective cohort studies, separately, that examined the relation between LCSs and body weight and composition. A systematic literature search identified 15 RCTs and 9 prospective cohort studies that examined LCSs from foods or beverages or LCSs consumed as tabletop sweeteners. Meta-analyses generated weighted mean differences in body weight and composition values between the LCS and control groups among RCTs and weighted mean correlations for LCS intake and these parameters among prospective cohort studies. In RCTs, LCSs modestly but significantly reduced all outcomes examined, including body weight (-0.80 kg; 95% CI: -1.17, -0.43), body mass index [BMI (in kg/m²): -0.24; 95% CI: -0.41, -0.07], fat mass (-1.10 kg; 95% CI: -1.77, -0.44), and waist circumference (-0.83 cm; 95% CI: -1.29, -0.37). Among prospective cohort studies, LCS intake was not associated with body weight or fat mass, but was significantly associated with slightly higher BMI (0.03; 95% CI: 0.01, 0.06). The current meta-analysis provides a rigorous evaluation of the scientific evidence on LCSs and body weight and composition. Findings from observational studies showed no association between LCS intake and body weight or fat mass and a small positive association with BMI; however, data from RCTs, which provide the highest quality of evidence for examining the potentially causal effects of LCS intake, indicate that substituting LCS options for their regular-calorie versions results in a modest weight loss and may be a useful dietary tool to improve compliance with weight loss or weight maintenance plans. © 2014 American Society

  13. Preventive pancreatic stents in the management of acute biliary pancreatitis (PREPAST trial): pre-study protocol for a multicenter, prospective, randomized, interventional, controlled trial.

    PubMed

    Dubravcsik, Zsolt; Madácsy, László; Gyökeres, Tibor; Vincze, Áron; Szepes, Zoltán; Hegyi, Péter; Hritz, István; Szepes, Attila

    2015-01-01

    The outcome of the most common biliary form of acute pancreatitis has not changed even with the better described indications for early endoscopic intervention. It may be due to the fact that this intrevention theoretically can cause further pancreatic injury or cannot always relieve the pancreatic duct obstruction. We hypothesize that maintaining the outflow of the pancreatic duct with preventive pancreatic stents at the early ERCP improves the outcome of acute biliary pancreatitis. PREPAST is a prospective, randomized, controlled, multicenter trial. Patients with acute biliary pancreatitis with coexisting cholangitis are randomized to undergo urgent endoscopic intervention with or without pancreatic stenting within 48 h from the onset of pain, and in addition patients without signs of cholangitis but cholestasis are randomly allocated to recieve conservative treatment or early endoscopic intervention with or without pancreatic stenting within 48 h from the onset of pain. Patients without acute cholangitis and signs of cholestasis recieve conservative treatment. 230 patients are planned to be enrolled during a 48 months period from different centers. The primary endpoint is the outcome of acute biliary pancreatitis as described by the latest guidelines. Secondary endpoints include mortality data, and other variables not analyzed as a primary endpoint but related to the pancreatitis or the pancreatic stenting. The PREPAST trial is designed to show whether early endoscopic intervention with the usage of preventive pancreatic stenting improves the outcome of acute biliary pancreatitis. The study has been registered at the International Standard Randomised Controlled Trial Number (ISRCTN) Register (trial ID: ISRCTN13517695). Copyright © 2015 IAP and EPC. Published by Elsevier B.V. All rights reserved.

  14. A prospective, randomized, controlled trial assessing diazepam to reduce perception and recall of pain during transrectal ultrasonography-guided biopsy of the prostate.

    PubMed

    Li, Roger; Ruckle, Herbert C; Creech, Jon D; Culpepper, David J; Lightfoot, Michelle A; Alsyouf, Muhannad; Nicolay, Lesli; Jellison, Forrest; Baldwin, D Duane

    2014-07-01

    The effect of oral anxiolytics in diminishing patient discomfort and pain perception has been demonstrated in GI endoscopy, percutaneous coronary interventions, and various procedures in the emergency department setting, but has not been prospectively studied in the setting of prostate biopsy. The purpose of this study was to investigate the effect of diazepam on pain perception during and after prostate biopsy. Sixty patients undergoing prostate biopsy at a single academic institution were enrolled into a prospective, randomized, placebo-controlled study. A questionnaire was administered prebiopsy to determine baseline discomfort and pain history. A visual analog pain scale was used to determine pain associated with each step of the transrectal Ultrasonography-guided prostate biopsy and was administered 20 minutes after biopsy and 1 week later. Responses were compared between groups using the Mann-Whitney U test, Fisher exact test, and Wilcoxon signed rank test as appropriate. A total of 60 patients (29 diazepam, 31 placebo) completed pre- and postbiopsy surveys for analysis. The number of cores sampled during biopsy was controlled during analysis and was found to have no correlation with total pain measured. There were no differences between diazepam and placebo groups in age, prebiopsy survey results, immediate and 1 week postbiopsy survey results. There was no difference in the patients' willingness to undergo a repeated procedure in the control and treatment groups. Complications of taking diazepam prebiopsy included drowsiness, chills, and ankle injury. Diazepam does not improve patient pain perception immediately after or at 1-week recall after prostate biopsy. Omitting diazepam simplifies the biopsy regimen and allows the patient to drive himself home. Based on these results, routine use of diazepam in prostate biopsy is not recommended.

  15. Early application of pulsed electromagnetic field in the treatment of postoperative delayed union of long-bone fractures: a prospective randomized controlled study.

    PubMed

    Shi, Hong-fei; Xiong, Jin; Chen, Yi-xin; Wang, Jun-fei; Qiu, Xu-sheng; Wang, Yin-he; Qiu, Yong

    2013-01-19

    Pulsed electromagnetic field (PEMF) is reported to be an effective adjunct for the management of nonunion long-bone fractures. Most studies implement PEMF treatment after 6 months or longer of delayed union or nonunion following fracture treatment. Despite these variations in treatment, the early application of PEMF following a diagnosis of a postoperative delayed union has not been specifically analyzed. In this study, the outcomes of postoperative delayed union of long-bone fractures treated with an early application of PEMF were evaluated as compared with a sham-treated control group. In this prospective, randomized controlled study, a total of 58 long-bone fracture patients, who presented with delayed union of between 16 weeks and 6 months, were randomly split into two groups and subjected to an early application of PEMF or sham treatment. Clinical and radiological assessments were performed to evaluate the healing status. Treatment efficacy was assessed at three month intervals. Patients in the PEMF group showed a higher rate of union than those in the control group after the first three months of treatment, but this difference failed to achieve statistical significance. At the end of the study, PEMF treatment conducted for an average of 4.8 months led to a success rate of 77.4%. This was significantly higher than the control, which had an average duration of 4.4 months and a success rate of 48.1%. The total time from operation to the end of the study was a mean of 9.6 months for patients in the PEMF group. Fracture patients treated with an early application of PEMF achieved a significantly increased rate of union and an overall reduced suffering time compared with patients that receive PEMF after the 6 months or more of delayed union, as described by others.

  16. Early application of pulsed electromagnetic field in the treatment of postoperative delayed union of long-bone fractures: a prospective randomized controlled study

    PubMed Central

    2013-01-01

    Background Pulsed electromagnetic field (PEMF) is reported to be an effective adjunct for the management of nonunion long-bone fractures. Most studies implement PEMF treatment after 6 months or longer of delayed union or nonunion following fracture treatment. Despite these variations in treatment, the early application of PEMF following a diagnosis of a postoperative delayed union has not been specifically analyzed. In this study, the outcomes of postoperative delayed union of long-bone fractures treated with an early application of PEMF were evaluated as compared with a sham-treated control group. Methods In this prospective, randomized controlled study, a total of 58 long-bone fracture patients, who presented with delayed union of between 16 weeks and 6 months, were randomly split into two groups and subjected to an early application of PEMF or sham treatment. Clinical and radiological assessments were performed to evaluate the healing status. Treatment efficacy was assessed at three month intervals. Results Patients in the PEMF group showed a higher rate of union than those in the control group after the first three months of treatment, but this difference failed to achieve statistical significance. At the end of the study, PEMF treatment conducted for an average of 4.8 months led to a success rate of 77.4%. This was significantly higher than the control, which had an average duration of 4.4 months and a success rate of 48.1%. The total time from operation to the end of the study was a mean of 9.6 months for patients in the PEMF group. Conclusions Fracture patients treated with an early application of PEMF achieved a significantly increased rate of union and an overall reduced suffering time compared with patients that receive PEMF after the 6 months or more of delayed union, as described by others. PMID:23331333

  17. Heparin in pregnant women with previous placenta-mediated pregnancy complications: a prospective, randomized, multicenter, controlled clinical trial.

    PubMed

    Martinelli, Ida; Ruggenenti, Piero; Cetin, Irene; Pardi, Giorgio; Perna, Annalisa; Vergani, Patrizia; Acaia, Barbara; Facchinetti, Fabio; La Sala, Giovanni Battista; Bozzo, Maddalena; Rampello, Stefania; Marozio, Luca; Diadei, Olimpia; Gherardi, Giulia; Carminati, Sergio; Remuzzi, Giuseppe; Mannucci, Pier Mannuccio

    2012-04-05

    To assess whether antithrombotic prophylaxis with low-molecular-weight heparin effectively prevents recurrence of late pregnancy complications, 135 women with previous history of preeclampsia, hemolytic anemia, elevated liver enzymes and low platelet count syndrome, intrauterine fetal death, fetal growth restriction, or placental abruption who had been referred within the 12th gestational week were randomized to medical surveillance alone (n = 68) or combined to open-label nadroparin (3800 IU daily subcutaneous injections) treatment (n = 67) in the setting of a randomized, parallel-group, superiority trial, run in Italy from April 2007 to April 2010. Primary outcome was a composite end point of late-pregnancy complications. Analysis was by intention to treat. The study was stopped for futility at the time of the first planned interim analysis. Among the 128 women eventually available for final analyses, 13 of the 63 (21%) randomized to nadroparin compared with 12 of the 65 (18%) on medical surveillance alone progressed to the primary end point. The absolute event risk difference between treatment arms (2.2; -1.6 to 16.0) was not statistically significant (P = .76). Thus, nadroparin did not prevent late-pregnancy complications in women at risk of recurrence. This finding challenges the role of antithrombotic prophylaxis with low-molecular-weight heparin in the prevention of recurrent late pregnancy complications The trial was registered at http://ricerca-clinica.agenziafarmaco.it as EudraCT 2006-004205-26.

  18. Prospective Preference Assessment of Patients' Willingness to Participate in a Randomized Controlled Trial of Intensity-Modulated Radiotherapy Versus Proton Therapy for Localized Prostate Cancer

    SciTech Connect

    Shah, Anand; Efstathiou, Jason A.; Paly, Jonathan J.; Halpern, Scott D.; Bruner, Deborah W.; Christodouleas, John P.; Coen, John J.; Deville, Curtiland; Vapiwala, Neha; Shipley, William U.; Zietman, Anthony L.; Hahn, Stephen M.; Bekelman, Justin E.

    2012-05-01

    Purpose: To investigate patients' willingness to participate (WTP) in a randomized controlled trial (RCT) comparing intensity-modulated radiotherapy (IMRT) with proton beam therapy (PBT) for prostate cancer (PCa). Methods and Materials: We undertook a qualitative research study in which we prospectively enrolled patients with clinically localized PCa. We used purposive sampling to ensure a diverse sample based on age, race, travel distance, and physician. Patients participated in a semi-structured interview in which they reviewed a description of a hypothetical RCT, were asked open-ended and focused follow-up questions regarding their motivations for and concerns about enrollment, and completed a questionnaire assessing characteristics such as demographics and prior knowledge of IMRT or PBT. Patients' stated WTP was assessed using a 6-point Likert scale. Results: Forty-six eligible patients (33 white, 13 black) were enrolled from the practices of eight physicians. We identified 21 factors that impacted patients' WTP, which largely centered on five major themes: altruism/desire to compare treatments, randomization, deference to physician opinion, financial incentives, and time demands/scheduling. Most patients (27 of 46, 59%) stated they would either 'definitely' or 'probably' participate. Seventeen percent (8 of 46) stated they would 'definitely not' or 'probably not' enroll, most of whom (6 of 8) preferred PBT before their physician visit. Conclusions: A substantial proportion of patients indicated high WTP in a RCT comparing IMRT and PBT for PCa.

  19. Comparison between botulinum toxin and corticosteroid injection in the treatment of acute and subacute tennis elbow: a prospective, randomized, double-blind, active drug-controlled pilot study.

    PubMed

    Lin, Yu-Ching; Tu, Yuan-Kun; Chen, Sheng-Shiung; Lin, I-Ling; Chen, Shih-Ching; Guo, How-Ran

    2010-08-01

    To compare botulinum toxin type A injection with corticosteroid injection in the treatment of tennis elbow. In this prospective, randomized, double-blind, drug-controlled trial,19 affected elbows of 16 patients were randomly assigned to receive injection with botulinum toxin type A (Botox group) or triamcinolone acetonide (steroid group). We used the Visual Analog Scale, pain-free grip strength, and World Health Organization Quality of Life Brief Questionnaire to assess the perception of pain, grip strength, and quality of life, respectively. Measures were performed before and at 4, 8, and 12 wks after the treatment. Four weeks after the treatment, the Botox group had smaller decrease in pain (P = 0.02) but greater decrease in grip strength (P = 0.01). The difference in grip strength remained significant at 8 wks (P = 0.03). No significant differences in quality of life were observed throughout the study period. Corticosteroid is superior to botulinum toxin type A in relieving pain in tennis elbow at 4 wks after injection. Because botulinum toxin injection did not relieve pain significantly but is associated with weakness, the muscle weakness caused by botulinum toxin is unlikely to be the sole mechanism of the pain relief observed in previous studies.

  20. 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.

  1. Effects of Neck-Specific Exercises Compared to Waiting List for Individuals With Chronic Whiplash-Associated Disorders: A Prospective, Randomized Controlled Study.

    PubMed

    Peolsson, Anneli; Landén Ludvigsson, Maria; Tigerfors, Ann-Marie; Peterson, Gunnel

    2016-02-01

    To determine whether 3 months of neck-specific exercises (NSEs) could benefit individuals with chronic whiplash-associated disorder (WAD) who were on a waiting list (WL) for treatment. A prospective, randomized controlled study. Primary health care. Individuals (N=41; 31 women, 10 men; mean age ± SD, 38±11.2y) with chronic (6-36mo) WAD, grades 2 and 3, were analyzed. Patients were randomly assigned to NSEs or no treatment for 3 months. Neck-specific disability (Neck Disability Index [NDI]), neck pain (visual analog scale), general pain-related disability (Pain Disability Index [PDI]), self-perceived performance ability (Self-Efficacy Scale [SES]), and health-related quality of life (EuroQol 5 dimensions [EQ-5D]) were measured. NSEs significantly improved the NDI, SES, and EQ-5D compared with WL (P<.01). There was significant improvement (P<.0001) over time in all outcomes for NSEs, and apart from the PDI, significant worsening (P=.002-.0002) over time for the untreated group. NSEs were more beneficial than no intervention while on a WL for individuals with chronic WAD. Copyright © 2016 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  2. Ultrasound guided subcostal transversus abdominis plane (TAP) infiltration with liposomal bupivacaine for patients undergoing robotic assisted hysterectomy: A prospective randomized controlled study

    PubMed Central

    Hutchins, Jacob; Delaney, Daniel; Vogel, Rachel Isaksson; Ghebre, Rahel G.; Downs, Levi S.; Carson, Linda; Mullany, Sally; Teoh, Deanna; Geller, Melissa A.

    2015-01-01

    Introduction Optimal pain control after major surgery contributes to a patient’s recovery and satisfaction. The use of liposomal bupivacaine in subcostal transversus abdominis plane (TAP) blocks for postoperative pain control after robot assisted abdominal surgery has yet to be studied. Methods We conducted a prospective randomized controlled observer-blinded study comparing bilateral subcostal TAP blocks with bupivacaine to bilateral subcostal TAP blocks with liposomal bupivacaine. These were performed prior to the patient undergoing robot assisted hysterectomy. The patients’ pain scores, opioid use, side effects, and satisfaction were followed for 72 h after injection. Results Total opioid use in the first 72 h after injection was significantly decreased in the group that received liposomal bupivacaine compared to bupivacaine. Patients in the liposomal bupivacaine group had significantly lower maximal pain scores at all time periods studied as well as decreased incidence of nausea/vomiting. There was a trend toward decreased length of stay in the liposomal bupivacaine group. Conclusion Subcostal TAP blocks with liposomal bupivacaine decreased the total opioid requirement for the first 72 h after robot assisted hysterectomy when compared to subcostal TAP blocks with bupivacaine. PMID:26056753

  3. Comparison between the classical and a modified trans-septal technique of alar cinching for Le Fort I osteotomies: a prospective randomized controlled trial.

    PubMed

    Nirvikalpa, N; Narayanan, V; Wahab, A; Ramadorai, A

    2013-01-01

    The aim of this prospective randomized control trial was to analyse the efficacy of a new trans-septal alar base cinch suture in controlling alar width in patients undergoing maxillary intrusion and setback by comparing it with the traditional cinch suture. Statistical evaluation was carried out in 62 of 76 patients. Group I (31 patients) received the traditional alar base cinch suture, and group II (31 patients) received the alar base cinch suture with an anchoring bite taken through the nasal septum 10mm behind its anterior edge. In both groups the accurate identification of alar fibroareolar tissue was facilitated by an 18 gauge green needle passed extra orally. Alar base width was measured before and 6 months after surgery using Vernier callipers. Preoperative alar base width for group I was 29.76 mm (1.901SD) and for group II 29.79 mm (3.141SD); the postoperative values were 32.42 mm (1.858SD) and 29.94 mm (2.568SD), respectively. Mean alar base widening was 2.661 mm (0.800SD) in group I and 0.145 mm (2.050) in group II. The difference in alar widening was statistically significant (p<0.001). In conclusion, the trans-septal modified alar cinch suture offers better control of alar base architecture in maxillary intrusion and setback. Copyright © 2012 International Association of Oral and Maxillofacial Surgeons. Published by Elsevier Ltd. All rights reserved.

  4. Aquacel(®) Ag dressing versus Acticoat™ dressing in partial thickness burns: a prospective, randomized, controlled study in 100 patients. Part 1: burn wound healing.

    PubMed

    Verbelen, Jozef; Hoeksema, Henk; Heyneman, Alexander; Pirayesh, Ali; Monstrey, Stan

    2014-05-01

    Studies comparing contemporary silver dressings in burns are scarce. In a prospective, randomized, controlled study, counting 50 patients/research group, we compared two frequently used silver dressings, Acticoat™ and Aquacel(®) Ag, in the management of partial thickness burns with a predicted healing time between 7 and 21 days as assessed by laser Doppler imaging between 48 and 72h after burn. Variables investigated were related to baseline research group characteristics, wound healing, bacteriology, economics, nurse, and patient experience. Both research groups were comparably composed taking into account gender, age and burn characteristics. Similar results were obtained as to healing time and bacterial control with both silver dressings. A statistically significant difference in favor of the Aquacel(®) Ag dressing was found for average ease of use (p<0.001), average ease of application (p=0.001), patient pain (p<0.001), patient comfort with the dressing (p=0.017), silver staining (p<0.001), and cost effectiveness (p<0.001). Both silver dressings resulted in comparable healing times and bacterial control but the Aquacel(®) Ag dressing significantly increased comfort for patients as well as nurses and was significantly more cost-effective than the Acticoat™ dressing for the given indication. Copyright © 2013 Elsevier Ltd and ISBI. All rights reserved.

  5. Fistulectomy versus fistulotomy with marsupialisation in the treatment of low fistula-in- ano: a prospective randomized controlled trial.

    PubMed

    Chalya, Phillipo L; Mabula, Joseph B

    2013-07-01

    Low fistula-in-ano has traditionally been treated with fistulectomy and fistulotomy. Recent studies have shown that marsupialisation of the fistulotomy wounds can reduce the healing time. A randomized clinical trial was conducted at Bugando Medical Centre in north-western Tanzania between January 2008 and December 2012 to compare the efficacy of fistulectomy versus fistulotomy with marsupialisation in the treatment of low fistula in ano. Patients were randomized into two groups, namely Group A (fistulectomy) and Group B (fistulotomy with marsupialisation). A total of 162 patients were enrolled in the study and randomly assigned to Group A (n = 82) and Group B (n = 80). Both groups were comparable with respect to age, sex ratio, duration of symptoms, type of fistula and radial distance of the external opening from the anal verge. The mean healing time was statistically significantly longer in group A than in group B (P = 0.002). The duration of postoperative wound discharge was statistically significantly shorter in group B than in group A (P = 0.012). There was no statistically significant difference in the mean operating time, mean operation wound size, mean postoperative pain score, rate of surgical site infection and postoperative hospital stay between the two groups (P > 0.05). None of the patients in either group had recurrence or was found to have anal incontinence. No differences in the extent of adverse effects of surgery on the physical, social and sexual lives of the patients in the two groups. We conclude that in comparison to a fistulectomy, a fistulotomy with marsupialisation results in faster wound healing and a shorter duration of wound discharge and should therefore be recommended as a standard surgical procedure in the treatment of low fistula-in-ano.

  6. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study.

    PubMed

    Liu, Ngai; Chazot, Thierry; Genty, Antoine; Landais, Alain; Restoux, Aymeric; McGee, Kathleen; Laloë, Pierre-Antoine; Trillat, Bernard; Barvais, Luc; Fischler, Marc

    2006-04-01

    This report describes a closed-loop titration of propofol target control infusion based on a proportional-differential algorithm guided by the Bispectral Index (BIS) allowing induction and maintenance of general anesthesia and compares this to manual propofol target control infusion. One hundred sixty-four patients scheduled to undergo elective minor or major surgery were prospectively randomized in a multicenter study into the closed-loop (n = 83) or manual target control infusion group (n = 81). The goal was to reach a BIS target of 50 during induction and to maintain it between 40 and 60 during maintenance. For both groups, remifentanil target control infusion was adjusted manually, and ventilation was without nitrous oxide. Closed-loop control was able to provide anesthesia induction and maintenance for all patients. During induction, propofol consumption was lower in the closed-loop group (1.4 +/- 0.5 vs. 1.8 +/- 0.6 mg/kg; P < 0.0001), but the duration was longer (320 +/- 125 vs. 271 +/- 120 s; P < 0.0002). Adequate anesthesia maintenance, defined as the BIS in the range of 40-60, was significantly higher in the closed-loop group (89 +/- 9 vs. 70 +/- 21%; P < 0.0001), with a decrease of the occurrence of BIS less than 40 (8 +/- 8 vs. 26 +/- 22%; P < 0.0001). Time from discontinuation of propofol infusion to tracheal extubation was shorter in the closed-loop group (7 +/- 4 vs. 10 +/- 7 min; P < 0.017). Unwanted somatic events and hemodynamic instability were similar. Automatic control of consciousness using the BIS is clinically feasible and outperforms manual control.

  7. 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

  8. Spinal sealant system provides better intraoperative watertight closure than standard of care during spinal surgery: a prospective, multicenter, randomized controlled study.

    PubMed

    Wright, Neill M; Park, Jon; Tew, John M; Kim, Kee D; Shaffrey, Mark E; Cheng, Joseph; Choudhri, Haroon; Krishnaney, Ajit A; Graham, R Scott; Mendel, Ehud; Simmons, Nathan

    2015-04-15

    Prospective, 3:1 randomized, single-blind, multicenter investigational study. To assess the safety and efficacy of a low-swell spinal sealant when used as an adjunct to sutured dural repair compared with standard of care methods to obtain watertight dural closure in subjects undergoing spinal surgery. Watertight dural closure is paramount in spinal surgery to avoid complications of cerebrospinal fluid leak. Prior reports have proven the efficacy of a synthetic, absorbable polyethylene glycol (PEG) hydrogel sealant in spinal surgery compared with standard of care. Given the potential concerns of swelling in spinal applications, the hydrogel was modified to a low-swell formulation. The primary endpoint was success rate in obtaining intraoperative watertight dural closure in subjects receiving PEG hydrogel sealant versus a control group of subjects receiving any standard method designed to provide intraoperative watertight closure. Subjects were evaluated at discharge and at 30 and 90 days postprocedure for cerebrospinal fluid leaks, surgical site infections, and adverse events. Between May 2007 and May 2009, 98 subjects (74 PEG hydrogel spinal sealant, 24 control) were randomized at 14 clinical sites in the United States. Patients treated with the PEG hydrogel spinal sealant had a significantly higher rate of watertight closure than the control (98.6% vs. 79.2%, P = 0.003). No statistical differences were seen in postoperative cerebrospinal fluid, infection, and wound healing. No neurological deficits were seen attributable to the sealant. The low-swell PEG hydrogel spinal sealant evaluated in this study has been proven safe and effective for providing watertight closure when used as an adjunct to sutured closure of intentional durotomies during spinal surgery. PEG hydrogel sealants have again proved superior to other standard of care technologies for safe, efficacious dural closure. 2.

  9. Role of addition of dexamethasone to lignocaine 2% with adrenaline in dental nerve blocks for third molar surgery: A prospective randomized control trial

    PubMed Central

    Deo, Saroj Prasad

    2016-01-01

    Context: Dexamethasone has been frequently used in oral surgical procedure and accepted by oral and maxillofacial surgeon community worldwide. However, this is the first clinical trial that used dexamethasone as adjuvant with lignocaine in dental nerve block (DNB). Aims: The purpose of this double-blind, randomized control trial (RCT) was to compare the effect of dexamethasone with normal saline (NS) in a lignocaine DNB. Settings and Design: This prospective, double-blind, RCT was carried out after obtaining approval from the Institutional Ethical Committee. Subjects and Methods: In forty patients, the present placebo-controlled clinical trial was conducted; allocated randomly into two groups: study group (SG) or control group (CG). The single-dose submucosal dexamethasone or NS injection was administered immediately after 2% lignocaine with epinephrine 1:2,00,000 nerves block during mandibular third molar surgery (TMS). Visual analog scale score, number, and exact time nonsteroidal anti-inflammatory drugs were administered were used to measure postoperative analgesia in 2nd and 7th days. Statistical Analysis Used: All the data were entered into the Spreadsheet (Excel, Microsoft) and Chi-square test, Mann–Whitney U-test, Student's paired and unpaired t-test, and Fisher exact test were used. Results: This study found maximum duration of DNB in SG was 248.88 min and in CG was 175.44 min, whereas minimum duration in SG was 197 min and in CG was 140.78 min. Conclusions: Dexamethasone prolongs the action of lignocaine 2% in DNB for TMS. PMID:28299268

  10. A prospective, randomized, controlled cervical fusion study using recombinant human bone morphogenetic protein-2 with the CORNERSTONE-SR allograft ring and the ATLANTIS anterior cervical plate.

    PubMed

    Baskin, David S; Ryan, Patrick; Sonntag, Volker; Westmark, Richard; Widmayer, Marsha A

    2003-06-15

    A prospective, randomized, pilot clinical trial compared recombinant human bone morphogenetic protein-2 (rhBMP-2) with iliac crest autograft bone for the treatment of human cervical disc disease. To examine the safety and effectiveness of using INFUSE Bone Graft (rhBMP-2 applied to an absorbable collagen sponge), as compared with an autogenous iliac crest bone graft placed inside the CORNERSTONE-SR fibular allograft, in anterior cervical discectomy and interbody fusion. Recombinant human bone morphogenetic protein-2 is an osteoinductive protein that induces a reliable fusion in the lumbar spine, but it has not been studied in patients with degenerative cervical disc disease. For this study, 33 patients with degenerative cervical disc disease were randomly assigned to investigational or control groups. The investigational group received a fibular allograft (CORNERSTONE-SR Allograft Ring) with an rhBMP-2-laden collagen carrier inside the graft along with an ATLANTIS anterior cervical plate. The control group received a fibular allograft with cancellous iliac crest autograft placed inside it, along with an ATLANTIS anterior cervical plate. The patients underwent plain radiographs at 6 weeks, then at 3, 6, 12, and 24 months, and CT scans at 3 and 6 months after surgery. They also completed general health profiles and self-evaluation scales. Adverse events were evaluated for severity, duration, association with the implant, and the need for a second surgical procedure. All the patients evaluated had solid fusions 6, 12, and 24 months after surgery. There were no device-related adverse events. At 24 months, the investigational group had mean improvement superior to that of the control group in neck disability and arm pain scores (P < 0.03 each). This pilot study demonstrates the feasibility of using rhBMP-2 safely and effectively in the cervical spine.

  11. A randomized, placebo-controlled, double-blind, prospective clinical trial of silicone gel in prevention of hypertrophic scar development in median sternotomy wound.

    PubMed

    Chan, Kin Yoong; Lau, Chee Lan; Adeeb, Syed Mohd; Somasundaram, Sathappan; Nasir-Zahari, Mohd

    2005-09-15

    Hypertrophic scarring caused by sternotomy is prevalent among Asians. The effectiveness of silicone gel in scar prevention may influence the decision of surgeons and patients regarding its routine use during the postoperative period. The authors conducted a randomized, placebo-controlled, double-blind, prospective clinical trial. The susceptibility to scar development varied among patients; therefore, sternal wounds were divided into the upper half and the lower half. Two types of coded gel prepared by an independent pharmacist were used on either half. Thus, selection and assessment biases and confounders were eliminated. One hundred wounds in 50 patients were randomized into two arms, 50 control and 50 silicone gels. The median age was 61 years and there were 34 men and 16 women. Ethnic distribution was 28 Malays, 18 Chinese, and four Indians. No side effect caused by the silicone gel was noted. Ninety-eight percent of patients had moderate to good compliance. The incidence of sternotomy scar was 94 percent. At the third month postoperatively, the silicone gel wounds were scored lower when compared with the control wounds. The differences were statistically significant in all parameters, including pigmentation (p = 0.02), vascularity (p = 0.001), pliability (p = 0.001), height (p = 0.001), pain (p = 0.001), and itchiness (p = 0.02). The effect of silicone gel in prevention of hypertrophic scar development in sternotomy wounds is promising. There are no side effects and patients' compliance is satisfactory. This study may popularize the use of silicone gel in all types of surgery to minimize the formation of hypertrophic scars in the early postoperative period.

  12. Clarithromycin Versus Metronidazole as First-line Helicobacter pylori Eradication: A Multicenter, Prospective, Randomized Controlled Study in Japan.

    PubMed

    Nishizawa, Toshihiro; Maekawa, Takama; Watanabe, Noriko; Harada, Naohiko; Hosoda, Yasuo; Yoshinaga, Masahiro; Yoshio, Toshiyuki; Ohta, Hajime; Inoue, Syuuji; Toyokawa, Tatsuya; Yamashita, Haruhiro; Saito, Hiroki; Kuwai, Toshio; Katayama, Shunsuke; Masuda, Eiji; Miyabayashi, Hideharu; Kimura, Toshio; Nishizawa, Yuko; Takahashi, Masahiko; Suzuki, Hidekazu

    2015-07-01

    Helicobacter pylori eradication rates achieved with a first-line regimen of clarithromycin (CLR) combined with amoxicillin (AMX) and a proton pump inhibitor have recently fallen to ≤80% because of the increasing incidence of CLR resistance in Japan. This randomized multicenter trial aimed to compare the eradication success of 2 first-line triple therapy regimens: rabeprazole, amoxicillin, and clarithromycin (RAC) versus rabeprazole, amoxicillin, and metronidazole (RAM). A total of 124 consecutive patients infected with H. pylori were randomized into one of two 7-day therapeutic regimens: RAC (n=60) or RAM (n=64). Eradication was confirmed by the C-urea breath test. Adverse effects were also assessed. Intention-to-treat and per protocol H. pylori eradication rates were 73.3%/77.2% in the RAC group and 90.6%/93.5% in the RAM group. The eradication rate of RAM therapy was significantly higher than that of RAC therapy. CLR, metronidazole, and AMX resistance was found in 36.2%, 2.1%, and 0% of patients, respectively. In addition, no relevant differences in adverse effects were observed. Metronidazole-based therapy (RAM) was superior to standard CLR-based therapy (RAC) for first-line H. pylori eradication. This reflects the progressive increase in CLR resistance observed in Japan.

