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Sample records for surgery trials sst

  1. The Best Bypass Surgery Trial

    DEFF Research Database (Denmark)

    Møller, Christian H; Jensen, Birte Østergaard; Gluud, Christian

    2007-01-01

    Recent trials suggest that off-pump coronary artery bypass grafting (OPCAB) reduces the risk of mortality and morbidity compared with conventional coronary artery bypass grafting (CCAB) using cardiopulmonary bypass. Patients with a moderate- to high-risk of complications after CCAB may have addit...

  2. Clinical trial networks in orthopaedic surgery.

    Science.gov (United States)

    Rangan, A; Jefferson, L; Baker, P; Cook, L

    2014-05-01

    The aim of this study was to review the role of clinical trial networks in orthopaedic surgery. A total of two electronic databases (MEDLINE and EMBASE) were searched from inception to September 2013 with no language restrictions. Articles related to randomised controlled trials (RCTs), research networks and orthopaedic research, were identified and reviewed. The usefulness of trainee-led research collaborations is reported and our knowledge of current clinical trial infrastructure further supplements the review. Searching yielded 818 titles and abstracts, of which 12 were suitable for this review. Results are summarised and presented narratively under the following headings: 1) identifying clinically relevant research questions; 2) education and training; 3) conduct of multicentre RCTs and 4) dissemination and adoption of trial results. This review confirms growing international awareness of the important role research networks play in supporting trials in orthopaedic surgery. Multidisciplinary collaboration and adequate investment in trial infrastructure are crucial for successful delivery of RCTs. Cite this article: Bone Joint Res 2014;3:169-74. ©2014 The British Editorial Society of Bone & Joint Surgery.

  3. Challenges of randomized controlled trial design in plastic surgery.

    Science.gov (United States)

    Hassanein, Aladdin H; Herrera, Fernando A; Hassanein, Omar

    2011-01-01

    Randomized controlled trials are the gold standard of evidence-based medicine. In the field of plastic surgery, designing these studies is much more challenging than in pharmaceutical medicine. Randomized trials in plastic surgery encompass several road blocks including problems shared with other surgical trials: equipoise, high cost, placebo issues and learning curves following the establishment of a novel approach. In addition, plastic surgery has more subjective outcomes, thus making study design even more difficult in assessing the end result.

  4. A Multicenter Trial of Remote Ischemic Preconditioning for Heart Surgery.

    OpenAIRE

    Meybohm, Patrick; Bein, Berthold; Brosteanu, Oana; Cremer, Jochen; Gruenewald, Matthias; Stoppe, Christian; Coburn, Mark; Schaelte, Gereon; Böning, Andreas; Niemann, Bernd; Roesner, Jan; Kletzin, Frank; Strouhal, Ulrich; Reyher, Christian; Laufenberg-Feldmann, Rita

    2015-01-01

    BACKGROUND: Remote ischemic preconditioning (RIPC) is reported to reduce biomarkers of ischemic and reperfusion injury in patients undergoing cardiac surgery, but uncertainty about clinical outcomes remains. METHODS: We conducted a prospective, double-blind, multicenter, randomized, controlled trial involving adults who were scheduled for elective cardiac surgery requiring cardiopulmonary bypass under total anesthesia with intravenous propofol. The trial compared upper-limb RIPC with a s...

  5. Steroids In caRdiac Surgery (SIRS) trial: acute kidney injury substudy protocol of an international randomised controlled trial

    National Research Council Canada - National Science Library

    Garg, Amit X; Vincent, Jessica; Cuerden, Meaghan; Parikh, Chirag; Devereaux, P J; Teoh, Kevin; Yusuf, Salim; Hildebrand, Ainslie; Lamy, Andre; Zuo, Yunxia; Sessler, Daniel I; Shah, Pallav; Abbasi, Seyed Hesameddin; Quantz, Mackenzie; Yared, Jean-Pierre; Noiseux, Nicolas; Tagarakis, Georgios; Rochon, Antoine; Pogue, Janice; Walsh, Michael; Chan, Matthew T V; Lamontagne, Francois; Salehiomran, Abbas; Whitlock, Richard

    2014-01-01

    Steroids In caRdiac Surgery trial (SIRS) is a large international randomised controlled trial of methylprednisolone or placebo in patients undergoing cardiac surgery with the use of a cardiopulmonary bypass pump...

  6. Clinical outcomes in randomized trials of off- vs. on-pump coronary artery bypass surgery

    DEFF Research Database (Denmark)

    Møller, Christian H; Penninga, Luit; Wetterslev, Jørn

    2008-01-01

    To assess the clinical outcomes of off- vs. on-pump coronary artery bypass surgery in randomized trials.......To assess the clinical outcomes of off- vs. on-pump coronary artery bypass surgery in randomized trials....

  7. Diode laser surgery versus scalpel surgery in the treatment of fibrous hyperplasia: a randomized clinical trial.

    Science.gov (United States)

    Amaral, M B F; de Ávila, J M S; Abreu, M H G; Mesquita, R A

    2015-11-01

    Fibrous hyperplasia is treated by surgical incision using a scalpel, together with removal of the source of chronic trauma. However, scalpel techniques do not provide the haemostasis that is necessary when dealing with highly vascular tissues. Diode laser surgery can be used in the management of oral tissues due to its high absorption by water and haemoglobin, and has provided good results in both periodontal surgery and oral lesions. The aim of the present study was to compare the effects of diode laser surgery to those of the conventional technique in patients with fibrous hyperplasia. A randomized clinical trial was performed in which surgical and postoperative evaluations were analyzed. On comparison of the laser-treated (study group) patients to those treated with a scalpel (control group), significant differences were observed in the duration of surgery and the use of analgesic medications. Over a 3-week period, clinical healing of the postoperative wound was significantly faster in the control group as compared to the study group. In conclusion, diode laser surgery proved to be more effective and less invasive when compared to scalpel surgery in the management of fibrous hyperplasia. However, wound healing proved to be faster when using scalpel surgery.

  8. Rationale and design of the steroids in cardiac surgery trial.

    Science.gov (United States)

    Whitlock, Richard; Teoh, Kevin; Vincent, Jessica; Devereaux, P J; Lamy, Andre; Paparella, Domenico; Zuo, Yunxia; Sessler, Daniel I; Shah, Pallav; Villar, Juan-Carlos; Karthikeyan, Ganesan; Urrútia, Gerard; Alvezum, Alvaro; Zhang, Xiaohe; Abbasi, Seyed Hesameddin; Zheng, Hong; Quantz, Mackenzie; Yared, Jean-Pierre; Yu, Hai; Noiseux, Nicolas; Yusuf, Salim

    2014-05-01

    Steroids may improve outcomes in high-risk patients undergoing cardiac surgery with the use of cardiopulmonary bypass (CBP). There is a need\\ for a large randomized controlled trial to clarify the effect of steroids in such patients. We plan to randomize 7,500 patients with elevated European System for Cardiac Operative Risk Evaluation who are undergoing cardiac surgery with the use of CBP to methylprednisolone or placebo. The first coprimary outcome is 30-day all-cause mortality, and the most second coprimary outcome is a composite of death, MI, stroke, renal failure, or respiratory failure within 30 days. Other outcomes include a composite of MI or mortality at 30 days, new onset atrial fibrillation, bleeding and transfusion requirements, length of intensive care unit stay and hospital stay, infection, stroke, wound complications, gastrointestinal complications, delirium, postoperative insulin use and peak blood glucose, and all-cause mortality at 6 months. As of October 22, 2013, 7,034 patients have been recruited into SIRS in 82 centers from 18 countries. Patient's mean age is 67.3 years, and 60.4% are male. The average European System for Cardiac Operative Risk Evaluation is 7.0 with 22.1% having an isolated coronary artery bypass graft procedure, and 66.1% having a valve procedure. SIRS will lead to a better understanding of the safety and efficacy of prophylactic steroids for cardiac surgery requiring CBP. Copyright © 2014 Mosby, Inc. All rights reserved.

  9. Rapid Extremity Pain Relief by Battlefield Acupuncture after Orthopedic Surgery: A Randomized Clinical Trial

    Science.gov (United States)

    2017-03-21

    FINAL REPORT Project Title: Rapid Extremity Pain Relief by Battlefield Acupuncture after Orthopedic Surgery: A Randomized Clinical Trial...prevent adverse effects of sedation and decreased job performance. Auricular acupuncture has been evaluated in multiple trials, and although...generally proven to be useful, these trials were not rigorous. This study seeks to determine if modified Battlefield Acupuncture is more effective at

  10. Robotic Surgery in Uro-Oncology: a Systematic Review and Meta-Analysis of Randomised Controlled Trials.

    Science.gov (United States)

    Steffens, Daniel; Thanigasalam, Ruban; Leslie, Scott; Maneck, Bharvi; Young, Jane M; Solomon, Michael

    2017-03-20

    Robotic surgery represents a new horizon in minimally-invasive urological surgery. This systematic review of the literature and meta-analysis examines the effectiveness of robotic surgery compared with laparoscopic or open surgery for major uro-oncological procedures. 25 articles reported findings from 8 trials of prostatectomy (4 trials) and cystectomy (4 trials) including 1033 participants. Robotic surgery is comparable to laparoscopic or open surgery for oncological outcomes, overall complications, and provides somewhat better functional outcome, when compared to laparoscopic and open surgery.

  11. Effect of intermediate care on mortality following emergency abdominal surgery. The InCare trial

    DEFF Research Database (Denmark)

    Vester-Andersen, Morten; Waldau, Tina; Wetterslev, Jørn

    2013-01-01

    . The aim of the present trial is to evaluate the effect of postoperative intermediate care following emergency major abdominal surgery in high-risk patients.Methods and design: The InCare trial is a randomised, parallel-group, non-blinded clinical trial with 1:1 allocation. Patients undergoing emergency...... influence the survival of many high-risk surgical patients. As a pioneer trial in the area, it will provide important data on the feasibility of future large-scale randomised clinical trials evaluating different levels of postoperative care.Trial registration: Clinicaltrials.gov identifier: NCT01209663....

  12. A randomized trial of laparoscopic versus open surgery for rectal cancer

    DEFF Research Database (Denmark)

    Bonjer, H Jaap; Deijen, Charlotte L; Abis, Gabor A;

    2015-01-01

    (locoregional recurrence) and survival after laparoscopic and open resection of rectal cancer. METHODS: In this international trial conducted in 30 hospitals, we randomly assigned patients with a solitary adenocarcinoma of the rectum within 15 cm of the anal verge, not invading adjacent tissues, and without...... of locoregional recurrence and disease-free and overall survival similar to those for open surgery. (Funded by Ethicon Endo-Surgery Europe and others; COLOR II ClinicalTrials.gov number, NCT00297791.)....

  13. Cyanoacrylate Skin Microsealant for Preventing Surgical Site Infection after Vascular Surgery : A Discontinued Randomized Clinical Trial

    NARCIS (Netherlands)

    Vierhout, Bastiaan P.; Ott, Alewijn; Reijnen, Michel M. P. J.; Oskam, Jacques; Ott, Alewijn; van den Dungen, Jan J. A. M.; Zeebregts, Clark J.

    Background: Surgical site infections (SSI) after vascular surgery are related to substantial morbidity. Restriction of bacterial access to the site of surgery with a cyanoacrylate sealant is a new concept. We performed a randomized clinical trial to assess the effect of the sealing of skin with a

  14. The roles of funding source, clinical trial outcome, and quality of reporting in orthopedic surgery literature.

    Science.gov (United States)

    Khan, Safdar N; Mermer, Matthew J; Myers, Elizabeth; Sandhu, Harvinder S

    2008-12-01

    Compared with nonfunded or peer-reviewed funded projects, industry-sponsored clinical trials have traditionally been associated with more positive results. This relationship has been extensively studied in the nonsurgical literature. Although a few authors have addressed specialties, little has been reported on orthopedic clinical trials and their association with funding, study outcome, and efforts to reduce bias after randomization across journals of multiple subspecialties. For the study reported here, we selected 5 major orthopedic subspecialty journals: Journal of Bone and Joint Surgery (American Volume), Spine, Journal of Arthroplasty, Journal of Orthopaedic Trauma, and American Journal of Sports Medicine. We chose a 2-year limit for investigation (2002-2004); included all original randomized clinical trials reported in these 5 journals; and examined these trials for their study design, funding source, outcome, bias potential, and conclusion reached. Support for the 100 eligible orthopedic clinical trials was stated as coming from industry (26 trials, 26%), nonprofit sources (19 trials, 19%), and mixed sources (5 trials, 5%); no support was stated in 46 trials (46%), and support was not reported in 4 trials (4%). Of the 26 trials reporting industry support, 22 (85%) were graded as indicating an outcome favorable to the new treatment. The association between industry funding and favorable outcome was strong and significant (PJournal of Bone and Joint Surgery and Spine, measures taken to reduce bias were not documented.

  15. Chemotherapy followed by surgery versus surgery alone in patients with resectable oesophageal squamous cell carcinoma : Long-term results of a randomized controlled trial

    NARCIS (Netherlands)

    Boonstra, Jurjen J.; Kok, Tjebbe C.; Wijnhoven, Bas P. L.; van Heijl, Mark; Henegouwen, Mark I. van Berge; ten Kate, Fiebo J. W.; Siersema, Peter D.; Dinjens, Winand N. M.; van Lanschot, Jan J. B.; Tilanus, Hugo W.; van der Gaast, Ate

    2011-01-01

    Background: This is a randomized, controlled trial of preoperative chemotherapy in patients undergoing surgery for oesophageal squamous cell carcinoma (OSCC). Patients were allocated to chemotherapy, consisting of 2-4 cycles of cisplatin and etoposide, followed by surgery (CS group) or surgery alone

  16. Protocol for a multicentre randomised feasibility trial evaluating early Surgery Alone In LOw Rectal cancer (SAILOR)

    Science.gov (United States)

    Thorne, Kymberley; Hutchings, Hayley; Islam, Saiful; Holland, Gail; Hatcher, Olivia; Gwynne, Sarah; Jenkins, Ian; Coyne, Peter; Duff, Michael; Feldman, Melanie; Winter, Des C; Gollins, Simon; Quirke, Phil; West, Nick; Brown, Gina; Fitzsimmons, Deborah; Brown, Alan; Beynon, John

    2016-01-01

    Introduction There are 11 500 rectal cancers diagnosed annually in the UK. Although surgery remains the primary treatment, there is evidence that preoperative radiotherapy (RT) improves local recurrence rates. High-quality surgery in rectal cancer is equally important in minimising local recurrence. Advances in MRI-guided prediction of resection margin status and improvements in abdominoperineal excision of the rectum (APER) technique supports a reassessment of the contribution of preoperative RT. A more selective approach to RT may be appropriate given the associated toxicity. Methods and analysis This trial will explore the feasibility of a definitive trial evaluating the omission of RT in resectable low rectal cancer requiring APER. It will test the feasibility of randomising patients to (1) standard care (neoadjuvant long course RT±chemotherapy and APER, or (2) APER surgery alone for cT2/T3ab N0/1 low rectal cancer with clear predicted resection margins on MRI. RT schedule will be 45 Gy over 5 weeks as current standard, with restaging and surgery after 8–12 weeks. Recruitment will be for 24 months with a minimum 12-month follow-up. Objectives Objectives include testing the ability to recruit, consent and retain patients, to quantify the number of patients eligible for a definitive trial and to test feasibility of outcomes measures. These include locoregional recurrence rates, distance to circumferential resection margin, toxicity and surgical complications including perineal wound healing, quality of life and economic analysis. The quality of MRI staging, RT delivery and surgical specimen quality will be closely monitored. Ethics and dissemination The trial is approved by the Regional Ethics Committee and Health Research Authority (HRA) or equivalent. Written informed consent will be obtained. Serious adverse events will be reported to Swansea Trials Unit (STU), the ethics committee and trial sites. Trial results will be submitted for peer review

  17. Scandcleft Randomised Trials of Primary Surgery for Unilateral Cleft Lip and Palate. Planning and Management

    DEFF Research Database (Denmark)

    Semb, Gunvor; Enemark, Hans; Paulin, Gunnar

    2017-01-01

    Background and Aims This paper is an introduction to three concurrent, parallel group, randomised trials of primary surgery for patients born with complete unilateral cleft lip and palate (UCLP) outlining the development and performance of the project by ten North European cleft teams: Aarhus....../Copenhagen (Denmark), Bergen/Oslo (Norway), Gothenburg/Linköping/Stockholm (Sweden), Manchester/Belfast (UK) Method The three trials included patients born with complete unilateral cleft lip and palate (UCLP). One surgical protocol was defined to serve as a common method in each trial against which the established...... Words: Randomised control trials, Multicentre study, Scandcleft, Unilateral Cleft Lip and Palate, Palatal surgery. Running head: Scandcleft, planning and management....

  18. Randomized multicentre feasibility trial of intermediate care versus standard ward care after emergency abdominal surgery (InCare trial)

    DEFF Research Database (Denmark)

    Vester-Andersen, M; Waldau, T; Wetterslev, J;

    2015-01-01

    BACKGROUND: Emergency abdominal surgery carries a considerable risk of death and postoperative complications. Early detection and timely management of complications may reduce mortality. The aim was to evaluate the effect and feasibility of intermediate care compared with standard ward care...... no statistically significant effect on 30-day mortality after emergency abdominal surgery, nor any effect on secondary outcomes. The trial was stopped prematurely owing to slow recruitment and a much lower than expected mortality rate among the enrolled patients. REGISTRATION NUMBER: NCT01209663 (http://www.clinicaltrials.gov)....

  19. Surgery versus prolonged conservative treatment for sciatica: 5-year results of a randomised controlled trial

    OpenAIRE

    Lequin, Michiel B.; Verbaan, Dagmar; Jacobs, Wilco C. H.; Brand, Ronald; Gerrit J. Bouma; Vandertop, William P.; Peul, Wilco C; ,

    2013-01-01

    Objective This study describes the 5 years’ results of the Sciatica trial focused on pain, disability, (un)satisfactory recovery and predictors for unsatisfactory recovery. Design A randomised controlled trial. Setting Nine Dutch hospitals. Participants Five years’ follow-up data from 231 of 283 patients (82%) were collected. Intervention Early surgery or an intended 6 months of conservative treatment. Main outcome measures Scores from Roland disability questionnaire, visual analogue scale (V...

  20. Randomized trials and quality assurance in gastric cancer surgery.

    Science.gov (United States)

    Dikken, Johan L; Cats, Annemieke; Verheij, Marcel; van de Velde, Cornelis J H

    2013-03-01

    A D2 lymphadenectomy can be considered standard of surgical care for advanced resectable gastric cancer. Currently, several multimodality strategies are used, including postoperative monochemotherapy in Asia, postoperative chemoradiotherapy in the United States, and perioperative chemotherapy in Europe. As the majority of gastric cancer patients are treated outside the framework of clinical trials, quality assurance programs, including referral to high-volume centers and clinical auditing are needed to improve gastric cancer care on a nationwide level. Copyright © 2012 Wiley Periodicals, Inc.

  1. RANDOMIZED CONTROLLED TRIALS OF MATERNAL-FETAL SURGERY : A CHALLENGE TO CLINICAL EQUIPOISE

    NARCIS (Netherlands)

    Rodrigues, H. C. M. L.; van den Berg, P. P.

    2014-01-01

    This article focuses on maternal-fetal surgery (MFS) and on the concept of clinical equipoise that is a widely accepted requirement for conducting randomized controlled trials (RCT). There are at least three reasons why equipoise is unsuitable for MFS. First, the concept is based on a misconception

  2. One-day versus 3-day suprapubic catheterization after vaginal prolapse surgery : a prospective randomized trial

    NARCIS (Netherlands)

    Van der Steen, Annemarie; Detollenaere, Renee; Den Boon, Jan; Van Eijndhoven, Hugo

    2011-01-01

    For prolonged catheterization after vaginal prolapse surgery with anterior colporrhaphy, the optimal duration to prevent overdistention of the bladder remains unknown. We designed this study to determine the optimal length of catheterization. We conducted a prospective randomized trial in which 179

  3. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial.

    LENUS (Irish Health Repository)

    McDonnell, John G

    2007-01-01

    The transversus abdominis plane (TAP) block is a novel approach for blocking the abdominal wall neural afferents via the bilateral lumbar triangles of Petit. We evaluated its analgesic efficacy in patients during the first 24 postoperative hours after abdominal surgery, in a randomized, controlled, double-blind clinical trial.

  4. Clinical Trial of Manual Small Incision Surgery and Standard Extracapsular Surgery

    Directory of Open Access Journals (Sweden)

    Parikshit Gogate

    2003-01-01

    Full Text Available Introduction. Manual small incision cataract surgery (MSICS is used increasingly for cataract extraction and intraocular lens implantation. It is thought that the small wound heals faster than a conventional incision, leading to less astigmatism and a better uncorrected visual acuity. This is important as many patients do not wear or cannot afford spectacles after surgery, which means that their uncorrected visual acuity is what they rely on to carry out their every day functions. Often this is less than 6/18 on the Snellen’s chart, which would fall below the WHO ‘good outcome’ category for post-operative visual impairment. A post-operative vision of 6/18 or better without spectacles is a goal which appears to be within the reach of small incision techniques for cataract surgery. However, there are concerns that the method used to remove the nucleus in MSICS may be more traumatic to the corneal endothelium than conventional ECCE surgery.

  5. NOAA Optimum Interpolation (OI) SST V2

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — The optimum interpolation (OI) sea surface temperature (SST) analysis is produced weekly on a one-degree grid. The analysis uses in situ and satellite SST's plus...

  6. Chemotherapy Followed by Surgery versus Surgery Alone in Patients with Resectable Oesophageal Squamous Cell Carcinoma: Long-term Results of a Randomized Controlled Trial

    NARCIS (Netherlands)

    Boonstra, J.J.; Kok, T.C.; Wijnhoven, B.P.L.; van Heijl, M.; van Berge Henegouwen, M.I.; ten Kate, F.J.W.; Siersema, P.D.; Dinjens, W.N.M.; van Lanschot, J.J.B.; Tilanus, H.W.; van der Gaast, A.

    2011-01-01

    ABSTRACT: BACKGROUND: This is a randomized, controlled trial of preoperative chemotherapy in patients undergoing surgery for oesophageal squamous cell carcinoma (OSCC). Patients were allocated to chemotherapy, consisting of 2-4 cycles of cisplatin and etoposide, followed by surgery (CS group) or sur

  7. Chemotherapy followed by surgery versus surgery alone in patients with resectable oesophageal squamous cell carcinoma: Long-term results of a randomized controlled trial

    NARCIS (Netherlands)

    J.J. Boonstra (Jurjen); T.C. Kok (Tjebbe); B.P.L. Wijnhoven (Bas); M. van Heijl (Mark); M.I. van Berge Henegouwen (Mark); F.J.W. ten Kate (Fiebo); W.N.M. Dinjens (Winand); J.J.B. van Lanschot (Jan); H.W. Tilanus (Hugo); A. van der Gaast (Ate); P.D. Siersema (Peter)

    2011-01-01

    textabstractBackground: This is a randomized, controlled trial of preoperative chemotherapy in patients undergoing surgery for oesophageal squamous cell carcinoma (OSCC). Patients were allocated to chemotherapy, consisting of 2-4 cycles of cisplatin and etoposide, followed by surgery (CS group) or s

  8. Steroids In caRdiac Surgery (SIRS) trial: acute kidney injury substudy protocol of an international randomised controlled trial.

    Science.gov (United States)

    Garg, Amit X; Vincent, Jessica; Cuerden, Meaghan; Parikh, Chirag; Devereaux, P J; Teoh, Kevin; Yusuf, Salim; Hildebrand, Ainslie; Lamy, Andre; Zuo, Yunxia; Sessler, Daniel I; Shah, Pallav; Abbasi, Seyed Hesameddin; Quantz, Mackenzie; Yared, Jean-Pierre; Noiseux, Nicolas; Tagarakis, Georgios; Rochon, Antoine; Pogue, Janice; Walsh, Michael; Chan, Matthew T V; Lamontagne, Francois; Salehiomran, Abbas; Whitlock, Richard

    2014-03-05

    Steroids In caRdiac Surgery trial (SIRS) is a large international randomised controlled trial of methylprednisolone or placebo in patients undergoing cardiac surgery with the use of a cardiopulmonary bypass pump. At the time of surgery, compared with placebo, methylprednisolone divided into two intravenous doses of 250 mg each may reduce the risk of postoperative acute kidney injury (AKI). With respect to the study schedule, over 7000 substudy eligible patients from 81 centres in 18 countries were randomised in December 2013. The authors will use a logistic regression to estimate the adjusted OR of methylprednisolone versus placebo on the primary outcome of AKI in the 14 days following surgery (a postoperative increase in serum creatinine of ≥50%, or ≥26.5 μmol/L, from the preoperative value). The stage of AKI will also be considered, as will the outcome of AKI in those with and without preoperative chronic kidney disease. After receipt of grant funding, the authors began to record additional perioperative serum creatinine measurements in consecutive patients enrolled at substudy participating centres, and patients were invited to enroll in a 6-month serum creatinine collection. In these trial subpopulations, the authors will consider the outcome of AKI defined in alternate ways, and the outcome of a 6-month change in kidney function from the preoperative value. The authors were competitively awarded a grant from the Canadian Institutes of Health Research for this SIRS AKI substudy. Ethics approval was obtained for additional serum creatinine recordings in consecutive patients enrolled at participating centres. The additional kidney data collection first began for patients enrolled after 1 March 2012. In patients who provided consent, the last 6-month kidney outcome data will be collected in 2014. The results will be reported no later than 2015. Number NCT00427388.

  9. Septic patients of abdominal surgery | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available estudio de pacientes de cirugia abdominal con sepsis que pueden desarrollar un f...ic patients of abdominal surgery Tratamiento habitual para pacientes sépticos de cirugia abdominal G. Invest

  10. CTS Trials Network: Surgical ablation of atrial fibrillation during mitral valve surgery - many questions unanswered.

    Science.gov (United States)

    Afifi, Ahmed

    2015-01-01

    A disease that is associated with stroke and mortality, atrial fibrillation (AF) complicates 30 to 50% of mitral valve disease patients admitted for surgery.(1) Since the introduction of the Cox maze III procedure in 1992 many efforts have been made to come up with modified lesion sets and/or energy sources to surgically treat AF. This lead to the recently published American Heart Association (AHA)- American College of Cardiology (ACC)-Heart Rhythm Society (HRS) guidelines(2) stating that it is reasonable to perform atrial fibrillation ablation in selected patients undergoing other types of cardiac surgery. The effectiveness of different techniques in conversion to sinus rhythm and the clinical impact of freedom from AF remain a question. The CTS Trials Network have undertaken a trial to answer these questions. The first year results of their randomized trial comparing AF ablation at the time of mitral valve surgery with mitral valve surgery alone were published recently in The New England Journal of Medicine.(3).

  11. Nutrition before and during Surgery and the Inflammatory Response of the Heart: A Randomized Controlled Trial.

    Science.gov (United States)

    Visser, Marlieke; Niessen, Hans W M; Kok, Wouter E M; Cocchieri, Riccardo; Wisselink, Willem; van Leeuwen, Paul A M; de Mol, Bas A J M

    2015-01-01

    Major surgery induces a long fasting time and provokes an inflammatory response which increases the risk of infections. Nutrition given before and during surgery can avoid fasting and has been shown to increase the arginine/asymmetric dimetlhylarginine ratio, a marker of nitric oxide availability, in cardiac tissue and increased concentrations of branched chain amino acids in blood plasma. However, the effect of this new nutritional strategy on organ inflammatory response is unknown. Therefore, we studied the effect of nutrition before and during cardiac surgery on myocardial inflammatory response. In this trial, 32 patients were randomised between enteral, parenteral, and no nutrition supplementation (control) from 2 days before, during, up to 2 days after coronary artery bypass grafting. Both solutions included proteins or amino acids, glucose, vitamins, and minerals. Myocardial atrial tissue was sampled before and after revascularization and was analysed immunohistochemically, subdivided into cardiomyocytic, fatty, and fibrotic areas. Inflammatory cells, especially leukocytes, were present in cardiac tissue in all study groups. No significant differences were found in the myocardial inflammatory response between the enteral, parenteral, and control groups. In conclusion, nutrition given before and during surgery neither stimulates nor diminishes the myocardial inflammatory response in patients undergoing coronary artery bypass grafting. The trial was registered in Netherlands Trial Register (NTR): NTR2183.

  12. Thoracic paravertebral blocks in abdominal surgery - a systematic review of randomized controlled trials.

    Science.gov (United States)

    El-Boghdadly, K; Madjdpour, C; Chin, K J

    2016-09-01

    Thoracic paravertebral blocks (TPVBs) have an extensive evidence base as part of a multimodal analgesic strategy for thoracic and breast surgery and have gained popularity with the advent of ultrasound guidance. However, this role is poorly defined in the context of abdominal surgery. We performed a systematic review of randomized controlled trials, to clarify the impact of TPVB on perioperative analgesic outcomes in adult abdominal surgery. We identified 20 published trials involving a total of 1044 patients that met inclusion criteria; however there was significant heterogeneity in terms of type of surgery, TPVB technique, comparator groups and study quality. Pain scores and opioid requirements in the early postoperative period were generally improved when compared with systemic analgesia, but there was insufficient evidence for any definitive conclusions regarding comparison with epidural analgesia or other peripheral block techniques, or the benefit of continuous TPVB techniques. The reported primary block failure rate was 2.8% and the incidence of complications was 1.2% (6/504); there were no instances of pneumothorax. TPVB therefore appears to be a promising analgesic technique for abdominal surgery in terms of efficacy and safety. But further well-designed and adequately powered studies are needed to confirm its utility, particularly with respect to other regional anaesthesia techniques.

  13. [Metaanalysis to estimate the expected drop out-rates reported in clinical trials on cataract surgery].

    Science.gov (United States)

    Knippschild, S; Hirsch, J; Krummenauer, F

    2014-02-01

    A realistic sample size calculation is crucial to achieve significant results in clinical trials. As an expected drop out-rate has to be included in the sample size calculation, current practice consists in the presumption of drop out-rates published in previous similar investigations. This approach may, however, result in severely over- or under-estimated sample sizes. Therefore this meta-analysis sought to aggregate the drop out-rates from published clinical trial reports on cataract surgery to derive a quantitative suggestion for the planning of future clinical trials. The data collection was a complete review of all prospective and retrospective studies in five journals of the years 2002-2012; trial-wise recall rates of subjects at follow-up 3, 6, 12, and 24 months after recruitment were documented. The primary endpoint of the meta-analysis was the reported drop out-rates after 6 months. 95 % confidence intervals were calculated for each trial, respectively; a median drop out-rate was estimated including its 95 % confidence interval. The drop-out-rate estimates were furthermore stratified by design characteristics of the reported studies. For randomised clinical trials on cataract surgery, the median drop out-rate increased during the follow-up period of 24 months from 4 % at three months to 17 % at 24 months after recruitment; for the six-month drop out-rate a median drop-out rate of 3 % (95 % CI 0 %; 14 %) was estimated. Drop out-rates in sample size calculations for clinical trials on cataract surgery were found to be over-estimated in general, ending up in the calculation of overly large patient numbers and thereby in both ethical and economic consequences. For randomised clinical trials on cataract surgery the median drop out-rate can be expected to be 5 % during a six-month follow-up and may rise up to 15 % during a 12-month trial period. Georg Thieme Verlag KG Stuttgart · New York.

  14. "Novel Approach for Maximizing Follow-up in Cosmetic Surgery Clinical Trials: The Ideal Implant Core Trial Experience".

    Science.gov (United States)

    Mueller, Melissa A; Nichter, Larry S; Hamas, Robert S

    2017-06-12

    High follow-up rates are critical for robust research with minimal bias and particularly important for breast implant Core Studies seeking FDA approval. The Core Study for IDEAL IMPLANT, the most recently FDA-approved breast implant, utilized a novel incentive payment model to achieve higher follow-up rates than in previous breast implant trials. At enrollment, $3,500 was deposited into an independent, irrevocable trust for each of the 502 subjects and invested in a diversified portfolio. If a follow-up visit is missed, the subject is exited from the study and compensated for completed visits, but the remainder of her share of the funds stay in the trust. At the conclusion of the 10-year study, the trust will be divided among those subjects who completed all required follow-up visits. For primary and revision augmentation cohorts, FDA published follow-up rates from Core Studies were compared for all currently available breast implants. Five-year follow-up rates for the IDEAL IMPLANT Core Study are higher for both primary augmentation and revision augmentation cohorts (94.9% and 96.7%, respectively) when compared to all other trials that have used FDA standardized follow-up reporting (MemoryShape,® Allergan 410,® and Sientra® Core Studies). This trial demonstrates the utility of a novel incentive strategy to maximize follow-up in cosmetic surgery patients. This strategy may benefit future cosmetic surgery trials and perhaps any prospective research trial by providing more complete data.

  15. A MultiCenter Pilot Randomized Controlled Trial of Remote Ischemic Preconditioning in Major Vascular Surgery.

    Science.gov (United States)

    Healy, D A; Boyle, E; McCartan, D; Bourke, M; Medani, M; Ferguson, J; Yagoub, H; Bashar, K; O'Donnell, M; Newell, J; Canning, C; McMonagle, M; Dowdall, J; Cross, S; O'Daly, S; Manning, B; Fulton, G; Kavanagh, E G; Burke, P; Grace, P A; Moloney, M Clarke; Walsh, S R

    2015-11-01

    A pilot randomized controlled trial that evaluated the effect of remote ischemic preconditioning (RIPC) on clinical outcomes following major vascular surgery was performed. Eligible patients were those scheduled to undergo open abdominal aortic aneurysm repair, endovascular aortic aneurysm repair, carotid endarterectomy, and lower limb revascularization procedures. Patients were randomized to RIPC or to control groups. The primary outcome was a composite clinical end point comprising any of cardiovascular death, myocardial infarction, new-onset arrhythmia, cardiac arrest, congestive cardiac failure, cerebrovascular accident, renal failure requiring renal replacement therapy, mesenteric ischemia, and urgent cardiac revascularization. Secondary outcomes were components of the primary outcome and myocardial injury as assessed by serum troponin values. The primary outcome occurred in 19 (19.2%) of 99 controls and 14 (14.1%) of 99 RIPC group patients (P = .446). There were no significant differences in secondary outcomes. Our trial generated data that will guide future trials. Further trials are urgently needed. © The Author(s) 2015.

  16. Spinal versus general anaesthesia in surgery for inguinodynia (SPINASIA trial): study protocol for a randomised controlled trial.

    Science.gov (United States)

    Zwaans, Willem A R; le Mair, Léon H P M; Scheltinga, Marc R M; Roumen, Rudi M H

    2017-01-14

    Chronic inguinodynia (groin pain) is a common complication following open inguinal hernia repair or a Pfannenstiel incision but may also be experienced after other types of (groin) surgery. If conservative treatments are to no avail, tailored remedial surgery, including a neurectomy and/or a (partial) meshectomy, may be considered. Retrospective studies in patients with chronic inguinodynia suggested that spinal anaesthesia is superior compared to general anaesthesia in terms of pain relief following remedial operations. This randomised controlled trial is designed to study the effect of type of anaesthesia (spinal or general) on pain relief following remedial surgery for inguinodynia. A total of 190 adult patients who suffer from unacceptable chronic (more than 3 months) inguinodynia, as subjectively judged by the patients themselves, are included. Only patients scheduled to undergo a neurectomy and/or a meshectomy by an open approach are considered for inclusion and randomised to spinal or general anaesthesia. Patients are excluded if pain is attributable to abdominal causes or if any contraindications for either type of anaesthesia are present. Primary outcome is effect of type of anaesthesia on pain relief. Secondary outcomes include patient satisfaction, quality of life, use of analgesics and (in)direct medical costs. Patient follow-up period is one year. The first patient was included in January 2016. The expected trial deadline is December 2019. Potential effects are deemed related to the entire setting of type of anaesthesia. Since any setting is multifactorial, all of these factors may influence the outcome measures. This is the first large randomised controlled trial comparing the two most frequently used anaesthetic techniques in remedial surgery for groin pain. There is a definite need for evidence-based strategies to optimise results of these types of surgery. Besides pain relief, other important patient-related outcome measures are assessed to

  17. Controlled-Release Oxycodone Versus Naproxen at Home After Ambulatory Surgery: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Björn Stessel, MD

    2014-12-01

    Conclusions: Paracetamol/CR oxycodone and paracetamol/naproxen are equally effective in treatment of acute postoperative pain at home after ambulatory surgery with comparable patient satisfaction level. We suggest paracetamol/CR oxycodone to be a valuable alternative for the current paracetamol/naproxen gold standard, particularly in patients with a contraindication for nonsteroidal anti-inflammatory drugs. ClinicalTrials.gov identifier: NCT02152592.

  18. Conjunctival Goblet Cell Density Following Cataract Surgery With Diclofenac Versus Diclofenac and Rebamipide: A Randomized Trial.

    Science.gov (United States)

    Kato, Kumiko; Miyake, Kensaku; Kondo, Nagako; Asano, Sayaka; Takeda, Junko; Takahashi, Akiko; Takashima, Yuko; Kondo, Mineo

    2017-09-01

    To determine the effects of topical diclofenac or betamethasone with concomitant application of topical rebamipide on the conjunctival goblet cell density in eyes after cataract surgery. Randomized clinical trial. Eighty patients who were scheduled for cataract surgery. Patients were randomized into 4 groups according to the postoperative topical drugs to be given; Group A, diclofenac alone; Group B, diclofenac and rebamipide; Group C, betamethasone alone; and Group D, betamethasone and rebamipide. Impression cytology was performed before and at 1 month after the surgery, and the mean density of goblet cells was determined. The mean (± SD) density of goblet cells before the surgery in Group A was 257.0 ± 188.7 cells/mm(2), and it decreased significantly to 86.5 ± 76.7 cells/mm(2) at 1 month after the surgery (P = .002). In Group B, the goblet cell density was not statistically different between before (238.5 ± 116.6 cells/mm(2)) and at 1 month after the surgery (211.3 ± 184.4 cells/mm(2), P = .55). In Groups C and D, the mean density of goblet cells was decreased at 1 month after the surgery, but the decreases were not significant (P = .11 and P = .52, respectively). After cataract surgery with postoperative topical diclofenac, the conjunctival goblet cell density was significantly reduced, and this reduction was blocked by the concomitant use of topical rebamipide. These results suggest that the concomitant use of topical rebamipide with nonsteroidal anti-inflammatory drugs is beneficial, especially in cases with postoperative dry eyes. Copyright © 2017 The Author(s). Published by Elsevier Inc. All rights reserved.

  19. Oral nutrition or water loading before hip replacement surgery; a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Ljunggren Stefan

    2012-07-01

    Full Text Available Abstract Background Surgery induces insulin resistance that might be alleviated by a nutritional drink given preoperatively. The authors hypothesized that some of the beneficial effects of the drink could be attributed to the volume component (approximately 1 L rather than to the nutrients. Methods Sixty patients scheduled for elective total hip replacement under spinal anesthesia were recruited to a clinical trial, and randomly allocated to preoperative fasting, to oral ingestion of tap water, or to oral ingestion of a carbohydrate drink. An intravenous glucose tolerance test calculated glucose clearance and insulin sensitivity on the day before surgery, in the postoperative ward, and on the day after surgery. Other parameters were stress (cortisol in plasma and urine, muscle catabolism (urinary 3-methylhistidine, and wellbeing. Results Fifty-seven patients completed the study. In the postoperative ward, the glucose clearance and the insulin response had decreased from the previous day by 23% and 36%, respectively. Insulin sensitivity did not decrease until the next morning (−48% and was due to an increased insulin response (+51%. Cortisol excretion was highest on the day of surgery, while 3-methylhistidine increased 1 day later. Follow-up on the third postoperative day showed an average of 1.5 complications per patient. Wellbeing was better 2 weeks after than before the surgery. None of the measured parameters differed significantly between the study groups. Conclusions Preoperative ingestion of tap water or a nutritional drink had no statistically significant effect on glucose clearance, insulin sensitivity, postoperative complications, or wellbeing in patients undergoing elective hip surgery. Trial registration Registration number: NCT 01211184 (http://www.clinicaltrials.gov

  20. Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate

    DEFF Research Database (Denmark)

    Willadsen, Elisabeth; Lohmander, Anette; Persson, Christina

    2017-01-01

    for primary palatal repair. A secondary aim was to estimate burden of care in terms of received additional secondary surgeries and speech therapy. DESIGN: Three parallel group, randomised clinical trials were undertaken as an international multicentre study by 10 cleft teams in five countries: Denmark......, Finland, Norway, Sweden, and the UK. METHODS: Three different surgical protocols for primary palatal repair were tested against a common procedure in the total cohort of 448 children born with non-syndromic UCLP. Speech audio- and video-recordings of 391 children (136 girls and 255 boys) were available...... and transcribed phonetically. The main outcome measure was Percent Consonants Correct (PCC) from blinded assessments. RESULTS: In Trial 1, arm A showed statistically significant higher PCC scores (82%) than arm B (78%) (p = .045). No significant differences were found between prevalences in Trial 2, A: 79%, C: 82...

  1. The Quality Initiative in Rectal Cancer (QIRC trial: study protocol of a cluster randomized controlled trial in surgery

    Directory of Open Access Journals (Sweden)

    Thabane Lehana

    2008-02-01

    Full Text Available Abstract Background Two unfortunate outcomes for patients treated surgically for rectal cancer are placement of a permanent colostomy and local tumor recurrence. Total mesorectal excision is a new technique for rectal cancer surgery that can lead to improved patient outcomes. We describe a cluster randomized controlled trial that is testing if the above patient outcomes can be improved through a knowledge translation strategy called the Quality Initiative in Rectal Cancer (QIRC strategy. The strategy is designed to optimize the use of total mesorectal excision techniques. Methods and Design Hospitals were randomized to the QIRC strategy (experimental group versus normal practice environment (control group. Participating hospitals, and the respective surgeon group operating in them, are from Ontario, Canada and have an annual procedure volume for major rectal cancer resections of 15 or greater. Patients were eligible if they underwent major rectal surgery for a diagnosis of primary rectal cancer. The surgeon-directed QIRC interventions included a workshop, use of opinion leaders, operative demonstrations, a post-operative questionnaire, and, audit and feedback. For an operative demonstration participating surgeons invited a study team surgeon to assist them with a case of rectal cancer surgery. The intent was to demonstrate total mesorectal excision techniques. Control arm surgeons received no intervention. Sample size calculations were two-sided, considered the clustering of data at the hospital level, and were driven by requirements for the outcome local recurrence. To detect an improvement in local recurrence from 20% to 8% with confidence we required 16 hospitals and 672 patients – 8 hospitals and 336 patients in each arm. Outcomes data are collected via chart review for at least 30 months after surgery. Analyses will use an intention-to-treat principle and will consider the clustering of data. Data collection will be complete by the end of

  2. Selective elimination of breast cancer surgery in exceptional responders: historical perspective and current trials.

    Science.gov (United States)

    van la Parra, Raquel F D; Kuerer, Henry M

    2016-03-08

    With improvements in chemotherapy regimens, targeted therapies, and our fundamental understanding of the relationship of tumor subtype and pathologic complete response (pCR), there has been dramatic improvement in pCR rates in the past decade, especially among triple-negative and human epidermal growth factor receptor 2-positive breast cancers. Rates of pCR in these groups of patients can be in the 60 % range and thus question the paradigm for the necessity of breast and nodal surgery in all cases, particularly when the patient will be receiving adjuvant local therapy with radiotherapy. Current practice for patients who respond well to neoadjuvant chemotherapy (NCT) is often to proceed with the same breast and axillary procedures as would have been offered women who had not received NCT, regardless of the apparent clinical response. Given these high response rates in defined subgroups among exceptional responders it is appropriate to question whether surgery is now a redundant procedure in their overall management. Further, definitive radiation without surgical resection with or without systemic therapy has been proven effective for several other malignant disease sites including some stages of esophageal, anal, laryngeal, prostate, cervical, and lung carcinoma. The main impediments for potential elimination of surgery have been the fact that prior and current standard and functional breast imaging methods are incapable of accurate prediction of residual disease and that integrating percutaneous biopsy of the breast primary and nodes following NCT may circumvent this issue. This article highlights historical attempts at omission of surgery following NCT in an earlier era, the current status of breast and nodal imaging to predict residual carcinoma, and ongoing and planned trials designed to identify appropriate patients who might be selected for clinical trials designed to test the safety of selected elimination of breast cancer surgery in percutaneous image

  3. Glutamine dipeptide for parenteral nutrition in abdominal surgery: A meta-analysis of randomized controlled trials

    Institute of Scientific and Technical Information of China (English)

    Ya-Min Zheng; Fei Li; Ming-Ming Zhang; Xiao-Ting Wu

    2006-01-01

    AIM: To assess the clinical and economical validity of glutamine dipeptide supplemented to parenteral nutrition(PN) in patients undergoing abdominal surgery.METHODS: A meta-analysis of all the relevant randomized controlled trials (RCTs) was performed. The trials compared the standard PN and PN supplemented with glutamine dipeptide in abdominal surgery. RCTs were identified from the following electronic databases:the Cochrane Library, MEDLINE, EMBASE and ISI web of knowledge (SCI). The search was undertaken in April 2006. Literature references were checked by computer or hand at the same time. Clinical trials were extracted and evaluated by two reviewers independently. Statistical analysis was performed by RevMan4.2 software from Cochrane Collaboration. A P value of <0.05 was considered statistically significant.RESULTS: Nine RCTs involving 373 patients were included. The combined results showed that glutamine dipeptide has a positive effect in improving postoperative cumulative nitrogen balance (weighted mean difference (WMD = 8.35, 95% CI [2.98, 13.71], P = 0.002),decreasing postoperative infectious morbidity (OR = 0.24,95% CI [0.06, 0.93], P = 0.04), shortening the length of hospital stay (WMD= -3.55, 95% CI [-5.26, -1.84], P<0.00001). No serious adverse effects were found.CONCLUSION: Postoperative PN supplemented with glutamine dipeptide is effective and safe to decrease the infectious rate, reduce the length of hospital stay and improve nitrogen balance in patients undergoing abdominal surgery. Further high quality trials in children and severe patients are required, and mortality and hospital cost should be considered in future RCTs with sufficient size and rigorous design.

  4. Under-representation of women and ethnic minorities in vascular surgery randomized controlled trials.

    Science.gov (United States)

    Hoel, Andrew W; Kayssi, Ahmed; Brahmanandam, Soma; Belkin, Michael; Conte, Michael S; Nguyen, Louis L

    2009-08-01

    Gender and ethnicity are factors affecting the incidence and severity of vascular disease as well as subsequent treatment outcomes. Although well studied in other fields, balanced enrollment of patients with relevant demographic characteristics in vascular surgery randomized controlled trials (RCTs) is not well known. This study describes the reporting of gender and ethnicity data in vascular surgery RCTs and analyzes whether these studies adequately represent our diverse patient population. We conducted a retrospective review of United States-based RCTs from 1983 through 2007 for three broadly defined vascular procedures: aortic aneurysm repair (AAR), carotid revascularization (CR), and lower extremity revascularization (LER). Included studies were examined for gender and ethnicity data, study parameters, funding source, and geographic region. The Nationwide Inpatient Sample (NIS) database was analyzed to obtain group-specific procedure frequency as an estimate of procedure frequency in the general population. We reviewed 77 studies, and 52 met our inclusion criteria. Only 85% reported gender, and 21% reported ethnicity. Reporting of ethnicity was strongly associated with larger (>280 participants), multicenter, government-funded trials (P Women are disproportionately under-represented in RCTs for all procedure categories (AAR, 9.0% vs 21.5%; CR, 30.0% vs 42.9%; LER, 22.4% vs 41.3%). Minorities are under-represented in AAR studies (6.0% vs 10.7%) and CR studies (6.9% vs 9.5%) but are over-represented in LER studies (26.0% vs 21.8%, P < .001 for all). Minority ethnicity and female gender are under-reported and under-represented in vascular surgery RCTs, particularly in small, non-government-funded and single-center trials. The generalizability of some trial results may not be applicable to these populations. Greater effort to enroll a balanced study population in RCTs may yield more broadly applicable results.

  5. Nutritional Risk in Major Abdominal Surgery: Protocol of a Prospective Observational Trial to Evaluate the Prognostic Value of Different Nutritional Scores in Pancreatic Surgery

    OpenAIRE

    Probst, Pascal; Haller, Sebastian; Dörr-Harim, Colette; Bruckner, Thomas; Ulrich,Alexis; Hackert, Thilo; Diener, Markus K; Knebel, Phillip

    2015-01-01

    Background The influence of patients’ preoperative nutritional status on their clinical outcome has already been proven. Therefore, patients with malnutrition are in need of additional therapeutic efforts. However, for pancreatic surgery, evidence suggesting the adequacy of existing nutritional assessment scores to estimate malnutrition associated with postoperative outcome is limited. Objective The aim of the observational trial “Nutritional Risk in Major Abdominal Surgery (NURIMAS) Pancreas...

  6. Developing a placebo-controlled trial in surgery: Issues of design, acceptability and feasibility

    Directory of Open Access Journals (Sweden)

    McDonald AM

    2011-02-01

    Full Text Available Abstract Background Surgical placebos are controversial. This in-depth study explored the design, acceptability, and feasibility issues relevant to designing a surgical placebo-controlled trial for the evaluation of the clinical and cost effectiveness of arthroscopic lavage for the management of people with osteoarthritis of the knee in the UK. Methods Two surgeon focus groups at a UK national meeting for orthopaedic surgeons and one regional surgeon focus group (41 surgeons; plenary discussion at a UK national meeting for orthopaedic anaesthetists (130 anaesthetists; three focus groups with anaesthetists (one national, two regional; 58 anaesthetists; two focus groups with members of the patient organisation Arthritis Care (7 participants; telephone interviews with people on consultant waiting lists from two UK regional centres (15 participants; interviews with Chairs of UK ethics committees (6 individuals; postal surveys of members of the British Association of Surgeons of the Knee (382 surgeons and members of the British Society of Orthopaedic Anaesthetists (398 anaesthetists; two centre pilot (49 patients assessed. Results There was widespread acceptance that evaluation of arthroscopic lavage had to be conducted with a placebo control if scientific rigour was not to be compromised. The choice of placebo surgical procedure (three small incisions proved easier than the method of anaesthesia (general anaesthesia. General anaesthesia, while an excellent mimic, was more intrusive and raised concerns among some stakeholders and caused extensive discussion with local decision-makers when seeking formal approval for the pilot. Patients were willing to participate in a pilot with a placebo arm; although some patients when allocated to surgery became apprehensive about the possibility of receiving placebo, and withdrew. Placebo surgery was undertaken successfully. Conclusions Our study illustrated the opposing and often strongly held opinions about

  7. Effect of intermediate care on mortality following emergency abdominal surgery. The InCare trial: study protocol, rationale and feasibility of a randomised multicentre trial

    Directory of Open Access Journals (Sweden)

    Vester-Andersen Morten

    2013-02-01

    Full Text Available Abstract Background Emergency abdominal surgery carries a 15% to 20% short-term mortality rate. Postoperative medical complications are strongly associated with increased mortality. Recent research suggests that timely recognition and effective management of complications may reduce mortality. The aim of the present trial is to evaluate the effect of postoperative intermediate care following emergency major abdominal surgery in high-risk patients. Methods and design The InCare trial is a randomised, parallel-group, non-blinded clinical trial with 1:1 allocation. Patients undergoing emergency laparotomy or laparoscopic surgery with a perioperative Acute Physiology and Chronic Health Evaluation II score of 10 or above, who are ready to be transferred to the surgical ward within 24 h of surgery are allocated to either intermediate care for 48 h, or surgical ward care. The primary outcome measure is all-cause 30-day mortality. We aim to enrol 400 patients in seven Danish hospitals. The sample size allows us to detect or refute a 34% relative risk reduction of mortality with 80% power. Discussion This trial evaluates the benefits and possible harm of intermediate care. The results may potentially influence the survival of many high-risk surgical patients. As a pioneer trial in the area, it will provide important data on the feasibility of future large-scale randomised clinical trials evaluating different levels of postoperative care. Trial registration Clinicaltrials.gov identifier: NCT01209663

  8. The first experiments in SST-1

    Science.gov (United States)

    Pradhan, S.; Khan, Z.; Tanna, V. L.; Sharma, A. N.; Doshi, K. J.; Prasad, U.; Masand, H.; Kumar, Aveg; Patel, K. B.; Bhandarkar, M. K.; Dhongde, J. R.; Shukla, B. K.; Mansuri, I. A.; Varadarajulu, A.; Khristi, Y. S.; Biswas, P.; Gupta, C. N.; Sharma, D. K.; Raval, D. C.; Srinivasan, R.; Pandya, S. P.; Atrey, P. K.; Sharma, P. K.; Patel, P. J.; Patel, H. S.; Santra, P.; Parekh, T. J.; Dhanani, K. R.; Paravastu, Y.; Pathan, F. S.; Chauhan, P. K.; Khan, M. S.; Tank, J. K.; Panchal, P. N.; Panchal, R. N.; Patel, R. J.; George, S.; Semwal, P.; Gupta, P.; Mahesuriya, G. I.; Sonara, D. P.; Jayswal, S. P.; Sharma, M.; Patel, J. C.; Varmora, P. P.; Patel, D. J.; Srikanth, G. L. N.; Christian, D. R.; Garg, A.; Bairagi, N.; Babu, G. R.; Panchal, A. G.; Vora, M. M.; Singh, A. K.; Sharma, R.; Raju, D.; Kulkarni, S. V.; Kumar, M.; Manchanda, R.; Joisa, S.; Tahiliani, K.; Pathak, S. K.; Patel, K. M.; Nimavat, H. D.; Shah, P. R.; Chudasma, H. H.; Raval, T. Y.; Sharma, A. L.; Ojha, A.; Parghi, B. R.; Banaudha, M.; Makwana, A. R.; Chowdhuri, M. B.; Ramaiya, N.; kumar, A.; Raval, J. V.; Gupta, S.; Purohit, S.; Kaur, R.; Adhiya, A. N.; Jha, R.; Kumar, S.; Nagora, U. C.; Siju, V.; Thomas, J.; Chaudhari, V. R.; Patel, K. G.; Ambulkar, K. K.; Dalakoti, S.; Virani, C. G.; Parmar, P. R.; Thakur, A. L.; Das, A.; Bora, D.; the SST-1 Team

    2015-10-01

    A steady state superconducting tokamak (SST-1) has been commissioned after the successful experimental and engineering validations of its critical sub-systems. During the ‘engineering validation phase’ of SST-1; the cryostat was demonstrated to be leak-tight in all operational scenarios, 80 K thermal shields were demonstrated to be uniformly cooled without regions of ‘thermal runaway and hot spots’, the superconducting toroidal field magnets were demonstrated to be cooled to their nominal operational conditions and charged up to 1.5 T of the field at the major radius. The engineering validations further demonstrated the assembled SST-1 machine shell to be a graded, stress-strain optimized and distributed thermo-mechanical device, apart from the integrated vacuum vessel being validated to be UHV compatible etc. Subsequently, ‘field error components’ in SST-1 were measured to be acceptable towards plasma discharges. A successful breakdown in SST-1 was obtained in SST-1 in June 2013 assisted with electron cyclotron pre-ionization in the second harmonic mode, thus marking the ‘first plasma’ in SST-1 and the arrival of SST-1 into the league of contemporary steady state devices. Subsequent to the first plasma, successful repeatable plasma start-ups with E ˜ 0.4 V m-1, and plasma current in excess of 70 kA for 400 ms assisted with electron cyclotron heating pre-ionization at a field of 1.5 T have so far been achieved in SST-1. Lengthening the plasma pulse duration with lower hybrid current drive, confinement and transport in SST-1 plasmas and magnetohydrodynamic activities typical to large aspect ratio SST-1 discharges are presently being investigated in SST-1. In parallel, SST-1 has uniquely demonstrated reliable cryo-stable high field operation of superconducting TF magnets in the two-phase cooling mode, operation of vapour-cooled current leads with cold gas instead of liquid helium and an order less dc joint resistance in superconducting magnet winding

  9. Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate

    DEFF Research Database (Denmark)

    Karsten, Agneta; Marcusson, Agneta; Hurmerinta, Kirsti

    2017-01-01

    controlled trials were undertaken as an international multicentre study by 10 cleft teams in five countries: Denmark, Finland, Sweden, Norway, and the UK. METHODS: Three different surgical procedures for primary palatal repair (Arms B, C, and D) were tested against a common procedure (Arm A) in the total......BACKGROUND AND AIM: Good dentofacial development and good occlusion are main goals in the treatment of UCLP. The aim was to evaluate dental occlusion at age 5 years with the Huddart and Bodenham index after four different protocols of primary surgery for UCLP. DESIGN: Three parallel randomised......- and intra-examiner reliability was good-to-excellent (0.61-0.94; 0.66-1.0, respectively). The mean total scores (+2 to -18) varied from -5.56 (Trial 2C) to -7.21 (Trial 3D). The mean anterior scores (+2 to -6) varied from -1.66 (Trial 2C) to -2.56 (Trial 3A). The mean posterior cleft-side scores (0 to -6...

  10. Timing of surgery for sciatica: subgroup analysis alongside a randomized trial.

    Science.gov (United States)

    Peul, Wilco C; Arts, Mark P; Brand, Ronald; Koes, Bart W

    2009-04-01

    Surgery speeds up recovery for sciatica. Prolonged conservative care with surgery for those patients with persistent sciatica however, yields similar results at 1 year. To investigate whether baseline variables modify the difference in recovery rates between these treatment strategies, baseline data of 283 patients enrolled in a randomized trial, comparing early surgery with prolonged conservative care, were used to analyse effect modification of the allotted treatment strategy. For predictors shown to modify the effect of the treatment strategy, repeated measurement analyses with the Roland Disability Questionnaire and visual analogue scale pain as continuous outcomes were performed for every level of that predictor. Presumed predictive variables did not have any interaction with treatment, while "sciatica provoked by sitting" showed to be a significant effect modifier (P = 0.07). In a Cox model we estimated a hazard ratio (HR, surgery versus conservative) of 2.2 (95% CI 1.7-3.0) in favour of surgery when sciatica was provoked by sitting, while the HR was 1.3 (95% CI 0.8-2.2) when this sign was absent. The interaction effect is marginally significant (interactions are usually tested at the 10% level) but the patterns generated by the repeated measurement analyses of all primary outcomes are completely consistent with the inferred pattern from the survival analysis. Classical signs did not show any contribution as decision support tools in deciding when to operate for sciatica, whereas treatment effects of early surgery are emphasized when sciatica is provoked by sitting and negligible when this symptom is absent.

  11. Sutures versus staples for wound closure in orthopaedic surgery: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Shantz Jesse A

    2012-06-01

    Full Text Available Abstract Background A recently published meta-analysis comparing metallic staples to sutures in orthopaedic procedures revealed three fold increase in risk for infection in stapled wounds. The studies included in the meta-analysis are at risk of bias due to experimental design limitations. A large randomized controlled trial is proposed to direct orthopaedic surgeons in their choice of wound closure material. Methods/Design A parallel group randomized controlled trial with institutional review board approval will be conducted. Patients will be randomized intraoperatively to have skin wounds closed with sutures or staples. Dressings will be used to maintain blinding outcome assessors. The primary outcome measure will be a composite all-cause wound complication outcome measure composed of: infection, wound drainage, wound necrosis, blistering, dehiscence, suture abscess and material sensitivity reaction. An independent review board blinded to treatment assignment will adjudicate suspected complications based on clinical data. All deceased patients will also be reviewed. An interim analysis of complications will take place after half of the patients have been recruited. All data will be analyzed by a blinded statistician. Dichotomous primary and secondary outcome measures will be analyzed using the Chi-squared statistic. Continuous outcome measures will be analyzed using Student's t-test. Subgroup analysis will compare infection rates using sutures versus staples in each anatomic area (upper extremity, pelvis/acetabulum, hip/femur, knee, ankle. A further subgroup analysis will be conducted comparing trauma patients to elective surgery patients. Non-infected revision surgery will also be compared to primary surgery. Discussion Wound closure material is an afterthought for many orthopaedic surgeons. The combined results of several comparative trials suggests that the choice of wound closure materials may have an impact on the rate of surgical site

  12. Analgesic treatment in laparoscopic gastric bypass surgery: a systematic review of randomized trials.

    Science.gov (United States)

    Andersen, Lars P H; Werner, Mads U; Rosenberg, Jacob; Gögenur, Ismail

    2014-03-01

    This review aimed to present an overview of the randomized controlled trials investigating analgesic regimens used in laparoscopic Roux-en-Y gastric bypass (LRYGB) surgery. Literature search was performed in PubMed and EMBASE databases in August 2013 in accordance to PRISMA guidelines. The literature search identified nine studies eligible for inclusion. The administration of nonsteroidal anti-inflammatory drugs, local anesthetics (intraperitoneally or subfascially/subcutaneously), transversus abdominis plane block, dexmedetomidine, and ketamine may improve analgesia compared to placebo/controls in LRYGB. None of the studies incorporated multimodal procedure-specific analgesic regimens. The Oxford quality scoring system scores indicated a generally limited methodological quality of the included studies. This review documents a need for high-quality, procedure-specific literature concerning analgesic treatment in LRYGB surgery.

  13. A Systematic Review of Completeness of Reporting in Randomized Controlled Trials in Dermatologic Surgery: Adherence to CONSORT 2010 Recommendations.

    Science.gov (United States)

    Alam, Murad; Rauf, Mutahir; Ali, Sana; Patel, Parth; Schlessinger, Daniel I; Schaeffer, Matthew R; Yoo, Simon S; Minkis, Kira; Jiang, Shang I Brian; Maher, Ian A; Sobanko, Joseph F; Cartee, Todd V; Poon, Emily

    2016-12-01

    Randomized controlled trials are the gold standard for comparing safety and effectiveness of surgical interventions. Reporting guidelines are available for conveying the results of such trials. To assess adherence to standard reporting guidelines among randomized controlled trials in dermatologic surgery. Systematic review. Data source was randomized controlled trials in the journal Dermatologic Surgery, per PubMed search, 1995 to 2014. Studies were appraised for the number of the 37 CONSORT 2010 Checklist criteria reported in each. Analysis included comparison of reporting across 4 consecutive periods. Three hundred sixty-three studies were eligible. The mean number of items reported per study increased monotonically from 14.5 in 1995 to 1999 to 16.2 in 2002 to 2004, 17.7 in 2005 to 2009, and 18.0 in 2010 to 2014 (p dermatologic surgery has improved significantly during the preceding 2 decades. Some elements are still reported at lower rates.

  14. A randomised, double blind trial of N-Acetylcysteine for hearing protection during stapes surgery.

    Directory of Open Access Journals (Sweden)

    Dan Bagger-Sjöbäck

    Full Text Available Otosclerosis is a disorder that impairs middle ear function, leading to conductive hearing loss. Surgical treatment results in large improvement of hearing at low sound frequencies, but high-frequency hearing often suffers. A likely reason for this is that inner ear sensory cells are damaged by surgical trauma and loud sounds generated during the operation. Animal studies have shown that antioxidants such as N-Acetylcysteine can protect the inner ear from noise, surgical trauma, and some ototoxic substances, but it is not known if this works in humans. This trial was performed to determine whether antioxidants improve surgical results at high frequencies.We performed a randomized, double-blind and placebo-controlled parallel group clinical trial at three Swedish university clinics. Using block-stratified randomization, 156 adult patients undergoing stapedotomy were assigned to intravenous N-Acetylcysteine (150 mg/kg body weight or matching placebo (1:1 ratio, starting one hour before surgery. The primary outcome was the hearing threshold at 6 and 8 kHz; secondary outcomes included the severity of tinnitus and vertigo.One year after surgery, high-frequency hearing had improved 2.7 ± 3.8 dB in the placebo group (67 patients analysed and 2.4 ± 3.7 dB in the treated group (72 patients; means ± 95% confidence interval, p = 0.54; linear mixed model. Surgery improved tinnitus, but there was no significant intergroup difference. Post-operative balance disturbance was common but improved during the first year, without significant difference between groups. Four patients receiving N-Acetylcysteine experienced mild side effects such as nausea and vomiting.N-Acetylcysteine has no effect on hearing thresholds, tinnitus, or balance disturbance after stapedotomy.ClinicalTrials.gov NCT00525551.

  15. Physical conditioning and mental stress reduction - a randomised trial in patients undergoing cardiac surgery

    Directory of Open Access Journals (Sweden)

    van der Merwe Juliana

    2011-03-01

    Full Text Available Abstract Background Preoperative anxiety and physical unfitness have been shown to have adverse effects on recovery from cardiac surgery. This study involving cardiac surgery patients was primarily aimed at assessing the feasibility of delivering physical conditioning and stress reduction programs within the public hospital setting. Secondary aims were to evaluate the effect of these programs on quality of life (QOL, rates of postoperative atrial fibrillation (AF and length of stay (LOS in hospital. Methods Elective patients scheduled for coronary artery bypass graft and/or valve surgery at a public hospital in Melbourne, Australia were enrolled. Patients were randomized to receive either holistic therapy (HT or usual care (UC. HT consisted of a series of light physical exercise sessions together with a mental stress reduction program administered in an outpatient setting for the first two weeks after placement on the waiting list for surgery. A self-administered SF-36 questionnaire was used to measure QOL and hospital records to collect data on LOS and rate of postoperative AF. Results The study population comprised 117 patients of whom 60 received HT and 57 received UC. Both programs were able to be delivered within the hospital setting but ongoing therapy beyond the two week duration of the program was not carried out due to long waiting periods and insufficient resources. HT, as delivered in this study, compared to UC did not result in significant changes in QOL, LOS or AF incidence. Conclusions Preoperative holistic therapy can be delivered in the hospital setting, although two weeks is insufficient to provide benefits beyond usual care on QOL, LOS or postoperative AF. Further research is now required to determine whether a similar program of longer duration, or targeted to high risk patients can provide measurable benefits. Trial registration This trial was conducted as part of a larger study and according to the principles contained in

  16. Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate

    DEFF Research Database (Denmark)

    Heliövaara, Arja; Küseler, Annelise; Skaare, Pål

    2017-01-01

    BACKGROUND AND AIM: Good dentofacial growth is a major goal in the treatment of unilateral cleft lip and palate (UCLP). The aim was to evaluate dental arch relationships at age 5 years after four different protocols of primary surgery for UCLP. DESIGN: Three parallel randomised clinical trials were...... undertaken as an international multi-centre study by 10 cleft teams in five countries: Denmark, Finland, Sweden, Norway, and the UK. METHODS: Three different surgical procedures for primary palatal repair (Arms B, C, D) were tested against a common procedure (Arm A) in the total cohort of 448 children born...