  13. 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.

  14. P.O.P.A. study: prevention of postoperative abdominal adhesions by icodextrin 4% solution after laparotomy for adhesive small bowel obstruction. A prospective randomized controlled trial.

    PubMed

    Catena, Fausto; Ansaloni, Luca; Di Saverio, Salomone; Pinna, Antonio D

    2012-02-01

    Adhesive small bowel obstruction (ASBO) is an important cause of hospital admission, is associated with significant morbidity and mortality, and therefore is a substantial burden for healthcare systems worldwide. Icodextrin 4% solution (Adept, Shire Pharmaceuticals, UK) is a high-molecular-weight a-1,4 glucose polymer approved in Europe for use as intraoperative lavage and postoperative instillation to reduce the occurrence of post-surgery intra-abdominal adhesions. The present clinical study aimed to evaluate the safety and effectiveness of icodextrin 4% in decreasing the incidence, extent, and severity of adhesions in patients after abdominal surgery for ASBO. The study was a single-center prospective, randomized investigation. The study is designed and conducted in compliance with the principles of Good Clinical Practice regulations. Safety and efficacy of icodextrin 4% in the study group are compared to no anti-adhesion treatment in a parallel control group with blinded evaluation of primary endpoints. Primary endpoints are the evaluation of the therapeutic role of icodextrin 4% in reducing ASBO recurrence incidence and the need of laparotomies for ASBO recurrence, as well as adhesion formation (with evaluation of their incidence, extent, and severity). A sum of 181 patients with ASBO and surgical indication to laparotomy were enrolled and randomized in two groups. Patients were submitted to adhesiolysis with bowel resection if required with or without anastomosis. The first group received traditional treatment (control group), whereas the second group was treated with the addition of icodextrin 4% solution before the abdominal closure. Ninety-one patients were randomized to have icodextrin 4% solution administered intraperitoneally, and 90 patients were randomized to have the traditional treatment. The two study groups were homogeneous regarding their baseline characteristics. The ASBO recurrence rate was 2.19% (2/91) in the icodextrin groups vs 11.11% (10

  15. Doppler-guided haemorrhoidal artery ligation with suture mucopexy compared with suture mucopexy alone for the treatment of Grade III haemorrhoids: a prospective randomized controlled trial.

    PubMed

    Aigner, F; Kronberger, I; Oberwalder, M; Loizides, A; Ulmer, H; Gruber, L; Pratschke, J; Peer, S; Gruber, H

    2016-07-01

    Novel minimally invasive techniques aimed to reposition the haemorrhoidal zone have been established for prolapsing haemorrhoids. We present a prospective randomized controlled trial to evaluate the efficacy of additional Doppler-guided ligation of submucosal haemorrhoidal arteries (DG-HAL) in patients with symptomatic Grade III haemorrhoids. The trial was registered as ClinicalTrials.gov identifier NCT02372981. All consecutive patients with symptomatic Grade III haemorrhoids were randomly allocated to one of the two study arms: (i) Group A, DG-HAL with mucopexy or (ii) Group B, mucopexy alone. End-points were postoperative pain, faecal incontinence, bleeding, residual prolapse and alterations of the vascularization of the anorectal vascular plexus. Vascularization of the anorectal vascular plexus was assessed by transperineal contrast enhanced ultrasound. Patients recorded their symptoms in a diary maintained for a month. Forty patients were recruited and randomized to the two study groups. Patients in Group A had less pain in the first two postoperative weeks. At the 12-month follow-up, two patients in Group A (10%) and one in Group B (5%) showed recurrent Grade III haemorrhoids (P = 0.274). No significant morphological changes were observed in the transperineal ultrasound findings between the preoperative assessment and the assessment at 1 and 6 months in either group (P > 0.05). Mucopexy techniques for treating prolapsing haemorrhoids are effective, but DG-HAL does not add significantly to the results achieved by mucopexy. Repositioning the haemorrhoidal zone is the key to success, and mucopexy should be placed at the sites of the largest visible prolapse. Colorectal Disease © 2016 The Association of Coloproctology of Great Britain and Ireland.

  16. Effect of mobile phone reminder messages on adherence of stent removal or exchange in patients with benign pancreaticobiliary diseases: a prospectively randomized, controlled study.

    PubMed

    Gu, Yong; Wang, Limei; Zhao, Lina; Liu, Zhiguo; Luo, Hui; Tao, Qin; Zhang, Rongchun; He, Shuixiang; Wang, Xiangping; Huang, Rui; Zhang, Linhui; Pan, Yanglin; Guo, Xuegang

    2016-08-26

    Plastic and covered metal stents need to be removed or exchanged within appropriate time in case of undesirable complications. However, it is not uncommon that patients do not follow the recommendation for further stent management after Endoscopic Retrograde Cholangiopancreatography (ERCP). The effect of short message service (SMS) intervention monthly on the stent removal/exchange adherence in patients after ERCP is unknown at this time. A prospective, randomized controlled study was conducted. After receiving regular instructions, patients were randomly assigned to receive SMS reminding monthly (SMS group) for stent removal/exchange or not (control group). The primary outcome was stent removal/exchange adherence within appropriate time (4 months for plastic stent or 7 months for covered stent). Multivariate analysis was performed to assess factors associated with stent removal/exchange adherence within appropriate time. Intention-to-treat analysis was used. A total of 48 patients were randomized, 23 to the SMS group and 25 to the control. Adherence to stent removal/exchange was reported in 78.2 % (18/23) of patients receiving the SMS intervention compared with 40 % (10/25) in the control group (RR 1.98, 95 % CI 1.16-3.31; p = 0 · 010). Among patients with plastic stent insertion, the median interval time from stent implantation to stent removal/exchange were 90 days in the SMS group and 136 days in the control respectively (HR 0.36, 95 % CI 0.16-0.84, p = 0.018). No difference was found between the two groups regarding late-stage stent-related complications. The rate of recurrent abdominal pain tended to be lower in SMS group without significant difference (8.7 vs 28 %, p = 0.144). Multivariate logistic regression analyses revealed that SMS reminding was the only factor associated with adherence of stent removal/exchange (OR 6.73, 95 % CI 1.64-27.54, p = 0.008). This first effectiveness trial demonstrated that SMS reminding monthly

  17. The use of low output laser therapy to accelerate healing of diabetic foot ulcers: a randomized prospective controlled trial

    NASA Astrophysics Data System (ADS)

    Naidu, S. V. L. G.; Subapriya, S.; Yeoh, C. N.; Soosai, S.; Shalini, V.; Harwant, S.

    2005-11-01

    The aim of this study was to assess the effects of low output laser therapy as an adjuvant treatment in grade 1 diabetic foot ulcers. Methods: Sixteen patients were randomly divided equally into two groups. Group A had daily dressing only, while group B had low output laser therapy instituted five days a week in addition to daily dressing. Serial measurement of the ulcer was done weekly using digital photography and analyzed. Results: The rate of healing in group A was 10.42 mm2/week, and in group B was 66.14mm2/week. The difference in the rate of healing was statistically significant, p<0.05. Conclusion: Laser therapy as an adjuvant treatment accelerates diabetic ulcer healing by six times in a six week period.

  18. Psychotherapeutic process of cognitive-behavioral intervention in HIV-infected persons: results from a controlled, randomized prospective clinical trial.

    PubMed

    Znoj, Hans-Jörg; Messerli-Burgy, Nadine; Tschopp, Simone; Weber, Rainer; Christen, Lisanne; Christen, Stephan; Grawe, Klaus

    2010-03-01

    The aim of this exploratory study was to examine the possible mechanisms of behavioral change in a cognitive-behavioral intervention supporting medication adherence in HIV-infected persons. A total of 60 persons currently under medical treatment were randomized to psychotherapy or usual care and were compared with a sociodemographically matched group of general psychotherapy clients. Outcome measures included therapy adherence using medication event-monitoring system psychotherapeutic processes and changes of experience and behavior. The general psychotherapy group was initially more distressed than HIV psychotherapy patients and reached higher levels of psychotherapeutic effect. In the HIV psychotherapy patients, a significant effect was found for maintaining adherence to medical treatment (Weber et al., 2004). These findings show that psychotherapy is a beneficial intervention for HIV-infected persons, and therapeutic alliance and activation of resources do not differ from a general psychotherapy treatment. Differential effects were detected for specific process variables, namely problem actuation.

  19. Comparison of cast materials for the treatment of congenital idiopathic clubfoot using the Ponseti method: a prospective randomized controlled trial

    PubMed Central

    Hui, Catherine; Joughin, Elaine; Nettel-Aguirre, Alberto; Goldstein, Simon; Harder, James; Kiefer, Gerhard; Parsons, David; Brauer, Carmen; Howard, Jason

    2014-01-01

    Background The Ponseti method of congenital idiopathic clubfoot correction has traditionally specified plaster of Paris (POP) as the cast material of choice; however, there are negative aspects to using POP. We sought to determine the influence of cast material (POP v. semirigid fibreglass [SRF]) on clubfoot correction using the Ponseti method. Methods Patients were randomized to POP or SRF before undergoing the Ponseti method. The primary outcome measure was the number of casts required for clubfoot correction. Secondary outcome measures included the number of casts by severity, ease of cast removal, need for Achilles tenotomy, brace compliance, deformity relapse, need for repeat casting and need for ancillary surgical procedures. Results We enrolled 30 patients: 12 randomized to POP and 18 to SRF. There was no difference in the number of casts required for clubfoot correction between the groups (p = 0.13). According to parents, removal of POP was more difficult (p < 0.001), more time consuming (p < 0.001) and required more than 1 method (p < 0.001). At a final follow-up of 30.8 months, the mean times to deformity relapse requiring repeat casting, surgery or both were 18.7 and 16.4 months for the SRF and POP groups, respectively. Conclusion There was no significant difference in the number of casts required for correction of clubfoot between the 2 materials, but SRF resulted in a more favourable parental experience, which cannot be ignored as it may have a positive impact on psychological well-being despite the increased cost associated. PMID:25078929

  20. Effect of Microvascular Anastomosis Technique on End Product Outcome in Simulated Training: A Prospective Blinded Randomized Controlled Trial.

    PubMed

    Kim, Eunsol; Singh, Masha; Akelina, Yelena; Shurey, Sandra; Myers, Simon R; Ghanem, Ali M

    2016-09-01

    Background The aim of this article is to evaluate the difference in skills acquisition of two end-to-end microvascular anastomosis techniques-the triangulation and biangulation-in early microsurgery training. Method In this study, 32 candidates ranging from medical students to higher surgical trainees underwent a 5-day basic microsurgery course. On days 3 and 5 of the course, candidates performed two end-to-end anastomoses on cryopreserved rat aortas. One anastomosis was performed using the biangulation technique and the other using the triangulation technique. Candidates were randomized to the order of technique performed. Structural patency, errors performed, and suture distribution were evaluated randomly by a blinded reviewer using the anastomosis lapse index score and ImageJ (U.S. National Institutes of Health, Bethesda, MD) Software. Results A total of 128 anastomoses were evaluated during the study period. A total of six anastomoses performed with the biangulation technique, and four anastomoses with the triangulation technique, were physically occluded on day 3 of the course. On day 5, two biangulation technique anastomoses and one triangulation technique produced a nonpatent outcome. There was a statistically significant difference of patency rate between the 2 days of evaluation confirming evidence of skill acquisition but no statistically significant difference between the two techniques in relation to anastomotic patency, errors performed, or suture placement quality. Conclusion The biangulation and triangulation techniques of microvascular anastomosis produce similar outcomes in relation to vessel structural patency and quality of anastomosis when taught in early stages of microsurgery training. Our results suggest that both techniques are equally suitable in training novices, basic microsurgical skills.

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

    PubMed Central

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

    2011-01-01

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

  2. Benefits of short-term structured exercise in non-overweight women with polycystic ovary syndrome: a prospective randomized controlled study

    PubMed Central

    Turan, Volkan; Mutlu, Ebru Kaya; Solmaz, Ulas; Ekin, Atalay; Tosun, Ozge; Tosun, Gokhan; Mat, Emre; Gezer, Cenk; Malkoc, Mehtap

    2015-01-01

    [Purpose] The short-term effects of structured exercise on the anthropometric, cardiovascular, and metabolic parameters of non-overweight women diagnosed with polycystic ovary syndrome were evaluated. [Subjects and Methods] Thirty women with a diagnosis of polycystic ovary syndrome were prospectively randomized to either a control group (n=16) or a training group (n=14) for a period of 8 weeks. Anthropometric, cardiovascular, and metabolic parameters and hormone levels were measured and compared before and after the intervention. [Results] Waist and hip measurements (anthropometric parameters); diastolic blood pressure; respiratory rate (cardiovascular parameters); levels of low-density lipoprotein cholesterol, total cholesterol, fasting glucose, and fasting insulin; and the homeostasis model assessment of insulin resistance index (metabolic parameters) were significantly lower in the training group after 8 weeks of exercise compared to the baseline values. After exercise, the training group had significantly higher oxygen consumption and high-density lipoprotein levels and significantly shorter menstrual cycle intervals. The corresponding values for controls did not significantly differ between the start and end of the 8-week experiment. [Conclusion] Short-term regular exercise programs can lead to improvements in anthropometric, cardiovascular, and metabolic parameters of non-overweight women with polycystic ovary syndrome. PMID:26311969

  3. Placebo controlled, prospectively randomized, double-blinded study for the investigation of the effectiveness and safety of the acoustic wave therapy (AWT(®)) for cellulite treatment.

    PubMed

    Russe-Wilflingseder, Katharina; Russe-Wilfingsleder, Katharina; Russe, Elisabeth; Vester, Johannes C; Haller, Gerd; Novak, Pavel; Krotz, Alexander

    2013-06-01

    Placebo controlled double-blinded, prospectively randomized clinical trial with 17 patients (11 verum, 5 placebo) for evaluation of cellulite treatment with Acoustic Wave Therapy, (AWT(®)) was performed. The patients were treated once a week for 7 weeks, a total of 8 treatments with the D-ACTOR(®) 200 by Storz Medical AG. Data were collected at baseline, before 8th treatment, at 1 month (follow-up 1) and at 3 months (follow-up 2) after the last treatment with a patients' questionnaire, weight control, measurement of circumference and standardized photography. Treatment progress was further documented using a specially designed 3D imaging system (SkinSCAN(3D), 3D-Shape GmbH) providing an objective measure of cellulite (primary efficacy criteria). Patient's questionnaire in the verum group revealed an improvement in number and depth of dimples, skin firmness and texture, in shape and in reduction of circumference. The overall result (of skin waviness, Sq and Sz, surface and volume of depressions and elevations, Vvv and Vmp) at two follow-up visits indicates a more than medium sized superiority (MW = 0.6706) and is statistically significant (pWei-Lachin = 0.0106). The placebo group revealed no statistical significance. No side effects were seen. This indicates the efficacy and safety of AWT(®) for patients with cellulite.

  4. PCA3 as a second-line biomarker in a prospective controlled randomized opportunistic prostate cancer screening programme.

    PubMed

    Rubio-Briones, J; Casanova, J; Martínez, F; Domínguez-Escrig, J L; Fernández-Serra, A; Dumont, R; Ramírez-Backhaus, M; Gómez-Ferrer, A; Collado, A; Rubio, L; Molina, A; Vanaclocha, M; Sala, D; Lopez-Guerrero, J A

    2017-06-01

    PCA3 performance as a single second line biomarker is compared to the European Randomised Study of Screening for Prostate Cancer risk calculator model 3 (ERSPC RC-3) in an opportunistic screening in prostate cancer (PCa). 5,199 men, aged 40-75y, underwent prostate-specific antigen (PSA) screening and digital rectal examination (DRE). Men with a normal DRE and PSA ≥3ng/ml had a PCA3 test done. All men with PCA3 ≥35 underwent an initial biopsy (IBx) -12 cores-. Men with PCA3 <35 were randomized 1:1 to either IBx or observation. We compared them to those obtained with ERSPC RC-3. PCA3 test was performed on 838 men (16.1%). In PCA3(+) and PCA3(-) groups, global PCa detection rates were 40.9% and 14.7% with a median follow-up (FU) of 21.7 months (P<.001). In the PCA3(+) arm (n=301, 35.9%), PCa was identified in 115 men at IBx (38.2%). In the randomized arm, 256 underwent IBx and PCa was found in 46 (18.0%) (P<.001). The biopsy-sparing potential would have been 64.1% as opposed to 76.6% if we had used ERSPC RC-3. However, the estimated false negative cases for HGPCa would have been reduced by 37.1% (89 to 56 patients). Moreover, if we had applied PCA3-35 to avoid IBx, 14.7% PCa and 9.1% of clinical significant PCa patients would not have been diagnosed during this FU. When PCA3-35 is used as a second-line biomarker when PSA ≥3ng/ml and DRE is normal, IBx could be avoided in 12.5% less than if ERSPC RC-3 is used and would reduce the false negative cases by 36.2%. At a FU of 21.7 months, this dual protocol would miss 9.1% of clinically significant PCa, so strict FU is mandatory with established biopsy criteria based on PSA and DRE in cases with PCA3 <35. Copyright © 2016 AEU. Publicado por Elsevier España, S.L.U. All rights reserved.

  5. 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.

  6. Comparison of low-dose oxytocin and dinoprostone for labor induction in postterm pregnancies: a randomized controlled prospective study.

    PubMed

    Akay, Nezahat Öztürk; Hızlı, Deniz; Yılmaz, Saynur Sarıcı; Yalvaç, Serdar; Kandemir, Omer

    2012-01-01

    The aim of this study was to compare the efficacy of oxytocin and dinoprostone in achieving successful labor induction and vaginal delivery in postterm women with an unfavorable cervix. Postterm women with an uncomplicated pregnancy and a Bishop score of ≤6 were randomized to receive either dinoprostone vaginal pessary (Propess®) or low-dose oxytocin. The primary outcomes were the length of the induction-to-delivery period and the incidence of vaginal delivery. A total of 144 women were available for the analysis. The overall vaginal delivery rates were 75% (54/72) for the dinoprostone group and 80.6% (58/72; p = 0.35) for the oxytocin group; the mean induction-to-vaginal delivery interval was 13.3 and 10.3 h in the dinoprostone and the oxytocin group, respectively (p = 0.003). Uterine hyperstimulation was 7.4% compared with 6.8% (p = 0.8), and abnormal fetal heart rate was 26.4% compared with 18% (p = 0.2), respectively. Both oxytocin and dinoprostone seem to have similar obstetric outcomes in postterm pregnancies with an unfavorable cervix, except for a significant superiority of oxytocin for delivery in a shorter period. Copyright © 2012 S. Karger AG, Basel.

  7. A prospective, randomized, controlled trial of robot-assisted vs freehand pedicle screw fixation in spine surgery.

    PubMed

    Kim, Ho-Joong; Jung, Whan-Ik; Chang, Bong-Soon; Lee, Choon-Ki; Kang, Kyoung-Tak; Yeom, Jin S

    2017-09-01

    The purpose of this study was to compare the accuracy and safety of an instrumented posterior lumbar interbody fusion (PLIF) using a robot-assisted minimally invasive (Robot-PLIF) or a conventional open approach (Freehand-PLIF). Patients undergoing an instrumented PLIF were randomly assigned to be treated using a Robot-PLIF (37 patients) and a Freehand-PLIF (41 patients). For intrapedicular accuracy, there was no significant difference between the groups (P = 0.534). For proximal facet joint accuracy, none of the 74 screws in the Robot-PLIF group violated the proximal facet joint, while 13 of 82 in the Freehand-PLIF group violated the proximal facet joint (P < 0.001). The average distance of the screws from the facets was 5.2 ± 2.1 mm and 2.7 ± 1.6 mm in the Robot-PLIF and Freehand-PLIF groups, respectively (P < 0.001). Robotic-assisted pedicle screw placement was associated with fewer proximal facet joint violations and better convergence orientations. Copyright © 2016 John Wiley & Sons, Ltd.

  8. Lateral internal sphincterotomy versus 0.25 % isosorbide dinitrate ointment for chronic anal fissures: a prospective randomized controlled trial.

    PubMed

    Arslan, Kemal; Erenoğlu, Bülent; Doğru, Osman; Turan, Ersin; Eryilmaz, Mehmet Ali; Atay, Arif; Kökçam, Said

    2013-05-01

    To compare the healing properties of lateral internal sphincterotomy (LIS) and isosorbide dinitrate (ISDN) ointment for chronic anal fissure. Patients with a chronic anal fissure were randomly assigned to a group treated with ISDN ointment (n = 105) or a group treated with LIS (n = 102). The same investigators examined the patients in a blinded manner, 1, 2, 3, 6, and 12 months after the treatments. The anal fissure had healed completely by 4 weeks in 64.7 versus 92.2 %, and by 6 months in 77.1 versus 97.1 % of the ISDN and LIS group patients, respectively. At 12 months, the recurrence rates were 4.8 versus 1 % for the ISDN and LIS groups, respectively, and the success rates of the treatments were 72.4 versus 96.1 %, respectively. Six patients in the LIS group experienced minor fecal incontinence, and seven (6.7 %) patients in the ISDN group experienced headaches that responded well to paracetamol. ISDN ointment was reported by all patients to be easy to use. Although its success rate was lower than that of surgery, ISDN can be offered to selected patients with a chronic anal fissure, as it has a low recurrence rate and rare side effects are rare.

  9. Normobaric Hyperoxia for Treatment of Pneumocephalus after Posterior Fossa Surgery in the Semisitting Position: A Prospective Randomized Controlled Trial

    PubMed Central

    Hong, Bujung; Biertz, Frank; Raab, Peter; Scheinichen, Dirk; Ertl, Philipp; Grosshennig, Anika; Nakamura, Makoto; Hermann, Elvis J.; Lang, Josef M.; Lanfermann, Heinrich; Krauss, Joachim K.

    2015-01-01

    Background Supratentorial pneumocephalus after posterior fossa surgery in the semisitting position may lead to decreased alertness and other symptoms. We here aimed to prove the efficacy of normobaric hyperoxia on the absorption of postoperative pneumocephalus according to a standardized treatment protocol. Methods and Findings We enrolled 44 patients with postoperative supratentorial pneumocephalus (> 30 ml) after posterior fossa surgery in a semisitting position. After randomisation procedure, patients received either normobaric hyperoxia at FiO2 100% over an endotracheal tube for 3 hours (treatment arm) or room air (control arm). Routine cranial CT scans were performed immediately (CT1) and 24 hours (CT2) after completion of surgery and were rated without knowledge of the therapy arm. Two co-primary endpoints were assessed: (i) mean change of pneumocephalus volume, and (ii) air resorption rate in 24 hours. Secondary endpoints were subjective alertness (Stanford Sleepiness Scale) postoperatively and attention (Stroop test), which were evaluated preoperatively and 24 hours after surgery. The mean change in pneumocephalus volume was higher in patients in the treatment arm as compared to patients in the control arm (p = 0.001). The air resorption rate was higher in patients in the treatment arm as compared to patients in the control arm (p = 0.0015). Differences were more pronounced in patients aged 52 years and older. No difference between patients in treatment arm and control arm was observed for the Stroop test. The distribution of scores in the Stanford Sleepiness Scale differed in the treatment arm as compared to the control arm, and there was a difference in mean values (p = 0.015). Conclusions Administration of normobaric hyperoxia at FiO2 100% via an endotracheal tube for 3 hours is safe and efficacious in the treatment of pneumocephalus after posterior fossa surgery in the semisitting position. Largest benefit was found in elderly patients and particularly

  10. Randomized and non-randomized prospective controlled cohort studies in matched pair design for the long-term therapy of corpus uteri cancer patients with a mistletoe preparation (Iscador).

    PubMed

    Grossarth-Maticek, R; Ziegler, Renatus

    2008-03-31

    Mistletoe preparations such as Iscador are in common use as complementary/anthroposophic medications for many cancer indications, particularly for solid cancers. Efficacy of this complementary therapy is still discussed controversially. Does the long-term therapy with Iscador show any effect on survival or psychosomatic self-regulation of patients with corpus uteri cancer? Prospective recruitment and long-term follow-up in the following 4 controlled cohort studies. (1) Two randomized matched-pairs studies: corpus uteri cancer patients without (30 pairs) and with distant metastases (26 pairs) that never used any kind of mistletoe therapy were matched for prognostic factors. By pairwise random allocation, one of the patients was suggested mistletoe therapy to be applied by the attending physician. (2) Two non-randomized matched-pairs studies: corpus uteri cancer patients without (103 pairs) and with distant metastases (95 pairs) that already received mistletoe (Iscador) therapy were matched by the same criteria to control patients without Iscador therapy. Concerning overall survival in the randomized studies, a significant effect in favour of Iscador therapy was present only in the first study, the second showed no evidence for an effect: estimate of the hazard ratio and 95% confidence interval: 0.36 (0.16, 0.82) and 1.00 (0.46, 2.16) respectively. In the non-randomized studies, the results that adjusted for relevant prognostic variables were: 0.41 (0.26, 0.63), and 0.61 (0.39, 0.93). The effect of therapy with Iscador within 12 months on psychosomatic self-regulation as a measure of autonomous coping with the disease shows a significant rise in the Iscador group against the control group in the randomized as well as in the non-randomized study on patients with corpus uteri cancer without metastases: estimate of the median difference and 95% confidence interval: 0.40 (0.15, 0.70) and 0.70 (0.25, 1.15) respectively. The mistletoe preparation Iscador in these studies

  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. A prospective, randomized, blinded-endpoint, controlled study - continuous epidural infusion versus programmed intermittent epidural bolus in labor analgesia.

    PubMed

    Nunes, Joana; Nunes, Sara; Veiga, Mariano; Cortez, Mara; Seifert, Isabel

    2016-01-01

    There is evidence that administration of a programmed intermittent epidural bolus (PIEB) compared to continuous epidural infusion (CEI) leads to greater analgesia efficacy and maternal satisfaction with decreased anesthetic interventions. In this study, 166 women with viable pregnancies were included. After an epidural loading dose of 10mL with Ropivacaine 0.16% plus Sufentanil 10μg, parturient were randomly assigned to one of three regimens: A - Ropivacaine 0.15% plus Sufentanil 0.2μg/mL solution as continuous epidural infusion (5mL/h, beginning immediately after the initial bolus); B - Ropivacaine 0.1% plus Sufentanil 0.2μg/mL as programmed intermittent epidural bolus and C - Same solution as group A as programmed intermittent epidural bolus. PIEB regimens were programmed as 10mL/h starting 60min after the initial bolus. Rescue boluses of 5mL of the same solution were administered, with the infusion pump. We evaluated maternal satisfaction using a verbal numeric scale from 0 to 10. We also evaluated adverse, maternal and neonatal outcomes. We analyzed 130 pregnants (A=60; B=33; C=37). The median verbal numeric scale for maternal satisfaction was 8.8 in group A; 8.6 in group B and 8.6 in group C (p=0.83). We found a higher caesarean delivery rate in group A (56.7%; p=0.02). No differences in motor block, instrumental delivery rate and neonatal outcomes were observed. Maintenance of epidural analgesia with programmed intermittent epidural bolus is associated with a reduced incidence of caesarean delivery with equally high maternal satisfaction and no adverse outcomes. Copyright © 2015 Sociedade Brasileira de Anestesiologia. Published by Elsevier Editora Ltda. All rights reserved.

  13. [A prospective, randomized, blinded-endpoint, controlled study - continuous epidural infusion versus programmed intermittent epidural bolus in labor analgesia].

    PubMed

    Nunes, Joana; Nunes, Sara; Veiga, Mariano; Cortez, Mara; Seifert, Isabel

    2016-01-01

    There is evidence that administration of a programmed intermittent epidural bolus (PIEB) compared to continuous epidural infusion (CEI) leads to greater analgesia efficacy and maternal satisfaction with decreased anesthetic interventions. In this study, 166 women with viable pregnancies were included. After an epidural loading dose of 10mL with Ropivacaine 0.16% plus Sufentanil 10μg, parturient were randomly assigned to one of three regimens: A - Ropivacaine 0.15% plus Sufentanil 0.2μg/mL solution as continuous epidural infusion (5mL/h, beginning immediately after the initial bolus); B - Ropivacaine 0.1% plus Sufentanil 0.2μg/mL as programmed intermittent epidural bolus and C - Same solution as group A as programmed intermittent epidural bolus. PIEB regimens were programmed as 10mL/h starting 60min after the initial bolus. Rescue boluses of 5mL of the same solution were administered, with the infusion pump. We evaluated maternal satisfaction using a verbal numeric scale from 0 to 10. We also evaluated adverse, maternal and neonatal outcomes. We analyzed 130 pregnants (A=60; B=33; C=37). The median verbal numeric scale for maternal satisfaction was 8.8 in group A; 8.6 in group B and 8.6 in group C (p=0.83). We found a higher caesarean delivery rate in group A (56.7%; p=0.02). No differences in motor block, instrumental delivery rate and neonatal outcomes were observed. Maintenance of epidural analgesia with programmed intermittent epidural bolus is associated with a reduced incidence of caesarean delivery with equally high maternal satisfaction and no adverse outcomes. Copyright © 2015 Sociedade Brasileira de Anestesiologia. Publicado por Elsevier Editora Ltda. All rights reserved.

  14. A prospective randomized controlled trial comparing occupational therapy with home-based exercises in conservative treatment of rotator cuff tears.

    PubMed

    Krischak, Gert; Gebhard, Florian; Reichel, Heiko; Friemert, Benedikt; Schneider, Florian; Fisser, Christoph; Kaluscha, Rainer; Kraus, Michael

    2013-09-01

    This pilot study evaluates the outcome after occupational therapy, compared to home-based exercises in the conservative treatment of patients with full thickness rotator cuff tears. Forty-three adult subjects (range, 18-75 years), who had a full thickness rupture of the rotator cuff which was verified by magnetic imaging tomography, with clinical signs of a chronic rotator cuff impingement, and who were available for follow-up, were randomized to occupational therapy or to independent home-based exercises using a booklet. After drop-out, 38 patients were available for full examination at follow-up. Before therapy and after 2 months of conservative treatment, pain intensity, the Constant-Murley score, isokinetic strength testing in abduction and external rotation, functional limitation, clinical shoulder tests and health-related quality of life (EQ-5D) were evaluated. Two-thirds of the patients improved in clinical shoulder tests, regardless of the therapy group. There were no significant differences between the groups with reference to pain, range of motion, maximum peak force (abduction, external rotation), the Constant-Murley score, and the EQ-5D index. The only significant difference observed was the improvement in the self-assessed health- related quality of life (EQ-5D VAS) favoring home-based exercises. Home-based exercise, on the basis of an illustrated booklet with exercises twice a day, supplies comparable results to formal occupational therapy in the conservative treatment of rotator cuff tears. The results of this pilot study suggest some potential advantages related to psychological benefits using home-based treatment. Copyright © 2013 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

  15. Hyperalgesia and Persistent Pain after Breast Cancer Surgery: A Prospective Randomized Controlled Trial with Perioperative COX-2 Inhibition

    PubMed Central

    van Helmond, Noud; Steegers, Monique A.; Filippini-de Moor, Gertie P.; Vissers, Kris C.; Wilder-Smith, Oliver H.

    2016-01-01

    Background Persistent pain is a challenging clinical problem after breast cancer treatment. After surgery, inflammatory pain and nociceptive input from nerve injury induce central sensitization which may play a role in the genesis of persistent pain. Using quantitative sensory testing, we tested the hypothesis that adding COX-2 inhibition to standard treatment reduces hyperalgesia after breast cancer surgery. A secondary hypothesis was that patients developing persistent pain would exhibit more postoperative hyperalgesia. Methods 138 women scheduled for lumpectomy/mastectomy under general anesthesia with paravertebral block were randomized to COX-2 inhibition (2x40mg parecoxib on day of surgery, thereafter 2x200mg celecoxib/day until day five) or placebo. Preoperatively and 1, 5, 15 days and 1, 3, 6, 12 months postoperatively, we determined electric and pressure pain tolerance thresholds in dermatomes C6/T4/L1 and a 100mm VAS score for pain. We calculated the sum of pain tolerance thresholds and analyzed change in these versus preoperatively using mixed models analysis with factor medication. To assess hyperalgesia in persistent pain patients we performed an additional analysis on patients reporting VAS>30 at 12 months. Results 48 COX-2 inhibition and 46 placebo patients were analyzed in a modified intention to treat analysis. Contrary to our primary hypothesis, change in the sum of tolerance thresholds in the COX-2 inhibition group was not different versus placebo. COX-2 inhibition had an effect on pain on movement at postoperative day 5 (p<0.01). Consistent with our secondary hypothesis, change in sum of pressure pain tolerance thresholds in 11 patients that developed persistent pain was negative versus patients without pain (p<0.01) from day 5 to 1 year postoperatively. Conclusions Perioperative COX-2 inhibition has limited value in preventing sensitization and persistent pain after breast cancer surgery. Central sensitization may play a role in the genesis of

  16. The REDUCE pivotal trial: a prospective, randomized controlled pivotal trial of a dual intragastric balloon for the treatment of obesity.

    PubMed

    Ponce, Jaime; Woodman, George; Swain, James; Wilson, Erik; English, Wayne; Ikramuddin, Sayeed; Bour, Eric; Edmundowicz, Steven; Snyder, Brad; Soto, Flavia; Sullivan, Shelby; Holcomb, Richard; Lehmann, John

    2015-01-01

    Saline-filled intragastric balloon devices are reversible endoscopic devices designed to occupy stomach volume and reduce food intake. To evaluate the safety and effectiveness of a dual balloon system plus diet and exercise in the treatment of obesity compared to diet and exercise alone. Academic and community practice, United States. Participants (n = 326) with body mass index (BMI) 30-40 kg/m(2) were randomized to endoscopic DBS treatment plus diet and exercise (DUO, n = 187) or sham endoscopy plus diet and exercise alone (DIET, n = 139). Co-primary endpoints were a between-group comparison of percent excess weight loss (%EWL) and DUO subject responder rate, both at 24 weeks. Thereafter DUO patients had the DBS retrieved followed by 24 additional weeks of counseling; DIET patients were offered DBS treatment. Mean BMI was 35.4. Both primary endpoints were met. DUO weight loss was over twice that of DIET. DUO patients had significantly greater %EWL at 24 weeks (25.1% intent-to-treat (ITT), 27.9% completed cases (CC, n = 167) compared with DIET patients (11.3% ITT, P = .004, 12.3% CC, n = 126). DUO patients significantly exceeded a 35% response rate (49.1% ITT, P<.001, 54.5% CC) for weight loss dichotomized at 25%EWL. Accommodative symptoms abated rapidly with support and medication. Balloon deflation occurred in 6% without migrations. Early retrieval for nonulcer intolerance occurred in 9%. Gastric ulcers were observed; a minor device change led to significantly reduced ulcer size and frequency (10%). The DBS was significantly more effective than diet and exercise in causing weight loss with a low adverse event profile. Copyright © 2015 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.

  17. Sedation with propofol for interventional endoscopy by trained nurses in high-risk octogenarians: a prospective, randomized, controlled study.

    PubMed

    Schilling, D; Rosenbaum, A; Schweizer, S; Richter, H; Rumstadt, B

    2009-04-01

    Sedation with the short-acting anesthetic agent propofol has shown several advantages, particularly in interventional endoscopy. So far, however, there are no valid data on the safety of nurse-administered propofol sedation (NAPS) during interventional endoscopy in elderly high-risk patients. A total of 150 patients aged > 80 years with high comorbidity were randomized to receive midazolam plus meperidine (n = 75) or propofol alone (n = 76) for sedation during endoscopic retrograde cholangiopancreatography (ERCP), endoscopic ultrasound (EUS), or double-balloon endoscopy (DBE). Sedation was supervised by a trained nurse and a trained physician both of whom were not involved in the endoscopic procedure. Vital signs were continuously monitored as well as patient cooperation and tolerance. Mortality and morbidity at 30 days was analyzed. The overall cardiopulmonary complication rate was 16 % in the midazolam group and 23.7 % in the propofol group ( P > 0.05). The mean decline in oxygen saturation (initial vs. lowest O (2) saturation) and the mean decline of blood pressure (initial vs. lowest blood pressure) were significantly greater with propofol (7 % +/- 3 % vs. 4 % +/- 2 % [ P < 0.05] and 10 % +/- 2 % vs. 8 % +/- 2 %, respectively [ P < 0.05]). No procedure had to be interrupted due to serious adverse events. Patient cooperation was statistically significantly better in the propofol group (7 +/- 2 vs. 5 +/- 2 points). Patients sedated with propofol showed a significantly lower oxygen saturation rate during recovery time (8 % vs. 28 %; P < or = 0.01). NAPS during interventional endoscopy is as safe as midazolam/pethidine sedation even in high-risk patients aged > 80 years.

  18. A prospective randomized controlled study of erythromycin on gastric and small intestinal distention: implications for MR enterography.

    PubMed

    Bharucha, Adil E; Fidler, Jeff L; Huprich, James E; Ratuapli, Shiva K; Holmes, David R; Riederer, Stephen J; Zinsmeister, Alan R

    2014-11-01

    To assess if erythromycin increases gastric emptying and hence improves small intestinal distention during MR enterography. Gastric, small intestinal, and large intestinal volumes were assessed with MR after neutral oral contrast (1350ml in 45min) and balanced randomization to erythromycin (200mg i.v., age 31±3y, 13 females), or placebo (37±3y, 13 females) in 40 healthy asymptomatic volunteers. Fat-suppressed T2-weighted MR images of the abdomen were acquired on a 1.5T magnet at standard delay times for enterography. Gastric, small, and large intestinal volumes were measured by specialized software. In addition, two radiologists manually measured diameters and percentage distention of jejunal and ileal loops. Treatment effects were evaluated by an ITT analysis based on ANCOVA models. All subjects tolerated erythromycin. MRI scans of the stomach and intestine were obtained at 62±2 (mean±SEM) and 74±2min respectively after starting oral contrast. Gastric volumes were lower (P<0.0001) after erythromycin (260±49ml) than placebo (688±63ml) but jejunal, ileal, and colonic volumes were not significantly different. However, maximum (76-100%) jejunal distention was more frequently observed (P=0.03) after erythromycin (8/20 subjects [40%]) than placebo (2/20 subjects [10%]). The diameter of a representative ileal loop was greater (P=0.001) after erythromycin (18.8±4.3mm) than placebo (17.3±2.8mm) infusion. After ingestion of oral contrast, erythromycin accelerated gastric emptying but effects on small intestinal dimensions were variable. In balance, erythromycin did not substantially enhance small intestinal distention during enterography using current standard delay times. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

  19. Topical permethrin and oral ivermectin in the management of scabies: a prospective, randomized, double blind, controlled study.

    PubMed

    Sharma, Reena; Singal, Archana

    2011-01-01

    Scabies is a highly contagious and intensely pruritic parasitic infestation. It is a re-emerging infection in the new millennium especially with HIV pandemic and a significant health problem in developing countries. Various treatment modalities have been used since time immemorial but the search for an ideal scabicide is ongoing. In this study, we compared the therapeutic efficacy of single application of topical 5% permethrin with oral ivermectin (200 μg/kg/dose) in a single-dose and a two-dose regimen in patients with scabies. 120 clinically diagnosed cases of scabies (>5 years of age and/or >15 kg) were randomized into three treatment groups A, B, C of 40 patients each; receiving either topical 5% permethrin (group A) or oral ivermectin (200 μg/kg/dose) in a single dose (group B) or double dose regimen (group C) repeated at 2 weeks interval. Patients were followed up at 1, 2, and 4 weeks interval. At each visit, cure rate (>50% improvement in lesion count and pruritus and negative microscopy) was assessed and compared. Cure rate in three treatment groups at the end of 4 weeks was 94.7% (A), 90% (B), 89.7% (C), and thus all three treatment modalities were equally efficacious. However, at 1 week follow up, group A patients reported better improvement in both lesion count and pruritus. Both permethrin and ivermectin in both single and two dose regimen are equally efficacious and well tolerated in scabies. However, permethrin has a rapid onset of action.

  20. Smoking cessation induced by deep repetitive transcranial magnetic stimulation of the prefrontal and insular cortices: a prospective, randomized controlled trial.

    PubMed

    Dinur-Klein, Limor; Dannon, Pinhas; Hadar, Aviad; Rosenberg, Oded; Roth, Yiftach; Kotler, Moshe; Zangen, Abraham

    2014-11-01

    Tobacco smoking is the leading cause of preventable death in developed countries. Our previous studies in animal models and humans suggest that repeated activation of cue-induced craving networks followed by electromagnetic stimulation of the dorsal prefrontal cortex (PFC) can cause lasting reductions in drug craving and consumption. We hypothesized that disruption of these circuitries by deep transcranial magnetic stimulation (TMS) of the PFC and insula bilaterally can induce smoking cessation. Adults (N = 115) who smoke at least 20 cigarettes/day and failed previous treatments were recruited from the general population. Participants were randomized to receive 13 daily sessions of high-frequency, low-frequency or sham stimulation following, or without, presentation of smoking cues. Deep TMS was administered using an H-coil version targeting the lateral PFC and insula bilaterally. Cigarette consumption was evaluated during the treatment by measuring cotinine levels in urine samples and recording participants' self-reports as a primary outcome variable. Dependence and craving were assessed using standardized questionnaires. High (but not low) frequency deep TMS treatment significantly reduced cigarette consumption and nicotine dependence. The combination of this treatment with exposure to smoking cues enhanced reduction in cigarette consumption leading to an abstinence rate of 44% at the end of the treatment and an estimated 33% 6 months following the treatment. This study further implicates the lateral PFC and insula in nicotine addiction and suggests the use of deep high-frequency TMS of these regions following presentation of smoking cues as a promising treatment strategy. Copyright © 2014 Society of Biological Psychiatry. Published by Elsevier Inc. All rights reserved.

  1. ULTRAPRO Hernia System versus lichtenstein repair in treatment of primary inguinal hernias: a prospective randomized controlled study.

    PubMed

    Karateke, Faruk; Ozyazici, Sefa; Menekse, Ebru; Özdogan, Hatice; Kunt, Mevlüt; Bozkurt, Hilmi; Bali, İlhan; Özdogan, Mehmet

    2014-01-01

    The Lichtenstein repair has been recommended as the gold standard for inguinal hernia repair. However, postoperative discomfort still constitutes a concern and an area for improvement. New mesh materials have been continuously introduced to achieve this goal. The goal of the present study was to investigate the outcomes of ULTRAPRO Hernia System (UHS) compared with Lichtenstein mesh repair. A total of 99 male patients with primary unilateral inguinal hernia were included in the study during the period of September 2010-January 2012. Patients with body mass index>30, comorbid diseases, and anesthetic risk of ASA-III and ASA-IV were excluded. The patients were randomly allocated to operation with the Lichtenstein technique (group L) or UHS. Demographics, operative and postoperative/recovery data, and short- and medium-term outcomes of the patients were recorded. A total of 50 patients in group L and 49 patients in group UHS were analyzed. The median follow-up time for the study was 33 months. There were no significant differences regarding demographics, complications, and rehabilitation between the groups. Overall, there was a prolonged operation time in the UHS group compared with the L group (UHS: 53.7±5.7 minutes; L: 44.5±5.5 minutes; P<0.001). UHS may provide results similar to those for the Lichtenstein technique in open repair of inguinal hernias regarding perioperative course, complications, recovery, and recurrence rates. However, because of reduced costs and the lack of need for the exploration of the preperitoneal space, we conclude that the Lichtenstein technique should be recommended as the first choice.

  2. Effect of clonidine versus dexmedetomidine on pain control after laparoscopic gastric sleeve: A prospective, randomized, double-blinded study

    PubMed Central

    Naja, Zoher M.; Khatib, Rania; Ziade, Fouad M.; Moussa, Georges; Naja, Zeina Z.; Naja, Ahmad Salah Eddine; Kanawati, Saleh

    2014-01-01

    Background: The use of opioids in surgeries for morbidly obese patients could cause respiratory depression. Therefore, alternative analgesics are needed to improve anesthetic management for obese patients. The objective of this study was to compare the effect of dexmedetomidine and clonidine on pain as well as analgesic consumption at 24 h postoperatively in patients undergoing laparoscopic gastric sleeve. The secondary objective was to compare patients’ and surgeons’ satisfaction. Materials and Methods: A total of 60 obese and morbidly obese patients scheduled to undergo laparoscopic gastric sleeve were randomly assigned into two groups. 10 min after induction of general anesthesia, one group received 0.8-1.2 μg/kg/30 min intravenous (IV) clonidine through 500 mL lactated Ringer's solution and placebo (normal saline solution) through syringe pump. The second group received IV dexmedetomidine through syringe pump at a rate 0.5-0.8 μg/kg/h and placebo through 500 mL lactated Ringer's solution. Data on pain, analgesic consumption, and return to normal activity in addition to patients’ and surgeons’ satisfaction were collected. Results: Both groups were similar with respect to demographic and intraoperative hemodynamic characteristics. Fentanyl consumption, surgery duration and hospital stay were similar for the two groups. Pain scores on walking were significantly lower in the clonidine group at 12 h postoperatively (P = 0.014) compared with dexmedetomidine group. The number of patients who consumed pethidine was significantly lower in the clonidine group at 12 h postoperatively (P = 0.045). Conclusion: This study concluded that clonidine and dexmedetomidine yielded similar outcomes with a difference in pain and analgesic consumption at 12 h postoperatively. PMID:25538523

  3. The effectiveness of low laser therapy in subacromial impingement syndrome: a randomized placebo controlled double‐blind prospective study

    PubMed Central

    Dogan, Sebnem Koldas; AY, Saime; Evcik, Deniz

    2010-01-01

    OBJECTIVES: Conflicting results were reported about the effectiveness of Low level laser therapy on musculoskeletal disorders. The aim of this study was to investigate the effectiveness of 850‐nm gallium arsenide aluminum (Ga‐As‐Al) laser therapy on pain, range of motion and disability in subacromial impingement syndrome. METHODS: A total of 52 patients (33 females and 19 males with a mean age of 53.59±11.34 years) with subacromial impingement syndrome were included. The patients were randomly assigned into two groups. Group I (n = 30, laser group) received laser therapy (5 joule/cm2 at each point over maximum 5‐6 painful points for 1 minute). Group II (n = 22, placebo laser group) received placebo laser therapy. Initially cold pack (10 minutes) was applied to all of the patients. Also patients were given an exercise program including range of motion, stretching and progressive resistive exercises. The therapy program was applied 5 times a week for 14 sessions. Pain severity was assessed by using visual analogue scale. Range of motion was measured by goniometer. Disability was evaluated by using Shoulder Pain and Disability Index. RESULTS: In group I, statistically significant improvements in pain severity, range of motion except internal and external rotation and SPADI scores were observed compared to baseline scores after the therapy (p<0.05). In Group II, all parameters except range of motion of external rotation were improved (p<0.05). However, no significant differences were recorded between the groups (p>0.05). CONCLUSIONS: The Low level laser therapy seems to have no superiority over placebo laser therapy in reducing pain severity, range of motion and functional disability. PMID:21120304

  4. Prospective, randomized and controlled trial on magnesium sulfate administration during laparoscopic gastrectomy: effects on surgical space conditions and recovery profiles.

    PubMed

    Ryu, J H; Koo, B W; Kim, B G; Oh, A Y; Kim, H H; Park, D J; Lee, C M; Kim, S T; Do, S H

    2016-11-01

    The degree of neuromuscular blockade is one of the important factors that determine the condition of surgical space during laparoscopic surgery. Magnesium sulfate potentiates the actions of neuromuscular blocking agent, and we hypothesized that intraoperative magnesium sulfate infusion may improve surgical space condition during laparoscopic surgery. Eighty-four patients undergoing elective laparoscopic gastrectomy were randomized to receive isotonic saline (group C) or magnesium sulfate (group M, loading dose with 50 mg/kg over 10 min and then 15 mg/kg/h by continuous infusion) to maintain the moderate neuromuscular blockade using rocuronium. Two experienced surgeons scored the quality of surgical space condition using a 5-point surgical rating scale (SRS). The secondary outcomes included recovery profiles, postoperative pain and adverse events. The SRS in group M was higher than that of group C. The proportion of patients with a SRS of 5 (optimal) was 2.7 % in the group C and 40.5 % in the group M (P < 0.0001) although a lower amount of rocuronium was required in group M than group C [24.2 (6.5) mg/h for group M vs. 27.5 (6) mg/h for group C; P = 0.017]. Pain after operation site was less severe in group M than in group C at postoperative 24 h (P = 0.009). Recovery profiles and adverse events were similar between the two groups. Intraoperative administration of magnesium sulfate improved the quality of surgical space conditions and decreased neuromuscular blocking agent requirement and postoperative pain in patients undergoing laparoscopic gastrectomy.

  5. A prospective randomized controlled study comparing two doses of gestodene in cyclic combined HRT preparations on endometrial physiology.

    PubMed

    Okon, M A; Lee, S; Laird, S M; Li, T C

    2001-06-01

    Postmenopausal women taking oestradiol 17-beta 2 mg daily were randomized to receive either 25 or 50 microg gestodene from day 17 to 28 of the cycle in a double-blind study. Placental protein P14 (PP14) and CA 125 concentrations in uterine flushing, endometrial morphology and irregular bleeding after 12 cycles of study were observed. Eleven and 12 women in the 25 and 50 microg groups respectively completed the study. There were no significant differences in pre-treatment biochemical and morphological indices between the groups. The median PP14 concentration increased from 332 to 5800 ng/ml (P < 0.001) and from 145 to 27 160 ng/ml (P < 0.001) in the 25 and 50 microg gestodene groups respectively. No between-group significant rise of PP14 was observed. Similarly, no significant change was seen between the initial and post-treatment concentrations of CA 125 for either group. All biopsies were atrophic at inception of the study, and both regimens produced secretory endometrial transformation in the majority of biopsies. No between-group difference was observed in the morphometric indices measured, or any significant correlation between the concentrations of PP14 or CA 125 and morphology. The mean number of days of withdrawal bleeding (3.8 and 4.2 days for 25 and 50 microg respectively) were similar. In conclusion, both regimens produced a significant rise in uterine flushing concentrations of PP14, but not CA 125. PP14 is a sensitive biochemical marker in the assessment of endometrial response to hormone replacement therapy.

  6. Laparoscopic-assisted versus open resection of right-sided colonic cancer--a prospective randomized controlled trial.

    PubMed

    Li, Jimmy Chak-Man; Leung, Ka Lau; Ng, Simon Siu-Man; Liu, Shirley Yuk-Wa; Lee, Janet Fung-Yee; Hon, Sophie Sok-Fei

    2012-01-01

    This study aims to compare the perioperative outcomes and survival between laparoscopic-assisted right hemicolectomy (LARH) and open right hemicolectomy (ORH) for right-sided colon cancer. Between July 1996 and October 2005, 145 patients were randomized to receive LARH (n = 71) or ORH (n = 74). The median follow-up of living patients was 99.7 months. The demographic data of the two groups were similar. The time to resume diet (4 vs. 5 days, p = 0.045) and the hospital stay (7.8 vs. 10 days, p = 0.033) were significantly shorter in LARH group, but these benefits were at the expense of longer operating time (198 vs. 129 min, p = 0.002) and higher direct cost (USD8745 vs. USD6293, p < 0.001). The morbidity and mortality were comparable between the two groups. After curative resection, the probabilities of survival at 5 years of the LARH and ORH groups were 74.2% (SE 7.4%) and 75% (SE 7.1%), respectively. The probabilities of being disease free at 5 years were 82.3% (SE 6.9%) and 84.1% (SE 6.2%), respectively. Laparoscopic-assisted resection of right-sided colonic cancer has the advantage over open surgery in allowing earlier recovery. However this is at the expense of a longer operating time and higher direct cost (registration number: NCT00485316 ( http://www.clinicaltrials.gov )).

  7. Effects of tigecycline and doxycycline on inflammation and hemodynamics in porcine endotoxemia: a prospective, randomized, and placebo-controlled trial.

    PubMed

    von Seth, Magnus; Sjölin, Jan; Larsson, Anders; Eriksson, Mats; Hillered, Lars; Lipcsey, Miklós

    2015-06-01

    Antibiotics might, apart from an antimicrobial effect, also exert anti-inflammatory effects. The novel antibiotic tigecycline, potentially useful in septic shock from gram-negative multiresistant bacteria, is structurally related to antibiotics with known anti-inflammatory properties. However, its anti-inflammatory effects have not been previously explored in vivo. Using a sterile integrative porcine sepsis model, we investigated the anti-inflammatory and circulatory effects of tigecycline in comparison with doxycycline and placebo. Eighteen pigs were randomized to receive tigecycline 100 mg, doxycycline 200 mg, or placebo and subjected to 6-h endotoxin infusion at 0.5 μg kg(-1) h(-1). Markers of inflammation, nitric oxide production, vascular permeability, hemodynamics, organ dysfunction, tissue metabolism, and acid-base parameters were monitored. Peak plasma tumor necrosis factor-α was lower in the doxycycline group (P = 0.031) but not in the tigecycline group (P = 0.86) compared with placebo, with geometric mean plasma concentrations of 16, 79, and 63 ng mL(-1), respectively. Mean arterial pressure was higher 4 to 6 h in the tigecycline group, with values at 6 h of 107 ± 9 mmHg compared with the placebo and doxycycline groups (85 ± 27 mmHg and 90 ± 32 mmHg, respectively; P = 0.025). The white blood cell and the neutrophil granulocyte counts were less reduced in the doxycycline group but not in the tigecycline group at 4 to 6 h (P = 0.009 and P = 0.019, respectively). Other markers of inflammation, organ dysfunction, tissue metabolism, and acid-base parameters were unaffected by tigecycline. Consistent with known anti-inflammatory properties, doxycycline yielded decreased tumor necrosis factor-α levels. Tigecycline did not affect cytokine levels but counteracted hypotension and hypoperfusion.

  8. Can Low Level Laser Therapy Benefit Bone Regeneration in Localized Maxillary Cystic Defects? - A Prospective Randomized Control Trial

    PubMed Central

    Zaky, Ahmed Abbas; El Shenawy, Hanaa Mohamed Mohamed; Harhsh, Tarek Abdel Hamed; Shalash, Mahmoud; Awad, Noha Mohamed Ismael

    2016-01-01

    AIM: The aim of the study was to evaluate the effect of Low-Level Laser Therapy (LLLT) on bone formation in cystic defects following cyst enucleation. PATIENTS AND METHODS: The sample was composed of sixteen patients with enucleated maxillary bony cystic lesions. With an age range from 20 - 44 grouped as eight Laser and eight Control patients. Laser group was subjected to low intensity diode laser immediately after surgery and then for three times per week for two weeks using a therapeutic laser irradiation. Group B (control group): patients were not subjected laser therapy. RESULTS: The predictor variable was exposure of bone defect to LLLT or none. The outcome variable was bone density changes measured by digital radiographs at day 1 and days 90 postoperatively. Descriptive and bivariate statistics were computed. There were no statistically significant differences between the 2 groups for the bone density at day 1. There was a statistically significant difference in bone density changes in each group at day 90: Significant at P ≤ 0.05. After adjusting for differences in day 1 for bone density, the estimated mean change in bone density changes at day 90 was significantly larger for Laser compared with control. CONCLUSION: The results of this study suggested that LLLT can enhance bone healing in maxillary cystic defects. This can serve as an adjunct method in preventing possible delayed healing and pathological fractures This also will be helpful for more researchers in early loading in case of dental implants to accelerate osseointegration. PMID:28028422

  9. Rheumatoid arthritis exacerbates the severity of osteonecrosis of the jaws (ONJ) in mice. A randomized, prospective, controlled animal study

    PubMed Central

    de Molon, Rafael Scaf; Hsu, Chingyun; Bezouglaia, Olga; Dry, Sarah M.; Pirih, Flavia Q.; Soundia, Akrivoula; Cunha, Fernando Queiroz; Cirelli, Joni Augusto; Aghaloo, Tara L.; Tetradis, Sotirios

    2016-01-01

    Rheumatoid arthritis (RA), an autoimmune inflammatory disorder, results in persistent synovitis with severe bone and cartilage destruction. Bisphosphonates (BPs) are often utilized in RA patients to reduce bone destruction and manage osteoporosis. However, BPs, especially at high doses, are associated with osteonecrosis of the jaw (ONJ). Here, utilizing previously published ONJ animal models, we are exploring interactions between RA and ONJ incidence and severity. DBA1/J-mice were divided in 4 groups: control, zoledronic acid (ZA), collagen induced arthritis (CIA), and CIA-ZA. Animals were pre-treated with vehicle or ZA. Bovine collagen II emulsified in Freund’s adjuvant was injected to induce arthritis (CIA) and the mandibular molar crowns were drilled to induce periapical disease. Vehicle or ZA treatment continued for 8-weeks. ONJ indices were measured by micro-CT and histological examination of maxillae and mandibles. Arthritis development was assessed by visual scoring of paw swelling, and by micro-CT and histology of interphalangeal and knee joints. Maxillae and mandibles of control and CIA mice showed bone loss, PDL space widening, lamina dura loss and cortex thinning. ZA prevented theses changes in both ZA and CIA-ZA groups. Epithelial to alveolar crest distance was increased in the control and CIA mice. This distance was preserved in ZA and CIA-ZA animals. Empty osteocytic lacunae and areas of osteonecrosis were present in ZA and CIA-ZA but more extensively in CIA-ZA animals, indicating more severe ONJ. CIA and CIA-ZA groups developed severe arthritis in the paws and knees. Interphalangeal and knee joints of CIA mice showed advanced bone destruction with cortical erosions and trabecular bone loss, and ZA treatment reduced these effects. Importantly, no osteonecrosis was noted adjacent to areas of articular inflammation in CIA-ZA mice. Our data suggest that ONJ burden was more pronounced in ZA treated CIA mice and that RA could be a risk factor for ONJ

  10. A Prospective Randomized Controlled Trial of the Efficacy of External Physical Vibration Lithecbole after Extracorporeal Shock Wave Lithotripsy for a Lower Pole Renal Stone Less Than 2 cm.

    PubMed

    Long, Qilai; Zhang, Jian; Xu, Zhibing; Zhu, Yanjun; Liu, Li; Wang, Hang; Guo, Jianming; Wang, Guomin

    2016-04-01

    We evaluate the efficacy and safety of external physical vibration lithecbole in improving the clearance rates of lower pole renal stones after shock wave lithotripsy. A total of 71 patients with lower pole renal stones (6 to 20 mm) were prospectively randomized into 2 groups. In the treatment group 34 patients were treated with external physical vibration lithecbole after shock wave lithotripsy. In the control group 37 patients underwent shock wave lithotripsy only. External physical vibration lithecbole was performed without anesthesia by the same team using the Friend-I External Physical Vibration Lithecbole (Fu Jian Da Medical Instrument Co., Ltd, Zhengzhou, China). The stone-free rate, stone expulsion rate, stone expulsion time and incidence of complications were monitored. External physical vibration lithecbole was successful in assisting the discharge of stone fragments. The stone-free status was 76.5% in the treatment group and 48.6% in the control group (p=0.008). Stone expulsion rates at day 1, week 1 and week 3 were 76.5% (26), 94.1% (32) and 94.1% (32) in the treatment group vs 43.2% (16), 73.0% (27) and 89.2% (33) in the control group, respectively. Mean stone fragment expulsion time was 11.2 minutes in the treatment group and 9.17 hours in the control group (p=0.016). There was no significant difference in complications between the 2 groups (p >0.05). External physical vibration lithecbole was efficacious in assisting the discharge of lower pole renal stone fragments and can be used as an adjunctive method of minimally invasive stone treatment. However, additional investigations are needed to confirm the efficacy. Copyright © 2016 American Urological Association Education and Research, Inc. Published by Elsevier Inc. All rights reserved.

  11. Rheumatoid Arthritis Exacerbates the Severity of Osteonecrosis of the Jaws (ONJ) in Mice. A Randomized, Prospective, Controlled Animal Study.