  17. Preventing hypothermia in elective arthroscopic shoulder surgery patients: a protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Duff Jed

    2012-07-01

    Full Text Available Abstract Background Patients having arthroscopic shoulder surgery frequently experience periods of inadvertent hypothermia. This common perioperative problem has been linked to adverse patient outcomes such as myocardial ischaemia, surgical site infection and coagulopathy. International perioperative guidelines recommend patient warming, using a forced air warming device, and the use of warmed intraoperative irrigation solutions for the prevention of hypothermia in at-risk patient groups. This trial will investigate the effect of these interventions on patients’ temperature, thermal comfort, and total recovery time. Method/Design The trial will employ a randomised 2 x 2 factorial design. Eligible patients will be stratified by anaesthetist and block randomised into one of four groups: Group one will receive preoperative warming with a forced air warming device; group two will receive warmed intraoperative irrigation solutions; group three will receive both preoperative warming and warmed intraoperative irrigation solutions; and group four will receive neither intervention. Participants in all four groups will receive active intraoperative warming with a forced air warming device. The primary outcome measures are postoperative temperature, thermal comfort, and total recovery time. Primary outcomes will undergo a two-way analysis of variance controlling for covariants such as operating room ambient temperature and volume of intraoperative irrigation solution. Discussion This trial is designed to confirm the effectiveness of these interventions at maintaining perioperative normothermia and to evaluate if this translates into improved patient outcomes. Australian New Zealand Clinical Trials Registry number ACTRN12610000591055

  18. Expert opinion on laparoscopic surgery for colorectal cancer parallels evidence from a cumulative meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Guillaume Martel

    Full Text Available BACKGROUND: This study sought to synthesize survival outcomes from trials of laparoscopic and open colorectal cancer surgery, and to determine whether expert acceptance of this technology in the literature has parallel cumulative survival evidence. STUDY DESIGN: A systematic review of randomized trials was conducted. The primary outcome was survival, and meta-analysis of time-to-event data was conducted. Expert opinion in the literature (published reviews, guidelines, and textbook chapters on the acceptability of laparoscopic colorectal cancer was graded using a 7-point scale. Pooled survival data were correlated in time with accumulating expert opinion scores. RESULTS: A total of 5,800 citations were screened. Of these, 39 publications pertaining to 23 individual trials were retained. As well, 414 reviews were included (28 guidelines, 30 textbook chapters, 20 systematic reviews, 336 narrative reviews. In total, 5,782 patients were randomized to laparoscopic (n = 3,031 and open (n = 2,751 colorectal surgery. Survival data were presented in 16 publications. Laparoscopic surgery was not inferior to open surgery in terms of overall survival (HR = 0.94, 95% CI 0.80, 1.09. Expert opinion in the literature pertaining to the oncologic acceptability of laparoscopic surgery for colon cancer correlated most closely with the publication of large RCTs in 2002-2004. Although increasingly accepted since 2006, laparoscopic surgery for rectal cancer remained controversial. CONCLUSIONS: Laparoscopic surgery for colon cancer is non-inferior to open surgery in terms of overall survival, and has been so since 2004. The majority expert opinion in the literature has considered these two techniques to be equivalent since 2002-2004. Laparoscopic surgery for rectal cancer has been increasingly accepted since 2006, but remains controversial. Knowledge translation efforts in this field appear to have paralleled the accumulation of clinical trial evidence.

  19. Randomized controlled trial of postoperative belladonna and opium rectal suppositories in vaginal surgery.

    Science.gov (United States)

    Butler, Kristina; Yi, John; Wasson, Megan; Klauschie, Jennifer; Ryan, Debra; Hentz, Joseph; Cornella, Jeffrey; Magtibay, Paul; Kho, Roseanne

    2017-05-01

    After vaginal surgery, oral and parenteral narcotics are used commonly for pain relief, and their use may exacerbate the incidence of sedation, nausea, and vomiting, which ultimately delays convalescence. Previous studies have demonstrated that rectal analgesia after surgery results in lower pain scores and less intravenous morphine consumption. Belladonna and opium rectal suppositories may be used to relieve pain and minimize side effects; however, their efficacy has not been confirmed. We aimed to evaluate the use of belladonna and opium suppositories for pain reduction in vaginal surgery. A prospective, randomized, double-blind, placebo-controlled trial that used belladonna and opium suppositories after inpatient or outpatient vaginal surgery was conducted. Vaginal surgery was defined as (1) vaginal hysterectomy with uterosacral ligament suspension or (2) posthysterectomy prolapse repair that included uterosacral ligament suspension and/or colporrhaphy. Belladonna and opium 16A (16.2/60 mg) or placebo suppositories were administered rectally immediately after surgery and every 8 hours for a total of 3 doses. Patient-reported pain data were collected with the use of a visual analog scale (at 2, 4, 12, and 20 hours postoperatively. Opiate use was measured and converted into parenteral morphine equivalents. The primary outcome was pain, and secondary outcomes included pain medication, antiemetic medication, and a quality of recovery questionnaire. Adverse effects were surveyed at 24 hours and 7 days. Concomitant procedures for urinary incontinence or pelvic organ prolapse did not preclude enrollment. Ninety women were randomly assigned consecutively at a single institution under the care of a fellowship-trained surgeon group. Demographics did not differ among the groups with mean age of 55 years, procedure time of 97 minutes, and prolapse at 51%. Postoperative pain scores were equivalent among both groups at each time interval. The belladonna and opium group used a

  20. A trial of nebulised heparin to limit lung injury following cardiac surgery.

    Science.gov (United States)

    Dixon, B; Smith, R; Santamaria, J D; Orford, N R; Wakefield, B J; Ives, K; McKenzie, R; Zhang, B; Yap, C H

    2016-01-01

    Cardiac surgery with cardiopulmonary bypass triggers an acute inflammatory response in the lungs. This response gives rise to fibrin deposition in the microvasculature and alveoli of the lungs. Fibrin deposition in the microvasculature increases alveolar dead space, while fibrin deposition in alveoli causes shunting. We investigated whether prophylactic nebulised heparin could limit this form of lung injury. We undertook a single-centre double-blind randomised trial. Forty patients undergoing elective cardiac surgery with cardiopulmonary bypass were randomised to prophylactic nebulised heparin (50,000 U) or placebo. The primary endpoint was the change in arterial oxygen levels over the operative period. Secondary endpoints included end-tidal CO₂, the alveolar dead space fraction and bleeding complications. We found nebulised heparin did not improve arterial oxygen levels. Nebulised heparin was, however, associated with a lower alveolar dead space fraction (P heparin was not associated with bleeding complications. In conclusion, prophylactic nebulised heparin did not improve oxygenation, but was associated with evidence of better alveolar perfusion and CO₂elimination at the end of surgery.

  1. Analgesic Effect of Dexamethasone after Arthroscopic Knee Surgery: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Jairo Moyano

    2016-01-01

    Full Text Available Background. Dexamethasone is sometimes used as a coanalgesic because of its anti-inflammatory properties. Objective. To evaluate opioid use, postoperative pain intensity, and side effects after a single dose of dexamethasone in patients undergoing arthroscopic knee surgery. Methods. In this randomized controlled study patients were randomized to receive either 10 mg of intravenous dexamethasone (DM group or 0.9% normal saline (NS group during the intraoperative period. Primary outcomes were pain intensity and total morphine and codeine use after surgery. Results. Seventy-eight patients were included in the study. The DM group showed statistically significant higher pain intensity at the fourth postoperative hour (DM: 3.96/10, standard deviation [SD] 0.54; NS: 2.46/10, SD 0.45; p=0.036. No statistically significant difference in total opioid use (morphine plus codeine was identified with 15.9 (SD 1.97 codeine tablets used in DM group and 20 (SD 2.14 in NS group (p=0.25. Discussion. Pain intensity tended to decrease in both groups suggesting morphine as the main source of analgesia. Conclusions. Intravenous dexamethasone during the intraoperative period has no clinical impact on postoperative pain intensity during the first 48 h after arthroscopic knee surgery. This trial is registered with R000020892.

  2. Video-Assisted Informed Consent for Cataract Surgery: A Randomized Controlled Trial

    Science.gov (United States)

    Ruan, Xiangcai; Tang, Haoying; Yang, Weizhong; Xian, Zhuanhua; Lu, Min

    2017-01-01

    Purpose. To investigate whether adding video assistance to traditional verbal informed consent advisement improved satisfaction among cataract surgery patients. Methods. This trial enrolled 80 Chinese patients with age-related cataracts scheduled to undergo unilateral phacoemulsification surgery. Patients were randomized into two groups: the video group watched video explaining cataract-related consent information and rewatched specific segments of the video at their own discretion, before receiving traditional verbal consent advisement; the control group did not watch the video. Outcomes included patient satisfaction, refusal to consent, time to complete the consent process, and comprehension measured by a ten-item questionnaire. Results. All 80 enrolled patients signed informed consent forms. Compared with the control group, members of the video group exhibited greater satisfaction (65% versus 86%, p = 0.035) and required less time to complete the consent process (12.3 ± 6.7 min versus 5.6 ± 5.4 min, p < 0.001), while also evincing levels of comprehension commensurate with those reported for patients who did not watch the video (accuracy rate, 77.5% versus 80.2%, p = 0.386). Conclusion. The video-assisted informed consent process had a positive impact on patients' cataract surgery experiences. Additional research is needed to optimize patients' comprehension of the video. PMID:28191349

  3. The effect of music intervention in stress response to cardiac surgery in a randomized clinical trial.

    Science.gov (United States)

    Nilsson, Ulrica

    2009-01-01

    To evaluate the effect of bed rest with music on the first postoperative day to decrease stress for patients who have undergone heart surgery. A repeated-measures randomized controlled trial was used. The study took place in a cardiothoracic intermediary unit of a university hospital in Sweden. Fifty-eight patients who had undergone open coronary artery bypass grafting or aortic valve replacement surgery were included. Stress response was assessed by determining the serum cortisol, heart rate, respiratory rate, mean arterial pressure, arterial oxygen tension, arterial oxygen saturation, and subjective pain and anxiety levels. At 12:00 noon on postoperative day 1, patients were allocated to receive 30 minutes of uninterrupted bed rest with music and then 30 minutes of bed rest or alternatively 60 minutes of uninterrupted bed rest. The music was soft and relaxing, included different melodies in new-age style, played with a volume at 50 to 60 dB, and distributed through a music pillow connected to an MP3 player. After 30 minutes of bed rest, there was a significant difference in s-cortisol levels between the groups; 484. 4 mmol/L in the music group versus 618.8 mmol/L in the control group (P pain and anxiety levels between the groups. There is sufficient practical evidence of stress reduction to suggest that a proposed regimen of listening to music while resting in bed after open heart surgery be put into clinical use.

  4. Postoperative vasopressin and copeptin levels in noncardiac surgery patients: a prospective controlled trial.

    Science.gov (United States)

    Jochberger, Stefan; Zitt, Matthias; Luckner, Günter; Mayr, Viktoria D; Wenzel, Volker; Ulmer, Hanno; Morgenthaler, Nils G; Hasibeder, Walter R; Dünser, Martin W

    2009-02-01

    Further information on the endogenous arginine vasopressin (AVP) response in patients with postoperative systemic inflammatory response syndrome (SIRS) and vasodilatory shock would provide more insight into the pathophysiology of SIRS-associated cardiovascular failure and help indicate AVP therapy. Patients after uncomplicated abdominal surgery without SIRS (n = 10), critically ill patients after noncardiac surgery with SIRS (n = 9), and patients with SIRS plus vasodilatory shock (n = 22) were included in this prospective trial. Plasma AVP (radioimmunoassay) and copeptin (immunoluminometric assay) concentrations together with clinical parameters were documented daily during the first 7 days postoperative. The AVP response significantly differed between the three groups. Patients without SIRS had lower AVP concentrations than SIRS patients with (P = 0.001) or without shock (P = 0.003). Patients with SIRS and shock had higher AVP levels than patients with SIRS alone (P SIRS patients without shock, serum osmolarity was indirectly associated with AVP levels, whereas mean arterial blood pressure and serum osmolarity were associated with AVP in SIRS patients with shock. Arginine vasopressin and copeptin correlated significantly with each other (P surgery patients seems well maintained. The possibility that AVP plays a contributory role in the failure to restore vascular tone in patients with vasodilatory shock cannot be excluded but seems less important than in septic or postcardiotomy shock.

  5. Perioperative oxygen fraction - effect on surgical site infection and pulmonary complications after abdominal surgery: a randomized clinical trial. Rationale and design of the PROXI-Trial

    DEFF Research Database (Denmark)

    Meyhoff, Christian Sylvest; Wetterslev, Jørn; Jorgensen, Lars N;

    2008-01-01

    A high perioperative inspiratory oxygen fraction may reduce the risk of surgical site infections, as bacterial eradication by neutrophils depends on wound oxygen tension. Two trials have shown that a high perioperative inspiratory oxygen fraction (FiO(2) = 0.80) significantly reduced risk...... complications, such as atelectasis, pneumonia and respiratory failure. The aim of our trial is to assess the potential benefits and harms of a high perioperative oxygen fraction in patients undergoing abdominal surgery....

  6. Neuraxial anesthesia for orthopedic surgery: systematic review and meta-analysis of randomized clinical trials

    Directory of Open Access Journals (Sweden)

    Fabiano Timbó Barbosa

    Full Text Available CONTEXT AND OBJECTIVE: Taking the outcome of mortality into consideration, there is controversy about the beneficial effects of neuraxial anesthesia for orthopedic surgery. The aim of this study was to compare the effectiveness and safety of neuraxial anesthesia versus general anesthesia for orthopedic surgery. DESIGN AND SETTING: Systematic review at Universidade Federal de Alagoas. METHODS: We searched the Cochrane Central Register of Controlled Trials (Issue 10, 2012, PubMed (1966 to November 2012, Lilacs (1982 to November 2012, SciELO, EMBASE (1974 to November 2012 and reference lists of the studies included. Only randomized controlled trials were included. RESULTS: Out of 5,032 titles and abstracts, 17 studies were included. There were no statistically significant differences in mortality (risk difference, RD: -0.01; 95% confidence interval, CI: -0.04 to 0.01; n = 1903, stroke (RD: 0.02; 95% CI: -0.04 to 0.08; n = 259, myocardial infarction (RD: -0.01; 95% CI: -0.04 to 0.02; n = 291, length of hospitalization (mean difference, -0.05; 95% CI: -0.69 to 0.58; n = 870, postoperative cognitive dysfunction (RD: 0.00; 95% CI: -0.04 to 0.05; n = 479 or pneumonia (odds ratio, 0.61; 95% CI: 0.25 to 1.49; n = 167. CONCLUSION: So far, the evidence available from the studies included is insufficient to prove that neuraxial anesthesia is more effective and safer than general anesthesia for orthopedic surgery. However, this systematic review does not rule out clinically important differences with regard to mortality, stroke, myocardial infarction, length of hospitalization, postoperative cognitive dysfunction or pneumonia.

  7. Patient-reported genitourinary dysfunction after laparoscopic and open rectal cancer surgery in a randomized trial (COLOR II)

    DEFF Research Database (Denmark)

    Andersson, J; Abis, G; Gellerstedt, M

    2014-01-01

    BACKGROUND: This article reports on patient-reported sexual dysfunction and micturition symptoms following a randomized trial of laparoscopic and open surgery for rectal cancer. METHODS: Patients in the COLOR II randomized trial, comparing laparoscopic and open surgery for rectal cancer, completed...... the European Organization for Research and Treatment of Cancer (EORTC) QLQ-CR38 questionnaire before surgery, and after 4 weeks, 6, 12 and 24 months. Adjusted mean differences on a 100-point scale were calculated using changes from baseline value at the various time points in the domains of sexual functioning...... radiotherapy, did not change these results. CONCLUSION: Sexual dysfunction is common in patients with rectal cancer, and treatment (including surgery) increases the proportion of patients affected. A laparoscopic approach does not change this. REGISTRATION NUMBER: NCT0029779 (http://www.clinicaltrials.gov)....

  8. Unused opioid analgesics and drug disposal following outpatient dental surgery: A randomized controlled trial.

    Science.gov (United States)

    Maughan, Brandon C; Hersh, Elliot V; Shofer, Frances S; Wanner, Kathryn J; Archer, Elizabeth; Carrasco, Lee R; Rhodes, Karin V

    2016-11-01

    Individuals who abuse prescription opioids often use leftover pills that were prescribed for friends or family members. Dental surgery has been identified as a common source of opioid prescriptions. We measured rates of used and unused opioids after dental surgery for a pilot program to promote safe drug disposal. We conducted a randomized controlled trial of opioid use patterns among patients undergoing surgical tooth extraction at a university-affiliated oral surgery practice. The primary objective was to describe opioid prescribing and consumption patterns, with the number of unused opioid pills remaining on postoperative day 21 serving as the primary outcome. The secondary aim was to measure the effect of a behavioral intervention (informing patients of a pharmacy-based opioid disposal program) on the proportion of patients who disposed or reported intent to dispose of unused opioids. (NCT02814305) Results: We enrolled 79 patients, of whom 72 filled opioid prescriptions. On average, patients received 28 opioid pills and had 15 pills (54%) left over, for a total of 1010 unused pills among the cohort. The behavioral intervention was associated with a 22% absolute increase in the proportion of patients who disposed or reported intent to dispose of unused opioids (Fisher's exact p=0.11). Fifty-four percent of opioids prescribed in this pilot study were not used. The pharmacy-based drug disposal intervention showed a robust effect size but did not achieve statistical significance. Dentists and oral surgeons could potentially reduce opioid diversion by moderately reducing the quantity of opioid analgesics prescribed after surgery. Copyright © 2016. Published by Elsevier Ireland Ltd.

  9. Desmopressin after cardiac surgery in bleeding patients. A multicenter randomized trial.

    Science.gov (United States)

    Bignami, E; Cattaneo, M; Crescenzi, G; Ranucci, M; Guarracino, F; Cariello, C; Baldassarri, R; Isgrò, G; Baryshnikova, E; Fano, G; Franco, A; Gerli, C; Crivellari, M; Zangrillo, A; Landoni, G

    2016-08-01

    Previous studies showed that desmopressin decreases post-operative blood loss in patients undergoing cardiac surgery. These studies were small and never studied the effect of desmopressin in patients with active bleeding. Objective of the study was to determine whether desmopressin reduces red blood cells transfusion requirements in patients with active bleeding after cardiac surgery who had been pre-treated with tranexamic acid. This multicenter, randomized, double-blind, placebo-controlled, parallel-group study randomized elective patients with bleeding after cardiac surgery despite pre-treatment with tranexamic acid, to receive placebo (saline solution) or a single administration of desmopressin (0.3 μg/kg in saline solution). The primary endpoint was the number of patients requiring red blood cells transfusion after randomization and during hospital stay. Secondary end points were: blood loss from chest tubes during the first 24 h after study drug administration, hours of mechanical ventilation, intensive care unit stay, and in-hospital mortality. The study was interrupted after inclusion of 67% of the planned patients for futility. The number of patients requiring red blood cells transfusion after randomization was 37/68 (54%) in desmopressin group and 33/67 (49%) in placebo group (P = 0.34) with no difference in blood loss: 575 (interquartile 422-770) ml in desmopressin group and 590 (476-1013) ml in placebo group (P = 0.42), mechanical ventilation, intensive care unit stay or mortality. This multicenter randomized trial demonstrated that, in patients pre-treated with tranexamic acid, desmopressin should not be expected to improve treatment of patients who experience bleeding after cardiac surgery. © 2016 The Acta Anaesthesiologica Scandinavica Foundation. Published by John Wiley & Sons Ltd.

  10. Dexmedetomidine versus Propofol Sedation Reduces Delirium after Cardiac Surgery: A Randomized Controlled Trial.

    Science.gov (United States)

    Djaiani, George; Silverton, Natalie; Fedorko, Ludwik; Carroll, Jo; Styra, Rima; Rao, Vivek; Katznelson, Rita

    2016-02-01

    Postoperative delirium (POD) is a serious complication after cardiac surgery. Use of dexmedetomidine to prevent delirium is controversial. The authors hypothesized that dexmedetomidine sedation after cardiac surgery would reduce the incidence of POD. After institutional ethics review board approval, and informed consent, a single-blinded, prospective, randomized controlled trial was conducted in patients 60 yr or older undergoing cardiac surgery. Patients with a history of serious mental illness, delirium, and severe dementia were excluded. Upon admission to intensive care unit (ICU), patients received either dexmedetomidine (0.4 μg/kg bolus followed by 0.2 to 0.7 μg kg h infusion) or propofol (25 to 50 μg kg min infusion) according to a computer-generated randomization code in blocks of four. Assessment of delirium was performed with confusion assessment method for ICU or confusion assessment method after discharge from ICU at 12-h intervals during the 5 postoperative days. Primary outcome was the incidence of POD. POD was present in 16 of 91 (17.5%) and 29 of 92 (31.5%) patients in dexmedetomidine and propofol groups, respectively (odds ratio, 0.46; 95% CI, 0.23 to 0.92; P = 0.028). Median onset of POD was on postoperative day 2 (1 to 4 days) versus 1 (1 to 4 days), P = 0.027, and duration of POD 2 days (1 to 4 days) versus 3 days (1 to 5 days), P = 0.04, in dexmedetomidine and propofol groups, respectively. When compared with propofol, dexmedetomidine sedation reduced incidence, delayed onset, and shortened duration of POD in elderly patients after cardiac surgery. The absolute risk reduction for POD was 14%, with a number needed to treat of 7.1.

  11. The Effects of Perioperative Music Interventions in Pediatric Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    OpenAIRE

    Van Der Heijden, Marianne J. E.; Sadaf Oliai Araghi; Monique van Dijk; Johannes Jeekel; M G Myriam Hunink

    2015-01-01

    Objective Music interventions are widely used, but have not yet gained a place in guidelines for pediatric surgery or pediatric anesthesia. In this systematic review and meta-analysis we examined the effects of music interventions on pain, anxiety and distress in children undergoing invasive surgery. Data Sources We searched 25 electronic databases from their first available date until October 2014. Study Selection Included were all randomized controlled trials with a parallel group, crossove...

  12. Respiratory Muscle Training in Patients Recovering Recent Open Cardiothoracic Surgery: A Randomized-Controlled Trial

    Directory of Open Access Journals (Sweden)

    Ernesto Crisafulli

    2013-01-01

    Full Text Available Objectives. To evaluate the clinical efficacy and feasibility of an expiratory muscle training (EMT device (Respilift applied to patients recovering from recent open cardiothoracic surgery (CTS. Design. Prospective, double-blind, 14-day randomised-controlled trial. Participants and Setting. A total of 60 inpatients recovering from recent CTS and early admitted to a pulmonary rehabilitation program. Interventions. Chest physiotherapy plus EMT with a resistive load of 30 cm H2O for active group and chest physiotherapy plus EMT with a sham load for control group. Measures. Changes in maximal expiratory pressure (MEP were considered as primary outcome, while maximal inspiratory pressures (MIP, dynamic and static lung volumes, oxygenation, perceived symptoms of dyspnoea, thoracic pain, and well being (evaluated by visual analogic scale—VAS and general health status were considered secondary outcomes. Results. All outcomes recorded showed significant improvements in both groups; however, the change of MEP (+34.2 mmHg, and +26.1%, for absolute and % of predicted, resp. was significantly higher in active group. Also VAS dyspnoea improved faster and more significantly ( at day 12, and 14 in active group when compared with control. The drop-out rate was 6%, without differences between groups. Conclusions. In patients recovering from recent CTS, specific EMT by Respilift is feasible and effective. This trial is registered with ClinicalTrials.gov NCT01510275.

  13. Preoperative education interventions to reduce anxiety and improve recovery among cardiac surgery patients: a review of randomised controlled trials.

    Science.gov (United States)

    Guo, Ping

    2015-01-01

    To update evidence of the effectiveness of preoperative education among cardiac surgery patients. Patients awaiting cardiac surgery may experience high levels of anxiety and depression, which can adversely affect their existing disease and surgery and result in prolonged recovery. There is evidence that preoperative education interventions can lead to improved patient experiences and positive postoperative outcomes among a mix of general surgical patients. However, a previous review suggested limited evidence to support the positive impact of preoperative education on patients' recovery from cardiac surgery. Comprehensive review of the literature. The Cochrane Central Register of Controlled Trials from the Cochrane Library, MEDLINE, CINAHL, PsycINFO, EMBASE and Web of Science were searched for English-language articles published between 2000-2011. Original articles were included reporting randomised controlled trials of cardiac preoperative education interventions. Six trials were identified and have produced conflicting findings. Some trials have demonstrated the effects of preoperative education on improving physical and psychosocial recovery of cardiac patients, while others found no evidence that patients' anxiety is reduced or of any effect on pain or hospital stay. Evidence of the effectiveness of preoperative education interventions among cardiac surgery patients remains inconclusive. Further research is needed to evaluate cardiac preoperative education interventions for sustained effect and in non-Western countries. A nurse-coordinated multidisciplinary preoperative education approach may offer a way forward to provide a more effective and efficient service. Staff training in developing and delivering such interventions is a priority. © 2014 John Wiley & Sons Ltd.

  14. Post-operative behavioural management in bariatric surgery: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Rudolph, A; Hilbert, A

    2013-04-01

    Recent research has provided evidence that bariatric surgery maximizes long-term weight loss in patients with severe obesity. However, a substantial number of patients experience poor weight loss outcome and weight regain over time. Post-operative behavioural management may facilitate long-term weight control in bariatric surgery population. The objective of this systematic review and meta-analysis was to determine the effects of post-operative behavioural management on weight loss following bariatric surgery. Eligible articles were systematically searched in electronic databases. Among the 414 citations, five randomized controlled trials, two prospective and eight retrospective cohort trials analysing behavioural lifestyle interventions and support groups fulfilled the inclusion criteria. The main finding is that behavioural management had a positive effect on weight loss following surgery. In 13 studies, patients receiving behavioural management had greater weight loss than patients receiving usual care or no treatment. A meta-analysis of five randomized controlled trials suggests greater weight loss in patients with behavioural lifestyle interventions compared with control groups. Post-operative behavioural management has the potential to facilitate optimal weight loss following bariatric surgery, but conclusions were limited by the small and heterogeneous samples of studies. A more rigorous empirical evaluation on its clinical significance is warranted to improve effectiveness of bariatric surgery.

  15. Comparison of Present SST Gravity Field Models

    Institute of Scientific and Technical Information of China (English)

    LUO Jia; SHI Chuang; ZOU Xiancai; WANG Haihong

    2006-01-01

    Taking the main land of Europe as the region to be studied, the potential of the new satellite gravity technique: satellite-to-satellite tracking (SST) and improving the accuracy of regional gravity field model with the SST models are investigated. The drawbacks of these models are discussed. With GPM98C as the reference, the gravity anomaly residuals of several other models, the latest SST global gravity field models (EIGEN series and GGM series), were computed and compared. The results of the comparison show that in the selected region, some systematic errors with periodical properties exist in the EIGEN and GGM's S series models in the high degree and order. Some information that was not shown in the classic gravity models is detected in the low and middle degree and order of EIGEN and GGM's S series models. At last, the effective maximum degrees and orders of SST models are suggested.

  16. Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate

    DEFF Research Database (Denmark)

    Lohmander, Anette; Persson, Christina; Willadsen, Elisabeth

    2017-01-01

    BACKGROUND AND AIM: Adequate velopharyngeal function and speech are main goals in the treatment of cleft palate. The objective was to investigate if there were differences in velopharyngeal competency (VPC) and hypernasality at age 5 years in children with unilateral cleft lip and palate (UCLP......) operated on with different surgical methods for primary palatal repair. A secondary aim was to estimate burden of care in terms of received additional secondary surgeries and speech therapy. DESIGN: Three parallel group, randomised clinical trials were undertaken as an international multicentre study by 10...... cleft teams in five countries: Denmark, Finland, Sweden, Norway, and the UK. METHODS: Three different surgical protocols for primary palatal repair were tested against a common procedure in the total cohort of 448 children born with a non-syndromic UCLP. Speech audio and video recordings of 391 children...

  17. Rivaroxaban for venous thromboembolism prevention after major orthopedic surgery: translating trial data into routine clinical practice

    Directory of Open Access Journals (Sweden)

    Beyer-Westendorf J

    2017-01-01

    Full Text Available Jan Beyer-Westendorf,1 Patrick Mouret,2 Alexander GG Turpie3 1Thrombosis Research and Angiology, Dresden University Clinic, Dresden, Germany; 2Orthopedic Clinic, Klinikum Frankfurt Höchst GmbH, Frankfurt, Germany; 3Department of Medicine, General Division, Hamilton Health Sciences, Hamilton, ON, Canada Abstract: An established standard of care for the prevention of venous thromboembolism after major orthopedic surgery has been subcutaneous low-molecular-weight heparin. The non-vitamin K antagonist oral anticoagulant rivaroxaban has demonstrated superior efficacy and similar safety to all tested regimens of enoxaparin in large Phase III clinical studies of venous thromboembolism prevention after elective hip and knee arthroplasty. Despite regulatory approval of rivaroxaban for this indication, concerns remain among physicians regarding its optimal and effective use in routine clinical practice. Real-life studies, such as XAMOS and ORTHO-TEP, are providing physicians with more information on the routine use of rivaroxaban for venous thromboembolism prevention after orthopedic surgery, helping to establish its safety and effectiveness in everyday clinical care. Among the most important issues are the risk of bleeding complications, wound healing, timing of first dose, impact of type of anesthesia on thromboprophylaxis effectiveness, patient comorbidities and comedication use, periprocedural management, associated costs, and clinical outcomes in trauma-related fractures. Many of these issues are difficult to study in randomized, double-blind, Phase III trials, and can be assessed more readily using real-life data. In particular, real-life or noninterventional studies lack many of the strict inclusion and exclusion criteria associated with Phase III trials and involve unselected patients who often present with significant comorbidities or comedication use. Keywords: anticoagulants, arthroplasty, orthopedics, rivaroxaban, thrombosis

  18. Conservative Care in Lumbar Spine Surgery Trials: A Descriptive Literature Review.

    Science.gov (United States)

    Yang, Aaron J; Coronado, Rogelio A; Hoffecker, Lilian; Gao, Chan; Saurwein, Kelly; Shoreman, Danielle; Hoffberg, Adam S; Akuthota, Venu

    2017-01-01

    To evaluate the degree to which conservative care and failure were specifically defined in studies comparing nonoperative treatment versus surgery for low back pain (LBP) conditions in adults. A comprehensive literature search was conducted by an experienced librarian using MEDLINE (PubMed), Embase, Google Scholar, and CENTRAL from January 2003 to June 2014. Endnote bibliographic management application was used to remove duplicates and organize the citations. Prospective, randomized, or cohort trials comparing surgery versus conservative intervention for patients with LBP conditions. Study selection was conducted by 2 independent reviewers. Three independent reviewers extracted data from each article using a structured data extraction form. Data extracted included type of study, participant characteristics, sample size, description, and duration of conservative care and whether failed conservative care criterion was defined. A total of 852 unique records were screened for eligibility; of those, 72 articles were identified for further full-text review. Thirty-four full texts were excluded based on the exclusion criteria, and 38 articles, representing 20 unique studies, were included for qualitative synthesis. Fifteen of the 20 studies defined the duration of conservative care. Only 3 studies defined the dosage of physical therapy sessions, including total number of visits and visit duration. Two studies described medication usage, including the duration and type. No studies specifically defined what constituted failed conservative therapy. This literature review suggests conservative care is poorly defined in randomized trials, which can lead to ambiguity of research procedures and unclear guidelines for clinicians. Future studies should increase transparency and explicitly define conservative care. Copyright © 2016 American Congress of Rehabilitation Medicine. All rights reserved.

  19. Memantine before Mastectomy Prevents Post-Surgery Pain: A Randomized, Blinded Clinical Trial in Surgical Patients.

    Directory of Open Access Journals (Sweden)

    Véronique Morel

    Full Text Available Neuropathic pain following surgical treatment for breast cancer with or without chemotherapy is a clinical burden and patients frequently report cognitive, emotional and quality of life impairment. A preclinical study recently showed that memantine administered before surgery may prevent neuropathic pain development and cognitive dysfunction. With a translational approach, a clinical trial has been carried out to evaluate whether memantine administered before and after mastectomy could prevent the development of neuropathic pain, the impairment of cognition and quality of life.A randomized, pilot clinical trial included 40 women undergoing mastectomy in the Oncology Department, University Hospital, Clermont-Ferrand, France. Memantine (5 to 20 mg/day; n = 20 or placebo (n = 20 was administered for four weeks starting two weeks before surgery. The primary endpoint was pain intensity measured on a (0-10 numerical rating scale at three months post-mastectomy.Data analyses were performed using mixed models and the tests were two-sided, with a type I error set at α = 0.05. Compared with placebo, patients receiving memantine showed at three months a significant difference in post-mastectomy pain intensity, less rescue analgesia and a better emotional state. An improvement of pain symptoms induced by cancer chemotherapy was also reported.This study shows for the first time the beneficial effect of memantine to prevent post-mastectomy pain development and to diminish chemotherapy-induced pain symptoms. The lesser analgesic consumption and better well-being of patients for at least six months after treatment suggests that memantine could be an interesting therapeutic option to diminish the burden of breast cancer therapy.Clinicaltrials.gov NCT01536314.

  20. Surrendering control, or nothing to lose: Parents' preferences about participation in a randomised trial of childhood strabismus surgery.

    Science.gov (United States)

    Buck, Deborah; Hogan, Vanessa; Powell, Christine J; Sloper, John J; Speed, Chris; Taylor, Robert H; Tiffin, Peter; Clarke, Michael P

    2015-08-01

    Intermittent exotropia is the most common form of divergent strabismus (squint) in children. Evidence regarding its optimum management is limited. A pilot randomised controlled trial has recently been completed (Surgery versus Active Monitoring in Intermittent Exotropia trial) to determine the feasibility of a full randomised controlled trial. To identify drivers for and barriers against parents' participation in Surgery versus Active Monitoring in Intermittent Exotropia and to seek their views on information received, the need for randomisation, and enhancing acceptability. Multiple method qualitative study using semi-structured telephone interviews to explore parents' motivations and trial screening logs to provide an indication of common barriers. Exploratory thematic analysis identified key themes. A total of 48 interviews were conducted (14 participants; 34 non-participants). Barriers included no desire for surgery/preference to 'wait and see', wanting surgery immediately, feeling uncomfortable about 'surrendering control' over decision-making/being managed 'at random', lack of confidence in the effectiveness of surgery, believing the risks outweighed the benefits, and lack of trust. Drivers included desiring surgery, 'nothing to lose', benefits offsetting the risks, and being in a trial would result in better care. Some also mentioned 'doing their bit' for research. Suggestions for enhancing acceptability included allowing choice of treatment group, giving more time for decision-making, expanding on information given, and improving communication. Many felt the necessity of randomisation was adequately explained, but there was some indication that it was misunderstood. Information extracted from the screening logs of 80/89 eligible non-participants indicated the most prevalent barrier was not wanting surgery/preferring to observe (56%), followed by desiring surgery straightaway (15%). Opposition to randomisation/wanting to retain control was recorded in 9% of

  1. Intraoperative Fluid Restriction in Pancreatic Surgery: A Double Blinded Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Ganapathy van Samkar

    Full Text Available Perioperative fluid restriction in a variety of operations has shown improvement of: complications, recovery of gastrointestinal function and length of stay (LOS. We investigated effects of crystalloid fluid restriction in pancreatic surgery. Our hypothesis: enhanced recovery of gastrointestinal function.In this double-blinded randomized trial, patients scheduled to undergo pancreatoduodenectomy (PD were randomized: standard (S:10ml/kg/hr or restricted (R:5ml/kg/hr fluid protocols.gastric emptying scintigraphically assessed on postoperative day 7.In 66 randomized patients, complications and 6-year survival were analyzed. 54 patients were analyzed in intention to treat: 24 S-group and 30 R-group. 32 patients actually underwent a PD and 16 patients had a palliative gastrojejunostomy bypass operation in the full protocol analysis. The median gastric emptying time (T½ was 104 minutes (S-group, 95% confidence interval: 74-369 versus 159 minutes (R-group, 95% confidence interval: 61-204 (P = 0.893, NS. Delayed gastric emptying occurred in 10 patients in the S-group and in 13 patients in the R-group (45% and 50%, P = 0.779, NS. The primary outcome parameter, gastric emptying time, did not show a statistically significant difference between groups.A fluid regimen of 10ml/kg/hr or 5ml/kg/hr during pancreatic surgery did not lead to statistically significant differences in gastric emptying. A larger study would be needed to draw definite conclusions about fluid restriction in pancreatic surgery.ISRCTN62621488.

  2. Dexmedetomidine Versus Propofol Sedation Improves Sublingual Microcirculation After Cardiac Surgery: A Randomized Controlled Trial.

    Science.gov (United States)

    Liu, Xu; Zhang, Kai; Wang, Wei; Xie, Guohao; Cheng, Baoli; Wang, Yan; Hu, Yaoqin; Fang, Xiangming

    2016-12-01

    To compare the effects of dexmedetomidine and propofol on sublingual microcirculation in patients after cardiac surgery. A prospective, randomized, single-blind study. University hospital. Adult patients undergoing elective valve surgery with cardiopulmonary bypass. On arrival in the intensive care unit (ICU), patients were assigned randomly to receive either dexmedetomidine (0.2-1.5 μg/kg/h) or propofol (5-50 μg/kg/min) with open-label titration to a target Richmond Agitation-Sedation Scale of 0 to -3. Sublingual microcirculation was recorded using sidestream dark-field imaging at ICU admission (baseline [T1]) and 4 hours (T2) and 24 hours after ICU admission (T3). At T2, median changes in perfused small-vessel density and the De Backer score from baseline were significantly greater in the dexmedetomidine group (n = 29) than in the propofol group (n = 32) (1.3 v 0 mm/mm(2), p = 0.025; 0.9 v -0.1/mm, p = 0.005, respectively); median changes in small-vessel density and the proportion of perfused small vessels from baseline also tended to be higher in the dexmedetomidine group compared with the propofol group (1.0 v -0.1 mm/mm(2), p = 0.050; 2.1% v 0.5%, p = 0.062, respectively). At T3, there still was a trend toward greater improvements in the small-vessel density, proportion of perfused small-vessels, perfused small-vessel density, and De Backer score from baseline in the dexmedetomidine group than in the propofol group. This trial demonstrated that dexmedetomidine sedation may be better able to improve microcirculation in cardiac surgery patients during the early postoperative period compared with propofol. Copyright © 2016. Published by Elsevier Inc.

  3. Antiplatelet Therapy in Carotid Artery Stenting and Carotid Endarterectomy in the Asymptomatic Carotid Surgery Trial-2.

    Science.gov (United States)

    Huibers, A; Halliday, A; Bulbulia, R; Coppi, G; de Borst, G J

    2016-03-01

    Strokes are infrequent but potentially serious complications following carotid intervention, but antiplatelet therapy can reduce these risks. There are currently no specific guidelines on dose or duration of peri-procedural antiplatelet treatment for patients undergoing carotid intervention. Within the ongoing Asymptomatic Carotid Surgery Trial-2 (ACST-2), this study aimed at assessing the current use of antiplatelet therapy before, during, and after CEA and CAS in patients with asymptomatic carotid stenosis. Questionnaires were sent to ACST-2 collaborators seeking information about the use of antiplatelet therapy during the pre-, peri-, and post-operative periods in patients undergoing carotid intervention at 77 participating sites and also whether sites tested for antiplatelet therapy resistance. The response rate was 68/77 (88%). For CAS, 82% of sites used dual antiplatelet therapy (DAPT) pre-operatively and 86% post-operatively with a mean post-procedural duration of 3 months (range 1-12), while 9% continued DAPT life-long. For CEA only 31% used DAPT pre-operatively, 24% post-operatively with a mean post-procedural duration of 3 months (range 1-5), while 10% continued DAPT life-long. For those prescribing post-procedural mono antiplatelet (MAPT) therapy (76%), aspirin was more commonly prescribed (59%) than clopidogrel (6%) and 11% of centres did not show a preference for either aspirin or clopidogrel. Eleven centres (16%) tested for antiplatelet therapy resistance. There appears to be broad agreement on the use of antiplatelet therapy in ACST-2 patients undergoing carotid artery stenting and surgery. Although evidence to help guide the duration of peri-procedural antiplatelet therapy is limited, long-term treatment with DAPT appears similar between both treatment arms. Copyright © 2015 European Society for Vascular Surgery. Published by Elsevier Ltd. All rights reserved.

  4. Impact of Albumin on Coagulation Competence and Hemorrhage During Major Surgery: A Randomized Controlled Trial.

    Science.gov (United States)

    Rasmussen, Kirsten C; Højskov, Michael; Johansson, Pär I; Kridina, Irina; Kistorp, Thomas; Salling, Lisbeth; Nielsen, Henning B; Ruhnau, Birgitte; Pedersen, Tom; Secher, Niels H

    2016-03-01

    For patients exposed to a massive blood loss during surgery, maintained coagulation competence is important. It is less obvious whether coagulation competence influences bleeding during elective surgery where patients are exposed to infusion of a crystalloid or a colloid. This randomized controlled trial evaluates whether administration of 5% human albumin (HA) or lactated Ringer solution (LR) affects coagulation competence and in turn blood loss during cystectomy due to bladder cancer. Forty patients undergoing radical cystectomy were included to receive either 5% HA (n = 20) or LR (n = 20). Nineteen patients were analyzed in the HA group and 20 patients in the lactated Ringer group. Blinded determination of the blood loss was similar in the 2 groups of patients: 1658 (800-3300) mL with the use of HA and 1472 (700-4330) mL in the lactated Ringer group (P = 0.45). Yet, by thrombelastography (TEG) evaluated coagulation competence, albumin affected clot growth (TEG-angle 69 ± 5 vs 74° ± 3°, P blood loss (P = 0.042) while administration of albumin was related to the changes in TEG-MA (P = 0.029), aPPT (P blood loss as compared to infusion of LR. Also the use of HA did not affect the need for blood transfusion, the incidence of postoperative complications, or the hospital in-stay. Yet, albumin decreases coagulation competence during major surgery and the blood loss is related to TEG-MA rather than to plasma coagulation variables.

  5. Randomized clinical trial of surgery versus conservative therapy for carpal tunnel syndrome [ISRCTN84286481

    Directory of Open Access Journals (Sweden)

    Turner Judith A

    2005-01-01

    Full Text Available Abstract Background Conservative treatment remains the standard of care for treating mild to moderate carpal tunnel syndrome despite a small number of well-controlled studies and limited objective evidence to support current treatment options. There is an increasing interest in the usefulness of wrist magnetic resonance imaging could play in predicting who will benefit for various treatments. Method and design Two hundred patients with mild to moderate symptoms will be recruited over 3 1/2 years from neurological surgery, primary care, electrodiagnostic clinics. We will exclude patients with clinical or electrodiagnostic evidence of denervation or thenar muscle atrophy. We will randomly assign patients to either a well-defined conservative care protocol or surgery. The conservative care treatment will include visits with a hand therapist, exercises, a self-care booklet, work modification/ activity restriction, B6 therapy, ultrasound and possible steroid injections. The surgical care would be left up to the surgeon (endoscopic vs. open with usual and customary follow-up. All patients will receive a wrist MRI at baseline. Patients will be contacted at 3, 6, 9 and 12 months after randomization to complete the Carpal Tunnel Syndrome Assessment Questionnaire (CTSAQ. In addition, we will compare disability (activity and work days lost and general well being as measured by the SF-36 version II. We will control for demographics and use psychological measures (SCL-90 somatization and depression scales as well as EDS and MRI predictors of outcomes. Discussion We have designed a randomized controlled trial which will assess the effectiveness of surgery for patients with mild to moderate carpal tunnel syndrome. An important secondary goal is to study the ability of MRI to predict patient outcomes.

  6. A systematic review of reporting in randomized controlled trials in Dermatologic Surgery: Jadad scores, power analysis, and sample size determination.

    Science.gov (United States)

    Alam, Murad; Rauf, Mutahir; Ali, Sana; Nodzenski, Michael; Minkis, Kira

    2014-12-01

    Dermatologic surgery is a fruitful research area that has spawned numerous randomized control trials (RCTs). To assess the quality of reporting of randomization, blinding, sample size, and power analysis in RCTs published in the journal Dermatologic Surgery. Randomized control trials published in Dermatologic Surgery between 1995 and 2012 were assessed regarding the quality of trial reporting. Data extraction performed independently by 2 data extractors. Dramatic increases in the numbers of RCTs in dermatologic surgery were noted in successive 5-year periods, from 39 in 1995 to 1999 to 66 in 2000 to 2004 and 131 in 2005 to 2009. The median Jadad score for articles from 1995 to 1999 was 1 and was 2 for articles since 2000. Subjects per study were 20 during 1995 to 1999, 25.5 from 2000 to 2004, and over 30 since 2005. Power analysis with sample size determination was reported in 0 articles during 1995 to 1999; greater than 13% of articles since 2005. Alpha level was specified for 37% of RCTs from 1995 to 1999 and 64% to 70% since 2005. During the last 20 years, the number of RCTs in Dermatologic Surgery has grown rapidly, almost doubling every 5 years, because the number of subjects per study has also increased and the quality of reporting has significantly improved.

  7. Sustained postoperative anaemia is associated with an impaired outcome after coronary artery bypass graft surgery : insights from the IMAGINE trial

    NARCIS (Netherlands)

    Westenbrink, B. Daan; Kleijn, Lennaert; de Boer, Rudolf A.; Tijssen, Jan G.; Warnica, Wayne J.; Baillot, Richard; Rouleau, Jean L.; van Gilst, Wiek H.

    2011-01-01

    Objective To investigate the association between sustained postoperative anaemia and outcome after coronary artery bypass graft (CABG) surgery. Design Retrospective analysis of the IMAGINE trial, which tested the effect of the ACE inhibitor quinapril on cardiovascular events after CABG. Setting Thor

  8. Health-related quality of life after laparoscopic and open surgery for rectal cancer in a randomized trial

    DEFF Research Database (Denmark)

    Andersson, J; Angenete, E; Gellerstedt, M

    2013-01-01

    Previous studies comparing laparoscopic and open surgical techniques have reported improved health-related quality of life (HRQL). This analysis compared HRQL 12¿months after laparoscopic versus open surgery for rectal cancer in a subset of a randomized trial....

  9. Value of internal limiting membrane peeling in surgery for idiopathic macular hole stage 2 and 3: a randomised clinical trial

    DEFF Research Database (Denmark)

    Christensen, U C; Krøyer, K; Sander, B

    2009-01-01

    AIM: To determine the effect of internal limiting membrane (ILM) peeling on anatomical and functional success rates in stage 2 and 3 idiopathic macular hole surgery (MHS). METHODS: Randomised clinical trial of stage 2 and 3 idiopathic macular hole without visible epiretinal fibrosis and with less...

  10. Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial (Stent-in 2 study

    Directory of Open Access Journals (Sweden)

    Scholten Pieter

    2007-07-01

    analysis of variance. Mortality will be compared using Kaplan-Meier curves and log-rank statistics. Discussion The Stent-in 2 study is a randomized controlled multicenter trial that will provide evidence whether or not colonic stenting as bridge to surgery is to be performed in patients with acute left-sided colonic obstruction. Trial registration Current Controlled Trials ISRCTN46462267.

  11. Impacts of SST and SST Anomalies on Low-Frequency Oscillation in the Tropical Atmosphere

    Institute of Scientific and Technical Information of China (English)

    HE Jinhai; YU Jingjing; SHEN Xinyong

    2007-01-01

    Considering the multiscale character of LFO (low-frequency oscillation) in the tropical atmosphere, the effects of SST on LFO in the tropical atmosphere are discussed by using an absolute ageostrophic, baroclinic model. Here, SST effects include sea surface heating and forcing of SST anomalies (SSTAs). Studies of the influences of sea surface heating on LFO frequency and stability show that sea surface heating can slow the speed of waves and lower their frequency when SST is comparatively low; while higher SST leads to unstable waves and less periods of LFO. Since the impact of a SSTA on ultra-long waves is more evident than that on kilometer-scale waves, long-wave approximation is used when we continue to study the effect of SSTAs. Results indicate that SSTAs can lead to a longer period of LFO, and make waves unstable. In other words,positive (negative) SSTAs can make waves decay (grow).

  12. Surgery versus Active Monitoring in Intermittent Exotropia (SamExo: study protocol for a pilot randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Buck Deborah

    2012-10-01

    Full Text Available Abstract Background Childhood intermittent exotropia [X(T] is a type of strabismus (squint in which one eye deviates outward at times, usually when the child is tired. It may progress to a permanent squint, loss of stereovision and/or amblyopia (reduced vision. Treatment options for X(T include eye patches, glasses, surgery and active monitoring. There is no consensus regarding how this condition should be managed, and even when surgery is the preferred option clinicians disagree as to the optimal timing. Reports on the natural history of X(T are limited, and there is no randomised controlled trial (RCT evidence on the effectiveness or efficiency of surgery compared with active monitoring. The SamExo (Surgery versus Active Monitoring in Intermittent Exotropia pilot study has been designed to test the feasibility of such a trial in the UK. Methods Design: an external pilot patient randomised controlled trial. Setting: four UK secondary ophthalmology care facilities at Newcastle NHS Hospitals Foundation Trust, Sunderland Eye Infirmary, Moorfields Eye Hospital and York NHS Trust. Participants: children aged between 6 months and 16 years referred with suspected and subsequently diagnosed X(T. Recruitment target is a total of 144 children over a 9-month period, with 120 retained by 9-month outcome visit. Randomisation: permuted blocks stratified by collaborating centre, age and severity of X(T. Interventions: initial clinical assessment; randomisation (eye muscle surgery or active monitoring; 3-, 6- and 9-month (primary outcome clinical assessments; participant/proxy completed questionnaire covering time and travel costs, health services use and quality of life (Intermittent Exotropia Questionnaire; qualitative interviews with parents to establish reasons for agreeing or declining participation in the pilot trial. Outcomes: recruitment and retention rates; nature and extent of participation bias; nature and extent of biases arising from crossover or

  13. Surgery and postoperative radiotherapy versus surgery alone for patients with stage-1 endometrial carcinoma : multicentre randomised trial

    NARCIS (Netherlands)

    Creutzberg, CL; van Putten, WLJ; Koper, PCM; Lybeert, MLM; Jobsen, JJ; Warlam-Rodenhuis, CC; De Winter, KAJ; Lutgens, LCHW; van den Bergh, ACM; van de Steen-Banasik, E; Beerman, H; van Lent, M

    2000-01-01

    Background Postoperative radiotherapy for international Federation of Gynaecology and Obstetrics (FIGO) stage-1 endometrial carcinoma is a subject of controversy due to the low relapse rate and the lack of data from randomised trials. We did a multicentre prospective randomised trial to find whether

  14. Intravenous Magnesium Sulfate to Deliberate Hypotension and Bleeding after Bimaxillary Orthognathic Surgery; A Randomized Double-blind Controlled Trial.

    Science.gov (United States)

    Modanlou Juibari, Hamed; Eftekharian, Hamid Reza; Arabion, Hamid Reza

    2016-09-01

    The preoperative or intraoperative administration of intravenous magnesium sulfate has been approved as an accepted medication for stabilizing hemodynamic indices during surgeries. Intraoperative blood loss during orthognathic surgery is frequently abundant and sometimes requires blood transfusion. The present trial addressed the efficacy of intravenous magnesium sulfate on deliberating hypotension and bleeding reduction in patients undergoing bimaxillary orthognathic surgery. This randomized double-blinded placebo controlled trial was conducted on 52 consecutive patients who underwent orthognathic surgery. The participants were randomly assigned to two groups receiving intravenous magnesium sulfate 30 mg/kg body weight bolus for 15 minutes immediately before anesthesia induction, followed by 10 mg/kg/hr dissolved in saline via pump infusion (n=26) and the second group received placebo as same bolus volume of normal saline in a 15-minute intravenous infusion which was continued until the end of operation (n=26). Both systolic and diastolic blood pressures were measured before anesthesia induction at baseline, during surgery, and at the end of the surgery. Intraoperative blood loss was also determined. Systolic and diastolic blood pressures did not differ between the two groups at baseline. Although a downward trend of both systolic and diastolic blood pressures was seen during the operation in both groups, the decrease in blood pressures occurred with greater gradient in the group administered magnesium sulfate. Assessing difference in the trend of the changes in systolic and diastolic blood pressures between the two study groups (adjusted for gender, age, mean body mass index, and time of surgery) showed different trends in the changes of blood pressures. No differences were observed in blood loss or blood product requirement between the two groups. The administration of intravenous magnesium sulfate can attenuate both systolic and diastolic blood pressures during

  15. Short-term costs of conventional vs laparoscopic assisted surgery in patients with colorectal cancer (MRC CLASICC trial)

    Science.gov (United States)

    Franks, P J; Bosanquet, N; Thorpe, H; Brown, J M; Copeland, J; Smith, A M H; Quirke, P; Guillou, P J

    2006-01-01

    The short-term clinical results of the CLASICC trial indicated that clinical outcomes were similar between laparoscopic and open approaches. This study presents the short-term (3 month) cost analysis undertaken on a subset of patients entered into the CLASICC trial (682 of 794 patients). As expected the costs associated with the operation were higher in the 452 patients randomised to laparoscopic surgery (lap) compared with the 230 randomised to open procedure (open), £1703 vs £1386. This was partially offset by the other hospital (nontheatre) costs, which were lower in the lap group (£2930 vs £3176). The average cost to individuals for reoperations was higher in the lap group (£762 vs £553). Overall costs were slightly higher in the lap group (£6899 vs £6631), with mean difference of £268 (95%CI −689 to 1457). Sensitivity analysis made little difference to these results. The cost of rectal surgery was higher than for colon, for lap (£8259 vs £5586) and open procedures (£7820 vs £5503). The short-term cost analysis for the CLASICC trial indicates that the costs of either laparoscopic or open procedure were similar, lap surgery costing marginally more on average than open surgery. PMID:16755298

  16. Exercise improves quality of life in bariatric surgery candidates: Results from the Bari-Active trial

    Science.gov (United States)

    Bond, Dale S.; Thomas, J. Graham; King, Wendy C.; Vithiananthan, Sivamainthan; Trautvetter, Jennifer; Unick, Jessica L.; Ryder, Beth A.; Pohl, Dieter; Roye, G. Dean; Sax, Harry C.; Wing, Rena R.

    2014-01-01

    OBJECTIVE To examine the impact of a pre-bariatric surgery physical activity intervention (PAI), designed to increase bout-related (≥10-minute) moderate-to-vigorous PA (MVPA), on health-related quality of life (HRQoL). METHODS Analyses included 75 adult participants (86.7% female; BMI=45.0±6.5 kg/m2) who were randomly assigned to 6 weeks of PAI (n=40) or standard pre-surgical care (SC; n=35). PAI received six individual weekly counseling sessions to increase walking exercise. Participants wore an objective PA monitor for 7 days and completed the SF-36 Health Survey at baseline and post-intervention to evaluate bout-related MVPA and HRQoL changes, respectively. RESULTS PAI increased bout-related MVPA from baseline to post-intervention (4.4±5.5 to 21.0±21.4 minutes/day) versus no change (7.9±16.6 to 7.6±11.5 minutes/day) for SC (p=0.001). PAI reported greater improvements than SC on all SF-36 physical and mental scales (p<0.05), except role-emotional. In PAI, better baseline scores on the physical function and general health scales predicted greater bout-related MVPA increases (p<0.05), and greater bout-related MVPA increases were associated with greater post-intervention improvements on the physical function, bodily pain, and general health scales (p<0.05). CONCLUSIONS Increasing PA preoperatively improves physical and mental HRQoL in bariatric surgery candidates. Future studies should examine whether this effect improves surgical safety, weight loss outcomes, and postoperative HRQoL. Trial Registration clinicaltrials.gov Identifier: NCT00962325 PMID:25611582

  17. Influence of perioperative oxygen fraction on pulmonary function after abdominal surgery: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Staehr Anne K

    2012-07-01

    Full Text Available Abstract Background A high perioperative inspiratory oxygen fraction (FiO2 may reduce the frequency of surgical site infection. Perioperative atelectasis is caused by absorption, compression and reduced function of surfactant. It is well accepted, that ventilation with 100% oxygen for only a few minutes is associated with significant formation of atelectasis. However, it is still not clear if a longer period of 80% oxygen results in more atelectasis compared to a low FiO2. Our aim was to assess if a high FiO2 is associated with impaired oxygenation and decreased pulmonary functional residual capacity (FRC. Methods Thirty-five patients scheduled for laparotomy for ovarian cancer were randomized to receive either 30% oxygen (n = 15 or 80% oxygen (n = 20 during and for 2 h after surgery. The oxygenation index (PaO2/FiO2 was measured every 30 min during anesthesia and 90 min after extubation. FRC was measured the day before surgery and 2 h after extubation by a rebreathing method using the inert gas SF6. Results Five min after intubation, the median PaO2/FiO2 was 69 kPa [53-71] in the 30%-group vs. 60 kPa [47-69] in the 80%-group (P = 0.25. At the end of anesthesia, the PaO2/FiO2 was 58 kPa [40-70] vs. 57 kPa [46-67] in the 30%- and 80%-group, respectively (P = 0.10. The median FRC was 1993 mL [1610-2240] vs. 1875 mL [1545-2048] at baseline and 1615 mL [1375-2318] vs. 1633 mL [1343-1948] postoperatively in the 30%- and 80%-group, respectively (P = 0.70. Conclusion We found no significant difference in oxygenation index or functional residual capacity between patients given 80% and 30% oxygen for a period of approximately 5 hours. Trial registration ClinicalTrials.gov Identifier: NCT00637936.

  18. Early Surgery versus Initial Conservative Treatment in Patients with Traumatic Intracerebral Hemorrhage (STITCH[Trauma]): The First Randomized Trial.

    Science.gov (United States)

    Mendelow, A David; Gregson, Barbara A; Rowan, Elise N; Francis, Richard; McColl, Elaine; McNamee, Paul; Chambers, Iain R; Unterberg, Andreas; Boyers, Dwayne; Mitchell, Patrick M

    2015-09-01

    Intraparenchymal hemorrhages occur in a proportion of severe traumatic brain injury TBI patients, but the role of surgery in their treatment is unclear. This international multi-center, patient-randomized, parallel-group trial compared early surgery (hematoma evacuation within 12 h of randomization) with initial conservative treatment (subsequent evacuation allowed if deemed necessary). Patients were randomized using an independent randomization service within 48 h of TBI. Patients were eligible if they had no more than two intraparenchymal hemorrhages of 10 mL or more and did not have an extradural or subdural hematoma that required surgery. The primary outcome measure was the traditional dichotomous split of the Glasgow Outcome Scale obtained by postal questionnaires sent directly to patients at 6 months. The trial was halted early by the UK funding agency (NIHR HTA) for failure to recruit sufficient patients from the UK (trial registration: ISRCTN19321911). A total of 170 patients were randomized from 31 of 59 registered centers worldwide. Of 82 patients randomized to early surgery with complete follow-up, 30 (37%) had an unfavorable outcome. Of 85 patients randomized to initial conservative treatment with complete follow-up, 40 (47%) had an unfavorable outcome (odds ratio, 0.65; 95% confidence interval, CI 0.35, 1.21; p=0.17), with an absolute benefit of 10.5% (CI, -4.4-25.3%). There were significantly more deaths in the first 6 months in the initial conservative treatment group (33% vs. 15%; p=0.006). The 10.5% absolute benefit with early surgery was consistent with the initial power calculation. However, with the low sample size resulting from the premature termination, we cannot exclude the possibility that this could be a chance finding. A further trial is required urgently to assess whether this encouraging signal can be confirmed.

  19. A Meta-analysis of Randomized Trials Comparing Surgery versus Endovascular Therapy for Thrombosed Arteriovenous Fistulas and Grafts in Hemodialysis

    Energy Technology Data Exchange (ETDEWEB)

    Kuhan, G., E-mail: gkuhan@nhs.net; Antoniou, G. A. [Central Manchester University Hospital Foundation Trust, Regional Vascular and Endovascular Unit (United Kingdom); Nikam, M.; Mitra, S. [Central Manchester University Hospital Foundation Trust, Department of Renal Medicine (United Kingdom); Farquharson, F. [Central Manchester University Hospital Foundation Trust, Department of Radiology (United Kingdom); Brittenden, J. [University of Aberdeen (United Kingdom); Chalmers, N. [Central Manchester University Hospital Foundation Trust, Department of Radiology (United Kingdom)

    2013-06-15

    Purpose. To carry out a systematic review of randomized trials comparing surgery vs. endovascular therapy for occluded fistulas and grafts. Methods. All randomized trials which compared surgery and endovascular therapy for occluded fistulas and grafts were retrieved from 1990 onwards. The following search terms were used: 'haemodialysis,' 'thrombosis,' 'arteriovenous fistula,' 'arteriovenous shunt,' 'end stage renal failure' on Medline and PubMed. The results of the pooled data were analysed by a fixed-effect model. Results. There were no randomized trials comparing surgery vs. endovascular therapy for native fistulas and vein grafts. Six randomized studies reporting on 573 occluded grafts were identified. Technical success, need for access line and primary patency at 30 days were similar between the two groups (odds ratio [OR] 1.40, 95 % confidence interval [CI] 0.91-2.14; OR 0.77, 95 % CI 0.44-1.34; and OR 1.15, 95 % CI 0.79-1.68, respectively). There was no significant difference in morbidity at 30 days between groups (OR 1.12, 95 % CI 0.67-1.86). There were no statistical difference between the two groups for 1 year primary patency (OR 2.08, 95 % CI 0.97-4.45). Primary assisted patency at 1 year was better with surgery (OR 3.03, 95 % CI 1.12-8.18) in a single study. Conclusion. Comparable results to surgery have been achieved with endovascular techniques for occluded prosthetic grafts for dialysis access. Long-term data comparing the two groups were lacking. Further trials designed to encompass variation in methods are warranted in order to obtain the best available evidence particularly for native fistulas.

  20. Cardiac rehabilitation increases physical capacity but not mental health after heart valve surgery: a randomised clinical trial.

    Science.gov (United States)

    Sibilitz, Kirstine L; Berg, Selina K; Rasmussen, Trine B; Risom, Signe Stelling; Thygesen, Lau C; Tang, Lars; Hansen, Tina B; Johansen, Pernille Palm; Gluud, Christian; Lindschou, Jane; Schmid, Jean Paul; Hassager, Christian; Køber, Lars; Taylor, Rod S; Zwisler, Ann-Dorthe

    2016-12-15

    The evidence for cardiac rehabilitation after valve surgery remains sparse. Current recommendations are therefore based on patients with ischaemic heart disease. The aim of this randomised clinical trial was to assess the effects of cardiac rehabilitation versus usual care after heart valve surgery. The trial was an investigator-initiated, randomised superiority trial (The CopenHeartVR trial, VR; valve replacement or repair). We randomised 147 patients after heart valve surgery 1:1 to 12 weeks of cardiac rehabilitation consisting of physical exercise and monthly psycho-educational consultations (intervention) versus usual care without structured physical exercise or psycho-educational consultations (control). Primary outcome was physical capacity measured by VO2 peak and secondary outcome was self-reported mental health measured by Short Form-36. 76% were men, mean age 62 years, with aortic (62%), mitral (36%) or tricuspid/pulmonary valve surgery (2%). Cardiac rehabilitation compared with control had a beneficial effect on VO2 peak at 4 months (24.8 mL/kg/min vs 22.5 mL/kg/min, p=0.045) but did not affect Short Form-36 Mental Component Scale at 6 months (53.7 vs 55.2 points, p=0.40) or the exploratory physical and mental outcomes. Cardiac rehabilitation increased the occurrence of self-reported non-serious adverse events (11/72 vs 3/75, p=0.02). Cardiac rehabilitation after heart valve surgery significantly improves VO2 peak at 4 months but has no effect on mental health and other measures of exercise capacity and self-reported outcomes. Further research is needed to justify cardiac rehabilitation in this patient group. NCT01558765, Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  1. Impact of preoperative patient education on prevention of postoperative complications after major visceral surgery: study protocol for a randomized controlled trial (PEDUCAT trial)

    OpenAIRE

    Fink, Christine; Diener, Markus K; Bruckner, Thomas; Müller,Gisela; Paulsen, Lisa; Keller, Monika; Büchler, Markus W; Knebel, Phillip

    2013-01-01

    Background In line with the growing number of surgical procedures being performed worldwide, postoperative complications are also increasing proportionately. Prevention of these postoperative complications is a high medical priority. Preoperative education of patients, including provision of preparatory information about the correct behavior after surgery, could improve the postoperative outcome, but the evidence for this is inconclusive. The aim of the PEDUCAT trial is to evaluate the feasib...

  2. Assessment of data quality in an international multi-centre randomised trial of coronary artery surgery

    Directory of Open Access Journals (Sweden)

    Bochenek Andrzej

    2011-09-01

    Full Text Available Abstract Background ART is a multi-centre randomised trial of cardiac surgery which provided a unique opportunity to evaluate the data from a large number of centres from a variety of countries. We attempted to assess data quality, including recruitment rates, timeliness and completeness of the data obtained from the centres in different socio-economic strata. Methods The analysis was based on the 2-page CRF completed at the 6 week follow-up. CRF pages were categorised into "clean" (no edit query and "dirty" (any incomplete, inconsistent or illegible data. The timelines were assessed on the basis of the time interval from the visit and receipt of complete CRF. Data quality was defined as the number of data queries (in percent and time delay (in days between visit and receipt of correct data. Analyses were stratified according to the World Bank definitions into: "Developing" countries (Poland, Brazil and India and "Developed" (Italy, UK, Austria and Australia. Results There were 18 centres in the "Developed" and 10 centres in the "Developing" countries. The rate of enrolment did not differ significantly by economic level ("Developing":4.1 persons/month, "Developed":3.7 persons/month. The time interval for the receipt of data was longer for "Developing" countries (median:37 days compared to "Developed" ones (median:11 days (p Conclusions In this study we showed that data quality was comparable between centres from "Developed" and "Developing" countries. Data was received in a less timely fashion from Developing countries and appropriate systems should be instigated to minimize any delays. Close attention should be paid to the training of centres and to the central management of data quality. Trial registration ISRCTN46552265

  3. Surgery versus Active Monitoring in Intermittent Exotropia (SamExo): study protocol for a pilot randomised controlled trial.

    Science.gov (United States)

    Buck, Deborah; McColl, Elaine; Powell, Christine J; Shen, Jing; Sloper, John; Steen, Nick; Taylor, Robert; Tiffin, Peter; Vale, Luke; Clarke, Michael P

    2012-10-16

    Childhood intermittent exotropia [X(T)] is a type of strabismus (squint) in which one eye deviates outward at times, usually when the child is tired. It may progress to a permanent squint, loss of stereovision and/or amblyopia (reduced vision). Treatment options for X(T) include eye patches, glasses, surgery and active monitoring. There is no consensus regarding how this condition should be managed, and even when surgery is the preferred option clinicians disagree as to the optimal timing. Reports on the natural history of X(T) are limited, and there is no randomised controlled trial (RCT) evidence on the effectiveness or efficiency of surgery compared with active monitoring. The SamExo (Surgery versus Active Monitoring in Intermittent Exotropia) pilot study has been designed to test the feasibility of such a trial in the UK. an external pilot patient randomised controlled trial. four UK secondary ophthalmology care facilities at Newcastle NHS Hospitals Foundation Trust, Sunderland Eye Infirmary, Moorfields Eye Hospital and York NHS Trust. children aged between 6 months and 16 years referred with suspected and subsequently diagnosed X(T). Recruitment target is a total of 144 children over a 9-month period, with 120 retained by 9-month outcome visit.Randomisation: permuted blocks stratified by collaborating centre, age and severity of X(T). initial clinical assessment; randomisation (eye muscle surgery or active monitoring); 3-, 6- and 9-month (primary outcome) clinical assessments; participant/proxy completed questionnaire covering time and travel costs, health services use and quality of life (Intermittent Exotropia Questionnaire); qualitative interviews with parents to establish reasons for agreeing or declining participation in the pilot trial. recruitment and retention rates; nature and extent of participation bias; nature and extent of biases arising from crossover or loss to follow-up; reasons for agreeing/declining participation; variability of cure rates

  4. Impact of preoperative patient education on prevention of postoperative complications after major visceral surgery: study protocol for a randomized controlled trial (PEDUCAT trial).

    Science.gov (United States)

    Fink, Christine; Diener, Markus K; Bruckner, Thomas; Müller, Gisela; Paulsen, Lisa; Keller, Monika; Büchler, Markus W; Knebel, Phillip

    2013-08-26

    In line with the growing number of surgical procedures being performed worldwide, postoperative complications are also increasing proportionately. Prevention of these postoperative complications is a high medical priority. Preoperative education of patients, including provision of preparatory information about the correct behavior after surgery, could improve the postoperative outcome, but the evidence for this is inconclusive. The aim of the PEDUCAT trial is to evaluate the feasibility and the impact of preoperative patient education on postoperative morbidity, mortality and quality of life in patients scheduled for elective major visceral surgery. PEDUCAT is designed as a cluster-randomized controlled pilot study. The experimental group will visit a standardized preoperative seminar to learn how best to behave after surgery in addition to being given a standard information brochure, whereas the control group will only receive the information brochure. Outcome measures such as postoperative morbidity, postoperative pain, postoperative anxiety and depression, patient satisfaction, quality of life, length of hospital stay and postoperative mortality will be evaluated. Statistical analysis will be based on the intention-to-treat population. Analysis of covariance will be applied for the intervention group comparison, adjusting for age, center and quality of life before surgery. This is a pilot study to show the feasibility of the concept. Nevertheless, the planned sample size of n = 204 is large enough to show an effect with power of 90% and a significance level of 5%. German Clinical Trial Register number: DRKS00004226.