    PubMed

    de Molon, Rafael Scaf; Hsu, Chingyun; Bezouglaia, Olga; Dry, Sarah M; Pirih, Flavia Q; Soundia, Akrivoula; Cunha, Fernando Queiroz; Cirelli, Joni Augusto; Aghaloo, Tara L; Tetradis, Sotirios

    2016-08-01

    Rheumatoid arthritis (RA), an autoimmune inflammatory disorder, results in persistent synovitis with severe bone and cartilage destruction. Bisphosphonates (BPs) are often utilized in RA patients to reduce bone destruction and manage osteoporosis. However, BPs, especially at high doses, are associated with osteonecrosis of the jaw (ONJ). Here, utilizing previously published ONJ animal models, we are exploring interactions between RA and ONJ incidence and severity. DBA1/J mice were divided into four groups: control, zoledronic acid (ZA), collagen-induced arthritis (CIA), and CIA-ZA. Animals were pretreated with vehicle or ZA. Bovine collagen II emulsified in Freund's adjuvant was injected to induce arthritis (CIA) and the mandibular molar crowns were drilled to induce periapical disease. Vehicle or ZA treatment continued for 8 weeks. ONJ indices were measured by micro-CT (µCT) and histological examination of maxillae and mandibles. Arthritis development was assessed by visual scoring of paw swelling, and by µCT and histology of interphalangeal and knee joints. Maxillae and mandibles of control and CIA mice showed bone loss, periodontal ligament (PDL) space widening, lamina dura loss, and cortex thinning. ZA prevented these changes in both ZA and CIA-ZA groups. Epithelial to alveolar crest distance was increased in the control and CIA mice. This distance was preserved in ZA and CIA-ZA animals. Empty osteocytic lacunae and areas of osteonecrosis were present in ZA and CIA-ZA but more extensively in CIA-ZA animals, indicating more severe ONJ. CIA and CIA-ZA groups developed severe arthritis in the paws and knees. Interphalangeal and knee joints of CIA mice showed advanced bone destruction with cortical erosions and trabecular bone loss, and ZA treatment reduced these effects. Importantly, no osteonecrosis was noted adjacent to areas of articular inflammation in CIA-ZA mice. Our data suggest that ONJ burden was more pronounced in ZA treated CIA mice and that RA could

  12. The Effect of Information About Gynecological Examination on the Anxiety Level of Women Applying to Gynecology Clinics: A Prospective, Randomized, Controlled Study

    PubMed Central

    Ulker, Kahraman; Kivrak, Yuksel

    2016-01-01

    Background: Crowded hospital outpatient clinics and endless waiting lines that make patients feel overlooked tend to exaggerate patients’ anxiety levels. In addition, fear of pain, shyness, religious and traditional thoughts, women’s sexual role in society, and previous information and experience also contribute to people’s anxiety levels with regard to gynecologic examination. Objectives: We aimed to analyze the effect of specific information about gynecologic examination on anxiety levels of women applying to gynecology clinics. Materials and Methods: In this randomized prospective study, the women applying for a gynecological examination were randomly allocated into control, intervention 1, and intervention 2 groups. Power analysis indicated that in order to achieve a one-point decrease from the previous anxiety score of 43.85 ± 5.41 at one side alpha 0.05 with a power of 80%, at least 79 women were needed in each group. Four medical school students interviewed 75 women (25 in control, 25 in intervention 1, and 25 in intervention 2). The data were collected using the demographic, social, and economic data form, and the Turkish version of the state-trait anxiety inventory (STAI). The women in the intervention 1 and 2 groups were instructed to read a paper that contained brief information about the gynecological examination procedure and the profits obtained from forests, respectively. All participants, including the women in the control group, filled the STAI by themselves. The three groups were compared appropriately. Results: The demographics pertaining to age, gravidity and parity, miscarriage, induced abortion, ectopic pregnancy, offspring number, place of residence, working status, education level and previous experience of gynecological examination did not differ among the groups (P > 0.05). According to the STAI scores, all groups had mild state (control: 40.20 ± 10.53, intervention 1: 42.00 ± 11.98, and intervention 2: 39.53 ± 10.32) and severe

  13. Target-Controlled Infusion of Propofol in Training Anesthesiology Residents in Colonoscopy Sedation: A Prospective Randomized Crossover Trial

    PubMed Central

    Wang, Jia-feng; Li, Bo; Yang, Yu-guang; Fan, Xiao-hua; Li, Jin-bao; Deng, Xiao-ming

    2016-01-01

    Background Propofol is widely used in sedation for colonoscopy, but its adverse effects on cardiovascular and respiratory systems are still concerning. The present study investigated whether target controlled infusion (TCI) of propofol could provide a better sedation quality than manually controlled infusion (MCI) in training inexperienced anesthesiology residents. Material/Methods Eighteen training residents were allocated into 2 groups receiving TCI and MCI training in their first month in the endoscopy center, while receiving MCI and TCI training instead in their second month. The last 2 patients at the end of each month were included to analyze the sedation quality of TCI and MCI techniques by comparing satisfaction of endoscopist and patients based on the visual analogue scale (VAS). Heart rate (HR), mean blood pressure (MAP), SpO2, and recovery time were also compared as the secondary outcomes. Results The demographic data were similarly distributed among the TCI and MCI patients. Endoscopist’s satisfaction score in the TCI group was significantly higher than in the MCI group, 81.3±7.2 versus 74.2±9.5 (P=0.003), but the patients’ satisfaction score was similar between the 2 groups. More stable hemodynamic status was obtained in the TCI group, manifested as higher lowest MAP and lower highest MAP than in the MCI group. Lowest SpO2 in the TCI group was significantly higher than in the MCI group. Patients in the TCI group recovered earlier than in the MCI group. Conclusions TCI is a more effective and safer technique for anesthesiology residents in sedation for colonoscopy. PMID:26787637

  14. Prospective randomized controlled study of prophylaxis with cefamandole in high risk patients undergoing operations upon the biliary tract.

    PubMed

    Cáinzos, M; Potel, J; Puente, J L

    1985-01-01

    In this study, 52 high risk patients who underwent operations upon the biliary tract were assigned to receive either antibiotic prophylaxis or no treatment with antibiotics. Twenty-seven patients were given 2 grams of cefamandole intramuscularly 30 minutes before operation and 2 grams every eight hours for two days postoperatively. The remaining patients were in the control group and did not receive antibiotics. Surgical wounds were inspected daily by a surgeon while the patients were in the hospital and a follow-up revision was done four weeks after discharge from the hospital. Samples of exudate or pus were taken when the wound appeared infected and cultures of aerobic and anaerobic organism done. Chi-square affinity test with Yate's correction was used for statistical results; only p values more than or equal to 0.5 were considered significant. Seven patients (28 per cent) in the control group had complications develop postoperatively; seven surgical wound infections, one of which included a subphrenic abscess. Postoperatively, there were no septic complications in the group who received cefamandole as a prophylaxis. The incidence of infection was higher for females than males. The organisms most frequently isolated were Escherichia coli and Klebsiella; only in one instance was Clostridum sporogenes found. Polymicrobial infections accounted for 42.8 per cent of the infections. No incidences were reported with the use of cefamandole in those patients who were treated prophylactically. In view of these results, we believe that cefamandole is an ideal antibiotic to be used in the prophylactic treatment of infections of high risk patients who undergo operations upon the biliary tract.

  15. Effect of oral nutritional supplementation on wound healing in diabetic foot ulcers: a prospective randomized controlled trial.

    PubMed

    Armstrong, D G; Hanft, J R; Driver, V R; Smith, A P S; Lazaro-Martinez, J L; Reyzelman, A M; Furst, G J; Vayser, D J; Cervantes, H L; Snyder, R J; Moore, M F; May, P E; Nelson, J L; Baggs, G E; Voss, A C

    2014-09-01

    Among people with diabetes, 10-25% will experience a foot ulcer. Research has shown that supplementation with arginine, glutamine and β-hydroxy-β-methylbutyrate may improve wound repair. This study tested whether such supplementation would improve healing of foot ulcers in persons with diabetes. Along with standard of care, 270 subjects received, in a double-blinded fashion, (twice per day) either arginine, glutamine and β-hydroxy-β-methylbutyrate or a control drink for 16 weeks. The proportion of subjects with total wound closure and time to complete healing was assessed. In a post-hoc analysis, the interaction of serum albumin or limb perfusion, as measured by ankle-brachial index, and supplementation on healing was investigated. Overall, there were no group differences in wound closure or time to wound healing at week 16. However, in subjects with an albumin level of ≤ 40 g/l and/or an ankle-brachial index of < 1.0, a significantly greater proportion of subjects in the arginine, glutamine and β-hydroxy-β-methylbutyrate group healed at week 16 compared with control subjects (P = 0.03 and 0.008, respectively). Those with low albumin or decreased limb perfusion in the supplementation group were 1.70 (95% CI 1.04-2.79) and 1.66 (95% CI 1.15-2.38) times more likely to heal. While no differences in healing were identified with supplementation in non-ischaemic patients or those with normal albumin, addition of arginine, glutamine and β-hydroxy-β-methylbutyrate as an adjunct to standard of care may improve healing of diabetic foot ulcers in patients with risk of poor limb perfusion and/or low albumin levels. Further investigation involving arginine, glutamine and β-hydroxy-β-methylbutyrate in these high-risk subgroups might prove clinically valuable. © 2014 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.

  16. Paclitaxel-coated balloon angioplasty vs. plain balloon dilation for the treatment of failing dialysis access: 6-month interim results from a prospective randomized controlled trial.

    PubMed

    Katsanos, Konstantinos; Karnabatidis, Dimitris; Kitrou, Panagiotis; Spiliopoulos, Stavros; Christeas, Nikolaos; Siablis, Dimitris

    2012-04-01

    To report the 6-month results of a prospective randomized trial investigating angioplasty with paclitaxel-coated balloons (PCB) vs. plain balloon angioplasty (BA) for the treatment of failing native arteriovenous fistulae (AVF) or prosthetic arteriovenous grafts (AVG). The enrollment criteria for this non-inferiority hypothesis trial included clinical signs of failing dialysis access with angiographic documentation of a significant venous stenotic lesion in patients with AVF or AVG circuits. From March to December 2010, 40 patients (29 men; mean age 64.1 ± 14.3 years) were randomized to undergo either PCB dilation (n = 20) or standard BA (n = 20) of a stenosed venous outflow lesion. Regular angiographic follow-up was scheduled bimonthly. Study outcome measures included device success (<30% residual stenosis without postdilation), procedural success (<30% residual stenosis), and primary patency of the treated lesion (<50% angiographic restenosis and no need for any interim repeat procedures). Baseline and procedural variables were comparably distributed between both groups. Device success was 9/20 (45%) for the PCB device vs. 20/20 (100%) for standard control BA (p<0.001). Procedural success was 100% in both groups after further high-pressure post-dilation as necessary. There were no major or minor complications in either group. At 6 months, cumulative target lesion primary patency was significantly higher after PCB application (70% in PCB group vs. 25% in BA group, p<0.001; HR 0.30, 95% CI 0.12 to 0.71, p<0.006). PCB angioplasty improves patency after angioplasty of venous stenoses of failing vascular access used for dialysis.

  17. Comparison of Mineral Trioxide Aggregate and iRoot BP Plus Root Repair Material as Root-end Filling Materials in Endodontic Microsurgery: A Prospective Randomized Controlled Study.

    PubMed

    Zhou, Wei; Zheng, Qinghua; Tan, Xuelian; Song, Dongzhe; Zhang, Lan; Huang, Dingming

    2017-01-01

    This prospective randomized controlled study evaluated the clinical and radiographic outcome of endodontic microsurgery when using iRoot BP Plus Root Repair Material (BP-RRM; Innovative BioCeramix Inc, Vancouver, BC, Canada) or mineral trioxide aggregate (MTA) as the retrograde filling material and analyzed the relationship between some potential prognostic factors and the outcome of the surgery. By using strict inclusion and exclusion criteria, 240 teeth were successfully enrolled and randomly and equally allocated to either the MTA or BP-RRM treatment group. A standardized surgical procedure was performed by a single operator. The patients were followed up at 1 week, 3 months, 6 months, and 12 months; follow-up included clinical and radiographic examination. Clinical and radiographic evaluations acquired at the 12-month follow-up were taken as the primary outcome. For the identification of prognostic factors, the dichotomous outcome (success vs failure) was taken as the dependent variable. A total of 158 teeth were analyzed at the 12-month follow-up, including 87 teeth in the MTA group and 71 teeth in the BP-RRM group. The success rate in the MTA and BP-RRM groups was 93.1% (81/87 teeth) and 94.4% (67/71 teeth), respectively (P > .05). Three significant outcome predictors were identified: quality of root filling (P < .05), tooth type (P < .05), and size of the lesion (P < .05) CONCLUSIONS: These results suggest that BP-RRM is comparable with MTA in clinical outcome when used as root-end filling materials in endodontic microsurgery. Copyright © 2016 American Association of Endodontists. Published by Elsevier Inc. All rights reserved.

  18. 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

  19. Effect of intravenous dexmedetomidine on spinal anaesthesia with 0.5% hyperbaric bupivacaine in lower abdominal surgeries: A prospective randomized control study.

    PubMed

    Santpur, Madhavi Unmesh; Kahalekar, Govind Marutrao; Saraf, Nowreen; Losari, Aparna

    2016-01-01

    Regional anesthesia is the preferred technique for most of lower abdominal and lower limb surgeries. For decades, lignocaine had been the local anesthetic of choice for spinal anesthesia. Recent studies show that intravenous clonidine and dexmedetomidine can prolong the duration of the spinal anesthesia. Dexmedetomidine is a more suitable adjuvant compared to clonidine due to its more selective α2A receptor agonist activity. The study was undertaken to evaluate the effects of intravenous administration of dexmedetomidine on spinal anesthesia with 0.5% hyperbaric bupivacaine in lower abdominal surgeries. Prospective randomized, double-blind control study. Sixty patients of American Society of Anaesthesiologists Grades I and II, 20-60 years age, undergoing lower abdominal surgeries under spinal anesthesia were randomized into two groups by computer-generated table. Group 1: Bupivacaine and dexmedetomidine group; and Group 2: Bupivacaine and saline group. Spinal anesthesia was given with 15 mg of 0.5% bupivacaine. Patients in Group 1 received dexmedetomidine 1 μg/kg over 20 min followed by 0.5 μg/kg/h, intravenously till the end of surgery. Patients in Group 2 received normal saline. Observations were analyzed using Student's unpaired t-test. The mean duration of analgesia in group 1 was 219.7 ± 2.55 minutes and in group 2 was 150.2 ± 5.7 minutes. The prolongation in duration of analgesia in dexmedetomidine group was statistically significant. The mean durations of motor blockade in Group 1 and Group 2 were 189.6 ± 2.14 and 158.2 ± 5.31 min, respectively. Intravenous dexmedetomidine is useful to maintain hemodynamic stability and prolong spinal analgesia.

  20. Fast track multi-discipline treatment (FTMDT trial) versus conventional treatment in colorectal cancer--the design of a prospective randomized controlled study

    PubMed Central

    2011-01-01

    Background Laparoscopy-assisted surgery, fast-track perioperative treatment are both increasingly used in colorectal cancer treatment, for their short-time benefits of enhanced recovery and short hospital stays. However, the benefits of the integration of the Laparoscopy-assisted surgery, fast-track perioperative treatment, and even with the Xelox chemotherapy, are still unknown. In this study, the three treatments integration is defined as "Fast Track Multi-Discipline Treatment Model" for colorectal cancer and this model extends the benefits to the whole treatment process of colorectal cancer. The main purpose of the study is to explore the feasibility of "Fast Track Multi-Discipline Treatment" model in treatment of colorectal cancer. Methods The trial is a prospective randomized controlled study with 2 × 2 balanced factorial design. Patients eligible for the study will be randomized to 4 groups: (I) Laparoscopic surgery with fast track perioperative treatment and Xelox chemotherapy; (II) Open surgery with fast track perioperative treatment and Xelox chemotherapy; (III) Laparoscopic surgery with conventional perioperative treatment and mFolfox6 chemotherapy; (IV) Open surgery with conventional perioperative treatment and mFolfox6 chemotherapy. The primary endpoint of this study is the hospital stays. The secondary endpoints are the quality of life, chemotherapy related adverse events, surgical complications and hospitalization costs. Totally, 340 patients will be enrolled with 85 patients in each group. Conclusions The study initiates a new treatment model "Fast Track Multi-Discipline Treatment" for colorectal cancer, and will provide feasibility evidence on the new model "Fast Track Multi-Discipline Treatment" for patients with colorectal cancer. Trial registration ClinicalTrials.gov: NCT01080547 PMID:22111914

  1. Boswellia serrata acts on cerebral edema in patients irradiated for brain tumors: a prospective, randomized, placebo-controlled, double-blind pilot trial.

    PubMed

    Kirste, Simon; Treier, Markus; Wehrle, Sabine Jolie; Becker, Gerhild; Abdel-Tawab, Mona; Gerbeth, Kathleen; Hug, Martin Johannes; Lubrich, Beate; Grosu, Anca-Ligia; Momm, Felix

    2011-08-15

    Patients irradiated for brain tumors often suffer from cerebral edema and are usually treated with dexamethasone, which has various side effects. To investigate the activity of Boswellia serrata (BS) in radiotherapy-related edema, we conducted a prospective, randomized, placebo-controlled, double-blind, pilot trial. Forty-four patients with primary or secondary malignant cerebral tumors were randomly assigned to radiotherapy plus either BS 4200 mg/day or placebo. The volume of cerebral edema in the T2-weighted magnetic resonance imaging (MRI) sequence was analyzed as a primary endpoint. Secondary endpoints were toxicity, cognitive function, quality of life, and the need for antiedematous (dexamethasone) medication. Blood samples were taken to analyze the serum concentration of boswellic acids (AKBA and KBA). Compared with baseline and if measured immediately after the end of radiotherapy and BS/placebo treatment, a reduction of cerebral edema of >75% was found in 60% of patients receiving BS and in 26% of patients receiving placebo (P = .023). These findings may be based on an additional antitumor effect. There were no severe adverse events in either group. In the BS group, 6 patients reported minor gastrointestinal discomfort. BS did not have a significant impact on quality of life or cognitive function. The dexamethasone dose during radiotherapy in both groups was not statistically different. Boswellic acids could be detected in patients' serum. BS significantly reduced cerebral edema measured by MRI in the study population. BS could potentially be steroid-sparing for patients receiving brain irradiation. Our findings will need to be further validated in larger studies. Copyright © 2011 American Cancer Society.

  2. A prospective, randomized, placebo-controlled, double-blind, multicenter study of the effects of irbesartan on aortic dilatation in Marfan syndrome (AIMS trial): study protocol

    PubMed Central

    2013-01-01

    Background Cardiovascular complications are the leading cause of mortality and morbidity in Marfan syndrome (MFS), a dominantly inherited disorder caused by mutations in the gene that encodes fibrillin-1. There are approximately 18,000 patients in the UK with MFS. Current treatment includes careful follow-up, beta blockers, and prophylactic surgical intervention; however, there is no known treatment which effectively prevents the rate of aortic dilatation in MFS. Preclinical, neonatal, and pediatric studies have indicated that angiotensin receptor blockers (ARBs) may reduce the rate of aortic dilatation. This trial will investigate the effects of irbesartan on aortic dilatation in Marfan syndrome. Methods/Design The Aortic Irbesartan Marfan Study (AIMS) is an investigator-led, prospective, randomized, placebo-controlled, double-blind, phase III, multicenter trial. Currently, 26 centers in the UK will recruit 490 clinically confirmed MFS patients (aged ≥6 to ≤40 years) using the revised Ghent diagnostic criteria. Patients will be randomized to irbesartan or placebo. Aortic root dilatation will be measured by transthoracic echocardiography at baseline and annually thereafter. The primary outcome is the absolute change in aortic root diameter per year measured by echocardiography. The follow-up period will be a minimum of 36 months with an expected mean follow-up period of 48 months. Discussion This is the first clinical trial to evaluate the ARB irbesartan versus placebo in reducing the rate of aortic root dilatation in MFS. Not only will this provide useful information on the safety and efficacy of ARBs in MFS, it will also provide a rationale basis for potentially lifesaving therapy for MFS patients. Trial registration ISRCTN, 90011794 PMID:24289736

  3. 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.

  4. Ketamine does not inhibit interleukin-6 synthesis in hepatic resections requiring a temporary porto-arterial occlusion (Pringle manoeuvre): a controlled, prospective, randomized, double-blinded study

    PubMed Central

    Bonofiglio, Francisco Carlos; Molmenti, Ernesto P; de Santibañes, Eduardo

    2011-01-01

    Introduction Previous studies have shown that interleukin-6 (IL-6) levels correlated with mortality in critically ill patients. Goal To determine the effect of ketamine on IL-6 levels in liver resections patients with a temporary porto-arterial occlusion (Pringle manoeuvre). Materials and methods Controlled, prospective, randomized, double-blinded study. One group (n = 21) received ketamine whereas the other group (n = 17) received placebo. IL-6 levels were obtained at baseline, 4, 12, 24 h, 3 and 5 days. Results There were no significant differences in IL-6 levels between the groups (basal P = 089, 4 h P = 0.83, 12 h P = 0.39, 24 h, P = 0.55, 3 days P = 0.80 and 5 days P = 0.45). Both groups had elevated IL-6 levels that became almost undetectable by day 5. There was no major morbidity and no mortality in either group. Conclusions Ketamine does not seem to have an effect on plasma levels of IL-6. This could be interpreted as a potential finding associated with outcome as we did not encounter any deaths or major complications. Further studies will likely be needed to determine the range of IL-6 levels associated with survival and mortality, and whether it could be a predictor of survival. PMID:21929671

  5. Effects of Korean red ginseng as an adjuvant to bile acids in medical dissolution therapy for gallstones: a prospective, randomized, controlled, double-blind pilot trial.

    PubMed

    Lee, Jun Kyu; Kang, Hyoun Woo; Kim, Jae Hak; Lim, Yun Jeong; Koh, Moon-Soo; Lee, Jin Ho

    2013-01-01

    Although ginseng, the root of Panax quinquefolium and P. ginseng, was reported to have anti-cholelithogenic effects in animal experiments, there have, to date, been no human studies. We conducted this prospective, controlled, double-blind pilot trial to evaluate the safety and efficiency of Korean red ginseng (KRG), the steamed root of P. ginseng C.A. Meyer. Twenty eight consecutive patients were randomized to receive either KRG (7.5 g divided into three daily doses) or a placebo as an adjuvant to the standard regimen of bile acids for gallstones (500 mg of chenodeoxycholic acid and 500 mg of ursodeoxycholic acid divided into three daily doses) for 24 weeks. No case of serious adverse reaction occurred in both groups. Although the decrease in stone burden was larger in the KRG group (3.4 ± 0.6 ml3) than in the placebo group (2.3 ± 1.1 ml(3)), it did not reach statistical significance (p = 0.09). Also there were no differences in the rate of complete dissolution, subjective improvement in symptoms, and the rate of cholecystectomy due to worsening pain or the development of complications and changes in laboratory tests before and after treatment. In conclusion, the addition of KRG as an adjuvant was safe for patients undergoing bile acid dissolution therapy for gallstones although it did not affect the results. Large-scaled trials to optimize regimens are expectantly needed.

  6. The Impact of Brief Messages on HSV-2 Screening Uptake Among Female Defendants in a Court Setting: A Randomized Controlled Trial Utilizing Prospect Theory

    PubMed Central

    ROTH, ALEXIS M.; VAN DER POL, BARBARA; FORTENBERRY, J. DENNIS; DODGE, BRIAN; REECE, MICHAEL; CERTO, DAVID; ZIMET, GREGORY D.

    2015-01-01

    Epidemiologic data demonstrate that women involved with the criminal justice system in the United States are at high risk for sexually transmitted infections, including herpes simplex virus type 2 (HSV-2). Female defendants were recruited from a misdemeanor court to assess whether brief framed messages utilizing prospect theory could encourage testing for HSV-2. Participants were randomly assigned to a message condition (gain, loss, or control), completed an interviewer-administered survey assessing factors associated with antibody test uptake/refusal and were offered free point-of-care HSV-2 serologic testing. Although individuals in the loss-frame group accepted testing at the highest rate, an overall statistical difference in HSV-2 testing behavior by group (p ≤.43) was not detected. The majority of the sample (74.6%) characterized receiving a serological test for HSV-2 as health affirming. However, this did not moderate the effect of the intervention nor was it significantly associated with test acceptance (p ≤.82). Although the effects of message framing are subtle, the findings have important theoretical implications given the participants’ characterization of HSV-2 screening as health affirming despite being a detection behavior. Implications of study results for health care providers interested in brief, low cost interventions are also explored. PMID:25494832

  7. A comparison of the transillumination-assisted technique versus midline approach technique in novices: a prospective randomized controlled trial about the Bonfils intubation fiberscope.

    PubMed

    Wang, Jian; Yuan, Lan; Fu, Guoqiang; Tang, Wei; Yu, Guijie; Guo, Feng; Song, Jiangang

    2017-02-21

    The present study aimed to compare the safety and efficacy for novices to conduct intubation with the Bonfils intubation fiberscope (BIF) using the transillumination-assisted or midline approach technique in patients with normal airways. In this prospective randomized control study, 10 trainees were assigned to the transillumination-assisted technique group (T group) or the midline approach technique group (R group). Each trainee was required to conduct intubation in 50 patients. The primary outcome was intubation time. The secondary outcomes were success rate (%), number of attempts, and complications. Among the cases of successful intubation, the intubation time was not significantly different between the two groups (P > 0.05). The overall success rate of intubation was not significantly different between the two groups (P > 0.05). The intubation success rates at the first, second, and third attempts as well as the average intubation times were similar between the two groups (P > 0.05), but in patients receiving successful intubation at the second attempt, the intubation time was longer in the T group (P = 0.0006). The incidences of dry throat, sore throat, and hoarseness were higher in the T group (all P < 0.05). For patients with a normal airway, the transillumination-assisted technique was unlikely to increase the success rate of intubation with the BIF compared with the midline approach technique, but led to more complications. ChiCTR-INR-16009967 , retrospectively registered on November 22, 2016.

  8. Comparison between Nintendo Wii Fit and conventional rehabilitation on functional performance outcomes after hamstring anterior cruciate ligament reconstruction: prospective, randomized, controlled, double-blind clinical trial.

    PubMed

    Baltaci, Gul; Harput, Gulcan; Haksever, Bunyamin; Ulusoy, Burak; Ozer, Hamza

    2013-04-01

    The aim of this prospective, randomized, controlled, double-blind clinical trial was to compare the outcomes, including knee strength, balance, coordination, proprioception and response time, of Nintendo Wii Fit with those of conventional rehabilitation on the subjects with anterior cruciate ligament reconstruction. Thirty volunteer subjects were enrolled in either Wii Fit (n = 15; mean age, 29 ± 7 years) or conventional rehabilitation (n = 15; mean age, 29 ± 6 years) programmes from the first week up to 12th weeks of the operation. Endoscopic reconstruction of a completely ruptured ACL was performed by using graft harvested from hamstrings. Each subject underwent an individual therapeutic programme. Functional examinations included the measurements of the balance using modified star excursion balance test, coordination, proprioception and response time using functional squat system and strength of flexor and extensor muscles of the involved and uninvolved leg using an isokinetic machine. There was no significant difference between Wii Fit and conventional group in terms of isokinetic knee strength at 12th week, and dynamic balance, and functional squat tests including coordination, proprioception and response time at first, 8th and 12th weeks of the rehabilitation. Two different 12-week-physiotherapy programmes following ACL reconstruction have the same affect on muscle strength, dynamic balance and functional performance values in both groups. We considered that the practice of Wii Fit activities like conventional rehabilitation could also address physical therapy goals, which included improving visual-perceptual processing, coordination, proprioception and functional mobility.

  9. A prospective double-blind randomized controlled trial comparing the suitability of KTP laser tonsillectomy with conventional dissection tonsillectomy for day case surgery.

    PubMed

    Kothari, P; Patel, S; Brown, P; Obara, L; O'Malley, S

    2002-10-01

    Tonsillectomy using a KTP laser has been performed increasingly but is not a routinely practised technique in the UK. In the USA, tonsillectomy is often performed as a day case procedure but, here in the UK, it is still standard practice to admit patients for overnight stay. We present the largest prospective double-blind randomized controlled trial to date (151 patients) comparing KTP laser with standard dissection tonsillectomy and assess the suitability of both procedures for day case surgery. We found that there was significantly less peroperative haemorrhage if tonsillectomy was performed using the KTP laser, but it did cause more postoperative pain, more depression in mood and a higher rate of both reactionary and secondary haemorrhage, which was not significant when compared with conventional dissection. There was no difference in operating time, and over 40% of patients in each group needed overnight admission. We conclude that KTP laser tonsillectomy offers no benefit apart from less intraoperative bleeding over standard dissection tonsillectomy. Discharge from hospital after tonsillectomy was found to be unpredictable. Tonsillectomy is therefore an unsuitable procedure for planned surgery through a day unit, but approximately 58% of patients could be discharged on the same day from an extended day surgery unit, and the rest have one night in hospital.

  10. Eprinomectin treatment of psoroptic mange in hunter/jumper and dressage horses: a prospective, randomized, double-blinded, placebo-controlled clinical trial.

    PubMed

    Ural, K; Ulutas, B; Kar, S

    2008-10-01

    The purpose of this prospective, double-blinded, placebo-controlled clinical trial was to investigate the efficacy of topical eprinomectin for the treatment of psoroptic mange infestation in horses. 24 privately owned hunter/jumper and dressage horses were diagnosed with psoroptic mange infestation based on physical findings and skin scraping results were enrolled and randomly assigned to either topical eprinomectin pour-on solution (at a dose of 500microg/kg body weight weekly once for four applications) treatment group or a placebo group (purified water). Clinical evaluations and skin scrapings were done by the same veterinary investigator at the beginning, during and at the end of the treatment. Both owners and veterinary investigator were blinded to the allocation to the groups. The efficacy of eprinomectin was assessed both clinically and parasitologically by the presence or absence of viable mites. Horses were scraped for psoroptic mites on days 7, 14, 21, 28 and 40 for follow-up. Fisher's exact test was used to assess differences between the eprinomectin treatment and placebo in the number of horses without mites (cure rates) on each assessment date. It was found that significantly fewer eprinomectin treated horses had P. equi mites detected on skin scrapings (p<0.01) than the placebo group. In conclusion, eprinomectin was effective and safe therapy against natural infestations of P. equi in the horses included in this study.

  11. Randomized prospective parallel controlled study of the safety and effectiveness of Er:YAG laser use in children for caries removal

    NASA Astrophysics Data System (ADS)

    Den Besten, Pam K.; White, Joel M.; Pelino, Jose; Lee, Kisup; Parkins, Frederick M.

    2000-03-01

    The Er:YAG laser has been proposed as a useful tool for caries removal. In this study, we report a prospective parallel controlled study of the Dental Erbium Laser for caries removal and cavity preparation in pediatric patients. A total of 92 patients in two separate sites were randomized to treatment in a 2:1 ratio laser to conventional dental drill. The subject ages ranged from 4 to 18 years with a mean of 10.5 years with an even distribution by gender. The mean recorded treatment energy for caries removal was 147 mJ and for cavity preparation was 170 mJ. There were no significant differences in pain reported by the drill or laser treated subjects, and no complications or adverse events were reported after treatment or at any other interval during the study. The determination of success was based on four criteria: (1) acceptable caries removal, (2) acceptable cavity preparation, (3) maintenance of pulp vitality, and (4) restoration intact and serviceable. Using these criteria, it was found that all 32 of the drill procedures were a success and 59 out of 60 laser procedures were a success. This study shows that the Erbium-YAG laser is suitable for caries removal and cavity preparation in children.

  12. Static balance and function in children with cerebral palsy submitted to neuromuscular block and neuromuscular electrical stimulation: Study protocol for prospective, randomized, controlled trial

    PubMed Central

    2012-01-01

    Background The use of botulinum toxin A (BT-A) for the treatment of lower limb spasticity is common in children with cerebral palsy (CP). Following the administration of BT-A, physical therapy plays a fundamental role in potentiating the functionality of the child. The balance deficit found in children with CP is mainly caused by muscle imbalance (spastic agonist and weak antagonist). Neuromuscular electrical stimulation (NMES) is a promising therapeutic modality for muscle strengthening in this population. The aim of the present study is to describe a protocol for a study aimed at analyzing the effects of NMES on dorsiflexors combined with physical therapy on static and functional balance in children with CP submitted to BT- A. Methods/Design Protocol for a prospective, randomized, controlled trial with a blinded evaluator. Eligible participants will be children with cerebral palsy (Levels I, II and III of the Gross Motor Function Classification System) between five and 12 years of age, with independent gait with or without a gait-assistance device. All participants will receive BT-A in the lower limbs (triceps surae). The children will then be randomly allocated for either treatment with motor physical therapy combined with NMES on the tibialis anterior or motor physical therapy alone. The participants will be evaluated on three occasions: 1) one week prior to the administration of BT-A; 2) one week after the administration of BT-A; and 3) four months after the administration of BT-A (end of intervention). Spasticity will be assessed by the Modified Ashworth Scale and Modified Tardieu Scale. Static balance will be assessed using the Medicapteurs Fusyo pressure platform and functional balance will be assessed using the Berg Balance Scale. Discussion The aim of this protocol study is to describe the methodology of a randomized, controlled, clinical trial comparing the effect of motor physical therapy combined with NMES on the tibialis anterior muscle or motor

  13. High Voltage Pulsed Radiofrequency for the Treatment of Refractory Neuralgia of the Infraorbital Nerve: A Prospective Double-Blinded Randomized Controlled Study.