  5. Twenty-year perspective of randomized controlled trials for surgery of chronic nonspecific low back pain: citation bias and tangential knowledge.

    Science.gov (United States)

    Andrade, Nicholas S; Flynn, John P; Bartanusz, Viktor

    2013-11-01

    After decades of clinical research, the role of surgery for chronic nonspecific low back pain (CNLBP) remains equivocal. Despite significant intellectual, human, and economic investments into randomized controlled trials (RCTs) in the past two decades, the role of surgery in the treatment for CNLBP has not been clarified. To delineate the historical research agenda of surgical RCTs for CNLBP performed between 1993 and 2012 investigating whether conclusions from earlier published trials influenced the choice of research questions of subsequent RCTs on elucidating the role of surgery in the management of CNLBP. Literature review. We searched the literature for all RCTs involving surgery for CNLBP. We reviewed relevant studies to identify the study question, comparator arms, and sample size. Randomized controlled trials were classified as "indication" trials if they evaluated the effectiveness of surgical therapy versus nonoperative care or as "technical" if they compared different surgical techniques, adjuncts, or procedures. We used citation analysis to determine the impact of trials on subsequent research in the field. Altogether 33 technical RCTs (3,790 patients) and 6 indication RCTs (981 patients) have been performed. Since 2007, despite the unclear benefits of surgery reported by the first four indication trials published in 2001 to 2006, technical trials have continued to predominate (16 vs. 2). Of the technical trials, types of instrumentation (13 trials, 1,332 patients), bone graft materials and substitutes (11 trials, 833 patients), and disc arthroplasty versus fusion (5 trials, 1,337 patients) were the most common comparisons made. Surgeon authors have predominantly cited one of the indication trials that reported more favorable results for surgery, despite a lack of superior methodology or sample size. Trials evaluating bone morphogenic protein, instrumentation, and disc arthroplasty were all cited more frequently than the largest trial of surgical versus

  6. The role of surgery for treatment of low back pain: insights from the randomized controlled Spine Patient Outcomes Research Trials

    Directory of Open Access Journals (Sweden)

    Peter Abraham

    2016-01-01

    Full Text Available Low back pain (LBP is a common medical problem with high morbidity and healthcare costs. The optimal management strategy, including the role of surgical intervention, remains controversial. The Spine Patient Outcomes Research Trials were randomized controlled studies conducted to assess the effectiveness of surgery for three of the most common conditions implicated in LBP: Intervertebral disc herniation, degenerative spondylolisthesis, and spinal stenosis. Despite challenges in data interpretation related to patient cross over, these studies support the efficacy of surgery as treatment for these three common conditions.

  7. A comparative effectiveness trial of postoperative management for lumbar spine surgery: changing behavior through physical therapy (CBPT) study protocol.

    Science.gov (United States)

    Archer, Kristin R; Coronado, Rogelio A; Haug, Christine M; Vanston, Susan W; Devin, Clinton J; Fonnesbeck, Christopher J; Aaronson, Oran S; Cheng, Joseph S; Skolasky, Richard L; Riley, Lee H; Wegener, Stephen T

    2014-10-01

    The United States has the highest rate of lumbar spine surgery in the world, with rates increasing over 200% since 1990. Medicare spends over $1 billion annually on lumbar spine surgery. Despite surgical advances, up to 40% of patients report chronic pain and disability following surgery. Our work has demonstrated that fear of movement is a risk factor for increased pain and disability and decreased physical function in patients following lumbar spine surgery for degenerative conditions. Cognitive-behavioral therapy and self-management treatments have the potential to address psychosocial risk factors and improve outcomes after spine surgery, but are unavailable or insufficiently adapted for postoperative care. Our research team developed a cognitive-behavioral based self-management approach to postoperative rehabilitation (Changing Behavior through Physical Therapy (CBPT)). Pilot testing of the CBPT program demonstrated greater improvement in pain, disability, physical and mental health, and physical performance compared to education. The current study compares which of two treatments provided by telephone - a CBPT Program or an Education Program about postoperative recovery - are more effective for improving patient-centered outcomes in adults following lumbar spine surgery for degenerative conditions. A multi-center, comparative effectiveness trial will be conducted. Two hundred and sixty patients undergoing lumbar spine surgery for degenerative conditions will be recruited from two medical centers and community surgical practices. Participants will be randomly assigned to CBPT or Education at 6 weeks following surgery. Treatments consist of six weekly telephone sessions with a trained physical therapist. The primary outcome will be disability and secondary outcomes include pain, general health, and physical activity. Outcomes will be assessed preoperatively and at 6 weeks, 6 months and 12 months after surgery by an assessor masked to group allocation

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

    Science.gov (United States)

    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.

  9. Randomized controlled trials of maternal-fetal surgery: a challenge to clinical equipoise.

    Science.gov (United States)

    Rodrigues, H C M L; van den Berg, P P

    2014-10-01

    This article focuses on maternal-fetal surgery (MFS) and on the concept of clinical equipoise that is a widely accepted requirement for conducting randomized controlled trials (RCT). There are at least three reasons why equipoise is unsuitable for MFS. First, the concept is based on a misconception about the nature of clinical research and the status of research subjects. Second, given that it is not clear who the research subject/s in MFS is/are, if clinical equipoise is to be used as a criterion to test the ethical appropriateness of RCT, its meaning should be unambiguous. Third, because of the multidisciplinary character of MFS, it is not clear who should be in equipoise. As a result, we lack an adequate criterion for the ethical review of MFS protocols. In our account, which is based on Chervenak and McCullough's seminal work in the field of obstetric ethics, equipoise is abandoned. and RCT involving MFS can be ethically initiated when a multidisciplinary ethics review board (ERB), having an evidence-based assessment of the risks involved, is convinced that the value of answering the research hypothesis, for the sake of the health interests of future pregnant women carrying fetuses with certain congenital birth defects, justifies the actual risks research participants might suffer within a set limit of low/manageable.

  10. Assessment of data quality in an international multi-centre randomised trial of coronary artery surgery.

    Science.gov (United States)

    Krzych, Lukasz J; Lees, Belinda; Nugara, Fiona; Banya, Winston; Bochenek, Andrzej; Cook, Jo; Taggart, David; Flather, Marcus D

    2011-09-26

    ART is a multi-centre randomised trial of cardiac surgery which provided a unique opportunity to evaluate the data from a large number of centres from a variety of countries. We attempted to assess data quality, including recruitment rates, timeliness and completeness of the data obtained from the centres in different socio-economic strata. The analysis was based on the 2-page CRF completed at the 6 week follow-up. CRF pages were categorised into "clean" (no edit query) and "dirty" (any incomplete, inconsistent or illegible data). The timelines were assessed on the basis of the time interval from the visit and receipt of complete CRF. Data quality was defined as the number of data queries (in percent) and time delay (in days) between visit and receipt of correct data. Analyses were stratified according to the World Bank definitions into: "Developing" countries (Poland, Brazil and India) and "Developed" (Italy, UK, Austria and Australia). There were 18 centres in the "Developed" and 10 centres in the "Developing" countries. The rate of enrolment did not differ significantly by economic level ("Developing":4.1 persons/month, "Developed":3.7 persons/month). The time interval for the receipt of data was longer for "Developing" countries (median:37 days) compared to "Developed" ones (median:11 days) (p central management of data quality. ISRCTN46552265.

  11. [Evaluation of a Micro-Manipulator for Middle Ear Surgery: A Preclinical Trial].

    Science.gov (United States)

    Peschka, A; Berger, Th; Maier, Th; Scholz, M; Lüth, T C; Strauß, G

    2016-02-01

    Microsurgical preparation is limited by geometric and mechanical constraints. In preparation for clinical use, this study investigates performance, ease of handling and precision of a novel manipulator concept for microsurgery. A group of 15 ENT experienced doctors, as well as a group of 17 medical students with low/non surgical experience participated in the study. Each of the subjects carried out 4 trials of simulated surgeries on a phantom with built-in force sensors. The task was to apply a defined force between 1.5 and 2 N using a Fisch micro perforator, 16 cm length, 0.4 mm (Storz) targeting holes with a diameter of 0.5 mm. For comparison, the Fisch micro perforator was moved manually or with the manipulator. Assessing the total number of errors proved a significantly lower error number (pmanipulator. The time requirement for the procedure with the micro manipulator is on average 2-3 times higher than with manual control (pmanipulator concept compared to the non-augmented human hand in an experimental setup. We observed a significant learning effect when subjects applied the micro manipulator, resulting in reduction of the time requirement while maintaining a constant number of errors. © Georg Thieme Verlag KG Stuttgart · New York.

  12. Day-case stapes surgery : Day-case versus inpatient stapes surgery for otosclerosis: a randomized controlled trial

    NARCIS (Netherlands)

    Derks, Laura S M; Wegner, Inge; Tange, RA; Kamalski, Digna M A; Grolman, Wilko

    2016-01-01

    BACKGROUND: Otosclerosis is characterized by bony deposits in the otic capsule, resulting in stapes fixation and progressive hearing loss. It can be treated effectively by surgically removing (part of) the stapes and replacing it with a prosthesis. Increasingly, stapes surgery is performed as a day-

  13. Assessment of patient-specific surgery effect based on weighted estimation and propensity scoring in the re-analysis of the sciatica trial.

    Directory of Open Access Journals (Sweden)

    Bart J A Mertens

    Full Text Available We consider a re-analysis of the wait-and-see (control arm of a recent clinical trial on sciatica. While the original randomised trial was designed to evaluate the public policy effect of a conservative wait-and-see approach versus early surgery, we investigate the impact of surgery at the individual patient level in a re-analysis of the wait-and-see group data. Both marginal structural model re-weighted estimates as well as propensity score adjusted analyses are presented. Results indicate that patients with high propensity to receive surgery may have beneficial effects at 2 years from delayed disc surgery.

  14. Improved VIIRS and MODIS SST Imagery

    Directory of Open Access Journals (Sweden)

    Irina Gladkova

    2016-01-01

    Full Text Available Moderate Resolution Imaging Spectroradiometers (MODIS and Visible Infrared Imaging Radiometer Suite (VIIRS radiometers, flown onboard Terra/Aqua and Suomi National Polar-orbiting Partnership (S-NPP/Joint Polar Satellite System (JPSS satellites, are capable of providing superior sea surface temperature (SST imagery. However, the swath data of these multi-detector sensors are subject to several artifacts including bow-tie distortions and striping, and require special pre-processing steps. VIIRS additionally does two irreversible data reduction steps onboard: pixel aggregation (to reduce resolution changes across the swath and pixel deletion, which complicate both bow-tie correction and destriping. While destriping was addressed elsewhere, this paper describes an algorithm, adopted in the National Oceanic and Atmospheric Administration (NOAA Advanced Clear-Sky Processor for Oceans (ACSPO SST system, to minimize the bow-tie artifacts in the SST imagery and facilitate application of the pattern recognition algorithms for improved separation of ocean from cloud and mapping fine SST structure, especially in the dynamic, coastal and high-latitude regions of the ocean. The algorithm is based on a computationally fast re-sampling procedure that ensures a continuity of corresponding latitude and longitude arrays. Potentially, Level 1.5 products may be generated to benefit a wide range of MODIS and VIIRS users in land, ocean, cryosphere, and atmosphere remote sensing.

  15. PXL01 in sodium hyaluronate for improvement of hand recovery after flexor tendon repair surgery: randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Monica E Wiig

    Full Text Available Postoperative adhesions constitute a substantial clinical problem in hand surgery. Fexor tendon injury and repair result in adhesion formation around the tendon, which restricts the gliding function of the tendon, leading to decreased digit mobility and impaired hand recovery. This study evaluated the efficacy and safety of the peptide PXL01 in preventing adhesions, and correspondingly improving hand function, in flexor tendon repair surgery.This prospective, randomised, double-blind trial included 138 patients admitted for flexor tendon repair surgery. PXL01 in carrier sodium hyaluronate or placebo was administered around the repaired tendon. Efficacy was assessed by total active motion of the injured finger, tip-to-crease distance, sensory function, tenolysis rate and grip strength, and safety parameters were followed, for 12 months post-surgery.The most pronounced difference between the treatment groups was observed at 6 months post-surgery. At this timepoint, the total active motion of the distal finger joint was improved in the PXL01 group (60 vs. 41 degrees for PXL01 vs. placebo group, p = 0.016 in PPAS. The proportion of patients with excellent/good digit mobility was higher in the PXL01 group (61% vs. 38%, p = 0.0499 in PPAS. Consistently, the PXL01 group presented improved tip-to-crease distance (5.0 vs. 15.5 mm for PXL01 vs. placebo group, p = 0.048 in PPAS. Sensory evaluation showed that more patients in the PXL01 group felt the thinnest monofilaments (FAS: 74% vs. 35%, p = 0.021; PPAS: 76% vs. 35%, p = 0.016. At 12 months post-surgery, more patients in the placebo group were considered to benefit from tenolysis (30% vs. 12%, p = 0.086 in PPAS. The treatment was safe, well tolerated, and did not increase the rate of tendon rupture.Treatment with PXL01 in sodium hyaluronate improves hand recovery after flexor tendon repair surgery. Further clinical trials are warranted to determine the most efficient dose and

  16. PXL01 in sodium hyaluronate for improvement of hand recovery after flexor tendon repair surgery: randomized controlled trial.

    Science.gov (United States)

    Wiig, Monica E; Dahlin, Lars B; Fridén, Jan; Hagberg, Lars; Larsen, Sören E; Wiklund, Kerstin; Mahlapuu, Margit

    2014-01-01

    Postoperative adhesions constitute a substantial clinical problem in hand surgery. Fexor tendon injury and repair result in adhesion formation around the tendon, which restricts the gliding function of the tendon, leading to decreased digit mobility and impaired hand recovery. This study evaluated the efficacy and safety of the peptide PXL01 in preventing adhesions, and correspondingly improving hand function, in flexor tendon repair surgery. This prospective, randomised, double-blind trial included 138 patients admitted for flexor tendon repair surgery. PXL01 in carrier sodium hyaluronate or placebo was administered around the repaired tendon. Efficacy was assessed by total active motion of the injured finger, tip-to-crease distance, sensory function, tenolysis rate and grip strength, and safety parameters were followed, for 12 months post-surgery. The most pronounced difference between the treatment groups was observed at 6 months post-surgery. At this timepoint, the total active motion of the distal finger joint was improved in the PXL01 group (60 vs. 41 degrees for PXL01 vs. placebo group, p = 0.016 in PPAS). The proportion of patients with excellent/good digit mobility was higher in the PXL01 group (61% vs. 38%, p = 0.0499 in PPAS). Consistently, the PXL01 group presented improved tip-to-crease distance (5.0 vs. 15.5 mm for PXL01 vs. placebo group, p = 0.048 in PPAS). Sensory evaluation showed that more patients in the PXL01 group felt the thinnest monofilaments (FAS: 74% vs. 35%, p = 0.021; PPAS: 76% vs. 35%, p = 0.016). At 12 months post-surgery, more patients in the placebo group were considered to benefit from tenolysis (30% vs. 12%, p = 0.086 in PPAS). The treatment was safe, well tolerated, and did not increase the rate of tendon rupture. Treatment with PXL01 in sodium hyaluronate improves hand recovery after flexor tendon repair surgery. Further clinical trials are warranted to determine the most efficient dose and health

  17. A Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate: 1. Planning and management.

    Science.gov (United States)

    Semb, Gunvor; Enemark, Hans; Friede, Hans; Paulin, Gunnar; Lilja, Jan; Rautio, Jorma; Andersen, Mikael; Åbyholm, Frank; Lohmander, Anette; Shaw, William; Mølsted, Kirsten; Heliövaara, Arja; Bolund, Stig; Hukki, Jyri; Vindenes, Hallvard; Davenport, Peter; Arctander, Kjartan; Larson, Ola; Berggren, Anders; Whitby, David; Leonard, Alan; Neovius, Erik; Elander, Anna; Willadsen, Elisabeth; Bannister, R Patricia; Bradbury, Eileen; Henningsson, Gunilla; Persson, Christina; Eyres, Philip; Emborg, Berit; Kisling-Møller, Mia; Küseler, Annelise; Granhof Black, Birthe; Schöps, Antje; Bau, Anja; Boers, Maria; Andersen, Helene Søgaard; Jeppesen, Karin; Marxen, Dorte; Paaso, Marjukka; Hölttä, Elina; Alaluusua, Suvi; Turunen, Leena; Humerinta, Kirsti; Elfving-Little, Ulla; Tørdal, Inger Beate; Kjøll, Lillian; Aukner, Ragnhild; Hide, Øydis; Feragen, Kristin Billaud; Rønning, Elisabeth; Skaare, Pål; Brinck, Eli; Semmingsen, Ann-Magritt; Lindberg, Nina; Bowden, Melanie; Davies, Julie; Mooney, Jeanette; Bellardie, Haydn; Schofield, Nina; Nyberg, Jill; Lundberg, Maria; Karsten, Agneta Linder-Aronson; Larson, Margareta; Holmefjord, Anders; Reisæter, Sigvor; Pedersen, Nina-Helen; Rasmussen, Therese; Tindlund, Rolf; Sæle, Paul; Blomhoff, Reidunn; Jacobsen, Gry; Havstam, Christina; Rizell, Sara; Enocson, Lars; Hagberg, Catharina; Najar Chalien, Midia; Paganini, Anna; Lundeborg, Inger; Marcusson, Agneta; Mjönes, Anna-Britta; Gustavsson, Annica; Hayden, Christine; McAleer, Eilish; Slevan, Emma; Gregg, Terry; Worthington, Helen

    2017-02-01

    Longstanding uncertainty surrounds the selection of surgical protocols for the closure of unilateral cleft lip and palate, and randomised trials have only rarely been performed. This paper is an introduction to three randomised trials of primary surgery for children born with complete unilateral cleft lip and palate (UCLP). It presents the protocol developed for the trials in CONSORT format, and describes the management structure that was developed to achieve the long-term engagement and commitment required to complete the project. Ten established national or regional cleft centres participated. Lip and soft palate closure at 3-4 months, and hard palate closure at 12 months served as a common method in each trial. Trial 1 compared this with hard palate closure at 36 months. Trial 2 compared it with lip closure at 3-4 months and hard and soft palate closure at 12 months. Trial 3 compared it with lip and hard palate closure at 3-4 months and soft palate closure at 12 months. The primary outcomes were speech and dentofacial development, with a series of perioperative and longer-term secondary outcomes. Recruitment of 448 infants took place over a 9-year period, with 99.8% subsequent retention at 5 years. The series of reports that follow this introductory paper include comparisons at age 5 of surgical outcomes, speech outcomes, measures of dentofacial development and appearance, and parental satisfaction. The outcomes recorded and the numbers analysed for each outcome and time point are described in the series. ISRCTN29932826.

  18. Ear Acupuncture for Post-Operative Pain Associated with Ambulatory Arthroscopic Knee Surgery: A Randomized Controlled Trial

    Science.gov (United States)

    2014-01-14

    E7(/(3+21(180%(5 ,QFOXGHDUHDFRGH 14 Jan 2014 Final Report Ear acupuncture for post-operative pain associated with ambulatory arthroscopic...DISTRIBUTION A. Approved for public release: distribution unlimited. The purpose of this study is to compare ear acupuncture plus standard therapy versus...3298 Ear Acupuncture for Post-operative Pa111 Assoc1ated With Ambulatory Arthroscopic Knee Surgery A Randomized Controlled Trial ’• V ’’ ’-’ I

  19. Brief smoking cessation intervention in relation to breast cancer surgery: a randomized controlled trial

    DEFF Research Database (Denmark)

    Thomsen, Thordis; Tønnesen, Hanne; Okholm, Mette;

    2010-01-01

    Smokers are more prone to develop postoperative complications. Smoking cessation intervention beginning 4-8 weeks prior to surgery improves the postoperative outcome. Cancer patients, however, often undergo surgery less than 4 weeks after diagnosis. The primary objective of this study was therefore...... to examine if a brief smoking cessation intervention shortly before breast cancer surgery would influence postoperative complications and smoking cessation....

  20. [Randomized controlled trial on the effectiveness of Corpitolinol 60 in the prevention of pressure sores in patients undergoing surgery].

    Science.gov (United States)

    Chiari, Paolo; Giorgi, Sabina; Ugolini, Daniela; Montanari, Morena; Giudanella, Pietro; Gramantieri, Antonella; Collesi, Franca; Pau, Michelina; Smaldone, Maddalena; Matarasso, Maddalena; Mazzini, Cinzia; Russo, Francesca; Gazineo, Domenica; Fontana, Mirella; Taddia, Patrizia

    2012-01-01

    Randomized controlled trial on the effectiveness of Corpitolinol 60 in the prevention of pressure sores in surgical patients. The risk of pressure sores in surgical patients is widely recognised. The Corpitolinol 60 (Sanyréne®) applied on compressed areas seems to reduce the risk of pressure sores. To assess the efficacy of Corpitolinol 60 in preventing pressure sores in the operatory theatre. The open label randomized clinical trial was conducted in 5 operating theatres of Northen Italy. Patients were randomized to receive Corpitolinol 60 in areas undergoing compression. Experimental group and controls were treated with usual measures for preventing pressure sores. The lesions were staged according to NPUAP up to 24 hours after surgery. Three-hundred-one patients were randomized (155 in the Sanyréne® group and 143 controls). The main variables predictive of pressure sores risk (ASA class, sex, age, duration of the surgery, and BMI) were comparable across groups. At the end of the surgery 71 patients (23.8%) in the experimental group and 47 controls (30.8%) had a pressure sore (p 0.006; RR 1.81 IC95% 1.17-2.79). Twelve and 24 hours after surgery the differences between groups were not significant. The aim of reducing pressure sores was not reached for patients treated with Corpitolinol 60.

  1. Protocol design and current status of CLIVIT: a randomized controlled multicenter relevance trial comparing clips versus ligatures in thyroid surgery

    Directory of Open Access Journals (Sweden)

    Wollermann C

    2006-09-01

    Full Text Available Abstract Background Annually, more than 90000 surgical procedures of the thyroid gland are performed in Germany. Strategies aimed at reducing the duration of the surgical procedure are relevant to patients and the health care system especially in the context of reducing costs. However, new techniques for quick and safe hemostasis have to be tested in clinically relevance randomized controlled trials before a general recommendation can be given. The current standard for occlusion of blood vessels in thyroid surgery is ligatures. Vascular clips may be a safe alternative but have not been investigated in a large RCT. Methods/design CLIVIT (Clips versus Ligatures in Thyroid Surgery is an investigator initiated, multicenter, patient-blinded, two-group parallel relevance randomized controlled trial designed by the Study Center of the German Surgical Society. Patients scheduled for elective resection of at least two third of the gland for benign thyroid disease are eligible for participation. After surgical exploration patients are randomized intraoperatively into either the conventional ligature group, or into the clip group. The primary objective is to test for a relevant reduction in operating time (at least 15 min when using the clip technique. Since April 2004, 121 of the totally required 420 patients were randomized in five centers. Discussion As in all trials the different forms of bias have to be considered, and as in this case, a surgical trial, the role of surgical expertise plays a key role, and will be documented and analyzed separately. This is the first randomized controlled multicenter relevance trial to compare different vessel occlusion techniques in thyroid surgery with adequate power and other detailed information about the design as well as framework. If significant, the results might be generalized and may change the current surgical practice.

  2. Benefits of post-operative oral protein supplementation in gastrointestinal surgery patients: A systematic review of clinical trials

    Institute of Scientific and Technical Information of China (English)

    Mike Crickmer; Colum P Dunne; Andrew O’Regan; J Calvin Coffey; Suzanne S Dunne

    2016-01-01

    AIM: To evaluate published trials examining oral postoperative protein supplementation in patients having undergone gastrointestinal surgery and assessment of reported results.METHODS: Database searches(MEDLINE, BIOSIS, EMBASE, Cochrane Trials, Cinahl, and CAB), searches of reference lists of relevant papers, and expert referral were used to identify prospective randomized controlled clinical trials. The following terms were used to locate articles: "oral’’ or "enteral’’ and "postoperative care’’ or "post-surgical’’ and "proteins’ ’ or "milk proteins’ ’ or "dietary proteins’ ’ or "dietary supplements’ ’ or "nutritional supplements’ ’. In databases that allowed added limitations, results were limited to clinical trials that studied humans, and publications between 1990 and 2014. Quality of collated studies was evaluated using a qualitative assessment tool and the collective results interpreted.RESULTS: Searches identified 629 papers of which, following review, 7 were deemed eligible for qualitative evaluation. Protein supplementation does not appear to affect mortality but does reduce weight loss, and improve nutritional status. Reduction in grip strength deterioration was observed in a majority of studies, and approximately half of the studies described reduced complication rates. No changes in duration of hospital stay or plasma protein levels were reported. There is evidence to suggest that protein supplementation should be routinely provided post-operatively to this population. However, despite comprehensive searches, clinical trials that varied only the amount of protein provided via oral nutritional supplements(discrete from other nutritionalcomponents) were not found. At present, there is some evidence to support routinely prescribed oral nutritional supplements that contain protein for gastrointestinal surgery patients in the immediate post-operative stage.CONCLUSION: The optimal level of protein supplementation required

  3. Prolonged conservative treatment or 'early' surgery in sciatica caused by a lumbar disc herniation: Rationale and design of a randomized trial [ISRCT 26872154

    NARCIS (Netherlands)

    W.C. Peul (Wilco); H.C. van Houwelingen (Hans); W.B. van den Hout (Wilbert); R. Brand (René); J.A.H. Eekhof (Just); J.T.J. Tans (Th); R.T.W.M. Thomeer (Raph); B.W. Koes (Bart)

    2005-01-01

    textabstractBackground: The design of a randomized multicenter trial is presented on the effectiveness of a prolonged conservative treatment strategy compared with surgery in patients with persisting intense sciatica (lumbosacral radicular syndrome). Methods/design: Patients presenting themselves to

  4. Prolonged conservative care versus early surgery in patients with sciatica from lumbar disc herniation : cost utility analysis alongside a randomised controlled trial

    NARCIS (Netherlands)

    Hout, van den W.B.; Peul, W.C.; Koes, B.W.; Brand, R.; Kievit, J.; Thomeer, R.T.W.M.

    2008-01-01

    Objective: To determine whether the faster recovery after early surgery for sciatica compared with prolonged conservative care is attained at reasonable costs. Design: Cost utility analysis alongside a randomised controlled trial. Setting: Nine Dutch hospitals. Participants: 283 patients with sciati

  5. Prolonged conservative care versus early surgery in patients with sciatica from lumbar disc herniation: cost utility analysis alongside a randomised controlled trial.

    NARCIS (Netherlands)

    Hout, W.B. van den; Peul, W.C.; Koes, B.W.; Brand, R.; Kievit, J.; Thomeer, R.T.

    2008-01-01

    OBJECTIVE: To determine whether the faster recovery after early surgery for sciatica compared with prolonged conservative care is attained at reasonable costs. DESIGN: Cost utility analysis alongside a randomised controlled trial. SETTING: Nine Dutch hospitals. PARTICIPANTS: 283 patients with sciati

  6. Robust GEFA Assessment of Climate Feedback to SST EOF Modes

    Institute of Scientific and Technical Information of China (English)

    FAN Lei; Zhengyu LIU; LIU Qinyu

    2011-01-01

    Atmospheric response to SST variability was estimated using generalized equilibrium feedback analysis (GEFA) in the SST EOF space with synthesis data from an idealized climate model. Results show that the GEFA atmospheric response to the leading SST EOF modes is much more accurate and robust than the GEFA feedback matrix in physical space. Therefore, GEFA provides a practical method for assessing atmospheric response to large-scale SST anomalies in terms of the leading EOFs.

  7. A stepped strategy that aims at the nationwide implementation of the Enhanced Recovery After Surgery programme in major gynaecological surgery: study protocol of a cluster randomised controlled trial.

    Science.gov (United States)

    de Groot, Jeanny Ja; Maessen, José Mc; Slangen, Brigitte Fm; Winkens, Bjorn; Dirksen, Carmen D; van der Weijden, Trudy

    2015-07-30

    Enhanced Recovery After Surgery (ERAS) programmes aim at an early recovery after surgical trauma and consequently at a reduced length of hospitalisation. This paper presents the protocol for a study that focuses on large-scale implementation of the ERAS programme in major gynaecological surgery in the Netherlands. The trial will evaluate effectiveness and costs of a stepped implementation approach that is characterised by tailoring the intensity of implementation activities to the needs of organisations and local barriers for change, in comparison with the generic breakthrough strategy that is usually applied in large-scale improvement projects in the Netherlands. All Dutch hospitals authorised to perform major abdominal surgery in gynaecological oncology patients are eligible for inclusion in this cluster randomised controlled trial. The hospitals that already fully implemented the ERAS programme in their local perioperative management or those who predominantly admit gynaecological surgery patients to an external hospital replacement care facility will be excluded. Cluster randomisation will be applied at the hospital level and will be stratified based on tertiary status. Hospitals will be randomly assigned to the stepped implementation strategy or the breakthrough strategy. The control group will receive the traditional breakthrough strategy with three educational sessions and the use of plan-do-study-act cycles for planning and executing local improvement activities. The intervention group will receive an innovative stepped strategy comprising four levels of intensity of support. Implementation starts with generic low-cost activities and may build up to the highest level of tailored and labour-intensive activities. The decision for a stepwise increase in intensive support will be based on the success of implementation so far. Both implementation strategies will be completed within 1 year and evaluated on effect, process, and cost-effectiveness. The primary

  8. Non-inferiority of short-term urethral catheterization following fistula repair surgery: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Barone Mark A

    2012-03-01

    Full Text Available Abstract Background A vaginal fistula is a devastating condition, affecting an estimated 2 million girls and women across Africa and Asia. There are numerous challenges associated with providing fistula repair services in developing countries, including limited availability of operating rooms, equipment, surgeons with specialized skills, and funding from local or international donors to support surgeries and subsequent post-operative care. Finding ways of providing services in a more efficient and cost-effective manner, without compromising surgical outcomes and the overall health of the patient, is paramount. Shortening the duration of urethral catheterization following fistula repair surgery would increase treatment capacity, lower costs of services, and potentially lower risk of healthcare-associated infections among fistula patients. There is a lack of empirical evidence supporting any particular length of time for urethral catheterization following fistula repair surgery. This study will examine whether short-term (7 day urethral catheterization is not worse by more than a minimal relevant difference to longer-term (14 day urethral catheterization in terms of incidence of fistula repair breakdown among women with simple fistula presenting at study sites for fistula repair service. Methods/Design This study is a facility-based, multicenter, non-inferiority randomized controlled trial (RCT comparing the new proposed short-term (7 day urethral catheterization to longer-term (14 day urethral catheterization in terms of predicting fistula repair breakdown. The primary outcome is fistula repair breakdown up to three months following fistula repair surgery as assessed by a urinary dye test. Secondary outcomes will include repair breakdown one week following catheter removal, intermittent catheterization due to urinary retention and the occurrence of septic or febrile episodes, prolonged hospitalization for medical reasons, catheter blockage, and

  9. Epidural versus intravenous fentanyl for postoperative analgesia following orthopedic surgery: randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Marcelo Soares Privado

    Full Text Available CONTEXT AND OBJECTIVE: Controversy exists regarding the site of action of fentanyl after epidural injection. The objective of this investigation was to compare the efficacy of epidural and intravenous fentanyl for orthopedic surgery. DESIGN AND SETTING: A randomized double-blind study was performed in Hospital São Paulo. METHODS: During the postoperative period, in the presence of pain, 29 patients were divided into two groups: group 1 (n = 14 received 100 µg of fentanyl epidurally and 2 ml of saline intravenously; group 2 (n = 15 received 5 ml of saline epidurally and 100 µg of fentanyl intravenously. The analgesic supplementation consisted of 40 mg of tenoxicam intravenously and, if necessary, 5 ml of 0.25% bupivacaine epidurally. Pain intensity was evaluated on a numerical scale and plasma concentrations of fentanyl were measured simultaneously. RESULTS: The percentage of patients who required supplementary analgesia with tenoxicam was lower in group 1 (71.4% than in group 2 (100%: 95% confidence interval (CI = 0.001-0.4360 (P = 0.001, Fisher's exact test; relative risk, RR = 0.07. Epidural bupivacaine supplementation was also lower in group 1 (14.3% than in group 2 (53.3%: 95% CI = 0.06-1.05 (P = 0.03, Fisher's exact test; RR = 0.26. There was no difference in pain intensity on the numerical scale. Mean fentanyl plasma concentrations were similar in the two groups. CONCLUSION: Intravenous and epidural fentanyl appear to have similar efficacy for reducing pain according to the numerical scale, but supplementary analgesia was needed less frequently when epidural fentanyl was used. CLINICAL TRIAL REGISTRATION NUMBER: NCT00635986

  10. Association between funding, risk of bias, and outcome of randomised controlled trials in oral and maxillofacial surgery.

    Science.gov (United States)

    Oomens, M A E M; Lazzari, S; Heymans, M W; Forouzanfar, T

    2016-01-01

    The influence of funding on the main outcome of a random control trial (RCT) is important, as it could potentially lead to bias towards industry, and results that are too optimistic. We investigated the association between funding, the published outcome, and the risk of bias in trials in oral and maxillofacial surgery (OMFS) published from January 2000 to May 2013 listed in PubMed. The methods used were scored using the risk of bias items given in a Delphi List. Sources of funding were recorded and categorised five ways: not funded, funded by industry, not funded by industry, supported by industry, and source of funds not clear. A total of 390 RCT met the inclusion criteria, and there was a correlation between funding and favourable main outcomes, although this was not significant. There was no correlation between the risk of bias and favourable results of the main outcome of a trial, or between the risk of bias and the reported source of funding in post-hoc analysis. We were unable to show a significant correlation between funding and a higher likelihood of a favourable result for the primary outcome in RCT in OMFS. We also failed to show a significant correlation between the risk of bias of a trial and its main outcome. In contrast, the source of funding proved to affect the risk of bias of a trial significantly, although not in post-hoc analysis. Funded trials were better organised, and so had a lower risk of bias.

  11. Dexmedetomidine vs propofol sedation reduces delirium in patients after cardiac surgery: A meta-analysis with trial sequential analysis of randomized controlled trials.

    Science.gov (United States)

    Liu, Xu; Xie, Guohao; Zhang, Kai; Song, Shengwen; Song, Fang; Jin, Yue; Fang, Xiangming

    2017-04-01

    It is uncertain whether dexmedetomidine is better than propofol for sedation in postcardiac surgery patients. The purpose of this meta-analysis was to compare the effects of dexmedetomidine and propofol sedation on outcomes in adult patients after cardiac surgery. Randomized controlled trials comparing outcomes in cardiac surgery patients sedated with dexmedetomidine or propofol were retrieved from PubMed, Embase, Web of Science, the Cochrane Library, and Clinicaltrials.Gov until May 23, 2016. A total of 969 patients in 8 studies met the selection criteria. The results revealed that dexmedetomidine was associated with a lower risk of delirium (risk ratio, 0.40;95% confidence interval [CI], 0.24-0.64; P=.0002), a shorter length of intubation (hours; mean difference, -0.95; 95% CI, -1.26 to -0.64; Ppropofol. There were no statistical differences in the incidence of hypotension or atrial fibrillation, or the length of intensive care unit stay between dexmedetomidine and propofol sedation regimens. Dexmedetomidine sedation could reduce postoperative delirium and was associated with shorter length of intubation, but might increase bradycardia in patients after cardiac surgery compared with propofol. Copyright © 2016 The Authors. Published by Elsevier Inc. All rights reserved.

  12. Surgical site infections following colorectal cancer surgery: a randomized prospective trial comparing common and advanced antimicrobial dressing containing ionic silver

    Directory of Open Access Journals (Sweden)

    Biffi Roberto

    2012-05-01

    Full Text Available Abstract Background An antimicrobial dressing containing ionic silver was found effective in reducing surgical-site infection in a preliminary study of colorectal cancer elective surgery. We decided to test this finding in a randomized, double-blind trial. Methods Adults undergoing elective colorectal cancer surgery at two university-affiliated hospitals were randomly assigned to have the surgical incision dressed with Aquacel® Ag Hydrofiber dressing or a common dressing. To blind the patient and the nursing and medical staff to the nature of the dressing used, scrub nurses covered Aquacel® Ag Hydrofiber with a common wound dressing in the experimental arm, whereas a double common dressing was applied to patients of control group. The primary end-point of the study was the occurrence of any surgical-site infection within 30 days of surgery. Results A total of 112 patients (58 in the experimental arm and 54 in the control group qualified for primary end-point analysis. The characteristics of the patient population and their surgical procedures were similar. The overall rate of surgical-site infection was lower in the experimental group (11.1% center 1, 17.5% center 2; overall 15.5% than in controls (14.3% center 1, 24.2% center 2, overall 20.4%, but the observed difference was not statistically significant (P = 0.451, even with respect to surgical-site infection grade 1 (superficial versus grades 2 and 3, or grade 1 and 2 versus grade 3. Conclusions This randomized trial did not confirm a statistically significant superiority of Aquacel® Ag Hydrofiber dressing in reducing surgical-site infection after elective colorectal cancer surgery. Trial registration Clinicaltrials.gov: NCT00981110

  13. Progressive resistance training and stretching following surgery for breast cancer: study protocol for a randomised controlled trial

    Directory of Open Access Journals (Sweden)

    Ward Leigh C

    2006-12-01

    Full Text Available Abstract Background Currently 1 in 11 women over the age of 60 in Australia are diagnosed with breast cancer. Following treatment, most breast cancer patients are left with shoulder and arm impairments which can impact significantly on quality of life and interfere substantially with activities of daily living. The primary aim of the proposed study is to determine whether upper limb impairments can be prevented by undertaking an exercise program of prolonged stretching and resistance training, commencing soon after surgery. Methods/design We will recruit 180 women who have had surgery for early stage breast cancer to a multicenter single-blind randomized controlled trial. At 4 weeks post surgery, women will be randomly assigned to either an exercise group or a usual care (control group. Women allocated to the exercise group will perform exercises daily, and will be supervised once a week for 8 weeks. At the end of the 8 weeks, women will be given a home-based training program to continue indefinitely. Women in the usual care group will receive the same care as is now typically provided, i.e. a visit by the physiotherapist and occupational therapist while an inpatient, and receipt of pamphlets. All subjects will be assessed at baseline, 8 weeks, and 6 months later. The primary measure is arm symptoms, derived from a breast cancer specific questionnaire (BR23. In addition, range of motion, strength, swelling, pain and quality of life will be assessed. Discussion This study will determine whether exercise commencing soon after surgery can prevent secondary problems associated with treatment of breast cancer, and will thus provide the basis for successful rehabilitation and reduction in ongoing problems and health care use. Additionally, it will identify whether strengthening exercises reduce the incidence of arm swelling. Trial Registration The protocol for this study is registered with the Australian Clinical Trials Registry (ACTRN012606000050550.

  14. Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation: two year results of a randomised controlled trial

    OpenAIRE

    Peul, Wilco; Hout, Wilbert; Brand, René; Thomeer, Raph; Koes, Bart

    2008-01-01

    Objectives: To evaluate the effects of early lumbar disc surgery compared with prolonged conservative care for patients with sciatica over two years of follow-up. Design: Randomised controlled trial. Setting: Nine Dutch hospitals. Participants: 283 patients with 6-12 weeks of sciatica. Interventions: Early surgery or an intended six months of continued conservative treatment, with delayed surgery if needed. Main outcome measures: Scores from Roland disability questionnaire for sciatica, visua...

  15. Ringer’s lactate, but not hydroxyethyl starch, prolongs the food intolerance time after major abdominal surgery; an open-labelled clinical trial

    OpenAIRE

    Li, Yuhong; He, Rui; Ying, Xiaojiang; Hahn, Robert

    2015-01-01

    Background: The infusion of large amounts of Ringers lactate prolongs the functional gastrointestinal recovery time and increases the number of complications after open abdominal surgery. We performed an open-labelled clinical trial to determine whether hydroxyethyl starch or Ringers lactate exerts these adverse effects when the surgery is performed by laparoscopy. Methods: Eighty-eight patients scheduled for major abdominal cancer surgery (83% by laparoscopy) received a first-line fluid trea...

  16. Untreated invasive breast carcinoma eligible for primary definitive surgery (Stage I-IIIA) | EU Clinical Trials Register [EU Clinical Trials Register

    Lifescience Database Archive (English)

    Full Text Available atinib y trastuzumab en pacientes con cancer de mama inicial HER2+ previo a la cirugia. A.3.2Name or abbrevi...lapatinib y trastuzumab en el momento de la cirugia. E.5.1.1Timepoint(s) of evaluation of this end point Aft...er the surgery Despues de la cirugia E.5.2Secondary end point(s) -Comparison between the PAM50 HER2-enriched... con lapatinib y trastuzumab en el momento de la cirugia. E.5.2.1Timepoint(s) of evaluation of this end poin...t After the surgery Despues de la cirugia E.6 and E.7 Scope of the trial E.6Scope

  17. Architectural Design for European SST System

    Science.gov (United States)

    Utzmann, Jens; Wagner, Axel; Blanchet, Guillaume; Assemat, Francois; Vial, Sophie; Dehecq, Bernard; Fernandez Sanchez, Jaime; Garcia Espinosa, Jose Ramon; Agueda Mate, Alberto; Bartsch, Guido; Schildknecht, Thomas; Lindman, Niklas; Fletcher, Emmet; Martin, Luis; Moulin, Serge

    2013-08-01

    The paper presents the results of a detailed design, evaluation and trade-off of a potential European Space Surveillance and Tracking (SST) system architecture. The results have been produced in study phase 1 of the on-going "CO-II SSA Architectural Design" project performed by the Astrium consortium as part of ESA's Space Situational Awareness Programme and are the baseline for further detailing and consolidation in study phase 2. The sensor network is comprised of both ground- and space-based assets and aims at being fully compliant with the ESA SST System Requirements. The proposed ground sensors include a surveillance radar, an optical surveillance system and a tracking network (radar and optical). A space-based telescope system provides significant performance and robustness for the surveillance and tracking of beyond-LEO target objects.

  18. Comparative Effects of Snoring Sound between Two Minimally Invasive Surgeries in the Treatment of Snoring: A Randomized Controlled Trial

    Science.gov (United States)

    Lee, Li-Ang; Yu, Jen-Fang; Lo, Yu-Lun; Chen, Ning-Hung; Fang, Tuan-Jen; Huang, Chung-Guei; Cheng, Wen-Nuan; Li, Hsueh-Yu

    2014-01-01

    of subjective and objective snoring. Multi-stage radiofrequency surgery was not tested. Trial Registration ClinicalTrials.gov NCT01955083 PMID:24816691

  19. Immunohistochemical detection of somatostatin receptor subtypes sst1 and sst2A in human somatostatin receptor positive tumors

    NARCIS (Netherlands)

    L.J. Hofland (Leo); Q. Liu; P.M. van Koetsveld (Peter); J. Zuijderwijk; F. van der Ham (Frieda); R.R. de Krijger (Ronald); A. Schonbrunn; S.W.J. Lamberts (Steven)

    1999-01-01

    textabstractAlthough in situ hybridization has been used to examine the distribution of messenger RNA for somatostatin receptor subtypes (sst) in human tumors, the cellular localization of sst1 and sst2A receptors has not been reported. In this study, we describe the ce

  20. Endoscopic Saphenous harvesting with an Open CO2 System (ESOS trial for coronary artery bypass grafting surgery: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Campanella Antonio

    2011-11-01

    Full Text Available Abstract Background In coronary artery bypass grafting surgery, arterial conduits are preferred because of more favourable long-term patency and outcome. Anyway the greater saphenous vein continues to be the most commonly used bypass conduit. Minimally invasive endoscopic saphenous vein harvesting is increasingly being investigated in order to reduce the morbidity associated with conventional open vein harvesting, includes postoperative leg wound complications, pain and patient satisfaction. However, to date the short and the long-term benefits of the endoscopic technique remain controversial. This study provides an interesting opportunity to address this gap in the literature. Methods/Design Endoscopic Saphenous harvesting with an Open CO2 System trial includes two parallel vein harvesting arms in coronary artery bypass grafting surgery. It is an interventional, single centre, prospective, randomized, safety/efficacy, cost/effectiveness study, in adult patients with elective planned and first isolated coronary artery disease. A simple size of 100 patients for each arm will be required to achieve 80% statistical power, with a significant level of 0.05, for detecting most of the formulated hypotheses. A six-weeks leg wound complications rate was assumed to be 20% in the conventional arm and less of 4% in the endoscopic arm. Previously quoted studies suggest a first-year vein-graft failure rate of about 20% with an annual occlusion rate of 1% to 2% in the first six years, with practically no difference between the endoscopic and conventional approaches. Similarly, the results on event-free survival rates for the two arms have barely a 2-3% gap. Assuming a 10% drop-out rate and a 5% cross-over rate, the goal is to enrol 230 patients from a single Italian cardiac surgery centre. Discussion The goal of this prospective randomized trial is to compare and to test improvement in wound healing, quality of life, safety/efficacy, cost-effectiveness, short

  1. Impact of dexmedetomidine on the incidence of delirium in elderly patients after cardiac surgery: A randomized controlled trial

    Science.gov (United States)

    Nie, Xiao-Lu; Zhang, Yan; Li, Xue-Ying; Li, Li-Huan; Ma, Daqing

    2017-01-01

    Background Delirium is a frequent complication after cardiac surgery and its occurrence is associated with poor outcomes. The purpose of this study was to investigate the impact of perioperative dexmedetomidine administration on the incidence of delirium in elderly patients after cardiac surgery. Methods This randomized, double-blinded, and placebo-controlled trial was conducted in two tertiary hospitals in Beijing between December 1, 2014 and July 19, 2015. Eligible patients were randomized into two groups. Dexmedetomidine (DEX) was administered during anesthesia and early postoperative period for patients in the DEX group, whereas normal saline was administered in the same rate for the same duration for patients in the control (CTRL) group. The primary endpoint was the incidence of delirium during the first five days after surgery. Secondary endpoints included the cognitive function assessed on postoperative days 6 and 30, the overall incidence of non-delirium complications within 30 days after surgery, and the all-cause 30-day mortality. Results Two hundred eighty-five patients were enrolled and randomized. Dexmedetomidine did not decrease the incidence of delirium (4.9% [7/142] in the DEX group vs 7.7% [11/143] in the CTRL group; OR 0.62, 95% CI 0.23 to 1.65, p = 0.341). Secondary endpoints were similar between the two groups; however, the incidence of pulmonary complications was slightly decreased (OR 0.51, 95% CI 0.26 to 1.00, p = 0.050) and the percentage of early extubation was significantly increased (OR 3.32, 95% CI 1.36 to 8.08, p = 0.008) in the DEX group. Dexmedetomidine decreased the required treatment for intraoperative tachycardia (21.1% [30/142] in the DEX group vs 33.6% [48/143] in the CTRL group, p = 0.019), but increased the required treatment for postoperative hypotension (84.5% [120/142] in the DEX group vs 69.9% [100/143] in the CTRL group, p = 0.003). Conclusions Dexmedetomidine administered during anesthesia and early postoperative period

  2. Stimulation of the autonomic nervous system in colorectal surgery: a study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Berghmans Tim MP

    2012-06-01

    Full Text Available Abstract Background Postoperative ileus (POI is a well-known complication of abdominal surgery and is considered to be caused by a local inflammation in the gut. Previously it has been shown that both local and systemic inflammation can be reduced by stimulation of the autonomic nervous system via lipid rich nutrition. Stimulation of the autonomic nervous system releases acetylcholine from efferent vagal nerve endings that binds to nicotinic receptors located on the inflammatory cells leading to a decrease of pro-inflammatory mediators. Besides administration of nutrition there are other ways of stimulating the autonomic nervous system such as gum chewing. Methods/design This prospective, placebo-controlled randomized trial will include 120 patients undergoing colorectal surgery which are randomized for gum chewing preoperatively and in the direct postoperative phase or a placebo. Postoperative ileus will be assessed both clinically by time to first flatus and time to first defecation and by determination of gastric motility using ultrasound to measure dimensions of the antrum. Furthermore the inflammatory response is quantified by analyzing pro-inflammatory mediators. Finally, markers of gut barrier integrity will be measured as well as occurrence of postoperative complications. Discussion We hypothesize that chewing gum preoperatively and in the direct postoperative phase in patients undergoing colorectal surgery dampens local and systematic inflammation, via activation of the autonomic nervous system. Down-regulation of the inflammatory cascade via stimulation of the vagus nerve will ameleriote POI and enhance postoperative recovery. Trial registration NTR2867

  3. Timing of surgery for sciatica: Subgroup analysis alongside a randomized trial

    NARCIS (Netherlands)

    W.C. Peul (Wilco); M.P. Arts (Mark); R. Brand (René); B.W. Koes (Bart)

    2009-01-01

    textabstractSurgery speeds up recovery for sciatica. Prolonged conservative care with surgery for those patients with persistent sciatica however, yields similar results at 1 year. To investigate whether baseline variables modify the difference in recovery rates between these treatment strategies, b

  4. Ten-year outcomes of a randomised trial of laparoscopic versus open surgery for colon cancer

    NARCIS (Netherlands)

    Deijen, C.L. (Charlotte L.); Vasmel, J.E. (Jeanine E.); E.S.M. De Lange-De Klerk (E. S M); M.A. Cuesta (Miguel); P-P. Coene (Peter Paul); J.F. Lange (Johan); W.J.H.J. Meijerink (Jeroen); J.J. Jakimowicz; J. Jeekel (Hans); Kazemier, G. (Geert); Janssen, I.M.C. (Ignace M. C.); L. Påhlman (Lars); E. Haglind (Eva); H.J. Bonjer (H. Jaap); Hellberg, R.; Haglind, E.; Kurlberg, G.; P.G. Lindgren (P.); B. Lindholm (Bengt); L. Påhlman (Lars); C. Dahlberg (Caroline); M.S. Raab; B. Anderberg (Bo); Ewerth, S.; M. Janson (Martin); J.E. Åkerlund (J.); K. Smedh (K.); A. Montgomery; S. Skullman (Stefan); P.O. Nyström; A. Kald (A.); A. Wänström (A.); J. Dalén (Johan); I. Svedberg (I.); G. Edlund (G.); U. Kressner (U.); K. Öberg (Kjell); O. Lundberg (O.); G.E. Lindmark (G.); T. Heikkinen (T.); M. Morino (Mario); G. Giraudo (G.); Lacy, A.M.; S. Delgado (Salvadora); Macarulla Sanz, E.; Díez, J.M. (J. Medina); O. Schwandner (O.); T.H. Schiedeck (T.); Shekarriz, H.; Bloechle, C.; I. Baca (I.); Weiss, O.; S. Msika (Simon); G. Desvignes (G.); K.L. Campbell (K.); A. Cuschieri (A.); H.J. Bonjer (Jaap); W.R. Schouten (Ruud); G. Kazemier (Geert); J.F. Lange (Johan); E. van der Harst (Erwin); Coene, P.P.L.O.; P.W. Plaisier; M.J.O.E. Bertleff (Marietta); Cuesta, M.A.; W. van der Broek (W.); Meijerink, W.J.H.J.; J.J. Jakimowicz; G.A.P. Nieuwenhuijzen (Gerard); J.K. Maring (John); Kivit, J.; I.M.C. Janssen (Ignace); E.J. Spillenaar Bilgen (Ernst Jan); F.J. Berends (Frits)

    2016-01-01

    textabstractBackground: Laparoscopic surgery for colon cancer is associated with improved recovery and similar cancer outcomes at 3 and 5 years in comparison with open surgery. However, long-term survival rates have rarely been reported. Here, we present survival and recurrence rates of the Dutch pa

  5. Brief smoking cessation intervention in relation to breast cancer surgery: a randomized controlled trial

    DEFF Research Database (Denmark)

    Thomsen, Thordis; Tønnesen, Hanne; Okholm, Mette

    2010-01-01

    Smokers are more prone to develop postoperative complications. Smoking cessation intervention beginning 4-8 weeks prior to surgery improves the postoperative outcome. Cancer patients, however, often undergo surgery less than 4 weeks after diagnosis. The primary objective of this study was therefore...

  6. Ten-year outcomes of a randomised trial of laparoscopic versus open surgery for colon cancer

    NARCIS (Netherlands)

    Deijen, C.L. (Charlotte L.); Vasmel, J.E. (Jeanine E.); E.S.M. De Lange-De Klerk (E. S M); M.A. Cuesta (Miguel); P-P. Coene (Peter Paul); J.F. Lange (Johan); W.J.H.J. Meijerink (Jeroen); J.J. Jakimowicz; J. Jeekel (Hans); Kazemier, G. (Geert); Janssen, I.M.C. (Ignace M. C.); L. Påhlman (Lars); E. Haglind (Eva); H.J. Bonjer (H. Jaap)

    2016-01-01

    markdownabstractBackground: Laparoscopic surgery for colon cancer is associated with improved recovery and similar cancer outcomes at 3 and 5 years in comparison with open surgery. However, long-term survival rates have rarely been reported. Here, we present survival and recurrence rates of the

  7. Ten-year outcomes of a randomised trial of laparoscopic versus open surgery for colon cancer

    NARCIS (Netherlands)

    Deijen, C.L.; Vasmel, J.E.; Lange-de Klerk, E.S. de; Cuesta, M.A.; Coene, P.L.O.; Lange, J.F.; Meijerink, W.J.H.J.; Jakimowicz, J.J.; Jeekel, J.; Kazemier, G.; Pahlman, L.; Haglind, E.; Bonjer, H.J.

    2017-01-01

    BACKGROUND: Laparoscopic surgery for colon cancer is associated with improved recovery and similar cancer outcomes at 3 and 5 years in comparison with open surgery. However, long-term survival rates have rarely been reported. Here, we present survival and recurrence rates of the Dutch patients

  8. Continence promotion for older hospital patients following surgery for fractured neck of femur: Pilot of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Lynne Parkinson

    2008-01-01

    Full Text Available Lynne Parkinson1,2, Pauline Chiarelli3, Jennifer Byrne1, Richard Gibson1, Suzanne McNeill4, Gillian Lloyd5, Wendy Watts6, Julie Byles11Research Centre for Gender, Health and Ageing, Faculty of Health, The University of Newcastle, NSW, Australia; 2Hunter Ageing Research, Faculty of Health, The University of Newcastle, NSW, Australia; 3Faculty of Health, The University of Newcastle, NSW, Australia; 4NC Trauma Orthopedics, John Hunter Hospital, New Lambton Heights, NSW, Australia; 5Hunter New England Health, Wallsend Community Health Centre, Wallsend, NSW, Australia; 6Royal Newcastle Centre, John Hunter Hospital, New Lambton Heights, NSW, AustraliaAbstract: Evidence suggests that bladder control problems develop or worsen as a result of fractured neck of femur (#NOF and its subsequent management. The primary aim of this study was to reduce the prevalence and severity of post surgery continence problems among patients, aged from 60-years, undergoing surgery for #NOF, using a best practice “case-management model” multifactorial intervention. Eligible consenting patients admitted with #NOF were randomized to intervention or control group. Self-report questionnaires compared pre-surgery, post surgery, and follow-up continence status between groups.This pilot randomized controlled trial, which included 45 eligible patients aged 60 to 93-years, found no evidence that the intervention was effective in reducing prevalence of post-surgery incontinence in this acute setting. Staff surveys highlighted the need for open communication between the research team and hospital staff. Unclear results were attributed to the small sample size.A central outcome was evidence that intervention to improve continence management for older people post-surgery is imperative. Focused assessment and treatment for those most at risk of incontinence after #NOF would be more acceptable to staff and a more efficient use of resources. A simple screening tool would ensure that

  9. Impact of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery: a systematic review of randomized controlled trials.

    Science.gov (United States)

    McCarthy, Grace C; Megalla, Sohair A; Habib, Ashraf S

    2010-06-18

    Postoperative pain continues to be inadequately managed. While opioids remain the mainstay for postoperative analgesia, their use can be associated with adverse effects, including ileus, which can prolong hospital stay. A number of studies have investigated the use of perioperative intravenous lidocaine infusion for improving postoperative analgesia and enhancing recovery of bowel function. This systematic review was performed to determine the overall efficacy of intravenous lidocaine infusion on postoperative analgesia and recovery from surgery in patients undergoing various surgical procedures. We searched the databases of MEDLINE, CINAHL and the Cochrane Library from 1966 to December 2009. We searched for randomized controlled comparisons of lidocaine infusion with placebo in the surgical setting and reporting on postoperative analgesia and other aspects of patient recovery from surgery. The quality of all included studies was assessed using the Modified Oxford Scale. Information on postoperative pain intensity and analgesic requirements was extracted from the trials and compared qualitatively. Other relevant data such as return of bowel function, length of hospital stay, intraoperative anaesthetic requirement and adverse effects were also compared. Sixteen trials were included. A total of 395 patients received intravenous lidocaine with 369 controls. In open and laparoscopic abdominal surgery, as well as in ambulatory surgery patients, intravenous perioperative infusion of lidocaine resulted in significant reductions in postoperative pain intensity and opioid consumption. Pain scores were reduced at rest and with cough or movement for up to 48 hours postoperatively. Opioid consumption was reduced by up to 85% in lidocaine-treated patients when compared with controls. Infusion of lidocaine also resulted in earlier return of bowel function, allowing for earlier rehabilitation and shorter duration of hospital stay. First flatus occurred up to 23 hours earlier

  10. Perioperative hyperoxia - Long-term impact on cardiovascular complications after abdominal surgery, a post hoc analysis of the PROXI trial

    DEFF Research Database (Denmark)

    Fonnes, Siv; Gogenur, Ismail; Sondergaard, Edith Smed;

    2016-01-01

    BACKGROUND: Increased long-term mortality was found in patients exposed to perioperative hyperoxia in the PROXI trial, where patients undergoing laparotomy were randomised to 80% versus 30% oxygen during and after surgery. This post hoc follow-up study assessed the impact of perioperative hyperoxia...... on long-term risk of cardiovascular events. METHODS: A total of 1386 patients undergoing either elective or emergency laparotomy were randomised to 80% versus 30% oxygen during and two hours after surgery. At follow-up, the primary outcome of acute coronary syndrome was assessed. Secondary outcomes...... included myocardial infarction, other heart disease, and acute coronary syndrome or death. Data were analysed in the Cox proportional hazards model. RESULTS: The primary outcome, acute coronary syndrome, occurred in 2.5% versus 1.3% in the 80% versus 30% oxygen group; HR 2.15 (95% CI 0.96-4.84). Patients...

  11. Enhanced recovery pathways optimize health outcomes and resource utilization: A meta-analysis of randomized controlled trials in colorectal surgery

    DEFF Research Database (Denmark)

    Adamina, Michel; Kehlet, Henrik; Tomlinson, George A;

    2011-01-01

    Background Health care systems provide care to increasingly complex and elderly patients. Colorectal surgery is a prime example, with high volumes of major procedures, significant morbidity, prolonged hospital stays, and unplanned readmissions. This situation is exacerbated by an exponential rise...... in costs that threatens the stability of health care systems. Enhanced recovery pathways (ERP) have been proposed as a means to reduce morbidity and improve effectiveness of care. We have reviewed the evidence supporting the implementation of ERP in clinical practice. Methods Medline, Embase......, and the Cochrane library were searched for randomized, controlled trials comparing ERP with traditional care in colorectal surgery. Systematic reviews and papers on ERP based on data published in major surgical and anesthesiology journals were critically reviewed by international contributors, experienced...

  12. A multicenter prospective trial evaluating fetal bovine dermal graft (Xenform® Matrix for pelvic reconstructive surgery

    Directory of Open Access Journals (Sweden)

    Aguirre Oscar A

    2010-12-01

    Full Text Available Abstract Background A prospective multicenter clinical study was performed to evaluate the safety and efficacy of a bovine dermal graft (Xenform® Matrix, Boston Scientific, Natick, MA, USA during vaginal reconstructive surgery. Methods Forty-five women with ICS stage 2 or higher pelvic organ prolapse (POP were enrolled at 4 centers. POP-Q, pelvic floor function (PFDI-20, sexual function (PISQ-12, and patient satisfaction tools were used to assess subjects at baseline, and at 2 and 6 weeks, and 3, 6 and 12 months post surgery. The significance of symptom score changes at 6 months and 1 year were determined by the t-test for paired data. Forty-three of the 45 patients completed the 12 month study. Results The majority of the subjects had cystocele (98% and/or rectocele (84% defects at study entry. At 12 months, 74% of the defects had improved to a stage 0 or 1. Mean PFDI-20 scores improved by 72% (p ®. One subject had severe pyelonephritis resulting in dialysis. This subject had a previous history of pyelonephritis, sepsis and acute renal failure. The third subject had a reported recurrent cystocele of moderate severity, possibly related to the device. No graft related erosions or pain lasting more than 30 days were reported. No subjects withdrew due to an adverse event. Conclusion This study is the first to investigate the use of Xenform® Matrix in vaginal reconstructive surgery among patients with POP. Significant improvement was maintained at 12 months utilizing both objective and subjective assessment tools, confirming the safety and efficacy of this material in vaginal surgery. Trial Registration ClinicalTrials.gov NCT01244165

  13. Xenon for the prevention of postoperative delirium in cardiac surgery: study protocol for a randomized controlled clinical trial.

    Science.gov (United States)

    Al Tmimi, Layth; Van de Velde, Marc; Herijgers, Paul; Meyns, Bart; Meyfroidt, Geert; Milisen, Koen; Fieuws, Steffen; Coburn, Mark; Poesen, Koen; Rex, Steffen

    2015-10-09

    Postoperative delirium (POD) is a manifestation of acute postoperative brain dysfunction that is frequently observed after cardiac surgery. POD is associated with short-term complications such as an increase in mortality, morbidity, costs and length of stay, but can also have long-term sequelae, including persistent cognitive deficits, loss of independence, and increased mortality for up to 2 years. The noble gas xenon has been demonstrated in various models of neuronal injury to exhibit remarkable neuroprotective properties. We therefore hypothesize that xenon anesthesia reduces the incidence of POD in elderly patients undergoing cardiac surgery with the use of cardiopulmonary bypass. One hundred and ninety patients, older than 65 years, and scheduled for elective cardiac surgery, will be enrolled in this prospective, randomized, controlled trial. Patients will be randomized to receive general anesthesia with either xenon or sevoflurane. Primary outcome parameter will be the incidence of POD in the first 5 postoperative days. The occurrence of POD will be assessed by trained research personnel, blinded to study group, with the validated 3-minute Diagnostic Confusion Assessment Method (3D-CAM) (on the intensive care unit in its version specifically adapted for the ICU), in addition to chart review and the results of delirium screening tools that will be performed by the bedside nurses). Secondary outcome parameters include duration and severity of POD, and postoperative cognitive function as assessed with the Mini-Mental State Examination. Older patients undergoing cardiac surgery are at particular risk to develop POD. Xenon provides remarkable hemodynamic stability and has been suggested in preclinical studies to exhibit neuroprotective properties. The present trial will assess whether the promising profile of xenon can be translated into a better outcome in the geriatric population. EudraCT Identifier: 2014-005370-11 (13 May 2015).

  14. Pain after pediatric otorhinolaryngologic surgery: a prospective multi-center trial.

    Science.gov (United States)

    Guntinas-Lichius, Orlando; Volk, Gerd Fabian; Geissler, Katharina; Komann, Marcus; Meissner, Winfried

    2014-07-01

    The purpose of this study was to describe postoperative pain within the first day after pediatric otorhinolaryngologic surgery and to identify factors influencing postoperative pain. Using a prospective evaluation and a Web-based multi-center registry, children ≥4 years of age (n = 365) rated their pain using questionnaires of the project Quality Improvement in Postoperative Pain Treatment for Children including faces numeric rating scales (FNRS, 0-10) for the determination of patient's pain on ambulation and his/her maximal and minimal pain within 8 h after day case surgery or at the first postoperative day for inpatient cases. Additionally, functional interference and therapy-related side effects were assessed. Half of the children were 4 or 5 years of age. The predominant types of surgery were adenoidectomy and tonsillectomy ± ear ventilation tubes. Although analgesics were applied preoperatively, intraoperatively, in the recovery room and on ward, maximal pain within the first day after surgery reached 4.4 ± 3.3 (FNRS). Pain was highest after oral surgery, especially after tonsillectomy and nose surgery. 39% of the children reported pain interference with breathing (39%). The most frequent side effect was drowsiness (55%). Multivariate analysis revealed that maximal pain was independently associated with the non-standardized use of opioids in the recovery room, or use of non-opioid or opioids on ward. Analgesia and perioperative pain management in pediatric otorhinolaryngologic surgery seems to be highly variable. Tonsillectomy and nose surgery are very painful. After otorhinolaryngologic surgery many children seem to receive less analgesia than needed or ineffective analgesic drug regimes.

  15. Hemicraniectomy after middle cerebral artery infarction with life-threatening Edema trial (HAMLET). Protocol for a randomised controlled trial of decompressive surgery in space-occupying hemispheric infarction.

    Science.gov (United States)

    Hofmeijer, Jeannette; Amelink, G Johan; Algra, Ale; van Gijn, Jan; Macleod, Malcolm R; Kappelle, L Jaap; van der Worp, H Bart

    2006-09-11

    Patients with a hemispheric infarct and massive space-occupying brain oedema have a poor prognosis. Despite maximal conservative treatment, the case fatality rate may be as high as 80%, and most survivors are left severely disabled. Non-randomised studies suggest that decompressive surgery reduces mortality substantially and improves functional outcome of survivors. This study is designed to compare the efficacy of decompressive surgery to improve functional outcome with that of conservative treatment in patients with space-occupying supratentorial infarction The study design is that of a multi-centre, randomised clinical trial, which will include 112 patients aged between 18 and 60 years with a large hemispheric infarct with space-occupying oedema that leads to a decrease in consciousness. Patients will be randomised to receive either decompressive surgery in combination with medical treatment or best medical treatment alone. Randomisation will be stratified for the intended mode of conservative treatment (intensive care or stroke unit care). The primary outcome measure will be functional outcome, as determined by the score on the modified Rankin Scale, at one year.

  16. Temporary epicardial cardiac resynchronisation versus conventional right ventricular pacing after cardiac surgery: study protocol for a randomised control trial

    Directory of Open Access Journals (Sweden)

    Russell Stuart J

    2012-02-01

    Full Text Available Abstract Background Heart failure patients with stable angina, acute coronary syndromes and valvular heart disease may benefit from revascularisation and/or valve surgery. However, the mortality rate is increased- 5-30%. Biventricular pacing using temporary epicardial wires after surgery is a potential mechanism to improve cardiac function and clinical endpoints. Method/design A multi-centred, prospective, randomised, single-blinded, intervention-control trial of temporary biventricular pacing versus standard pacing. Patients with ischaemic cardiomyopathy, valvular heart disease or both, an ejection fraction ≤ 35% and a conventional indication for cardiac surgery will be recruited from 2 cardiac centres. Baseline investigations will include: an electrocardiogram to confirm sinus rhythm and measure QRS duration; echocardiogram to evaluate left ventricular function and markers of mechanical dyssynchrony; dobutamine echocardiogram for viability and blood tests for renal function and biomarkers of myocardial injury- troponin T and brain naturetic peptide. Blood tests will be repeated at 18, 48 and 72 hours. The principal exclusions will be subjects with permanent atrial arrhythmias, permanent pacemakers, infective endocarditis or end-stage renal disease. After surgery, temporary pacing wires will be attached to the postero-lateral wall of the left ventricle, the right atrium and right ventricle and connected to a triple chamber temporary pacemaker. Subjects will be randomised to receive either temporary biventricular pacing or standard pacing (atrial inhibited pacing or atrial-synchronous right ventricular pacing for 48 hours. The primary endpoint will be the duration of level 3 care. In brief, this is the requirement for invasive ventilation, multi-organ support or more than one inotrope/vasoconstrictor. Haemodynamic studies will be performed at baseline, 6, 18 and 24 hours after surgery using a pulmonary arterial catheter. Measurements will be

  17. Back school or brain school for patients undergoing surgery for lumbar radiculopathy? Protocol for a randomised, controlled trial.

    Science.gov (United States)

    Ickmans, Kelly; Moens, Maarten; Putman, Koen; Buyl, Ronald; Goudman, Lisa; Huysmans, Eva; Diener, Ina; Logghe, Tine; Louw, Adriaan; Nijs, Jo

    2016-07-01

    Despite scientific progress with regard to pain neuroscience, perioperative education tends to stick to the biomedical model. This may involve, for example, explaining the surgical procedure or 'back school' (education that focuses on biomechanics of the lumbar spine and ergonomics). Current perioperative education strategies that are based on the biomedical model are not only ineffective, they can even increase anxiety and fear in patients undergoing spinal surgery. Therefore, perioperative pain neuroscience education is proposed as a dramatic shift in educating patients prior to and following surgery for lumbar radiculopathy. Rather than focusing on the surgical procedure, ergonomics or lumbar biomechanics, perioperative pain neuroscience education teaches people about the underlying mechanisms of pain, including the pain they will feel following surgery. The primary objective of the study is to examine whether perioperative pain neuroscience education ('brain school') is more effective than classic back school in reducing pain and improving pain inhibition in patients undergoing surgery for spinal radiculopathy. A secondary objective is to examine whether perioperative pain neuroscience education is more effective than classic back school in: reducing postoperative healthcare expenditure, improving functioning in daily life, increasing return to work, and improving surgical experience (ie, being better prepared for surgery, reducing incongruence between the expected and actual experience) in patients undergoing surgery for spinal radiculopathy. A multi-centre, two-arm (1:1) randomised, controlled trial with 2-year follow-up. People undergoing surgery for lumbar radiculopathy (n=86) in two Flemish hospitals (one tertiary care, university-based hospital and one regional, secondary care hospital) will be recruited for the study. All participants will receive usual preoperative and postoperative care related to the surgery for lumbar radiculopathy. The experimental

  18. Centrifugal pump and roller pump in adult cardiac surgery: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Saczkowski, Richard; Maklin, Michelle; Mesana, Thierry; Boodhwani, Munir; Ruel, Marc

    2012-08-01

    Centrifugal pump (CP) and roller pump (RP) designs are the dominant main arterial pumps used in cardiopulmonary bypass (CPB). Trials reporting clinical outcome measures comparing CP and RP are controversial. Therefore, a meta-analysis was undertaken to evaluate clinical variables from randomized controlled trials (RCTs). Keyword searches were performed on Medline (1966-2011), EmBase (1980-2011), and CINAHL (1981-2011) for studies comparing RP and CP as the main arterial pump in adult CPB. Pooled fixed-effects estimates for dichotomous and continuous data were calculated as an odds ratio and weighted-mean difference, respectively. The P value was utilized to assess statistical significance (P pump-related malfunction or mishap. The meta-analysis of RCTs comparing CP and RP in adult cardiac surgery suggests no significant difference for hematological variables, postoperative blood loss, transfusions, neurological outcomes, or mortality.

  19. Effects of remote ischemic preconditioning in high-risk patients undergoing cardiac surgery (Remote IMPACT): a randomized controlled trial.

    Science.gov (United States)

    Walsh, Michael; Whitlock, Richard; Garg, Amit X; Légaré, Jean-François; Duncan, Andra E; Zimmerman, Robert; Miller, Scott; Fremes, Stephen; Kieser, Teresa; Karthikeyan, Ganesan; Chan, Matthew; Ho, Anthony; Nasr, Vivian; Vincent, Jessica; Ali, Imtiaz; Lavi, Ronit; Sessler, Daniel I; Kramer, Robert; Gardner, Jeff; Syed, Summer; VanHelder, Tomas; Guyatt, Gordon; Rao-Melacini, Purnima; Thabane, Lehana; Devereaux, P J

    2016-03-15

    Remote ischemic preconditioning is a simple therapy that may reduce cardiac and kidney injury. We undertook a randomized controlled trial to evaluate the effect of this therapy on markers of heart and kidney injury after cardiac surgery. Patients at high risk of death within 30 days after cardiac surgery were randomly assigned to undergo remote ischemic preconditioning or a sham procedure after induction of anesthesia. The preconditioning therapy was three 5-minute cycles of thigh ischemia, with 5 minutes of reperfusion between cycles. The sham procedure was identical except that ischemia was not induced. The primary outcome was peak creatine kinase-myocardial band (CK-MB) within 24 hours after surgery (expressed as multiples of the upper limit of normal, with log transformation). The secondary outcome was change in creatinine level within 4 days after surgery (expressed as log-transformed micromoles per litre). Patient-important outcomes were assessed up to 6 months after randomization. We randomly assigned 128 patients to remote ischemic preconditioning and 130 to the sham therapy. There were no significant differences in postoperative CK-MB (absolute mean difference 0.15, 95% confidence interval [CI] -0.07 to 0.36) or creatinine (absolute mean difference 0.06, 95% CI -0.10 to 0.23). Other outcomes did not differ significantly for remote ischemic preconditioning relative to the sham therapy: for myocardial infarction, relative risk (RR) 1.35 (95% CI 0.85 to 2.17); for acute kidney injury, RR 1.10 (95% CI 0.68 to 1.78); for stroke, RR 1.02 (95% CI 0.34 to 3.07); and for death, RR 1.47 (95% CI 0.65 to 3.31). Remote ischemic precnditioning did not reduce myocardial or kidney injury during cardiac surgery. This type of therapy is unlikely to substantially improve patient-important outcomes in cardiac surgery. ClinicalTrials.gov, no. NCT01071265. © 2016 Canadian Medical Association or its licensors.

  20. One-year results of total arterial revascularization vs. conventional coronary surgery: CARRPO trial

    DEFF Research Database (Denmark)

    Damgaard, Sune; Wetterslev, Jørn; Lund, Jens T

    2009-01-01

    AIMS: To investigate clinical and angiographic outcomes after coronary surgery using total arterial revascularization (TAR). METHODS AND RESULTS: We randomized 331 patients with multivessel or isolated left main disease to TAR [internal thoracic (ITA) and radial arteries] vs. conventional...

  1. The SINS trial: A randomised controlled trial of excisional surgery versus imiquimod 5% cream for nodular and superficial basal cell carcinoma

    Directory of Open Access Journals (Sweden)

    Armstrong Sarah J

    2010-04-01

    Full Text Available Abstract Background Basal cell carcinoma is the commonest human cancer. Despite increasing incidence it remains poorly researched. While not life threatening it can cause significant cosmetic disfigurement. Imiquimod, a cream which enhances the body's immune response, may help deal with the number of cases that occur in low-risk sites, especially when good cosmetic results and home use without surgery are needed. This study aims 1. To compare excisional surgery with imiquimod cream for nodular or superficial basal cell carcinoma in low risk sites, with respect to 3 year clinical clearance, cost-effectiveness and cosmetic results. 2. To ascertain if certain phenotypic features and gene polymorphisms predict tumour responsiveness to treatment. Methods/Design Five hundred participants with low risk nodular or superficial basal cell carcinoma will be recruited from hospitals to this multi-centre, randomised, parallel group, controlled phase III trial. Treatment in the imiquimod group is for 6 weeks for superficial basal cell carcinoma and 12 weeks for nodular basal cell carcinoma. Both treatment groups are followed up in clinic for 3 years. Primary outcome variable: the proportion of participants with clinical evidence of success (no recurrence at 3 years. The primary outcome will be compared between the two treatment groups. Secondary outcomes include: i clinical success at 1, 2 and 5 years, ii time to first recurrence, iii cosmetic appearance of lesion site after treatment, iv level of pain, and v cost-effectiveness. Safety and tolerability data will also be reported. Discussion This study protocol describes a pragmatic randomised controlled trial which it is hoped will address the above uncertainties. Three-year results will be available towards the end of 2010. Trial registration Meta-register: NCT00066872, Eudract No. 2004-004506-24, ISRCTN48755084.

  2. Comparison of Clonidine and Midazolam Premedication Before Endoscopic Sinus Surgery: Results of Clinical Trial

    OpenAIRE

    Wawrzyniak, Katarzyna; Kusza, Krzysztof; Cywinski, Jacek B.

    2014-01-01

    Objectives Premedication with clonidine has been found to reduce the bleeding during endoscopic sinus surgery (ESS), therefore lowering the risk of surgical complications. Premedication is an essential part of pre-surgical care and can potentially affect magnitude of systemic stress response to a surgical procedure. The aim of this study was to compare the efficacy of premedication with clonidine and midazolam in patients undergoing sinus surgery. Methods Forty-four patients undergoing ESS fo...

  3. Neoadjuvant chemoradiation therapy with gemcitabine/cisplatin and surgery versus immediate surgery in resectable pancreatic cancer. Results of the first prospective randomized phase II trial

    Energy Technology Data Exchange (ETDEWEB)

    Golcher, Henriette; Merkel, Susanne; Hohenberger, Werner [University Hospital Erlangen, Department of Surgery, Erlangen (Germany); Brunner, Thomas B. [University Hospital Erlangen, Department of Radiation Oncology, Erlangen (Germany); University Hospital Freiburg, Department of Radiation Oncology, Freiburg (Germany); Witzigmann, Helmut [University Hospital Leipzig, Department of Surgery, Leipzig (Germany); Hospital Dresden-Friedrichstadt, General Surgery, Dresden (Germany); Marti, Lukas [Hospital of Kanton St. Gallen, General Surgery, St. Gallen (Switzerland); Bechstein, Wolf-Otto [University Hospital Frankfurt, Department of Surgery, Frankfurt/Main (Germany); Bruns, Christiane [University Hospital Munich, Department of Surgery - Hospital Campus Grosshadern, Munich (Germany); University Hospital Magdeburg, Department of Surgery, Magdeburg (Germany); Jungnickel, Henry [Hospital Dresden-Friedrichstadt, General Surgery, Dresden (Germany); Schreiber, Stefan [University Hospital Leipzig, Department of Surgery, Leipzig (Germany); Grabenbauer, Gerhard G. [University Hospital Erlangen, Department of Radiation Oncology, Erlangen (Germany); Hospital Coburg, Department of Radiation Oncology, Coburg (Germany); Meyer, Thomas [University Hospital Erlangen, Department of Surgery, Erlangen (Germany); Hospital Ansbach, General Surgery, Ansbach (Germany); Fietkau, Rainer [University Hospital Erlangen, Department of Radiation Oncology, Erlangen (Germany)

    2014-09-25

    In nonrandomized trials, neoadjuvant treatment was reported to prolong survival in patients with pancreatic cancer. As neoadjuvant chemoradiation is established for the treatment of rectal cancer we examined the value of neoadjuvant chemoradiotherapy in pancreatic cancer in a randomized phase II trial. Radiological staging defining resectability was basic information prior to randomization in contrast to adjuvant therapy trials resting on pathological staging. Patients with resectable adenocarcinoma of the pancreatic head were randomized to primary surgery (Arm A) or neoadjuvant chemoradiotherapy followed by surgery (Arm B), which was followed by adjuvant chemotherapy in both arms. A total of 254 patients were required to detect a 4.33-month improvement in median overall survival (mOS). The trial was stopped after 73 patients; 66 patients were eligible for analysis. Twenty nine of 33 allocated patients received chemoradiotherapy. Radiotherapy was completed in all patients. Chemotherapy was changed in 3 patients due to toxicity. Tumor resection was performed in 23 vs. 19 patients (A vs. B). The R0 resection rate was 48 % (A) and 52 % (B, P = 0.81) and (y)pN0 was 30 % (A) vs. 39 % (B, P = 0.44), respectively. Postoperative complications were comparable in both groups. mOS was 14.4 vs. 17.4 months (A vs. B; intention-to-treat analysis; P = 0.96). After tumor resection, mOS was 18.9 vs. 25.0 months (A vs. B; P = 0.79). This worldwide first randomized trial for neoadjuvant chemoradiotherapy in pancreatic cancer showed that neoadjuvant chemoradiation is safe with respect to toxicity, perioperative morbidity, and mortality. Nevertheless, the trial was terminated early due to slow recruiting and the results were not significant. ISRCTN78805636; NCT00335543. (orig.) [German] Mehrere nichtrandomisierte Studien zeigten, dass eine neoadjuvante Therapie das Ueberleben bei Patienten mit Pankreaskarzinom verlaengert. Beim lokal fortgeschrittenen Rektumkarzinom gehoert die

  4. Value of Prophylactic Postoperative Antibiotic Therapy after Bimaxillary Orthognathic Surgery: A Clinical Trial

    Science.gov (United States)

    Eshghpour, Majid; Khajavi, Amin; Bagheri, Mahmoud; Banihashemi, Elham

    2014-01-01

    Introduction: Antibiotic therapy before or after orthognathic surgery is commonly recommended by surgeons to minimize the risk of wound infection. This article evaluates the value of Prophylactic antibiotic therapy in order to diminish the incidence of postoperative wound infection after orthognathic surgery. Materials and Methods: Fifty candidates for bimaxillary orthognathic surgery were divided into cases and controls. Cefazolin (1g) was administered intravenously to all participants 30 mins prior to surgery followed by a similar dose 4 hours later. Case-group patients ingested amoxicillin (500 mg) orally for 7 days after surgery. Postoperative wound infection was assessed using clinical features, and the P-value significance was set at P<0.05. Results: Both groups were similar according to gender, age, and operating time. During the follow-up period no infection was observed in either the case or control group. Conclusion: The results of this study suggest that long-term postoperative antibiotic therapy is not essential for the prevention of postoperative infection, and that application of aseptic surgical technique and hygiene instruction after surgery are sufficient. PMID:25320697

  5. Value of Prophylactic Postoperative Antibiotic Therapy after Bimaxillary Orthognathic Surgery: A Clinical Trial

    Directory of Open Access Journals (Sweden)

    Majid Eshghpour

    2014-10-01

    Full Text Available Introduction: Antibiotic therapy before or after orthognathic surgery is commonly recommended by surgeons to minimize the risk of wound infection. This article evaluates the value of Prophylactic antibiotic therapy in order to diminish the incidence of postoperative wound infection after orthognathic surgery.   Materials and Methods: Fifty candidates for bimaxillary orthognathic surgery were divided into cases and controls. Cefazolin (1g was administered intravenously to all participants 30 mins prior to surgery followed by a similar dose 4 hours later. Case-group patients ingested amoxicillin (500 mg orally for 7 days after surgery. Postoperative wound infection was assessed using clinical features, and the P-value significance was set at P  Results: Both groups were similar according to gender, age, and operating time. During the follow-up period no infection was observed in either the case or control group.   Conclusion:  The results of this study suggest that long-term postoperative antibiotic therapy is not essential for the prevention of postoperative infection, and that application of aseptic surgical technique and hygiene instruction after surgery are sufficient.

  6. Value of Prophylactic Postoperative Antibiotic Therapy after Bimaxillary Orthognathic Surgery: A Clinical Trial

    Directory of Open Access Journals (Sweden)

    Majid Eshghpour

    2014-10-01

    Full Text Available Introduction: Antibiotic therapy before or after orthognathic surgery is commonly recommended by surgeons to minimize the risk of wound infection. This article evaluates the value of Prophylactic antibiotic therapy in order to diminish the incidence of postoperative wound infection after orthognathic surgery.   Materials and Methods: Fifty candidates for bimaxillary orthognathic surgery were divided into cases and controls. Cefazolin (1g was administered intravenously to all participants 30 mins prior to surgery followed by a similar dose 4 hours later. Case-group patients ingested amoxicillin (500 mg orally for 7 days after surgery. Postoperative wound infection was assessed using clinical features, and the P-value significance was set at P  Results: Both groups were similar according to gender, age, and operating time. During the follow-up period no infection was observed in either the case or control group.   Conclusion:  The results of this study suggest that long-term postoperative antibiotic therapy is not essential for the prevention of postoperative infection, and that application of aseptic surgical technique and hygiene instruction after surgery are sufficient. 

  7. Normobaric hyperoxia for treatment of pneumocephalus after posterior fossa surgery in the semisitting position: a prospective randomized controlled trial.

    Directory of Open Access Journals (Sweden)

    Bujung Hong

    Full Text Available 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.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.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 in older men.German Clinical Trials

  8. The Effects of Steroids on Coagulation Dysfunction Induced by Cardiopulmonary Bypass: A Steroids in Cardiac Surgery (SIRS) Trial Substudy.

    Science.gov (United States)

    Paparella, Domenico; Parolari, Alessandro; Rotunno, Crescenzia; Vincent, Jessica; Myasoedova, Veronica; Guida, Pietro; De Palo, Micaela; Margari, Vito; Devereaux, Philip J; Lamy, Andre; Alamanni, Francesco; Yusuf, Salim; Whitlock, Richard

    2017-01-01

    Cardiopulmonary bypass (CPB) surgery, despite heparin administration, elicits activation of coagulation system resulting in coagulopathy. Anti-inflammatory effects of steroid treatment have been demonstrated, but its effects on coagulation system are unknown. The primary objective of this study is to assess the effects of methylprednisolone on coagulation function by evaluating thrombin generation, fibrinolysis, and platelet activation in high-risk patients undergoing cardiac surgery with CPB. The Steroids In caRdiac Surgery study is a double-blind, randomized, controlled trial performed on 7507 patients worldwide who were randomized to receive either intravenous methylprednisolone, 250 mg at anesthetic induction and 250 mg at initiation of CPB (n = 3755), or placebo (n = 3752). A substudy was conducted in 2 sites to collect blood samples perioperatively to measure prothrombin fragment 1.2 (PF1+2, thrombin generation), plasmin-antiplasmin complex (PAP, fibrinolysis), platelet factor 4 (PF4 platelet activation), and fibrinogen. Eighty-one patients were enrolled in the substudy (37 placebo vs 44 in treatment group). No difference in clinical outcome was detected, including postoperative bleeding and need for blood products transfusion. All patients showed changes of all plasma biomarkers with greater values than baseline in both groups. This reaction was attenuated significantly in the treatment group for PF1.2 (P = 0.040) and PAP (P = 0.042) values at the first intraoperative measurement. No difference between groups was detected for PF4. Methylprednisolone treatment attenuates activation of coagulation system in high-risk patients undergoing CPB surgery. Reduction of thrombin generation and fibrinolysis activation may lead to reduced blood loss after surgery. Copyright © 2017 Elsevier Inc. All rights reserved.

  9. Clinical Experience amongst Surgeons in the Asymptomatic Carotid Surgery Trial-1

    NARCIS (Netherlands)

    Huibers, Anne; de Waard, Djurre; Bulbulia, Richard; de Borst, Gert Jan; Halliday, Alison

    2016-01-01

    INTRODUCTION: Hospital volume may influence the outcomes of carotid revascularization, but in trials the effect of the clinical experience of individual surgeons on procedural outcome is less certain. We assessed perioperative event rates amongst centers with different trial entry volumes and also t

  10. COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer

    DEFF Research Database (Denmark)

    2009-01-01

    INTRODUCTION: Laparoscopic resection of rectal cancer has been proven efficacious but morbidity and oncological outcome need to be investigated in a randomized clinical trial. Trial design: Non-inferiority randomized clinical trial. METHODS: The COLOR II trial is an ongoing international randomized...... clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy...... analysis. RESULTS: By July 2008, 27 hospitals from the Netherlands, Belgium, Germany, Sweden, Spain, Denmark, South Korea and Canada had included 739 patients. The intra-operative conversion rate in the laparoscopic group was 17%. Distribution of age, location of the tumor and radiotherapy were equal...

  11. Ten-year risk of stroke in patients with previous cerebral infarction and the impact of carotid surgery in the Asymptomatic Carotid Surgery Trial.

    Science.gov (United States)

    Streifler, Jonathan Y; den Hartog, Anne G; Pan, Samuel; Pan, Hongchao; Bulbulia, Richard; Thomas, Dafydd J; Brown, Martin M; Halliday, Alison

    2016-12-01

    Silent brain infarcts are common in patients at increased risk of stroke and are associated with a poor prognosis. In patients with asymptomatic carotid stenosis, similar adverse associations were claimed, but the impact of previous infarction or symptoms on the beneficial effects of carotid endarterectomy is not clear. Our aim was to evaluate the impact of prior cerebral infarction in patients enrolled in the Asymptomatic Carotid Surgery Trial, a large trial with 10-year follow-up in which participants whose carotid stenosis had not caused symptoms for at least six months were randomly allocated either immediate or deferred carotid endarterectomy. The first Asymptomatic Carotid Surgery Trial included 3120 patients. Of these, 2333 patients with baseline brain imaging were identified and divided into two groups irrespective of treatment assignment, 1331 with evidence of previous cerebral infarction, defined as a history of ischemic stroke or transient ischemic attack > 6 months prior to randomization or radiological evidence of an asymptomatic infarct (group 1) and 1002 with normal imaging and no prior stroke or transient ischemic attack (group 2). Stroke and vascular deaths were compared during follow-up, and the impact of carotid endarterectomy was observed in both groups. Baseline characteristics of patients with and without baseline brain imaging were broadly similar. Of those included in the present report, male gender and hypertension were more common in group 1, while mean ipsilateral stenosis was slightly greater in group 2. At 10 years follow-up, stroke was more common among participants with cerebral infarction before randomization (absolute risk increase 5.8% (1.8-9.8), p = 0.004), and the risk of stroke and vascular death was also higher in this group (absolute risk increase 6.9% (1.9-12.0), p = 0.007). On multivariate analysis, prior cerebral infarction was associated with a greater risk of stroke (hazard ratio = 1.51, 95% confidence

  12. Operation of SST-1 TF power supply during SST-1 campaigns

    Energy Technology Data Exchange (ETDEWEB)

    Sharma, Dinesh Kumar, E-mail: dinesh@ipr.res.in; Vora, Murtuza M.; Ojha, Amit; Singh, Akhilesh Kumar; Bhavsar, Chirag

    2015-10-15

    Highlights: • SST-1 TF power supply is 12 pulse SCR converter circuit. • TF power supply protection, measurement and control scheme are explained. • Quench, emergency and normal shot process is explained and results of SST-1 campaigns are shown. • Dynamic control of TF current. • The paper shows the results of last ten SST-1 campaigns. - Abstract: SST-1 TF power supply provides the direct current for the required magnetic field of TF coil. TF power supply includes transformer, 12-pulse converter, bus bar, water-cooled cable, protection and measuring equipments, and isolator, VME DAC system and GUI software. TF power supply is operated through GUI software built in TCL/Tk. VME DAC system monitors the parameters, provides On/Off commands, voltage and current references and initiates predefined reference to emergency shutdown. The emergency shutdown is hardwired to TF power supply from central control. During quench power supply converter opens DCCB and dump resistor is connected in the circuit and VME DAC system acquires bus bar voltage, dump voltage and dump current. Operation of TF power supply also requires monitoring of SCR and transformer temperature and water flow rate of water-cooled cable during high current long pulse shot. Before start up of TF power supply a quench simulation is performed to check the readiness of protection. This paper describes pre startup operation, normal shot operation, emergency and quench process, dynamic control and complete shutdown operation of TF power supply.

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

    Science.gov (United States)

    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]). 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 vasopressor and fluid demands, whereas the

  14. Effect of submucosal injection of dexamethasone after third molar surgery: a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Moraschini, V; Hidalgo, R; Porto Barboza, E dS

    2016-02-01

    The aim of this meta-analysis was to analyse the effectiveness of submucosal injection of dexamethasone to control the postoperative signs and symptoms resulting from impacted third molar surgery. An electronic search was conducted, without restriction on date or language, in the PubMed/MEDLINE, Cochrane Central Register of Controlled Trials, and Web of Science databases until June 2015 . The eligibility criteria included non-randomized or randomized clinical trials in humans. After the search and selection process, eight articles were included. The fixed-effects or random-effects model, depending on heterogeneity, was built on the inverse-variance method used. The estimations of intervention were expressed as the mean difference (MD) in millimetres. The results of this meta-analysis suggest that the submucosal injection of dexamethasone presents a reduction in the postoperative signs and symptoms resulting from impacted third molar surgery, especially those associated with oedema and pain. In relation to trismus, the meta-analysis showed no statistically significant difference between dexamethasone and the placebo solution.

  15. Perioperative analgesic profile of dexmedetomidine infusions in morbidly obese undergoing bariatric surgery: a meta-analysis and trial sequential analysis.

    Science.gov (United States)

    Singh, Preet Mohinder; Panwar, Rajesh; Borle, Anuradha; Mulier, Jan P; Sinha, Ashish; Goudra, Basavana

    2017-08-01

    Opioid-sparing analgesia for bariatric surgery in morbidly obese can potentially prevent catastrophic airway complications. Our meta-analysis attempts to consolidate the evidence on dexmedetomidine evaluating its analgesic and safety profile. Trails comparing perioperative dexmedetomidine infusion to conventional analgesic regimens for bariatric surgery were searched. Comparisons were made for 24-hour and postanesthesia care unit (PACU) morphine consumed, PACU pain scores, postoperative nausea and vomiting pain scores, and heartrate. Meta-regression was performed for length of stay to evaluate various analgesic control subgroups. Six trials were included in the final analysis. Dexmedetomidine infusion (reported in 5 intraoperative subgroups and 2 postoperative subgroups) decreased 24-hour morphine by 18.13±6.11 mg (random effects: P<.001, I(2) = 95.48%). Despite the small number of included studies, the sample size for avoiding a false positive result was adequate as the trial sequential analysis found the present sample size (362) to be well past the required "sample size" (n = 312) for 85% power. Meta-regression for infusion dose on morphine consumption difference found a predictability of 49% (coefficient = 39.93, random-effects, Tau(2) = 396.08), and predictability of the model improved to 68% on inclusion of time of initiation of infusion. The dexmedetomidine group had lower PACU morphine consumption (by 6.91±1.19, I(2) = 34.37%), lower pain scores (scale of 0-10±2.27, I(2) = 88.14%), lower postoperative nausea and vomiting incidence (odds ratio =±0.26, I(2) = 0%), and lower heart rate (73.25 versus. 83.50) (mean difference =±10.15 I(2) = 94.04%). No adverse events were reported across trials. Perioperative dexmedetomidine infusion in obese patients undergoing bariatric surgery is a promising and safe alternative. Both intraoperative or postoperative infusions lead to significant opioid sparing in early and extend postoperative recovery phase. Morbidly

  16. Use of activity tracking in major visceral surgery-the Enhanced Perioperative Mobilization (EPM) trial: study protocol for a randomized controlled trial.

    Science.gov (United States)

    Wolk, Steffen; Meißner, Theresa; Linke, Sebastian; Müssle, Benjamin; Wierick, Ann; Bogner, Andreas; Sturm, Dorothée; Rahbari, Nuh N; Distler, Marius; Weitz, Jürgen; Welsch, Thilo

    2017-02-21

    assess objectively, and to implement in clinical practice. Consequently, there is a discrepancy between ERAS targets and actual practice, especially in patients undergoing major visceral surgery. This study is the first randomized controlled trial investigating the use and feasibility of activity tracking to monitor and enhance postoperative early mobilization. ClinicalTrials.gov identifier: NCT02834338 . Registered on 15 June 2016.

  17. Evaluations of SST Climatologies in the Tropical Pacific Ocean

    Science.gov (United States)

    2009-02-27

    boundaries Casey and Cornillon, 1999]. An observation-based clima - r 1 -ru 1 r.u- • . .r e...along with SSTs from AVHRR satellite retrievals. The NOAA SST product was built from two intermediate climatologies: a 2° SST clima - tology developed...2D-Var data sets, depending on the period considered. Thus, ECMWF clima - tologies examined here are the analyses of SST observations prescribed as

  18. Clonazepam for the Management of Anxiety Associated with Oral Surgery: A Randomized Double-blind Controlled Trial

    Directory of Open Access Journals (Sweden)

    Zamiri B.

    2012-06-01

    Full Text Available Statement of Problem: Anxiety is one of the most common challenges which affect both the patient and the surgeon throughout dental procedures. Thus, there has been growing interest in the application of sedatives in dentistry. Purpose: This study evaluated the efficacy of clonazepam in reducing anxiety prior to oral surgery. Materials and Method: The participants of this, randomized controlled trial, study included 60 patients who referred to the Department of Oral and Maxillof-acial Surgery, Shiraz University of Medical Sciences. They were randomly allocated to either a single 2 mg dose of Clonazepam or a placebo one hour prior to the surgery. The participants and the outcome assessors were blind to the inter-vention. Levels of anxiety were recorded using Visual Analogue Scale (VAS and measuring blood pressure (BP, pulse rate and arterial oxygen saturation percentage. After collecting the data, the Chi-square test was run and then the data was analyzed.Results: The participants in the treatment and control groups were matched for age, sex, education, marital status and employment status ( p >0.05. All anxiety determinants (VAS, BP, pulse, and oxygen saturation rates changed significan-tly one hour after the administration of clonazepam ( p <0.05.Conclusion: Clonazepam is an effective anxiolytic drug with minimal side effects which can be used to reduce anxiety in dental patients.

  19. Is early oral feeding after gastric cancer surgery feasible? A systematic review and meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    Xiaoping Liu

    Full Text Available AIM: To assess the feasibility and safety of early oral feeding (EOF after gastrectomy for gastric cancer through a systematic review and meta-analysis based on randomized controlled trials. METHODS: A literature search in PubMed, Embase, Web of Science and Cochrane library databases was performed for eligible studies published between January 1995 and March 2014. Systematic review was carried out to identify randomized controlled trials comparing EOF and traditional postoperative oral feeding after gastric cancer surgery. Meta-analyses were performed by either a fixed effects model or a random effects model according to the heterogeneity using RevMan 5.2 software. RESULTS: Six studies remained for final analysis. Included studies were published between 2005 and 2013 reporting on a total of 454 patients. No significant differences were observed for postoperative complication (RR = 0.95; 95%CI, 0.70 to 1.29; P = 0.75, the tolerability of oral feeding (RR = 0.98; 95%CI, 0.91 to 1.06; P = 0.61, readmission rate (RR = 1; 95%CI, 0.30 to 3.31; P = 1.00 and incidence of anastomotic leakage (RR = 0.31; 95%CI, 0.01 to 7.30; P = 0.47 between two groups. EOF after gastrectomy for gastric cancer was associated with significant shorter duration of the hospital stay (WMD = -2.36; 95%CI, -3.37 to -1.34; P<0.0001 and time to first flatus (WMD = -19.94; 95%CI, -32.03 to -7.84; P = 0.001. There were no significant differences in postoperative complication, tolerability of oral feeding, readmission rates, duration of hospital stay and time to first flatus among subgroups stratified by the time to start EOF or by partial and total gastrectomy or by laparoscopic and open surgery. CONCLUSIONS: The result of this meta-analysis showed that EOF after gastric cancer surgery seems feasible and safe, even started at the day of surgery irrespective of the extent of the gastric resection and the type of surgery. However, more

  20. A mindfulness-based intervention to control weight after bariatric surgery: Preliminary results from a randomized controlled pilot trial.

    Science.gov (United States)

    Chacko, Sara A; Yeh, Gloria Y; Davis, Roger B; Wee, Christina C

    2016-10-01

    This study aimed to develop and test a novel mindfulness-based intervention (MBI) designed to control weight after bariatric surgery. Randomized, controlled pilot trial. Beth Israel Deaconess Medical Center, Boston, MA, USA. Bariatric patients 1-5 years post-surgery (n=18) were randomized to receive a 10-week MBI or a standard intervention. Primary outcomes were feasibility and acceptability of the MBI. Secondary outcomes included changes in weight, eating behaviors, psychosocial outcomes, and metabolic and inflammatory biomarkers. Qualitative exit interviews were conducted post-intervention. Major themes were coded and extracted. Attendance was excellent (6 of 9 patients attended ≥7 of 10 classes). Patients reported high satisfaction and overall benefit of the MBI. The intervention was effective in reducing emotional eating at 6 months (-4.9±13.7 in mindfulness vs. 6.2±28.4 in standard, p for between-group difference=0.03) but not weight. We also observed a significant increase in HbA1C (0.34±0.38 vs. -0.06±0.31, p=0.03). Objective measures suggested trends of an increase in perceived stress and symptoms of depression, although patients reported reduced stress reactivity, improved eating behaviors, and a desire for continued mindfulness-based support in qualitative interviews. This novel mindfulness-based approach is highly acceptable to bariatric patients post-surgery and may be effective for reducing emotional eating, although it did not improve weight or glycemic control in the short term. Longer-term studies of mindfulness-based approaches may be warranted in this population. ClinicalTrials.gov identifier NCT02603601. Copyright © 2016 Elsevier Ltd. All rights reserved.

  1. Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate

    DEFF Research Database (Denmark)

    Pedersen, Kirsten Mølsted; Humerinta, Kirsti; Küseler, Annelise

    2017-01-01

    BACKGROUND AND AIM: Facial appearance is one of the most relevant measures of success in cleft lip and palate treatment. The aim was to assess nasolabial appearance at 5 years of age in all children in the project. In this part of the project the local protocol for lip closure continued to be used...... the three trials. CONCLUSION: The Millard procedure combined with McComb technique had been used in the majority of the cases in all three trials. There were statistically significant differences between the three trials concerning upper lip, nasal form, and cleft side profile. TRIAL REGISTRATION: ISRCTN...... because the primary lip and nose operations were not part of the randomisation. The great majority of the surgeons used Millard's technique together with McComb's technique for the nose. One center used Tennison-Randalls technique and in one center the centers own technique as well as nose plugs were used...

  2. The Anxiolytic Effect of Aromatherapy on Patients Awaiting Ambulatory Surgery: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Cheng-Hua Ni

    2013-01-01

    Full Text Available The aim of this study was to determine if aromatherapy could reduce preoperative anxiety in ambulatory surgery patients. A total of 109 preoperative patients were randomly assigned to experimental (bergamot essential oil and control (water vapor conditions and their responses to the State Trait Anxiety Inventory and vital signs were monitored. Patients were stratified by previous surgical experience, but that did not influence the results. All those exposed to bergamot essential oil aromatherapy showed a greater reduction in preoperative anxiety than those in the control groups. Aromatherapy may be a useful part of a holistic approach to reducing preoperative anxiety before ambulatory surgery.

  3. Voice Quality After Treatment of Early Vocal Cord Cancer: A Randomized Trial Comparing Laser Surgery With Radiation Therapy

    Energy Technology Data Exchange (ETDEWEB)

    Aaltonen, Leena-Maija, E-mail: leena-maija.aaltonen@hus.fi [Department of Otorhinolaryngology–Head and Neck Surgery, Helsinki University Central Hospital, and University of Helsinki, Helsinki (Finland); Rautiainen, Noora; Sellman, Jaana [Institute of Behavioural Sciences, University of Helsinki, Helsinki (Finland); Saarilahti, Kauko [Department of Oncology, Helsinki University Central Hospital, and University of Helsinki, Helsinki (Finland); Mäkitie, Antti; Rihkanen, Heikki [Department of Otorhinolaryngology–Head and Neck Surgery, Helsinki University Central Hospital, and University of Helsinki, Helsinki (Finland); Laranne, Jussi; Kleemola, Leenamaija [Department of Otorhinolaryngology–Head and Neck Surgery, Tampere University Hospital, and University of Tampere, Tampere (Finland); Wigren, Tuija [Department of Oncology, Tampere University Hospital, and University of Tampere, Tampere (Finland); Sala, Eeva [Department of Otorhinolaryngology–Head and Neck Surgery, Turku University Hospital, and University of Turku, Turku (Finland); Lindholm, Paula [Department of Oncology, Turku University Hospital, and University of Turku, Turku (Finland); Grenman, Reidar [Department of Otorhinolaryngology–Head and Neck Surgery, Turku University Hospital, and University of Turku, Turku (Finland); Joensuu, Heikki [Department of Oncology, Helsinki University Central Hospital, and University of Helsinki, Helsinki (Finland)

    2014-10-01

    Objective: Early laryngeal cancer is usually treated with either transoral laser surgery or radiation therapy. The quality of voice achieved with these treatments has not been compared in a randomized trial. Methods and Materials: Male patients with carcinoma limited to 1 mobile vocal cord (T1aN0M0) were randomly assigned to receive either laser surgery (n=32) or external beam radiation therapy (n=28). Surgery consisted of tumor excision with a CO{sub 2} laser with the patient under general anaesthesia. External beam radiation therapy to the larynx was delivered to a cumulative dose of 66 Gy in 2-Gy daily fractions over 6.5 weeks. Voice quality was assessed at baseline and 6 and 24 months after treatment. The main outcome measures were expert-rated voice quality on a grade, roughness, breathiness, asthenia, and strain (GRBAS) scale, videolaryngostroboscopic findings, and the patients' self-rated voice quality and its impact on activities of daily living. Results: Overall voice quality between the groups was rated similar, but voice was more breathy and the glottal gap was wider in patients treated with laser surgery than in those who received radiation therapy. Patients treated with radiation therapy reported less hoarseness-related inconvenience in daily living 2 years after treatment. Three patients in each group had local cancer recurrence within 2 years from randomization. Conclusions: Radiation therapy may be the treatment of choice for patients whose requirements for voice quality are demanding. Overall voice quality was similar in both treatment groups, however, indicating a need for careful consideration of patient-related factors in the choice of a treatment option.

  4. Effects of coffee consumption on gut recovery after surgery of gynecological cancer patients: a randomized controlled trial.

    Science.gov (United States)

    Güngördük, Kemal; Özdemir, İsa Aykut; Güngördük, Özgü; Gülseren, Varol; Gokçü, Mehmet; Sancı, Muzaffer

    2017-02-01

    Paralytic ileus that develops after elective surgery is a common and uncomfortable complication and is considered inevitable after an intraperitoneal operation. The purpose of this study was to investigate whether coffee consumption accelerates the recovery of bowel function after complete staging surgery of gynecologic cancers. In this randomized controlled trial, 114 patients were allocated preoperatively to either postoperative coffee consumption with 3 times daily (n=58) or routine postoperative care without coffee consumption (n=56). Total abdominal hysterectomy and bilateral salpingo-oophorectomy with systematic pelvic and paraaortic lymphadenectomy were performed on all patients as part of complete staging surgery for endometrial, ovarian, cervical, or tubal cancer. The primary outcome measure was the time to the first passage of flatus after surgery. Secondary outcomes were the time to first defecation, time to first bowel movement, and time to tolerance of a solid diet. The mean time to flatus (30.2±8.0 vs 40.2±12.1 hours; P<.001), mean time to defecation (43.1±9.4 vs 58.5±17.0 hours; P<.001), and mean time to the ability to tolerate food (3.4±1.2 vs 4.7±1.6 days; P<.001) were reduced significantly in patients who consumed coffee compared with control subjects. Mild ileus symptoms were observed in 17 patients (30.4%) in the control group compared with 6 patients (10.3%) in the coffee group (P=.01). Coffee consumption was well-tolerated and well-accepted by patients, and no intervention-related side-effects were observed. Coffee consumption after total abdominal hysterectomy and systematic paraaortic lymphadenectomy expedites the time to bowel motility and the ability to tolerate food. This simple, cheap, and well-tolerated treatment should be added as an adjunct to the postoperative care of gynecologic oncology patients. Copyright © 2016 Elsevier Inc. All rights reserved.

  5. Remote ischemic preconditioning in patients undergoing cardiovascular surgery: Evidence from a meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Sardar, Partha; Chatterjee, Saurav; Kundu, Amartya; Samady, Habib; Owan, Theophilus; Giri, Jay; Nairooz, Ramez; Selzman, Craig H; Heusch, Gerd; Gersh, Bernard J; Abbott, J Dawn; Mukherjee, Debabrata; Fang, James C

    2016-10-15

    Remote ischemic preconditioning (RIPC) has been associated with reduced risk of myocardial injury in patients undergoing cardiovascular surgery, but uncertainty about clinical outcomes remains, particularly in the light of 2 recent large randomized clinical trials (RCTs) which were neutral. We performed a meta-analysis to evaluate the efficacy of RIPC on clinically relevant outcomes in patients undergoing cardiovascular surgery. We searched PubMed, Cochrane CENTRAL, EMBASE, EBSCO, Web of Science and CINAHL databases from inception through November 30, 2015. RCTs that compared the effects of RIPC vs. control in patients undergoing cardiac and/or vascular surgery were selected. We calculated summary random-effect odds ratios (ORs) and 95% confidence intervals (CI). The analysis included 5652 patients from 27 RCTs. RIPC reduced the risk of myocardial infarction (MI) (OR 0.72, 95% CI, 0.52 to 1.00; p=0.05; number needed to treat (NNT)=42), acute renal failure (OR 0.73, 95% CI, 0.53 to 1.00; p=0.05; NNT=44) as well as the composite of all cause mortality, MI, stroke or acute renal failure (OR 0.60, 95% CI, 0.39 to 0.90; p=0.01; NNT=25). No significant difference between RIPC and the control groups was observed for the outcome of all-cause mortality (OR 1.10, 95% CI, 0.81 to 1.51). Randomization to RIPC group was also associated with significantly shorter hospital stay (weighted mean difference -0.15days; 95% CI -0.27 to -0.03days). RIPC did not decrease overall mortality, but was associated with less MI and acute renal failure and shorter hospitalizations in patients undergoing cardiac or vascular surgery. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

  6. Impact of Patient-Controlled Analgesia on Pain Relief after Coronary Artery Bypass Graft Surgery: A Randomized Clinical Trial

    Directory of Open Access Journals (Sweden)

    Sima Lakdizaji

    2012-11-01

    Full Text Available Introduction: Pain has been pointed out as one of the concerns of cardiac surgery patients. Acute pain management has been a challenge for health professionals and several regiments have been described. We designed this study to evaluate the effectiveness of pain control with patient-controlled analgesia (PCA versus conventional nurse-controlled analgesia (NCA during the postoperative period in the intensive care unit (ICU after coronary artery bypass graft (CABG surgery. Methods: In this randomized clinical trial, 80 elective CABG candidates were selected by convenience sampling. They were randomly allocated to two groups to receive either PCA or NCA. PCA plus continuous infusion of morphine started immediately after transferring the patients to the ICU. NCA was based on intravenous injections of morphine on demand. Pain was assessed using a verbal rating scale (VRS. Sedation level and morphine consumption were also evaluated from extubation until 48 hours after surgery. Data was analyzed using SPSS13. Results: VRS scores were higher in the NCA group compared to the PCA group [3.27 (1.17 vs. 0.75 (0.66; p < 0.001]. Morphine consumption was significantly higher in the PCA group compared to the NCA group [28.43 (7.15 mg vs. 8.37 (5.36 mg; p < 0.001]. PCA was safe and respiratory depression was not observed in any of the subjects. Mean sedation scores did not differ between the two groups. Conclusion: PCA with background infusion of morphine increases morphine consumption and improves pain relief. It appears to be superior to NCA and can be recommended for patients after CABG surgery.

  7. Haemodynamic Optimization by Oesophageal Doppler and Pulse Power Wave Analysis in Liver Surgery: A Randomised Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Aarne Feldheiser

    Full Text Available Liver surgery is still associated with a high rate of morbidity and mortality. We aimed to compare different haemodynamic treatments in liver surgery. In a prospective, blinded, randomised, controlled pilot trial patients undergoing liver resection were randomised to receive haemodynamic management guided by conventional haemodynamic parameters or by oesophageal Doppler monitor (ODM, CardioQ-ODM or by pulse power wave analysis (PPA, LiDCOrapid within a goal-directed algorithm adapted for liver surgery. The primary endpoint was stroke volume index before intra-operative start of liver resection. Secondary endpoints were the haemodynamic course during surgery and postoperative pain levels. Due to an unbalance in the extension of the surgical procedures with a high rate of only minor procedures the conventional group was dropped from the analysis. Eleven patients in the ODM group and 10 patients in the PPA group were eligible for statistical analysis. Stroke volume index before start of liver resection was 49 (37; 53 ml/m2 and 48 (41; 56 ml/m2 in the ODM and PPA group, respectively (p=0.397. The ODM guided group was haemodynamically stable as shown by ODM and PPA measurements. However, the PPA guided group showed a significant increase of pulse-pressure-variability (p=0.002 that was not accompanied by a decline of stroke volume index displayed by the PPA (p=0.556 but indicated by a decline of stroke volume index by the ODM (p<0.001. The PPA group had significantly higher postoperative pain levels than the ODM group (p=0.036. In conclusion, goal-directed optimization by ODM and PPA showed differences in intraoperative cardiovascular parameters indicating that haemodynamic optimization is not consistent between the two monitors.ISRCTN.com ISRCTN64578872.

  8. Predictors and Outcomes of Crossover to Surgery from Physical Therapy for Meniscal Tear and Osteoarthritis: A Randomized Trial Comparing Physical Therapy and Surgery.

    Science.gov (United States)

    Katz, Jeffrey N; Wright, John; Spindler, Kurt P; Mandl, Lisa A; Safran-Norton, Clare E; Reinke, Emily K; Levy, Bruce A; Wright, Rick W; Jones, Morgan H; Martin, Scott D; Marx, Robert G; Losina, Elena

    2016-11-16

    Arthroscopic partial meniscectomy (APM) combined with physical therapy (PT) have yielded pain relief similar to that provided by PT alone in randomized trials of subjects with a degenerative meniscal tear. However, many patients randomized to PT received APM before assessment of the primary outcome. We sought to identify factors associated with crossing over to APM and to compare pain relief between patients who had crossed over to APM and those who had been randomized to APM. We used data from the MeTeOR (Meniscal Tear in Osteoarthritis Research) Trial of APM with PT versus PT alone in subjects ≥45 years old who had mild-to-moderate osteoarthritis and a degenerative meniscal tear. We assessed independent predictors of crossover to APM among those randomized to PT. We also compared pain relief at 6 months among those randomized to PT who crossed over to APM, those who did not cross over, and those originally randomized to APM. One hundred and sixty-four subjects were randomized to and received APM and 177 were randomized to PT, of whom 48 (27%) crossed over to receive APM in the first 140 days after randomization. In multivariate analyses, factors associated with a higher likelihood of crossing over to APM among those who had originally been randomized to PT included a baseline Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Score of ≥40 (risk ratio [RR] = 1.99; 95% confidence interval [CI] = 1.00, 3.93) and symptom duration of <1 year (RR = 1.74; 95% CI = 0.98, 3.08). Eighty-one percent of subjects who crossed over to APM and 82% of those randomized to APM had an improvement of ≥10 points in their pain score at 6 months, as did 73% of those who were randomized to and received only PT. Subjects who crossed over to APM had presented with a shorter symptom duration and greater baseline pain than those who did not cross over from PT. Subjects who crossed over had rates of surgical success similar to those of the patients who had been

  9. Neoadjuvant chemotherapy followed by surgery versus surgery alone for gastric carcinoma: systematic review and meta-analysis of randomized controlled trials.

    Directory of Open Access Journals (Sweden)

    A-Man Xu

    Full Text Available BACKGROUND: The effect of neoadjuvant chemotherapy (NAC on Gastric carcinoma (GC has been extensively studied, while its survival and surgical benefits remain controversial. This study aims to perform a meta-analysis of high-quality randomized controlled trials (RCTs, comparing efficacy, safety and other outcomes of NAC followed by surgery with surgery alone (SA for GC. METHODS: We systematically searched databases of MEDLINE, EMBASE, The Cochrane Library and Springer for RCTs comparing NAC with SA when treating GC. Reference lists of relevant articles and reviews, conference proceedings and ongoing trial databases were also searched. Primary outcomes were 3-year and 5-year survival rates, survival time, and total and perioperative mortalities. Secondary outcomes included down-staging effects, R0 resection rate, and postoperative complications. Meta-analysis was conducted where possible comparing items using relative risks (RRs and weighted mean differences (WMDs according to type of data. NAC-related objective response, safety and toxicity were also specifically analyzed. RESULTS: A total of 9 RCTs comparing NAC (n = 511 with SA (n = 545 published from 1995 to 2010 were identified. SA tended to be accompanied with higher overall mortality rate than NAC (46.03% vs 40.61%, RR: 0.83, 95% CI: 0.65-1.06, P = 0.14. Significantly, higher incidence of cases without regional lymph node metastasis observed upon resection were achieved among patients receiving NAC than those undergoing SA (25.68% vs 16.95%, RR: 1.92, 95% CI: 1.20-3.06, P = 0.006. All other parameters were comparable. Of the evaluable patients, 43.0% demonstrated either complete or partial response. The comprehensive NAC-related side-effect rate was 18.2% among patients available for safety assessment. CONCLUSIONS: NAC contributes to lowering nodal stages, and potentially reduces overall mortality. Response rate may be an important influential factor impacting advantages

  10. Effect of smoking cessation intervention on results of acute fracture surgery: a randomized controlled trial

    DEFF Research Database (Denmark)

    Nåsell, Hans; Adami, Johanna; Samnegård, Eva;

    2010-01-01

    Tobacco smoking is a major health and economic concern and is also known to have a significant negative effect on surgical outcomes. The benefits of a smoking cessation intervention prior to elective orthopaedic surgery have been evaluated previously. Our aim was to assess whether a smoking cessa...

  11. A randomized, double blind trial of prophylactic fibrinogen to reduce bleeding in cardiac surgery.

    Science.gov (United States)

    Sadeghi, Mostafa; Atefyekta, Reza; Azimaraghi, Omid; Marashi, Seyed Mojtaba; Aghajani, Yasaman; Ghadimi, Fatemeh; Spahn, Donat R; Movafegh, Ali

    2014-01-01

    Postoperative bleeding has a great clinical importance and can contribute to increased mortality and morbidity in patients undergoing coronary artery bypass graft surgery. In this prospective, randomized, double-blind study, we evaluated the effect of prophylactic administration of fibrinogen concentrate on post-coronary artery bypass graft surgery bleeding. A total of 60 patients undergoing coronary artery bypass surgery were randomly divided into two groups. Patients in the fibrinogen group received 1g of fibrinogen concentrate 30 min prior to the operation, while patients in the control group received placebo. Post-operative bleeding volumes, prothrombin time, partial thromboplastin time, INR, hemoglobin and transfused blood products in both groups were recorded. A strict red blood cell transfusion protocol was used in all patients. There were no significant differences between intra-operative packed red blood cells infusion in the studied groups (1.0±1.4 in fibrinogen group, and 1.3±1.1 in control group). Less postoperative bleeding was observed in the fibrinogen group (477±143 versus 703±179, p=0.0001). Fifteen patients in the fibrinogen group and 21 in the control group required post-op packed red blood cells infusion (p=0.094). No thrombotic event was observed through 72 h after surgery. Prophylactic fibrinogen reduces post-operative bleeding in patients undergoing coronary artery bypass graft. Copyright © 2013 Sociedade Brasileira de Anestesiologia. Published by Elsevier Editora Ltda. All rights reserved.

  12. Ibuprofen - a Safe Analgesic During Cardiac Surgery Recovery? A Randomized Controlled Trial?

    Directory of Open Access Journals (Sweden)

    Saddiq Mohammad Qazi

    2015-12-01

    Conclusion: The results of this study suggest that patients treated postoperatively, following cardiac surgery, are at no greater risk of harm if short term slow release ibuprofen combined with lansoprazole treatment is used when compared to an oxycodone based regimen. Renal function should, however, be closely monitored and in the event of any decrease in renal function ibuprofen must be discontinued.

  13. SINGLE-DOSE VERSUS 3-DAY PROPHYLAXIS WITH CIPROFLOXACIN IN TRANSURETHRAL SURGERY - A CLINICAL-TRIAL

    NARCIS (Netherlands)

    BIJL, W; JANKNEGT, RA

    1993-01-01

    in 235 patients who underwent transurethral surgery, perioperative oral ciprofloxacin prophylaxis was given as a single dose 500 mg versus a 3-day regimen. Out of 180 evaluable patients, 84 received a single dose and 96 received a 3-day course. In the single dose prophylaxis group there were 5 failu

  14. SINGLE-DOSE VERSUS 3-DAY PROPHYLAXIS WITH CIPROFLOXACIN IN TRANSURETHRAL SURGERY - A CLINICAL-TRIAL

    NARCIS (Netherlands)

    BIJL, W; JANKNEGT, RA

    1993-01-01

    in 235 patients who underwent transurethral surgery, perioperative oral ciprofloxacin prophylaxis was given as a single dose 500 mg versus a 3-day regimen. Out of 180 evaluable patients, 84 received a single dose and 96 received a 3-day course. In the single dose prophylaxis group there were 5

  15. SINGLE-DOSE VERSUS 3-DAY PROPHYLAXIS WITH CIPROFLOXACIN IN TRANSURETHRAL SURGERY - A CLINICAL-TRIAL

    NARCIS (Netherlands)

    BIJL, W; JANKNEGT, RA

    1993-01-01

    in 235 patients who underwent transurethral surgery, perioperative oral ciprofloxacin prophylaxis was given as a single dose 500 mg versus a 3-day regimen. Out of 180 evaluable patients, 84 received a single dose and 96 received a 3-day course. In the single dose prophylaxis group there were 5 failu

  16. Effect of desflurane-remifentanil vs. Propofol-remifentanil anesthesia on arterial oxygenation during one-lung ventilation for thoracoscopic surgery: a prospective randomized trial

    OpenAIRE

    Cho, Youn Joung; Kim, Tae Kyong; Hong, Deok Man; Seo, Jeong-Hwa; Bahk, Jae-Hyon; Jeon, Yunseok

    2017-01-01

    Background One-lung ventilation during thoracic surgery frequently disturbs normal systemic oxygenation. However, the effect of anesthetics on arterial oxygenation during one-lung ventilation has not been well established in human study. In this clinical trial, we investigated whether a difference between desflurane-remifentanil and propofol-remifentanil anesthesia can be observed with regard to oxygenation during one-lung ventilation for thoracoscopic surgery. Methods Adult patients with lun...

  17. Impact of bariatric surgery on renal functions in patients with type 2 diabetes: systematic review of randomized trials and observational studies.

    Science.gov (United States)

    Zhou, Xu; Li, Ling; Kwong, Joey S W; Yu, Jiajie; Li, Youping; Sun, Xin

    2016-12-01

    The impact of bariatric surgery on renal functions in patients with type 2 diabetes (T2D) remains uncertain. To assess the impact of bariatric surgery on renal functions in patients with T2D. Systemic review and meta-analysis of randomized trials and observational studies. We searched PubMed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) from inception to April 3, 2016. We included studies assessing bariatric surgery for renal functions in patients with T2D. We analyzed changes in renal functions before and after surgery and compared outcomes between surgeries versus nonsurgical treatments. Twenty-nine studies (4 randomized controlled trials, 5 cohort studies, 20 before-and-after studies; all at moderate to high risk of bias) were eligible, involving 18,172 patients. Analyses of changes before and after surgeries suggested a significantly lower proportion of albuminuria (difference -21.2%, 95% confidence interval [CI] -28.8% to -13.5%), 24-hour urine albumin excretion rate (weighted mean difference -48.78 mg/24 hr, 95% CI -75.32 to -22.24) and urine albumin-to-creatinine ratio (uACR) (weighted mean difference -16.10 mg/g, 95% CI -22.26 to -9.94) after surgery. Compared with nonsurgical treatment, bariatric surgery was associated with a statistically lower level of uACR and lower risk of new-onset albuminuria (odds ratio .18, 95% CI .03-.99 from randomized controlled trials). The effects on glomerular filtration rate, serum creatinine, creatinine clearance, and risk of end-stage renal disease were not statistically significant. Low-quality evidence suggests that bariatric surgery possibly improves albuminuria and uACR in patients with T2D; its effects on other outcomes were uncertain. Well-conducted, adequately powered, randomized controlled trials are warranted to examine the effect of bariatric surgery on renal functions in the T2D population. Copyright © 2016 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights

  18. Pulmonary perfusion with oxygenated blood or custodiol HTK solution during cardiac surgery for postoperative pulmonary function in COPD patients: a trial protocol for the randomized, clinical, parallel group, assessor and data analyst blinded Pulmonary Protection Trial

    Directory of Open Access Journals (Sweden)

    Buggeskov Katrine B

    2013-01-01

    Full Text Available Abstract Background Five to thirty percent of patients undergoing cardiac surgery present with chronic obstructive pulmonary disease (COPD and have a 2- to 10-fold higher 30-day mortality risk. Cardiopulmonary bypass (CPB creates a whole body systemic inflammatory response syndrome (SIRS that could impair pulmonary function. Impaired pulmonary function can, however, be attenuated by pulmonary perfusion with oxygenated blood or custodiol HTK (histidine-tryptophan-ketoglutarate solution. Methods/Design The Pulmonary Protection Trial (PP-Trial randomizes 90 patients undergoing CPB-dependent cardiac surgery to evaluate whether pulmonary perfusion with oxygenated blood or custodiol HTK solution reduces postoperative pulmonary dysfunction in COPD patients. Further, we aim for a non-randomized evaluation of postoperative pulmonary function after transcatheter aortic-valve implantation (TAVI. The primary outcome measure is the oxygenation index measured from anesthesia induction to the end of surgery and until 24 hours after anesthesia induction for a total of six evaluations. Discussion Patients with COPD may be impaired by hypoxemia and SIRS. Thus, prolonged recovery and even postoperative complications and death may be reflected by the degree of hypoxemia and SIRS. The limited sample size does not aim for confirmatory conclusions on mortality, cardiovascular complications or risk of pneumonia and sepsis, but the PP-Trial is considered an important feasibility trial paving the road for a multicenter confirmatory trial. Trial registration ClinicalTrials.gov: NCT01614951.

  19. A virtual reality application in role-plays of social skills training for schizophrenia: a randomized, controlled trial.

    Science.gov (United States)

    Park, Kyung-Min; Ku, Jeonghun; Choi, Soo-Hee; Jang, Hee-Jeong; Park, Ji-Yeon; Kim, Sun I; Kim, Jae-Jin

    2011-09-30

    Although social skills training (SST) is an effective approach for improving social skills for schizophrenia, the motivational deficit attenuates its efficacy. Virtual reality (VR) applications have allowed individuals with mental disabilities to enhance their motivation for rehabilitation. We compared SST using VR role-playing (SST-VR) to SST using traditional role-playing (SST-TR). This randomized, controlled trial included 91 inpatients with schizophrenia who were assigned to either SST-VR (n=46) or SST-TR (n=45). Both groups were administered over 10 semiweekly group sessions. An experienced, blinded rater assessed vocal, nonverbal and conversational skills. We also obtained data on motivation for SST and various social abilities. Throughout the 10 sessions, the SST-VR group (n=33) showed greater interest in SST and generalization of the skills than the SST-TR group (n=31). After SST, the SST-VR group improved more in conversational skills and assertiveness than the SST-TR group, but less in nonverbal skills. The VR application in role-plays of SST for schizophrenia may be particularly beneficial in terms of improving the conversational skills and assertiveness, possibly through its advantages in enhancing motivation for SST and generalization of the skills, and thus it may be a useful supplement to traditional SST. Copyright © 2011 Elsevier Ltd. All rights reserved.

  20. On the diurnal ranges of sea surface temperature (SST) in the north Indian Ocean

    Digital Repository Service at National Institute of Oceanography (India)

    Shenoi, S.S.C.; Nasnodkar, N.; Rajesh, G.; Joseph, K.J.; Suresh, I.; Almeida, A.M.

    ) High-Resolution SST Pilot Project (GHRSST-PP) science team cate- gorised them under five kinds of SSTs (Donlon and the GHRSST-PP science team 2005). They are, interface SST, skin SST, sub-skin SST, SST at depth and foundation SST. The satellite based... measurements report the ‘skin SST’ (at a depth of few micrometers) and most of the in situ measure- ments report the ‘SST at depth’ (at depths of few cm to 1.0–5.0 m). The SST at depth is also simply referred as ‘bulk’ SST. Following this categorisa- tion...

  1. QUALITY ASSURANCE OF 4D-CT SCAN TECHNIQUES IN MULTICENTER PHASE III TRIAL OF SURGERY VERSUS STEREOTACTIC RADIOTHERAPY (RADIOSURGERY OR SURGERY FOR OPERABLE EARLY STAGE (STAGE 1A) NON-SMALL-CELL LUNG CANCER [ROSEL] STUDY)

    NARCIS (Netherlands)

    Hurkmans, Coen W.; van Lieshout, Maarten; Schuring, Danny; van Heumen, Marielle J. T.; Cuijpers, Johan P.; Lagerwaard, Frank J.; Widder, Joachim; van der Heide, Uulke A.; Senan, Suresh

    2011-01-01

    Purpose: To determine the accuracy of four-dimensional computed tomography (4D-CT) scanning techniques in institutions participating in a Phase III trial of surgery vs. stereotactic radiotherapy (SBRT) for lung cancer. Methods and Materials: All 9 centers performed a 4D-CT scan of a motion phantom (

  2. Fracture Surgery of the extremities with the intra-operative use of 3D-RX: A randomized multicenter trial (EF3X-trial

    Directory of Open Access Journals (Sweden)

    Marmor Meir

    2011-07-01

    Full Text Available Abstract Background Posttraumatic osteoarthritis can develop after an intra-articular extremity fracture, leading to pain and loss of function. According to international guidelines, anatomical reduction and fixation are the basis for an optimal functional result. In order to achieve this during fracture surgery, an optimal view on the position of the bone fragments and fixation material is a necessity. The currently used 2D-fluoroscopy does not provide sufficient insight, in particular in cases with complex anatomy or subtle injury, and even an 18-26% suboptimal fracture reduction is reported for the ankle and foot. More intra-operative information is therefore needed. Recently the 3D-RX-system was developed, which provides conventional 2D-fluoroscopic images as well as a 3D-reconstruction of bony structures. This modality provides more information, which consequently leads to extra corrections in 18-30% of the fracture operations. However, the effect of the extra corrections on the quality of the anatomical fracture reduction and fixation as well as on patient relevant outcomes has never been investigated. The objective of this study protocol is to investigate the effectiveness of the intra-operative use of the 3D-RX-system as compared to the conventional 2D-fluoroscopy in patients with traumatic intra-articular fractures of the wrist, ankle and calcaneus. The effectiveness will be assessed in two different areas: 1 the quality of fracture reduction and fixation, based on the current golden standard, Computed Tomography. 2 The patient-relevant outcomes like functional outcome range of motion and pain. In addition, the diagnostic accuracy of the 3D-RX-scan will be determined in a clinical setting and a cost-effectiveness as well as a cost-utility analysis will be performed. Methods/design In this protocol for an international multicenter randomized clinical trial, adult patients (age > 17 years with a traumatic intra-articular fracture of the

  3. Safety and efficacy of recombinant activated factor VII: a randomized placebo-controlled trial in the setting of bleeding after cardiac surgery

    DEFF Research Database (Denmark)

    Gill, Ravi; Herbertson, Mike; Vuylsteke, Alain

    2009-01-01

    BACKGROUND: Blood loss is a common complication of cardiac surgery. Evidence suggests that recombinant activated factor VII (rFVIIa) can decrease intractable bleeding in patients after cardiac surgery. Our objective was to investigate the safety and possible benefits of rFVIIa in patients who bleed...... after cardiac surgery. METHODS AND RESULTS: In this phase II dose-escalation study, patients who had undergone cardiac surgery and were bleeding were randomized to receive placebo (n=68), 40 microg/kg rFVIIa (n=35), or 80 microg/kg rFVIIa (n=69). The primary end points were the number of patients...... for treating bleeding after cardiac surgery, but caution should be applied and further clinical trials are required because there is an increase in the number of critical serious adverse events, including stroke, in those patients randomized to receive rFVIIa....

  4. Effect of Dexmedetomidine on Postoperative Pain in Knee Arthroscopic Surgery; a Randomized Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Mohammad Alipour

    2014-03-01

    Full Text Available knee surgery. The purpose of this study was to assess the analgesic effects of intra-articular injection of a dexmedetomidine following knee arthroscopy. Methods:   Forty six patients schadualed for arthroscopic knee surgery under general anaesthesia, were randomly devided into two groups. Intervention group received 1μg/kg dexmedetomidine (D and isotonic saline. Control group received 25ml isotonic saline (P. Analgesic effects were evaluated by measuring pain intensity (VAS scores and duration of analgesia. Results:   There was no significant difference between the two groups in terms of age, sex and weight. The mean of post-operation pain severity in 1, 3, 6,12, and 24 h was significantly lower in the intervention group (D in comparison with the control group (P. the mean of the total dose of tramadol consumption was significantly lower in the interven   tion group in comparison with the control group (   P

  5. Multimodal analgesia versus traditional opiate based analgesia after cardiac surgery, a randomized controlled trial

    DEFF Research Database (Denmark)

    Rafiq, Sulman; Steinbrüchel, Daniel Andreas; Wanscher, Michael Jaeger

    2014-01-01

    BACKGROUND: To evaluate if an opiate sparing multimodal regimen of dexamethasone, gabapentin, ibuprofen and paracetamol had better analgesic effect, less side effects and was safe compared to a traditional morphine and paracetamol regimen after cardiac surgery. METHODS: Open-label, prospective...... significantly lower average pain scores from the day of surgery throughout the third postoperative day. Extensive nausea and vomiting, was found in no patient in the multimodal group but in 13 patients in the morphine group, p ...-significant rise in the multimodal group, 33.0±53.4 vs. 19.9±48.5, p = 0.133. Patients in the multimodal group suffered less major in-hospital events in crude numbers: myocardial infarction (MI) (1 vs. 2, p = 0.54), stroke (0 vs. 3, p = 0.075), dialysis (1 vs. 2, p = 0.54), and gastrointestinal (GI) bleeding (0 vs...

  6. Study of MHD activities in the plasma of SST-1

    Energy Technology Data Exchange (ETDEWEB)

    Dhongde, Jasraj; Bhandarkar, Manisha; Pradhan, Subrata, E-mail: pradhan@ipr.res.in; Kumar, Sameer

    2016-10-15

    Highlights: • An account of MHD activity in the plasma of SST-1 • Observation of MHD instabilities with mode m = 2, n = 1 in SST-1 plasma. • MHD instabilities study of characteristic growth time, growth rate of island and island width etc. in SST-1 plasma. - Abstract: Steady State Superconducting Tokamak (SST-1) is a medium size Tokamak in operation at the Institute for Plasma Research, India. SST-1 has been consistently producing plasma currents in excess of 60 kA, with plasma durations above 400 ms and a central magnetic field of 1.5 T over last few experimental campaigns of 2014. Investigation of these experimental data suggests the presence of MHD activity in the SST-1 plasma. Further analysis clearly explains the behavior of MHD instabilities observed (i.e. tearing modes with m = 2, n = 1), estimating the growth rate and the island width in the SST-1 plasma. Poloidal magnetic field and Toroidal magnetic field fluctuations in SST-1 are observed using Mirnov coils. Onsets of disruptions in connection with MHD activities have been correlated with other diagnostics such as ECE, Density and Hα etc. The observations have been cross compared with the theoretical calculations and are found to be in good agreement.

  7. The One-stop trial: Does electronic referral and booking by the general practitioner (GPs to outpatient day case surgery reduce waiting time and costs? A randomized controlled trial protocol

    Directory of Open Access Journals (Sweden)

    Vonen Barthold

    2008-08-01

    Full Text Available Abstract Background Waiting time and costs from referral to day case outpatient surgery are at an unacceptably high level. The waiting time in Norway averages 240 days for common surgical conditions. Furthermore, in North Norway the population is scattered throughout a large geographic area, making the cost of travel to a specialist examination before surgery considerable. Electronic standardised referrals and booking of day case outpatient surgery by GPs are possible through the National Health Network, which links all health care providers in an electronic network. New ways of using this network might reduce the waiting time and cost of outpatient day case surgery. Materials and Methods In a randomised controlled trial, selected patients (inguinal hernia, gallstone disease and pilonidal sinus referred to the university hospital are either randomised to direct electronic referral and booking for outpatient surgery (one stop, or to the traditional patient pathway where all patients are seen at the outpatient clinic several weeks ahead of surgery. Consultants in gastrointestinal surgery designed standardised referral forms and guidelines. New software has been designed making it possible to implement referral forms, guidelines and patient information in the GP's electronic health record. For "one-stop" referral, GPs must provide mandatory information about the specific condition. Referrals were linked to a booking system, enabling the GPs to book the hospital, day and time for outpatient surgery. The primary endpoints are waiting time and costs. The sample size calculation was based on waiting time. A reduction in waiting time of 60 days (effect size, 25%, is significant, resulting in a sample size of 120 patients in total. Discussion Poor communication between primary and secondary care often results in inefficiencies and unsatisfactory outcomes. We hypothesised that standardised referrals would improve the quality of information, making it

  8. Paracetamol versus metamizol in the treatment of postoperative pain after breast surgery: a randomized, controlled trial.