    PubMed

    Luo, Fang; Wang, Tao; Shen, Ying; Meng, Lan; Lu, Jingjing; Ji, Nan

    2017-05-01

    A recent study showed that 50% of patients who suffered from refractory neuralgia of the infraorbital nerve obtained satisfactory efficacy after pulsed radiofrequency (PRF) treatment. A pilot study showed that increasing the output voltage of PRF significantly improved the efficacy for trigeminal neuralgia; however, whether increasing the output voltage of PRF can improve the treatment outcomes for neuralgia of the infraorbital nerve is unknown. To evaluate the efficacy and safety of high voltage PRF treatment in comparison with standard voltage PRF for neuralgia of the infraorbital nerve. Prospective, single-center, double-blinded, randomized, controlled trial. Beijing Tiantan Hospital, Capital Medical University. A total of 60 patients with refractory neuralgia of the infraorbital nerve were randomly divided into the high voltage PRF group and the standard voltage PRF group to treat their infraorbital nerves. Neither the patients, pain physicians, nor the follow-up evaluators knew the patient group assignments. The primary outcome measure was the one-year response rate. The secondary outcome measures included the time to take effect after PRF, the one-month, 3-month, and 6-month response rates, the relapse rate, and adverse reactions. The intent-to-treat analysis showed that the one-month, 3-month, 6-month, and one-year response rates were all 90% in the high voltage group, which were significantly higher than the rates in the standard voltage group (67% [P < 0.05], 67% [P < 0.05], 63% [P < 0.05], and 60% [P <0.01], respectively). Furthermore, 27% of the patients in the high-voltage group and 13% of the patients in the standard voltage group experienced minor transient (10 - 30 days) numbness in the innervation area after PRF; no other serious adverse reactions were observed in the 2 groups (P > 0.05). We did not investigate the dose-effect relationship between the output voltage and efficacy or the effect of a higher pulse dose on efficacy. This study was a

  14. Cost effective analysis of recall methods for cervical cancer screening in Selangor--results from a prospective randomized controlled trial.

    PubMed

    Rashid, Rima Marhayu Abdul; Ramli, Sophia; John, Jennifer; Dahlui, Maznah

    2014-01-01

    Cervical cancer screening in Malaysia is by opportunistic Pap smear which contributes to the low uptake rate. To overcome this, a pilot project called the SIPPS program (translated as information system of Pap smear program) had been introduced whereby women aged 20-65 years old are invited for Pap smear and receive recall to repeat the test. This study aimed at determining which recall method is most cost-effective in getting women to repeat Pap smear. A randomised control trial was conducted where one thousand women were recalled for repeat smear either by registered letter, phone messages, phone call or the usual postal letter. The total cost applied for cost-effectiveness analysis includes the cost of sending letter for first invitation, cost of the recall method and cost of two Pap smears. Cost-effective analysis (CEA) of Pap smear uptake by each recall method was then performed. The uptake of Pap smear by postal letter, registered letters, SMS and phone calls were 18.8%, 20.0%, 21.6% and 34.4%, respectively (p<0.05). The CER for the recall method was lowest by phone call compared to other interventions; RM 69.18 (SD RM 0.14) compared to RM 106.53 (SD RM 0.13), RM 134.02 (SD RM 0.15) and RM 136.38 (SD RM 0.11) for SMS, registered letter and letter, respectively. ICER showed that it is most cost saving if the usual method of recall by postal letter be changed to recall by phone call. The possibility of letter as a recall for repeat Pap smear to reach the women is higher compared to sending SMS or making phone call. However, getting women to do repeat Pap smear is better with phone call which allows direct communication. Despite the high cost of the phone call as a recall method for repeat Pap smear, it is the most cost-effective method compared to others.

  15. [Postoperative pain therapy with hydromorphone and metamizole. A prospective randomized study in intravenous patient-controlled analgesia (PCA)].

    PubMed

    Lehmann, K A; Paral, F; Sabatowski, R

    2001-10-01

    Most potent opioid analgesics available in Germany have been investigated for use in postoperative patient-controlled analgesia (PCA). To conclude an older comparative series, it was the aim of the present study to define analgesic potency, side effects and patient acceptance of hydromorphone and its interaction with the non-opioid analgesic metamizole. A total of 120 patients recovering from elective abdominal or orthopaedic surgery, performed under standardised general anaesthesia, were randomised into 3 double-blind treatment groups to receive intravenous PCA demand doses of hydromorphone 283 micrograms (low dose, LD), 566 micrograms (high dose, HD) or a combination of hydromorphone 283 micrograms and metamizole 50 mg (low dose hydromorphone + metamizole, LM). Demand-independent low-dose background infusions were added to deliver hydromorphone at 67.9 micrograms/h in all groups, with additional metamizole at 12 mg/h in group LM. Lockout times were set to 2 min. After an average observation time of 24.5 +/- 2.6 h (mean, SD) since start of PCA, cumulative PCA hydromorphone doses in groups LD, HD and LM were 7.8 +/- 3.3, 12.1 +/- 4.8 and 7.5 +/- 2.0 mg, respectively, with the well known large inter-individual variability in all groups. Although hydromorphone consumption was significantly higher in group HD, self-reported pain intensities (VAS, retrospective pain scores) were quite comparable between the groups. Low dose, PCA bolus-linked metamizole did not significantly reduce hydromorphone consumption nor improve patient acceptance. Side-effects were typical for potent postoperative opioids, but never required special treatment; haemodynamic or respiratory complications were not observed in any patient. It can be concluded by comparison with other PCA opioid investigations performed under the same study protocol that hydromorphone is about 3-4 times as potent an analgesic as morphine under the conditions of intravenous postoperative PCA. Due to a favourable

  16. A prospective randomized trial of nebulized morphine compared with patient-controlled analgesia morphine in the management of acute thoracic pain.

    PubMed

    Fulda, Gerard J; Giberson, Frederick; Fagraeus, Lennart

    2005-08-01

    Successfully managing pain for the trauma patient decreases morbidity, improves patient satisfaction, and is an essential component of critical care. Using patient-controlled analgesia (PCA) morphine to control pain may be complicated by concerns of respiratory depression, hemodynamic instability, addiction, urinary retention, and drug-induced ileus. Morphine is rapidly absorbed by mucosal surfaces in the respiratory tract, achieving systemic concentrations equal to 20% of equivalent intravenous doses. The purpose of this study was to evaluate the safety, efficacy, and utility of nebulized morphine in patients with posttraumatic thoracic pain. This double-blinded, prospective study randomized patients with severe posttraumatic thoracic pain into two groups. The experimental group (NMS) received nebulized morphine every 4 hours and normal saline by PCA. The control group (PCA) received nebulized saline every 4 hours and morphine by PCA. Dose adjustments were made based on patient response to treatments using a 10-point visual analog scale (VAS) for pain. Pulmonary function, pain relief (VAS), level of sedation (0-3), total drug administration, and systematic side effects were recorded. Forty-four patients were randomized (22 per group). Seven hundred seventy observations were made. The mean 4-hour dose of morphine was 11.96 +/- 3.4 mg for NMS and 6.22 +/- 4.7 mg for PCA (p < 0.001). Patients with NMS had lower heart rates compared with PCA (79 +/- 11 bpm versus 92 +/- 12 bpm; p < 0.001) and were less sedated (0.33 +/- 0.7 versus 0.56 +/- 0.9; p = 0.03). The mean pain level (VAS) was 3.38 +/- 1.8 for NMS and 3.84 +/- 2.7 for PCA (p = 0.2). There was no difference between pain levels before and after dosing. There were no differences between groups with respect to arterial blood pressure, respiratory rate, vital capacity, mean forced expiratory volume in 1 second, spirometric volumes, or Sao2. Nebulized morphine can be safely and effectively used to control

  17. Efficacy of augmenting a subacromial continuous-infusion pump with a preoperative interscalene block in outpatient arthroscopic shoulder surgery: a prospective, randomized, blinded, and placebo-controlled study.

    PubMed

    DeMarco, James R; Componovo, Roger; Barfield, William R; Liles, Laura; Nietert, Paul

    2011-05-01

    This study's purpose was to determine the effectiveness of adding a preoperative interscalene brachial plexus block to standard postoperative management, including oral narcotics and a subacromial bupivacaine infusion pump, after arthroscopic shoulder surgery. After performing a prospective power analysis and obtaining institutional board approval, we conducted a randomized placebo-controlled trial of 53 patients separated into a preoperative interscalene brachial plexus group and a control group. Group 1 received an interscalene block with 30 mL of 0.5% ropivacaine. Group 2 received a placebo with 10 mL of saline solution. All patients postoperatively received an arthroscopically placed subacromial infusion pump catheter for 72 hours and oral narcotics. Pain scores on a visual analog scale (VAS) and narcotic pill use were recorded at 6, 12, 20, 32, 40, 52, 60, 72, and 80 hours. Preoperative pain scores between groups were not significant (P > .05). A statistically significant difference was found for decreased pain scores at 6 hours after discharge in patients receiving an interscalene block (P = .001) (VAS of 30.9 in group 1 v 61.8 in group 2). There was also a decrease in the number of narcotic pills taken at the 6-hour time interval (P = .1) (0.6 pills v 1.1 pills). Group 1 had a rebound phenomenon 20 hours after discharge. Pain scores spiked as the effects of the block wore off (P = .08) (net change in VAS score increase, 25.0 v 10.3). No other statistical or clinical differences were observed. The addition of a preoperative interscalene block to a postoperative subacromial infusion pump provided significant improvement of pain control only at 6 hours after discharge. Twelve hours after discharge, this benefit had disappeared. A rebound phenomenon of increased pain at 20 hours was seen after the interscalene block had worn off. After 20 hours, no statistically significant or clinically applicable differences were found. Level I, randomized controlled trial

  18. Effect of extracorporeal shock wave therapy on scar pain in burn patients: A prospective, randomized, single-blind, placebo-controlled study.

    PubMed

    Cho, Yoon Soo; Joo, So Young; Cui, Huisong; Cho, Sung-Rae; Yim, Haejun; Seo, Cheong Hoon

    2016-08-01

    Extracorporeal shock wave therapy (ESWT) has been used to reduce pain in patients with various musculoskeletal diseases and wounds. We investigated the effect of ESWT on scar pain after complete wound epithelialization in burn patients. A prospective, single-blind, placebo-controlled study was conducted from February 2014 to 2015. Forty patients with burn scar pain despite standard therapy (medication, physical therapy, and burn rehabilitation massage therapy) were randomized into ESWT or control (sham ESWT) groups. ESWT was administered at 100 impulses/cm (0.05-0.15 mJ/mm) once per week for 3 weeks. The treatment effects were assessed using the numerical rating scale (NRS), pain threshold, Nirschl pain phase system, and Roles and Maudsley scores. The characteristics of patients between the 2 study groups were balanced (P >0.05) for age, sex, and total burn surface area (%). In both groups, the NRS, pain threshold (Ib/cm), and Nirschl pain phase system values significantly improved (P <0.05) after 3 sessions of ESWT or sham therapy, and there were significant differences between the 2 groups in terms of these 3 variables (P <0.001, P <0.001, P = 0.013, respectively). The Roles and Maudsley scores significantly improved; among 20 patients, 17 reported a score of poor (85%) and 3 reported fair (15%) before ESWT, whereas 3 reported poor (15%), 8 reported fair (40%), 5 reported good (25%), and 4 reported excellent (20%) after ESWT (P = 0.004). The scores did not improve in the control group (P = 0.128). ESWT significantly reduced scar pain in burn patients after wound recovery.

  19. Randomized, prospective, placebo-controlled double-blind study of dextrose prolotherapy for osteoarthritic thumb and finger (DIP, PIP, and trapeziometacarpal) joints: evidence of clinical efficacy.

    PubMed

    Reeves, K D; Hassanein, K

    2000-08-01

    To determine the clinical benefit of dextrose prolotherapy (injection of growth factors or growth factor stimulators) in osteoarthritic finger joints. Prospective randomized double-blind placebo-controlled trial. Outpatient physical medicine clinic. Six months of pain history was required in each joint studied as well as one of the following: grade 2 or 3 osteophyte, grade 2 or 3 joint narrowing, or grade 1 osteophyte plus grade 1 joint narrowing. Distal interphalangeal (DIP), proximal interphalangeal (PIP), and trapeziometacarpal (thumb CMC) joints were eligible. Thirteen patients (with seventy-four symptomatic osteoarthitic joints) received active treatment, and fourteen patients (with seventy-six symptomatic osteoarthritic joints) served as controls. One half milliliter (0.5 mL) of either 10% dextrose and 0.075% xylocaine in bacteriostatic water (active solution) or 0.075% xylocaine in bacteriostatic water (control solution) was injected on medial and lateral aspects of each affected joint. This was done at 0, 2, and 4 months with assessment at 6 months after first injection. One-hundred millimeter (100 mm) Visual Analogue Scale (VAS) for pain at rest, pain with joint movement and pain with grip, and goniometrically-measured joint flexion. Pain at rest and with grip improved more in the dextrose group but not significantly. Improvement in pain with movement of fingers improved significantly more in the dextrose group (42% versus 15% with a p value of .027). Flexion range of motion improved more in the dextrose group (p = .003). Side effects were minimal. Dextrose prolotherapy was clinically effective and safe in the treatment of pain with joint movement and range limitation in osteoarthritic finger joints.

  20. The Efficacy of a Viscoelastic Foam Overlay on Prevention of Pressure Injury in Acutely Ill Patients: A Prospective Randomized Controlled Trial.

    PubMed

    Park, Kyung Hee; Park, Joohee

    The purpose of this study was to compare a viscoelastic foam overlay (VEFO) to a standard hospital mattress for pressure injury (PI) prevention. We also compared interface pressures (IPs) of the VEFO to our facility's standard hospital mattress. Prospective, randomized controlled trial. Data analysis was based on 110 participants (55 in each group) who were 19 years or older, had a Braden Scale for Pressure Sore Risk score of 16 or less, and were cared for on a neurology, oncology, or pulmonology inpatient care unit. The research setting was the Samsung Medical Center in Seoul, South Korea. Participants were divided into 2 groups: the experimental group were based on a VEFO on top of the standard hospital mattress used in our facility. Participants in the control group were placed on a standard hospital mattress with/without air overlay. All patients were given standard nursing care for prevention of PI. Skin assessments were completed daily over a period of 2 weeks. In addition, we compared IPs of the standard hospital mattress and the VEFO in participants randomly allocated to the intervention group. Interface pressure was measured over the sacral/coccygeal area with subjects in the supine position. Pressures were measured immediately before and immediately following placement of the VEFO and just before data collection began. Data were collected between October 2013 and November 2014. Pressure injury incidence was compared between groups using the χ test, and IPs were compared using the paired t test. Pressure injury development was determined using the staging system described in guidelines from the National Pressure Ulcer Advisory Panel, European Pressure Ulcer Advisory Panel, and Pan Pacific Pressure Injury Alliance in 2014. Interface pressure was measured using a device manufactured for this purpose. The incidence of PI development was significantly lower in subjects assigned to the experimental group as compared to those in the control group (3

  1. A comparison between intravenous lidocaine and ketamine on acute and chronic pain after open nephrectomy: A prospective, double-blind, randomized, placebo-controlled study

    PubMed Central

    Jendoubi, Ali; Naceur, Imed Ben; Bouzouita, Abderrazak; Trifa, Mehdi; Ghedira, Salma; Chebil, Mohamed; Houissa, Mohamed

    2017-01-01

    Background: Recently, there has been increasing interest in the use of analgesic adjuncts such as intravenous (IV) ketamine and lidocaine. Objectives: To compare the effects of perioperative IV lidocaine and ketamine on morphine requirements, pain scores, quality of recovery, and chronic pain after open nephrectomy. Study Design: A prospective, randomized, placebo-controlled, double-blind trial. Settings: The study was conducted in Charles Nicolle University Hospital of Tunis. Methods: Sixty patients were randomly allocated to receive IV lidocaine: bolus of 1.5 mg/kg at the induction of anesthesia followed by infusion of 1 mg/kg/h intraoperatively and for 24 h postoperatively or ketamine: bolus of 0.15 mg/kg followed by infusion of 0.1 mg/kg/h intraoperatively and for 24 h postoperatively or an equal volume of saline (control group [CG]). Measurements: Morphine consumption, visual analog scale pain scores, time to the first passage of flatus and feces, postoperative nausea and vomiting (PONV), 6-min walk distance (6MWD) at discharge, and the incidence of chronic neuropathic pain using the “Neuropathic Pain Questionnaire” at 3 months. Results: Ketamine and lidocaine reduced significantly morphine consumption (by about 33% and 42%, respectively) and pain scores compared with the CG (P < 0.001). Lidocaine and ketamine also significantly improved bowel function in comparison to the CG (P < 0.001). Ketamine failed to reduce the incidence of PONV. The 6 MWD increased significantly from a mean ± standard deviation of 27 ± 16.2 m in the CG to 82.3 ± 28 m in the lidocaine group (P < 0.001). Lidocaine, but not ketamine, reduced significantly the development of neuropathic pain at 3 months (P < 0.05). Conclusion: Ketamine and lidocaine are safe and effective adjuvants to decrease opioid consumption and control early pain. We also suggest that lidocaine infusion serves as an interesting alternative to improve the functional walking capacity and prevent chronic

  2. Efficacy and safety of a very-low-protein diet when postponing dialysis in the elderly: a prospective randomized multicenter controlled study.

    PubMed

    Brunori, Giuliano; Viola, Battista F; Parrinello, Giovanni; De Biase, Vincenzo; Como, Giovanna; Franco, Vincenzo; Garibotto, Giacomo; Zubani, Roberto; Cancarini, Giovanni C

    2007-05-01

    A supplemented very-low-protein diet (sVLPD) seems to be safe when postponing dialysis therapy. Prospective multicenter randomized controlled study designed to assess the noninferiority of diet versus dialysis in 1-year mortality assessed by using intention-to-treat and per-protocol analysis. Italian uremic patients without diabetes older than 70 years with glomerular filtration rate of 5 to 7 mL/min (0.08 to 0.12 mL/s). Randomization to an sVLPD (diet group) or dialysis. The sVLPD is a vegan diet (35 kcal; proteins, 0.3 g/kg body weight daily) supplemented with keto-analogues, amino acids, and vitamins. Patients following an sVLPD started dialysis therapy in the case of malnutrition, intractable fluid overload, hyperkalemia, or appearance of uremic symptoms. Mortality, hospitalization, and metabolic markers. 56 patients were randomly assigned to each group, median follow-up was 26.5 months (interquartile range, 40), and patients in the diet group spent a median of 10.7 months (interquartile range, 11) following an sVLPD. Forty patients in the diet group started dialysis treatment because of either fluid overload or hyperkalemia. There were 31 deaths (55%) in the dialysis group and 28 deaths (50%) in the diet group. One-year observed survival rates at intention to treat were 83.7% (95% confidence interval [CI], 74.5 to 94.0) in the dialysis group versus 87.3% (95% CI, 78.9 to 96.5) in the diet group (log-rank test for noninferiority, P < 0.001; for superiority, P = 0.6): the difference in survival was -3.6% (95% CI, -17 to +10; P = 0.002). The hazard ratio for hospitalization was 1.50 for the dialysis group (95% CI, 1.11 to 2.01; P < 0.01). The unblinded nature of the study, exclusion of patients with diabetes, and incomplete enrollment. An sVLPD was effective and safe when postponing dialysis treatment in elderly patients without diabetes.

  3. A prospective randomized controlled trial of hydrating nail solution for prevention or treatment of onycholysis in breast cancer patients who received neoadjuvant/adjuvant docetaxel chemotherapy.

    PubMed

    Kim, Ji-Yeon; Ok, Oh Nam; Seo, Jeong-Ju; Lee, Soo-Hyeon; Ahn, Jin Seok; Im, Young-Hyuck; Park, Yeon Hee

    2017-08-01

    Onycholysis and other nail toxicities occur in approximately 20-30% of breast cancer (BC) patients receiving docetaxel chemotherapy. Onycholysis is often associated with painful paronychia, decreasing patients' quality of life. In this study, we aimed to evaluate the efficacy of hydrating nail solution (HNS) (EVONAIL(®) solution, Evaux Laboratories, France) for the prevention and treatment of docetaxel-induced onycholysis and nail toxicities. This study was a prospective, randomized, controlled study of HNS for the prevention or treatment of onycholysis in patients with docetaxel after doxorubicin plus cyclophosphamide. In the experimental arm, patients painted HNS on nails and periungual areas once a day till developing onycholysis grade 2. After grade 2 onycholysis development, patients applied HNS twice a day regardless of treatment arm. The primary endpoints were the incidence of onycholysis grade 2 and recovery rate from grade 2 onycholysis. From August 2015 to May 2016, 103 patients were enrolled and completed this study. Of these, 25 cases of grade 1 and 22 of grade 2 onycholysis were observed. Prophylactic application of HNS resulted in a statistically significant reduction of grade 2 onycholysis compared to controls (P = 0.001) and all grade onycholysis was also significantly lower in the experimental arm (P = 0.034). Multivariate analysis showed that HNS decreased grade 2 onycholysis (Hazard ratio (HR) 0.366, 95% confidence interval (CI) 0.148, 0.902; P = 0.029) and all grade onycholysis (HR 0.372, 95% CI 0.201-0.687, P = 0.002). Hydrating nail solution significantly reduced the incidence of docetaxel-induced onycholysis in BC patients (NCT02670603).

  4. Prospective Randomized Controlled Trial of The Stabilis Stand Alone Cage (SAC) Versus Bagby and Kuslich (BAK) Implants for Anterior Lumbar Interbody Fusion

    PubMed Central

    Lavelle, William; McLain, Robert F.; Rufo-Smith, Candace; Gurd, David P.

    2014-01-01

    Background Degenerative disc disease is common and debilitating for many patients. If conservative extensive care fails, anterior lumbar interbody fusion has proven to be an alternative form of surgical management. The Stabilis Stand Alone Cage(SAC) was introduced as a method to obtain stability and fusion. The purpose of this study was to determine whether the Stabilis Stand Alone Cage (SAC) is comparable in safety and efficacy to the Bagby and Kuslich (BAK) device. Methods As part of a prospective, randomized, controlled FDA trial, 73 patients underwent anterior interbody fusion using either the SAC(56%) or the BAK device (44%). Results Background characteristics were similar between the two groups. There was no significant difference between the SAC and BAK groups in mean operative time or mean blood loss during surgery. Adverse event rates did not differ between the groups. Assessment of plain radiographs could not confirm solid fusion in 63% of control and 71% of study patients. Functional scores from Owestry and SF-36 improved in both groups by the two-year follow-up. There were no significant differences between the SAC and BAK patients with respect to outcome. Conclusions Both the Stabilis Stand Alone Cage and the BAK Cage provided satisfactory improvement in function and pain relief, despite less than expected radiographic fusion rates. The apparent incongruency between fusion rates and functional outcomes suggests that either radiographs underestimate the true incidence of fusion, or that patients are obtaining good pain relief and improved function despite a lower rate of fusion than previously reported. This was a Level III study. PMID:25694930

  5. Validation and usefulness of a computer-assisted cup-positioning system in total hip arthroplasty. A prospective, randomized, controlled study.

    PubMed

    Parratte, Sebastien; Argenson, Jean-Noel A

    2007-03-01

    Malpositioning of the acetabular component during total hip arthroplasty increases the risk of dislocation, reduces the range of motion, and can be responsible for early wear and loosening. The purpose of this study was to compare computer-assisted with freehand insertion of the acetabular component. A randomized, controlled, matched prospective study of two groups of thirty patients each was performed. In the first group, cup positioning was assisted by an imageless computer-assisted surgical system based on bone morphing. In the control group, the cup was placed freehand. All of the patients were operated on by the same surgeon through an anterolateral approach. Cup anteversion and abduction angles were measured on three-dimensional computed tomography reconstructions postoperatively for each patient by an independent observer using special cup-evaluation software. There were sixteen men and fourteen women in each group, and the mean body-mass index was approximately 25 in each group. The computer-assisted procedure took a mean of twelve minutes longer than the freehand procedure. Fifty-seven percent (seventeen) of the thirty cups placed freehand and 20% (six) of the thirty in the computer-assisted group were outside of the defined safe zone (outliers). This difference was significant (p = 0.002). There were no differences between the computer-assisted group and the freehand-placement group with regard to the mean abduction and anteversion angles, but there was a significant heterogeneity of variances, with the lowest variations in the computer-assisted group. Use of an imageless navigation system can improve cup positioning in total hip arthroplasty by reducing the percentage of outliers.

  6. Off-pump Versus On-pump Coronary Artery Bypass Surgery: Graft Patency Assessment With Coronary Computed Tomographic Angiography: A Prospective Multicenter Randomized Controlled Pilot Study.

    PubMed

    Noiseux, Nicolas; Stevens, Louis-Mathieu; Chartrand-Lefebvre, Carl; Soulez, Gilles; Prieto, Ignacio; Basile, Fadi; Mansour, Samer; Dyub, Adel M; Kieser, Teresa M; Lamy, André

    2017-06-05

    A large multicenter randomized trial (RCT) is needed to assess off-pump coronary artery bypass graft (CABG) patency when performed by skilled surgeons. This prospective multicenter randomized pilot study compares graft patency after on-pump and off-pump techniques and addresses the feasibility of such an RCT. Consecutive patients were prospectively recruited for ≥64-slice computed tomography angiography graft patency assessment 1 year after randomization to off-pump or on-pump CABG. Blinded assessment of graft patency was performed, and the results were categorized as normal, ≥50% stenosis, or occlusion. A multilevel model with random effects on the patient was used to account for correlation of results in patients with multiple grafts. A total of 157 patients (3 centers, 84 off-pump and 73 on-pump patients, 512 grafts, assessability rate 98.4%) were included. Patency index (% nonoccluded grafts) was 89% for the off-pump technique and 95% for the on-pump technique (P=0.09). Patency was similar for arterial and vein grafts (both 92%; P=0.88), as well as between target territories (89% to 94%; P=0.53). In this pilot study, 1-year graft patency results after off-pump and on-pump surgery were similar. This feasibility trial demonstrates that a large multicenter RCT to compare CABG patency after on-pump with that after off-pump techniques is feasible and can be reliably undertaken using computed tomography angiography.

  7. Effects of elastic resistance exercise on body composition and physical capacity in older women with sarcopenic obesity: A CONSORT-compliant prospective randomized controlled trial.

    PubMed

    Liao, Chun-De; Tsauo, Jau-Yih; Lin, Li-Fong; Huang, Shih-Wei; Ku, Jan-Wen; Chou, Lin-Chuan; Liou, Tsan-Hon

    2017-06-01

    Sarcopenia is associated with loss of muscle mass and an increased risk of physical disability in elderly people. However, the prevalence of sarcopenia has increased in obese elderly populations. The purpose of this study was to identify the clinical efficacy of elastic resistance exercise training (RET) in patients with sarcopenic obesity. This study was conducted at the rehabilitation center of a university-based teaching hospital and was designed as a prospective and randomized controlled trial with an intention-to-treat analysis. A total of 46 women aged 67.3 (5.2) years were randomly assigned to an experimental group (EG) and control group (CG). The EG underwent elastic RET for 12 weeks, and the CG received no RET intervention. All outcome measures were assessed at the baseline and posttest, including body composition measured using dual-energy X-ray absorptiometry, muscle quality (MQ) defined as a ratio of muscular strength to muscle mass, and physical capacity assessed using functional mobility tests. One-way analysis of covariance and Pearson correlation were used to compare outcomes between the 2 groups and to identify the relationship between changes in body composition and physical outcomes, respectively. A chi-square test was performed to identify differences in qualitative data between the 2 groups. At the posttest, a significant between-group difference was observed in fat-free mass, MQ, and physical capacity (all P < .05); and a significant correlation was found between leg-lean-mass change and gait speed (r = 0.36; P < .05). After 12 weeks of elastic RET intervention, the EG had significantly fewer patients exhibiting sarcopenia (P < .05) and experiencing physical difficulty (P < .001) than the CG. The present data suggest that elastic resistance exercise exerted benefits on the body composition, MQ, and physical function in patients with sarcopenic obesity. Regular exercise incorporating elastic RET should be used to attenuate

  8. Comparing blastocyst quality and live birth rates of intravaginal culture using INVOcell™ to traditional in vitro incubation in a randomized open-label prospective controlled trial.

    PubMed

    Doody, Kevin J; Broome, E Jason; Doody, Kathleen M

    2016-04-01

    The purpose of this study is to to compare the efficacy of intravaginal culture (IVC) of embryos in INVOcell™ (INVO Bioscience, MA, USA) to traditional in vitro fertilization (IVF) incubators in a laboratory setting using a mild pre-determined stimulation regimen based solely on anti-mullerian hormone (AMH) and body weight with minimal ultrasound monitoring. The primary endpoint examined was total quality blastocysts expressed as a percentage of total oocytes placed in incubation. Secondary endpoints included percentage of quality blastocysts transferred, pregnancy, and live birth rates. In this prospective randomized open-label controlled single-center study, 40 women aged <38 years of age with a body mass index (BMI) of <36 and an AMH of 1-3 ng/mL were randomized prior to trigger to receive either IVC or IVF. Controlled ovarian stimulation was administered with human menopausal gonadotropin (hMG) in a fixed gonadotropin-releasing hormone (GnRH) agonist cycle based solely on AMH and body weight. A single ultrasound-monitoring visit was performed on the 10th day of stimulation. One or two embryos were transferred following 5 days of culture. IVF produced a greater percentage of total quality embryos as compared to IVC (50.6 vs. 30.7 %, p = 0.0007, respectively). There was no significant difference between in IVF and IVC in the percentage of quality blastocysts transferred (97.5 vs. 84.9 %, p = 0.09) or live birth rate (60 % IVF, 55 % IVC). IVF was shown to be superior to IVC in creating quality blastocysts. However, both IVF and IVC produced identical blastocysts for transfer resulting in similar live birth rates. IVC using INVOcell™ is effective and may broaden access to fertility care in selected patient populations by ameliorating the need for a traditional IVF laboratory setting. Further studies will help elucidate the potential physiological, psychological, geographic, and financial impact of IVC on the delivery of fertility care.