    Science.gov (United States)

    Ohnesorge, Henning; Bein, Berhold; Hanss, Robert; Francksen, Helga; Mayer, Laura; Scholz, Jens; Tonner, Peter H

    2009-08-01

    Intravenously administered paracetamol is an effective analgesic in postoperative pain management. However, there is a lack of data on the effect of intravenous (i.v.) paracetamol on pain following soft tissue surgery. Eighty-seven patients undergoing elective breast surgery with total i.v. anaesthesia (propofol/remifentanil) were randomized to three groups. Group para received 1 g i.v. paracetamol 20 min before and 4, 10 and 16 h after the end of the operation. Group meta and plac received 1 g i.v. metamizol or placebo, respectively, scheduled at the same time points. All patients had access to i.v. morphine on demand to achieve adequate pain relief. No significant difference in total morphine consumption between groups was detectable. The proportion of patients who did not receive any morphine in the postoperative period was significantly higher in group para (42%) than in group plac (4%). Ambulation was significantly (P metamizol provided a significant reduction in total postoperative morphine consumption compared with placebo in the management of postoperative pain after elective breast surgery. Administration of paracetamol resulted in a significant reduction in the number of patients needing opioid analgesics to achieve adequate postoperative pain relief.

  9. Effect of dexmedetomidine on postoperative pain in knee arthroscopic surgery; a randomized controlled clinical trial.

    Science.gov (United States)

    Alipour, Mohammad; Tabari, Masoomeh; Faz, Reza Farhadi; Makhmalbaf, Hadi; Salehi, Maryam; Moosavitekye, Seyed Mostafa

    2014-03-01

    Various drugs are administered intra-articularly to provide postoperative analgesia after arthroscopic knee surgery. The purpose of this study was to assess the analgesic effects of intra-articular injection of a dexmedetomidine following knee arthroscopy. Forty six patients scheduled for arthroscopic knee surgery under general anaesthesia, were randomly devided into two groups. Intervention group received 1µg/kg dexmedetomidine (D) and isotonic saline. Control group received 25ml isotonic saline (P). Analgesic effects were evaluated by measuring pain intensity (VAS scores) and duration of analgesia. There was no significant difference between the two groups in terms of age, sex and weight. The mean of post-operation pain severity in 1, 3, 6,12, and 24 h was significantly lower in the intervention group (D) in comparison with the control group (P). the mean of the total dose of tramadol consumption was significantly lower in the intervention group in comparison with the control group (PIntra-articular injection of dexmedetomidine at the end of arthroscopic knee surgery, alleviates the patients' pain, reducing the postoperative need for narcotics as analgesics, and increase the first analgesic request after operation.

  10. The use of a biocompatible cement in endodontic surgery. A randomized clinical trial 1.

    Science.gov (United States)

    Silva, Sérgio Ribeiro da; Silva, José Dias da; Schnaider, Taylor Brandão; Veiga, Daniela Francescato; Novo, Neil Ferreira; Mesquita, Marcos; Ferreira, Lydia Masako

    2016-06-01

    To evaluate the clinical applicability of Pozzolana Biologic Silva cement (PBS(r)) in endodontic surgery. Persistent apical periodontitis was diagnosed in 30 teeth of 12 patients by cone-beam computed tomography (CT). All patients had 2 or 4 affected teeth and underwent endodontic surgery with root-end filling. Patients with 2 affected teeth had one tooth (control) treated with mineral trioxide aggregate (MTA-Angelus(r)) as a root-end filling material, and the other tooth treated with PBS (experiment). When the patient had four affected teeth, two of them were treated with MTA and two with PBS. Six months after surgery, all patients were assessed by CT scan. Between-group comparisons of measurements were performed using the Wilcoxon test. Periradicular tissue regeneration was observed in all cases. Significant within-group differences in long axes of the lesion were found in the bucco-palatal direction (PBS group, p=0.0012; MTA group, p=0.024) and coronal-apical direction (PBS group, p=0.0007; MTA group, p=0.0015) between pre- and postoperative measurements. Pozzolana Biologic Silva cement can be used in the treatment of persistent periradicular lesions. The clinical use of PBS as a root-end filling material may be an alternative to MTA. PBS has additives, which provide enhanced strength.

  11. Preliminary analysis of a clinical trial for threedimensional conformal radiation therapy after conservative surgery

    Institute of Scientific and Technical Information of China (English)

    Hui Yao; Jinlan Gong; Li Li; Yun Wang; Xiaofeng Wu; Kezhu Hou

    2012-01-01

    Objective: The aim of this study was to evaluate the efficacy, complications and cosmetic results of three-dimensional conformal radiation therapy for early breast cancer after conservative surgery. Methods: Among 80 patients, 44 were treated by modified radical mastectomy followed by adjuvant radiotherapy (modified radical mastectomy, MMT), 36 were treated with breast conservative surgery with adjuvant irradiation [breast-conservation therapy (BCT)]. Tangential fields were used to deliver 6 MV X-ray beams to a total dose of 50 Gy. Another 16 Gy was added to the tumor bed with 6-9 MeV electron beams for BCT. Results: In MMT group, the local control, metastasis-free and death were 41, 41 and 1 respectively; in BCT group, the local control, metastasis-free and death were 35, 35 and 0. The difference of the above two indicators between the two groups showeed no statistical insignificance (P > 0. 05). In MMT group, 32 patients suffer radiation dermatitis above 2-level, 12 patients suffer radiation pneumonia, and 10 patients suffer edema of illness-side upper extremity; in BCT group, the above indicators were only 6, 2 and 1 respectively. Three months, six months and one year after radiation therapy, 90%, 92% and 95% patients were assessed as excellence in fine cosmetic state in BCT group. Conclusion: The effects of threedimensional conformal radiation therapy after conservative surgery are the same as that of modified radical mastectomy, while the former has better cosmetic results and lower radiation therapy induced complications.

  12. Assessment of risk of bias in randomized clinical trials in surgery

    DEFF Research Database (Denmark)

    Gurusamy, K S; Gluud, C; Nikolova, D;

    2009-01-01

    BACKGROUND: Meta-analysis of randomized clinical trials (RCTs) with low risk of bias is considered the highest level of evidence available for evaluating an intervention. Bias in RCTs may overestimate or underestimate the true effectiveness of an intervention. METHODS: The causes of bias...

  13. Prophylactic antibiotic regimens in tumour surgery (PARITY) A PILOT MULTICENTRE RANDOMISED CONTROLLED TRIAL

    NARCIS (Netherlands)

    Ghert, M.; Bhandari, M.; Deheshi, B.; Guyatt, G.; Holt, G.; O'Shea, T.; Randall, R. L.; Thabane, L.; Wunder, J.; Evaniew, N.; McKay, P.; Schneider, P.; Turcotte, R.; Madden, K.; Scott, T.; Sprague, S.; Simunovic, N.; Swinton, M.; Racano, A.; Heels-Ansdell, D.; Buckingham, L.; Rose, P.; Brigman, B.; Pullenayegum, E.; Ghert, M.; Evaniew, N.; Mckay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Biljan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Fetzer, S.; Aikens, W.; Clarkson, P.; Wang, B.; Kondo, L.; Yip, J.; Isler, M.; Mottard, S.; Barry, J.; St Yves, H.; Quach, M.; Assayag, H.; Daoust, K.; Goyette, K.; Projean, D.; Dion, N.; Arteau, A.; Turmel, S.; Bertrand, A.; Gagnon, N.; Labbe, V.; Holt, G.; Halpern, J.; Schwartz, H.; Atkinson, A.; Daniels, J.; Moore, M. S.; Anderson, M.; Gebhardt, M.; Wagner, K.; Patel, H.; Jolin, H.; Anderson, M.; Gebhardt, M.; Allar, B.; Naqvi, M.; Bennett, J.; Albuquerque, S.; Randall, R. L.; Jones, K.; Crabtree, S.; Davis, R.; Sorenson, S.; Healey, J. H.; Galle, J.; O'Neill, G.; Del Corral, B.; Lopez, S.; Galli Serra, M.; Parizzia, W.; Podrzaj, A.; Foa Torres, M.; Clayer, M.; Chai, Y.; Slobodian, P.; Balach, T.; Coyle, K.; LaCasse, R.; Abraham, J.; Morrison, T.; Angelos, M.; Sailor, L.; Sadaka, R.; Miller, B.; Milhem, M.; McCurdy, N.; Kain, J.; Nohr, J.; Johnson, K.; Merriss, A.; Cheng, E.; Luke, D. G.; Scharschmidt, T. J.; Crist, M. K.; Dimeo, A.; Marmon, L.; Reimer, N.; Monson, D.; Oskouei, S.; Lomba, C.; Rogers, S.; Avedian, R.; Jordan, L.; Chinn, S.; Hamilton, M.; Ghert, M.; Evaniew, N.; McKay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Bil-Jan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Fetzer, S.; Aikens, W.; Clarkson, P.; Wang, B.; Kondo, L.; Yip, J.; Isler, M.; Mottard, S.; Barry, J.; Yves, H. St.; Quach, M.; Assayag, H.; Daoust, K.; Goyette, Kristine; Projean, D.; Dion, N.; Arteau, A.; Turmel, S.; Bertrand, A.; Gagnon, N.; Labbe, V.; Holt, G.; Halpern, J.; Schwartz, H.; Atkinson, A.; Daniels, J.; Moore, M. S.; Anderson, M.; Gebhardt, M.; Wagner, K.; Patel, H.; Jolin, H.; Anderson, M.; Gebhardt, M.; Allar, B.; Naqvi, M.; Bennett, J.; Albuquerque, S.; Randall, R. L.; Jones, K.; Crabtree, S.; Davis, R.; Sorenson, S.; Healey, J. H.; Galle, J.; O'Neill, G.; Del Corral, B.; Lopez, S.; Galli Serra, M.; Parizzia, W.; Podrzaj, A.; Foa Torres, M.; Clayer, M.; Tran, N.; Slobodian, P.; Balach, T.; Coyle, K.; LaCasse, R.; Abraham, J.; Morrison, T.; Angelos, M.; Sailor, L.; Sadaka, R.; Miller, B.; Milhem, M.; McCurdy, N.; Kain, J.; Nohr, J.; Johnson, K.; Merriss, A.; Cheng, E.; Luke, D. G.; Scharschmidt, T. J.; Crist, M. K.; Dimeo, A.; Marmon, L.; Reimer, N.; Monson, D.; Oskouei, S.; Lomba, C.; Rogers, S.; Geller, D.; Hoang, B.; Tingling, J.; Solorzano, C.; Avedian, R.; Jordan, L.; Chinn, S.; Hamilton, M.; Puloski, S.; Monument, M.; Carcary, K.; Cameron, C.; Aboulafia, A.; Loo-Mis, M.; Bosley, J.; Bonvegna, R.; Kassa, M.; Damron, T.; Craig, T.; Reale, M.; Goodman, H. J.; Culbertson, M. Deza; Caruso, P.; Garling, E.; Schwab, J.; Fiore, A.; Phukan, R.; Park, C.; Joshi, L.; Aboulafia, A.; Wallace, M.; Flack, J.; Vaughan, K.; Avergas, A.; Brady, M.; Brown, S.; Schadie, N.; Battersby, R.; Weiss, K.; Goodman, M.; Heyl, A.; Yeschke, C. A.; Sumic, P.; Dudgeon, M.; Prosser, R.; Korenoski, C.; DiCaprio, M.; Palmer, B.; Cioppa, E.; Schaeffer, T. M.; Paul, P.; Toreson, J.; Cummings, J.; Schwartz, L.; Zahner, B.; Morris, C.; Laljani, V.; Mesko, N.; Joyce, M.; Lietman, S.; Wustrack, R.; O'Donnell, R.; Stevenson, C.; Carmody, E.; Tyler, W.; McIntyre, A.; Spiguel, A.; Scarborough, M.; Gibbs, C. P.; Steshyn, J.; Nunn, B.; Rosenthal, H.; Haynes, K.; Leddy, L.; Walton, Z.; Doung, Y-C.; Hayden, J.; Velez, R.; Aguirre, M.; Perez, M.; Barrera, S.; Garca Lopez, A.; Grimer, R.; Dunn, K.; Virdee, H.; Rankin, K.; Beckingsale, T.; Gerrand, C.; Campbell, I.; Allen, M.; Khan, S. Alam; Bakshi, S.; Rastogi, S.; Poudel, R.; Kumar, V. Sampath; Rai, A.; Baptista, A. M.; de Camargo, O. P.; Marais, L.; Rodseth, R.; Ferreira, N.; Rajah, C.; Gumede, S.; Gortzak, Y.; Sternheim, A.; Bickels, J.; Kolander, Y.; Lev, S.; Hettwer, W.; Petersen, M. M.; Grum-Schwensen, T.; Jutte, P.; Ploegmakers, J. J. W.; Stevens, M.; Mahendra, A.; Gupta, S.; Bergovec, M.; Leithner, A.; Funovics, P.; Dijkstra, P. D. S.; Van De Sande, M.; Hoogenstraaten, A.; Leijerzapf, N.; Steadman, P.; Steadman, P.; Boffano, M.; Piana, R.; Marone, S.; Albertini, U.; Boux, E.; Maiello, A.; Repsa, L.; Zile, S.; Aston, W.; Pollock, R.; Cool, P.; Gibbons, M.; Whit-Well, D.; Cosker, T.; Hemingway, J.; Porter, D.; Patton, S.; Navia, J.; Betancur, A. F.; Laitenen, M.; Pakarinen, K.; Nieminen, J.; Yla-Mononen, S.; Rautiainen, S.; Fiorenza, F.

    Objective Clinical studies of patients with bone sarcomas have been challenged by insufficient numbers at individual centres to draw valid conclusions. Our objective was to assess the feasibility of conducting a definitive multi-centre randomised controlled trial (RCT) to determine whether a

  14. Prophylactic antibiotic regimens in tumour surgery (PARITY) A PILOT MULTICENTRE RANDOMISED CONTROLLED TRIAL

    NARCIS (Netherlands)

    Ghert, M.; Bhandari, M.; Deheshi, B.; Guyatt, G.; Holt, G.; O'Shea, T.; Randall, R. L.; Thabane, L.; Wunder, J.; Evaniew, N.; McKay, P.; Schneider, P.; Turcotte, R.; Madden, K.; Scott, T.; Sprague, S.; Simunovic, N.; Swinton, M.; Racano, A.; Heels-Ansdell, D.; Buckingham, L.; Rose, P.; Brigman, B.; Pullenayegum, E.; Ghert, M.; Evaniew, N.; Mckay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Biljan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Fetzer, S.; Aikens, W.; Clarkson, P.; Wang, B.; Kondo, L.; Yip, J.; Isler, M.; Mottard, S.; Barry, J.; St Yves, H.; Quach, M.; Assayag, H.; Daoust, K.; Goyette, K.; Projean, D.; Dion, N.; Arteau, A.; Turmel, S.; Bertrand, A.; Gagnon, N.; Labbe, V.; Holt, G.; Halpern, J.; Schwartz, H.; Atkinson, A.; Daniels, J.; Moore, M. S.; Anderson, M.; Gebhardt, M.; Wagner, K.; Patel, H.; Jolin, H.; Anderson, M.; Gebhardt, M.; Allar, B.; Naqvi, M.; Bennett, J.; Albuquerque, S.; Randall, R. L.; Jones, K.; Crabtree, S.; Davis, R.; Sorenson, S.; Healey, J. H.; Galle, J.; O'Neill, G.; Del Corral, B.; Lopez, S.; Galli Serra, M.; Parizzia, W.; Podrzaj, A.; Foa Torres, M.; Clayer, M.; Chai, Y.; Slobodian, P.; Balach, T.; Coyle, K.; LaCasse, R.; Abraham, J.; Morrison, T.; Angelos, M.; Sailor, L.; Sadaka, R.; Miller, B.; Milhem, M.; McCurdy, N.; Kain, J.; Nohr, J.; Johnson, K.; Merriss, A.; Cheng, E.; Luke, D. G.; Scharschmidt, T. J.; Crist, M. K.; Dimeo, A.; Marmon, L.; Reimer, N.; Monson, D.; Oskouei, S.; Lomba, C.; Rogers, S.; Avedian, R.; Jordan, L.; Chinn, S.; Hamilton, M.; Ghert, M.; Evaniew, N.; McKay, P.; Schneider, P.; Sobhi, G.; Chan, R.; Bil-Jan, M.; Ferguson, P.; Wunder, J.; Griffin, A.; Mantas, I.; Wylie, A.; Han, A.; Grewal, G.; Turcotte, R.; Goulding, K.; Dandachli, F.; Matte, G.; Werier, J.; Abdelbary, H.; Paquin, K.; Cosgrove, H.; Dugal, A-M.; Fetzer, S.; Aikens, W.; Clarkson, P.; Wang, B.; Kondo, L.; Yip, J.; Isler, M.; Mottard, S.; Barry, J.; Yves, H. St.; Quach, M.; Assayag, H.; Daoust, K.; Goyette, Kristine; Projean, D.; Dion, N.; Arteau, A.; Turmel, S.; Bertrand, A.; Gagnon, N.; Labbe, V.; Holt, G.; Halpern, J.; Schwartz, H.; Atkinson, A.; Daniels, J.; Moore, M. S.; Anderson, M.; Gebhardt, M.; Wagner, K.; Patel, H.; Jolin, H.; Anderson, M.; Gebhardt, M.; Allar, B.; Naqvi, M.; Bennett, J.; Albuquerque, S.; Randall, R. L.; Jones, K.; Crabtree, S.; Davis, R.; Sorenson, S.; Healey, J. H.; Galle, J.; O'Neill, G.; Del Corral, B.; Lopez, S.; Galli Serra, M.; Parizzia, W.; Podrzaj, A.; Foa Torres, M.; Clayer, M.; Tran, N.; Slobodian, P.; Balach, T.; Coyle, K.; LaCasse, R.; Abraham, J.; Morrison, T.; Angelos, M.; Sailor, L.; Sadaka, R.; Miller, B.; Milhem, M.; McCurdy, N.; Kain, J.; Nohr, J.; Johnson, K.; Merriss, A.; Cheng, E.; Luke, D. G.; Scharschmidt, T. J.; Crist, M. K.; Dimeo, A.; Marmon, L.; Reimer, N.; Monson, D.; Oskouei, S.; Lomba, C.; Rogers, S.; Geller, D.; Hoang, B.; Tingling, J.; Solorzano, C.; Avedian, R.; Jordan, L.; Chinn, S.; Hamilton, M.; Puloski, S.; Monument, M.; Carcary, K.; Cameron, C.; Aboulafia, A.; Loo-Mis, M.; Bosley, J.; Bonvegna, R.; Kassa, M.; Damron, T.; Craig, T.; Reale, M.; Goodman, H. J.; Culbertson, M. Deza; Caruso, P.; Garling, E.; Schwab, J.; Fiore, A.; Phukan, R.; Park, C.; Joshi, L.; Aboulafia, A.; Wallace, M.; Flack, J.; Vaughan, K.; Avergas, A.; Brady, M.; Brown, S.; Schadie, N.; Battersby, R.; Weiss, K.; Goodman, M.; Heyl, A.; Yeschke, C. A.; Sumic, P.; Dudgeon, M.; Prosser, R.; Korenoski, C.; DiCaprio, M.; Palmer, B.; Cioppa, E.; Schaeffer, T. M.; Paul, P.; Toreson, J.; Cummings, J.; Schwartz, L.; Zahner, B.; Morris, C.; Laljani, V.; Mesko, N.; Joyce, M.; Lietman, S.; Wustrack, R.; O'Donnell, R.; Stevenson, C.; Carmody, E.; Tyler, W.; McIntyre, A.; Spiguel, A.; Scarborough, M.; Gibbs, C. P.; Steshyn, J.; Nunn, B.; Rosenthal, H.; Haynes, K.; Leddy, L.; Walton, Z.; Doung, Y-C.; Hayden, J.; Velez, R.; Aguirre, M.; Perez, M.; Barrera, S.; Garca Lopez, A.; Grimer, R.; Dunn, K.; Virdee, H.; Rankin, K.; Beckingsale, T.; Gerrand, C.; Campbell, I.; Allen, M.; Khan, S. Alam; Bakshi, S.; Rastogi, S.; Poudel, R.; Kumar, V. Sampath; Rai, A.; Baptista, A. M.; de Camargo, O. P.; Marais, L.; Rodseth, R.; Ferreira, N.; Rajah, C.; Gumede, S.; Gortzak, Y.; Sternheim, A.; Bickels, J.; Kolander, Y.; Lev, S.; Hettwer, W.; Petersen, M. M.; Grum-Schwensen, T.; Jutte, P.; Ploegmakers, J. J. W.; Stevens, M.; Mahendra, A.; Gupta, S.; Bergovec, M.; Leithner, A.; Funovics, P.; Dijkstra, P. D. S.; Van De Sande, M.; Hoogenstraaten, A.; Leijerzapf, N.; Steadman, P.; Steadman, P.; Boffano, M.; Piana, R.; Marone, S.; Albertini, U.; Boux, E.; Maiello, A.; Repsa, L.; Zile, S.; Aston, W.; Pollock, R.; Cool, P.; Gibbons, M.; Whit-Well, D.; Cosker, T.; Hemingway, J.; Porter, D.; Patton, S.; Navia, J.; Betancur, A. F.; Laitenen, M.; Pakarinen, K.; Nieminen, J.; Yla-Mononen, S.; Rautiainen, S.; Fiorenza, F.

    2015-01-01

    Objective Clinical studies of patients with bone sarcomas have been challenged by insufficient numbers at individual centres to draw valid conclusions. Our objective was to assess the feasibility of conducting a definitive multi-centre randomised controlled trial (RCT) to determine whether a five-da

  15. COLOR II. A randomized clinical trial comparing laparoscopic and open surgery for rectal cancer

    DEFF Research Database (Denmark)

    Buunen, M; Bonjer, H J; Hop, W C J;

    2009-01-01

    clinical trial. Currently 27 hospitals from Europe, South Korea and Canada are including patients. The primary endpoint is loco-regional recurrence rate three years post-operatively. Secondary endpoints cover quality of life, overall and disease free survival, post-operative morbidity and health economy...

  16. Complications following lung surgery in the Dutch-Belgian randomized lung cancer screening trial

    NARCIS (Netherlands)

    van't Westeinde, Susan C.; Horeweg, Nanda; De Leyn, Paul; Groen, Harry J. M.; Lammers, Jan-Willem J.; Weenink, Carla; Nackaerts, Kristiaan; van Klaveren, Rob J.

    2012-01-01

    To assess the complication rate in participants of the screen arm of the NELSON lung cancer screening trial who underwent surgical resection and to investigate, based on a literature review, whether the complication rate, length of hospital stay, re-thoracotomy and mortality rates after a surgical p

  17. Perioperative glutamine supplementation restores disturbed renal arginine synthesis after open aortic surgery: a randomized controlled clinical trial.

    Science.gov (United States)

    Brinkmann, Saskia J H; Buijs, Nikki; Vermeulen, Mechteld A R; Oosterink, Efraim; Schierbeek, Henk; Beishuizen, Albertus; de Vries, Jean-Paul P M; Wisselink, Willem; van Leeuwen, Paul A M

    2016-09-01

    Postoperative renal failure is a common complication after open repair of an abdominal aortic aneurysm. The amino acid arginine is formed in the kidneys from its precursor citrulline, and citrulline is formed from glutamine in the intestines. Arginine enhances the function of the immune and cardiovascular systems, which is important for recovery after surgery. We hypothesized that renal arginine production is diminished after ischemia-reperfusion injury caused by clamping of the aorta during open abdominal aortic surgery and that parenteral glutamine supplementation might compensate for this impaired arginine synthesis. This open-label clinical trial randomized patients who underwent clamping of the aorta during open abdominal aortic surgery to receive a perioperative supplement of intravenous alanyl-glutamine (0.5 g·kg(-1)·day(-1); group A, n = 5) or no supplement (group B, n = 5). One day after surgery, stable isotopes and tracer methods were used to analyze the metabolism and conversion of glutamine, citrulline, and arginine. Whole body plasma flux of glutamine, citrulline, and arginine was significantly higher in group A than in group B (glutamine: 391 ± 34 vs. 258 ± 19 μmol·kg(-1)·h(-1), citrulline: 5.7 ± 0.4 vs. 2.8 ± 0.4 μmol·kg(-1)·h(-1), and arginine: 50 ± 4 vs. 26 ± 2 μmol·kg(-1)·h(-1), P glutamine (4.8 ± 0.7 vs. 1.6 ± 0.3 μmol·kg(-1)·h(-1)), citrulline from arginine (2.3 ± 0.3 vs. 0.96 ± 0.1 μmol·kg(-1)·h(-1)), and arginine from glutamine (7.7 ± 0.4 vs. 2.8 ± 0.2 μmol·kg(-1)·h(-1)), respectively (P arginine is severely reduced after clamping during aortic surgery. This study shows that an intravenous supplement of glutamine increases the production of citrulline and arginine and compensates for the inhibitory effect of ischemia-reperfusion injury.

  18. Effectiveness of a Cognitive Behavioral Therapy for Dysfunctional Eating among Patients Admitted for Bariatric Surgery: A Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Hege Gade

    2014-01-01

    Full Text Available Objective. To examine whether cognitive behavioral therapy (CBT alleviates dysfunctional eating (DE patterns and symptoms of anxiety and depression in morbidly obese patients planned for bariatric surgery. Design and Methods. A total of 98 (68 females patients with a mean (SD age of 43 (10 years and BMI 43.5 (4.9 kg/m2 were randomly assigned to a CBT-group or a control group receiving usual care (i.e., nutritional support and education. The CBT-group received ten weekly intervention sessions. DE, anxiety, and depression were assessed by the TFEQ R-21 and HADS, respectively. Results. Compared with controls, the CBT-patients showed significantly less DE, affective symptoms, and a larger weight loss at follow-up. The effect sizes were large (DE-cognitive restraint, g=-.92, P≤.001; DE-uncontrolled eating, g=-.90, P≤.001, moderate (HADS-depression, g=-.73, P≤.001; DE-emotional eating, g=-.67, P≤.001; HADS-anxiety, g=-.62, P=.003, and low (BMI, g=-.24, P=.004. Conclusion. This study supports the use of CBT in helping patients preparing for bariatric surgery to reduce DE and to improve mental health. This clinical trial is registered with NCT01403558.

  19. Pharmacological strategies to reduce pruritus during postoperative epidural analgesia after lumbar fusion surgery - a prospective randomized trial in 150 patients

    Directory of Open Access Journals (Sweden)

    Robinson Yohan

    2011-05-01

    Full Text Available Abstract Background Epidural analgesia with bupivacain, epinephrine and fentanyl provides excellent pain control after lumbar fusion surgery, but pruritus and motor block are frequent side effects. Theoretically epidural ropivacain combined with oral oxycodone could decrease the incidence of these side effects. The two regimens were compared in a prospective randomized trial. Patients and methods 150 patients (87 women treated with posterior instrumented lumbar fusion were included. The mean age was 51 +/- 11 years. 76 were randomized to bupivacain, epinephrine and fentanyl (group B and 74 to ropivacain and oxycodone (group R. Pruritus, motor block and pain were measured 6 hours after surgery, thereafter 6 times per day for 5 days. Any pain breakthrough episode was registered whenever it occurred. Results The epidural treatment could be performed in 143 patients (72 in group B and 71 in group R. Disturbing pruritus occurred in 53 patients in group B compared to 12 in group R (p Conclusions Pruritus could be reduced with a combination of epidural ropivacain and oral oxycodone, at the price of a slightly higher pain level. Ropivacaine was not found to be superior to bupivacaine with regard to motor blocks.

  20. The Effects of Perioperative Music Interventions in Pediatric Surgery: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.

    Directory of Open Access Journals (Sweden)

    Marianne J E van der Heijden

    Full Text Available Music interventions are widely used, but have not yet gained a place in guidelines for pediatric surgery or pediatric anesthesia. In this systematic review and meta-analysis we examined the effects of music interventions on pain, anxiety and distress in children undergoing invasive surgery.We searched 25 electronic databases from their first available date until October 2014.Included were all randomized controlled trials with a parallel group, crossover or cluster design that included pediatric patients from 1 month to 18 years old undergoing minimally invasive or invasive surgical procedures, and receiving either live music therapy or recorded music.4846 records were retrieved from the searches, 26 full text reports were evaluated and data was extracted by two independent investigators.Pain was measured with the Visual Analogue Scale, the Coloured Analogue Scale and the Facial Pain Scale. Anxiety and distress were measured with an emotional index scale (not validated, the Spielberger short State Trait Anxiety Inventory and a Facial Affective Scale.Three RCTs were eligible for inclusion encompassing 196 orthopedic, cardiac and day surgery patients (age of 1 day to 18 years receiving either live music therapy or recorded music. Overall a statistically significant positive effect was demonstrated on postoperative pain (SMD -1.07; 95%CI-2.08; -0.07 and on anxiety and distress (SMD -0.34 95% CI -0.66; -0.01 and SMD -0.50; 95% CI -0.84; - 0.16.This systematic review and meta-analysis indicates that music interventions may have a statistically significant effect in reducing post-operative pain, anxiety and distress in children undergoing a surgical procedure. Evidence from this review and other reviews suggests music therapy may be considered for clinical use.

  1. Whey Protein Supplementation Enhances Body Fat and Weight Loss in Women Long After Bariatric Surgery: a Randomized Controlled Trial.

    Science.gov (United States)

    Lopes Gomes, Daniela; Moehlecke, Milene; Lopes da Silva, Fernanda Bassan; Dutra, Eliane Said; D'Agord Schaan, Beatriz; Baiocchi de Carvalho, Kenia Mara

    2017-02-01

    The ideal nutritional approach for weight regain after bariatric surgery remains unclear. The objective of this study is to assess the effect of whey protein supplementation on weight loss and body composition of women who regained weight 24 or more months after bariatric surgery. This is a 16-week open-label, parallel-group, randomized controlled trial of women who regained at least 5 % of their lowest postoperative weight after a Roux-en-Y gastric bypass (RYGB). A total of 34 participants were treated with hypocaloric diet and randomized (1:1) to receive or not supplementation with whey protein, 0.5 g/kg of the ideal body weight. The primary outcomes were changes in body weight, fat free mass (FFM), and fat mass (FM), evaluated by tetrapolar bioelectrical impedance analysis (BIA). Secondary outcomes included resting energy expenditure, blood glucose, lipids, adiponectin, interleukin 6 (IL-6), and cholecystokinin levels. Statistical analyses included generalized estimating equations adjusted for age and physical activity. Fifteen patients in each group were evaluated: mean age was 45 ± 11 years, body mass index (BMI) was 35.7 ± 5.2 kg/m(2), and time since surgery was 69 ± 23 months. Protein intake during follow-up increased by approximately 75 % in the intervention group (p = 0.01). The intervention group presented more body weight loss (1.86 kg, p = 0.017), accounted for FM loss (2.78, p = 0.021) and no change in FFM, as compared to controls (gain of 0.42 kg of body weight and 0.6 kg of FM). No differences in secondary outcomes were observed between groups. Whey protein supplementation promoted body weight and FM loss in women with long-term weight regain following RYGB.

  2. Comparing the Effect of Dexamethasone before and after Tracheal Intubation on Sore Throat after Tympanoplasty Surgery: A Randomized Controlled trial

    Directory of Open Access Journals (Sweden)

    Mahmoud Eidi

    2014-04-01

    Full Text Available Introduction: Presence of a sore throat after surgery is a common side effect of general anesthesia with intratracheal intubation and can cause discomfort for the patient and prolong the recovery process. In this study we compared the effect of dexamethasone before and after intubation on the incidence of sore throat after tympanoplasty surgery.   Materials and Methods: In a double-blind, randomized clinical trial, 70 patients aged 30–60 years with American Society of Anesthesiologists (ASA physical status I or II who were candidates for tympanoplasty under anesthetic conditions were studied in two separate groups. The first group received intravenous (IV dexamethasone (8 mg 30 mins prior to intubation while the second group received the same dose of dexamethasone 30 mins after intubation. The incidence and severity of the sore throat in both groups were then evaluated.   Results: There was no significant difference between two groups in intensity of sore throat (62.9% vs. 57.1%, cough (65.7% vs. 62.9%, or hoarseness (62.9% vs. 65.7% within 24 h after surgery. Detection of blood in oral secretions or on the tracheal tube was the same in both groups (5.7%. The incidence of coughs during the extubation was 0% in first group and 11.4% in second group.   Conclusion:  According to the results of this research there was no significant difference in incidence and intensity of sore throat in patients receiving dexamethasone before or after intubation. Further, no significant difference in intensity of coughs or hoarseness was observed.  

  3. Enhancing detection sensitivity of SST-1 Thomson scattering experiment

    Energy Technology Data Exchange (ETDEWEB)

    Chaudhari, Vishnu; Patel, Kiran; Thomas, Jinto; Kumar, Ajai, E-mail: ajai@ipr.res.in

    2016-10-15

    Thomson Scattering System (TSS) is the main diagnostic to extract electron temperature and density of steady state superconducting (SST-1) tokamak plasma. Silicon avalanche photo diode is used with low noise and fast signal conditioning electronics (SCE) to detect incoming Thomson scattered laser photons. A stringent requirement for the measurement is to detect high speed and low level light signal (detection of 100 numbers of Thomson scattered photons for 50 ns pulse width at input of active area of detector) in the presence of wide band electro-magnetic interference (EMI) noise. The electronics and instruments for different sub-systems kept in laboratory contribute to the radiated and conductive noise in a complex manner to the experiment, which can degrade the resultant signal to noise ratio (SNR <1). In general a repeated trial method with flexible grounding scheme are used to improve system signal to noise ratio, which is time consuming and less efficient. In the present work a simple, robust, cost-effective instrumentation system is used for the measurement and monitoring with improved ground scheme and shielding method to minimize noise, isolating the internal sub-system generated noise and external interference which leads to an improved SNR.

  4. Diabetic Macular Edema at the time of Cataract Surgery trial: a prospective, randomized clinical trial of intravitreous bevacizumab versus triamcinolone in patients with diabetic macular oedema at the time of cataract surgery - preliminary 6 month results.

    Science.gov (United States)

    Lim, Lyndell L; Morrison, Julie L; Constantinou, Marios; Rogers, Sophie; Sandhu, Sukhpal S; Wickremasinghe, Sanjeewa S; Kawasaki, Ryo; Al-Qureshi, Salmaan

    2016-05-01

    To compare visual and anatomical outcomes between intravitreous bevacizumab (BVB, Avastin) and triamcinolone (TA, Triesence) when administered at the time of cataract surgery in patients with diabetic macular oedema (DME). Prospective, single-masked, randomized clinical trial at The Royal Victorian Eye and Ear Hospital, Melbourne. Patients with clinically significant cataract and either centre-involving DME or DME treated within the previous 24 months. Participants were randomized 1:1 to receive intravitreous BVB 1.25 mg or TA 4 mg during cataract surgery, and at subsequent review if required over 6 months. Change in central macular thickness (CMT) and best corrected visual acuity at 6 months. Forty-one patients (mean age 66.4 years, 73.2% male) were recruited. Visual acuity and CMT were similar between groups at baseline (P > 0.2).After six months, both groups gained vision (mean +21.4 letters in TA group P < 0.0001, +12.5 letters in BVB, P = 0.002), with no significant difference between groups (P = 0.085). In addition, 60.9% of eyes receiving TA achieved a VA of ≥6/12 compared to 73.3% in the BVB group (P = 0.501). However, only TA was associated with a sustained reduction in CMT (-43.8-µm reduction TA vs. +37.3-µm increase BVB, P = 0.006 over 6 months). Following surgery, additional injections were required in 70.6% of participants in the BVB group, compared to 16.7% in the TA group (P < 0.0001). Three patients in the TA group experienced a rise of IOP over 21 mmHg (12.5%) during the 6-month follow-up; BVB had no cases (P = 0.130). There were no cases of endophthalmitis in either group. When administered at the time of cataract surgery in patients with DME, at 6 months both TA and BVB improve visual acuity; however, only TA results in a sustained reduction in CMT. Further follow-up will determine whether this translates into better long-term visual outcomes in the TA group. © 2016 Royal Australian and New

  5. Impaired alcohol metabolism after gastric bypass surgery: a case-crossover trial.

    Science.gov (United States)

    Woodard, Gavitt A; Downey, John; Hernandez-Boussard, Tina; Morton, John M

    2011-02-01

    Severe obesity remains the leading public health crisis of the industrialized world, with bariatric surgery the only effective and enduring treatment. Poor psychological adjustment has been occasionally reported postoperatively. In addition, evidence suggests that patients can metabolize alcohol differently after gastric bypass. Preoperatively and at 3 and 6 months postoperatively, 19 Roux-en-Y gastric bypass (RYGB) patients' breath alcohol content (BAC) was measured every 5 minutes after drinking 5 oz red wine to determine peak BAC and time until sober in a case-crossover design preoperatively and at 6 months postoperatively. Patients reported symptoms experienced when intoxicated and answered a questionnaire of drinking habits. The peak BAC in patients after RYGB was considerably higher at 3 months (0.059%) and 6 months (0.088%) postoperatively than matched preoperative levels (0.024%). Patients also took considerably more time to return to sober at 3 months (61 minutes) and 6 months (88 minutes) than preoperatively (49 minutes). Postoperative intoxication was associated with lower levels of diaphoresis, flushing, and hyperactivity and higher levels of dizziness, warmth, and double vision. Postoperative patients reported drinking considerably less alcohol, fewer preferred beer, and more preferred wine than before surgery. This is the first study to match preoperative and postoperative alcohol metabolism in gastric bypass patients. Post-RYGB patients have much higher peak BAC after ingesting alcohol and require more time to become sober. Patients who drink alcohol after gastric bypass surgery should exercise caution. Copyright © 2011 American College of Surgeons. Published by Elsevier Inc. All rights reserved.

  6. Efficacy of topical plus intracameral anesthesia for cataract surgery in high myopia: randomized controlled trial.

    Science.gov (United States)

    Lofoco, Giorgio; Ciucci, Francesco; Bardocci, Antonio; Quercioli, Pierpaolo; De Gaetano, Cristiano; Ghirelli, Giorgio; Perdicaro, Serenella; Schiano Lomoriello, Domenico; Cacciamani, Andrea

    2008-10-01

    To assess the efficacy of intracameral lidocaine supplementation of topical anesthesia during cataract surgery in eyes with high myopia. Department of Ophthalmology, Ospedale San Pietro-Fatebenefratelli, Rome, Italy. This prospective double-blind study comprised 120 highly myopic eyes with an axial length (AL) greater than 26.0 mm scheduled for routine cataract surgery. Cases were divided into 2 groups of 60 eyes each. One group received a placebo of balanced salt solution (BSS) (control group) and the other group, a supplement of 0.1 mL preservative-free lidocaine hydrochloride 1% injected in the capsular bag during hydrodissection (lidocaine group). Intraoperative pain was assessed by recording spontaneous patient reports of sensation of pain or ocular discomfort during 3 surgical stages: phaco tip insertion, irrigation/aspiration (I/A) system insertion for cortical aspiration, I/A system insertion for ophthalmic viscosurgical device removal after intraocular lens implantation. Postoperative pain was assessed on a visual analog scale (range 0 to 10). Data were compared by chi-square and Mann-Whitney U tests. The overall mean AL was 28.58 mm (28.57 mm control group; 28.50 mm lidocaine group). Fewer patients in the lidocaine group reported intraoperative pain, ocular discomfort, or tissue manipulation (odds ratio=0.36; 95% confidence interval, 0.16-0.80; P= .019). The mean postoperative pain score was 1.88+/-2.17 (SD) in the control group and 1.36+/-2.02 in the lidocaine group; the difference was not statistically significant (P= .21). Intracameral lidocaine supplementation for cataract surgery may improve intraoperative comfort under topical anesthesia in highly myopic eyes.

  7. Osteopathic Manipulative Treatment Improves Heart Surgery Outcomes: A Randomized Controlled Trial.

    Science.gov (United States)

    Racca, Vittorio; Bordoni, Bruno; Castiglioni, Paolo; Modica, Maddalena; Ferratini, Maurizio

    2017-07-01

    Controlling sternal pain after heart surgery is important to reduce the risk of postoperative complications, but pain is often undertreated because of contraindications and side effects of analgesic drugs. Recently, osteopathic manipulative treatment (OMT) was demonstrated to reduce pain in different clinical contexts, suggesting its potential utility after cardiac surgery. The aim of this open-label, controlled study is to assess whether OMT contributes to sternal pain relief and improves postoperative outcomes. Eighty post-sternotomy adult inpatients were randomly allocated one to one to receive a standardized cardiorespiratory rehabilitation program alone (control group) or combined with OMT. Pain intensity and respiratory functional capacity were quantified by the Visual Analogue Scale score and by a standardized breathing test, at the start and end of rehabilitation. At the start of rehabilitation, the control group and the OMT group had similar Visual Analogue Scale median scores (controls 4, interquartile range [IQR]: 2 to 5; OMT 4, IQR: 3 to 5; p = not significant) and mean inspiratory volumes (controls 825 ± 381 mL; OMT 744 ± 291 mL; p = not significant). At the end of rehabilitation, the OMT group had a lower Visual Analogue Scale median score (controls 3, IQR: 2 to 4; OMT 1, IQR: 1 to 2; p OMT 1,781 ± 633 mL; p OMT group than in the control group (19.1 ± 4.8 versus 21.7 ± 6.3 days; p OMT is effective in inducing pain relief and functional recovery, and significantly improves the management of patients after heart surgery with sternotomy. Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.

  8. Prospective randomized trial of surgery combined with preoperative and postoperative radiotherapy for rectal carcinoma

    Institute of Scientific and Technical Information of China (English)

    2008-01-01

    Objective To assess the effect of surgery combined with preoperative and postoperative radiotherapy(sandwich treatment)in rectal carcinoma.Methods From October 1990 to January 2002,260 patients with stage Ⅱ(117 patients)and stage Ⅲ(143 patients)rectal carcinoma were randomly divided into three groups:sandwich group(92 patients,group A),postoperative radiotherapy group(98 patients,Group B)and operation group(70 patients,Group C).The preoperative accelerated hyperfractionation(15Gy/6f/3d)was given for sandwic...

  9. Vacuum system of SST-1 Tokamak

    Energy Technology Data Exchange (ETDEWEB)

    Khan, Ziauddin, E-mail: ziauddin@ipr.res.in [Institute for Plasma Research, Near Indira Bridge, Bhat, Gandhinagar 382 428 (India); Pathan, Firozkhan; George, Siju; Semwal, Pratibha; Dhanani, Kalpesh; Paravastu, Yuvakiran; Thankey, Prashant; Ramesh, Gattu; Himabindu, Manthena; Pradhan, Subrata [Institute for Plasma Research, Near Indira Bridge, Bhat, Gandhinagar 382 428 (India)

    2013-10-15

    Highlights: ► Air leaks developed during ongoing SST-1 cooldown campaign were detected online using RGA. ► The presence of N{sub 2} and O{sub 2} gases with the ratio of their partial pressures with ∼3.81:1 confirmed the air leaks. ► Baking of SST-1 was done efficiently by flowing hot N{sub 2} gas in C-channels welded on inner surfaces without any problem. ► In-house fabricated demountable bull nose couplers were demonstrated for high temperature and pressure applications. ► Cryopumping effect was observed when liquid helium cooled superconducting magnets reached below 63 K. -- Abstract: Vacuum chambers of Steady State Superconducting (SST-1) Tokamak comprises of the vacuum vessel and the cryostat. The plasma will be confined inside the vacuum vessel while the cryostat houses the superconducting magnet systems (TF and PF coils), LN{sub 2} cooled thermal shields and hydraulics for these circuits. The vacuum vessel is an ultra-high (UHV) vacuum chamber while the cryostat is a high-vacuum (HV) chamber. In order to achieve UHV inside the vacuum vessel, it would be baked at 150 °C for longer duration. For this purpose, U-shaped baking channels are welded inside the vacuum vessel. The baking will be carried out by flowing hot nitrogen gas through these channels at 250 °C at 4.5 bar gauge pressure. During plasma operation, the pressure inside the vacuum vessel will be raised between 1.0 × 10{sup −4} mbar and 1.0 × 10{sup −5} mbar using piezoelectric valves and control system. An ultimate pressure of 4.78 × 10{sup −6} mbar is achieved inside the vacuum vessel after 100 h of pumping. The limitation is due to the development of few leaks of the order of 10{sup −5} mbar l/s at the critical locations of the vacuum vessel during baking which was confirmed with the presence of nitrogen gas and oxygen gas with the ratio of ∼3.81:1 indicating air leak. Similarly an ultimate vacuum of 2.24 × 10{sup −5} mbar is achieved inside the cryostat. Baking of the

  10. Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation : two year results of a randomised controlled trial

    NARCIS (Netherlands)

    Peul, W.C.; Hout, van den W.B.; Brand, R.; Thomeer, R.T.W.M.; Koes, B.W.

    2008-01-01

    Objectives: To evaluate the effects of early lumbar disc surgery compared with prolonged conservative care for patients with sciatica over two years of follow-up. Design: Randomised controlled trial. Setting: Nine Dutch hospitals. Participants: 283 patients with 6-12 weeks of sciatica. Interventions

  11. Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation: Two year results of a randomised controlled trial

    NARCIS (Netherlands)

    W.C. Peul (Wilco); W.B. van den Hout (Wilbert); R. Brand (René); R.T.W.M. Thomeer (Raph); B.W. Koes (Bart)

    2008-01-01

    textabstractObjectives: To evaluate the effects of early lumbar disc surgery compared with prolonged conservative care for patients with sciatica over two years of follow-up. Design: Randomised controlled trial. Setting: Nine Dutch hospitals. Participants: 283 patients with 6-12 weeks of sciatica. I

  12. Prolonged conservative care versus early surgery in patients with sciatica caused by lumbar disc herniation: two year results of a randomised controlled trial.

    NARCIS (Netherlands)

    Peul, W.C.; Hout, W.B. van den; Brand, R.; Thomeer, R.T.; Koes, B.W.; Eekhof, J.A.H.; Tans, J.T.; Houwelingen, H.C. van; Nuyten, M.; Bergman, P.; Holtkamp, G.; Dukker, S.; Mast, A.; Smakman, L.; Waanders, C.; Polak, P.; Nieborg, A.; Walchenbach, R.; Rossum, J. van; Schutte, P.J.; Verheul, G.A.; Dalman, J.A.; Wurzer, J.A.; Sven, J.W.; Kloet, A.; Merkies, I.S.; Dulken, H. van; Lambrechts, P.C.; Keunen, R.W.; Hoffmann, C.; Haan, J.; Groen, R.; Kuiters, R.R.; Roos, R.A.C.; Voormolen, J.H.

    2008-01-01

    OBJECTIVES: To evaluate the effects of early lumbar disc surgery compared with prolonged conservative care for patients with sciatica over two years of follow-up. DESIGN: Randomised controlled trial. SETTING: Nine Dutch hospitals. PARTICIPANTS: 283 patients with 6-12 weeks of sciatica. INTERVENTIONS

  13. Costs of revascularization over eight years in the randomized and eligible patients in the Emory Angioplasty versus Surgery Trial (EAST).

    Science.gov (United States)

    Weintraub, W S; Becker, E R; Mauldin, P D; Culler, S; Kosinski, A S; King, S B

    2000-10-01

    The Emory Angioplasty versus Surgery Trial (EAST) was a randomized trial that compared, by intention to treat, the clinical outcome and costs of percutaneous transluminal coronary angioplasty (PTCA) and coronary bypass grafting (CABG) for multivessel coronary artery disease. We present the findings of the economic analysis of EAST through 8 years of follow-up and compare the cost and outcomes of patients randomized in EAST versus patients eligible but not randomized (registry patients). Charges were assessed from hospital UB82 and UB92 bills and professional charges from the Emory Clinic. Hospital charges were reduced to cost through step-down accounting methods. All costs and charges were inflated to 1997 dollars. Costs were assessed for initial hospitalization and for cumulative costs of the initial hospitalization and additional revascularization procedures up to 8 years. Total 8-year costs were $46,548 for CABG and $44,491 for PTCA (p = 0.37). Cost of CABG in the eligible registry group showed a pattern similar to that for randomized patients, but total cost of PTCA was lower for registry patients than for randomized patients. Thus, the primary procedural costs of CABG are more than those for PTCA; this cost advantage, given the limits of measurement, is largely or even completely lost for randomized patients over the course of 8 years because of additional procedures after a first revascularization by PTCA.

  14. Disclosure of funding sources and conflicts of interest in phase III surgical trials: survey of ten general surgery journals.

    Science.gov (United States)

    Bridoux, Valérie; Moutel, Grégoire; Schwarz, Lilian; Michot, Francis; Herve, Christian; Tuech, Jean-Jacques

    2014-10-01

    Discussions regarding disclosure of funding sources and conflicts of interest (COI) in published peer-reviewed journal articles are becoming increasingly more common and intense. The aim of the present study was to examine whether randomized controlled trials (RCTs) published in leading surgery journals report funding sources and COI. All articles reporting randomized controlled phase III trials published January 2005 through December 2010 were chosen for review from ten international journals. We evaluated the number of disclosed funding sources and COI, and the factors associated with such disclosures. From a review of 657 RCT from the ten journals, we discovered that presence or absence of a funding source and COI was disclosed by 47 % (309) and 25.1 % (165), respectively. Most articles in "International Committee of Medical Journal Editors (ICMJE)-affiliated journals" did not disclose COI. Disclosure of funding was associated with a journal impact factor >3 (51.7 vs 41.6 %; p journal being ICMJE-affiliated (49.3 vs 40 %; p journal not being affiliated with ICMJE (36.9 vs 21.3 %; p < 0.001). Of the published studies we investigated, over half did not disclose funding sources (i.e., whether or not there was a funding source), and almost three quarters did not disclose whether COI existed. Our findings suggest the need to adopt best current practices regarding disclosure of competing interests to fulfill responsibilities to readers and, ultimately, to patients.

  15. Morphine versus Nalbuphine for Open Gynaecological Surgery: A Randomized Controlled Double Blinded Trial

    Directory of Open Access Journals (Sweden)

    Shiv Akshat

    2014-01-01

    Full Text Available Introduction. Pain is the commonest morbidity after open surgical procedures. The most effective treatment of postoperative pain is opioid therapy. Morphine, the commonly used opioid, is associated with many side effects including respiratory depression, sedation, postoperative nausea vomiting, and pruritus. Nalbuphine, on the other hand, is known to cause less respiratory depression. Thus this study was undertaken to compare the intraoperative and postoperative analgesic efficacy and side effect profile of the two drugs. Methodology. 60 patients undergoing open gynaecological surgery were randomized to receive either morphine (Group M or nalbuphine (Group N in the intraoperative and postoperative period. Intraoperative analgesic efficacy (measured by need for rescue analgesics, postoperative pain by visual analogue scale, and side effects like postoperative nausea, vomiting, sedation, respiratory depression, and pruritus were compared in both groups. Intraoperative and postoperative heart rate and blood pressure were also compared between the groups. Results. Need for intraoperative analgesia was significantly more in Group N (P=0.023. Postoperative VAS scores were significantly different between the groups at various time points; however, none of the patients required any rescue analgesia. The incidence of various side effects was not significantly different between the groups. The haemodynamic profile of patients was comparable between the groups in both intraoperative and postoperative period. Conclusion. Nalbuphine provides less effective intraoperative analgesia than morphine in patients undergoing open gynaecological surgery under general anaesthesia. Both drugs, however, provided similar postoperative analgesia and had similar haemodynamic and side effect profile.

  16. A randomized controlled trial evaluating early versus traditional oral feeding after colorectal surgery

    Directory of Open Access Journals (Sweden)

    Ahmet Dag

    2011-01-01

    Full Text Available OBJECTIVE: This prospective randomized clinical study was conducted to evaluate the safety and tolerability of early oral feeding after colorectal operations. METHODS: A total of 199 patients underwent colorectal surgery and were randomly assigned to early feeding (n = 99 or a regular diet (n = 100. Patients’ characteristics, diagnoses, surgical procedures, comorbidity, bowel movements, defecation, nasogastric tube reinsertion, time of tolerance of solid diet, complications, and length of hospitalization were assessed. RESULTS: The two groups were similar in terms of gender, age, diagnosis, surgical procedures, and comorbidity. In the early feeding group, 85.9% of patients tolerated the early feeding schedule. Bowel movements (1.7±0.89 vs. 3.27±1.3, defecation (3.4±0.77 vs. 4.38±1.18 and time of tolerance of solid diet (2.48±0.85 vs. 4.77±1.81 were significantly earlier in the early feeding group. There was no change between the groups in terms of nasogastric tube reinsertion, overall complication or anastomotic leakage. Hospitalization (5.55±2.35 vs. 9.0±6.5 was shorter in the early feeding group. CONCLUSIONS: The present study indicated that early oral feeding after elective colorectal surgery was not only well tolerated by patients but also affected the postoperative outcomes positively. Early postoperative feeding is safe and leads to the early recovery of gastrointestinal functions.

  17. A multicenter,phase III trial of hemocoagulase Agkistrodon:hemostasis,coagulation,and safety in patients undergoing abdominal surgery

    Institute of Scientific and Technical Information of China (English)

    WEI Jun-min; LI Jie; XU Jing-yong; ZHENG Qing-shan; ZHU Ming-wei; ZHANG Zhong-tao; JIA Zhen-geng; HE Xiao-dong; WAN Yuan-lian; WANG Shan; XIU Dian-rong; TANG Yun

    2010-01-01

    Background Hemocoagulase Agkistrodon for injection is a single component thrombin which has passed phases I and II clinical trials. The purpose of this phase III clinical trial was to evaluate the effect of Hemocoagulase Agkistrodon on hemostasis and coagulation in abdominal skin and subcutaneous incisions and to assess the safety of this agent in surgical patients. Methods This is a phase III, prospective, randomized, double-blind, and controlled multicenter clinical trial including 432 consecutive patients randomized into either a study group (injected with hemocoagulase Agkistrodon at 2 U, n=324) or a control group (injected with hemocoagulase Atrox, n=108). The hemostatic time, hemorrhagic volume, hemorrhagic volume per unit area, blood coagulation, and adverse events were measured and compared between the two groups. Results The mean hemostatic time in the study group was (36.8±18.7) seconds; the hemorrhagic volume was (3.77±3.93) g; and the hemorrhagic volume per unit area was (0.091±0.125) g/cm~2. In the control group, the corresponding values were (38.1±19.7) seconds, (4.00±4.75) g, and (0.095±0.101) g/cm~2, respectively. No significant difference in values existed between the two groups (P >0.05). Blood coagulation results and hepatic and renal function were also similar between the two groups. Adverse events were reported in two cases, but were deemed non-drug-related. Conclusions Hemocoagulase Agkistrodon has good hemostatic and coagulative function and is safe for the use of arresting capillary hemorrhage that occurs while incising the abdomen during surgery.

  18. Update to the study protocol, including statistical analysis plan for a randomized clinical trial comparing comprehensive cardiac rehabilitation after heart valve surgery with control

    DEFF Research Database (Denmark)

    Sibilitz, Kirstine Laerum; Berg, Selina Kikkenborg; Hansen, Tina Birgitte

    2015-01-01

    -benefit will be assessed. A mixed-method design will be used to evaluate qualitative and quantitative findings, encompassing a survey-based study before the trial and a qualitative pre- and post-intervention study. CONCLUSION: This randomized clinical trial will contribute with evidence of whether cardiac rehabilitation...... (VO2 peak) measured by cardiopulmonary exercise testing with ventilatory gas analysis. The secondary outcome is self-assessed mental health measured by the standardized questionnaire Short Form-36. Long-term healthcare utilization and mortality as well as biochemistry, echocardiography and cost...... should be provided after heart valve surgery. The study is approved by the local regional Research Ethics Committee (H-1-2011-157), and the Danish Data Protection Agency (j.nr. 2007-58-0015). TRIAL REGISTRATION: Trial registered 16 March 2012; ClinicalTrials.gov ( NCT01558765 )....

  19. Assessment of a Standardized Pre-Operative Telephone Checklist Designed to Avoid Late Cancellation of Ambulatory Surgery: The AMBUPROG Multicenter Randomized Controlled Trial

    Science.gov (United States)

    Marchand-Maillet, Florence; Baron, Gabriel; Douard, Richard; Béthoux, Jean-Pierre

    2016-01-01

    Objectives To assess the impact of a standardized pre-operative telephone checklist on the rate of late cancellations of ambulatory surgery (AMBUPROG trial). Design Multicenter, two-arm, parallel-group, open-label randomized controlled trial. Setting 11 university hospital ambulatory surgery units in Paris, France. Participants Patients scheduled for ambulatory surgery and able to be reached by telephone. Intervention A 7-item checklist designed to prevent late cancellation, available in five languages and two versions (for children and adults), was administered between 7 and 3 days before the planned date of surgery, by an automated phone system or a research assistant. The control group received standard management alone. Main Outcome Measures Rate of cancellation on the day of surgery or the day before. Results The study population comprised 3900 patients enrolled between November 2012 and September 2013: 1950 patients were randomized to the checklist arm and 1950 patients to the control arm. The checklist was administered to 68.8% of patients in the intervention arm, 1002 by the automated phone system and 340 by a research assistant. The rate of late cancellation did not differ significantly between the checklist and control arms (109 (5.6%) vs. 113 (5.8%), adjusted odds ratio [95% confidence interval] = 0.91 [0.65–1.29], (p = 0.57)). Checklist administration revealed that 355 patients (28.0%) had not undergone tests ordered by the surgeon or anesthetist, and that 254 patients (20.0%) still had questions concerning the fasting state. Conclusions A standardized pre-operative telephone checklist did not avoid late cancellations of ambulatory surgery but enabled us to identify several frequent causes. Trial Registration ClinicalTrials.gov NCT01732159 PMID:26829478

  20. The effect of peritoneal gas drain on postoperative pain in benign gynecologic laparoscopic surgery: a double-blinded randomized controlled trial controlled trial

    Directory of Open Access Journals (Sweden)

    Tharanon C

    2016-08-01

    Full Text Available Chantip Tharanon, Kovit Khampitak Department of Obstetrics and Gynecology, Srinagarind Hospital, Khon Kaen University, Khon Kaen, Thailand Objectives: To compare the effect of peritoneal gas drain on postoperative pain in benign gynecologic laparoscopic surgery and the amount of postoperative analgesic dosage.Methods: The trial included 45 females who had undergone operations during the period December 2014 to October 2015. The patients were block randomized based on operating time (<2 and ≥2 hours. The intervention group (n=23 was treated with postoperative intraperitoneal gas drain and the control group (n=22 was not. The mean difference in scores for shoulder, epigastric, suprapubic, and overall pain at 6, 24, 48 hours postoperatively were statistically evaluated using mixed-effect restricted maximum likelihood regression. The differences in the analgesic drug usage between the groups were also analyzed using a Student’s t-test. The data were divided and analyzed to two subgroups based on operating time (<2 hours, n=20; and ≥2 hours, n=25.Results: The intervention had significantly lower overall pain than the control group, with a mean difference and 95% confidence interval at 6, 24, and 48 hours of 2.59 (1.49–3.69, 2.23 (1.13–3.34, and 1.48 (0.3–2.58, respectively. Correspondingly, analgesic drug dosage was significantly lower in the intervention group (3.52±1.47 mg vs 5.72±2.43 mg, P<0.001. The three largest mean differences in patients with operating times of ≥2 hours were in overall pain, suprapubic pain at 6 hours, and shoulder pain at 24 hours at 3.27 (1.14–5.39, 3.20 (1.11–5.26, and 3.13 (1.00–5.24, respectively. These were greater than the three largest mean differences in the group with operating times of <2 hours, which were 2.81 (1.31–4.29, 2.63 (0.51–4.73, and 2.02 (0.68–3.36. The greatest analgesic drug requirement was in the control group with a longer operative time.Conclusion: The use of

  1. Analgesic Effects of Intravenous Acetaminophen vs Placebo for Endoscopic Sinus Surgery and Postoperative Pain: A Randomized Clinical Trial.

    Science.gov (United States)

    Tyler, Matthew A; Lam, Kent; Ashoori, Faramarz; Cai, Chunyan; Kain, Joshua J; Fakhri, Samer; Citardi, Martin J; Cattano, Davide; Luong, Amber

    2017-08-01

    Intravenous acetaminophen is a commonly prescribed analgesic for the prevention and treatment of postsurgical pain. Its efficacy in the context of endoscopic sinus surgery (ESS) has yielded mixed results. To compare the efficacy of perioperative intravenous acetaminophen (IVAPAP) with that of placebo in improving early postoperative pain after endoscopic sinus surgery (ESS). A prospective, randomized clinical trial including 62 patients undergoing ESS for chronic rhinosinusitis in a single tertiary referral hospital. Participants were randomized to receive 1 g of IVAPAP or 100 mL of placebo consisting of saline infusions immediately before the start of surgery and 4 hours after the initial dose. The primary outcome was postoperative pain measured by visual analog scale (VAS) scores up to 24 hours after surgery by blinded observers. Secondary endpoints included postoperative opioid (intravenous and oral) use and adverse events in the 24-hour postoperative period. Of the 62 enrolled adult participants, 60 were randomized (31 to IVAPAP intervention and 29 to placebo). The mean (SD) age of participants was 53.7 (14.7) years and 35 (58%) of the participants were men and 25 (42%) were women. Within the first hour, mean pain scores were reduced in the IVAPAP group compared with the control group, reaching a maximum difference of 7.7 mm on a VAS scale favoring the treatment group with a true difference possibly as high as 22 mm, and the data are compatible with a clinically meaningful difference. At 12- and 24-hours, average pain scores were less in the placebo group and the data are compatible with a clinically meaningful difference of 5.8 (-5.2 to 16.8) and 8.2 (-1.9 to 18.4), respectively, favoring the placebo group. However, at all time points the CIs included the null value and were wide, thus preventing definitive conclusions. Inspection of the secondary outcomes favored IVAPAP, but the wide range of the CIs and inclusion of the null value prevent definitive

  2. Effect of water-soluble contrast in colorectal surgery: A prospective randomized trial

    Institute of Scientific and Technical Information of China (English)

    Jia-Hui Chen; Chung-Bao Hsieh; Pei-Chieh Chao; Hsiao-Dung Liu; Chung-Jueng Chen; Yao-Chi Liu; Jyh-Cherng Yu

    2005-01-01

    AIM: Postoperative gastrointestinal-tract motility is normally delayed. Early feeding after colorectal surgery has beenreposed recently, but late feeding is common. Gastrografin not only enhances bowel peristalsis, but also decreases bowel-wall edema. Whether contrast medium allows early oral feeding and reduces the duration of hospitalization requires clarification.METHODS: Fifty patients underwent elective colorectal surgery in a regional medical center. Patients were prospectively randomized into a Gastrografin group or control group (n = 25 each). Patients in the Gastrografin group began their feeding schedule with 100 mL of 5% dextrose water with 100 mL of Gastrografin on postoperative d 3 and were advanced to a full liquid diet when the contrast reached the colon in 4 h. Patients in the control group began their feeding schedule with 200 mL of 5% dextrosewater on postoperative d 3 and were advanced to a full liquid diet after the passage of flatus and stool. Nasogastric tubes were inserted for persistent postoperative vomiting. Fullness, nausea, vomiting, complications, time of anesthesia, time of operation, time of mobilization, time of oral feeding, and duration of hospital stay were recorded and analyzed with Student's t-test.RESULTS: In the Gastrografin group, one patient hadaspiration pneumonia and one patient had anastomotic leakage resulting in sepsis and eventual death. This mortality was excluded from the subsequent statistical analysis. In the control group, two patients had wound infections. There was no significant difference between the two groups at the time of anesthesia, time of operation, or time of mobilization. There were significant differences between the two groups in the time of oral feeding (3.3±0.3 d in the Gastrografin group vs4.8±0.4 d in the control group; P = odds ratio--, 95%CI [-0.5 to +0.7 d]) and in the length of hospital stay (7.6±1.1 d in the Gastrografingroup vs10.2±1.3 d in the control group; P = odds ratio--, 95% CI

  3. Impact of High Resolution SST Data on Regional Weather Forecasts

    Science.gov (United States)

    Jedlovec, Gary J.; Case, Jonathon; LaFontaine, Frank; Vazquez, Jorge; Mattocks, Craig

    2010-01-01

    Past studies have shown that the use of coarse resolution SST products such as from the real-time global (RTG) SST analysis[1] or other coarse resolution once-a-day products do not properly portray the diurnal variability of fluxes of heat and moisture from the ocean that drive the formation of low level clouds and precipitation over the ocean. For example, the use of high resolution MODIS SST composite [2] to initialize the Advanced Research Weather Research and Forecast (WRF) (ARW) [3] has been shown to improve the prediction of sensible weather parameters in coastal regions [4][5}. In an extend study, [6] compared the MODIS SST composite product to the RTG SST analysis and evaluated forecast differences for a 6 month period from March through August 2007 over the Florida coastal regions. In a comparison to buoy data, they found that that the MODIS SST composites reduced the bias and standard deviation over that of the RTG data. These improvements led to significant changes in the initial and forecasted heat fluxes and the resulting surface temperature fields, wind patterns, and cloud distributions. They also showed that the MODIS composite SST product, produced for the Terra and Aqua satellite overpass times, captured a component of the diurnal cycle in SSTs not represented in the RTG or other one-a-day SST analyses. Failure to properly incorporate these effects in the WRF initialization cycle led to temperature biases in the resulting short term forecasts. The forecast impact was limited in some situations however, due to composite product inaccuracies brought about by data latency during periods of long-term cloud cover. This paper focuses on the forecast impact of an enhanced MODIS/AMSR-E composite SST product designed to reduce inaccuracies due data latency in the MODIS only composite product.

  4. Global SST influence on twentieth century NAO variability

    Energy Technology Data Exchange (ETDEWEB)

    Paeth, H.; Hense, A. [Meteorologisches Institut, Universitaet Bonn, 53121 Bonn (Germany); Latif, M. [Max-Planck-Institut fuer Meteorologie, 20146 Hamburg (Germany)

    2003-07-01

    Recent studies have suggested that sea surface temperature (SST) is an important source of variability of the North Atlantic Oscillation (NAO). Here, we deal with four basic aspects contributing to this issue: (1) we investigate the characteristic time scales of this oceanic influence; (2) quantify the scale-dependent hindcast potential of the NAO during the twentieth century as derived from SST-driven atmospheric general circulation model (AGCM) ensembles; (3) the relevant oceanic regions are identified, corresponding SST indices are defined and their relationship to the NAO are evaluated by means of cross spectral analysis and (4) our results are compared with long-term coupled control experiments with different ocean models in order to ensure whether the spectral relationship between the SST regions and the NAO is an intrinsic mode of the coupled climate system, involving the deep ocean circulation, rather than an artefact of the unilateral SST forcing. The observed year-to-year NAO fluctuations are barely influenced by the SST. On the decadal time scales the major swings of the observed NAO are well reproduced by various ensembles from the middle of the twentieth century onward, including the negative state in the 1960s and part of the positive trend afterwards. A six-member ECHAM4-T42 ensemble reveals that the SST boundary condition affects 25% of total decadal-mean and interdecadal-trend NAO variability throughout the twentieth century. The most coherent NAO-related SST feature is the well-known North Atlantic tripole. Additional contributions may arise from the southern Pacific and the low-latitude Indian Ocean. The coupled climate model control runs suggest only the North Atlantic SST-NAO relationship as being a true characteristic of the coupled climate system. The coherence and phase spectra of observations and coupled simulations are in excellent agreement, confirming the robustness of this decadal-scale North Atlantic air-sea coupled mode. (orig.)

  5. Identification of Phosphorylation Sites Regulating sst3 Somatostatin Receptor Trafficking.

    Science.gov (United States)

    Lehmann, Andreas; Kliewer, Andrea; Günther, Thomas; Nagel, Falko; Schulz, Stefan

    2016-06-01

    The human somatostatin receptor 3 (sst3) is expressed in about 50% of all neuroendocrine tumors and hence a promising target for multireceptor somatostatin analogs. The sst3 receptor is unique among ssts in that it exhibits a very long intracellular C-terminal tail containing a huge number of potential phosphate acceptor sites. Consequently, our knowledge about the functional role of the C-terminal tail in sst3 receptor regulation is very limited. Here, we have generated a series of phosphorylation-deficient mutants that enabled us to determine crucial sites for its agonist-induced β-arrestin mobilization, internalization, and down-regulation. Based on this information, we generated phosphosite-specific antibodies for C-terminal Ser(337)/Thr(341), Thr(348), and Ser(361) that enabled us to investigate the temporal patterns of sst3 phosphorylation and dephosphorylation. We found that the endogenous ligand somatostatin induced a rapid and robust phosphorylation that was completely blocked by the sst3 antagonist NVP-ACQ090. The stable somatostatin analogs pasireotide and octreotide promoted clearly less phosphorylation compared with somatostatin. We also show that sst3 phosphorylation occurred within seconds to minutes, whereas dephosphorylation of the sst3 receptor occurred at a considerable slower rate. In addition, we also identified G protein-coupled receptor kinases 2 and 3 and protein phosphatase 1α and 1β as key regulators of sst3 phosphorylation and dephosphorylation, respectively. Thus, we here define the C-terminal phosphorylation motif of the human sst3 receptor that regulates its agonist-promoted phosphorylation, β-arrestin recruitment, and internalization of this clinically relevant receptor.

  6. A Scandcleft randomised trials of primary surgery for unilateral cleft lip and palate

    DEFF Research Database (Denmark)

    Semb, Gunvor; Enemark, Hans; Friede, Hans

    2017-01-01

    months. Trial 3 compared it with lip and hard palate closure at 3-4 months and soft palate closure at 12 months. The primary outcomes were speech and dentofacial development, with a series of perioperative and longer-term secondary outcomes. RESULTS: Recruitment of 448 infants took place over a 9-year...... period, with 99.8% subsequent retention at 5 years. CONCLUSION: The series of reports that follow this introductory paper include comparisons at age 5 of surgical outcomes, speech outcomes, measures of dentofacial development and appearance, and parental satisfaction. The outcomes recorded...

  7. Effect of virtual reality training on laparoscopic surgery: randomised controlled trial

    DEFF Research Database (Denmark)

    2009-01-01

    OBJECTIVE: To assess the effect of virtual reality training on an actual laparoscopic operation. DESIGN: Prospective randomised controlled and blinded trial. SETTING: Seven gynaecological departments in the Zeeland region of Denmark. PARTICIPANTS: 24 first and second year registrars specialising...... in gynaecology and obstetrics. INTERVENTIONS: Proficiency based virtual reality simulator training in laparoscopic salpingectomy and standard clinical education (controls). MAIN OUTCOME MEASURE: The main outcome measure was technical performance assessed by two independent observers blinded to trainee......-14 minutes) and in the control group was 24 (20-29) minutes (Pvirtual reality simulator training. The performance level of novices...

  8. Effectiveness of a multidisciplinary care program on recovery and return to work of patients after gynaecological surgery; design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Vonk Noordegraaf Antonie

    2012-02-01

    Full Text Available Abstract Background Return to work after gynaecological surgery takes much longer than expected, irrespective of the level of invasiveness. In order to empower patients in recovery and return to work, a multidisciplinary care program consisting of an e-health intervention and integrated care management including participatory workplace intervention was developed. Methods/Design We designed a randomized controlled trial to assess the effect of the multidisciplinary care program on full sustainable return to work in patients after gynaecological surgery, compared to usual clinical care. Two hundred twelve women (18-65 years old undergoing hysterectomy and/or laparoscopic adnexal surgery on benign indication in one of the 7 participating (university hospitals in the Netherlands are expected to take part in this study at baseline. The primary outcome measure is sick leave duration until full sustainable return to work and is measured by a monthly calendar of sickness absence during 26 weeks after surgery. Secondary outcome measures are the effect of the care program on general recovery, quality of life, pain intensity and complications, and are assessed using questionnaires at baseline, 2, 6, 12 and 26 weeks after surgery. Discussion The discrepancy between expected physical recovery and actual return to work after gynaecological surgery contributes to the relevance of this study. There is strong evidence that long periods of sick leave can result in work disability, poorer general health and increased risk of mental health problems. We expect that this multidisciplinary care program will improve peri-operative care, contribute to a faster return to work of patients after gynaecological surgery and, as a consequence, will reduce societal costs considerably. Trial registration Netherlands Trial Register (NTR: NTR2087

  9. Surgery vs medical treatment in the management of PFAPA syndrome: a comparative trial.

    Science.gov (United States)

    Erdogan, Firat; Kulak, Kudret; Öztürk, Ozmen; İpek, İlke Özahı; Ceran, Ömer; Seven, Hüseyin

    2016-11-01

    Periodic fever, aphthous stomatitis, pharyngitis and cervical adenitis (PFAPA) syndrome is a common disorder in children but there is little or no consensus on its optimal diagnosis and management. To compare the outcome of different management approaches - medical therapy or tonsillectomy. The medical records of children diagnosed with PFAPA between 2008 and 2013 were retrospectively reviewed according to the modified Thomas test criteria. Patients were divided into two groups: group 1 for medical treatment - corticosteroids, a single intramuscular injection of methylprednisolone, and group 2 for surgery - tonsillectomy alone or tonsillectomy plus adenoidectomy .The course of the disease including the number and duration of episodes and the presence of remission, was documented. 105 patients (30 in group 1, 75 in group 2) met the study's inclusion criteria. Groups 1 and 2 were followed up for a mean (SD) of 23.6 (11.0) and 24 (10.3) months, respectively. At the end of the follow-up period, the number of episodes was 5.8 (6.3) vs 1.8 (1.9) (P<0.01) and their duration was 2.2 (1.3) vs 1.1 (0.8) days (P=0.03), both of which were significantly lower in group 2.The need for hospitalization during this period was significantly lower for group 2 at 1.1 (2.0) vs 0.1 (0.3) (P<0.01) and the remission rate in group 2 was significantly higher than in group 1 (98.6% vs 56.6%, P<0.01). This study demonstrated that surgery is superior to medical treatment for PFAPA in terms of increased remission rates and a decrease in the number and duration of episodes.

  10. Cardioprotection of Electroacupuncture for Enhanced Recovery after Surgery on Patients Undergoing Heart Valve Replacement with Cardiopulmonary Bypass: A Randomized Control Clinical Trial

    Directory of Open Access Journals (Sweden)

    Fangxiang Zhang

    2017-01-01

    Full Text Available We attempted to investigate cardioprotection of electroacupuncture (EA for enhanced recovery after surgery on patients undergoing heart valve replacement with cardiopulmonary bypass. Forty-four patients with acquired heart valve replacement were randomly allocated to the EA group or the control group. Patients in the EA group received EA stimulus at bilateral Neiguan (PC6, Ximen (PC4, Shenting (GV24, and Baihui (GV20 acupoints twenty minutes before anesthesia induction to the end of surgery. The primary end point was cardioprotection effect of electroacupuncture postoperatively and the secondary endpoints were quality of recovery and cognitive functioning postoperatively. The present study demonstrated that electroacupuncture reduced the occurrence of complications and played a role of cardioprotective effect on patients after heart valve replacement surgery with cardiopulmonary bypass, and it benefits patients more comfortable and contributes to recovery after surgery. This trial is registered with ChiCTR-IOC-16009123.

  11. Protocol for the CUPIDO trials; multicenter randomized controlled trials to assess the value of combining prolapse surgery and incontinence surgery in patients with genital prolapse and evident stress incontinence (CUPIDO I and in patients with genital prolapse and occult stress incontinence (CUPIDO II

    Directory of Open Access Journals (Sweden)

    van der Vaart Huub

    2010-05-01

    Full Text Available Abstract Background About 40% of all patients with genital prolapse report stress-incontinence. In about half of the 60% patients that do not report stress-incontinence, occult urinary stress-incontinence can be detected. In these patients stress-incontinence is masked due to kinking or compression of the urethra by the prolapse. In case surgical correction is indicated there are two strategies to manage patients with combined prolapse and (occult stress incontinence. This strategy is either (i a combination of prolapse surgery and stress-incontinence surgery or (ii to correct the prolapse first and evaluate afterwards whether additional stress-incontinence surgery is indicated. The advantage of combining prolapse and stress-incontinence surgery is that only few patients report stress-incontinence following such combination. However, this combination has been associated with an increased risk on complications, of which the development of obstructive micturition symptoms, overactive bladder symptoms and bladder retention are the most important ones. Furthermore, combining two procedures may be unnecessary as performing only prolapse surgery may cure stress-incontinence In the randomized CUPIDO trials both strategies are compared in patients with prolapse and evident stress incontinence (CUPIDO I trial and in patients with prolapse and occult stress incontinence (CUPIDO II trial. Methods/Design The CUPIDO trials are two multicenter randomized controlled trials in which women with stress urinary incontinence (SUI or occult stress urinary incontinence (OSUI are randomized to prolapse surgery combined with anti incontinence surgery (concomitant surgery or to prolapse surgery only. Patients with at least stage 2 POP are eligible, women with evident SUI are randomized in CUPIDO I. Patients without SUI are eligible for CUPIDO II and will have urodynamic evaluation or a standardized redression test. Women with OSUI are randomized, women without OSUI are

  12. The Comparison of Two Types of Relaxation Techniques on Postoperative State Anxiety in Candidates for The Mastectomy Surgery: A Randomized Controlled Clinical Trial.

    Science.gov (United States)

    Parsa Yekta, Zohreh; Sadeghian, Fatemeh; Taghavi Larijani, Taraneh; Mehran, Abbas

    2017-01-01

    Anxiety among patients after surgery can affect their physiological and psychological well-being. The aim of this study was to investigate and compare the effects of Benson's relaxation and rhythmic breathing techniques on postoperative anxiety in candidates for the mastectomy surgery. This randomized controlled clinical trial study was conducted with ninety patients in 2013. The patients were hospitalized for the mastectomy surgery in three surgical wards in a teaching hospital, Tehran, Iran. They were randomly assigned into three groups: Benson's relaxation including the cognitive relaxation technique type, rhythmic breathing including the somatic relaxation technique type and control groups. According to the Davidson and Schwartz multi-process theory, the Benson's relaxation and the rhythmic breathing techniques have cognitive and somatic effects, respectively. One day before the surgery, the patients in the intervention groups were trained regarding relaxation and breathing techniques and were asked to perform the techniques under the supervision of the researcher in the night before the surgery. The cognitive somatic anxiety questionnaire was used to measure anxiety before the intervention and half an hour after recovery of consciousness after the surgery. Descriptive and inferential statistics were used for data analysis via the SPSS v.21 software. There were no statistically significant differences between the groups in terms of demographic characteristics. The application of both techniques reduced the level of patients' anxiety after the surgery. The patients in the Benson's relaxation technique group reported only the relief of somatic anxiety. However, the breathing technique patients reported a reduction in both cognitive and somatic anxiety. The Benson's relaxation and rhythmic breathing techniques can reduce postoperative anxiety in patients after the mastectomy surgery. Trial Registration Number: IRCT2014042017350N1.

  13. Comparison of the acute-phase response after laparoscopic versus open aortobifemoral bypass surgery: a substudy of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Krog AH

    2016-09-01

    Full Text Available Anne H Krog,1,2 Mehdi Sahba,3 Erik M Pettersen,4 Irene Sandven,5 Per M Thorsby,1,6 Jørgen J Jørgensen,1,2 Jon O Sundhagen,2 Syed SS Kazmi2 1Institute of Clinical Medicine, University of Oslo, 2Department of Vascular Surgery, Division of Cardiovascular and Pulmonary Diseases, Oslo University Hospital, Oslo, 3Department of Vascular Surgery, Østfold Central Hospital, Fredrikstad, 4Department of Vascular Surgery, Sørlandet Hospital HF, Kristiansand, 5Oslo Center for Biostatistics and Epidemiology (OCBE, 6Hormone Laboratory, Department of Medical Biochemistry, Oslo University Hospital, Oslo, Norway Purpose: Minimally invasive surgical techniques have been shown to reduce the inflammatory response related to a surgical procedure. The main objective of our study was to measure the inflammatory response in patients undergoing a totally laparoscopic versus open aortobifemoral bypass surgery. This is the first randomized trial on subjects in this population.Patients and methods: This is a substudy of a larger randomized controlled multicenter trial (Norwegian Laparoscopic Aortic Surgery Trial. Thirty consecutive patients with severe aortoiliac occlusive disease eligible for aortobifemoral bypass surgery were randomized to either a totally laparoscopic (n=14 or an open surgical procedure (n=16. The inflammatory response was measured by perioperative monitoring of serum interleukin-6 (IL-6, IL-8, and C-reactive protein (CRP at six different time points.Results: The inflammatory reaction caused by the laparoscopic procedure was reduced compared with open surgery. IL-6 was significantly lower after the laparoscopic procedure, measured by comparing area under the curve (AUC, and after adjusting for the confounding effect of coronary heart disease (P=0.010. The differences in serum levels of IL-8 and CRP did not reach statistical significance.Conclusion: In this substudy of a randomized controlled trial comparing laparoscopic and open aortobifemoral bypass

  14. Comparison of standard fusion with a "topping off" system in lumbar spine surgery: a protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Kaulhausen Thomas

    2011-10-01

    Full Text Available Abstract Background Fusion of lumbar spine segments is a well-established therapy for many pathologies. The procedure changes the biomechanics of the spine. Initial clinical benefits may be outweighed by ensuing damage to the adjacent segments. Various surgical devices and techniques have been developed to prevent this deterioration. "Topping off" systems combine rigid fusion with a flexible pedicle screw system to prevent adjacent segment disease (ASD. To date, there is no convincing evidence that these devices provide any patient benefits. Methods/Design The study is designed as a randomized, therapy-controlled trial in a clinical care setting at a university hospital. Patients presenting to the outpatient clinic with degenerative disc disease or spondylolisthesis will be assessed against study inclusion and exclusion criteria. After randomization, the control group will undergo conventional fusion. The intervention group will undergo fusion with a supplemental flexible pedicle screw system to protect the adjacent segment ("topping off". Follow-up examination will take place immediately after treatment during hospital stay, after 6 weeks, and then after 6, 12, 24 and 36 months. Subsequently, ongoing assessments will be performed annually. Outcome measurements will include quality of life and pain assessments using questionnaires (SF-36™, ODI, COMI. In addition, clinical and radiologic ASD, work-related disability, and duration of work disability will be assessed. Inpatient and 6-month mortality, surgery-related data (e.g., intraoperative complications, blood loss, length of incision, surgical duration, postoperative complications, adverse events, and serious adverse events will be documented and monitored throughout the study. Cost-effectiveness analysis will also be provided. Discussion New hybrid systems might improve the outcome of lumbar spine fusion. To date, there is no convincing published data on effectiveness or safety of these

  15. The use of autologous platelet gel in toenail surgery: a within-patient clinical trial.

    Science.gov (United States)

    Córdoba-Fernández, Antonio; Rayo-Rosado, Rafael; Juárez-Jiménez, José María

    2010-01-01

    A number of studies have stressed the importance of platelets in acute and chronic wound healing, although their clinical utility remains controversial. To analyze the use of autologous platelet gel in the surgical treatment of ingrown toenails, a within-patient clinical trial was conducted. Thirty-five healthy volunteers (70 feet) underwent surgical treatment for bilateral ingrown hallux nails. Recovery time (days), postoperative pain (analog chromatic scale), and inflammation (digital circumference) at 48 hours postoperative were the outcomes of interest. Recovery time and postoperative pain were less in the experimental group, although the differences of means were not statistically significant. Based on these results, we suggest that local application of APG in surgical ingrown toenail wounds may produce a slight increase in acute inflammatory phase dermal wound healing, but it does not cause a statistically significant reduction in recovery times or postoperative pain.

  16. Laparoendoscopic Single-Site Surgery for the Treatment of Benign Adnexal Disease: A Prospective Trial

    Directory of Open Access Journals (Sweden)

    Anna Fagotti

    2010-01-01

    Full Text Available Background. To validate feasibility, efficacy, and safeness of laparoscopic treatment of benign adnexal diseases through a single transumbilical access (LESS in a prospective series of patients. Methods. A prospective clinical trial including 30 women has been conducted at the Division of Gynecology of Catholic University of Sacred Hearth of Rome. Patients underwent different laparoscopic procedures by LESS utilizing a multiport trocar and conventional straight laparoscopic instrumentation. Intra and perioperative outcome has been reported. Results. Ten mono/bilateral adnexectomies and 20 cystectomies have been performed by LESS approach. Laparoscopic procedures were completed through a single access in 28 cases (93.4%. No major intra- or postoperative complications were observed. Mean hospital stay was 1.3 days. Conclusions. LESS approach is feasible to treat benign adnexal disease with a very low conversion rate and no early or late complications. More clinical data are needed to confirm these advantages compared to standard laparoscopic technique.

  17. Surgery is more cost-effective than splinting for carpal tunnel syndrome in the Netherlands: results of an economic evaluation alongside a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Adèr Herman J

    2006-11-01

    Full Text Available Abstract Background Carpal tunnel syndrome (CTS is a common disorder, often treated with surgery or wrist splinting. The objective of this economic evaluation alongside a randomized trial was to evaluate the cost-effectiveness of splinting and surgery for patients with CTS. Methods Patients at 13 neurological outpatient clinics with clinically and electrophysiologically confirmed idiopathic CTS were randomly allocated to splinting (n = 89 or surgery (n = 87. Clinical outcome measures included number of nights waking up due to symptoms, general improvement, severity of the main complaint, paraesthesia at night and during the day, and utility. The economic evaluation was performed from a societal perspective and involved all relevant costs. Results There were no differences in costs. The mean total costs per patient were in the surgery group EURO 2,126 compared to EURO 2,111 in the splint group. After 12 months, the success rate in the surgery group (92% was significantly higher than in the splint group (72%. The acceptability curve showed that at a relatively low ceiling ratio of EURO 2,500 per patient there is a 90% probability that surgery is cost-effective. Conclusion In the Netherlands, surgery is more cost-effective compared with splinting, and recommended as the preferred method of treatment for patients with CTS.

  18. Intrathecal sufentanil versus fentanyl for lower limb surgeries - A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Poonam Motiani

    2011-01-01

    Full Text Available Background:To compare the efficacy and safety of intrathecal sufentanil or fentanyl as adjuvants to hyperbaric bupivacaine in patients undergoing major orthopaedic lower limb surgeries in terms of onset and duration of sensory block, motor block and post-operative pain relief. Patients & Methods: Ninety patients were recruited in this Prospective, randomized double blind study to receive either intrathecal sufentanil 5 μg (Group S, fentanyl 25 μg (Group F or normal saline 0.5 ml (Group C as adjuvants to 15 mg of 0.5% hyperbaric bupivacaine. The onset and duration of sensory and motor block were assessed intraoperatively. The pain scores were assessed postoperatively. Duration of complete and effective analgesia was recorded. The incidence of side effects such as nausea, vomiting, pruritus, shivering and PDPH was recorded. Results: The Demographic data, hemodynamic and respiratory parameters were comparable in the three groups. There was a significantly earlier onset and prolonged duration of sensory block in the sufentanil and fentanyl groups. The duration of complete and effective analgesia were also significantly prolonged in the fentanyl and sufentanil groups. Pruritus was noticed in the study groups (Groups S&F. Conclusions: Intrathecal sufentanil (5 μg and fentanyl (25 μg, as adjuvants lead to an earlier onset and prolonged duration of sensory block. The duration of effective analgesia with intrathecal sufentanil and fentanyl as adjuvants to hyperbaric bupivacaine is longer than that of bupivacaine alone.

  19. Prebiotic and Synbiotic Treatment before Colorectal Surgery--Randomised Double Blind Trial.

    Science.gov (United States)

    Krebs, Bojan

    2016-04-01

    The aim of our study was to demonstrate higher concentrations of lactic acid bacteria (LAB) on the colonic mucosa in operated colorectal cancer patients treated with oral intake of synbiotics or prebiotics preoperatively. We also tried to prove that the systemic inflammatory response after surgery is not so severe in patients who took synbiotics or prebiotics, furthermore these patients have less postoperative complications and a favorable postoperative course. 73 patients with preceding colorectal operations were recruited. They were randomized into three groups. One group received preoperatively prebiotics, the second synbiotics in and third was preoperatively cleansed. We have defined the number of four different probiotic bacteria on colonic mucosa with polymerase chain reaction (PCR). Serum levels of interleukin-6, CRP, fibrinogen, white cell count and differential blood count were measured pre- and postoperatively to determine systemic inflammatory response. We succeed in confirming that in the synbiotic group there were considerably more LAB presented on the mucosa. They did pass the upper gastrointestinal tract and were isolated in colonic mucosa. On the other hand, we did not find any statistical differences in systemic inflammatory response measured by upper factors and no differences in postoperative course and complications rate between all three groups.

  20. A RANDOMIZED CLINICAL TRIAL ON THE ANTI - INFLAMATORY EFFECT OF INTRACAMERAL LOW MOLECULAR WE HEPARIN (ENOXAPAIN IN DIABETIC CATARACT SURGERY

    Directory of Open Access Journals (Sweden)

    Shivanand

    2015-08-01

    Full Text Available AIM: To study the effect intracameral low molecular weight on postoperative inflammation after cataract surgery in diabetic patients. SETTING: Department of Ophtha lmology J. N. Medical College. Belgaum. DESIGN: Randomized control trial . MATERIAL AND METHODS: Forty patients with diabetes undergoing small incision cataract surgery with posterior chamber intraocular lens (IOL implantation were randomly assigned to two groups, group A and group B. All patients in g roup A received low molecular weight heparin (enoxaparin in the concentration of 40 IU in 500ml in the irrigating solution and patients in group B received irrigating solution without low molecular weight heparin. In all patients polymethyl methacrylate ( PMMA IOLs were implanted. The patients were examined postoperatively on day 1, day 7, day 30 and day 60 for anterior chamber cells and flare and iris pigments on cell by slit lamp biomicroscopy. RESULTS: A statistically significant reduction in postoperat ive cells, flare and intraocular lens surface pigments was noted in group with addition of low molecular weight heparin (enoxaparin at day 1(p0.001 and 1 week (p<0.001. At 4 weeks and 8 weeks no statistically significant reduction in post - operative cell s and flare was seen between the two groups but there was a significant reduction in the intraocular lens pigments in the group with addition of low molecular weight heparin (enoxaparin. CONCLUSION: Intraoperative use of low molecular weight heparin (enox aparin reduced disturbance in the blood - aq ueous barrier in the early post - operative period evidenced by lower postoperative anterior chamber cells and flare, and also reduced iris pigments on the intraocular lens. At 8 weeks cells and flare in both the gr oups did not show significant difference.

  1. Daily MUR SST, Interim near-real-time (nrt) product

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — A daily, global Sea Surface Temperature (SST) data set is produced at 1-km (MUR, or Multi-scale ultra-high resolution Temperature) by the JPL sciengists Drs. Mike...

  2. SST, Aqua MODIS, NPP, 0.0125 degrees, Indonesia, Daytime

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — NOAA CoastWatch provides SST data from NASA's Aqua Spacecraft. Measurements are gathered by the Moderate Resolution Imaging Spectroradiometer (MODIS) carried aboard...

  3. SST, Blended, 0.1 degrees, Global, EXPERIMENTAL

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — NOAA OceanWatch provides a blended sea surface temperature (SST) products derived from both microwave and infrared sensors carried on multiple platforms. The...

  4. Monthly SST images of Stellwagen Bank National Marine Sanctuary

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — Average monthy Sea Surfact Temperature http://podaac.jpl.nasa.gov/ Naming Convention: XXXX_YYYYMM_SST.tif XXXX=location (Stell) YYYY=year MM=month Example filename:...

  5. Global 1-km Sea Surface Temperature (G1SST)

    Data.gov (United States)

    National Aeronautics and Space Administration — JPL OurOcean Portal: A daily, global Sea Surface Temperature (SST) data set is produced at 1-km (also known as ultra-high resolution) by the JPL ROMS (Regional Ocean...

  6. COBE-SST2 Sea Surface Temperature and Ice

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — A new sea surface temperature (SST) analysis on a centennial time scale is presented. The dataset starts in 1850 with monthly 1x1 means and is periodically updated....

  7. SST, Aqua AMSR-E, 0.25 degrees, Global

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — NOAA OceanWatch provides sea surface temperature (SST) products derived from microwave sensors, which can measure ocean temperatures even in the presence of clouds....

  8. NOAA High-Resolution Sea Surface Temperature (SST) Analysis Products

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — This archive covers two high resolution sea surface temperature (SST) analysis products developed using an optimum interpolation (OI) technique. The analyses have a...

  9. SST, Aqua MODIS, NPP, 0.0125 degrees, Indonesia, Daytime

    Data.gov (United States)

    National Oceanic and Atmospheric Administration, Department of Commerce — NOAA CoastWatch provides SST data from NASA's Aqua Spacecraft. Measurements are gathered by the Moderate Resolution Imaging Spectroradiometer (MODIS) carried aboard...

  10. Investigation of Sea Surface Temperature (SST) anomalies over Cyprus area

    Science.gov (United States)

    Georgiou, Andreas; Akçit, Nuhcan

    2016-08-01

    The temperature of the sea surface has been identified as an important parameter of the natural environment, governing processes that occur in the upper ocean. This paper focuses on the analysis of the Sea Surface Temperature (SST) anomalies at the greater area of Cyprus. For that, SST data derived from MODerate-resolution Imaging Spectroradiometer (MODIS) instrument on board both Aqua and Terra sun synchronous satellites were used. A four year period was chosen as a first approach to address and describe this phenomenon. Geographical Information Systems (GIS) has been used as an integrated platform of analysis and presentation in addition of the support of MATLAB®. The methodology consists of five steps: (i) Collection of MODIS SST imagery, (ii) Development of the digital geo-database; (iii) Model and run the methodology in GIS as a script; (iv) Calculation of SST anomalies; and (v) Visualization of the results. The SST anomaly values have presented a symmetric distribution over the study area with an increase trend through the years of analysis. The calculated monthly and annual average SST anomalies (ASST) make more obvious this trend, with negative and positive SST changes to be distributed over the study area. In terms of seasons, the same increase trend presented during spring, summer, autumn and winter with 2013 to be the year with maximum ASST observed values. Innovative aspects comprise of straightforward integration and modeling of available tools, providing a versatile platform of analysis and semi-automation of the operation. In addition, the fine resolution maps that extracted from the analysis with a wide spatial coverage, allows the detail representation of SST and ASST respectively in the region.

  11. Rationale and study design of PROVHILO - a worldwide multicenter randomized controlled trial on protective ventilation during general anesthesia for open abdominal surgery

    Directory of Open Access Journals (Sweden)

    Hedenstierna Göran

    2011-05-01

    Full Text Available Abstract Background Post-operative pulmonary complications add to the morbidity and mortality of surgical patients, in particular after general anesthesia >2 hours for abdominal surgery. Whether a protective mechanical ventilation strategy with higher levels of positive end-expiratory pressure (PEEP and repeated recruitment maneuvers; the "open lung strategy", protects against post-operative pulmonary complications is uncertain. The present study aims at comparing a protective mechanical ventilation strategy with a conventional mechanical ventilation strategy during general anesthesia for abdominal non-laparoscopic surgery. Methods The PROtective Ventilation using HIgh versus LOw positive end-expiratory pressure ("PROVHILO" trial is a worldwide investigator-initiated multicenter randomized controlled two-arm study. Nine hundred patients scheduled for non-laparoscopic abdominal surgery at high or intermediate risk for post-operative pulmonary complications are randomized to mechanical ventilation with the level of PEEP at 12 cmH2O with recruitment maneuvers (the lung-protective strategy or mechanical ventilation with the level of PEEP at maximum 2 cmH2O without recruitment maneuvers (the conventional strategy. The primary endpoint is any post-operative pulmonary complication. Discussion The PROVHILO trial is the first randomized controlled trial powered to investigate whether an open lung mechanical ventilation strategy in short-term mechanical ventilation prevents against postoperative pulmonary complications. Trial registration ISRCTN: ISRCTN70332574

  12. Sleep study, respiratory mechanics, chemosensitive response and quality of life in morbidly obese patients undergoing bariatric surgery: a prospective, randomized, controlled trial

    Directory of Open Access Journals (Sweden)

    Leitao Filho Fernando SS

    2011-10-01

    Full Text Available Abstract Background Obesity is a major public health problem in both developed and developing countries alike and leads to a series of changes in respiratory physiology. There is a strong correlation between obesity and cardiopulmonary sleep disorders. Weight loss among such patients leads to a reduction in these alterations in respiratory physiology, but clinical treatment is not effective for a long period of time. Thus, bariatric surgery is a viable option. Methods/Design The present study involves patients with morbid obesity (BMI of 40 kg/m2 or 35 kg/m2 to 39.9 kg/m2 with comorbidities, candidates for bariatric surgery, screened at the Santa Casa de Misericórdia Hospital in the city of Sao Paulo (Brazil. The inclusion criteria are grade III morbid obesity, an indication for bariatric surgery, agreement to participate in the study and a signed term of informed consent. The exclusion criteria are BMI above 55 kg/m2, clinically significant or unstable mental health concerns, an unrealistic postoperative target weight and/or unrealistic expectations of surgical treatment. Bariatric surgery candidates who meet the inclusion criteria will be referred to Santa Casa de Misericórdia Hospital and will be reviewed again 30, 90 and 360 days following surgery. Data collection will involve patient records, personal data collection, objective assessment of HR, BP, neck circumference, chest and abdomen, collection and analysis of clinical preoperative findings, polysomnography, pulmonary function test and a questionnaire on sleepiness. Discussion This paper describes a randomised controlled trial of morbidly obese patients. Polysomnography, respiratory mechanics, chemosensitive response and quality of life will be assessed in patients undergoing or not undergoing bariatric surgery. Trial Registration The protocol for this study is registered with the Brazilian Registry of Clinical Trials - ReBEC (RBR-9k9hhv.

  13. Assessment of a Standardized Pre-Operative Telephone Checklist Designed to Avoid Late Cancellation of Ambulatory Surgery: The AMBUPROG Multicenter Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    Sonia Gaucher

    Full Text Available To assess the impact of a standardized pre-operative telephone checklist on the rate of late cancellations of ambulatory surgery (AMBUPROG trial.Multicenter, two-arm, parallel-group, open-label randomized controlled trial.11 university hospital ambulatory surgery units in Paris, France.Patients scheduled for ambulatory surgery and able to be reached by telephone.A 7-item checklist designed to prevent late cancellation, available in five languages and two versions (for children and adults, was administered between 7 and 3 days before the planned date of surgery, by an automated phone system or a research assistant. The control group received standard management alone.Rate of cancellation on the day of surgery or the day before.The study population comprised 3900 patients enrolled between November 2012 and September 2013: 1950 patients were randomized to the checklist arm and 1950 patients to the control arm. The checklist was administered to 68.8% of patients in the intervention arm, 1002 by the automated phone system and 340 by a research assistant. The rate of late cancellation did not differ significantly between the checklist and control arms (109 (5.6% vs. 113 (5.8%, adjusted odds ratio [95% confidence interval] = 0.91 [0.65-1.29], (p = 0.57. Checklist administration revealed that 355 patients (28.0% had not undergone tests ordered by the surgeon or anesthetist, and that 254 patients (20.0% still had questions concerning the fasting state.A standardized pre-operative telephone checklist did not avoid late cancellations of ambulatory surgery but enabled us to identify several frequent causes.ClinicalTrials.gov NCT01732159.

  14. Association Between Flexible Duty Hour Policies and General Surgery Resident Examination Performance: A Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial Analysis.

    Science.gov (United States)

    Blay, Eddie; Hewitt, D Brock; Chung, Jeanette W; Biester, Thomas; Fiore, James F; Dahlke, Allison R; Quinn, Christopher M; Lewis, Frank R; Bilimoria, Karl Y

    2017-02-01

    Concerns persist about the effect of current duty hour reforms on resident educational outcomes. We investigated whether a flexible, less-restrictive duty hour policy (Flexible Policy) was associated with differential general surgery examination performance compared with current ACGME duty hour policy (Standard Policy). We obtained examination scores on the American Board of Surgery In-Training Examination, Qualifying Examination (written boards), and Certifying Examination (oral boards) for residents in 117 general surgery residency programs that participated in the Flexibility in Duty Hour Requirements for Surgical Trainees (FIRST) Trial. Using bivariate analyses and regression models, we compared resident examination performance across study arms (Flexible Policy vs Standard Policy) for 2015 and 2016, and 1 year of the Qualifying Examination and Certifying Examination. Adjusted analyses accounted for program-level factors, including the stratification variable for randomization. In 2016, FIRST trial participants were 4,363 general surgery residents. Mean American Board of Surgery In-Training Examination scores for residents were not significantly different between study groups (Flexible Policy vs Standard Policy) overall (Flexible Policy: mean [SD] 502.6 [100.9] vs Standard Policy: 502.7 [98.6]; p = 0.98) or for any individual postgraduate year level. There was no difference in pass rates between study arms for either the Qualifying Examination (Flexible Policy: 90.4% vs Standard Policy: 90.5%; p = 0.99) or Certifying Examination (Flexible Policy: 86.3% vs Standard Policy: 88.6%; p = 0.24). Results from adjusted analyses were consistent with these findings. Flexible, less-restrictive duty hour policies were not associated with differences in general surgery resident performance on examinations during the FIRST Trial. However, more years under flexible duty hour policies might be needed to observe an effect. Copyright © 2016 American College of Surgeons

  15. Identifying and Investigating the Late-1960s Interhemispheric SST Shift

    Science.gov (United States)

    Friedman, A. R.; Lee, S. Y.; Liu, Y.; Chiang, J. C. H.

    2014-12-01

    The global north-south interhemispheric sea surface temperature (SST) difference experienced a pronounced and rapid decrease in the late 1960s, which has been linked to drying in the Sahel, South Asia, and East Asia. However, some basic questions about the interhemispheric SST shift remain unresolved, including its scale and whether the constituent changes in different basins were coordinated. In this study, we systematically investigate the spatial and temporal behavior of the late-1960s interhemispheric SST shift using ocean surface and subsurface observations. We also evaluate potential mechanisms using control and specific-forcing CMIP5 simulations. Using a regime shift detection technique, we identify the late-1960s shift as the most prominent in the historical observational SST record. We additionally examine the corresponding changes in upper-ocean heat content and salinity associated with the shift. We find that there were coordinated upper-ocean cooling and freshening in the subpolar North Atlantic, the region of the largest-magnitude SST decrease during the interhemispheric shift. These upper-ocean changes correspond to a weakened North Atlantic thermohaline circulation (THC). However, the THC decrease does not fully account for the rapid global interhemispheric SST shift, particularly the warming in the extratropical Southern Hemisphere.

  16. Analysis of observed and simulated SST spectra in the midlatitudes

    Energy Technology Data Exchange (ETDEWEB)

    Dommenget, D. [Scripps Institution of Oceanography, Physical Oceanography Research Division, La Jolla, CA (United States); Latif, M. [Max Planck Institut fuer Meteorologie, Hamburg (Germany)

    2002-07-01

    Statistical analyses of monthly mean sea surface temperatures (SST) from observations and from a hierarchy of global coupled ocean-atmosphere models were carried out with the focus on the midlatitudes (25 N-50 N). The spectra of the simulated SSTs have been tested against the null hypothesis of Hasselmann's stochastic climate model, which assumes an AR(1)-process for the SST variability in its simplest version. It was found that the spectra of the SST variability in the observations and in the CGCMs with fully dynamical ocean models differ significantly from AR(1)-processes, while the SST variability in an AGCM coupled to a slab ocean is consistent with an AR(1)-process. The deviations of the SST spectra from the fitted AR(1) spectra are not due to spectral peaks but are due to a slower increase of variance from seasonal to decadal time scales. Parts of these differences can be attributed to the interaction between the mixed layer and the sub-mixed-layer ocean. While the mixed layer depth variability generates SST variability on seasonal and shorter time scales, the heat exchange with the deep ocean, reduces variability on longer time scales. (orig.)

  17. [Postoperative transcutaneous electrical nerve stimulation (TENS) in shoulder surgery (randomized, double blind, placebo controlled pilot trial)].

    Science.gov (United States)

    Likar, R; Molnar, M; Pipam, W; Koppert, W; Quantschnigg, B; Disselhoff, B; Sittl, R

    2001-06-01

    The aim of this study was to determine whether 3 days of TENS therapy postoperatively after shoulder operations would result in better pain relief and/or reduced analgesic intake when compared to placebo. The study was carried out randomized, double-blind and placebo controlled. Thirty patients were randomized to two groups. The verum group received TENS SM1AKS 80 Hz 6 mA and the placebo group received TENS SM1AKS 80 Hz 0 mA. The pain was assessed pre-operatively using the Hamburg Pain Adjective List. Premedication and Anaesthesia were standardized. TENS was applied to the patients immediately postoperatively for 8 hours and then on the following days 5 times daily for 45 minutes. The effectiveness was evaluated postoperatively using a visual analogue scale (rest, activity), the Hamburg Pain Adjective List and postoperative analgesic consumption. The visual analogue scale at rest and on activity showed no significant difference between the groups. Postoperative analgesic consumption of morphine hydrochloride in the first 24 hours was at time 8 hours postoperative significantly and at all other time points markedly less in the verum group compared to the placebo group. The sensory secondary scale score of the "Hamburg Pain Adjective List" was significantly lower postoperatively compared to preoperatively in the verum group. We were able to show in this study that TENS applied postoperatively after shoulder surgery clearly reduced analgesic consumption in the first 72 hours. Furthermore there was a significant difference in the pain scores using the "Hamburg Pain Adjective List" in favour of the verum group. TENS applied postoperatively is a effective, simple modality with few side-effects.

  18. Spinal mepivacaine with fentanyl for outpatient knee arthroscopy surgery: a randomized controlled trial.

    Science.gov (United States)

    O'Donnell, Dermot; Manickam, Baskar; Perlas, Anahi; Karkhanis, Reena; Chan, Vincent W S; Syed, Khalid; Brull, Richard

    2010-01-01

    The foremost limitation of local anesthetic solutions for spinal anesthesia in the outpatient setting is prolonged motor blockade and delayed ambulation. The purpose of this study was to determine if the addition of intrathecal fentanyl to low-dose spinal mepivacaine provides adequate anesthesia with shorter duration of functional motor blockade for ambulatory knee surgery compared with spinal mepivacaine alone. Following institutional review board approval and informed consent, 34 patients undergoing unilateral knee arthroscopy were enrolled in this study. The patients were randomly assigned to receive either 30 mg of isobaric mepivacaine 1.5% plus fentanyl 10 microg (M + F group) or 45 mg of isobaric mepivacaine 1.5% alone (M group) intrathecally. Postoperatively, the times to achieve sensory block regression to the S1 dermatome and to attain functional motor block recovery enabling ambulation were recorded. All assessments were blinded. The time to completion of Phase I recovery was shorter in the M + F group (104.6 +/- 28.4 min) than in the M group (129.1 +/- 30.4 min; P = 0.023). Regression of sensory blockade to S1 was earlier in the M + F group (118.4 +/- 53.5 min) than in the M group (169.7 +/- 38.9 min; P = 0.003). Patients in the M + F group (176.4 +/- 40.3 min) were able to ambulate significantly earlier than those in the M group (205.6 +/- 31.4 min; P = 0.025). No cases of transient or persistent neurological dysfunction were noted. When compared with 45 mg isobaric mepivacaine 1.5%, an intrathecal dose of 30 mg isobaric mepivacaine 1.5% plus 10 microg fentanyl produces reliable anesthesia, hastens block regression, shortens stay in Phase I recovery, and enables earlier ambulation for patients undergoing unilateral knee arthroscopy (Registration no. NCT00803725).

  19. Effects of tolvaptan in the early postoperative stage after heart valve surgery: results of the STAR (Study of Tolvaptan for fluid retention AfteR valve surgery) trial.

    Science.gov (United States)

    Nishi, Hiroyuki; Toda, Koichi; Miyagawa, Shigeru; Yoshikawa, Yasushi; Fukushima, Satsuki; Kawamura, Masashi; Yoshioka, Daisuke; Saito, Tetsuya; Ueno, Takayoshi; Kuratani, Toru; Sawa, Yoshiki

    2015-12-01

    The purpose of this study was to assess the efficacy of tolvaptan, a vasopressin V2 receptor antagonist, for the management of postoperative surgical fluid retention after heart valve surgery. This was a prospective observational study of 64 patients with heart valve disease who underwent valve surgery between 2013 and 2014. Those in the tolvaptan group received tolvaptan in addition to conventional diuretic therapy. The results were compared to the results of 55 patients who underwent heart valve surgery between 2007 and 2010 and received conventional postoperative diuretics alone. The time to return to the preoperative BW was significantly shorter in the patients who received tolvaptan (6.1 ± 3.8 vs. 8.7 ± 6.7 days, p fluid retention during the early postoperative stage in cardiac surgery patients, without increased renal failure or abnormal electrolyte levels. This new type of diuretic therapy may be a suitable option for postoperative fluid management in patients undergoing cardiac surgery.

  20. The effect of ranitidine on postoperative infectious complications following emergency colorectal surgery: a randomized, placebo-controlled, double-blind trial

    DEFF Research Database (Denmark)

    Moesgaard, F; Jensen, L S; Christiansen, P M

    1998-01-01

    OBJECTIVE AND DESIGN: To study the potential effect of ranitidine on postoperative infectious complications following emergency colorectal surgery. A randomized, placebo-controlled, double-blind trial was carried out in three university clinics and two county hospitals in Denmark. PATIENTS......) or i.v. placebo (group II). All patients were given 1.5 g metronidazole plus 3.0 g cefuroxime at the time of surgery. Patients with perforation of the colon or rectum were given metronidazole and cefuroxime for further 3 days. All patients were assessed daily until discharge from the hospital. Thirty...

  1. Virtual reality robotic surgery simulation curriculum to teach robotic suturing: a randomized controlled trial.

    Science.gov (United States)

    Kiely, Daniel J; Gotlieb, Walter H; Lau, Susie; Zeng, Xing; Samouelian, Vanessa; Ramanakumar, Agnihotram V; Zakrzewski, Helena; Brin, Sonya; Fraser, Shannon A; Korsieporn, Pira; Drudi, Laura; Press, Joshua Z

    2015-09-01

    The objective of this randomized, controlled trial was to assess whether voluntary participation in a proctored, proficiency-based, virtual reality robotic suturing curriculum using the da Vinci(®) Skills Simulator™ improves robotic suturing performance. Residents and attending surgeons were randomized to participation or non-participation during a 5 week training curriculum. Robotic suturing skills were evaluated before and after training using an inanimate vaginal cuff model, which participants sutured for 10 min using the da Vinci(®) Surgical System. Performances were videotaped, anonymized, and subsequently graded independently by three robotic surgeons. 27 participants were randomized. 23 of the 27 completed both the pre- and post-test, 13 in the training group and 10 in the control group. Mean training time in the intervention group was 238 ± 136 min (SD) over the 5 weeks. The primary outcome (improvement in GOALS+ score) and the secondary outcomes (improvement in GEARS, total knots, satisfactory knots, and the virtual reality suture sponge 1 task) were significantly greater in the training group than the control group in unadjusted analysis. After adjusting for lower baseline scores in the training group, improvement in the suture sponge 1 task remained significantly greater in the training group and a trend was demonstrated to greater improvement in the training group for the GOALS+ score, GEARS score, total knots, and satisfactory knots.

  2. The OPERA trial - comparison of early nasal high flow oxygen therapy with standard care for prevention of postoperative hypoxemia after abdominal surgery: study protocol for a multicenter randomized controlled trial.

    Science.gov (United States)

    Futier, Emmanuel; Paugam-Burtz, Catherine; Constantin, Jean-Michel; Pereira, Bruno; Jaber, Samir

    2013-10-18

    Respiratory support following postoperative extubation is of major importance to prevent hypoxemia and subsequent respiratory failure and reintubation. High-flow nasal cannula oxygen (HFNC) delivers a flow-dependent positive airway pressure and improves oxygenation by increasing end-expiratory lung volume. Whether application of HFNC may have therapeutic advantages over conventional oxygen therapy for respiratory support in the early postextubation surgical period remains to be established. The Optiflow for prevention of post-extubation hypoxemia after abdominal surgery (OPERA) trial is an investigator-initiated multicenter randomized controlled two-arm trial with assessor-blinded outcome assessment, randomizing 220 patients with intermediate to high risk of pulmonary complications after abdominal surgery to receive HFNC or conventional oxygen therapy following extubation, stratified by the presence of epidural analgesia and center. The primary outcome measure is the percentage of patients with postoperative hypoxemia one hour after tracheal extubation. Secondary outcome measures are postoperative pulmonary complications, need for noninvasive ventilation and intubation for respiratory failure. The OPERA trial is the first randomized controlled study powered to investigate whether early application of HFNC following extubation after abdominal surgery prevents against postoperative hypoxemia and pulmonary complications. ClinicalTrials.gov Identifier: NCT01887015.

  3. Traditional endodontic surgery versus modern technique: a 5-year controlled clinical trial.

    Science.gov (United States)

    Tortorici, Silvia; Difalco, Paolo; Caradonna, Luigi; Tetè, Stefano

    2014-05-01

    In this study, we compared outcomes of traditional apicoectomy versus modern apicoectomy, by means of a controlled clinical trial with a 5-year follow-up. The study investigated 938 teeth in 843 patients. On the basis of the procedure performed, the teeth were grouped in 3 groups. Differences between the groups were the method of osteotomy (type of instruments used), type of preparation of retrograde cavity (different apicoectomy angles and instruments used for root-end preparation), and root-end filling material used (gray mineral trioxide aggregate or silver amalgam). Outcome (tooth healing) was estimated after 1 and 5 years, postoperatively. Clinical success rates after 1 year were 67% (306 teeth), 90% (186 teeth), and 94% (256 teeth) according to traditional apicoectomy (group 1), modern microsurgical apicoectomy using burns for osteotomy (group 2) or using piezo-osteotomy (group 3), respectively. After 1 year, group comparison results were statistically significant (P < 0.0001). Linear trend test was also statistically significant (P < 0.0001), pointing out larger healing from group 1 to group 3. After 5 years, teeth were classified into 2 groups on the basis of root-end filling material used. Clinical success was 90.8% (197 teeth) in the silver amalgam group versus 96% (309 teeth) in the mineral trioxide aggregate group (P < 0.00214). Multiple logistic regression analysis found that surgical technique was independently associated to tooth healing. In conclusion, modern apicoectomy resulted in a probability of success more than 5 times higher (odds ratio, 5.20 [95% confidence interval, 3.94-6.92]; P < 0.001) compared with the traditional technique.

  4. Adipose-Derived Stem Cells in Aesthetic Surgery: A Mixed Methods Evaluation of the Current Clinical Trial, Intellectual Property, and Regulatory Landscape.

    Science.gov (United States)

    Arshad, Zeeshaan; Halioua-Haubold, Celine-Lea; Roberts, Mackenna; Urso-Baiarda, Fulvio; Branford, Oliver A; Brindley, David A; Davies, Benjamin M; Pettitt, David

    2017-06-07

    Adipose tissue, which can be readily harvested via a number of liposuction techniques, offers an easily accessible and abundant source of adipose-derived stem cells (ASCs). Consequently, ASCs have become an increasingly popular reconstructive option and a novel means of aesthetic soft tissue augmentation. This paper examines recent advances in the aesthetic surgery field, extending beyond traditional review formats to incorporate a comprehensive analysis of current clinical trials, adoption status, and the commercialization pathway. Keyword searches were carried out on clinical trial databases to search for trials using ASCs for aesthetic indications. An intellectual property landscape was created using commercial software (Thomson Reuters Thomson Innovation, New York, NY). Analysis of who is claiming what in respect of ASC use in aesthetic surgery for commercial purposes was analyzed by reviewing the patent landscape in relation to these techniques. Key international regulatory guidelines were also summarized. Completed clinical trials lacked robust controls, employed small sample sizes, and lacked long-term follow-up data. Ongoing clinical trials still do not address such issues. In recent years, claims to intellectual property ownership have increased in the "aesthetic stem cell" domain, reflecting commercial interest in the area. However, significant translational barriers remain including regulatory challenges and ethical considerations. Further rigorous randomized controlled trials are required to delineate long-term clinical efficacy and safety. Providers should consider the introduction of patient reported outcome metrics to facilitate clinical adoption. Robust regulatory and ethical policies concerning stem cells and aesthetic surgery should be devised to discourage further growth of "stem cell tourism."

  5. Multimedia educational tools for cognitive surgical skill acquisition in open and laparoscopic colorectal surgery: a randomized controlled trial.

    Science.gov (United States)

    Shariff, U; Kullar, N; Haray, P N; Dorudi, S; Balasubramanian, S P

    2015-05-01

    Conventional teaching in surgical training programmes is constrained by time and cost, and has room for improvement. This study aimed to determine the effectiveness of a multimedia educational tool developed for an index colorectal surgical procedure (anterior resection) in teaching and assessment of cognitive skills and to evaluate its acceptability amongst general surgical trainees. Multimedia educational tools in open and laparoscopic anterior resection were developed by filming multiple operations which were edited into procedural steps and substeps and then integrated onto interactive navigational platforms using Adobe® Flash® Professional CS5 10.1. A randomized controlled trial was conducted on general surgical trainees to evaluate the effectiveness of online multimedia in comparison with conventional 'study day' teaching for the acquisition of cognitive skills. All trainees were assessed before and after the study period. Trainees in the multimedia group evaluated the tools by completing a survey. Fifty-nine trainees were randomized but 27% dropped out, leaving 43 trainees randomized to the multimedia group (n = 25) and study day group (n = 18) who were available for analysis. Posttest scores improved significantly in both groups (P educational resource. Multimedia tools are effective for the acquisition of cognitive skills in colorectal surgery and are well accepted as an educational resource. Colorectal Disease © 2014 The Association of Coloproctology of Great Britain and Ireland.

  6. Parecoxib Supplementation to Morphine Analgesia Decreases Incidence of Delirium in Elderly Patients After Hip or Knee Replacement Surgery: A Randomized Controlled Trial.

    Science.gov (United States)

    Mu, Dong-Liang; Zhang, Da-Zhi; Wang, Dong-Xin; Wang, Geng; Li, Chun-Jing; Meng, Zhao-Ting; Li, Ya-Wei; Liu, Chao; Li, Xue-Ying

    2017-06-01

    Severe pain and high-dose opioids are both associated with increased risk of postoperative delirium. The authors investigated whether parecoxib-supplemented IV morphine analgesia could decrease the incidence of delirium in elderly patients after total hip or knee replacement surgery. In a randomized, double-blind, 2-center trial, patients of 60 years or older who underwent elective total hip or knee replacement surgery were assigned in a 1:1 ratio to receive either parecoxib (40 mg at the end of surgery and then every 12 hours for 3 days) or placebo (normal saline). All patients received combined spinal-epidural anesthesia during surgery and IV morphine for postoperative analgesia. The primary outcome was the incidence of delirium within 5 days after surgery. Between January 2011 and May 2013, 620 patients were enrolled and were included in the intention-to-treat and safety analyses. The incidence of delirium was significantly reduced from 11.0% (34/310) with placebo to 6.2% (19/310) with parecoxib (relative risk 0.56, 95% confidence interval 0.33-0.96, P = .031). The severity of pain and the cumulative consumptions of morphine at 24, 48, and 72 hours after surgery were significantly lower with parecoxib than with placebo (all P delirium without increasing adverse events.

  7. Thromboprophylaxis With Apixaban in Patients Undergoing Major Orthopedic Surgery: Meta-Analysis and Trial-Sequential Analysis

    Directory of Open Access Journals (Sweden)

    Daniel Caldeira

    2017-05-01

    Full Text Available Background: Venous thromboembolism (VTE is a potentially fatal complication of orthopedic surgery, and until recently, few antithrombotic compounds were available for postoperative thromboprophylaxis. The introduction of the non–vitamin K antagonists oral anticoagulants (NOAC, including apixaban, has extended the therapeutic armamentarium in this field. Therefore, estimation of NOAC net clinical benefit in comparison with the established treatment is needed to inform clinical decision making. Objectives: Systematic review to assess the efficacy and safety of apixaban 2.5 mg twice a day versus low-molecular-weight heparins (LMWH for thromboprophylaxis in patients undergoing knee or hip replacement. Data sources: MEDLINE, Embase, and CENTRAL were searched from inception to September 2016, other systematic reviews, reference lists, and experts were consulted. Study eligibility criteria, participants, and intervention: All major orthopedic surgery randomized controlled trials comparing apixaban 2.5 mg twice daily with LMWH, reporting thrombotic and bleeding events. Data extraction: Two independent reviewers, using a predetermined form. Study appraisal and synthesis methods: The Cochrane tool to assess risk bias was used by two independent authors. RevMan software was used to estimate pooled risk ratio (RR and 95% confidence intervals (95% CI using random-effects meta-analysis. Trial sequential analysis (TSA was performed in statistical significant results to evaluate whether cumulative sample size was powered for the obtained effect. Overall confidence in cumulative evidence was assessed using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE Working Group methodology. Results: Four studies comparing apixaban 2.5 mg twice daily with LMWH were included, with a total of 11.828 patients (55% undergoing knee and 45% hip replacement. The overall risk of bias across studies was low. In comparison with LMWH (all regimens

  8. Prolonged conservative treatment or 'early' surgery in sciatica caused by a lumbar disc herniation: rationale and design of a randomized trial [ISRCT 26872154

    OpenAIRE

    Tans Joseph; Eekhof Just AH; Brand Ronald; van der Hout Wilbert B; van Houwelingen Hans C; Peul Wilco C; Thomeer Ralph TWM; Koes Bart W

    2005-01-01

    Abstract Background The design of a randomized multicenter trial is presented on the effectiveness of a prolonged conservative treatment strategy compared with surgery in patients with persisting intense sciatica (lumbosacral radicular syndrome). Methods/design Patients presenting themselves to their general practitioner with disabling sciatica lasting less than twelve weeks are referred to the neurology outpatient department of one of the participating hospitals. After confirmation of the di...

  9. Association of industry sponsorship and positive outcome in randomised controlled trials in general and abdominal surgery: protocol for a systematic review and empirical study.

    Science.gov (United States)

    Probst, Pascal; Grummich, Kathrin; Ulrich, Alexis; Büchler, Markus W; Knebel, Phillip; Diener, Markus K

    2014-11-27

    Industry sponsorship has been identified as a factor correlating with positive research findings in several fields of medical science. To date, the influence of industry sponsorship in general and abdominal surgery has not been fully studied. This protocol describes the rationale and planned conduct of a systematic review to determine the association between industry sponsorship and positive outcome in randomised controlled trials in general and abdominal surgery. A literature search in the Cochrane Library, MEDLINE and EMBASE and additional hand searches in relevant citations will be conducted. In order to cover all relevant areas of general and abdominal surgery, a new literature search strategy called multi-PICO search strategy (MPSS) has been developed. No language restriction will be applied. The search will be limited to publications between January 1985 and July 2014. Information on funding source, outcome, study characteristics and methodological quality will be extracted.The association between industry sponsorship and positive outcome will be tested by a chi-squared test. A multivariate logistic regression analysis will be performed to control for possible confounders, such as number of study centres, multinational trials, methodological quality, journal impact factor and sample size. This study was designed to clarify whether industry-sponsored trials report more positive outcomes than non-industry trials. It will be the first study to evaluate this topic in general and abdominal surgery. The findings of this study will enable surgical societies, in particular, to give advice about cooperation with the industry and disclosure of funding source based on empirical evidence. PROSPERO CRD42014010802.

  10. Intravenous lidocaine for post-operative pain relief after hand-assisted laparoscopic colon surgery: a randomized, placebo-controlled clinical trial

    OpenAIRE

    Tikuišis, R.; Miliauskas, P.; Samalavičius, N. E.; Žurauskas, A.; Samalavičius, R.; Zabulis, V.

    2013-01-01

    Background Perioperative intravenous (IV) infusion of lidocaine has been shown to decrease post-operative pain, shorten time to return of bowel function, and reduce the length of hospital stay. This randomized, prospective, double-blinded, placebo-controlled clinical trial evaluated the impact of IV lidocaine on the quality of post-operative analgesia and other outcomes after hand-assisted laparoscopic colon surgery. Methods Sixty four patients with colon cancer scheduled for elective colon r...

  11. Effect of perioperative beta blockade in patients with diabetes undergoing major non-cardiac surgery: randomised placebo controlled, blinded multicentre trial

    DEFF Research Database (Denmark)

    Juul, Anne Benedicte; Wetterslev, Jørn; Gluud, Christian;

    2006-01-01

    Objectives To evaluate the long term effects of perioperative blockade on mortality and cardiac morbidity in patients with diabetes undergoing major non-cardiac surgery. Design Randomised placebo controlled and blinded multicentre trial. Analyses were by intention to treat. Setting University...... anaesthesia and surgical centres and one coordinating centre. Participants 921 patients aged > 39 scheduled for major non-cardiac surgery. Interventions 100 mg metoprolol controlled and extended release or placebo administered from the day before surgery to a maximum of eight perioperative days. Main outcome...... was 4.6 days in the metoprolol group and 4.9 days in the placebo group. Metoprolol significantly reduced the mean heart rate by 11% (95% confidence interval 9% to 13%) and mean blood pressure by 3% (1% to 5%). The primary outcome occurred in 99 of 462 patients in the metoprolol group (21%) and 93 of 459...

  12. The Hip Fracture Surgery in Elderly Patients (HIPELD study: protocol for a randomized, multicenter controlled trial evaluating the effect of xenon on postoperative delirium in older patients undergoing hip fracture surgery

    Directory of Open Access Journals (Sweden)

    Coburn Mark

    2012-09-01

    Full Text Available Abstract Background Strategies to protect the brain from postoperative delirium (POD after hip fracture are urgently needed. The development of delirium often is associated with the loss of independence, poor functional recovery, and increased morbidity, as well as increases in length of hospital stay, discharges to nursing facilities, and healthcare costs. We hypothesize that xenon may reduce the burden of POD, (i by avoiding the need to provide anesthesia with a drug that targets the γ-amino-butyric acid (GABAA receptor and (ii through beneficial anesthetic and organ-protective effects. Methods and design An international, multicenter, phase 2, prospective, randomized, blinded, parallel group and controlled trial to evaluate the incidence of POD, diagnosed with the Confusion Assessment Method (CAM, in older patients undergoing hip fracture surgery under general anesthesia with xenon or sevoflurane, for a period of 4 days post surgery (primary outcome is planned. Secondary objectives are to compare the incidence of POD between xenon and sevoflurane, to evaluate the incidence of POD from day 5 post surgery until discharge from hospital, to determine the time to first POD diagnosis, to evaluate the duration of POD, to evaluate the evolution of the physiological status of the patients in the postoperative period, to evaluate the recovery parameters, to collect preliminary data to evaluate the economical impact of POD in the postoperative period and to collect safety data. Patients are eligible if they are older aged (≥ 75 years and assigned to a planned hip fracture surgery within 48 h after the hip fracture. Furthermore, patients need to be willing and able to complete the requirements of this study including the signature of the written informed consent. A total of 256 randomized patients in the 10 participating centers will be recruited, that is, 128 randomized patients in each of the 2 study groups (receiving either xenon or sevoflurane

  13. The Comparison of Two Types of Relaxation Techniques on Postoperative State Anxiety in Candidates for The Mastectomy Surgery: A Randomized Controlled Clinical Trial

    Directory of Open Access Journals (Sweden)

    Zohreh Parsa Yekta

    2017-01-01

    Full Text Available Background: Anxiety among patients after surgery can affect their physiological and psychological well-being. The aim of this study was to investigate and compare the effects of Benson’s relaxation and rhythmic breathing techniques on postoperative anxiety in candidates for the mastectomy surgery. Methods: This randomized controlled clinical trial study was conducted with ninety patients in 2013. The patients were hospitalized for the mastectomy surgery in three surgical wards in a teaching hospital, Tehran, Iran. They were randomly assigned into three groups: Benson’s relaxation including the cognitive relaxation technique type, rhythmic breathing including the somatic relaxation technique type and control groups. According to the Davidson and Schwartz multi-process theory, the Benson’s relaxation and the rhythmic breathing techniques have cognitive and somatic effects, respectively. One day before the surgery, the patients in the intervention groups were trained regarding relaxation and breathing techniques and were asked to perform the techniques under the supervision of the researcher in the night before the surgery. The cognitive somatic anxiety questionnaire was used to measure anxiety before the intervention and half an hour after recovery of consciousness after the surgery. Descriptive and inferential statistics were used for data analysis via the SPSS v.21 software. Results: There were no statistically significant differences between the groups in terms of demographic characteristics. The application of both techniques reduced the level of patients’ anxiety after the surgery. The patients in the Benson’s relaxation technique group reported only the relief of somatic anxiety. However, the breathing technique patients reported a reduction in both cognitive and somatic anxiety. Conclusion: The Benson’s relaxation and rhythmic breathing techniques can reduce postoperative anxiety in patients after the mastectomy surgery.

  14. Thrombelastographic haemostatic status and antiplatelet therapy after coronary artery bypass surgery (TEG-CABG trial: assessing and monitoring the antithrombotic effect of clopidogrel and aspirin versus aspirin alone in hypercoagulable patients: study protocol for a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Rafiq Sulman

    2012-04-01

    Full Text Available Abstract Background Hypercoagulability, assessed by the thrombelastography (TEG assay, has in several observational studies been associated with an increased risk of post-procedural thromboembolic complications. We hypothesize that intensified antiplatelet therapy with clopidogrel and aspirin, as compared to aspirin alone, will improve saphenous vein graft patency in preoperatively TEG-Hypercoagulable coronary artery bypass surgery (CABG patients and reduce their risk for thromboembolic complications and death postoperatively. Methods/Design This is a prospective randomized clinical trial, with an open-label design with blinded evaluation of graft patency. TEG-Hypercoagulability is defined as a TEG maximum amplitude above 69 mm. Two hundred and fifty TEG-Hypercoagulable patients will be randomized to either an interventional group receiving clopidogrel 75 mg daily for three months (after initial oral bolus of 300 mg together with aspirin 75 mg or a control group receiving aspirin 75 mg daily alone. Monitoring of antiplatelet efficacy and on-treatment platelet reactivity to clopidogrel and aspirin will be conducted with Multiplate aggregometry. Graft patency will be assessed with Multislice computed tomography (MSCT at three months after surgery. Conclusions The present trial is the first randomized clinical trial to evaluate whether TEG-Hypercoagulable CABG patients will benefit from intensified antiplatelet therapy after surgery. Monitoring of platelet inhibition from instituted antithrombotic therapy will elucidate platelet resistance patterns after CABG surgery. The results could be helpful in redefining how clinicians can evaluate patients preoperatively for their postoperative thromboembolic risk and tailor individualized postoperative antiplatelet therapy. Trial registration Clinicaltrials.gov Identifier NCT01046942

  15. Cryogenic heat loads analysis from SST-1 plasma experiments

    Science.gov (United States)

    Bairagi, N.; Tanna, V. L.; Pradhan, S.

    2017-02-01

    Cryogenic heat load analysis is an important aspect for stable operation of Tokamaks employing large scale superconducting magnets. Steady State Superconducting Tokamak (SST-1) at IPR is equipped with superconducting magnets system (SCMS) comprising sixteen numbers of modified ‘D’ shaped toroidal field (TF) and nine poloidal field (PF) superconducting coils which are wound using NbTi/Cu based cable-in conduit conductor (CICC). SST-1 magnets operation has flexibility to cool either in two-phase with sub-cooling, two-phase without sub-cooling or single phase (supercritical) helium using a dedicated 1.3 kW helium refrigerator cum liquefier (HRL). Here, we report gross heat losses for integrated TF superconducting magnets of SST-1 during the plasma campaign using cryogenic helium supply/return thermodynamic data from cryoplant. Heat loads mainly comprising of steady state as well as transient loads are smoothly absorbed by SST-1 cryogenic helium plant during plasma experiments. The corresponding heat produced in the coils is totally released to the helium flowing through the TF coils, which in turn is dumped into liquid helium stored in main control Dewar. These results are very useful reference for heat loss analysis for TF as well as PF coils and provides database for future operation of SST-1 machine.

  16. Vocational rehabilitation services for patients with cancer: design of a feasibility study incorporating a pilot randomised controlled trial among women with breast cancer following surgery

    Directory of Open Access Journals (Sweden)

    Ayansina Dolapo

    2011-03-01

    Full Text Available Abstract Background Due to improvements in cancer survival the number of people of working age living with cancer across Europe is likely to increase. UK governments have made commitments to reduce the number of working days lost to ill-health and to improve access to vocational rehabilitation (VR services. Return to work for people with cancer has been identified as a priority. However, there are few services to support people to remain in or return to work after cancer and no associated trials to assess their impact. A pilot randomised controlled trial among women with breast cancer has been designed to assess the feasibility of a larger definitive trial of VR services for people with cancer. Methods Patients are being recruited from three clinical sites in two Scottish National Health Service (NHS Boards for 6 months. Eligible patients are all women who are: (1 aged between 18 and 65 years; (2 in paid employment or self-employed; (3 living or working in Lothian or Tayside, Scotland, UK; (4 diagnosed with an invasive breast cancer tumour; (5 treated first with surgery. Patients are randomly allocated to receive referral to a VR service or usual care, which involves no formal employment support. The primary outcome measure is self-reported sickness absence in the first 6 months following surgery. Secondary outcome measures include changes in quality of life (FACT-B, fatigue (FACIT-Fatigue and employment status between baseline and 6- and 12-months post-surgery. A post-trial evaluation will be conducted to assess the acceptability of the intervention among participants and the feasibility of a larger, more definitive, trial with patients with lung and prostate cancer. Discussion To our knowledge this is the first study to determine the feasibility of a randomised controlled trial of the effectiveness of VR services to enable people with cancer to remain in or return to employment. The study will provide evidence to assess the relevance and

  17. Cost-Effectiveness of a Biodegradable Compared to a Titanium Fixation System in Maxillofacial Surgery: A Multicenter Randomized Controlled Trial.

    Directory of Open Access Journals (Sweden)

    N B van Bakelen

    Full Text Available Biodegradable fixation systems could reduce/delete the problems associated with titanium plate removal. This means less surgical discomfort, and a reduction in costs.The aim of the present study was to compare the cost-effectiveness between a biodegradable and a titanium system in Maxillofacial surgery.This multicenter RCT was performed in the Netherlands from December 2006 to July 2009. Included were 230 patients who underwent a bilateral sagittal split osteotomy (BSSO, a Le Fort-I osteotomy, or a bi-maxillary osteotomy and those treated for fractures of the mandible, maxilla, or zygoma. The patients were randomly assigned to a titanium group (KLS Martin or to a biodegradable group (Inion CPS. Costs were assessed from a societal perspective. Health outcomes in the incremental cost-effectiveness ratio (ICER were bone healing (8 weeks and plate removal (2 years.In 25 out of the 117 patients who were randomized to the biodegradable group, the maxillofacial surgeon made the decision to switch to the titanium system intra-operatively. This resulted in an Intention-To-Treat (ITT-analysis and a Treatment-Received (TR- analysis. Both analyses indicated that operations performed with titanium plates and screws had better health outcomes. In the TR-analysis the costs were lower in the biodegradable group, in the ITT-analysis costs were lower in the titanium group.The difference in costs between the ITT and the TR analyses can be explained by the intra-operative switches: In the TR-analysis the switches were analysed in the titanium group. In the ITT-analysis they were analysed in the biodegradable group. Considering the cost-effectiveness the titanium system is preferable to the biodegradable system in the regular treatment spectrum of mandibular, Le Fort-I, and zygomatic fractures, and BSSO's, Le Fort-I osteotomies and bimaxillary osteotomies.Controlled-Trials.com ISRCTN 44212338.