  9. Prospective association between the Dietary Inflammatory Index and mortality: modulation by antioxidant supplementation in the SU.VI.MAX randomized controlled trial12

    PubMed Central

    Graffouillère, Laurie; Deschasaux, Mélanie; Mariotti, François; Neufcourt, Lola; Shivappa, Nitin; Hébert, James R; Wirth, Michael D; Latino-Martel, Paule; Hercberg, Serge; Galan, Pilar; Julia, Chantal; Kesse-Guyot, Emmanuelle; Touvier, Mathilde

    2016-01-01

    Background: Chronic inflammation is a central mechanism involved in cardiovascular diseases, cancer, diabetes, and chronic respiratory diseases, 4 leading causes of mortality. Diet is a major source of pro- and anti-inflammatory bioactive compounds. The Dietary Inflammatory Index (DII) was designed to estimate the overall inflammatory potential of the diet. Objective: Our aim was to study the prospective association between the DII and mortality, as well as assess whether antioxidant supplementation could modulate this association. Design: The Supplémentation en Vitamines et Minéraux Antioxydants study was a randomized, double-blind, placebo-controlled trial in which participants received low-dose antioxidants or a placebo from 1994 to 2002. In this observational prospective analysis, 8089 participants (mean ± SD age at baseline: 49.0 ± 6.3 y) were followed between 1994 and 2007 (median: 12.4 y). The DII was calculated from repeated 24-h dietary records; higher scores correspond to more proinflammatory diets. A total of 207 deaths occurred during follow-up, including 123 due to cancer and 41 due to cardiovascular events. Multivariate Cox proportional hazards models were computed. Results: Sex-specific tertiles of the DII were positively associated with cardiovascular + cancer mortality (HR for tertile 3 compared with tertile 1 = 1.53; 95% CI: 1.01, 2.32; P-trend = 0.05) and specific cancer mortality (HR for tertile 3 compared with tertile 1 = 1.83; 95% CI: 1.12, 2.99; P-trend = 0.02). The corresponding P value was 0.07 for all-cause mortality. The DII was statistically significantly associated with increased all-cause mortality in the placebo group (HR for tertile 3 compared with tertile 1 = 2.10; 95% CI: 1.15, 3.84; P-trend = 0.02) but not in the antioxidant-supplemented group (P-trend = 0.8; P-interaction = 0.098). Conclusion: These results suggest that a proinflammatory diet is associated with increased all-cause and cancer mortality and antioxidants may

  10. A multicentre, prospective, randomized, controlled trial comparing EVARREST™ fibrin sealant patch to standard of care in controlling bleeding following elective hepatectomy: anatomic versus non-anatomic resection

    PubMed Central

    Koea, Jonathan B.; Batiller, Jonathan; Aguirre, Nicolas; Shen, Jessica; Kocharian, Richard; Bochicchio, Grant; Garden, O. James

    2016-01-01

    Background This multicentre, randomized clinical trial assessed the safety and effectiveness of the EVARREST™ Fibrin Sealant Patch (FP) in treating parenchymal bleeding following anatomic and non-anatomic liver resections. Methods One hundred and two patients were stratified according to the type of hepatic resection (anatomic/non-anatomic), and randomized (1:1) after identification of an appropriate bleeding site, to FP vs Standard of Care (SoC, manual compression ± topical haemostat). The primary endpoint was haemostasis at 4 min from bleeding site identification with no re-bleeding requiring re-treatment. Results The FP was superior in achieving haemostasis at 4 min (96%, 48/50) to SoC (46%, 24/52; p < 0.001). Stratification for resection type showed treatment differences for primary endpoint for anatomic (24/25 FP vs 13/23 SoC; p = 0.001) and non-anatomic liver resections (24/25FP vs 11/29 SoC; p < 0.001). Adverse events related to the study procedure were reported in 40/50 patients (80%) in the FP group and 43/52 patients (83%) in the SoC group. One (2%) adverse event (infected intra-abdominal fluid collection) was possibly related to study treatment. Conclusion This clinical trial confirms that the FP is safe and highly effective in controlling parenchymal bleeding following hepatectomy regardless of the type of resection. ClinicalTrials.gov NCT01993888. PMID:27017161

  11. Clinical impact of pharmacogenetic profiling with a clinical decision support tool in polypharmacy home health patients: A prospective pilot randomized controlled trial

    PubMed Central

    Henderson, John C.; Neradilek, Moni B.; Moyer, Nicolas A.; Ashcraft, Kristine C.; Thirumaran, Ranjit K.

    2017-01-01

    Background In polypharmacy patients under home health management, pharmacogenetic testing coupled with guidance from a clinical decision support tool (CDST) on reducing drug, gene, and cumulative interaction risk may provide valuable insights in prescription drug treatment, reducing re-hospitalization and emergency department (ED) visits. We assessed the clinical impact of pharmacogenetic profiling integrating binary and cumulative drug and gene interaction warnings on home health polypharmacy patients. Methods and findings This prospective, open-label, randomized controlled trial was conducted at one hospital-based home health agency between February 2015 and February 2016. Recruitment came from patient referrals to home health at hospital discharge. Eligible patients were aged 50 years and older and taking or initiating treatment with medications with potential or significant drug-gene-based interactions. Subjects (n = 110) were randomized to pharmacogenetic profiling (n = 57). The study pharmacist reviewed drug-drug, drug-gene, and cumulative drug and/or gene interactions using the YouScript® CDST to provide drug therapy recommendations to clinicians. The control group (n = 53) received treatment as usual including pharmacist guided medication management using a standard drug information resource. The primary outcome measure was the number of re-hospitalizations and ED visits at 30 and 60 days after discharge from the hospital. The mean number of re-hospitalizations per patient in the tested vs. untested group was 0.25 vs. 0.38 at 30 days (relative risk (RR), 0.65; 95% confidence interval (CI), 0.32–1.28; P = 0.21) and 0.33 vs. 0.70 at 60 days following enrollment (RR, 0.48; 95% CI, 0.27–0.82; P = 0.007). The mean number of ED visits per patient in the tested vs. untested group was 0.25 vs. 0.40 at 30 days (RR, 0.62; 95% CI, 0.31–1.21; P = 0.16) and 0.39 vs. 0.66 at 60 days (RR, 0.58; 95% CI, 0.34–0.99; P = 0.045). Differences in composite outcomes at

  12. Intradermal versus intramuscular hepatitis B vaccination in hemodialysis patients: a prospective open-label randomized controlled trial in nonresponders to primary vaccination.

    PubMed

    Barraclough, Katherine A; Wiggins, Kathryn J; Hawley, Carmel M; van Eps, Carolyn L; Mudge, David W; Johnson, David W; Whitby, Michael; Carpenter, Sally; Playford, E Geoffrey

    2009-07-01

    Primary hepatitis B virus (HBV) vaccination through the intramuscular (IM) route is less efficacious in dialysis patients than in the general population. Previous studies suggest improved seroconversion with intradermal (ID) vaccination. Prospective open-label randomized controlled trial. Hemodialysis patients nonresponsive to primary HBV vaccination. Revaccination with either ID (10 microg of vaccine every week for 8 weeks) [DOSAGE ERROR CORRECTED] or IM (40 microg of vaccine at weeks 1 and 8) HBV vaccine . proportion of patients achieving HBV surface antibody (anti-HBs) titer of 10 IU/L or greater within 2 months of vaccination course. time to seroconversion, predictors of seroconversion, peak antibody titer, duration of seroprotection, and safety and tolerability of vaccine. Anti-HBs titer to 24 months. 59 patients were analyzed. Seroconversion rates were 79% ID versus 40% IM (P = 0.002). The unadjusted odds ratio for seroconversion for ID versus IM was 5.5 (95% confidence interval [CI], 1.6 to 18.4) and increased with adjustment for baseline differences. The only factor predictive of seroconversion was the ID vaccination route. The geometric mean peak antibody titer was significantly greater in the ID versus IM group: 239 IU/L (95% CI, 131 to 434) versus 78 IU/L (95% CI, 36 to 168; P < 0.001). There was a trend toward longer duration of seroprotection with ID vaccination. ID vaccine was safe and well tolerated. Inability to distinguish whether the mechanism of the greater efficacy of ID vaccination was the cumulative effect of multiple injections or route of administration; use of anti-HBs as a surrogate marker of protection; lack of evidence of long-term protection. Significantly greater seroconversion rates and peak antibody titers can be achieved with ID compared with IM vaccination in hemodialysis patients nonresponsive to primary vaccination. ID vaccination should become the standard of care in this setting.

  13. An acetate-buffered balanced crystalloid versus 0.9% saline in patients with end-stage renal disease undergoing cadaveric renal transplantation: a prospective randomized controlled trial.

    PubMed

    Potura, Eva; Lindner, Gregor; Biesenbach, Peter; Funk, Georg-Christian; Reiterer, Christian; Kabon, Barbara; Schwarz, Christoph; Druml, Wilfred; Fleischmann, Edith

    2015-01-01

    Recent studies have shown a decline in glomerular filtration rate and increased renal vasoconstriction after administration of normal saline when compared with IV solutions with less chloride. In this study, we investigated the impact of normal saline versus a chloride-reduced, acetate-buffered crystalloid on the incidence of hyperkalemia during cadaveric renal transplantation. The incidence of metabolic acidosis and kidney function were secondary aims. In this prospective randomized controlled trial, 150 patients received normal saline or an acetate-buffered balanced crystalloid during and after cadaveric renal transplantation. Venous blood gases were obtained at the start of anesthesia and every 30 minutes until discharge from the postoperative surveillance unit. Serum creatinine and 24-hour urine output were obtained on postoperative days 1, 3, and 7. Patients received a similar amount of fluid (median: 2625mL [interquartile range: 2000 to 3100] vs 2500 mL [2000 to 3050], P = 0.83). Hyperkalemia, defined as serum potassium >5.9 mmol/L, occurred in 13 patients (17%) in the saline and 15 (21%) in the balanced group (P = 0.56; difference between proportions -0.037 [-16.5% to 8.9%]). Minimum base excess was lower in the saline group compared with the balanced regimen (-4.5 mmol/L [-6 to -2.4] vs -2.6 mmol/L [-4 to -1], P < 0.001) and maximum chloride was significantly higher in the saline group (109 mmol/L [107 to 111] vs 107 mmol/L [105 to 109], P < 0.001). No difference in creatinine or urine output was seen postoperatively. Significantly more patients needed catecholamines in the saline group (30% vs 15%, P = 0.03). The incidence of hyperkalemia differed by less than 17% between groups. Use of balanced crystalloid resulted in less hyperchloremia and metabolic acidosis. Significantly more patients in the saline group required administration of catecholamines for circulatory support.

  14. A Prospective, Randomized, Masked, and Placebo-Controlled Efficacy Study of Intraarticular Allogeneic Adipose Stem Cells for the Treatment of Osteoarthritis in Dogs

    PubMed Central

    Harman, Robert; Carlson, Kim; Gaynor, Jamie; Gustafson, Scott; Dhupa, Sarit; Clement, Keith; Hoelzler, Michael; McCarthy, Tim; Schwartz, Pamela; Adams, Cheryl

    2016-01-01

    Osteoarthritis (OA) is a degenerative joint disease with a high prevalence in dogs. Mesenchymal stem cells (MSCs) have been used to treat humans, dogs, and horses with OA. This report describes a prospective, randomized, blinded, and placebo-controlled clinical efficacy study of intraarticular allogeneic adipose stem cells for the treatment of dogs with OA. Health assessments and measurements of pain and activity impairment were performed at baseline and at selected time points through day 60. The primary outcome variable was the owner Client-Specific Outcome Measurement (CSOM) and secondary measures included veterinary pain on manipulation, veterinary global score, and owner global score. The dogs were treated with either a saline placebo or a single dose of allogeneic adipose-derived MSCs in either one or two joints. Seventy-four dogs were statistically analyzed for efficacy outcomes. Success in the primary outcome variable, CSOM, was statistically improved in the treated dogs compared to the placebo dogs (79.2 versus 55.4%, p = 0.029). The veterinary pain on manipulation score (92.8 versus 50.2%, p = 0.017) and the veterinary global score (86.9 versus 30.8%, p = 0.009) were both statistically improved in treated dogs compared to placebo. There was no detected significant difference between treated and placebo dogs in the incidence of adverse events or negative health findings. Allogeneic adipose-derived stem cell treatment was shown to be efficacious compared to placebo. This large study of dogs also provides valuable animal clinical safety and efficacy outcome data to our colleagues developing human stem cell therapy. PMID:27695698

  15. Meta-analysis of prospective randomized controlled trials comparing intracoronary versus intravenous abciximab in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention.

    PubMed

    Shimada, Yuichi J; Nakra, Navin C; Fox, John T; Kanei, Yumiko

    2012-03-01

    Abciximab is a glycoprotein IIb/IIIa receptor inhibitor that has been shown to improve outcomes in patients with ST-segment elevation myocardial infarction who undergo primary percutaneous coronary intervention (pPCI). An earlier study reported better efficacy with intracoronary (IC) compared to intravenous (IV) administration, but this finding has not been duplicated in other studies, thus leaving a great deal of uncertainty as to the most efficacious route of administration. To investigate if IC abciximab compared to IV administration decreases mortality and major adverse cardiac events in patients with ST-segment elevation myocardial infarction who undergo pPCI, a meta-analysis was performed consisting only of prospective randomized controlled trials. Subgroup analysis was performed to investigate the source of difference in efficacy between the 2 strategies. A meta-analysis of 4 trials including 1,148 subjects revealed that IC abciximab significantly reduced mortality compared to IV administration (1.5% vs 3.6%, odds ratio 0.44, 95% confidence interval 0.20 to 0.95, p = 0.04). Major adverse cardiac events were also reduced in a subgroup in which <30% of patients received aspiration thrombectomy (6.1% vs 16.2%, odds ratio 0.33, 95% confidence interval 0.18 to 0.61, p = 0.0004). In conclusion, the totality of the data available from relatively small but high-quality studies shows a significant mortality reduction associated using IC abciximab for pPCI compared to IV abciximab. IC abciximab in the setting of pPCI for ST-segment elevation myocardial infarction may be beneficial for patients with higher risk profiles.

  16. Effect of Zinc Supplementation on Antioxidant Defenses and Oxidative Stress Markers in Patients Undergoing Chemotherapy for Colorectal Cancer: a Placebo-Controlled, Prospective Randomized Trial.

    PubMed

    Ribeiro, Sofia Miranda de Figueiredo; Braga, Camila Bitu Moreno; Peria, Fernanda Maris; Domenici, Fernanda Aparecida; Martinez, Edson Zangiacomi; Feres, Omar; da Rocha, José Joaquim Ribeiro; da Cunha, Selma Freire de Carvalho

    2016-01-01

    The study aimed to investigate the effect of oral zinc supplementation on antioxidant defenses and oxidative stress markers during chemotherapy for colorectal cancer. Twenty-four patients who had undergone surgical resection of colorectal cancer participated in this placebo-controlled, prospective randomized study. The supplementation was started in the perioperative period, in which 10 patients received 70 mg of zinc (zinc group, n = 10) and 14 patients received placebo (placebo group, n = 14) for 16 weeks. Approximately 45 days after surgical resection of tumor, all patients received a chemotherapeutic regimen (capecitabine, capecitabine combined with oxaliplatin or 5-fluorouracil). Vitamin C, vitamin E, antioxidant enzymes superoxide dismutase (SOD) and glutathione peroxidase (GPx), and lipid peroxidation markers malondialdehyde (MDA) and 8-isoprostane were determined before the first, second, third, and fourth chemotherapy cycles. Compared with the placebo group, the zinc group presented higher SOD values before the first, second, and fourth chemotherapy cycles and lower GPx values before the third cycle. There were no statistical differences between the study groups in vitamin C, vitamin E, MDA, or 8-isoprostane plasma values. Longitudinal analysis revealed decreased vitamin E concentration in the placebo group before the second and fourth cycles as compared with the initial values. Zinc supplementation during chemotherapy cycles increased SOD activity and maintained vitamin E concentrations. Although no effect of zinc supplementation on oxidative stress markers was observed, the increase in SOD activity indicates a production of stable free radicals, which may have a positive effect in cancer treatment.

  17. Intra-capsular total thyroid enucleation versus total thyroidectomy in treatment of benign multinodular goiter. A prospective randomized controlled clinical trial.

    PubMed

    Sewefy, Alaa M; Tohamy, Tohamy A; Esmael, Tarek M; Atyia, Ahmed M

    2017-09-01

    Due to high recurrence rate after subtotal thyroidectomy, most of centers have shifted to total thyroidectomy as a surgical treatment for benign multinodular goiter (BMNG), but serious complications, as laryngeal nerve affection & hypocalcaemia, are still present. This study aimed to evaluate treatment of BMNG using intra-capsular total thyroid enucleation in comparison to standard total thyroidectomy. This is a prospective randomized controlled clinical trial conducted in a hospital in the period from December 2009 to December 2015. Of total 224 patients with clinically BMNG. 112 patients operated by intracapsular total thyroid enucleation (ITTE group) and the other 112 patients operated by standard total thyroidectomy (STT group). The minimal follow up period was 36 months. The mean operative time in ITTE group was (93.7 ± 9.6 min) compared to (86.9 ± 8.3 min) in STT group. Transient recurrent laryngeal nerve (RLN) palsy was 0% in ITTE group VS 7.1% in STT group. No cases (0%) developed permanent RLN palsy in ITTE group VS 0.9% in STT group. Symptomatic transient hypocalcaemia occurred in 1.8% in ITTE group VS 11.6% in STT group. No cases (0%) developed permanent hypocalcaemia in ITTE group VS 0.9% in STT group. No recurrence (0%) in both groups after minimal 3 years of follow up. Intracapsular Total thyroid enucleation technique is safe with the least serious complications, especially RLN injury and hypoparathyroidism, with no recurrence, but this technique still not radical so couldn't be used in suspicious cases for malignancy. Copyright © 2017 IJS Publishing Group Ltd. Published by Elsevier Ltd. All rights reserved.

  18. Prospective randomized controlled study using polyethylene mesh for inguinal hernia meshplasty as a safe and cost-effective alternative to polypropylene mesh.

    PubMed

    Gundre, Nitin P; Iyer, Sandhya P; Subramaniyan, Prabhakar

    2012-03-01

    Most patients who come to a general hospital in a developing country are poor. The most important prohibiting factor for use of polypropylene mesh in hernia repair is its exorbitant cost. Hence, research workers have been on the lookout for an equally effective but economically affordable mesh. Worldwide, surgical repair of inguinal hernia is the most common general surgery procedure performed at the present. Lifetime risk of groin hernia is 15% in males and 5% in females. Most of the patients who visit a general hospital are from either lower middle class or poor socioeconomic strata. The most important prohibiting factor for use of polypropylene mesh in hernia repair for the common man is its exorbitant cost. The aim of this study is to document the feasibility, safety and cost-effectiveness of the use of polyethylene mesh. A single blind, prospective, randomized controlled study, comparing 35 patients of two groups was conducted in a tertiary teaching hospital over a period of 5 years. The patients in both groups underwent inguinal hernioplasty, and were administered similar antibiotics and analgesics. The postoperative course with regard to pain, seroma formation, infection, hospital stay, recurrence and scar quality was evaluated and compared. Statistical analysis was performed with Chi square test. The properties of both meshes were the same with respect to ease of handling, pain score, seroma formation, infection rate, resumption of daily activities, scar quality and mesh rejection. Recurrence rate was zero for both groups. Polyethylene mesh was 2,808 times cheaper than the commercially available polypropylene mesh. This study proved the safety, simplicity, efficacy and cost-effectiveness of polyethylene mesh for inguinal hernia meshplasty, insuring economical, accessible health care for the financially weak section of the population.

  19. Psychophysiological effects of a web-based stress management system: A prospective, randomized controlled intervention study of IT and media workers [ISRCTN54254861

    PubMed Central

    Hasson, Dan; Anderberg, Ulla Maria; Theorell, Töres; Arnetz, Bengt B

    2005-01-01

    Background The aim of the present study was to assess possible effects on mental and physical well-being and stress-related biological markers of a web-based health promotion tool. Methods A randomized, prospectively controlled study was conducted with before and after measurements, involving 303 employees (187 men and 116 women, age 23–64) from four information technology and two media companies. Half of the participants were offered web-based health promotion and stress management training (intervention) lasting for six months. All other participants constituted the reference group. Different biological markers were measured to detect possible physiological changes. Results After six months the intervention group had improved statistically significantly compared to the reference group on ratings of ability to manage stress, sleep quality, mental energy, concentration ability and social support. The anabolic hormone dehydroepiandosterone sulphate (DHEA-S) decreased significantly in the reference group as compared to unchanged levels in the intervention group. Neuropeptide Y (NPY) increased significantly in the intervention group compared to the reference group. Chromogranin A (CgA) decreased significantly in the intervention group as compared to the reference group. Tumour necrosis factor α (TNFα) decreased significantly in the reference group compared to the intervention group. Logistic regression analysis revealed that group (intervention vs. reference) remained a significant factor in five out of nine predictive models. Conclusion The results indicate that an automatic web-based system might have short-term beneficial physiological and psychological effects and thus might be an opportunity in counteracting some clinically relevant and common stress and health issues of today. PMID:16042796

  20. Effects of nonpathogenic gram-negative bacterium Vitreoscilla filiformis lysate on atopic dermatitis: a prospective, randomized, double-blind, placebo-controlled clinical study.

    PubMed

    Gueniche, A; Knaudt, B; Schuck, E; Volz, T; Bastien, P; Martin, R; Röcken, M; Breton, L; Biedermann, T

    2008-12-01

    Atopic dermatitis (AD) is associated with elevated IgE levels and Th2 responses. The oral administration of nonpathogenic bacteria such as probiotics may improve the course of atopic diseases. It is believed that nonpathogenic bacteria prevent the development of allergic diseases by modulating intestinal immune responses. However, the effects of oral probiotics on AD could not be reproduced in all studies and the direct immunomodulation of the skin-associated immune response by nonpathogenic bacteria has not yet been investigated. We performed a prospective, double-blind, placebo-controlled clinical study with a cream containing a 5% lysate of the nonpathogenic bacteria Vitreoscilla filiformis. Seventy-five volunteers with AD (6-70 years of age) were randomized to receive either V. filiformis cream 5% or vehicle cream daily for 30 days. Efficacy was evaluated by the SCORe of Atopic Dermatitis (SCORAD), transepidermal water loss (TEWL), assessment of microflora, and the patient's assessment of itch and loss of sleep. Compared with placebo, V. filiformis lysate significantly decreased SCORAD levels (P=0.0044) and pruritus (P=0.0171). Active cream significantly decreased loss of sleep from day 0 to day 29 (P=0.0074). Qualitative and quantitative assessment of cutaneous microbial colonization revealed that V. filiformis lysate reduced Staphylococcus aureus colonization of the skin. The skin barrier as determined by TEWL also improved significantly with the cream alone. V. filiformis lysate significantly improved AD. This may be in part due to reduction of S. aureus, but seems to relate in most parts to a direct immunomodulatory effect on skin-associated immune responses.

  1. Psychophysiological effects of a web-based stress management system: a prospective, randomized controlled intervention study of IT and media workers [ISRCTN54254861].

    PubMed

    Hasson, Dan; Anderberg, Ulla Maria; Theorell, Töres; Arnetz, Bengt B

    2005-07-25

    The aim of the present study was to assess possible effects on mental and physical well-being and stress-related biological markers of a web-based health promotion tool. A randomized, prospectively controlled study was conducted with before and after measurements, involving 303 employees (187 men and 116 women, age 23-64) from four information technology and two media companies. Half of the participants were offered web-based health promotion and stress management training (intervention) lasting for six months. All other participants constituted the reference group. Different biological markers were measured to detect possible physiological changes. After six months the intervention group had improved statistically significantly compared to the reference group on ratings of ability to manage stress, sleep quality, mental energy, concentration ability and social support. The anabolic hormone dehydroepiandosterone sulphate (DHEA-S) decreased significantly in the reference group as compared to unchanged levels in the intervention group. Neuropeptide Y (NPY) increased significantly in the intervention group compared to the reference group. Chromogranin A (CgA) decreased significantly in the intervention group as compared to the reference group. Tumour necrosis factor alpha (TNFalpha) decreased significantly in the reference group compared to the intervention group. Logistic regression analysis revealed that group (intervention vs. reference) remained a significant factor in five out of nine predictive models. The results indicate that an automatic web-based system might have short-term beneficial physiological and psychological effects and thus might be an opportunity in counteracting some clinically relevant and common stress and health issues of today.

  2. Comparison of a microsliced modified chondroperichondrium shield graft and a temporalis fascia graft in primary type I tympanoplasty: A prospective randomized controlled trial.

    PubMed

    Bhattacharya, Shambhu Nath; Pal, Sudipta; Saha, Somnath; Gure, Prasanta Kumar; Roy, Anupam

    2016-07-01

    We conducted a prospective, randomized, controlled trial to compare outcomes in type I tympanoplasty patients who received an autologous microsliced modified cartilage perichondrium shield graft (cartilage group) and those who received an autologous temporalis muscle fascia graft (fascia group). Our three outcomes measures were (1) anatomic success rates at 3 months, (2) hearing results at 6 months, and (3) rates of morphologic success (i.e., the absence of reperforation, retraction, and graft displacement) at 2 years among those in each group who had an intact graft at 3 months. Of 56 patients who were initially enrolled and who underwent one of these type I tympanoplasty procedures, 51 completed the study-28 in the cartilage group and 23 in the fascia group. The former was made up of 11 males and 17 females, aged 15 to 48 years (mean: 27.4), and the latter included 9 males and 14 females, aged 15 to 52 years (mean: 31.7). The overall graft take rate at 3 months with respect to perforation closure (anatomic success) was 93.3% in the cartilage group and 91.7% in the fascia group, which was not a statistically significant difference. The mean hearing gain at 6 months was 11.7 ± 7.6 dB in the cartilage group and 12.6 ± 6.0 dB in the fascia group-again, not statistically significant. At 2 years, morphologic success rates were 92.3 and 81.0%, respectively-again, not statistically significant. We conclude that autologous microsliced modified cartilage perichondrium shield graft tympanoplasty is as effective as conventional temporalis fascia tympanoplasty in terms of graft take rates and functional results. Indeed, medium-term outcomes (2-yr follow-up) revealed that sustainable morphologic success was actually better with the cartilage technique than with the fascia technique because it was associated with fewer revision surgeries.

  3. The role of preoperative prophylactic antibiotic administration in periapical endodontic surgery: a randomized, prospective double-blind placebo-controlled study.

    PubMed

    Lindeboom, J A H; Frenken, J W H; Valkenburg, P; van den Akker, H P

    2005-12-01

    To determine the value of clindamycin prophylaxis in the prevention of postoperative wound infections in patients undergoing endodontic surgery. This study included 256 patients undergoing endodontic surgery in a prospective double-blind placebo-controlled trial comparing oral administration of an oral placebo versus a preoperative 600 mg dose of clindamycin. After randomization the study medication was administered orally 1 h before surgery in a double-blind fashion. For a period of 4 weeks the postoperative course was observed according to clinical parameters of infection. Primary end-point was infection at the surgical site. The mean age of the study population was 44.4 years (SD 11.4, range 18-82 years) with a sex distribution of 147 females (47.4%) and 109 males (42.6%). Mean age of the patients in the clindamycin group was 44.7 years (SD 12.0), and the mean age in the placebo group was 44.1 years (SD 10.8) (P = 0.49). In the clindamycin group, the mean duration of surgery was 32.3 min (SD 8.8) and in the placebo group the mean duration of surgery was 32.5 min (SD 8.4) (P = 0.89). Two infections [1.6%; 95 confidence interval (CI): 0.48-4.72] were identified in the clindamycin group and four (3.2%; 95 CI: 0.42-1.33) in the placebo group (P = 0.448). No statistically significant difference was found between clindamycin prophylaxis and placebo with regard to the prevention of postoperative infection in endodontic surgical procedures.

  4. Reduction Osteotomy vs Pie-Crust Technique as Possible Alternatives for Medial Release in Total Knee Arthroplasty and Compared in a Prospective Randomized Controlled Trial.

    PubMed

    Ahn, Ji Hyun; Yang, Tae Yeong; Lee, Jang Yun

    2016-07-01

    To compare the gap change between the pie-crust technique and reduction osteotomy to determine their effects on flexion and extension gaps and their success rates in achieving ligament balancing during total knee arthroplasty. In a prospective randomized controlled trial, 106 total knee arthroplasties were allocated to each group with 53 cases. If there was a narrow medial gap with an imbalance of ≥3 mm after the initial limited medial release, either reduction osteotomy or pie-crust technique was performed. The changes of extension and flexion medial gaps along with the success rate of mediolateral balancing were compared. There was a significant difference in the change of medial gap in knee extension with mean changes of 3.5 ± 0.5 mm and 2.3 ± 0.8 mm in the reduction osteotomy and pie-crust groups, respectively (P < .001). For flexion gap, greater change was found in the pie-crust group compared with the reduction osteotomy group; the mean medial gap changes in knee flexion were 1.1 ± 0.5 mm and 2.3 ± 1.2 mm in the reduction osteotomy and pie-crust groups, respectively. The success rates were 90.6% and 67.9% in reduction osteotomy and pie-crust groups, respectively (P = .007). As an alternative medial release method, reduction osteotomy was more effective in extension gap balancing, and pie-crust technique was more effective in flexion gap balancing. The overall success rate of mediolateral ligament balancing was higher in the reduction osteotomy group than in the pie-crust group. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. Effect of omega 3 polyunsaturated fatty acids derived from fish oil in major burn patients: A prospective randomized controlled pilot trial.

    PubMed

    Tihista, Serrana; Echavarría, Estrella

    2017-01-16

    The burn patient is the clearest example of prolonged inflammatory response. Various nutrients, particularly omega-3 polyunsaturated fatty acids (ω-3 PUFAs), have been demonstrated as attenuating the inflammatory response, and reduce infectious complications. In absence of definitive evidence in major burns the study aimed at investigating the effect particularly on infectious complications of enteral nutrition enriched with ω-3 PUFAs. Prospectively randomized controlled trial. adult patients admitted to intensive care (ICU), burns > 15% body surface area (BSA), with inhalation injury requiring mechanical ventilation for ≥ 6 days and enteral nutrition. low-fat (18% energy as fat) modular diet (LF-EN) or identical with 50% of fat as fish oil (FO-EN). Study endpoints: infectious and other complications, length of mechanical ventilation time, mortality. Altogether 92 patients, aged 40 years old and burned 38% BSA were analyzed (45 patients in LF-EN and 47 in FO-EN). Baseline characteristics were similar. Severe sepsis and septic shock together were significantly fewer in FO-EN group, 15% versus 33%, p = 0.03, (others infections unchanged). Non-infectious complications were less frequent in group FO-EN, with a significant reduction of high gastric residual volume (33% versus 8.5%: p = 0.003). Mechanical ventilation was non-significantly shorter with FO-EN (22 versus 26 days). Mortality did not differ. The inclusion of ω-3 PUFAs in a low fat diet in ICU burned patients was associated with significant clinical benefits compared to a conventional low fat diet, with lower rates of severe sepsis, septic shock and pyloric dysfunction. NCT02189538. Copyright © 2017 Elsevier Ltd and European Society for Clinical Nutrition and Metabolism. All rights reserved.

  6. Accuracy of Cup Positioning With the Computed Tomography-Based Two-dimensional to Three-Dimensional Matched Navigation System: A Prospective, Randomized Controlled Study.

    PubMed

    Yamada, Kazuki; Endo, Hirosuke; Tetsunaga, Tomonori; Miyake, Takamasa; Sanki, Tomoaki; Ozaki, Toshifumi

    2017-08-12

    The accuracy of various navigation systems used for total hip arthroplasty has been described, but no publications reported the accuracy of cup orientation in computed tomography (CT)-based 2D-3D (two-dimensional to three-dimensional) matched navigation. In a prospective, randomized controlled study, 80 hips including 44 with developmental dysplasia of the hips were divided into a CT-based 2D-3D matched navigation group (2D-3D group) and a paired-point matched navigation group (PPM group). The accuracy of cup orientation (absolute difference between the intraoperative record and the postoperative measurement) was compared between groups. Additionally, multiple logistic regression analysis was performed to evaluate patient factors affecting the accuracy of cup orientation in each navigation. The accuracy of cup inclination was 2.5° ± 2.2° in the 2D-3D group and 4.6° ± 3.3° in the PPM group (P = .0016). The accuracy of cup anteversion was 2.3° ± 1.7° in the 2D-3D group and 4.4° ± 3.3° in the PPM group (P = .0009). In the PPM group, the presence of roof osteophytes decreased the accuracy of cup inclination (odds ratio 8.27, P = .0140) and the absolute value of pelvic tilt had a negative influence on the accuracy of cup anteversion (odds ratio 1.27, P = .0222). In the 2D-3D group, patient factors had no effect on the accuracy of cup orientation. The accuracy of cup positioning in CT-based 2D-3D matched navigation was better than in paired-point matched navigation, and was not affected by patient factors. It is a useful system for even severely deformed pelvises such as developmental dysplasia of the hips. Copyright © 2017 Elsevier Inc. All rights reserved.

  7. Comparison of Space Glucose Control and Routine Glucose Management Protocol for Glycemic Control in Critically Ill Patients: A Prospective, Randomized Clinical Study.