  18. Attenuation of Hemodynamic Responses to Intubation by Gabapentin in Coronary Artery Bypass Surgery: a Randomized Clinical Trial.

    Science.gov (United States)

    Marashi, Seyed Mojtaba; Saeedinia, Seyed Mostafa; Sadeghi, Mostafa; Movafegh, Ali; Marashi, Shaqayeq

    2015-12-01

    A varieties of medications have been suggested to prevent hemodynamic instabilities following laryngoscopy and endotracheal intubation. This study was conducted to determine the beneficial effects of gabapentin on preventing hemodynamic instabilities associated with intubation in patients who were a candidate for coronary artery bypass surgery (CABG). This double blinded randomized, parallel group clinical trial was carried out on 58 normotensive patients scheduled for elective CABG under general anesthesia with endotracheal intubation in Shariati Hospital. Patients were randomly allocated to two groups of 29 patients that received 1200 mg of gabapentin in two dosages (600 mg, 8 hours before anesthesia induction and 600 mg, 2 hours before anesthesia induction) as gabapentin group or received talc powder as placebo (placebo group). Heart rate, mean arterial pressure, systolic and diastolic blood pressure were measured immediately before intubation, during intubation, immediately after intubation, 1 and 2 minutes after tracheal intubation. Inter-group comparisons significantly showed higher systolic and diastolic blood pressure, mean arterial pressure and heart rate immediately before intubation, during intubation, immediately after intubation, 1 and 2 minutes after tracheal intubation in the placebo group in comparison to gabapentin group. The median of anxiety verbal analog scale (VAS) at the pre-induction room in gabapentin and placebo groups were 2 and 4, respectively that was significantly lower in the former group (P. value =0.04 ); however, regarding median of pain score no difference was observed between them (P. value =0.07). Gabapentin (1200 mg) given preoperatively can effectively attenuate the hemodynamic response to laryngoscopy, intubation and also reduce preoperative related anxiety in patients who were a candidate for CABG.

  19. Effects of bariatric surgery on gout incidence in the Swedish Obese Subjects study: a non-randomised, prospective, controlled intervention trial.

    Science.gov (United States)

    Maglio, Cristina; Peltonen, Markku; Neovius, Martin; Jacobson, Peter; Jacobsson, Lennart; Rudin, Anna; Carlsson, Lena M S

    2017-04-01

    To assess the long-term effect of bariatric surgery on the incidence of gout and hyperuricaemia in participants of the Swedish Obese Subjects (SOS) study. This report includes 1982 subjects who underwent bariatric surgery and 1999 obese controls from the SOS study, a prospective intervention trial designed to assess the effect of bariatric surgery compared with conventional treatment. None of the subjects had gout at baseline. An endpoint on gout incidence was created based on information on gout diagnosis and use of gout medications through national registers and questionnaires. Median follow-up for the incidence of gout was about 19 years for both groups. Moreover, the incidence of hyperuricaemia over up to 20 years was examined in a subgroup of participants having baseline uric acid levels gout compared with usual care (adjusted HR 0.60, 95% CI 0.48 to 0.75, pgout event was 32 (95% CI 22 to 59). The effect of bariatric surgery on gout incidence was not influenced by baseline risk factors, including body mass index. During follow-up, the surgery group had a lower incidence of hyperuricaemia (adjusted HR 0.47, 95% CI 0.39 to 0.58, pgout and hyperuricaemia in obese subjects. NCT01479452; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  20. Influence of SST biases on future climate change projections

    Energy Technology Data Exchange (ETDEWEB)

    Ashfaq, Moetasim [Stanford University, Department of Environmental Earth System Science, Stanford, CA (United States); Purdue University, Department of Earth and Atmospheric Sciences, West Lafayette, IN (United States); Climate Change Science Institute, Oak Ridge National Laboratory, Oak Ridge, TN (United States); Skinner, Christopher B. [Stanford University, Department of Environmental Earth System Science, Stanford, CA (United States); Purdue University, Department of Earth and Atmospheric Sciences, West Lafayette, IN (United States); Diffenbaugh, Noah S. [Stanford University, Department of Environmental Earth System Science, Stanford, CA (United States); Purdue University, Department of Earth and Atmospheric Sciences, West Lafayette, IN (United States); Stanford University, Woods Institute for the Environment, Stanford, CA (United States)

    2011-04-15

    We use a quantile-based bias correction technique and a multi-member ensemble of the atmospheric component of NCAR CCSM3 (CAM3) simulations to investigate the influence of sea surface temperature (SST) biases on future climate change projections. The simulations, which cover 1977-1999 in the historical period and 2077-2099 in the future (A1B) period, use the CCSM3-generated SSTs as prescribed boundary conditions. Bias correction is applied to the monthly time-series of SSTs so that the simulated changes in SST mean and variability are preserved. Our comparison of CAM3 simulations with and without SST correction shows that the SST biases affect the precipitation distribution in CAM3 over many regions by introducing errors in atmospheric moisture content and upper-level (lower-level) divergence (convergence). Also, bias correction leads to significantly different precipitation and surface temperature changes over many oceanic and terrestrial regions (predominantly in the tropics) in response to the future anthropogenic increases in greenhouse forcing. The differences in the precipitation response from SST bias correction occur both in the mean and the percent change, and are independent of the ocean-atmosphere coupling. Many of these differences are comparable to or larger than the spread of future precipitation changes across the CMIP3 ensemble. Such biases can affect the simulated terrestrial feedbacks and thermohaline circulations in coupled climate model integrations through changes in the hydrological cycle and ocean salinity. Moreover, biases in CCSM3-generated SSTs are generally similar to the biases in CMIP3 ensemble mean SSTs, suggesting that other GCMs may display a similar sensitivity of projected climate change to SST errors. These results help to quantify the influence of climate model biases on the simulated climate change, and therefore should inform the effort to further develop approaches for reliable climate change projection. (orig.)

  1. The effect of an educational intervention on coronary artery bypass graft surgery patients' participation rate in cardiac rehabilitation programs: a controlled health care trial

    Directory of Open Access Journals (Sweden)

    Novikov Ilia

    2011-10-01

    Full Text Available Abstract Background Cardiac rehabilitation has a beneficial effect on the prognosis and quality of life of cardiac patients, and has been found to be cost-effective. This report describes a comprehensive and low cost educational intervention designed to increase the attendance at cardiac rehabilitation programs of patients who have undergone coronary artery bypass graft surgery. Methods/Design A controlled prospective intervention trial. The control arm comprised 520 patients who underwent coronary artery bypass graft surgery between January 2004 and May 2005 in five medical centers across Israel. This group received no additional treatment beyond usual care. The intervention arm comprised 504 patients recruited from the same cardiothoracic departments between June 2005 and November 2006. This group received oral and written explanations about the advantages of participating in cardiac rehabilitation programs and a telephone call two weeks after hospital discharge intended to further encourage their enrollment. The medical staff attended a one-hour seminar on cardiac rehabilitation. In addition, it was recommended that referral to cardiac rehabilitation be added to the letter of discharge from the hospital. Both study groups were interviewed before surgery and one-year post surgery. A one-year post-operative interview assessed factors affecting patient attendance at cardiac rehabilitation programs, as well as the structure and content of the cardiac rehabilitation programs attended. Anthropometric parameters were measured at pre- and post-operative interviews;- and medical information was obtained from patient medical records. The effect of cardiac rehabilitation on one- and three-year mortality was assessed. Discussion We report a low cost yet comprehensive intervention designed to increase cardiac rehabilitation participation by raising both patient and medical staff awareness to the potential benefits of cardiac rehabilitation. Trial

  2. FLAMMABLE GAS DIFFUSION THROUGH SINGLE SHELL TANK (SST) DOMES

    Energy Technology Data Exchange (ETDEWEB)

    MEACHAM, J.E.

    2003-11-10

    This report quantified potential hydrogen diffusion through Hanford Site Single-Shell tank (SST) domes if the SSTs were hypothetically sealed airtight. Results showed that diffusion would keep headspace flammable gas concentrations below the lower flammability limit in the 241-AX and 241-SX SST. The purpose of this document is to quantify the amount of hydrogen that could diffuse through the domes of the SSTs if they were hypothetically sealed airtight. Diffusion is assumed to be the only mechanism available to reduce flammable gas concentrations. The scope of this report is limited to the 149 SSTs.

  3. SST Diurnal Variability: Regional Extent & Implications in Atmospheric Modelling

    DEFF Research Database (Denmark)

    Karagali, Ioanna; Høyer, Jacob L.

    2013-01-01

    and quantify regional diurnal warming from the experimental MSG/SEVIRI hourly SST fields, for the period 2006-2012. ii) To investigate the impact of the increased SST temporal resolution in the atmospheric model WRF, in terms of modeled 10-m winds and surface heat fluxes. Withing this context, 3 main tasks...... regional diurnal warming over the SEVIRI disk, a SEVIRI derived reference field representative of the well mixed night-time conditions is required. Different methodologies are tested and the results are validated against SEVIRI pre-dawn SSTs and in situ data from moored and drifting buoys....

  4. The ASTRI SST-2M Prototype: Camera and Electronics

    CERN Document Server

    Catalano, Osvaldo; La Rosa, Giovanni; Maccarone, Maria Concetta; Mineo, Teresa; Russo, Francesco; Sottile, Giuseppe; Impiombato, Domenico; Bonanno, Giovanni; Belluso, Massimiliano; Billotta, Sergio; Grillo, Alessandro; Marano, Davide; De Caprio, Vincenzo; Fiorini, Mauro; Stringhetti, Luca; GAROZZO, Salvo; ROMEO, Giuseppe

    2013-01-01

    ASTRI is a Flagship Project financed by the Italian Ministry of Education, University and Research, and led by INAF, the Italian National Institute of Astrophysics. The primary goal of the ASTRI project is the realization of an end-to-end prototype of a Small Size Telescope for the Cherenkov Telescope Array. The prototype, named ASTRI SST-2M, is based on a completely new double mirror optics design and will be equipped with a camera made of a matrix of SiPM detectors. Here we describe the ASTRI SST-2M camera concept: basic idea, detectors, electronics, current status and some results coming from experiments in lab.

  5. Choosing surgery

    DEFF Research Database (Denmark)

    Thorstensson, Carina; Lohmander, L; Frobell, Richard

    2009-01-01

    ABSTRACT: BACKGROUND: The objective was to understand patients' views of treatment after acute anterior cruciate ligament (ACL) injury, and their reasons for deciding to request surgery despite consenting to participate in a randomised controlled trial (to 'cross-over'). METHODS: Thirty-four in......-depth qualitative interviews were conducted with young (aged 18-35), physically active individuals with ACL rupture who were participating in a RCT comparing training and surgical reconstruction with training only. 22/34 were randomised to training only but crossed over to surgery. Of these, 11 were interviewed...... before surgery, and 11 were interviewed at least 6 months after surgery. To provide additional information, 12 patients were interviewed before randomisation. Interviews were audio-recorded, transcribed and analysed using the Framework approach. RESULTS: Strong preference for surgery was commonplace...

  6. Ensayos clínicos en Cirugía Pediátrica: Consideraciones bioéticas Clinical trials in Pediatric Surgery: Bioethical considerations

    Directory of Open Access Journals (Sweden)

    José Carlos Bueno Rodríguez

    2010-04-01

    Full Text Available Los ensayos clínicos son considerados como una de las mejores fuentes primarias de evidencia; sin embargo, este tipo de estudio es poco utilizado en Cirugía. El presente trabajo revisa algunas particularidades bioéticas de los ensayos clínicos en Cirugía Pediátrica. Las principales dificultades y limitaciones bioéticas son: la poca tradición de los cirujanos en la realización de ensayos clínicos, la irreversibilidad del tratamiento quirúrgico, la necesidad de entrenamiento técnico y experiencia manual, la ausencia de criterios de calidad de la técnica empleada y la influencia del periodo de aprendizaje en los resultados. Se presentan posibles soluciones para estas particularidades. Cuando se utilice el ensayo clínico como la mejor opción de diseño para contestar una pregunta de investigación clínica en cirugía con niños, deberán valorarse tanto las ventajas como las limitaciones y las dificultades bioéticas de este tipo de estudio.Clinical trials are considered the best primary source of evidence; however, this kind of study is slightly used in surgery. This paper revises some of the bioethical characteristics of clinical trials in Pediatric Surgery. The main bioethical difficulties and limitations are: surgeons´ little experience in clinical trials, irreversibility of surgical treatments, need of technical training and manual experience, absence of quality criteria concerning the technique used, and influence of the learning period in the results. Possible solutions to these aspects are presented. When clinical trials are used as the best option to answer any clinical research questions in pediatric surgery, their advantages and bioethical limitations and difficulties should taken into consideration.

  7. A stepped strategy that aims at the nationwide implementation of the Enhanced Recovery After Surgery programme in major gynaecological surgery: study protocol of a cluster randomised controlled trial

    NARCIS (Netherlands)

    Groot, J.J.A.M. de; Maessen, J.M.; Slangen, B.F.; Winkens, B.; Dirksen, C.D.; Weijden, T.T. van der

    2015-01-01

    BACKGROUND: Enhanced Recovery After Surgery (ERAS) programmes aim at an early recovery after surgical trauma and consequently at a reduced length of hospitalisation. This paper presents the protocol for a study that focuses on large-scale implementation of the ERAS programme in major gynaecological

  8. A stepped strategy that aims at the nationwide implementation of the Enhanced Recovery After Surgery programme in major gynaecological surgery: study protocol of a cluster randomised controlled trial

    NARCIS (Netherlands)

    Groot, J.J.A.M. de; Maessen, J.M.; Slangen, B.F.; Winkens, B.; Dirksen, C.D.; Weijden, T.T. van der

    2015-01-01

    BACKGROUND: Enhanced Recovery After Surgery (ERAS) programmes aim at an early recovery after surgical trauma and consequently at a reduced length of hospitalisation. This paper presents the protocol for a study that focuses on large-scale implementation of the ERAS programme in major gynaecological

  9. Minimally invasive lumbar interbody fusion via MAST Quadrant retractor versus open surgery: a prospective randomized clinical trial

    Institute of Scientific and Technical Information of China (English)

    WANG Hong-li; L(U) Fei-zhou; JIANG Jian-yuan; MA Xin; XIA Xin-lei; WANG Li-xun

    2011-01-01

    Background In recent years,a variety of minimally invasive lumbar surgery techniques have achieved desirable efficacy,but some dispute remains regarding the advantages over open surgery.This study aimed to compare minimally invasive lumbar interbody fusion via MAST Quadrant retractor with open surgery in terms of perioperative factors,postoperative back muscle function,and 24-month postoperative follow-up results.Methods From September 2006 to June 2008,patients with single-level degenerative lumbar spine disease who were not responsive to conservative treatment were enrolled in this study.Patients were randomized to undergo either minimally invasive surgery (MIS,transforaminal lumbar interbody fusion via MAST Quadrant retractor,41 cases) or open surgery (improved transforaminal lumbar interbody fusion,38 cases).Results The MIS group had longer intraoperative fluoroscopy time than the open surgery group,and the open surgery group had significantly increased postoperative drainage volume and significantly prolonged postoperative recovery time compared with the MIS group (P <0.05 for all).MRI scanning showed that the T2 relaxation time in the multifidus muscle was significantly shorter in the MIS group than in the open surgery group at 3 months after surgery (P <0.01).Surface electromyography of the sacrospinalis muscle showed that the average discharge amplitude and frequency were significantly higher in the MIS group than in the open surgery group (P <0.01).The Oswestry disability index and visual analog scale scores were better at 3,6,12 and 24 months postoperatively than preoperatively in both groups.Both groups of patients met the imaging convergence criteria at the last follow-up.Conclusions MIS can effectively reduce sacrospinalis muscle injury compared with open surgery,which is conducive to early functional recovery.In the short term,MIS is superior to open surgery,but in the long term there is no significant difference between the two procedures.

  10. No effect of melatonin to modify surgical-stress response after major vascular surgery: a randomised placebo-controlled trial

    DEFF Research Database (Denmark)

    Kücükakin, B; Wilhelmsen, M; Lykkesfeldt, Jens

    2010-01-01

    A possible mechanism underlying cardiovascular morbidity after major vascular surgery may be the perioperative ischaemia-reperfusion with excessive oxygen-derived free-radical production and increased levels of circulating inflammatory mediators. We examined the effect of melatonin infusion durin...... surgery and oral melatonin treatment for 3 days after surgery on biochemical markers of oxidative and inflammatory stress.......A possible mechanism underlying cardiovascular morbidity after major vascular surgery may be the perioperative ischaemia-reperfusion with excessive oxygen-derived free-radical production and increased levels of circulating inflammatory mediators. We examined the effect of melatonin infusion during...

  11. Effect of comprehensive cardiac rehabilitation after heart valve surgery (CopenHeartVR): study protocol for a randomised clinical trial

    National Research Council Canada - National Science Library

    Sibilitz, Kirstine Laerum; Berg, Selina Kikkenborg; Hansen, Tina Birgitte; Risom, Signe Stelling; Rasmussen, Trine Bernholdt; Hassager, Christian; Køber, Lars; Steinbrüchel, Daniel; Gluud, Christian; Winkel, Per; Thygesen, Lau Caspar; Hansen, Jane Lindschou; Schmid, Jean Paul; Conraads, Viviane; Brocki, Barbara Christina; Zwisler, Ann-Dorthe

    2013-01-01

    .... We hypothesise that a comprehensive cardiac rehabilitation programme can improve physical capacity and self-assessed mental health and reduce hospitalisation and healthcare costs after heart valve surgery...

  12. Maintaining endotracheal tube cuff pressure at 20 mm Hg to prevent dysphagia after anterior cervical spine surgery; protocol of a double-blind randomised controlled trial.

    Science.gov (United States)

    Arts, Mark P; Rettig, Thijs C D; de Vries, Jessica; Wolfs, Jasper F C; in't Veld, Bas A

    2013-09-25

    In anterior cervical spine surgery a retractor is obligatory to approach the spine. Previous studies showed an increase of endotracheal tube cuff pressure after placement of a retractor. It is known that high endotracheal tube cuff pressure increases the incidence of postoperative dysphagia, hoarseness, and sore throat. However, until now no evidence supports the fact whether adjusting the endotracheal tube cuff pressure during anterior cervical spine surgery will prevent this comorbidity. We present the design of a randomized controlled trial to determine whether adjusting endotracheal tube cuff pressure after placement of a retractor during anterior cervical spine surgery will prevent postoperative dysphagia. 177 patients (aged 18-90 years) scheduled for anterior cervical spine surgery on 1 or more levels will be included. After intubation, endotracheal tube cuff pressure is manually inflated to 20 mm Hg in all patients. Patients will be randomized into two groups. In the control group endotracheal tube cuff pressure is not adjusted after retractor placement. In the intervention group endotracheal tube cuff pressure after retractor placement is maintained at 20 mm Hg and air is withdrawn when cuff pressure exceeds 20 mm Hg. Endotracheal tube cuff pressure is measured after intubation, before and after placement and removal of the retractor. Again air is inflated if cuff pressure sets below 20 mmHg after removal of the retractor. The primary outcome measure is postoperative dysphagia. Other outcome measures are postoperative hoarseness, postoperative sore throat, degree of dysphagia, length of hospital stay, and pneumonia. The study is a single centre double blind randomized trial in which patients and research nurses will be kept blinded for the allocated treatment during the follow-up period of 2 months. Postoperative dysphagia occurs frequently after anterior cervical spine surgery. This may be related to high endotracheal tube cuff pressure. Whether

  13. Postoperative Analgesic Efficacy of Bilateral Transversus Abdominis Plane Block in Patients Undergoing Midline Colorectal Surgeries Using Ropivacaine: A Randomized, Double-blind, Placebo-controlled Trial

    Science.gov (United States)

    Qazi, Nahida; Bhat, Wasim Mohammad; Iqbal, Malik Zaffar; Wani, Anisur Rehman; Gurcoo, Showkat A.; Rasool, Sahir

    2017-01-01

    Background: Ultrasound-guided transversus abdominis plane (TAP) block is done as a part of multimodal analgesia for pain relief after abdominal surgeries. This prospective randomized, double-blind, placebo-controlled trial was conducted to evaluate the postoperative analgesic efficacy of bilateral TAP block in patients undergoing midline colorectal surgeries using ropivacaine. Materials and Methods: Eighty patients scheduled for elective colorectal surgeries involving midline abdominal wall incision under general anesthesia were enrolled in this prospective randomized controlled trial. Group A received TAP block with 20 ml of 0.2% ropivacaine on either side of the abdominal wall, and Group B received 20 ml of normal saline. The time to request for rescue analgesia, total analgesic consumption in 24 h, and satisfaction with the anesthetic technique were assessed. Results: The mean visual analog scale scores at rest and on coughing were higher in control group (P > 0.05). Time (min) to request for the first rescue analgesia was prolonged in study group compared to control group (P tramadol consumption in 24 h postoperatively was significantly high in control group (P 0.05). The level of satisfaction concerning postoperative pain control/anesthetic technique was higher in study group (P tramadol requirements, reduction in postoperative pain scores, and increased time to first request for further analgesia, both at rest and on movement. PMID:28928585

  14. Evaluation of the preliminary effectiveness of hand massage therapy on postoperative pain of adults in the intensive care unit after cardiac surgery: a pilot randomized controlled trial.

    Science.gov (United States)

    Boitor, Mădălina; Martorella, Géraldine; Arbour, Caroline; Michaud, Cécile; Gélinas, Céline

    2015-06-01

    Although many intensive care unit patients experience significant pain, very few studies explored massage to maximize their pain relief. This study aimed to evaluate the preliminary effects of hand massage on pain after cardiac surgery in the adult intensive care unit. A pilot randomized controlled trial was used for this study. The study was conducted in a Canadian medical-surgical intensive care unit. Forty adults who were admitted to the intensive care unit after undergoing elective cardiac surgery in the previous 24 hours participated in the study. They were randomly assigned to the experimental (n = 21) or control (n = 19) group. The experimental group received a 15-minute hand massage, and the control group received a 15-minute hand-holding without massage. In both groups the intervention was followed by a 30-minute rest period. The interventions were offered on 2-3 occasions within 24 hours after surgery. Pain, muscle tension, and vital signs were assessed. Pain intensity and behavioral scores were decreased for the experimental group. Although hand massage decreased muscle tension, fluctuations in vital signs were not significant. This study supports potential benefits of hand massage for intensive care unit postoperative pain management. Although larger randomized controlled trials are necessary, this low-cost nonpharmacologic intervention can be safely administered.

  15. Long-term outcomes of palliative colonic stenting versus emergency surgery for acute proximal malignant colonic obstruction: a multicenter trial

    Science.gov (United States)

    Siddiqui, Ali; Cosgrove, Natalie; Yan, Linda H.; Brandt, Daniel; Janowski, Raymond; Kalra, Ankush; Zhan, Tingting; Baron, Todd H.; Repici, Allesandro; Taylor, Linda Jo; Adler, Douglas. G.

    2017-01-01

    Background and study aims Long-term data are limited regarding clinical outcomes of self-expanding metal stents as an alternative for surgery in the treatment of acute proximal MBO. The aim of this study was to compare the long-term outcomes of stenting to surgery for palliation in patients with incurable obstructive CRC for lesions proximal to the splenic flexure. Patients and methods Retrospective multicenter cohort study of obstructing proximal CRC patients with who underwent insertion of a SEMS (n = 69) or surgery (n = 36) from 1999 to 2014. The primary endpoint was relief of obstruction. Secondary endpoints included technical success, duration of hospital stay, early and late adverse events (AEs) and survival. Results Technical success was achieved in 62/69 (89.8 %) patients in the SEMS group and in 36 /36 (100 %) patients who underwent surgery (P = 0.09). In the SEMS group, 10 patients underwent stenting as a bridge to surgery and 59 underwent stent placement for palliation. Clinical relief was achieved in 78 % of patients with stenting and in 100 % of patients who underwent surgery (P group (7.2 % vs. 30.5 %, P = 0.003). Hospital mortality for the SEMS group was 0 % compared to 5.6 % in the surgery group (P = 0.11). Patients in the SEMS group had a significantly shorter median hospital stay (4 days) as compared to the surgery group (8 days) (P group (73.9 %) than the surgery group (97.3 %; P = 0.003). SEMS placement was associated with higher long-term complication rates compared to surgery (21 % and 11 % P = 0.27). Late SEMS AEs included occlusion (10 %), migration (5 %), and colonic ulcer (6 %). At 120 weeks, survival in the SEMS group was 5.6 % vs. 0 % in the surgery group (P = 0.8). Conclusions Technical and clinical success associated with proximal colonic obstruction are higher with surgery when compared to SEMS, but surgery is associated with longer hospital stays and more

  16. Randomized clinical trial comparing manual suture and different models of mechanical suture in the mimicking of bariatric surgery in swine

    Directory of Open Access Journals (Sweden)

    Fernandes MA

    2014-02-01

    analysis included the formation of foreign body granuloma in the gastroenteroanastomosis and enteroanastomosis in 88.9% of the swine that underwent manual suture and in none of the swine that underwent stapling. There was also a significant statistical difference among swine from Group A, and those from groups B, C and D regarding the degree of inflammation, being more intense in those swine that underwent manual suture. Conclusion: This study shows that both types of suture promoted proper healing of gastroenteroanastomosis and enteroanastomosis, although there was a higher degree of inflammation and an increased occurrence of foreign body granuloma in swine subjected to manual suture, although there have been similarities in safety, efficiency, and effectiveness between the models of linear mechanical staplers tested during the performance of these anastomoses on swine. Keywords: linear mechanical stapler, stapler, manual suture, surgery, gastroenteroanastomosis, enteroanastomosis, swine, randomized clinical trial

  17. Ultrasound guided pectoral nerve blockade versus thoracic spinal blockade for conservative breast surgery in cancer breast: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Hala M.S. ELdeen

    2016-01-01

    Conclusion: In conclusion, both Pecs and TSB provide effective intraoperative anesthesia and prolonged postoperative pain relief after breast surgery, but the Pecs block is technically simple and easy to learn with few contraindications, provides hemodynamic stability, and has a low complication rate and it is therefore a safe and effective technique in performing intraoperative anesthesia and controlling postoperative pain after unilateral conservative breast surgery.

  18. Effectiveness of a nursing intervention in decreasing the anxiety levels of family members of patients undergoing cardiac surgery: a randomized clinical trial

    Science.gov (United States)

    Hamester, Letícia; de Souza, Emiliane Nogueira; Cielo, Cibele; Moraes, Maria Antonieta; Pellanda, Lúcia Campos

    2016-01-01

    ABSTRACT Objective: to verify the effectiveness of nursing orientation provided to families of patients in the immediate post-operative following cardiac surgery before the first visit to the post-anesthesia care unit, in decreasing anxiety levels, compared to the unit's routine orientation. Method: open randomized clinical trial addressing family members in the waiting room before the first visit in the immediate post-operative period. The family members assigned to the intervention group received audiovisual orientation concerning the patients' conditions at the time and the control group received the unit's routine orientation. Outcome anxiety was assessed using the STAI-State. Results: 210 individuals were included, 105 in each group, aged 46.4 years old on average (±14.5); 69% were female and 41% were the patients' children. The mean score obtained on the anxiety assessment in the intervention group was 41.3±8.6, while the control group scored 50.6±9.4 (p<0.001). Conclusion: a nursing intervention focused on providing guidance to families before their first visit to patients in the immediate post-operative period of cardiac surgery helps to decrease the levels of anxiety of companions, making them feel better prepared for the moment. ReBEC (Brazilian Clinical Trials Registry) and The Universal Trial Number (UTN), No. U1111-1145-6172. PMID:27533263

  19. COMPARATIVE STUDY OF BUPIVACAINE 0.25% VERSUS ROPIVACAINE 0.5% IN TRANSVERSUS ABDOMINIS PLANE BLOCK FOR POSTOPERATIVE ANALGESIA IN LOWER ABDOMINAL SURGERIES: A RANDOMISED CONTROLLED TRIAL

    Directory of Open Access Journals (Sweden)

    Neha

    2014-04-01

    Full Text Available BACKGROUND: Transversus Abdominis Plane Block (TAPB is a regional anesthesia technique. It provides analgesia after lower abdominal surgery particularly where parietal wall pain forms major component of pain. It allows sensory blockade of lower abdominal wall skin and muscles via local anesthetic deposition above Transversus Abdominis muscle. We evaluated efficacy of unilateral TAPB with bupivacaine and ropivacaine for postoperative analgesia in lower abdominal surgeries like hernia repair, appendicectomy in a hospital based, single blind, and prospective, randomized controlled clinical trial. METHOD: 75 adult patients undergoing elective unilateral lower abdominal surgery were randomized to undergo TAPB with ropivacaine (n = 25 or bupivacaine (n = 25 or Normal saline (n = 25. At end of surgery performed under spinal anesthesia unilateral TAPB on side of surgery was performed using 20 ml of 0.5 % ropivacaine or 0.25 % bupivacaine or saline. Each patient was assessed postoperatively by a blinded investigator in post-anesthesia care unit every 5 minutes for half an hour, then every 15 minutes till 2 hours and at 4, 6, 12, 24, 48 hours postoperatively in ward. RESULT: Mean duration of analgesia was 420.6 minutes with SD of +14.01 in Bupivacaine group and 2187 minutes with SD of +1011.09 in Ropivacaine group which was found to be statistically significant. CONCLUSION: Hence 0.5% ropivacaine provided longer duration of analgesia than 0.25 % bupivacaine when used in TAPB on patients of lower abdominal surgeries. There were no complications attributable to TAPB or drugs under study

  20. A randomised control trial assessing the impact of an investment based intervention on weight-loss, beliefs and behaviour after bariatric surgery: study protocol.

    Science.gov (United States)

    Hollywood, Amelia; Ogden, Jane; Hashemi, Majid

    2015-01-01

    Although obesity surgery is currently the most effective method for achieving weight loss, not all patients lose the desired amount of weight and some show weight regain. Previous research shows that successful weight loss may be associated with the amount of investment the patient feels that they have made in their operation. For example, those who feel that it has taken more time and effort to organise, has cost more money, has been more disruptive to their lives and has caused pain are more likely to lose weight after their operation. Therefore, it seems as if the greater the sense of investment, the greater the motivation to make the operation a success. The present study aims to build on these findings by encouraging weight loss surgery patients to focus on the investment they have made, thus making their investment more salient to them and a means to improve weight loss outcomes. The study involves an open randomised parallel group control trial with patients allocated either to the control or investment intervention group. Using third party blinded randomization, half the patients will be asked to rate and describe the investment they have made in their operation just before surgery then 3 and 6 months after surgery. All patients will record their weight, beliefs about food, intentions to change and actual eating and exercise behaviour at baseline then 3, 6 and 12 months follow up. Patients will be recruited from the bariatric surgery pre-assessment clinic at University College Hospital, London. The primary outcome is to explore the impact of the investment based intervention on patient's weight and BMI, with secondary outcomes of patients' beliefs about foods, behavioural intentions and diet and exercise behaviours. It is predicted that the investment intervention will improve excess weight loss post-surgery, together with beliefs about food, intentions to change and actual change in diet and exercise behaviour. This has cost implications for the NHS and

  1. The effect of SST emissions on the earth's ozone layer

    Science.gov (United States)

    Whitten, R. C.; Turco, R. P.

    1974-01-01

    The work presented here is directed toward assessment of environmental effects of the supersonic transport (SST). The model used for the purpose includes vertical eddy transport and the photochemistry of the O-H-N system. It is found that the flight altitude has a pronounced effect on ozone depletion. The largest ozone reduction occurs for NO deposition above an altitude of 20 km.

  2. Are North Atlantic Multidecadal SST Anomalies Westward Propagating?

    NARCIS (Netherlands)

    Feng, Qingyi; Dijkstra, Hendrik

    2014-01-01

    The westward propagation of sea surface temperature (SST) anomalies is one of the main characteristics of one of the theories of the Atlantic Multidecadal Oscillation. Here we use techniques from complex network modeling to investigate the existence of the westward propagation in the North Atlantic

  3. Comparative assessment of seller's staining test (SST) and direct ...

    African Journals Online (AJOL)

    Conclusion:The relatively low sensitivity of the SST observed in this study calls for its ... Slides were examined under royal blue. LED (455nm) excitation filter at X10 eye piece and X20 ... using a light microscope (Olympus CH) for presence.

  4. Value of Bulk Heat Flux Parameterizations for Ocean SST Prediction

    Science.gov (United States)

    2008-03-01

    Value of bulk heat flux parameterizations for ocean SST prediction Alan J. Wallcraft a,⁎, A. Birol Kara a, Harley E. Hurlburt a, Eric P. Chassignet b...G., Doney, S.C., McWilliams , J.C., 1997. Sensitivity to surface forcing and boundary layer mixing in a global ocean model: annual-mean climatology. J

  5. Safety and efficacy of landiolol hydrochloride for prevention of atrial fibrillation after cardiac surgery in patients with left ventricular dysfunction: Prevention of Atrial Fibrillation After Cardiac Surgery With Landiolol Hydrochloride for Left Ventricular Dysfunction (PLATON) trial.

    Science.gov (United States)

    Sezai, Akira; Osaka, Shunji; Yaoita, Hiroko; Ishii, Yusuke; Arimoto, Munehito; Hata, Hiroaki; Shiono, Motomi

    2015-10-01

    We previously conducted a prospective study of landiolol hydrochloride (INN landiolol), an ultrashort-acting β-blocker, and reported that it could prevent atrial fibrillation after cardiac surgery. This trial was performed to investigate the safety and efficacy of landiolol hydrochloride in patients with left ventricular dysfunction undergoing cardiac surgery. Sixty patients with a preoperative left ventricular ejection fraction of less than 35% were randomly assigned to 2 groups before cardiac surgery and then received intravenous infusion with landiolol hydrochloride (landiolol group) or without landiolol (control group). The primary end point was occurrence of atrial fibrillation as much as 1 week postoperatively. The secondary end points were blood pressure, heart rate, intensive care unit and hospital stays, ventilation time, ejection fraction, biomarkers of ischemia, and brain natriuretic peptide. Atrial fibrillation occurred in 3 patients (10%) in the landiolol group versus 12 (40%) in the control group, and its frequency was significantly lower in the landiolol group (P = .002). During the early postoperative period, levels of brain natriuretic peptide and ischemic biomarkers were significantly lower in the landiolol group than the control group. The landiolol group also had a significantly shorter hospital stay (P = .019). Intravenous infusion was not discontinued for hypotension or bradycardia in either group. Low-dose infusion of landiolol hydrochloride prevented atrial fibrillation after cardiac surgery in patients with cardiac dysfunction and was safe, with no effect on blood pressure. This intravenous β-blocker seems useful for perioperative management of cardiac surgical patients with left ventricular dysfunction. Copyright © 2015 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.

  6. Three-Year Outcomes of Bariatric Surgery vs Lifestyle Intervention for Type 2 Diabetes Mellitus Treatment: A Randomized Clinical Trial.

    Science.gov (United States)

    Courcoulas, Anita P; Belle, Steven H; Neiberg, Rebecca H; Pierson, Sheila K; Eagleton, Jessie K; Kalarchian, Melissa A; DeLany, James P; Lang, Wei; Jakicic, John M

    2015-10-01

    Questions remain about the role and durability of bariatric surgery for type 2 diabetes mellitus (T2DM). To compare the remission of T2DM following surgical and nonsurgical treatments. In this 3-arm randomized clinical trial conducted at the University of Pittsburgh Medical Center from October 1, 2009, to June 26, 2014, in Pittsburgh, Pennsylvania, outcomes were assessed 3 years after treating 61 obese participants aged 25 to 55 years with T2DM. Analysis was conducted with an intent-to-treat population. Participants were randomized to either an intensive lifestyle weight loss intervention for 1 year followed by a low-level lifestyle intervention for 2 years or surgical treatments (Roux-en-Y gastric bypass [RYGB] or laparoscopic adjustable gastric banding [LAGB]) followed by low-level lifestyle intervention in years 2 and 3. Primary end points were partial and complete T2DM remission and secondary end points included diabetes medications and weight change. Body mass index (calculated as weight in kilograms divided by height in meters squared) was less than 35 for 26 participants (43%), 50 (82%) were women, and 13 (21%) were African American. Mean (SD) values were 100.5 (13.7) kg for weight, 47.3 (6.6) years for age, 7.8% (1.9%) for hemoglobin A1c level, and 171.3 (72.5) mg/dL for fasting plasma glucose level. Partial or complete T2DM remission was achieved by 40% (n = 8) of RYGB, 29% (n = 6) of LAGB, and no intensive lifestyle weight loss intervention participants (P = .004). The use of diabetes medications was reduced more in the surgical groups than the lifestyle intervention-alone group, with 65% of RYGB, 33% of LAGB, and none of the intensive lifestyle weight loss intervention participants going from using insulin or oral medication at baseline to no medication at year 3 (P lifestyle treatment at 5.7% (2.4%) (P lifestyle intervention resulted in more disease remission than did lifestyle intervention alone. clinicaltrials.gov Identifier: NCT

  7. Randomised clinical trial: conventional Lichtenstein vs. hernioplasty with self-adhesive mesh in bilateral inguinal hernia surgery.

    Science.gov (United States)

    Porrero, Jose L; Castillo, María J; Pérez-Zapata, Ana; Alonso, María T; Cano-Valderrama, Oscar; Quirós, Esther; Villar, Sol; Ramos, Beatriz; Sánchez-Cabezudo, Carlos; Bonachia, Oscar; Marcos, Alberto; Pérez, Brígido

    2015-10-01

    To compare the results of conventional Lichtenstein hernioplasty with polypropylene mesh (PLP) with a lightweight self-adhesive mesh (Parietene Progrip®; Covidien, Dublin, Ireland) (PPG) used in patients with bilateral inguinal hernia. Randomised clinical trial with 89 patients with a minimum follow-up of 1 year. Every patient had bilateral inguinal hernia and had both prostheses implanted randomly, one on each side. Early postoperative and chronic pain was evaluated using the visual analogue scale. Also recurrence rate and subjective evaluation of patients were analysed. Pain in the early postoperative period was inferior on the side where the self-adhesive mesh had been implanted (6.12 vs. 6.62, p=0.005 during the 1st postoperative day; 2.12 vs. 2.62, p=0.001 during the 7th postoperative day). Differences disappeared with the long-term evaluation (0.71 vs. 0.98, p=0.148 1 year after the surgery). The operative time was significantly shorter on the PPG mesh side (24.37 ± 5.1 in case of the PPG mesh and 29.66 ± 5.6 in case of the PLP mesh, p<0,001). Recurrence occurred in seven patients (7.8%), six of them (6.7%, CI 3.0-14.4) on the PPG mesh side and one (1.1%, CI 0.2-7.8) on the PLP side. These differences were not statistically significant (p=0.125) CONCLUSIONS: Although hernioplasty with self-adhesive mesh reduced early postoperative pain, this reduction was clinically irrelevant and it had no influence on chronic pain. There was a trend towards a higher recurrence rate when self-adhesive meshes were used, and although in this study differences were not statistically significant they should be confirmed in later studies using larger samples. Surgical procedures that do not need fixing sutures are promising, but further studies are needed before they become the gold standard of inguinal hernia repair.

  8. Comparison of the analgesic efficacy of oral ketorolac versus intramuscular tramadol after third molar surgery: A parallel, double-blind, randomized, placebo-controlled clinical trial

    Science.gov (United States)

    Isiordia-Espinoza, Mario-Alberto; Martinez-Rider, Ricardo; Perez-Urizar, Jose

    2016-01-01

    Background Preemptive analgesia is considered an alternative for treating the postsurgical pain of third molar removal. The aim of this study was to evaluate the preemptive analgesic efficacy of oral ketorolac versus intramuscular tramadol after a mandibular third molar surgery. Material and Methods A parallel, double-blind, randomized, placebo-controlled clinical trial was carried out. Thirty patients were randomized into two treatment groups using a series of random numbers: Group A, oral ketorolac 10 mg plus intramuscular placebo (1 mL saline solution); or Group B, oral placebo (similar tablet to oral ketorolac) plus intramuscular tramadol 50 mg diluted in 1 mL saline solution. These treatments were given 30 min before the surgery. We evaluated the time of first analgesic rescue medication, pain intensity, total analgesic consumption and adverse effects. Results Patients taking oral ketorolac had longer time of analgesic covering and less postoperative pain when compared with patients receiving intramuscular tramadol. Conclusions According to the VAS and AUC results, this study suggests that 10 mg of oral ketorolac had superior analgesic effect than 50 mg of tramadol when administered before a mandibular third molar surgery. Key words:Ketorolac, tramadol, third molar surgery, pain, preemptive analgesia. PMID:27475688

  9. A randomised controlled pilot trial to evaluate and optimize the use of anti-platelet agents in the perioperative management in patients undergoing general and abdominal surgery--the APAP trial (ISRCTN45810007).

    Science.gov (United States)

    Antolovic, D; Rakow, A; Contin, P; Ulrich, A; Rahbari, N N; Büchler, M W; Weitz, J; Koch, M

    2012-02-01

    Surgeons are increasingly confronted by patients on long-term low-dose acetylsalicylic acid (ASA). However, owing to a lack of evidence-based data, a widely accepted consensus on the perioperative management of these patients in the setting of non-cardiac surgery has not yet been reached. Primary objective was to evaluate the safety of continuous versus discontinuous use of ASA in the perioperative period in elective general or abdominal surgery. Fifty-two patients undergoing elective cholecystectomy, inguinal hernia repair or colonic/colorectal surgery were recruited to this pilot study. According to cardiological evaluation, non-high-risk patients who were on long-term treatment with low-dose ASA were eligible for inclusion. Patients were allocated randomly to continuous use of ASA or discontinuation of ASA intake for 5 days before until 5 days after surgery. The primary outcome was the incidence of major haemorrhagic and thromboembolic complications within 30 days after surgery. A total of 26 patients were allocated to each study group. One patient (3.8%) in the ASA continuation group required re-operation due to post-operative haemorrhage. In neither study group, further bleeding complications occurred. No clinically apparent thromboembolic events were reported in the ASA continuation and the ASA discontinuation group. Furthermore, there were no significant differences between both study groups in the secondary endpoints. Perioperative intake of ASA does not seem to influence the incidence of severe bleeding in non-high-risk patients undergoing elective general or abdominal surgery. Further, adequately powered trials are required to confirm the findings of this study.

  10. Prolonged conservative treatment or 'early' surgery in sciatica caused by a lumbar disc herniation: rationale and design of a randomized trial [ISRCT 26872154

    Directory of Open Access Journals (Sweden)

    Tans Joseph

    2005-02-01

    Full Text Available Abstract Background The design of a randomized multicenter trial is presented on the effectiveness of a prolonged conservative treatment strategy compared with surgery in patients with persisting intense sciatica (lumbosacral radicular syndrome. Methods/design Patients presenting themselves to their general practitioner with disabling sciatica lasting less than twelve weeks are referred to the neurology outpatient department of one of the participating hospitals. After confirmation of the diagnosis and surgical indication MRI scanning is performed. If a distinct disc herniation is discerned which in addition covers the clinically expected site the patient is eligible for randomization. Depending on the outcome of the randomization scheme the patient will either be submitted to prolonged conservative care or surgery. Surgery will be carried out according to the guidelines and between six and twelve weeks after onset of complaints. The experimental therapy consists of a prolonged conservative treatment under supervision of the general practitioner, which may be followed by surgical intervention in case of persisting or progressive disability. The main primary outcome measure is the disease specific disability of daily functioning. Other primary outcome measures are perceived recovery and intensity of legpain. Secondary outcome measures encompass severity of complaints, quality of life, medical consumption, absenteeism, costs and preference. The main research question will be answered at 12 months after randomization. The total follow-up period covers two years. Discussion Evidence is lacking concerning the optimal treatment of lumbar disc induced sciatica. This pragmatic randomized trial, focusses on the 'timing' of intervention, and will contribute to the decision of the general practictioner and neurologist, regarding referral of patients for surgery.

  11. Does point of care prothrombin time measurement reduce the transfusion of fresh frozen plasma in patients undergoing major surgery? The POC-OP randomized-controlled trial

    Directory of Open Access Journals (Sweden)

    Alberio Lorenzo

    2009-11-01

    Full Text Available Abstract Background Bleeding is a frequent complication during surgery. The intraoperative administration of blood products, including packed red blood cells, platelets and fresh frozen plasma (FFP, is often live saving. Complications of blood transfusions contribute considerably to perioperative costs and blood product resources are limited. Consequently, strategies to optimize the decision to transfuse are needed. Bleeding during surgery is a dynamic process and may result in major blood loss and coagulopathy due to dilution and consumption. The indication for transfusion should be based on reliable coagulation studies. While hemoglobin levels and platelet counts are available within 15 minutes, standard coagulation studies require one hour. Therefore, the decision to administer FFP has to be made in the absence of any data. Point of care testing of prothrombin time ensures that one major parameter of coagulation is available in the operation theatre within minutes. It is fast, easy to perform, inexpensive and may enable physicians to rationally determine the need for FFP. Methods/Design The objective of the POC-OP trial is to determine the effectiveness of point of care prothrombin time testing to reduce the administration of FFP. It is a patient and assessor blind, single center randomized controlled parallel group trial in 220 patients aged between 18 and 90 years undergoing major surgery (any type, except cardiac surgery and liver transplantation with an estimated blood loss during surgery exceeding 20% of the calculated total blood volume or a requirement of FFP according to the judgment of the physicians in charge. Patients are randomized to usual care plus point of care prothrombin time testing or usual care alone without point of care testing. The primary outcome is the relative risk to receive any FFP perioperatively. The inclusion of 110 patients per group will yield more than 80% power to detect a clinically relevant relative risk

  12. Moderate hypothermia and its effects in reducing the applied dose of anesthetics for patients with opium dependence in cardiac surgery: A randomized controlled trial

    Science.gov (United States)

    Taghadomi, Reza Jalaian; Golmakani, Ebrahim; Alizadeh, Kambiz; Mottahedi, Behrooz; Rahdari, Ali; Sheybani, Shima

    2016-01-01

    Background An increasing number of patients addicted to opium are experiencing awareness during coronary artery bypass surgery (CABG) as a result of tolerance to anesthetics. Objectives This research was primarily intended to determine the potential diminishing effects of moderate hypothermia on anesthetic dosage and recall of anesthesia during the procedure. Methods In this double-blind randomized controlled trial, a total of 80 CABG candidates with known addiction to opium were divided into two groups: one normothermic (N) and the other moderately hypothermic (H), both undergoing induction as well as close monitoring from September 2014 to January 2016. The candidates were initially set for a target bispectral index (BIS) score of between 40 and 60. As the score rose to 60, an additional dose of propofol was administered, alongside rise in blood pressure and tear-shedding. To enhance the accuracy of our evaluation of anesthetic depth, we also used two questionnaires to test candidates’ recall filled with the assistance of a colleague 24 hours following surgery. Independent-samples t-test and chi-square test were used by SPSS v 18 for data analysis. Results Eighty patients were studied in two groups of normothermic (N) (n = 40) and hypothermic (H) (n = 40). Given similar demographic data as well as the duration of surgery, we arrived at a propofol dose of 122.52±13.11 cc for normothermic patients and 101.28±14.06 cc for hypothermic subjects (p=0.001). As for fentanyl, the total required sum came up to 39.60±21.04 cc and 31.72±5.81 cc for the above-mentioned groups in order (p=0.025). Moreover, the post-operative interview showed that there was no report of a patient with memory recall following surgery. Conclusions Moderate hypothermia can substantially reduce the need for anesthetics in patients with addiction to opium when undergoing CABG surgery. Trial registration This study is registered in Iranian Registry of Clinical Trials with registration number of

  13. Patient participation in postoperative care activities in patients undergoing total knee replacement surgery: Multimedia Intervention for Managing patient Experience (MIME). Study protocol for a cluster randomised crossover trial.

    Science.gov (United States)

    McDonall, Jo; de Steiger, Richard; Reynolds, John; Redley, Bernice; Livingston, Patricia; Botti, Mari

    2016-07-18

    Patient participation is an important indicator of quality care. Currently, there is little evidence to support the belief that participation in care is possible for patients during the acute postoperative period. Previous work indicates that there is very little opportunity for patients to participate in care in the acute context. Patients require both capability, in terms of having the required knowledge and understanding of how they can be involved in their care, and the opportunity, facilitated by clinicians, to engage in their acute postoperative care. This cluster randomised crossover trial aims to test whether a multimedia intervention improves patient participation in the acute postoperative context, as determined by pain intensity and recovery outcomes. A total of 240 patients admitted for primary total knee replacement surgery will be invited to participate in a cluster randomised, crossover trial and concurrent process evaluation in at least two wards at a major non-profit private hospital in Melbourne, Australia. Patients admitted to the intervention ward will receive the multimedia intervention daily from Day 1 to Day 5 (or day of discharge, if prior). The intervention will be delivered by nurses via an iPad™, comprising information on the goals of care for each day following surgery. Patients admitted to the control ward will receive usual care as determined by care pathways currently in use across the organization. The primary endpoint is the "worst pain experienced in the past 24 h" on Day 3 following TKR surgery. Pain intensity will be measured using the numerical rating scale. Secondary outcomes are interference of pain on activities of daily living, length of stay in hospital, function and pain following TKR surgery, overall satisfaction with hospitalisation, postoperative complications and hospital readmission. The results of this study will contribute to our understanding of the effectiveness of interventions that provide knowledge and

  14. Effect of early postextubation high-flow nasal cannula vs conventional oxygen therapy on hypoxaemia in patients after major abdominal surgery: a French multicentre randomised controlled trial (OPERA).

    Science.gov (United States)

    Futier, Emmanuel; Paugam-Burtz, Catherine; Godet, Thomas; Khoy-Ear, Linda; Rozencwajg, Sacha; Delay, Jean-Marc; Verzilli, Daniel; Dupuis, Jeremie; Chanques, Gerald; Bazin, Jean-Etienne; Constantin, Jean-Michel; Pereira, Bruno; Jaber, Samir

    2016-12-01

    High-flow nasal cannula (HFNC) oxygen therapy is attracting increasing interest in acute medicine as an alternative to standard oxygen therapy; however, its use to prevent hypoxaemia after major abdominal surgery has not been evaluated. Our trial was designed to close this evidence gap. A multicentre randomised controlled trial was carried out at three university hospitals in France. Adult patients at moderate to high risk of postoperative pulmonary complications who had undergone major abdominal surgery using lung-protective ventilation were randomly assigned using a computer-generated sequence to receive either HFNC oxygen therapy or standard oxygen therapy (low-flow oxygen delivered via nasal prongs or facemask) directly after extubation. The primary endpoint was absolute risk reduction (ARR) for hypoxaemia at 1 h after extubation and after treatment discontinuation. Secondary outcomes included occurrence of postoperative pulmonary complications within 7 days after surgery, the duration of hospital stay, and in-hospital mortality. The analysis was performed on data from the modified intention-to-treat population. This trial was registered with ClinicalTrials.gov (NCT01887015). Between 6 November 2013 and 1 March 2015, 220 patients were randomly assigned to receive either HFNC (n = 108) or standard oxygen therapy (n = 112); all of these patients completed follow-up. The median duration of the allocated treatment was 16 h (interquartile range 14-18 h) with standard oxygen therapy and 15 h (interquartile range 12-18) with HFNC therapy. Twenty-three (21 %) of the 108 patients treated with HFNC 1 h after extubation and 29 (27 %) of the 108 patients after treatment discontinuation had postextubation hypoxaemia, compared with 27 (24 %) and 34 (30 %) of the 112 patients treated with standard oxygen (ARR 4, 95 % CI -8 to 15 %; p = 0.57; adjusted relative risk [RR] 0.87, 95 % CI 0.53-1.43; p = 0.58). Over the 7-day postoperative follow-up period

  15. One-year outcomes of coronary artery bypass graft surgery versus percutaneous coronary intervention with multiple stenting for multisystem disease: a meta-analysis of individual patient data from randomized clinical trials.

    Science.gov (United States)

    Mercado, Nestor; Wijns, William; Serruys, Patrick W; Sigwart, Ulrich; Flather, Marcus D; Stables, Rodney H; O'Neill, William W; Rodriguez, Alfredo; Lemos, Pedro A; Hueb, Whady A; Gersh, Bernard J; Booth, Jean; Boersma, Eric

    2005-08-01

    We aimed to provide a quantitative analysis of the 1-year clinical outcomes of patients with multisystem coronary artery disease who were included in recent randomized trials of percutaneous coronary intervention with multiple stenting versus coronary artery bypass graft surgery. An individual patient database was composed of 4 trials (Arterial Revascularization Therapies Study, Stent or Surgery Trial, Argentine Randomized Trial of Percutaneous Transluminal Coronary Angioplasty Versus Coronary Artery Bypass Surgery in Multivessel Disease 2, and Medicine, Angioplasty, or Surgery Study 2) that compared percutaneous coronary intervention with multiple stenting (N = 1518) versus coronary artery bypass graft surgery (N = 1533). The primary clinical end point of this study was the combined incidence of death, myocardial infarction, and stroke at 1 year after randomization. Secondary combined end points included the incidence of repeat revascularization at 1 year. All analyses were based on the intention-to-treat principle. After 1 year of follow-up, 8.7% of patients randomized to percutaneous coronary intervention with multiple stenting versus 9.1% of patients randomized to coronary artery bypass graft surgery reached the primary clinical end point (hazard ratio 0.95 and 95% confidence interval 0.74-1.2). Repeat revascularization procedures occurred more frequently in patients allocated to percutaneous coronary intervention with multiple stenting compared with coronary artery bypass graft surgery (18% vs 4.4%; hazard ratio 4.4 and 95% confidence interval 3.3-5.9). The percentage of patients who were free from angina was slightly lower after percutaneous coronary intervention with multiple stenting than after coronary artery bypass graft surgery (77% vs 82%; P = .002). One year after the initial procedure, percutaneous coronary intervention with multiple stenting and coronary artery bypass graft surgery provided a similar degree of protection against death, myocardial

  16. EFFICACY OF PERIBULBAR ANAESTHESIA VERSUS TOPICAL WITH INTRACAMERAL LIGNOCAINE ANAESTHESIA IN MANUAL SMALL INCISION CATARACT SURGERY: A 1-YEAR RANDOMISED CONTROLLED TRIAL

    Directory of Open Access Journals (Sweden)

    Samyakta Ashok

    2016-05-01

    Full Text Available AIMS To study the efficacy of peribulbar anaesthesia versus topical with intracameral anaesthesia in manual small incision cataract surgery and to compare surgeon’s experience as well as surgical outcome under both techniques. METHODS In a randomised controlled trial conducted at KLES Dr. Prabhakar Kore Hospital and MRC Belgaum from January 2012 to December 2012; 120 patients who met inclusion criteria were randomised into peribulbar group or topical with intracameral group (60 in each. Parameters studied in both the groups were akinesia, analgesia and complications occurring during administration of anaesthesia; surgeon’s experience was evaluated in terms of patient’s cooperation, difficulty while doing surgery due to ocular movements, anterior chamber stability, time taken to complete surgery; surgical outcome was studied with regards to any complications during surgery, best corrected visual acuity at 6 weeks. RESULTS Lid akinesia (96.66% and globe akinesia (100% was seen only in peribulbar anaesthesia which obviously lacked in topical anaesthesia which was both statistically and clinically significant. Patients in topical group mainly had pain during scleral incision (18.33%, sclera-corneal tunnelling (10%, cortical wash (13.33% which were statistically and clinically significant compared to peribulbar group. Button holing (3.33% and posterior capsular rent (3.33% occurred in topical group due to unexpected eye movement which was clinically significant. Pain scale between both the groups showed no difference during surgery. Most of patients had mild pain 61.66% in peribulbar group and 51.66% patients in topical group. Pain scale was significant in peribulbar group after 4 hrs. of surgery (p<0.001. Patient cooperation and lesser ocular movements during surgery was better in peribulbar group and also clinically significant. Anterior chamber stability was similar in both the groups. Unwanted ocular movements and lid squeezing were common

  17. Protocol for a multicentre, parallel-arm, 12-month, randomised, controlled trial of arthroscopic surgery versus conservative care for femoroacetabular impingement syndrome (FASHIoN).

    Science.gov (United States)

    Griffin, D R; Dickenson, E J; Wall, P D H; Donovan, J L; Foster, N E; Hutchinson, C E; Parsons, N; Petrou, S; Realpe, A; Achten, J; Achana, F; Adams, A; Costa, M L; Griffin, J; Hobson, R; Smith, J

    2016-08-31

    Femoroacetabular impingement (FAI) syndrome is a recognised cause of young adult hip pain. There has been a large increase in the number of patients undergoing arthroscopic surgery for FAI; however, a recent Cochrane review highlighted that there are no randomised controlled trials (RCTs) evaluating treatment effectiveness. We aim to compare the clinical and cost-effectiveness of arthroscopic surgery versus best conservative care for patients with FAI syndrome. We will conduct a multicentre, pragmatic, assessor-blinded, two parallel arm, RCT comparing arthroscopic surgery to physiotherapy-led best conservative care. 24 hospitals treating NHS patients will recruit 344 patients over a 26-month recruitment period. Symptomatic adults with radiographic signs of FAI morphology who are considered suitable for arthroscopic surgery by their surgeon will be eligible. Patients will be excluded if they have radiographic evidence of osteoarthritis, previous significant hip pathology or previous shape changing surgery. Participants will be allocated in a ratio of 1:1 to receive arthroscopic surgery or conservative care. Recruitment will be monitored and supported by qualitative intervention to optimise informed consent and recruitment. The primary outcome will be pain and function assessed by the international hip outcome tool 33 (iHOT-33) measured 1-year following randomisation. Secondary outcomes include general health (short form 12), quality of life (EQ5D-5L) and patient satisfaction. The primary analysis will compare change in pain and function (iHOT-33) at 12 months between the treatment groups, on an intention-to-treat basis, presented as the mean difference between the trial groups with 95% CIs. The study is funded by the Health Technology Assessment Programme (13/103/02). Ethical approval is granted by the Edgbaston Research Ethics committee (14/WM/0124). The results will be disseminated through open access peer-reviewed publications, including Health Technology

  18. Prospective Randomized Controlled Trial to Analyze the Effects of Intermittent Pneumatic Compression on Edema Following Autologous Femoropopliteal Bypass Surgery

    NARCIS (Netherlands)

    A. te Slaa (Alexander); D.E.J.G.J. Dolmans (Dennis); G.H. Ho (Gwan); P.G.H. Mulder (Paul); J.C.H. van der Waal (Jan); L. van der Laan (Lyckle)

    2011-01-01

    textabstractBackground: Patients who undergo autologous femoropopliteal bypass surgery develop postoperative edema in the revascularized leg. The effects of intermittent pneumatic compression (IPC) to treat and to prevent postreconstructive edema were examined in this study. Methods: In a prospectiv

  19. Comparative study between ultrasound guided tap block and paravertebral block in upper abdominal surgeries. Randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Ruqaya M. Elsayed

    2017-01-01

    Conclusion: We concluded that ultrasound guided transversus abdominis plane block and thoracic paravertebral block were safe and effective anesthetic technique for upper abdominal surgery with longer and potent postoperative analgesia in thoracic paravertebral block than transversus abdominis block.

  20. The impact of routine open nonsuction drainage on fluid accumulation after thyroid surgery: a prospective randomised clinical trial.

    LENUS (Irish Health Repository)

    Neary, Peter M

    2012-01-01

    Thyroid drains following thyroid surgery are routinely used despite minimal supportive evidence. Our aim in this study is to determine the impact of routine open drainage of the thyroid bed postoperatively on ultrasound-determined fluid accumulation at 24 hours.

  1. The effect of sub-Tenon's bupivacaine on oculocardiac reflex during strabismus surgery and postoperative pain: A randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Mohammad Reza Talebnejad

    2017-01-01

    Conclusions: Sub-Tenon injection of bupivacaine as a local anesthetic can significantly prevent OCR and decrease the severity of bradycardia. This technique can also diminish postoperative pain in patients who underwent strabismus surgery.

  2. Microvascular Outcomes after Metabolic Surgery (MOMS) in patients with type 2 diabetes mellitus and class I obesity: rationale and design for a randomised controlled trial

    Science.gov (United States)

    Cohen, Ricardo Vitor; Pereira, Tiago Veiga; Aboud, Cristina Mamédio; Caravatto, Pedro Paulo de Paris; Petry, Tarissa Beatrice Zanata; Correa, José Luis Lopes; Schiavon, Carlos Aurélio; Correa, Mariangela; Pompílio, Carlos Eduardo; Pechy, Fernando Nogueira Quirino; le Roux, Carel

    2017-01-01

    Introduction There are several randomised controlled trials (RCTs) that have already shown that metabolic/bariatric surgery achieves short-term and long-term glycaemic control while there are no level 1A of evidence data regarding the effects of surgery on the microvascular complications of type 2 diabetes mellitus (T2DM). Purpose The aim of this trial is to investigate the long-term efficacy and safety of the Roux-en-Y gastric bypass (RYGB) plus the best medical treatment (BMT) versus the BMT alone to improve microvascular outcomes in patients with T2DM with a body mass index (BMI) of 30–34.9 kg/m2. Methods and analysis This study design includes a unicentric randomised unblinded controlled trial. 100 patients (BMI from 30 to 34.9 kg/m2) will be randomly allocated to receive either RYGB plus BMT or BMT alone. The primary outcome is the change in the urine albumin-to-creatinine ratio (uACR) captured as the proportion of patients who achieved nephropathy remission (uACR<30 mg/g of albumin/mg of creatinine) in an isolated urine sample over 12, 24 and 60 months. Ethics and dissemination The study was approved by the local Institutional Review Board. This study represents the first RCT comparing RYGB plus BMT versus BMT alone for patients with T2DM with a BMI below 35 kg/m2. Trial registration number NCT01821508; Pre-results. PMID:28077412

  3. Back school or brain school for patients undergoing surgery for lumbar radiculopathy? Protocol for a randomised, controlled trial

    Directory of Open Access Journals (Sweden)

    Kelly Ickmans

    2016-07-01

    Discussion: This study will determine whether pain neuroscience education is worthwhile for patients undergoing surgery for lumbar radiculopathy. It is expected that participants who receive perioperative pain neuroscience education will report less pain and have improved endogenous pain modulation, lower postoperative healthcare costs and improved surgical experience. Lower pain and improved endogenous pain modulation after surgery may reduce the risk of developing postoperative chronic pain.

  4. Effect of melatonin on depressive symptoms and anxiety in patients undergoing breast cancer surgery: a randomized, double-blind, placebo-controlled trial.

    Science.gov (United States)

    Hansen, Melissa V; Andersen, Lærke T; Madsen, Michael T; Hageman, Ida; Rasmussen, Lars S; Bokmand, Susanne; Rosenberg, Jacob; Gögenur, Ismail

    2014-06-01

    Depression, anxiety and sleep disturbances are known problems in patients with breast cancer. The effect of melatonin as an antidepressant in humans with cancer has not been investigated. We investigated whether melatonin could lower the risk of depressive symptoms in women with breast cancer in a three-month period after surgery and assessed the effect of melatonin on subjective parameters: anxiety, sleep, general well-being, fatigue, pain and sleepiness. Randomized, double-blind, placebo-controlled trial undertaken from July 2011 to December 2012 at a department of breast surgery in Copenhagen, Denmark. Women, 30-75 years, undergoing surgery for breast cancer and without signs of depression on Major Depression Inventory (MDI) were included 1 week before surgery and received 6 mg oral melatonin or placebo for 3 months. The primary outcome was the incidence of depressive symptoms measured by MDI. The secondary outcomes were area under the curve (AUC) for the subjective parameters. 54 patients were randomized to melatonin (n = 28) or placebo (n = 26) and 11 withdrew from the study (10 placebo group and 1 melatonin group, P = 0.002). The risk of developing depressive symptoms was significantly lower with melatonin than with placebo (3 [11 %] of 27 vs. 9 [45 %] of 20; relative risk 0.25 [95 % CI 0.077-0.80]), giving a NNT of 3.0 [95 % CI 1.7-11.0]. No significant differences were found between AUC for the subjective parameters. No differences in side effects were found (P = 0.78). Melatonin significantly reduced the risk of depressive symptoms in women with breast cancer during a three-month period after surgery.

  5. A randomized controlled trial of subcutaneous closed-suction Blake drains for the prevention of incisional surgical site infection after colorectal surgery.

    Science.gov (United States)

    Watanabe, Jun; Ota, Mitsuyoshi; Kawamoto, Makoto; Akikazu, Yago; Suwa, Yusuke; Suwa, Hirokazu; Momiyama, Masashi; Ishibe, Atsushi; Watanabe, Kazuteru; Masui, Hidenobu; Nagahori, Kaoru

    2017-03-01

    The effects of subcutaneous closed-suction Blake drain for preventing incisional surgical site infections (SSIs) after colorectal surgery have never been evaluated in a randomized controlled trial (RCT). Thus, we performed a RCT to evaluate the clinical benefits of using a subcutaneous closed-suction Blake drain in patients undergoing colorectal surgery. Consecutive patients who underwent colorectal surgery were enrolled in this study. Patients were randomly assigned to the subcutaneous closed-suction drainage arm or the control (no subcutaneous drainage) arm. The primary endpoint was incidence rate of incisional SSIs. And, we performed logistic regression analysis to detect predictive factors for incisional SSIs after colorectal surgery. From November 2012 to September 2014, a total of 240 patients were enrolled in this study. One-hundred-seventeen patients who were treated by the control arm and 112 patients by the subcutaneous drainage arm were judged to be eligible for analysis. The incidence of incisional SSIs rate was 8.7 % in the overall patients. The incidence of incisional SSIs rate was 12.8 % in the control arm and 4.5 % in the subcutaneous drainage arm. There was significantly reduction of the incidence in the subcutaneous drainage arm than in the control arm (p = 0.025). Logistic regression analysis demonstrated that thickness of subcutaneous fat >3.0 cm, forced expiratory volume in 1 s as percent of forced vital capacity (FEV1.0 %) >70 %, and subcutaneous drain were independent predictors of postoperative incisional SSIs (p = 0.008, p = 0.004, and p = 0.017, respectively). The results of our RCT suggest that a subcutaneous Blake drain is beneficial for preventing incisional SSIs in patients undergoing colorectal surgery.

  6. AVHRR GAC SST Reanalysis Version 1 (RAN1

    Directory of Open Access Journals (Sweden)

    Alexander Ignatov

    2016-04-01

    Full Text Available In response to its users’ needs, the National Oceanic and Atmospheric Administration (NOAA initiated reanalysis (RAN of the Advanced Very High Resolution Radiometer (AVHRR Global Area Coverage (GAC; 4 km sea surface temperature (SST data employing its Advanced Clear Sky Processor for Oceans (ACSPO retrieval system. Initially, AVHRR/3 data from five NOAA and two Metop satellites from 2002 to 2015 have been reprocessed. The derived SSTs have been matched up with two reference SSTs—the quality controlled in situ SSTs from the NOAA in situ Quality Monitor (iQuam and the Canadian Meteorological Centre (CMC L4 SST analysis—and analyzed in the NOAA SST Quality Monitor (SQUAM online system. The corresponding clear-sky ocean brightness temperatures (BT in AVHRR bands 3b, 4 and 5 (centered at 3.7, 11, and 12 µm, respectively have been compared with the Community Radiative Transfer Model simulations in another NOAA online system, Monitoring of Infrared Clear-sky Radiances over Ocean for SST (MICROS. For some AVHRRs, the time series of “AVHRR minus reference” SSTs and “observed minus model” BTs are unstable and inconsistent, with artifacts in the SSTs and BTs strongly correlated. In the official “Reanalysis version 1” (RAN1, data from only five platforms—two midmorning (NOAA-17 and Metop-A and three afternoon (NOAA-16, -18 and -19—were included during the most stable periods of their operations. The stability of the SST time series was further improved using variable regression SST coefficients, similarly to how it was done in the NOAA/NASA Pathfinder version 5.2 (PFV5.2 dataset. For data assimilation applications, especially those blending satellite and in situ SSTs, we recommend bias-correcting the RAN1 SSTs using the newly developed sensor-specific error statistics (SSES, which are reported in the product files. Relative performance of RAN1 and PFV5.2 SSTs is discussed. Work is underway to improve the calibration of AVHRR/3s and

  7. Prevention of Bleeding in Orthognathic Surgery--A Systematic Review and Meta-Analysis of Randomized Controlled Trials

    DEFF Research Database (Denmark)

    Olsen, Jesper J; Skov, Jane; Ingerslev, Janne

    2016-01-01

    and operating time. This review is registered at PROSPERO (CRD42014014840). RESULTS: Eleven trials were included for review. The individual trials demonstrated the effects on IOB from hypotensive anesthetic regimens, the use of aprotinin, and the herbal medicine Yunnan Baiyao. Six studies of tranexamic acid...