    PubMed

    Xu, Biao; Jiang, Wei; Wang, Chun-Yao; Weng, Li; Hu, Xiao-Yun; Peng, Jin-Min; Du, Bin

    2017-09-05

    The Space Glucose Control (SGC) system is a computer-assisted device combining infusion pumps with the enhanced Model Predictive Control algorithm to achieve the target blood glucose (BG) level safely. The objective of this study was to evaluate the efficacy and safety of glycemic control by SGC with customized BG target range of 5.8-8.9 mmol/L in the critically ill patients. It is a randomized controlled trial of seventy critically ill patients with mechanical ventilation and hyperglycemia (BG ≥ 9.0 mmol/L). Thirty-six patients in the SGC group and 34 in the routine glucose management group were observed for three consecutive days. Target BG for both groups was 5.8-8.9 mmol/L. The primary outcome was the percentage time in the target range. The percentage time within BG target range in the SGC group (69 ± 15%) was significantly higher than in the routine management group (52 ± 24%; P< 0.01). No measurement was ≤2.2 mmol/L, and there was only one episode of hypoglycemia (2.3-3.3 mmol/L) in each group. The average BG was significantly lower in the SGC group (7.8 ± 0.7 mmol/L) than in the routine management group (9.1 ± 1.6 mmol/L, P< 0.001). Target BG level was reached earlier in the SGC group than routine management group (2.5 ± 2.9 vs. 12.1 ± 15.3 h, P= 0.001). However, the SGC group performed worse for daily insulin requirement (59.8 ± 39.3 vs. 28.4 ± 36.7 U, P= 0.001) and sampling interval (2.0 ± 0.5 vs. 3.7 ± 0.5 h, P< 0.001) than the routine management group did. Multiple linear regression showed that the intervention group remained a significant individual predictor (P < 0.001) of the percentage time in target range. The SGC system, with a BG target of 5.8-8.9 mmol/L, resulted in effective and reliable glycemic control with few hypoglycemic episodes in critically ill patients with mechanical ventilation and hyperglycemia. However, the workload was increased. http://www.clinicaltrials.gov, NCT 02491346; https://www.clinicaltrials.gov/ct2/show

  8. Tourniquet application after local forearm warming to improve venodilation for peripheral intravenous cannulation in young and middle-aged adults: A single-blind prospective randomized controlled trial.

    PubMed

    Yamagami, Yuki; Tomita, Kohei; Tsujimoto, Tomomi; Inoue, Tomoko

    2017-07-01

    Local forearm warming before tourniquet application is often used to promote venodilation for peripheral intravenous cannulation; however, few studies have compared the effect of tourniquet application with and without local warming on vein size. To evaluate the effectiveness of tourniquet application after local forearm warming with that of tourniquet application alone in young and middle-aged adults. A single-blind, prospective, parallel group, randomized controlled trial. A national university in Japan. Seventy-two volunteers aged 20-64 years. Participants were randomly allocated to one of two groups: tourniquet application for 30s after forearm application of a heat pack warmed to 40°C±2°C for 15min (active warming group; n=36) or tourniquet application for 30s after applying a non-warmed heat pack for 15min (passive warming group; n=36). The primary outcomes were vein cross-sectional area on the forearm, measured after the intervention by blinded research assistants using ultrasound. Secondary outcomes were shortest diameter, and longest diameter of vein on the forearm, forearm skin temperature, body temperature, pulse, systolic blood pressure, and diastolic blood pressure. All outcomes were assessed at the same site before and immediately after the intervention, once per participant. Vein cross-sectional area, shortest vein diameter, and longest vein diameter were significantly increased in the active warming group compared with the passive warming group (p <0.01). Tourniquet application after local warming was superior to tourniquet application alone in increasing vein cross-sectional, shortest diameter, and longest diameter (between-group differences of 2.2mm(2), 0.5mm, and 0.5mm, respectively), and in raising skin temperature (between-group difference: 5.2°C). However, there were no significant differences in body temperature, pulse, or systolic or diastolic blood pressure between the groups. There were no adverse events associated with either

  9. Washing red blood cells and platelets transfused in cardiac surgery reduces post-operative inflammation and number of transfusions: Results of a prospective, randomized, controlled clinical trial

    PubMed Central

    Cholette, Jill M; Henrichs, Kelly F; Alfieris, George M; Powers, Karen S.; Phipps, Richard; Spinelli, Sherry L.; Swartz, Michael; Gensini, Francisco; Daugherty, L. Eugene; Nazarian, Emily; Rubenstein, Jeffrey S.; Sweeney, Dawn; Eaton, Michael; Lerner, Norma B; Blumberg, Neil

    2013-01-01

    Objective Children undergoing cardiac surgery with cardiopulmonary bypass (CPB) are susceptible to additional inflammatory and immunogenic insults from blood transfusions. We hypothesize that washing red blood cells (RBC) and platelets transfused to these patients will reduce post-operative transfusion-related immune modulation and inflammation. Design Prospective randomized controlled clinical trial. Setting University hospital pediatric cardiac intensive care unit. Patients Children from birth to 17 years old undergoing cardiac surgery with CPB. Interventions Children were randomized to an unwashed or washed RBC and platelet transfusion protocol for their surgery and postoperative care. All blood was leukoreduced, irradiated, and ABO identical. Plasma was obtained for laboratory analysis: pre-op, immediately, six and 12 hours after CPB. Primary outcome was the 12-hour post-CPB interleukin (IL)-6: IL-10 ratio. Secondary measures were IL levels, C-reactive protein (CRP), and clinical outcomes. Measurements and main results 162 subjects were studied, 81 per group. 34 subjects (17 per group) did not receive any blood transfusions. Storage duration of blood products was similar between groups. Among transfused subjects, the 12-hour IL ratio was significantly lower in the washed group (3.8 v. 4.8; p=0.04) secondary to lower IL-6 levels (post-CPB: 65 v.100 pg/ml; p = 0.06; 6 hour: 89 v.152 pg/ml; p = 0.02; 12-hour: 84 v.122 pg/ml; p = 0.09). Post-operative CRP was lower in subjects receiving washed blood (38 v. 43 mg/L; p = 0.03). There was a numerical, but not statistically significant decrease in total blood product transfusions (203 v. 260) and mortality (2 v. 6 deaths) in the washed group compared to the unwashed group. Conclusions Washed blood transfusions in cardiac surgery reduced inflammatory biomarkers, number of transfusions, donor exposures, and were associated with a non-significant trend towards reduced mortality. A larger study powered to test for clinical

  10. Collagen cross-linking in keratoconus in Asian eyes: visual, refractive and confocal microscopy outcomes in a prospective randomized controlled trial.

    PubMed

    Sharma, Namrata; Suri, Kunal; Sehra, Sri Vatsa; Titiyal, Jeewan S; Sinha, Rajesh; Tandon, Radhika; Vajpayee, Rasik B

    2015-12-01

    To evaluate the safety and efficacy of collagen cross-linking (CXL) in the treatment of keratoconus. A prospective randomized sham-controlled clinical trial was undertaken and 43 eyes with moderate to severe keratoconus were randomized into two groups that is the treatment (n = 23) and the sham (n = 20) group. CXL was performed with riboflavin (0.1 in 20 % dextran) followed by UVA radiation (365 nm, 3 mW/cm(2), 30 min). In the sham group, only riboflavin was administered without UVA radiation. Uncorrected distance visual acuity (UDVA), corrected distance visual acuity, intraocular pressure, corneal thickness, keratometry, endothelial count, confocal microscopy were evaluated at baseline and at 1 week, 1, 3, and 6 months. In cases where CXL was done, UDVA improved by mean 0.11 ± 0.06 logMAR units at 6 months (P = 0.01). The refractive cylinder and spherical equivalent decreased by mean of 0.62 D (P = 0.01) and 0.5 D (P = 0.19), respectively. Ultrasonic central corneal thickness decreased by mean 22.7 ± 10.3 μm (P = 0.01). The maximum and minimum keratometry decreased by mean of 1.2 ± 0.8 D (P = 0.01) and 0.83 ± 1.2 D (P = 0.39), respectively. The specular count and intraocular pressure did not show any significant change. In the sham group, no significant change was observed in any parameter. Confocal analysis showed that the epithelial healing was complete at 1 week after crosslinking. The sub-epithelial plexus showed loss of nerve plexus at 1 month, regeneration of nerve fibers which started at 3 months and was complete at 6 months. The anterior stroma showed loss of keratocytes with honeycomb oedema and apoptotic bodies till 3 months. The regeneration of keratocytes started at 3 months and was complete at 6 months of follow-up. Collagen cross-linking is an effective procedure to halt progression in keratoconus. The confocal microscopic changes correlate with the outcomes in the treatment and the sham groups.

  11. The efficacy of dextrose prolotherapy for temporomandibular joint hypermobility: a preliminary prospective, randomized, double-blind, placebo-controlled clinical trial.

    PubMed

    Refai, Hamida; Altahhan, Obada; Elsharkawy, Rehab

    2011-12-01

    The aim of this study was to assess the efficacy of dextrose prolotherapy for the treatment of temporomandibular joint (TMJ) hypermobility. A prospective, randomized, double-blind clinical study using a placebo control was carried out. Twelve patients with painful subluxation or dislocation of the TMJ were randomly assigned to 1 of 2 equal-sized groups. Patients in the active group received 4 injections of dextrose solution (2 mL of 10% dextrose and 1 mL of 2% mepivacaine) for each TMJ, each 6 weeks apart, whereas patients in the placebo group received injections of placebo solution (2 mL of saline solution and 1 mL of 2% mepivacaine) on the same schedule. A verbal scale expressing TMJ pain on palpation, maximal mouth opening (MMO), clicking sound, and frequency of luxations (number of locking episodes per month) were assessed at each injection appointment just before the injection procedure and 3 months after the last injection. The collected data were then statistically analyzed. By the end of the study, each group showed significant improvement in TMJ pain on palpation and number of locking episodes and insignificant improvement in clicking sound. With the exception of the MMO, there were no statistically significant differences throughout the study intervals between the active and placebo groups. The active group showed a significant reduction in MMO at the 12th week postoperatively. Differences compared with mean baseline value remained significant at the end of the follow-up period. On the other hand, the placebo group showed an insignificant difference in MMO throughout the study periods. For the last 2 intervals, the placebo group showed statistically significantly higher mean MMO values than the active group. By the end of the 12th postoperative week, the percentages of decrease in MMO were significantly greater in the active group. Prolotherapy with 10% dextrose appears promising for the treatment of symptomatic TMJ hypermobility, as evidenced by the

  12. Fusion and failure following anterior cervical plating with dynamic or rigid plates: 6-months results of a multi-centric, prospective, randomized, controlled study

    PubMed Central

    Stulik, Jan; Chrobok, Jan; Ruffing, Sabine; Drumm, Jörg; Sova, Laurentius; Kucera, Ravel; Vyskocil, Tomas; Steudel, Wolf Ingo

    2007-01-01

    Anterior cervical plate fixation is an approved surgical technique for cervical spine stabilization in the presence of anterior cervical instability. Rigid plate design with screws rigidly locked to the plate is widely used and is thought to provide a better fixation for the treated spinal segment than a dynamic design in which the screws may slide when the graft is settling. Recent biomechanical studies showed that dynamic anterior plates provide a better graft loading possibly leading to accelerated spinal fusion with a lower incidence of implant complications. This, however, was investigated in vitro and does not necessarily mean to be the case in vivo, as well. Thus, the two major aspects of this study were to compare the speed of bone fusion and the rate of implant complications using either rigid- or dynamic plates. The study design is prospective, randomized, controlled, and multi-centric, having been approved by respective ethic committees of all participating sites. One hundred and thirty-two patients were included in this study and randomly assigned to one of the two groups, both undergoing routine level-1- or level-2 anterior cervical discectomy with autograft fusion receiving either a dynamic plate with screws being locked in ap - position (ABC, Aesculap, Germany), or a rigid plate (CSLP, Synthes, Switzerland). Segmental mobility and implant complications were compared after 3- and 6 months, respectively. All measurements were performed by an independent radiologist. Mobility results after 6 months were available for 77 patients (43 ABC/34 CSLP). Mean segmental mobility for the ABC group was 1.7 mm at the time of discharge, 1.4 mm after 3 months, and 0.8 mm after 6 months. For the CSLP- group the measurements were 1.0, 1.8, and 1.7 mm, respectively. The differences of mean segmental mobility were statistically significant between both groups after 6 months (P = 0.02). Four patients of the CSLP-group demonstrated surgical hardware complications

  13. Randomized Prospective Controlled Trial of Recombinant Granulocyte Colony-Stimulating Factor as Adjunctive Therapy for Limb-Threatening Diabetic Foot Infection

    PubMed Central

    de Lalla, Fausto; Pellizzer, Giampietro; Strazzabosco, Marco; Martini, Zeno; Du Jardin, Giovanni; Lora, Luciano; Fabris, Paolo; Benedetti, Paolo; Erle, Giuseppe

    2001-01-01

    Adult diabetic patients admitted to our Diabetes Center from September 1996 to January 1998 for severe, limb-threatening foot infection were consecutively enrolled in a prospective, randomized, controlled clinical study aimed at assessing the safety and efficacy of recombinant human granulocyte colony-stimulating factor (G-CSF) (lenograstim) as an adjunctive therapy for the standard treatment of diabetic foot infection. Forty patients, all of whom displayed evidence of osteomyelitis and long-standing ulcer infection, were randomized 1:1 to receive either conventional treatment (i.e., antimicrobial therapy plus local treatment) or conventional therapy plus 263 μg of G-CSF subcutaneously daily for 21 days. The empiric antibiotic treatment (a combination of ciprofloxacin plus clindamycin) was further adjusted, when necessary, according to the results of cultures and sensitivity testing. Microbiologic assessment of foot ulcers was performed by both deep-tissue biopsy and swab cultures, performed at enrollment and on days 7 and 21 thereafter. Patients were monitored for 6 months; the major endpoints (i.e., cure, improvement, failure, and amputation) were blindly assessed at weeks 3 and 9. At enrollment, both patient groups were comparable in terms of both demographic and clinical data. None of the G-CSF-treated patients experienced either local or systemic adverse effects. At the 3- and 9-week assessments, no significant differences between the two groups could be observed concerning the number of patients either cured or improved, the number of patients displaying therapeutic failure, or the species and number of microorganisms previously yielded from cultures at day 7 and day 21. Conversely, among this small series of patients the cumulative number of amputations observed after 9 weeks of treatment appeared to be lower in the G-CSF arm; in fact, only three patients (15%) in this group had required amputation, whereas nine patients (45%) in the other group had

  14. Low dose lignocaine + butorphanol vs. low dose bupivacaine for spinal anaesthesia in day care urological surgeries: a prospective randomized control trial.

    PubMed

    Khant, Shahil Rameshbhai; Chaudhari, Rajeev; Kore, Rishikesh Arun; Bhagwat, Shirish; Jakhalekar, Ranjan Purushottam

    2017-06-01

    A local anaesthetic with fast onset, short and reliable duration of anaesthesia may be preferable for day care urological surgeries. Low dose lignocaine is believed to act faster and to have a shorter duration of action than low dose bupivacaine. Use of lignocaine for spinal anesthesia is discouraged now a days because of rare reports of transient neurological symptoms. The purpose of this study was to compare effectiveness and safety of low dose of lignocaine + butorphanol against low dose of bupivacaine for day care urological surgeries. A prospective randomized control trial was conducted between December 2012 to November 2015. After taking ethical committe approval and patient consent, total 990 patients were randomized in two groups. Group A received 0.5 mL of 5% lignocaine (25 mg) + 0.3 mL butorphanol (0.3 mg) and group B received 1 mL of 0.5% bupivacaine (5 mg) for spinal anesthesia. Spinal anesthesia was given at the L3-L4 interspace with the patient in the sitting or lateral position. The criteria for evaluation were time till onset of sensory and motor block, duration of sensory and motor block, time till ambulation, time till fit for discharge and any complications. Both the groups were comparable in terms of age, male to female ratio, American Society of Anesthesiologists (ASA) grade and duration surgery. Group A and Group B were statistically different in terms of mean time till onset of sensory block (120±22 sec and 274±36 sec), onset of motor block (228±34 sec and 372±41 sec), duration of sensory block (100±21 min and 230±28 min), duration of motor block (60±15 min and 152±23 min), time till ambulation (138±24 min and 292±48 min), time till fit for discharge (256±35 min and 428±46 min) respectively (<0.0001). Nausea, vomitings, hypotension, bradycarida and pruritis were less in group A compared to group B (<0.01). None of patient in any group had temporary or permanent neurological defecit. Spinal anaesthesia is an effective as well as a

  15. A prospective, randomized, controlled trial comparing radiographic and clinical outcomes between stand-alone lateral interbody lumbar fusion with either silicate calcium phosphate or rh-BMP2.

    PubMed

    Pimenta, Luiz; Marchi, Luis; Oliveira, Leonardo; Coutinho, Etevaldo; Amaral, Rodrigo

    2013-11-01

    Iliac crest autograft has traditionally been considered the gold standard for lumbar spine fusion, though it is not without drawbacks related to harvesting site pain and other complications. Bone graft alternatives, such as recombinant human bone morphogenetic protein 2 (rh-BMP2), are now widely used but also have unique risk profiles and substantially increase costs. The purpose of the current study was to compare the efficacy of rh-BMP2 and synthetic silicate calcium phosphate (SiCaP) as bone graft substitutes on fusion rates and clinical outcomes in patients undergoing single-level lumbar stand-alone extreme lateral interbody fusion (XLIF). A prospective, randomized, controlled, clinical, and radiographic study was performed at a single institution. Thirty patients with L4-L5 degenerative disc disease (DDD) were enrolled. Patients were randomized into one of two groups, 15 underwent lumbar single-level stand-alone XLIF using SiCaP, and 15 using rh-BMP2. Clinical and radiographic results were compared between the study groups. Pain (visual analogue scale) and disability (Oswestry disability index) were assessed preoperatively and at postoperative weeks 1 and 6 and postoperative months 3, 6, 12, 24, and 36. Radiographic evaluations were performed at 6, 12, 24, and 36 months. Neurological examinations and adverse events were recorded at each visit. No intraoperative complications were observed in either treatment group, and clinical outcomes were similarly improved between bone graft substitutes from baseline to 36 months postoperative. Complications were transient hip flexion weakness (13%), insufficient indirect decompression (7%), subsidence (17%), excessive bone formation (4%), and adjacent segment disease (14%). Complication rates between the groups were similar, though with slightly more instances of subsidence in the SiCaP group and higher rates of excessive bone formation and adjacent segment disease in the rh-BMP2 group. Rates of fusion at different time

  16. Control of acute postoperative pain by transcutaneous electrical nerve stimulation after open cardiac operations: a randomized placebo-controlled prospective study.

    PubMed

    Emmiler, Mustafa; Solak, Ozlem; Kocogullari, Cevdet; Dundar, Umit; Ayva, Ercument; Ela, Yuksel; Cekirdekci, Ahmet; Kavuncu, Vural

    2008-01-01

    We investigated the effectiveness of transcutaneous electrical nerve stimulation (TENS) therapy on pain during the first 24 hours after a cardiac surgical procedure. A total of 60 patients who had undergone median sternotomy (MS) for coronary artery bypass graft (n = 55) or valve repair surgery (n = 5) were randomized to receive TENS and pharmacologic analgesia, placebo TENS and pharmacologic analgesia, or pharmacologic analgesia alone (control group). For each group we recorded severity of pain, analgesic intake, and pulmonary complications. Pethidine HCL and metamizol sodium were administered for postsurgical analgesia. Pain after MS was measured on a 10-point visual analogue scale (VAS). Mean scores in the TENS, placebo TENS, and control groups, respectively, were 5.70 +/- 1.78, 5.75 +/- 1.83, and 5.95 +/- 1.63 before treatment (P >.05); 2.40 +/- 1.18, 3.90 +/- 1.48, and 3.55 +/- 1.60 on the 12th hour of the intervention (P < .05); and 1.25 +/- 0.91, 2.30 +/- 1.34, and 2.15 +/- 1.13 on the 24th hour of the intervention (P < .05). The mean VAS scores decreased within each group (P < .05). However, the mean VAS scores decreased much more significantly in the TENS group (P < .05). Metamizol sodium intake was 1.05 +/- 0.39 g, 2.30 +/- 1.08 g, and 2.90 +/- 1.20 g and pethidine HCL intake was 17 +/- 16.25 mg, 57 +/- 21.54 mg, and 51.50 +/- 18.99 mg, respectively, in the TENS, placebo TENS, and control groups. Metamizol sodium and pethidine HCL intake was least in the TENS group (P < .05). Postoperative complications were observed in 6 (10%) of patients. The most frequent complication was atelectasia. TENS was more effective than placebo TENS or control treatments in decreasing pain and limiting opioid and nonopioid medication intake during the first 24-hour period following MS.

  17. In Metastatic Non-small cell Lung Cancer Platinum-Based Treated Patients, Herbal Treatment Improves the Quality of Life. A Prospective Randomized Controlled Clinical Trial

    PubMed Central

    Guo, Huiru; Liu, Jia X.; Li, Hegen; Baak, Jan P. A.

    2017-01-01

    Background: According to clinical experience, Traditional Chinese Medicine (TCM) herbs added to platinum-based therapy (PBT) improve the Quality of Life (QOL) in metastatic non-small cell lung cancer (NSCLC) patients, but this must be prospectively validated. Patients and Methods: Based on clinical impressions regarding the effect of adding TCM herbs to platinum-based chemotherapy, we anticipated that 2 × 21 patients would be sufficient to obtain significant results with an α < 0.05 and power (1 - β) of 90%. To be on the safe side, we enrolled at least 28 patients in each group. In a prospective randomized controlled trial, 61 uniquely defined consecutive patients (PBT+PLACEBO, N = 32; PBT+TCM, N = 29) with stage IIIB-IV, Eastern Cooperative Oncology Group (ECOG) performance scores (PS) = 0–1 and TCM syndrome combined Qi-Yin deficiency were enrolled. These 61 patients were selected from originally 154 consecutive stage IIIB-IV lung cancer patients in the enrollment period. Patients were hospitalized and strictly controlled/surveyed during the entire 2-month treatment period, to guarantee use of or abstinence from TCM herbal and placebo fluids. Occurrence of nausea-vomiting, QOL by Functional Assessment of Cancer Therapy-Lung (FACT-L) scales and changes in ECOG “improved and stable rates” were compared before and after two treatment cycles. Results: Before treatment, the clinico-pathologic and QOL features in PBT+PLACEBO and PBT+TCM patients did not differ (P > 0.10). The only side effects attributed by some of the patients to the TCM herbs were transient, mild gastric/abdominal heaviness in the first 2 weeks, but these also occurred amongst the PBT+PLACEBO patients (17 and 13%, P > 0.10). The incidence rates of nausea during treatment were 17% in PBT+TCM versus 75% in PBT+PLACEBO; vomiting rates were 14 and 56% (P < 0.0001 and 0.002). Moreover, ECOG “improved and stable rates” were 90% in the PBT+TCM versus 69% in the PBT+PLACEBO group (P = 0.04). In

  18. 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.

  19. [Epidural anaesthesia: Simulated intravascular test dose with S(+) ketamine, lidocaine and adrenaline. A prospective, randomized, double blind and placebo controlled study].

    PubMed

    Higueras, R; Errando, C L; Soriano-Bru, J L

    2015-02-01

    The use of a test dose in epidural anaesthesia is a safety recommendation. However specificity and sensitivity of the drugs used with this indication have been not conclusive. The main objective of this study was to compare the effectiveness and the adverse effects of a simulated intravascular test dose of adrenaline, lidocaine and S(+)-ketamine. A prospective, randomized, double blinded, placebo controlled study was designed. ASA I patients scheduled for elective surgery were included. These were randomized to the following study groups: S(+)-ketamine 0.5 mg.kg-1 (S+K group), 5% lidocaine 1.5 mg.kg-1 (L5% group), adrenaline 15μg (ADR group), and physiological saline 3 ml (SF group; control group). An evaluation was made during the first 15 minutes after the study drug was administered. Variables including heart rate (HR) systolic and diastolic blood pressure (sBP and dBP), mean arterial pressure (MAP), and SpO2 were recorded at 0 min (baseline) and at 2, 5, 8, 10 and 15 minutes after drug injection. An increase of at least 20 beats per minute (bpm) in relation to the baseline measurement was considered a positive result, as was an increase sBP >15 mmHg. The clinical effects described as related to iv injection of the study drugs recorded were: sedation-hypnosis, dizziness, nystagmus, metallic taste perception, perioral or facial paresthesias, tinnitus, as well as any other effect the patients mentioned. Sensitivity and specificity were calculated as was the percent increase in the parameters in order to see if these were clinically useful. A total of 80 patients, 20 per group, were included. The sBP, dBP, and MAP were significantly raised at the 2, 5, 8 and 10 minutes measurements in the S(+)K group compared to the rest of the groups (P<.05), as well as HR in the 2, 5, 8, 10 and 15 minute measurements in the S(+)K compared to the rest of the groups (P<.05). Sensitivity and specificity were high, and significant in the S(+)K group from minute 2 to minute 8

  20. Effects of antihypertensive treatment in Asian populations: a meta-analysis of prospective randomized controlled studies (CARdiovascular protectioN group in Asia: CARNA).

    PubMed

    Yano, Yuichiro; Briasoulis, Alexandros; Bakris, George L; Hoshide, Satoshi; Wang, Ji-Guang; Shimada, Kazuyuki; Kario, Kazuomi

    2014-02-01

    To examine the effects of antihypertensive treatment on cardiovascular disease (CVD) in Asian populations, we systematically evaluated prospective randomized studies carried out in Asia (1991-2013). We identified 18 trials with 23,215 and 21,986 hypertensive patients in the intervention (ie, strict blood pressure [BP] lowering or add-on treatment) and reference groups, respectively (mean age, 65 years; follow-up duration, 3.2 years). Analysis was performed through 1) first subgroup: eight trials that compared active antihypertensive treatment with placebo or intensive with less intensive BP control and 2) second subgroup: 10 trials that compared different antihypertensive treatments. In the first subgroup analysis, BP was reduced from 160.3/87.3 mm Hg to 140.2/78.4 mm Hg in the intervention group with a -6.7/-2.2 mm Hg (P < .001) greater BP reduction than the reference group. Compared with the reference group, the intervention group had a lower risk of composite CVD events (odd ratio [OR], 0.73; 95% confidence interval [CI], 0.66-0.81), myocardial infarction (OR, 0.79; 95% CI, 0.63-1.0), stroke (OR, 0.71; 95% CI, 0.63-0.80), and CVD mortality (OR, 0.81; 95% CI, 0.68-0.97; all P ≤ .05). In the second subgroup analysis, no difference was found for any outcome between renin-angiotensin blockers and calcium-channel blockers or diuretics. The meta-regression line among the 18 trials indicated that a 10 mm Hg reduction in systolic BP was associated with a reduced risk for composite CVD events (-39.5%) and stroke (-30.0%). Our meta-analysis shows a benefit when a BP target of less than 140/80 mm Hg is achieved in Asian hypertensives. BP reduction itself, regardless of BP lowering agents, is important for achieving CVD risk reduction. Copyright © 2014 American Society of Hypertension. Published by Elsevier Inc. All rights reserved.

  1. EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as tobacco cigarettes substitute: a prospective 12-month randomized control design study.

    PubMed

    Caponnetto, Pasquale; Campagna, Davide; Cibella, Fabio; Morjaria, Jaymin B; Caruso, Massimo; Russo, Cristina; Polosa, Riccardo

    2013-01-01

    Electronic cigarettes (e-cigarettes) are becoming increasingly popular with smokers worldwide. Users report buying them to help quit smoking, to reduce cigarette consumption, to relieve tobacco withdrawal symptoms, and to continue having a 'smoking' experience, but with reduced health risks. Research on e-cigarettes is urgently needed in order to ensure that the decisions of regulators, healthcare providers and consumers are based on science. Methods ECLAT is a prospective 12-month randomized, controlled trial that evaluates smoking reduction/abstinence in 300 smokers not intending to quit experimenting two different nicotine strengths of a popular e-cigarette model ('Categoria'; Arbi Group Srl, Italy) compared to its non-nicotine choice. GroupA (n = 100) received 7.2 mg nicotine cartridges for 12 weeks; GroupB (n = 100), a 6-week 7.2 mg nicotine cartridges followed by a further 6-week 5.4 mg nicotine cartridges; GroupC (n = 100) received no-nicotine cartridges for 12 weeks. The study consisted of nine visits during which cig/day use and exhaled carbon monoxide (eCO) levels were measured. Smoking reduction and abstinence rates were calculated. Adverse events and product preferences were also reviewed. Declines in cig/day use and eCO levels were observed at each study visits in all three study groups (p<0.001 vs baseline), with no consistent differences among study groups. Smoking reduction was documented in 22.3% and 10.3% at week-12 and week-52 respectively. Complete abstinence from tobacco smoking was documented in 10.7% and 8.7% at week-12 and week-52 respectively. A substantial decrease in adverse events from baseline was observed and withdrawal symptoms were infrequently reported during the study. Participants' perception and acceptance of the product under investigation was satisfactory. In smokers not intending to quit, the use of e-cigarettes, with or without nicotine, decreased cigarette consumption and elicited enduring tobacco abstinence

  2. Comparison of secure messaging application (WhatsApp) and standard telephone usage for consultations on Length of Stay in the ED. A prospective randomized controlled study.

    PubMed

    Gulacti, Umut; Lok, Ugur

    2017-07-19

    Consultation, the process of an Emergency Physician seeking an opinion from other specialties, occurs frequently in the Emergency Department (ED). The aim of this study was to determine the effect of secure messaging application (WhatsApp) usage for medical consultations on Emergency Department Length of Stay (ED LOS) and consult time. We conducted a prospective, randomized controlled trial in the ED using allocation concealment over three months. Consultations requested in the ED were allocated into two groups: consultations requested via the secure messaging application and consultations requested by telephone as verbal. A total of 439 consultations requested in the ED were assessed for eligibility and 345 were included in the final analysis: 173 consultations were conducted using secure messaging application and 172 consultations were conducted using standard telephone communications. The median ED LOS was 240 minutes (IQR:230-270, 95% CI:240 to 255.2) for patients in the secure messaging application group and 277 minutes (IQR:270-287.8, 95% CI:277 to 279) for patients in the telephone group. The median total ED LOS was significantly lower among consults conducted using Secure messaging application relative to consults conducted by telephone (median dif: -30, 95%CI:-37to-25, p<0.0001). The median consult time was 158 minutes (IQR:133 to 177.25, 95% CI:150 to 169) for patients in the Secure messaging application group and 170 minutes (IQR:165 to 188.5, 95% CI:170-171) for patients in the Telephone group (median dif: -12, 95%CI:-19 to-7,p<0.0001). Consultations completed without ED arrival was 61.8% in the secure messaging group and 33.1% in the Telephone group (dif: 28.7, 95% CI:48.3 to 66, p<0.001). Use of secure messaging application for consultations in the ED reduces the total ED LOS and consultation time. Consultation with secure messaging application eliminated more than half of in-person ED consultation visits.

  3. Long-term clinical and radiographic outcomes of the Prestige LP artificial cervical disc replacement at 2 levels: results from a prospective randomized controlled clinical trial.

    PubMed

    Lanman, Todd H; Burkus, J Kenneth; Dryer, Randall G; Gornet, Matthew F; McConnell, Jeffrey; Hodges, Scott D

    2017-07-01

    OBJECTIVE The aim of this study was to assess long-term clinical safety and effectiveness in patients undergoing anterior cervical surgery using the Prestige LP artificial disc replacement (ADR) prosthesis to treat degenerative cervical spine disease at 2 adjacent levels compared with anterior cervical discectomy and fusion (ACDF). METHODS A prospective, randomized, controlled, multicenter FDA-approved clinical trial was conducted at 30 US centers, comparing the low-profile titanium ceramic composite-based Prestige LP ADR (n = 209) at 2 levels with ACDF (n = 188). Clinical and radiographic evaluations were completed preoperatively, intraoperatively, and at regular postoperative intervals to 84 months. The primary end point was overall success, a composite variable that included key safety and efficacy considerations. RESULTS At 84 months, the Prestige LP ADR demonstrated statistical superiority over fusion for overall success (observed rate 78.6% vs 62.7%; posterior probability of superiority [PPS] = 99.8%), Neck Disability Index success (87.0% vs 75.6%; PPS = 99.3%), and neurological success (91.6% vs 82.1%; PPS = 99.0%). All other study effectiveness measures were at least noninferior for ADR compared with ACDF. There was no statistically significant difference in the overall rate of implant-related or implant/surgical procedure-related adverse events up to 84 months (26.6% and 27.7%, respectively). However, the Prestige LP group had fewer serious (Grade 3 or 4) implant- or implant/surgical procedure-related adverse events (3.2% vs 7.2%, log hazard ratio [LHR] and 95% Bayesian credible interval [95% BCI] -1.19 [-2.29 to -0.15]). Patients in the Prestige LP group also underwent statistically significantly fewer second surgical procedures at the index levels (4.2%) than the fusion group (14.7%) (LHR -1.29 [95% BCI -2.12 to -0.46]). Angular range of motion at superior- and inferior-treated levels on average was maintained in the Prestige LP ADR group to 84 months

  4. 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

  5. Sacroiliac Joint Fusion Using Triangular Titanium Implants vs. Non-Surgical Management: Six-Month Outcomes from a Prospective Randomized Controlled Trial

    PubMed Central

    Whang, Peter; Polly, David; Frank, Clay; Lockstadt, Harry; Glaser, John; Limoni, Robert; Sembrano, Jonathan

    2015-01-01

    Background Sacroiliac (SI) joint pain is a prevalent, underdiagnosed cause of lower back pain. SI joint fusion can relieve pain and improve quality of life in patients who have failed nonoperative care. To date, no study has concurrently compared surgical and non-surgical treatments for chronic SI joint dysfunction. Methods We conducted a prospective randomized controlled trial of 148 subjects with SI joint dysfunction due to degenerative sacroiliitis or sacroiliac joint disruptions who were assigned to either minimally invasive SI joint fusion with triangular titanium implants (N=102) or non-surgical management (NSM, n=46). SI joint pain scores, Oswestry Disability Index (ODI), Short-Form 36 (SF-36) and EuroQol-5D (EQ-5D) were collected at baseline and at 1, 3 and 6 months after treatment commencement. Six-month success rates, defined as the proportion of treated subjects with a 20-mm improvement in SI joint pain in the absence of severe device-related or neurologic SI joint-related adverse events or surgical revision, were compared using Bayesian methods. Results Subjects (mean age 51, 70% women) were highly debilitated at baseline (mean SI joint VAS pain score 82, mean ODI score 62). Six-month follow-up was obtained in 97.3%. By 6 months, success rates were 81.4% in the surgical group vs. 23.9% in the NSM group (difference of 56.6%, 95% posterior credible interval 41.4-70.0%, posterior probability of superiority >0.999). Clinically important (≥15 point) ODI improvement at 6 months occurred in 75% of surgery subjects vs. 27.3% of NSM subjects. At six months, quality of life improved more in the surgery group and satisfaction rates were high. The mean number of adverse events in the first six months was slightly higher in the surgical group compared to the non-surgical group (1.3 vs. 1.0 events per subject, p=0.1857). Conclusions Six-month follow-up from this level 1 study showed that minimally invasive SI joint fusion using triangular titanium implants was more

  6. Does the baricity of bupivacaine influence intrathecal spread in the prolonged sitting position before elective cesarean delivery? A prospective randomized controlled study.

    PubMed

    Loubert, Christian; Hallworth, Stephen; Fernando, Roshan; Columb, Malachy; Patel, Nisa; Sarang, Kavita; Sodhi, Vinnie

    2011-10-01

    Difficulties in inserting an epidural catheter while performing combined spinal-epidural anesthesia for cesarean delivery may lead to undue delays between the spinal injection of the local anesthetic mixture and the adoption of the supine position with lateral tilt. We hypothesized that this delay may affect the intrathecal distribution of local anesthetic of different baricities such that hypobaric local anesthetic would lead to a higher sensory block level. Healthy parturients with uncomplicated pregnancies undergoing elective cesarean delivery under combined spinal-epidural anesthesia were enrolled in this prospective double-blind randomized controlled trial. The subjects were allocated to receive hyperbaric (hyperbaric group), isobaric (isobaric group), or hypobaric (hypobaric group) spinal bupivacaine 10 mg. After the spinal injection, the subjects remained in the sitting position for 5 minutes (to simulate difficulty in inserting the epidural catheter) before being helped into the supine lateral tilt position. The primary outcome was the sensory block level during the 25 minutes after the spinal injection. Other end points included motor block score, maternal hypotension, and vasopressor requirements. Data from 89 patients were analyzed. Patient characteristics were similar in all groups. The median [interquartile range] (95% confidence interval) sensory levels after spinal injection were significantly higher with decreasing baricity: hyperbaric T10 [T11-8] (T10-9), isobaric T9 [T10-7] (T9-7), and hypobaric T6 [T8-4] (T8-5) (P < 0.001, Cuzick trend). All patients in the hypobaric group reached a sensory block level of T4 at 25 minutes after spinal injection compared with 80% of the patients in both the isobaric and hyperbaric groups (P = 0.04; difference 20%, 95% confidence interval of difference 4%-33%). Significantly more patients in the hypobaric group had complete lower limb motor block (Bromage score = 4) (hyperbaric 43%, isobaric 63%, and hypobaric 90

  7. Controlling intraoperative hemorrhage during burn surgery: A prospective, randomized trial comparing NuStat(®) hemostatic dressing to the historic standard of care.

    PubMed

    Butts, C Caleb; Bose, Kelly; Frotan, M Amin; Hodge, Juvonda; Gulati, Salil

    2017-03-01

    One of the primary intraoperative challenges during burn surgery is to adequately excise the burn while avoiding massive hemorrhage. This has become increasingly important, as we see more burn patients that are older and with more medical comorbidities. While adequate excision down to healthy tissues for deep burns is essential for skin graft to take, it also leads to active bleeding that can be a challenge to control. Good hemostasis is imperative as a hematoma is the most common cause of graft loss. Several new products have become available to help control intraoperative hemorrhage. A new hemostatic dressing, NuStat(®), is available and approved by FDA in United States. A single institution prospective randomized control trial was completed at Regional Burn Center of the University of South Alabama comparing NuStat(®) with the institutional historic standard of care. Twenty such patients were included in our study. A cost analysis was also completed as part of the study retrospectively. For dressings used to treat the burn site, blood loss on the side treated with NuStat(®) was on average less (27g/100cm(2)) than the side treated with our historic standard of care (31g/100cm(2)), though it was not statistically significant (p=0.81). Similarly, on the donor site, blood loss on the side treated with NuStat(®) was on average less (14g/100cm(2)) than the side treated with our historic standard of care (15g/100cm(2)), but it was also not statistically significant (p=0.92). Average total blood loss from both excision and donor sites was also less with NuStat(®) (10g/100cm(2)) compared to the historic standard of care (12g/100cm(2)), but it was also not significant (p=0.77). There was no difference in the number of cycles required to achieve hemostasis for either the burn (1.15 NuStat(®) vs. 1.1 for historic standard of care, p=0.70) or the donor site (1 vs. 1, p=1.0). When comparing the cost of NuStat(®) versus the historic standard of care, the actual costs

  8. The Effectiveness of Gelfoam Technique before Percutaneous Vertebroplasy: Is It Helpful for Prevention of Cement Leakage? A Prospective Randomized Control Study.

    PubMed

    Oh, Jae-Sang; Doh, Jae-Won; Shim, Jai-Joon; Lee, Kyeong-Seok; Yoon, Seok-Mann; Bae, Hack-Gun

    2016-06-01

    Preinjection gelfoam embolization during percutaneous vertebroplasty (PVP) has been thought alternative technique to prevent the leakage of bone cement. The goal of this study was to evaluate whether the gelfoam techniques are useful to reduce bone cement leakage. Total 100 PVPs of osteoporotic spine compression fractures were performed by 1 spine surgeon who experienced more than 500 PVP cases under prospective control study. Operation was done in T-L junction (T10-L2) fractures with bi-transpedicular approach. Preinjection gelfoam PVP was done in the 50 levels. As control group, PVP without gelfoam was done in the 50 levels. We did not perform preoperative venography. We inserted normal saline-mixed gelfoam to the anterior third of vertebral body via PVP needle, and then 3mL of polymethylmetacrylate (PMMA) was injected. We prospectively evaluated the incidence and leakage pattern of PMMA by postoperative computed tomography. Between gelfoam and control groups, there were 11 leaks (22%) versus 12 leaks (26%). The mean operation time was 7.00 minutes versus 6.30 minutes. In gelfoam group, there were 6 spinal canal leaks, 4 paravertebral venous leaks, and 1 soft tissue leaks. In control group, there were 4 spinal canal leaks, 8 paravertebral venous leaks, and 1 disc space leak. In spite of cement leakage, there was no symptomatic case in both groups. Statistically, gelfoam technique was not related to decrease the incidence of leakage (p=0.64). Our prospective study showed that it did not significantly decrease cement leakage when vertebroplasty is performed by experienced spine surgeon.

  9. The Effectiveness of Gelfoam Technique before Percutaneous Vertebroplasy: Is It Helpful for Prevention of Cement Leakage? A Prospective Randomized Control Study

    PubMed Central

    Oh, Jae-Sang; Shim, Jai-Joon; Lee, Kyeong-Seok; Yoon, Seok-Mann; Bae, Hack-Gun

    2016-01-01

    Objective Preinjection gelfoam embolization during percutaneous vertebroplasty (PVP) has been thought alternative technique to prevent the leakage of bone cement. The goal of this study was to evaluate whether the gelfoam techniques are useful to reduce bone cement leakage. Methods Total 100 PVPs of osteoporotic spine compression fractures were performed by 1 spine surgeon who experienced more than 500 PVP cases under prospective control study. Operation was done in T-L junction (T10-L2) fractures with bi-transpedicular approach. Preinjection gelfoam PVP was done in the 50 levels. As control group, PVP without gelfoam was done in the 50 levels. We did not perform preoperative venography. We inserted normal saline-mixed gelfoam to the anterior third of vertebral body via PVP needle, and then 3mL of polymethylmetacrylate (PMMA) was injected. We prospectively evaluated the incidence and leakage pattern of PMMA by postoperative computed tomography. Results Between gelfoam and control groups, there were 11 leaks (22%) versus 12 leaks (26%). The mean operation time was 7.00 minutes versus 6.30 minutes. In gelfoam group, there were 6 spinal canal leaks, 4 paravertebral venous leaks, and 1 soft tissue leaks. In control group, there were 4 spinal canal leaks, 8 paravertebral venous leaks, and 1 disc space leak. In spite of cement leakage, there was no symptomatic case in both groups. Statistically, gelfoam technique was not related to decrease the incidence of leakage (p=0.64). Conclusion Our prospective study showed that it did not significantly decrease cement leakage when vertebroplasty is performed by experienced spine surgeon. PMID:27437015

  10. Twelve-Month Efficacy and Safety Data for the "Stress Incontinence Control, Efficacy and Safety Study": A Phase III, Multicenter, Prospective, Randomized, Controlled Study Treating Female Stress Urinary Incontinence Using the Vesair Intravesical Balloon.

    PubMed

    Winkler, Harvey; Jacoby, Karny; Kalota, Susan; Snyder, Jeffrey; Cline, Kevin; Robertson, Kaiser; Kahan, Randall; Green, Lonny; McCammon, Kurt; Rovner, Eric; Rardin, Charles

    2017-09-26

    The "Stress Incontinence Control, Efficacy and Safety Study" (SUCCESS) is a phase III study of the Vesair Balloon in women with stress urinary incontinence who had failed conservative therapy, and either failed surgery, were not candidates for surgery, or chose not to have surgery. The safety and efficacy of the balloon at 12 months is reported for those participants in the treatment arm who elected to continue with the SUCCESS trial beyond the primary end point at 3 months. The SUCCESS trial is a multicenter, prospective, single-blinded, randomized, sham-controlled study. Participants were randomized on a 2.33:1 basis to either Vesair Balloon placement or placebo. The primary efficacy end point was a composite of both a greater than 50% reduction from baseline on 1-hour provocative pad weight test and an at least 10-point improvement in symptoms on the Incontinence Quality of Life questionnaire assessed at the 3-month study visit. Patients in the treatment arm who opted to continue in the trial were followed up prospectively up to 12 months. A total of 221 participants were randomized, including 157 in the treatment arm and 64 in the control arm. Sixty-seven participants in the treatment arm (42.7% of participants enrolled) were evaluated at 12 months, with 56.3% achieving the composite end point and 78.7% having greater than 50% reduction in pad weight from baseline in a per-protocol analysis. In an intent-to-treat analysis treating all participants who did not continue with the balloon as failures, 24% of the participants achieved the composite end point and 33.6% had a greater than 50% reduction in pad weight from baseline. Treatment-related adverse events in this group included dysuria (40.1%), gross hematuria (36.9%), and urinary tract infection (26.1%). In this phase III trial, symptom relief was maintained for those participants who continued therapy for 12 months. The balloon was found to be safe with no device- or procedure-related serious adverse events

  11. 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.

  12. Six-month efficacy of platelet-rich plasma for carpal tunnel syndrome: A prospective randomized, single-blind controlled trial.

    PubMed

    Wu, Yung-Tsan; Ho, Tsung-Yen; Chou, Yu-Ching; Ke, Ming-Jen; Li, Tsung-Ying; Huang, Guo-Shu; Chen, Liang-Cheng

    2017-12-01

    Recently, a few small reports with short follow-up period have shown clinical benefits of platelet-rich plasma (PRP) for peripheral neuropathy including one pilot study and one small, non-randomized trial in patients with carpal tunnel syndrome (CTS). Therefore, we conducted a randomized, single-blind, controlled trial to assess the 6-month effect of PRP in patients with CTS. Sixty patients with unilateral mild-to-moderate CTS were randomized into two groups of 30, namely the PRP and control groups. In the PRP group, patients were injected with one dose of 3 mL of PRP using ultrasound guidance and the control group received a night splint through the study period. The primary outcome measure was the visual analog scale (VAS) and secondary outcome measures included the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) score, the cross-sectional area (CSA) of the median nerve (MN), electrophysiological findings of the MN, and finger pinch strength. The evaluation was performed before treatment and at 1, 3, and 6 months post-injection. The PRP group exhibited a significant reduction in the VAS score, BCTQ score, and CSA of MN compared to the those of control group 6 months post-treatment (p < 0.05). Our study demonstrates that PRP is a safe modality that effectively relieves pain and improves disability in the patients with CTS.

  13. Predictors for contrast media-induced nephropathy and long-term survival: Prospectively assessed data from the randomized controlled Dialysis-Versus-Diuresis (DVD) trial

    PubMed Central

    Hölscher, Birgit; Heitmeyer, Christine; Fobker, Manfred; Breithardt, Günter; Schaefer, Roland M; Reinecke, Holger

    2008-01-01

    BACKGROUND: Among the numerous studies concerning contrast media-induced nephropathy (CIN), there was no prospective trial that provided data on the long-term outcomes. OBJECTIVES: To prospectively assess predictors of CIN and long-term outcomes of affected patients. METHODS: Four hundred twelve consecutive patients with serum creatinine levels of 115 μmol/L to 309 μmol/L (1.3 mg/dL to 3.5 mg/dL) undergoing elective coronary angiography were included. Patients were randomly assigned to periprocedural hydration alone, hydration plus onetime hemodialysis or hydration plus N-acetylcysteine. RESULTS: Multivariate logistic regression identified the following as predictors of CIN within 72 h (equivalent to an increase in creatinine 44.2 μmol/L [0.5 mg/dL] or more) : prophylactic postprocedural hemodialysis (OR 2.86, 95% CI 1.07 to 7.69), use of angiotensin-converting enzyme inhibitors (OR 6.16, 95% CI 2.01 to 18.93), baseline glomerular filtration rate (OR 0.94, 95% CI 0.90 to 0.98) and the amount of contrast media given (OR 1.01, 95% CI 1.00 to 1.01). With regard to long-term outcome (mean follow-up 649 days), multivariate Cox regression models found elevated creatinine levels at 30 days (hazard rate ratio [HRR] 5.48, 95% CI 2.85 to 10.53), but not CIN within 72 h (HRR 1.12, 95% CI 0.63 to 2.02), to be associated with increased mortality. In addition, independent predictors for death during follow-up included left ventricular ejection fraction lower than 35% (HRR 4.01, 95% CI 2.22 to 7.26), serum phosphate (HRR 1.64, 95% CI 1.10 to 2.43) and hemoglobin (HRR 0.80, 95% CI 0.67 to 0.96). CONCLUSION: From the present prospective trial, performance of post-procedural hemodialysis, use of angiotensin-converting enzyme inhibitors, reduced baseline glomerular filtration rate and amount of contrast media were independent predictors of CIN within 72 h after catheterization. Assessing renal function after 30 days, rather than within 72 h, seemed to be more predictive for

  14. Sex Differences in the Morphine-Sparing Effects of Intraoperative Dexmedetomidine in Patient-Controlled Analgesia Following General Anesthesia: A Consort-Prospective, Randomized, Controlled Clinical Trial.

    PubMed

    Li, Yuan-Yuan; Ge, Dong-Jian; Li, Jin-Yu; Qi, Bin

    2016-05-01

    Previous studies have reported that intraoperative dexmedetomidine has morphine-sparing effects in patient-controlled analgesia (PCA). The present study was designed to investigate the possible sex differences in the morphine-sparing effects of intraoperative dexmedetomidine following general anesthesia. A total of 223 patients scheduled for surgeries under general anesthesia were divided into female and male groups. Each group was then subdivided into 2 subgroups that were maintained using propofol/remifentanil/dexmedetomidine (PRD) or propofol/remifentanil/saline (PRS). During the first 24 hours postsurgery, both female and male PRD patients had lower scores on a visual analog scale (VAS) (fPRS vs fPRD, P < 0.05 or P < 0.01; mPRS mPRD, P < 0.05, P < 0.01, or P < 0.001) and consumed less morphine than their controls from the PRS group (fPRS vs fPRD, P = 0.0392; mPRS vs mPRD, P = 0.0041). Interestingly, the female PRD patients had similar VAS scores (fPRD vs mPRD, P > 0.05) and consumed comparable morphine compared to the male PRD patients (fPRD vs mPRD, P = 0.4238). However, when normalized to body weight, they consumed much more morphine than male PRD patients (fPRD vs mPRD, P < 0.001), and this effect was not seen in the PRS patients. Intraoperative administration of dexmedetomidine appeared to have a stronger morphine-sparing effect in controlling postoperative acute pain in male patients than in female patients.

  15. Optimizing prostate cancer screening; prospective randomized controlled study of the role of PSA and PCA3 testing in a sequential manner in an opportunistic screening program.

    PubMed

    Rubio-Briones, J; Casanova, J; Dumont, R; Rubio, L; Fernandez-Serra, A; Casanova-Salas, I; Domínguez-Escrig, J; Ramírez-Backhaus, M; Collado, A; Gómez-Ferrer, A; Iborra, I; Monrós, J L; Ricós, J V; Solsona, E; Salas, D; Martínez, F; Lopez-Guerrero, J A

    2014-05-01

    To reduce unnecessary biopsies (Bx) in an opportunistic screening programme of prostate cancer. We perform a prospective evaluation of PCA3 as a second line biomarker in an opportunistic screening for prostate cancer (PCa). From September-2010 until September-2012, 2,366 men, aged 40-74 years and with >10 years life expectancy, were initially screened with PSA/digital rectal examination (DRE). Men with previous Bx or with recent urine infections were excluded. Men with abnormal DRE and/or PSA >3 ng/ml were submitted for PCA3. All men with PCA3 ≥ 35 underwent an initial biopsy (IBx) -12cores-. Men with PCA3 < 35 were randomized 1:1 to either IBx or observation. Re-biopsy(16-18 cores) criteria were PSA increase >.5 ng/ml at 4-6 months or PSAv > .75 ng/ml/year. With median follow-up (FU) of 10.1 months, PCA3 was performed in 321/2366 men (13.57%), 289 at first visit and 32 during FU. All 110 PCA3+ men (34.3%) were biopsied and PCa was identified in 43 men in IBx (39.1%). In the randomized arm, 110 were observed and 101 underwent biopsy, finding 12 PCa (11.9%), showing a statistically significant reduction of PCa detection rate in this cohort (P<.001). Global PCa detection rates were 40.9% and 9.5% for the PCA3+ and PCA3- branches, respectively (P<.001). Area under the curve for PSA and PCA3 were .601 and .74, respectively. This is an ongoing prospective study limited by its short follow-up period and still limited enrolment. PCA3 as a second line biomarker within an opportunistic dual screening protocol, can potentially avoid 65.7% and 50.1% biopsies at first round and at median FU of 10.1 months, respectively, just missing around 3.2% of high grade PCa. Copyright © 2013 AEU. Published by Elsevier Espana. All rights reserved.

  16. Pallidal deep brain stimulation improves quality of life in segmental and generalized dystonia: results from a prospective, randomized sham-controlled trial.

    PubMed

    Mueller, Joerg; Skogseid, Inger M; Benecke, Reiner; Kupsch, Andreas; Trottenberg, Thomas; Poewe, Werner; Schneider, Gerd H; Eisner, Wilhelm; Wolters, Alexander; Müller, J U; Deuschl, Günther; Pinsker, Marcus O; Roeste, Geir K; Vollmer-Haase, Juliane; Brentrup, Angela; Krause, Martin; Tronnier, Volker; Schnitzler, Alfons; Voges, Jüergen; Nikkhah, Guido; Vesper, Jan; Naumann, Markus; Volkmann, Jens

    2008-01-01

    As part of the first randomized, sham-stimulation controlled trial on deep brain stimulation (DBS) in primary segmental or generalized dystonia, health-related quality of life (HRQoL) was assessed by SF-36. After the 3-month sham-controlled phase, significant HRQoL improvement occurred only in the active-stimulation group. The open-label extension phase resulted in a significant improvement in all SF-36 domains following 6 months of neurostimulation. These results demonstrate a favorable impact of DBS on HRQoL in primary dystonia. 2007 Movement Disorder Society

  17. 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.

  18. Prospective, randomized, controlled comparison of SYSTANE UD eye drops versus VISINE INTENSIV 1% EDO eye drops for the treatment of moderate dry eye.

    PubMed

    Jacobi, Christina; Kruse, Friedrich E; Cursiefen, Claus

    2012-12-01

    The aim of this prospective, randomized, clinical, single-center study was to compare the safety and efficacy of 2 ocular surface lubricant eye drops: preservative-free hydroxypropyl (HP)-Guar (SYSTANE UD(®)) eye drops versus preservative-free Tamarindus indica seed polysaccharide (TSP) 1% (VISINE INTENSIV 1% EDO(®)) eye drops. Fifty-six eyes of 28 patients with moderate keratoconjunctivitis sicca (DEWS severity level 2) were enrolled in the trial. Patients were randomized for 2 treatment groups (SYSTANE UD eye drops vs. VISINE INTENSIV 1% EDO eye drops). The eye drops in both groups were applied 5 times per day for 3 months. Statistical analyses were performed using Statistica™ software (Mann-Whitney U-test and Wilcoxon test). P-Values<0.05 were considered significant. After 3 months of treatment the patients of both groups had subjective benefit in the relief of symptoms of dry eye disease evaluated by the Ocular Surface Disease Index (OSDI) questionnaire score. Patients treated with HP-Guar and TSP showed improvements in tear film stability measured by tear break-up time (TBUT), which are statistically significant in the HP-Guar group (P=0.02). The results of this clinical trial show improvements of symptoms and signs in patients with moderate dry eye after the consistent use of preservative-free HP-Guar and TSP lubricant eye drops. Both artificial tear formulations produce amelioration in tear film stability improving eye conditions and patient quality of life. HP-Guar seems to be slightly more effective in improving ocular surface protection by decreasing tear film evaporation.

  19. Increasing prostate biopsy cores based on volume vs the sextant biopsy: a prospective randomized controlled clinical study on cancer detection rates and morbidity.

    PubMed

    Mariappan, Paramananthan; Chong, Wooi Loong; Sundram, Murali; Mohamed, Sahabudin R

    2004-08-01

    To determine if a volume-adjusted increase in the number of biopsy cores could detect more prostate cancers than the standard sextant biopsy alone, without increasing morbidity, and to determine its applicability in Malaysian patients, as a standard sextant biopsy misses 20-25% of prostate malignancies. In a prospective randomized study of patients undergoing transrectal ultrasonography (TRUS)-guided biopsy for a prostate-specific antigen (PSA) level of 4-20 ng/mL without abnormal digital rectal examination (DRE), the men were divided into five main groups (A-E) with prostate volumes of <20, 20-40, 40-60, 60-80 and >80 mL, respectively. Patients in groups B-E were randomized into sextant (B1 to E1) and increased biopsy-core subgroups, i.e. B2 (eight cores), C2 (10 cores), D2 (12 cores) and E2 (14 cores). The morbidity profile was also evaluated during and after TRUS biopsy, assessing a pain score, rectal bleeding, haematuria, haemospermia and development of fever. In all, 132 patients were recruited (mean age 67.8 years; mean PSA 9.41 ng/mL). The overall cancer detection rate was 24% (32 men). Taking more cores detected 65.5% of cancers, and the sextant biopsy 34.5% (P = 0.0025), but did not increase the overall morbidity. The volume-adjusted, increased-core regimen significantly increased the positive biopsy rate of TRUS-guided prostate biopsies with no added morbidity.

  20. Co-analgesic therapy for arthroscopic supraspinatus tendon repair pain using a dietary supplement containing Boswellia serrata and Curcuma longa: a prospective randomized placebo-controlled study.

    PubMed

    Merolla, G; Dellabiancia, F; Ingardia, A; Paladini, P; Porcellini, G

    2015-09-01

    The cuff tendon that is most prone to full-thickness rotator cuff tears is the supraspinatus (SSP). Arthroscopic SSP repair ensures good to satisfactory mid- to long-term clinical outcomes. However, the intense postoperative pain reduces rehabilitation compliance and is cause of patient dissatisfaction. Many natural compounds act by inhibiting inflammatory pathways in a similar way to anti-inflammatory drugs This was a prospective randomized trial designed to assess the analgesic effect of a dietary supplement (DS) containing Boswellia serrata and Curcuma longa in a population of subjects with full-thickness SSP tendon tear treated by arthroscopy. Three weeks before surgery, patients were randomized to receive Tendisulfur(®) (group T) or a placebo (group P) for 2 months. The primary outcome measure was subjective VAS pain. Secondary outcomes measures were Constant-Murley score simple shoulder test, and patient global assessment (PGA) scores. Patients were assessed immediately at baseline and subsequently at 1, 2, 4, 6, 8, 12, and 24 weeks. Stratification of pain scores and subscores demonstrated significantly lower overall pain scores in group T versus group P at 1 week (p = 0.0477), and lower but not significantly different scores on week 2 (p = 0.0988); at subsequent time points, differences were not significant (p > 0.05). PGA scores were good in all subjects. In conclusion, this study provides objective data on the effect of a DS containing natural substances, added to standard analgesics, on postoperative RC pain. DS alleviated short and partially mid-term pain, while long-term pain was unchanged. This limitation can probably be addressed by a dosage increase over the first 4 weeks and by extending treatment by 1 or 2 months.

  1. The Effects of Ramelteon on Glucose Metabolism and Sleep Quality in Type 2 Diabetic Patients With Insomnia: A Pilot Prospective Randomized Controlled Trial

    PubMed Central

    Tsunoda, Tetsuji; Yamada, Masayo; Akiyama, Tomoaki; Minami, Taichi; Yoshii, Taishi; Kondo, Yoshinobu; Satoh, Shinobu; Terauchi, Yasuo

    2016-01-01

    Background Insomnia is associated with the onset and development of diabetes. Melatonin affects sleep quality and glucose metabolism in diabetic patients with insomnia. We administered ramelteon, an agonist of melatonin, to type 2 diabetic patients and investigated its effects on glucose metabolism and insomnia. Methods This multicenter, prospective, randomized, and observational pilot study was performed between April 2014 and April 2015 at three institutes in Japan. Patients were prescribed ramelteon 8 mg/day for 3 months (first period). And patients were divided at random into the continuation group that continued taking ramelteon and the discontinuation group that discontinued taking ramelteon for 3 additional months (second period). The primary endpoint was change in glycated hemoglobin (HbA1c) level. Secondary endpoints were changes in global Pittsburgh sleep questionnaire index (PSQI) score and other glucose metabolism makers. Results We enrolled 42 patients, and 32 patients completed the first period. Their mean HbA1c was 6.7%, and global PSQI score was 8.1 on average. HbA1c level did not change but global PSQI score improved from 8.1 to 7.2 by ramelteon (P = 0.030). Thirty-one patients completed the second period. HbA1c level did not change in the continuation group, but it increased from 6.7% to 6.9% (P = 0.003) in the discontinuation group. Global PSQI score did not change in each group. There was no rebound insomnia. Conclusion Treatment with ramelteon did not change the HbA1c level but improved sleep quality in type 2 diabetic patients with insomnia. Discontinuation of ramelteon slightly increased the HbA1c level and did not worsen sleep quality. PMID:27829954

  2. Efficacy and safety of oral betaine glucuronate in non-alcoholic steatohepatitis. A double-blind, randomized, parallel-group, placebo-controlled prospective clinical study.

    PubMed

    Miglio, F; Rovati, L C; Santoro, A; Setnikar, I

    2000-08-01

    In a prospective, randomized, double-blind therapeutic trial, 191 patients with non-alcoholic steatohepatitis were treated for 8 weeks daily b.i.d. orally either with betaine glucuronate combined with diethanolamine glucuronate and nicotinamide ascorbate (Ietepar) (96 patients) or with undistinguishable placebo capsules (95 patients). The verum treatment effectively reduced by 25% hepatic steatosis (p < 0.01) and by 6% hepatomegaly (p < 0.05), while placebo did not significantly reduce the disorders. Verum was also more effective than placebo on discomfort in abdominal upper right quadrant. The global efficacy of treatment was rated by the doctor "very good" or "good" in 48% of verum treated patients and only in 17% after placcbo (P of difference = 9 x 10(-6)). 52% of patients self-rated efficacy as "very good" or "good" after verum and only 34% after placebo (P of difference = 0.017). The verum treatment provoked a significant reduction of the increased liver transaminases (ALT, AST and gamma-GT) while placebo was ineffective. Adverse events were recorded in 10% of verum-treated patients and in 7% under placebo (no significant difference). In both groups the adverse events were mild and transient, did not require treatment discontinuation and were undistinguishable from common symptoms of liver disorders. In conclusion, the 8-week treatment with betaine glucuronate combined with diethanolamine glucuronate and nicotinamide ascorbate was found effective in non-alcoholic steatohepatitis, a disorder for which the hitherto pharmacological interventions were poorly and inconsistently effective.

  3. 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.

  4. 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 t