  8. Cognitive consequences of early versus late antiepileptic drug withdrawal after pediatric epilepsy surgery, the TimeToStop (TTS) trial : study protocol for a randomized controlled trial

    NARCIS (Netherlands)

    Boshuisen, Kim; Lamberink, Herm J; van Schooneveld, Monique MJ; Cross, J Helen; Arzimanoglou, Alexis; van der Tweel, Ingeborg; Geleijns, Karin; Uiterwaal, Cuno Spm; Braun, Kees PJ

    2015-01-01

    BACKGROUND: The goals of intentional curative pediatric epilepsy surgery are to achieve seizure-freedom and antiepileptic drug (AED) freedom. Retrospective cohort studies have indicated that early postoperative AED withdrawal unmasks incomplete surgical success and AED dependency sooner, but not at

  9. High frequency oscillations in the intra-operative ECoG to guide epilepsy surgery ("The HFO Trial") : study protocol for a randomized controlled trial

    NARCIS (Netherlands)

    van 't Klooster, Maryse A; Leijten, Frans S S; Huiskamp, Geertjan; Ronner, Hanneke E; Baayen, Johannes C; van Rijen, Peter C; Eijkemans, Martinus J C; Braun, Kees P J; Zijlmans, Maeike

    2015-01-01

    BACKGROUND: Intra-operative electrocorticography, based on interictal spikes and spike patterns, is performed to optimize delineation of the epileptogenic tissue during epilepsy surgery. High frequency oscillations (HFOs, 80-500 Hz) have been identified as more precise biomarkers for epileptogenic

  10. High frequency oscillations in the intra-operative ECoG to guide epilepsy surgery ("The HFO Trial") : study protocol for a randomized controlled trial

    NARCIS (Netherlands)

    van 't Klooster, Maryse A; Leijten, Frans S S; Huiskamp, Geertjan; Ronner, Hanneke E; Baayen, Johannes C; van Rijen, Peter C; Eijkemans, Martinus J C; Braun, Kees P J; Zijlmans, Maeike

    2015-01-01

    BACKGROUND: Intra-operative electrocorticography, based on interictal spikes and spike patterns, is performed to optimize delineation of the epileptogenic tissue during epilepsy surgery. High frequency oscillations (HFOs, 80-500 Hz) have been identified as more precise biomarkers for epileptogenic t

  11. Patient-reported benefit of ReSTOR® multi-focal intraocular lenses after cataract surgery: Results of Principal Component Analysis on clinical trial data

    Directory of Open Access Journals (Sweden)

    Viala Muriel

    2008-01-01

    Full Text Available Abstract Background Restoration of functional distance and near vision independently of additional correction remains a goal for cataract surgery. ReSTOR®, a new multi-focal intraocular lens (IOL addresses this issue with an improvement in both distance and near vision, often without need for glasses. This analysis attempted to discuss the patient-reported benefit of ReSTOR® using a full but organised representation of data. Methods Two non-randomised, open-label clinical trials conducted in Europe and the United-States were conducted to compare the efficacy of ReSTOR® to AcrySof® mono-focal IOLs. A total of 710 patients in need of bilateral cataract extraction were included in the pooled study. The TyPE, a patient questionnaire, was fully completed by 672 of them before and after each eye surgery. The TyPE, composed of 67 items measuring overall visual functioning in both conditions (with and without wearing glasses, evaluates limitations, troubles and satisfaction in distance and near vision. A principal component analysis (PCA of the TyPE questionnaire was performed on pooled data from baseline and post-surgery observations in order to fully represent the change in the TyPE data over time. ReSTOR® and mono-focal groups were used as illustrative variables. The coordinates of the first 2 factors were compared between visits and between IOLs (ReSTOR® vs. mono-focal, using paired t-tests and t-tests, respectively. Results The first factor of the PCA explained 55% of the variance and represented 'visual functioning and patient satisfaction'. The second factor explained 6% of the variance and was interpreted as 'independence from glasses'. An overall difference in factorial coordinates in both factors was seen between baseline and the first eye surgery, and between the first and the second eye surgery. No difference between ReSTOR® and mono-focal IOL groups was observed at baseline. After surgery, ReSTOR® treated-patients had higher

  12. SST data assimilation experiments using an adaptive variational method

    Institute of Scientific and Technical Information of China (English)

    2002-01-01

    An adaptive variational data assimilation method is proposed by Zhu and Kamachi[1]. This method can adaptively adjust the model state without knowing explicitly the model error covariance matrix. The method enables very flexible ways to form some reduced order problems. A proper reduced order problem not only reduces computational burden but also leads to corrections that are more consistent with the model dynamics that trends to produce better forecast. These features make the adaptive variational method a good candidate for SST data assimilation because the model error of an ocean model is usually difficult to estimate. We applied this method to an SST data assimilation problem using the LOTUS data sets and an ocean mixed layer model (Mellor-Yamada level 2.5). Results of assimilation experiments showed good skill of improvement subsurface temperatures by assimilating surface observation alone.

  13. Climatic variability between SST and river discharge at Amazon region

    Science.gov (United States)

    Silva, M. E.; Silva, E. R. L.

    2012-04-01

    Climatic variability, related both to precipitation and river discharge, has been associated to ocean variability. Authors commonly relate Pacific sea surface temperature (SST) variation to South America (SA) precipitation. Zonal displacement of Walker cell, with intensified subsidence over northern portion of SA, Subtropical Jet strengthening/weakening over extratropical latitudes of SA are, respectively, dynamical reasons scientifically accepted for increasing and depletion of precipitation at the respective areas. Many studies point out the influence of tropical Atlantic SST anomalies in relation to precipitation/river discharge variability over northeast of Brazil. Aliseos variability at tropical Atlantic is also a physic process that contributes to explain precipitation and river flow variability over SA, mainly over the north portion. In this study, we aim to investigate the temporal correlation between SST, mainly from Pacific and Atlantic oceans, and rivers discharge at the Amazon region. Ji-Parana, Madeira and Tapajós river discharge in monthly and annual scale, between 1968 and 2008, were the time series selected to reach the purpose. Time series for river discharge were obtained from Agência Nacional de Águas (ANA, in Portuguese) and, SST data were obtained from CDC/NOAA. Before linear correlation computations between river discharge and SST have been made, seasonal cycle and linear tendency were removed from all original time series. Areas better correlated to river discharge at Amazon region show oceanic patterns apparently associated to PDO (Pacific Decadal Oscillation) and ENSO (El Niño-South Oscillation) variability, with absolute values greater than 0.3 and reaching 0.5 or 0.6. The spatial pattern observed at Pacific basin is similar to that showed by the first mode of PCA (Principal Component Analysis), such seen in many studies (the "horse shoe" pattern). In general, negative correlation values appear far more to the west of Pacific basin

  14. Tokamak Plasmas : Plasma position control in SST1 tokamak

    Indian Academy of Sciences (India)

    I Bandyopadhyay; S P Deshpande

    2000-11-01

    For long duration steady state operation of SST1, it would be very crucial to maintain the plasma radial and vertical positions accurately. For designing the position controller in SST1 we have adopted the simple linear RZIP control model. While the vertical position instability is slowed down by a set of passive stabilizers placed closed to the plasma edge, a pair of in-vessel active feedback coils can adequately control vertical position perturbations of up to 1 cm. The shifts in radial position arising due to minor disruptions would be controlled by a separate pair of poloidal field (PF) coils also placed inside the vessel, however the controller would ignore fast but insignificant changes in radius arising due to edge localised modes. The parameters of both vertical and radial position control coils and their power supplies are determined based on the RZIP simulations.

  15. Ketamine or atropine: which one better prevents oculocardiac reflex during eye surgery? A prospective randomized clinical trial.

    Directory of Open Access Journals (Sweden)

    Ebrahim Espahbodi

    2015-03-01

    Full Text Available Profound bradycardia during eye surgery is a potentially serious event. In clinical practice oculo-cardiac reflex (OCR is most often encountered during squint surgery. The objective of this study was to assess the occurrence of OCR and prove the effect of ketamine as an induction drug and anticholinergic premedication (atropine to prevent OCR. This study comprised 90 patients (aged 4-10 years operated for squint surgery under general anesthesia. Patients were divided into three groups. Using block randomization, each patient enrolled in one of the three groups based on organized random table prepared by statistician. Group K received ketamine as an induction drug, Group A was premedicated with intravenous injection of atropine and Group C did not receive any premedication. Patients were monitored during operation for any bradycardia or dysrhythmias. The observed data showed occurrence of 63% OCR in Group C as compared to 43% in group A and only 20% in Group K. Current study showed that induction with ketamine in the patients of squint surgery under general anesthesia definitely obtunds OCR and prevents any untoward effects of dysrhythmias during eye surgery.

  16. Exploring outcomes of a nurse practitioner-managed cardiac surgery follow-up intervention: a randomized trial.

    Science.gov (United States)

    Sawatzky, Jo-Ann V; Christie, Sandra; Singal, Rohit K

    2013-09-01

    To describe and compare the outcomes of a nurse practitioner-managed cardiac surgery follow-up model of care with the standard model of primary care provider follow-up for coronary artery bypass graft surgery patients. Advances in healthcare have had a favourable impact on length of stay following cardiac surgery; however, the shorter length of stay has not been accompanied by enhanced support to bridge the gap between acute care and the community setting. Prospective (2009-2010) randomized study. Elective cardiac surgery patients (N = 200) were randomly assigned to the nurse practitioner follow-up intervention or to the standard model of follow-up care. The main outcomes were health-related quality of life, patient satisfaction, symptoms, and health resource use. Outcome data were elicited via telephone interviews at 2 and 6 weeks postdischarge. Baseline differences between the two groups were non-significant; however, at 2 weeks postdischarge, the intervention group reported significantly fewer symptoms and higher physical functioning status. At 2 and 6 weeks postdischarge, the intervention group was significantly more satisfied with the amount of help, as well as the quality of the services received. Differences in healthcare resource use were not statistically significant. This evidence suggests that the nurse practitioner-managed model of follow-up care effectively bridges the gap between institutional and primary care in the cardiac surgery population. © 2013 Blackwell Publishing Ltd.

  17. Intensive perioperative glucose control does not improve outcomes of patients submitted to open-heart surgery: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Raquel Pei Chen Chan

    2009-01-01

    Full Text Available BACKGROUND: The objective of this study was to investigate the relationship between different target levels of glucose and the clinical outcomes of patients undergoing cardiac surgery with cardiopulmonary bypass. METHODS: We designed a prospective study in a university hospital where 109 consecutive patients were enrolled during a six-month period. All patients were scheduled for open-heart surgery requiring cardiopulmonary bypass. Patients were randomly allocated into two groups. One group consisted of 55 patients and had a target glucose level of 80-130 mg/dl, while the other contained 54 patients and had a target glucose level of 160-200 mg/dl. These parameters were controlled during surgery and for 36 hours after surgery in the intensive care unit. Primary outcomes were clinical outcomes, including time of mechanical ventilation, length of stay in the intensive care unit, infection, hypoglycemia, renal or neurological dysfunction, blood transfusion and length of stay in the hospital. The secondary outcome was a combined end-point (mortality at 30 days, infection or length of stay in the intensive care unit of more than 3 days. A p-value of 0.05. CONCLUSIONS: In 109 patients undergoing cardiac surgery with cardiopulmonary bypass, both protocols of glycemic control in an intraoperative setting and in the intensive care unit were found to be safe, easily achieved and not to differentially affect clinical outcomes.

  18. MIL-STD-1553B system design in SST application

    Science.gov (United States)

    Xiong, Ying

    2001-06-01

    In this paper, we will first introduce what is MIL-STD-1553B and why we choose it. Then we will analyze the characteristics and the reliability of this standard. When we use this protocol to implement our SDU system in the SST, we also need to describe the whole system in which the 1553 standard is used. Finally, we will put our most attention on the system design, including hardware interconnection and software program.

  19. Using SST, PDO and SOI for Streamflow Reconstruction

    Science.gov (United States)

    Bukhary, S. S.; Kalra, A.; Ahmad, S.

    2015-12-01

    Recurring droughts in southwestern U.S. particularly California, have strained the existing water reserves of the region. Frequency, severity and duration of these recurring drought events may not be captured by the available instrumental records. Thus streamflow reconstruction becomes imperative to identify the historic hydroclimatic extremes of a region and assists in developing better water management strategies, vital for sustainability of water reserves. Tree ring chronologies (TRC) are conventionally used to reconstruct streamflows, since tree rings are representative of climatic information. Studies have shown that sea surface temperature (SST) and climate indices of southern oscillation index (SOI) and pacific decadal oscillation (PDO) influence U.S. streamflow volumes. The purpose of this study was to improve the traditional reconstruction methodology by incorporating the oceanic-atmospheric variables of PDO, SOI, and Pacific Ocean SST, alongwith TRC as predictors in a step-wise linear regression model. The methodology of singular value decomposition was used to identify teleconnected regions of streamflow and SST. The approach was tested on eleven gage stations in Sacramento River Basin (SRB) and San Joaquin River Basin (JRB). The reconstructions were successfully generated from 1800-1980, having an overlap period of 1932-1980. Improved results were exhibited when using the predictor variable of SST along with TRC (calibration r2=0.6-0.91) compared to when using TRC in combination with SOI and PDO (calibration r2=0.51-0.78) or when using TRC by itself (calibration r2=0.51-0.86). For future work, this approach can be replicated for other watersheds by using the oceanic-atmospheric climate variables influencing that region.

  20. 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.

    Science.gov (United States)

    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.

  1. Antibiotic prophylaxis in third molar surgery: A randomized double-blind placebo-controlled clinical trial using split-mouth technique.

    Science.gov (United States)

    Siddiqi, A; Morkel, J A; Zafar, S

    2010-02-01

    The use of prophylactic antibiotics to reduce postoperative complications in third molar surgery remains controversial. The study was a prospective, randomized, double blind, placebo-controlled clinical trial. 100 patients were randomly assigned to two groups. Each patient acted as their own control using the split-mouth technique. Two unilateral impacted third molars were removed under antibiotic cover and the other two were removed without antibiotic cover. The first group received antibiotics on the first surgical visit. On the second surgical visit (after 3 weeks), placebo capsules were given or vice versa. The second group received antibiotics with continued therapy for 2 days on the first surgical visit and on the second surgical visit (after 3 weeks) placebo capsules were given or vice versa. Pain, swelling, infection, trismus and temperature were recorded on days 3, 7 and 14 after surgery. Of 380 impactions, 6 sockets (2%) became infected. There was no statistically significant difference in the infection rate, pain, swelling, trismus, and temperature between the two groups (p>0.05). Results of the study showed that prophylactic antibiotics did not have a statistically significant effect on postoperative infections in third molar surgery and should not be routinely administered when third molars are removed in non-immunocompromised patients.

  2. Comparing the effect of a desensitizing material and a self-etch adhesive on dentin sensitivity after periodontal surgery: a randomized clinical trial.

    Science.gov (United States)

    Hajizadeh, Hila; Nemati-Karimooy, Atefeh; Majidinia, Sara; Moeintaghavi, Amir; Ghavamnasiri, Marjaneh

    2017-08-01

    This double-blind randomized placebo-controlled clinical trial evaluated the ability of a desensitizing agent and a self-etch adhesive on cervical dentin sensitivity (CDS) after periodontal surgery. Ninety hypersensitive teeth of 13 subjects were included in the study. After periodontal surgery, the teeth of each posterior sextant treated with one of the following materials: G1: Clearfil S(3) Bond (Kuraray Dental), G2: Gluma Desensitizer (Heraeus Kulzer), and G3: placebo (water). The sensitivity was assessed using evaporative stimuli before treatment (baseline, T0), 1 day after treatment (T1), after 1 week (T2), and after 1 month (T3) according to visual analog scale (VAS). Following the treatment, all the 3 groups showed significant reduction of CDS in T1 compared to T0. Reduction of CDS between T1 and T2 was observed only in G1 but there was no significant difference between T2 and T3 in this group. Although we observed a significant difference in T3 compared to T1 and T2 in G2 and G3, comparison of treatment groups in each assessment time showed a significant difference only in T3. According to paired comparison, this was due to the difference between G2 and G3. Dentin sensitivity following periodontal surgery will decrease spontaneously over time, but treating the sensitive teeth with Gluma Desensitizer and Clearfil S(3) Bond can have some benefits.

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

    Science.gov (United States)

    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.

  4. A randomized controlled trial of the effectiveness of an educational intervention on outcomes of parents and their children undergoing inpatient elective surgery: study protocol.

    Science.gov (United States)

    He, Hong-Gu; Zhu, Lixia; Chan, Wai-Chi Sally; Xiao, Chunxiang; Klainin-Yobas, Piyanee; Wang, Wenru; Cheng, Kin Fong Karis; Luo, Nan

    2015-03-01

    To report a study protocol that tests the effectiveness of an educational intervention on outcomes of parents and their children who undergo inpatient elective surgery. Inadequate children's postoperative pain management remains a global problem. Parents are required to be involved in their child's pain assessment and management, yet they often lack relevant knowledge and skills. Education is an effective strategy for enhancing a person's knowledge, attitudes and behaviour. However, few studies have examined its effectiveness in parents and their children undergoing inpatient elective surgery. Randomized controlled trial and embedded qualitative process evaluation. One hundred and sixty-two pairs of participants (each comprised of one parent and his/her child undergoing inpatient elective surgery) will be recruited (protocol approved in January 2013). Participants will be randomized to either a Control group (routine care), an Intervention group 1 (routine care and an educational intervention with face-to-face teaching), or an Intervention group 2 (routine care and an educational intervention without face-to-face teaching). Outcome measures will include parents' knowledge, attitude and behaviour related to postoperative pain management; their child's postoperative pain; and parents' satisfaction with their child's pain management at baseline and around 6, 12 and 24 hours after the operation. A standardized educational intervention protocol and detailed study procedure have been developed in this study to improve parents' knowledge, attitude and behaviour related to postoperative pain management and reduce their child's postoperative pain. © 2014 John Wiley & Sons Ltd.

  5. Design and rationale of the PRAGUE-12 trial: a large, prospective, randomized, multicenter trial that compares cardiac surgery with left atrial surgical ablation with cardiac surgery without ablation in patients with coronary and/or valvular heart disease plus atrial fibrillation.

    Science.gov (United States)

    Straka, Zbyněk; Budera, Petr; Osmančík, Pavel; Vaněk, Tomáš; Hulman, Michal; Smíd, Michal; Malý, Marek; Widimský, Petr

    2013-01-01

    Surgical ablation procedure can restore sinus rhythm (SR) in patients with atrial fibrillation (AF) undergoing cardiac surgery. However, it is not known whether it has any impact on clinical outcomes. There is a need for a randomized trial with long-term follow-up to study the outcome of surgical ablation in patients with coronary and/or valve disease and AF. Patients are prospectively enrolled and randomized either to group A (cardiac surgery with left atrial ablation) or group B (cardiac surgery alone). The primary efficacy outcome is the SR presence (without any AF episode) during a 24-hour electrocardiogram after 1 year. The primary safety outcome is the combined end point of death, myocardial infarction, stroke, and renal failure at 30 days. Long-term outcomes are a composite of total mortality, stroke, bleeding, and heart failure at 1 and 5 years. We finished the enrollment with a total of 224 patients from 3 centers in 2 countries in December 2011. Currently, the incomplete 1-year data are available, and the patients who enrolled first will have their 5-year visits shortly. PRAGUE-12 is the largest study to be conducted so far comparing cardiac surgery with surgical ablation of AF to cardiac surgery without ablation in an unselected population of patients who are operated on for coronary and/or valve disease. Its long-term results will lead to a better recognition of ablation's potential clinical benefits.

  6. The Site of the ASTRI SST-2M Telescope Prototype

    CERN Document Server

    Maccarone, Maria Concetta; Bruno, Pietro; Fiorini, Mauro; Grillo, Alessandro; Segreto, Alberto; Stringhetti, Luca

    2013-01-01

    ASTRI is a Flagship Project financed by the Italian Ministry of Education, University and Research, and led by the Italian National Institute of Astrophysics, INAF. Primary goal of the ASTRI project is the design and production of an end-to-end prototype of Small Size Telescope for the CTA (Cherenkov Telescope Array) in a dual-mirror configuration (SST-2M) equipped with a camera at the focal plane composed by an array of Silicon Photo-Multipliers and devoted to the investigation of the highest gamma-ray energy band. The ASTRI SST-2M prototype will be placed at the INAF M.G. Fracastoro observing station in Serra La Nave on the Etna Mountain near Catania, Italy. After the verification tests, devoted to probe the technological solutions adopted, the ASTRI SST-2M prototype will perform scientific observations on the Crab Nebula and on some of the brightest TeV sources. Here we present the Serra La Nave site, its meteorological and weather conditions, the sky darkness and visibility, and the complex of auxiliary i...

  7. Analysis of pathfinder SST algorithm for global and regional conditions

    Indian Academy of Sciences (India)

    Ajoy Kumar; P Minnett; G Podesta; R Evans; K Kilpatrick

    2000-12-01

    As part of the Pathfinder program developed jointly by National Aeronautics and Space Administration (NASA) and National Oceanic and Atmospheric Administration (NOAA) a large database of in situ sea surface temperature (SST) measurements coincident with satellite data is now available to the user community. The Pathfinder Matchup Database (PMDB) is a multi-year, multi-satellite collection of coincident measurements from the Advanced Very High Resolution Radiometer (AVHRR) and broadly distributed buoy data (matchups). This database allows the user community to test and validate new SST algorithms to improve the present accuracy of surface temperature measurements from satellites. In this paper we investigate the performance of a global Pathfinder algorithm to specific regional conditions. It is shown that for zenith angles less than 45°, the best-expected statistical discrepancy between satellite and buoy data is about ∼0.5 K. In general, the bias of the residuals (satellite - buoy) is negative in most regions, except in the North Atlantic and adjacent seas, where the residuals are always positive. A seasonal signal in SST residuals is observed in all regions and is strongest in the Indian Ocean. The channel-difference term used as a proxy for atmospheric water vapor correction is observed to be unresponsive for columnar water vapor values greater than 45 mm and high zenith angles. This unresponsiveness of the channels leads to underestimation of sea surface temperature from satellites in these conditions.

  8. The Effects of Green Tea on Post-Operative Pain and Anxiety in Tibia Surgery: A Randomized Double Blind Clinical Trial

    Directory of Open Access Journals (Sweden)

    Bahram Naderi Nabi

    2016-07-01

    Full Text Available Postoperative pain is always not well controlled by current analgesics. Green tea is supposed to have analgesic and relaxing effect. This study assessed the effect of green tea on post-operative pain and anxiety in tibia surgery. A randomized double blind controlled trial has been conducted from May to September 2015in the north of Iran after being registered in Iranian Registry of Clinical Trials. Sixty eligible patients have randomly been assigned to either green tea (G or placebo (P group in quadripartite blocks. Pain severity and anxiety based on visual analogue scale (VASand State Trait Anxiety Inventory (STAIwere measured and compared two hours before surgery and drink intake (T0, after recovery filling Aldrete criteria(T1 and eight hours after the end of surgery (T2.Statistical analysis was performed by Chi-square test and repeated measurement in SPSS version 20. In the group of G and P 36 and 32patients remained with mean age of 36.76±1 0.96 and 41.26±11.44 years (p=0.120. Respectively 69.4% (n=25 and 75% (n=24 of participants were menin groups (p=0.787 and the mean of Body Mass Index (BMI was 27.81±3.88 and 28.27±5.37 (p=0.706. There was no significant difference in VAS score in each group and also between two groups in three measurement point times. The difference of STAI was significant in each group (p=0.001 and between two groups (p=0.01 in three measurement point times. Green tea could diminish postoperative anxiety but not post-operative pain.

  9. REGIONAL FEATURES OF LONG-TERM SST VARIATION IN THE WESTERN PACIFIC WARM POOL AREA

    Institute of Scientific and Technical Information of China (English)

    张启龙; 翁学传; 程明华

    2001-01-01

    The main features of SST interarmual and long-term variations in the Western Pacific Warm Pool area were studied by using regression analysis, running t-test and spectral analysis methods based on monthly mean SST data in the Pacific during 1950 - 1998. The results showed that the SST inter-annual and long-term variations in the Western Pacific Warm Pool area had evident regional features.There were significant differences in variation range, phase, period, occurrence time of abrupt variation between SST in the eastern area (east of 100°E) and SST in the western area (west of 100°E).

  10. Randomized Controlled Trial of Intensive Versus Conservative Glucose Control in Patients Undergoing Coronary Artery Bypass Graft Surgery: GLUCO-CABG Trial

    Science.gov (United States)

    Cardona, Saumeth; Pasquel, Francisco; Jacobs, Sol; Peng, Limin; Unigwe, Michael; Newton, Christopher A.; Smiley-Byrd, Dawn; Vellanki, Priyathama; Halkos, Michael; Puskas, John D.; Guyton, Robert A.; Thourani, Vinod H.

    2015-01-01

    OBJECTIVE The optimal level of glycemic control needed to improve outcomes in cardiac surgery patients remains controversial. RESEARCH DESIGN AND METHODS We randomized patients with diabetes (n = 152) and without diabetes (n = 150) with hyperglycemia to an intensive glucose target of 100–140 mg/dL (n = 151) or to a conservative target of 141–180 mg/dL (n = 151) after coronary artery bypass surgery (CABG) surgery. After the intensive care unit (ICU), patients received a single treatment regimen in the hospital and 90 days postdischarge. Primary outcome was differences in a composite of complications, including mortality, wound infection, pneumonia, bacteremia, respiratory failure, acute kidney injury, and major cardiovascular events. RESULTS Mean glucose in the ICU was 132 ± 14 mg/dL (interquartile range [IQR] 124–139) in the intensive and 154 ± 17 mg/dL (IQR 142–164) in the conservative group (P < 0.001). There were no significant differences in the composite of complications between intensive and conservative groups (42 vs. 52%, P = 0.08). We observed heterogeneity in treatment effect according to diabetes status, with no differences in complications among patients with diabetes treated with intensive or conservative regimens (49 vs. 48%, P = 0.87), but a significant lower rate of complications in patients without diabetes treated with intensive compared with conservative treatment regimen (34 vs. 55%, P = 0.008). CONCLUSIONS Intensive insulin therapy to target glucose of 100 and 140 mg/dL in the ICU did not significantly reduce perioperative complications compared with target glucose of 141 and 180 mg/dL after CABG surgery. Subgroup analysis showed a lower number of complications in patients without diabetes, but not in patients with diabetes treated with the intensive regimen. Large prospective randomized studies are needed to confirm these findings. PMID:26180108

  11. The LIPPSMAck POP (Lung Infection Prevention Post Surgery - Major Abdominal - with Pre-Operative Physiotherapy) trial: study protocol for a multi-centre randomised controlled trial

    OpenAIRE

    Boden, Ianthe; Browning, Laura; Elizabeth H Skinner; Reeve, Julie; El-Ansary, Doa; Robertson, Iain K.; Denehy, Linda

    2015-01-01

    Background Post-operative pulmonary complications are a significant problem following open upper abdominal surgery. Preliminary evidence suggests that a single pre-operative physiotherapy education and preparatory lung expansion training session alone may prevent respiratory complications more effectively than supervised post-operative breathing and coughing exercises. However, the evidence is inconclusive due to methodological limitations. No well-designed, adequately powered, randomised con...

  12. The effect of sevoflurane versus propofol anesthesia on troponin I after congenital heart surgery, a randomized clinical trial

    Directory of Open Access Journals (Sweden)

    Leila Mahdavi

    2015-01-01

    Full Text Available Background : The ischemic preconditioning phenomenon can save myocardium against move severe ischemic damages and reduce infarction size and furthermore a heart rhythm disturbance. In this study we examine relationship between troponin I (as a structural myocardial protein level and anesthetic agents in the children. Materials and Methods: In this study 84 children under 12 years age before cardiac surgery were divided randomly into two groups of 42 each. For anesthetic maintenance sevoflurane with dose of 0.5-1 MAC was used in Group 1 and 100-150 mg/kg/min of intravenous propofol in Group 2 for maintenance of anesthesia. Troponin I level was assessed 2 before and 1 hour after anesthetic induction. Outcome measures included the serum cardiac troponin I level in children before and after surgery in two study groups. Results: There was no significant difference between two groups in indices and both groups were homogenous in this point of view. The troponin I level after surgery was significantly increased in two groups. In the sevoflurane group it was 0.04 ± 0.12 to 0.05 ± 0.09 ng/ml (P value = 0.003 and the propofol group was 0.12 ± 0.26 to 0.19 ± 0.38 ng/ml (P value = 0.001. Conclusions: In this study two Anesthetic regimens were compared to assess the mean troponin I level before and after pediatric closed heart surgery, and it was shown that mean troponin level before and after surgery in the sevoflurane group was less than the propofol group. But this result was not statistically significant. These results indicate that although more protective effects of sevoflurane on myocardial injuries during pediatric cardiac surgery is predominant but this effect has no significant difference in the propofol group.

  13. Comparison of analgesic efficacy of flupirtine maleate and ibuprofen in gynaecological ambulatory surgeries: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Vanita Ahuja

    2015-01-01

    Full Text Available Background and Aims: Flupirtine maleate is a centrally acting, non-opioid analgesic with unique muscle relaxant properties as compared to common analgesics. The aim of this study was to compare post-operative analgesic efficacy of flupirtine maleate and ibuprofen in patients undergoing gynaecological ambulatory surgeries. Methods: This prospective, randomised controlled study was conducted in 60 women of American Society of Anesthesiologists physical status I/II, 18-70 years of age and scheduled to undergo gynaecological ambulatory surgeries. The participants were randomised to receive either 100 mg oral flupirtine maleate (group flupirtine, n = 30 or 800 mg oral ibuprofen (group ibuprofen, n = 30, 1 h prior to surgery and then every 8 h for 48 h. Verbal Numerical Rating Scale (VNRS on movement was assessed at 0, 2, 4, 6 and 8 h following surgery. Following discharge from hospital, the patients were interviewed telephonically at 12, 24 and 48 h post-operatively. VNRS was statistically analysed using Mann-Whitney test. Results: VNRS on movement was statistically reduced at 2 h after surgery (P = 0.04 in group flupirtine as compared to group ibuprofen. The analgesic efficacy was similar in both the groups at 4, 6, 8, 12, 24 and 48 h after surgery. The satisfaction scores at 24 and 48 h post-operatively were superior in group flupirtine as compared to group ibuprofen (P < 0.001. Conclusion: Analgesic efficacy of flupirtine maleate was comparable with ibuprofen in patients in ambulatory gynaecological patients up to 48 h postoperatively with superior satisfaction scores.

  14. Comparison of general anaesthesia versus regional anaesthesia with sedation in selected maxillofacial surgery: a randomized controlled trial.

    Science.gov (United States)

    Rastogi, Amit; Gyanesh, Prakhar; Nisha, Surbhi; Agarwal, Appurva; Mishra, Priya; Tiwari, Akhilesh Kumar

    2014-04-01

    The airway is the foremost challenge in maxillofacial surgery. The major concerns are difficulty in managing the patient's airway and sharing it between the anaesthetist and surgeons. General anaesthesia, with endotracheal intubation, is the commonly used technique for maxillofacial procedures. We assessed the efficacy and safety of a regional block with sedation technique in certain maxillofacial operations, specifically temporomandibular joint (TMJ) ankylosis and mandibular fracture cases, and compared it with conventional general anaesthesia. We compared the time to discharge from the post anaesthesia care unit (PACU) and the occurrence of side effects, as well as surgeon and patient satisfaction with the anaesthetic technique, between the two groups. We enrolled 50 patients of ASA grade 1 or 2, aged 15-50 years, scheduled for maxillofacial surgery (mandibular fracture or TMJ ankylosis). The patients were divided into two groups of 25 each, to receive sedation with a regional block with the use of a peripheral nerve stimulator in group I and general anaesthesia in group II. We observed haemodynamic parameters, intraoperative and postoperative complications and the amount of surgical bleeding in the two groups. Total anaesthesia time, patient and surgeon satisfaction, time to rescue analgesia, the number of rescue doses required, and the time to discharge from the PACU were compared. The groups were comparable with respect to demographic profile, intraoperative haemodynamic parameters, surgical time, and amount of blood loss. Postoperative pain was assessed using the visual analogue score (VAS). Patients in group I had lower VAS scores after surgery and remained pain-free for longer than those in group II. The mean pain-free interval in group I was 159.12 ± 43.95 min and in group II was 60.36 ± 19.77 min (p surgery under general anaesthesia (p surgery for mandible fracture or TMJ ankylosis, with clear advantages over general anaesthesia. Copyright © 2013

  15. Effect of remote ischemic preconditioning on renal dysfunction after complex valvular heart surgery: a randomized controlled trial.

    Science.gov (United States)

    Choi, Yong Seon; Shim, Jae Kwang; Kim, Jong Chan; Kang, Kyu-Sik; Seo, Yong Han; Ahn, Ki-Ryang; Kwak, Young Lan

    2011-07-01

    Acute kidney injury after cardiac surgery with cardiopulmonary bypass is closely related to systemic inflammatory reactions and oxidative stresses. Remote ischemic preconditioning is a systemic protective strategy whereby brief limb ischemia confers systemic protection against prolonged ischemia and inflammatory reactions in distant organs. This study investigated whether remote ischemic preconditioning provides systemic protective effect on kidneys that are not directly exposed to ischemia-reperfusion injury during complex valvular heart surgery. Seventy-six adult patients undergoing complex valvular heart surgery were randomly assigned to either remote ischemic preconditioning group (n = 38) or control group (n = 38). Remote ischemic preconditioning consisted of 3 10-minute cycles of lower limb ischemia and reperfusion with an automated cuff inflator. Primary end points were comparisons of biomarkers of renal injury including serum creatinine, cystatin C and neutrophil gelatinase-associated lipocalin, and incidence of acute kidney injury. Secondary end points were comparisons of myocardial enzyme release and pulmonary parameters. There were no significant differences in serum levels of biomarkers of renal injury between groups throughout the study period. The incidence of acute kidney injury did not differ between groups. Creatine kinase isoenzyme MB at 24 hours after surgery was lower, and intensive care unit stay was shorter in the remote ischemic preconditioning group than in the control group. In patients undergoing complex valvular heart surgery, remote ischemic preconditioning did not reduce degree of renal injury or incidence of acute kidney injury whereas it did reduce myocardial injury and intensive care unit stay. Copyright © 2011 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.

  16. Effect of 0.2% Chlorhexidine Gel on Frequency of Dry Socket Following Mandibular Third Molar Surgery: A Double-Blind Clinical Trial Clinical Trial

    Directory of Open Access Journals (Sweden)

    Baratollah Shaban

    2014-09-01

    Full Text Available Introduction: Alveolar osteitis (AO is one of the most common postoperative complications after third molar surgery. Various techniques have been used to reduce the risk of AO. The aim of the current study was to evaluate the effect of Chlorhexidine (CHX bioadhesive gel in preventing the development of AO. Methods: Patients with bilateral impacted mandibular third molars underwent surgical extraction of both teeth. One socket was randomly received CHX gel and the contralateral socket served as the control. The outcome variable was development of AO and the CHX gel application was the predictor variable. Data were analyzed using chi-square test with the confidence interval of 95%. Results: 41 patients (27 females and 14 males with mean age of 24.15 ± 5.02 years underwent 82 surgeries. Total of 11 sockets (13.41% developed AO. The frequency of AO in CHX gel (2 cases, 4.87% side was significantly lower than control (9 cases, 21.95% side (P-value < 0.05. No side effects observed following CHX gel application. Conclusion: Application of CHX gel could be an effective approach to reduce the risk of developing AO following mandibular third molar surgery.

  17. Protocol for a randomized controlled trial on risk adapted damage control orthopedic surgery of femur shaft fractures in multiple trauma patients

    Directory of Open Access Journals (Sweden)

    Rixen Dieter

    2009-08-01

    Full Text Available Abstract Background Fractures of the long bones and femur fractures in particular are common in multiple trauma patients, but the optimal management of femur fractures in these patients is not yet resolved. Although there is a trend towards the concept of "Damage Control Orthopedics" (DCO in the management of multiple trauma patients with long bone fractures as reflected by a significant increase in primary external fixation of femur fractures, current literature is insufficient. Thus, in the era of "evidence-based medicine", there is the need for a more specific, clarifying trial. Methods/Design The trial is designed as a randomized controlled open-label multicenter study. Multiple trauma patients with femur shaft fractures and a calculated probability of death between 20 and 60% will be randomized to either temporary fracture fixation with fixateur externe and defined secondary definitive treatment (DCO or primary reamed nailing (early total care. The primary objective is to reduce the extent of organ failure as measured by the maximum sepsis-related organ failure assessment (SOFA score. Discussion The Damage Control Study is the first to evaluate the risk adapted damage control orthopedic surgery concept of femur shaft fractures in multiple trauma patients in a randomized controlled design. The trial investigates the differences in clinical outcome of two currently accepted different ways of treating multiple trauma patients with femoral shaft fractures. This study will help to answer the question whether the "early total care" or the „damage control” concept is associated with better outcome. Trial registration Current Controlled Trials ISRCTN10321620

  18. North American Tropical Cyclone Landfall and SST: A Statistical Model Study

    Science.gov (United States)

    Hall, Timothy; Yonekura, Emmi

    2013-01-01

    A statistical-stochastic model of the complete life cycle of North Atlantic (NA) tropical cyclones (TCs) is used to examine the relationship between climate and landfall rates along the North American Atlantic and Gulf Coasts. The model draws on archived data of TCs throughout the North Atlantic to estimate landfall rates at high geographic resolution as a function of the ENSO state and one of two different measures of sea surface temperature (SST): 1) SST averaged over the NA subtropics and the hurricane season and 2) this SST relative to the seasonal global subtropical mean SST (termed relSST). Here, the authors focus on SST by holding ENSO to a neutral state. Jackknife uncertainty tests are employed to test the significance of SST and relSST landfall relationships. There are more TC and major hurricane landfalls overall in warm years than cold, using either SST or relSST, primarily due to a basinwide increase in the number of storms. The signal along the coast, however, is complex. Some regions have large and significant sensitivity (e.g., an approximate doubling of annual major hurricane landfall probability on Texas from -2 to +2 standard deviations in relSST), while other regions have no significant sensitivity (e.g., the U.S. mid-Atlantic and Northeast coasts). This geographic structure is due to both shifts in the regions of primary TC genesis and shifts in TC propagation.

  19. Effectiveness of Standardized Physical Therapy Exercises for Patients With Difficulty Returning to Usual Activities After Decompression Surgery for Subacromial Impingement Syndrome: Randomized Controlled Trial.

    Science.gov (United States)

    Christiansen, David Høyrup; Frost, Poul; Falla, Deborah; Haahr, Jens Peder; Frich, Lars Henrik; Andrea, Linda Christie; Svendsen, Susanne Wulff

    2016-06-01

    Little is known about the effectiveness of exercise programs after decompression surgery for subacromial impingement syndrome. For patients with difficulty returning to usual activities, special efforts may be needed to improve shoulder function. The purpose of this study was to evaluate the effectiveness at 3 and 12 months of a standardized physical therapy exercise intervention compared with usual care in patients with difficulty returning to usual activities after subacromial decompression surgery. A multicenter randomized controlled trial was conducted. The study was conducted in 6 public departments of orthopedic surgery, 2 departments of occupational medicine, and 2 physical therapy training centers in Central Denmark Region. One hundred twenty-six patients reporting difficulty returning to usual activities at the postoperative clinical follow-up 8 to 12 weeks after subacromial decompression surgery participated. A standardized exercise program consisting of physical therapist-supervised individual training sessions and home training was used. The primary outcome measure was the Oxford Shoulder Score. Secondary outcome measures were the Constant Score and the Fear-Avoidance Beliefs Questionnaire. At 3 and 12 months, follow-up data were obtained for 92% and 83% of the patients, respectively. Intention-to-treat analyses suggested a between-group difference on the Oxford Shoulder Score favoring the exercise group at 3 months, with an adjusted mean difference of 2.0 (95% confidence interval=-0.5, 4.6), and at 12 months, with an adjusted mean difference of 5.8 (95% confidence interval=2.8, 8.9). Significantly larger improvements for the exercise group were observed for most secondary and supplementary outcome measures. The nature of the exercise intervention did not allow blinding of patients and care providers. The standardized physical therapy exercise intervention resulted in statistically significant and clinically relevant improvement in shoulder pain and

  20. The effect of adjuvant vitamin C after varicocele surgery on sperm quality and quantity in infertile men: a double blind placebo controlled clinical trial

    Directory of Open Access Journals (Sweden)

    Ali Cyrus

    2015-04-01

    Full Text Available Varicocele is one of the most common causes of male infertility and spontaneous pregnancy rate after varicocelectomy is only about 30%. The most important seminal antioxidant is vitamin C but recent studies about the effects of vitamin C on spermatogenesis are controversial; therefore, we decided to evaluate its role after varicocelectomy. In a double blind randomized controlled clinical trial, 115 men with infertility and clinical varicocele with abnormal semen analyses were recruited. After surgery, the intervention group received vitamin C (250 mg bid and the control group received placebo for three months. Mean sperm count, motility, and morphology index of two semen analyses (before and after surgery were compared between the two groups. Univariate general linear model and stepwise linear regression were used in analysis. The mean age (±SD of participants was 27.6±5.3 years. Vitamin C group had statistically significant better normal motility (20.8 vs. 12.6, P=0.041 and morphology (23.2 vs. 10.5, P<0.001 than placebo group. Considering the values prior to surgery as covariate, vitamin C was not effective on sperm count (P=0.091; but it improved sperm motility (P=0.016 and morphology (P<0.001 even after excluding the confounding effect of age (P=0.044 and P=0.001, respectively. Vitamin C was also an independent factor in predicting motility and normal morphology after surgery. Ascorbic acid can play a role as adjuvant treatment after varicocelectomy in infertile men.

  1. Topical diclofenac versus dexamethasone after strabismus surgery: A double-blind randomized clinical trial of anti-inflammatory effect and ocular hypertensive response

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    Khan Hayat

    2007-01-01

    Full Text Available Background: Compared to steroids non-steroidal anti-inflammatory drugs offer comparable anti-inflammatory action without ocular side-effects. Aim: To compare the anti-inflammatory effect and effect on IOP (Goldmann of topical diclofenac 0.1% with dexamethasone 0.1% after strabismus surgery. Design: Prospective, randomized, double-blind, single-center, clinical trial. Materials and Methods: Forty-three cases of constant horizontal strabismus, qualifying for standard uniocular recession-resection surgery on two horizontal rectus muscles were randomized to either the dexamethasone or diclofenac group. They were excluded if they had previous ocular surgery, recently used anti-inflammatory drugs and had a neurological, systemic or an ocular inflammatory condition. In addition all received ciprofloxacin 0.3% four times daily. Assessment was done on the first postoperative day and at two and four weeks. The inflammatory characteristics graded from nil (0 to severe (3 were: discomfort, chemosis, injection, discharge and drop-intolerance. Their sum provided the total inflammatory score (TIS. Results: Dexamethasone group (n=21 was comparable in age, gender, preoperative IOP, strabismus, anesthesia administered and baseline IOP, to diclofenac (n=22. There were no significant differences in the inflammatory characteristics and TIS. The dexamethasone group had IOP significantly higher at two weeks (95% CI 0.17 to 3.25 and four weeks (95% CI 1.09 to 4.24 compared to diclofenac group and the net change of IOP at four weeks (95% CI 0.60 to 3.14. Compared to the baseline IOP. Conclusion: Topical diclofenac is comparable to dexamethasone in providing anti-inflammatory and analgesic effect with the advantage of significantly lesser IOP rise and should be preferred after strabismus surgery.

  2. Superior subconjunctival anesthesia versus retrobulbar anesthesia for manual small-incision cataract surgery in a residency training program: a randomized controlled trial

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    Kongsap P

    2012-11-01

    Full Text Available Pipat KongsapDepartment of Ophthalmology, Prapokklao Hospital, Chanthaburi, Thailand; Faculty of Medicine, Chulalongkorn University, Bangkok, ThailandPurpose: To evaluate the effectiveness of subconjunctival anesthesia as compared to retrobulbar anesthesia for pain control during manual small-incision cataract surgery (MSICS performed by third-year residents.Design: A randomized, controlled trial.Patients and methods: A total of 150 patients undergoing routine cataract surgery were randomly assigned to receive either subconjunctival anesthesia (group 1, n = 75 or retrobulbar anesthesia (group 2, n = 75. Third-year residents performed MSICS using the modified Blumenthal technique. Subconjunctival anesthesia was administered by injecting 2% xylocaine with adrenalin into the superior conjunctiva, and retrobulbar anesthesia by injecting 2 mL of 2% xylocaine with adrenalin into the retrobulbar space. We studied the following variables: intraoperative pain score rated on a 100-point visual analog scale (VAS, operative time, and injection and operative complications.Results: A mean age of 69 vs 70 years, an operative time of 47.1 (SD, 9.9 min vs 47.7 (10.9 min, and a median (interquartile range pain score of 40 (range, 20–70 vs 40 (range, 20–50 were observed in the subconjunctival and the retrobulbar groups, respectively. The injection complication of subconjunctival hemorrhage was significantly higher in the subconjunctival group (25.3% compared to the retrobulbar group (1.3%. The operative complication rate between groups was not different (P > 0.05.Conclusion: Both, superior subconjunctival anesthesia and retrobulbar anesthesia were effective during MSICS when used in a residency training program.Keywords: subconjunctival anesthesia, retrobulbar anesthesia, cataract surgery, small-incision cataract surgery, visual analog scale, pain score

  3. Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium and Cognitive Dysfunction in Elderly Patients Undergoing Major Elective Noncardiac Surgery: A Randomized Clinical Trial.

    Science.gov (United States)

    Deiner, Stacie; Luo, Xiaodong; Lin, Hung-Mo; Sessler, Daniel I; Saager, Leif; Sieber, Frederick E; Lee, Hochang B; Sano, Mary; Jankowski, Christopher; Bergese, Sergio D; Candiotti, Keith; Flaherty, Joseph H; Arora, Harendra; Shander, Aryeh; Rock, Peter

    2017-08-16

    Postoperative delirium occurs in 10% to 60% of elderly patients having major surgery and is associated with longer hospital stays, increased hospital costs, and 1-year mortality. Emerging literature suggests that dexmedetomidine sedation in critical care units is associated with reduced incidence of delirium. However, intraoperative use of dexmedetomidine for prevention of delirium has not been well studied. To evaluate whether an intraoperative infusion of dexmedetomidine reduces postoperative delirium. This study was a multicenter, double-blind, randomized, placebo-controlled trial that randomly assigned patients to dexmedetomidine or saline placebo infused during surgery and for 2 hours in the recovery room. Patients were assessed daily for postoperative delirium (primary outcome) and secondarily for postoperative cognitive decline. Participants were elderly (>68 years) patients undergoing major elective noncardiac surgery. The study dates were February 2008 to May 2014. Dexmedetomidine infusion (0.5 µg/kg/h) during surgery and up to 2 hours in the recovery room. The primary hypothesis tested was that intraoperative dexmedetomidine administration would reduce postoperative delirium. Secondarily, the study examined the correlation between dexmedetomidine use and postoperative cognitive change. In total, 404 patients were randomized; 390 completed in-hospital delirium assessments (median [interquartile range] age, 74.0 [71.0-78.0] years; 51.3% [200 of 390] female). There was no difference in postoperative delirium between the dexmedetomidine and placebo groups (12.2% [23 of 189] vs 11.4% [23 of 201], P = .94). After adjustment for age and educational level, there was no difference in the postoperative cognitive performance between treatment groups at 3 months and 6 months. Adverse events were comparably distributed in the treatment groups. Intraoperative dexmedetomidine does not prevent postoperative delirium. The reduction in delirium previously demonstrated

  4. The effect of cyclosporin-A on peri-operative myocardial injury in adult patients undergoing coronary artery bypass graft surgery: a randomised controlled clinical trial

    Science.gov (United States)

    Hausenloy, DJ; Kunst, G; Boston-Griffiths, E; Kolvekar, S; Chaubey, S; John, L; Desai, J; Yellon, DM

    2014-01-01

    Objective Cyclosporin-A (CsA) has been reported to reduce myocardial infarct size in both the experimental and clinical settings. This protective effect is dependent on its ability to prevent the opening of the mitochondrial permeability transition pore, a critical determinant of cell death in the setting of acute ischaemia-reperfusion injury. Whether CsA can reduce the extent of peri-operative myocardial injury (PMI) in patients undergoing coronary artery bypass graft (CABG) surgery is unknown, and is investigated in this randomised controlled clinical trial. Methods 78 adult patients undergoing elective CABG surgery were randomised to receive either an intravenous bolus of CsA (2.5 mg/kg) or placebo administered after induction of anaesthesia and prior to sternotomy. PMI was assessed by measuring serum cardiac enzymes, troponin T (cTnT) and CK-MB at 0, 6, 12, 24, 48 and 72 h after surgery. Results There was no significant difference in mean peak cTnT levels between control (n=43) and CsA treatment (n=40) patients (0.56±0.06 ng/mL with control vs 0.35±0.05 ng/mL with CsA; p=0.07). However, in higher-risk patients with longer cardiopulmonary bypass times, there was a significant reduction in PMI with CsA therapy (p=0.049), with a reduced postoperative cTnT rise by 0.03 ng/mL for every 10 min, when compared with control. Conclusions In patients with longer cardiopulmonary bypass times, a single intravenous bolus of CsA administered prior to CABG surgery reduced the extent of PMI. PMID:24488610

  5. Effects of oral clonidine premedication on hemodynamic status in bimaxillary orthognathic surgery: A double-blind randomized clinical trial.

    Science.gov (United States)

    Mohammadi, Farnoosh; Marashi, Mojtaba; Tavakoli, Iman; Khakbaz, Oveis

    2016-04-01

    Controlled hypotension during a surgical procedure is a way to decrease blood pressure and subsequently to improve the field of operation. Clonidine is an antihypertensive agent used for induced hypotension. Correction of maxillomandibular discrepancies may necessitate performing osteotomy on both jaws in many cases. Bimaxillary orthognathic surgery is a procedure that is associated with significant blood loss. A total of 30 participants who were candidates for double-jaw orthognathic surgery were classified into two groups with equal numbers. In one group, 300 μg oral clonidine premedication was administered 90 min before the operation, and in the other group a placebo with the same condition as in the first group. Mean arterial pressure (MAP) and heart rate at 10 min intervals, operation time, blood loss, and surgeon satisfaction were measured. A total of 10 men and 5 women with a mean age of 22.9 ± 2.9 years in the study group and 13 men and 2 women with a mean age of 22.1 ± 2.1 years in the control group were evaluated. The MAP was significantly lower in the clonidine group (P bimaxillary orthognathic surgery. Hemodynamic stability, bleeding control, decrease of operative time, and enhancement of surgical results are advantages of this method. Copyright © 2016 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

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

    Science.gov (United States)

    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.

  7. Success and spontaneous pregnancy rates following systemic methotrexate versus laparoscopic surgery for tubal pregnancies: A randomized trial

    DEFF Research Database (Denmark)

    Møller, Lars Bo Krag; Moeller, Charlotte; Thomsen, Sten Grove

    2009-01-01

    Objective. To determine which treatment should be offered to women with a non-ruptured tubal pregnancy: a single dose of methotrexate (MTX) or laparoscopic surgery. Design. Prospective, randomized, open multicenter study. Setting. Seven Danish departments of obstetrics and gynecology. Sample. A t...

  8. Nurse-led follow-up of patients after oesophageal or gastric cardia cancer surgery: A randomised trial

    NARCIS (Netherlands)

    E.M.L. Verschuur (Els); E.W. Steyerberg (Ewout); H.W. Tilanus (Hugo); S. Polinder (Suzanne); M.L.E. Essink-Bot (Marie-Louise); K.T.C. Tran (Khe); A. van der Gaast (Ate); L.P. Stassen (Laurents); E.J. Kuipers (Ernst); P.D. Siersema (Peter)

    2009-01-01

    textabstractBetween January 2004 and February 2006, 109 patients after intentionally curative surgery for oesophageal or gastric cardia cancer were randomised to standard follow-up of surgeons at the outpatient clinic (standard follow-up; n=55) or by regular home visits of a specialist nurse (nurse-

  9. Comparison of Biodegradable and Titanium Fixation Systems in Maxillofacial Surgery : A Two-year Multi-center Randomized Controlled Trial

    NARCIS (Netherlands)

    van Bakelen, N. B.; Buijs, G. J.; Jansma, J.; de Visscher, J. G. A. M.; Hoppenreijs, Th. J. M.; Bergsma, J. E.; Stegenga, B.; Bos, R. R. M.

    2013-01-01

    Biodegradable osteosynthesis could reduce/delete the problems associated with titanium plate removal. The aim of the present study was to compare the clinical performance in the first 2 post-operative years between a biodegradable and a titanium system in oral and maxillofacial surgery. The multicen

  10. The effects of perioperative music interventions in pediatric surgery: A systematic review and meta-analysis of randomized controlled trials

    NARCIS (Netherlands)

    M.J.E. Van Der Heijden (Marianne J. E.); S.O. Araghi (Sadaf Oliai); M. Van Dijk (Monique); J. Jeekel (Johannes); M.G.M. Hunink (Myriam)

    2015-01-01

    textabstractObjective: Music interventions are widely used, but have not yet gained a place in guidelines for pediatric surgery or pediatric anesthesia. In this systematic review and meta-analysis we examined the effects of music interventions on pain, anxiety and distress in children undergoing

  11. The effects of perioperative music interventions in pediatric surgery: A systematic review and meta-analysis of randomized controlled trials

    NARCIS (Netherlands)

    M.J.E. Van Der Heijden (Marianne J. E.); S.O. Araghi (Sadaf Oliai); M. Van Dijk (Monique); J. Jeekel (Johannes); M.G.M. Hunink (Myriam)

    2015-01-01

    textabstractObjective: Music interventions are widely used, but have not yet gained a place in guidelines for pediatric surgery or pediatric anesthesia. In this systematic review and meta-analysis we examined the effects of music interventions on pain, anxiety and distress in children undergoing inv

  12. A prospective randomized trial of open surgery versus endourological stone removal in patients of staghorn stones with chronic renal failure

    Directory of Open Access Journals (Sweden)

    Anant Kumar

    2001-01-01

    Conclusion: In view of the better clearance rate and lesser cost of treatment, open surgery still has a place in the management of staghorn stones with chronic renal failure even in a tertiary urological center. However postoperative pain and a larger scar cannot be ignored.

  13. The Effect of Abdominal Support on Functional Outcomes in Patients Following Major Abdominal Surgery: A Randomized Controlled Trial

    Science.gov (United States)

    Cheifetz, Oren; Overend, Tom J.; Crowe, Jean

    2010-01-01

    ABSTRACT Purpose: Immobility and pain are modifiable risk factors for development of venous thromboembolism and pulmonary morbidity after major abdominal surgery (MAS). The purpose of this study was to investigate the effect of abdominal incision support with an elasticized abdominal binder on postoperative walk performance (mobility), perceived distress, pain, and pulmonary function in patients following MAS. Methods: Seventy-five patients scheduled to undergo MAS via laparotomy were randomized to experimental (binder) or control (no binder) groups. Sixty (33 male, 27 female; mean age 58±14.9 years) completed the study. Preoperative measurements of 6-minute walk test (6MWT) distance, perceived distress, pain, and pulmonary function were repeated 1, 3, and 5 days after surgery. Results: Surgery was associated with marked postoperative reductions (p<0.001) in walk distance (∼75–78%, day 3) and forced vital capacity (35%, all days) for both groups. Improved 6MWT distance by day 5 was greater (p<0.05) for patients wearing a binder (80%) than for the control group (48%). Pain and symptom-associated distress remained unchanged following surgery with binder usage, increasing significantly (p<0.05) only in the no binder group. Conclusion: Elasticized abdominal binders provide a non-invasive intervention for enhancing recovery of walk performance, controlling pain and distress, and improving patients' experience following MAS. PMID:21629603

  14. Effect of Fibrinogen Concentrate on Intraoperative Blood Loss Among Patients With Intraoperative Bleeding During High-Risk Cardiac Surgery: A Randomized Clinical Trial.

    Science.gov (United States)

    Bilecen, Süleyman; de Groot, Joris A H; Kalkman, Cor J; Spanjersberg, Alexander J; Brandon Bravo Bruinsma, George J; Moons, Karel G M; Nierich, Arno P

    2017-02-21

    Fibrinogen concentrate might partly restore coagulation defects and reduce intraoperative bleeding. To determine whether fibrinogen concentrate infusion dosed to achieve a plasma fibrinogen level of 2.5 g/L in high-risk cardiac surgery patients with intraoperative bleeding reduces intraoperative blood loss. A randomized, placebo-controlled, double-blind clinical trial conducted in Isala Zwolle, the Netherlands (February 2011-January 2015), involving patients undergoing elective, high-risk cardiac surgery (ie, combined coronary artery bypass graft [CABG] surgery and valve repair or replacement surgery, the replacement of multiple valves, aortic root reconstruction, or reconstruction of the ascending aorta or aortic arch) with intraoperative bleeding (blood volume between 60 and 250 mL suctioned from the thoracic cavity in a period of 5 minutes) were randomized to receive either fibrinogen concentrate or placebo. Intravenous, single-dose administration of fibrinogen concentrate (n = 60) or placebo (n = 60), targeted to achieve a postinfusion plasma fibrinogen level of 2.5 g/L. The primary outcome was blood loss in milliliters between intervention (ie, after removal of cardiopulmonary bypass) and closure of chest. Safety variables (within 30 days) included: in-hospital mortality, myocardial infarction, cerebrovascular accident or transient ischemic attack, renal insufficiency or failure, venous thromboembolism, pulmonary embolism, and operative complications. Among 120 patients (mean age; 71 [SD, 10] years, 37 women [31%]) included in the study, combined CABG and valve repair or replacement surgery comprised 72% of procedures and had a mean (SD) cardiopulmonary bypass time of 200 minutes (83) minutes. For the primary outcome, median blood loss in the fibrinogen group was 50 mL (interquartile range [IQR], 29-100 mL) compared with 70 mL (IQR, 33-145 mL) in the control group (P = .19), the absolute difference 20 mL (95% CI, -13 to 35 mL). There were 6 cases

  15. Fast-track surgery protocol in elderly patients undergoing laparoscopic radical gastrectomy for gastric cancer: a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Liu G

    2016-06-01

    Full Text Available Guozheng Liu,1 Fengguo Jian,2 Xiuqin Wang,2 Lin Chen1 1Department of General Surgery, Chinese PLA General Hospital, Beijing, People’s Republic of China; 2Second Department of General Surgery, Changyi People’s Hospital, Shandong, People’s Republic of China Aim: To study the efficacy of the fast-track surgery (FTS program combined with laparoscopic radical gastrectomy for elderly gastric cancer (GC patients.Methods: Eighty-four elderly patients diagnosed with GC between September 2014 and August 2015 were recruited to participate in this study and were divided into four groups randomly based on the random number table as follows: FTS + laparoscopic group (Group A, n=21, FTS + laparotomy group (Group B, n=21, conventional perioperative care (CC + laparoscopic group (Group C, n=21, and CC + laparotomy group (Group D, n=21. Observation indicators include intrasurgery indicators, postoperative recovery indicators, nutritional status indicators, and systemic stress response indicators.Results: Preoperative and intraoperative baseline characteristics showed no significant differences between patients in each group (P>0.05. There were no significant differences between each group in nausea and vomiting, intestinal obstruction, urinary retention, incision infection, pulmonary infection, and urinary tract infection after operation (P>0.05. Time of first flatus and postoperative hospital stay time of FTS Group A were the shortest, and total medical cost of this group was the lowest. For all groups, serum albumin, prealbumin, and transferrin significantly decreased, while CRP and interleukin 6 were significantly increased postoperative day 1. From postoperative day 4–7, all indicators of the four groups gradually recovered, but compared with other three groups, those of Group A recovered fastest.Conclusion: FTS combined with laparoscopic surgery can promote faster postoperative recovery, improve early postoperative nutritional status, and more

  16. Photodynamic therapy followed by Mohs micrographic surgery compared to Mohs micrographic surgery alone for the treatment of basal cell carcinoma: Results of a pilot single-blinded randomised controlled trial

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    Firas Al-Niaimi

    2015-01-01

    Full Text Available Introduction: Basal cell carcinoma is a common cutaneous malignant tumour. Surgical excision is the "gold standard" treatment for most subtypes, with Mohs micrographic surgery (MMS offering the highest cure rate. Other treatment modalities used include photodynamic therapy (PDT. Background: We aimed to study the efficacy of combining MMS with PDT to see whether this would reduce the number of stages and final defect size when compared with MMS alone. Materials and Methods: Our study was a single-centre, single-blinded, randomised and controlled pilot study involving a total of 19 patients. Nine patients were randomised to pre-treatment with PDT followed by MMS of whom two withdrew; the remaining 10 patients were randomised to the MMS alone. Follow-up visits were arranged at 3 and 6 months post-surgery. Results: In the PDT arm, five out of the seven treated patients (71% had their initial tumour size decreased following PDT treatment prior to MMS. The average number of stages in the PDT arm was 1.85, compared to 2.5 in the MMS arm. The average number of sections in the PDT arm was 4.2, in comparison to 5.2 in the MMS arm. Conclusion: Our pilot study showed a promising but limited role for PDT as an adjunct in MMS in the treatment of selected cases of basal cell carcinomas. Larger trials, preferably multi-centred are required to further examine the role of this combination therapy.

  17. Randomized Controlled Trial of Intensive Versus Conservative Glucose Control in Patients Undergoing Coronary Artery Bypass Graft Surgery: GLUCO-CABG Trial.

    Science.gov (United States)

    Umpierrez, Guillermo; Cardona, Saumeth; Pasquel, Francisco; Jacobs, Sol; Peng, Limin; Unigwe, Michael; Newton, Christopher A; Smiley-Byrd, Dawn; Vellanki, Priyathama; Halkos, Michael; Puskas, John D; Guyton, Robert A; Thourani, Vinod H

    2015-09-01

    The optimal level of glycemic control needed to improve outcomes in cardiac surgery patients remains controversial. We randomized patients with diabetes (n = 152) and without diabetes (n = 150) with hyperglycemia to an intensive glucose target of 100-140 mg/dL (n = 151) or to a conservative target of 141-180 mg/dL (n = 151) after coronary artery bypass surgery (CABG) surgery. After the intensive care unit (ICU), patients received a single treatment regimen in the hospital and 90 days postdischarge. Primary outcome was differences in a composite of complications, including mortality, wound infection, pneumonia, bacteremia, respiratory failure, acute kidney injury, and major cardiovascular events. Mean glucose in the ICU was 132 ± 14 mg/dL (interquartile range [IQR] 124-139) in the intensive and 154 ± 17 mg/dL (IQR 142-164) in the conservative group (P < 0.001). There were no significant differences in the composite of complications between intensive and conservative groups (42 vs. 52%, P = 0.08). We observed heterogeneity in treatment effect according to diabetes status, with no differences in complications among patients with diabetes treated with intensive or conservative regimens (49 vs. 48%, P = 0.87), but a significant lower rate of complications in patients without diabetes treated with intensive compared with conservative treatment regimen (34 vs. 55%, P = 0.008). Intensive insulin therapy to target glucose of 100 and 140 mg/dL in the ICU did not significantly reduce perioperative complications compared with target glucose of 141 and 180 mg/dL after CABG surgery. Subgroup analysis showed a lower number of complications in patients without diabetes, but not in patients with diabetes treated with the intensive regimen. Large prospective randomized studies are needed to confirm these findings. © 2015 by the American Diabetes Association. Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work

  18. Probiotics and synbiotics for the prevention of postoperative infections following abdominal surgery: a systematic review and meta-analysis of randomized controlled trials.

    Science.gov (United States)

    Lytvyn, L; Quach, K; Banfield, L; Johnston, B C; Mertz, D

    2016-02-01

    Postoperative infections, particularly surgical site infections (SSIs), cause significant morbidity and mortality. Probiotics or synbiotics are a potential prevention strategy. To evaluate the efficacy of probiotics/synbiotics for reducing postoperative infection risk following abdominal surgery. We searched AMED, Central, CINAHL, Embase, Medline, and grey literature for randomized controlled trials of elective abdominal surgery patients administered probiotics or synbiotics compared to placebo or standard care. Primary outcome was SSIs. Secondary outcomes were adverse events, respiratory tract infections (RTIs), urinary tract infections (UTIs), combined infections, length of hospital stay, and mortality. Using random-effects meta-analyses, we estimated the relative risk (RR) or mean difference (MD) and 95% confidence interval (CI). Tests were performed for heterogeneity, subgroup and sensitivity analyses were conducted, and the overall evidence quality was graded. We identified 20 trials (N = 1374 participants) reporting postoperative infections. Probiotics/synbiotics reduced SSIs (RR: 0.63; 95% CI: 0.41-0.98; N = 15 studies), UTIs (RR: 0.29; 95% CI: 0.15-0.57; N = 11), and combined infections (RR: 0.49; 95% CI: 0.35-0.70; N = 18). There was no difference between groups for adverse events (RR: 0.89; 95% CI: 0.61-1.30; N = 6), RTIs (RR: 0.60; 95% CI: 0.36-1.00; N = 14), length of stay (MD: -1.19; 95% CI: -2.94 to 0.56; N = 12), or mortality (RR: 1.20; 95% CI: 0.58-2.48; N = 15). Our review suggests that probiotics/synbiotics reduce SSIs and UTIs from abdominal surgeries compared to placebo or standard of care, without evidence of safety risk. Overall study quality was low, owing mostly to imprecision (few patients and events, or wide CIs); thus larger multi-centered trials are needed to further assess the certainty in this estimate. Copyright © 2016 The Healthcare Infection Society. Published by Elsevier Ltd. All rights reserved.

  19. The use of a modified, oscillating positive expiratory pressure device reduced fever and length of hospital stay in patients after thoracic and upper abdominal surgery: a randomised trial

    Directory of Open Access Journals (Sweden)

    Xiang-yu Zhang

    2015-01-01

    Full Text Available Question: Does the use of an oscillating positive expiratory pressure (PEP device reduce postoperative pulmonary complications in thoracic and upper abdominal surgical patients? Design: A multi-centre, parallel-group, randomised controlled trial with intention-to-treat analysis, blinding of some outcomes, and concealed allocation. Participants: A total of 203 adults after thoracic or upper abdominal surgery with general anaesthesia. Intervention: Participants in the experimental group used an oscillating PEP device, thrice daily for 5 postoperative days. Both the experimental and control groups received standard medical postoperative management and early mobilisation. Outcome measures: Fever, days of antibiotic therapy, length of hospital stay, white blood cell count, and possible adverse events were recorded for 28 days or until hospital discharge. Results: The 99 participants in the experimental group and 104 in the control group were well matched at baseline and there was no loss to follow-up. Fever affected a significantly lower percentage of the experimental group (22% than the control group (42%, with a RR of 0.56 (95% CI 0.36 to 0.87, NNT 6. Similarly, length of hospital stay was significantly shorter in the experimental group, at 10.7 days (SD 8.1, than in the control group, at 13.3 days (SD 11.1; the mean difference was 2.6 days (95% CI 0.4 to 4.8. The groups did not differ significantly in the need for antibiotic therapy, white blood cell count or total expense of treatment. Conclusion: In adults undergoing thoracic and upper abdominal surgery, postoperative use of an oscillating PEP device resulted in fewer cases of fever and shorter hospital stay. However, antibiotic therapy and total hospital expenses were not significantly reduced by this intervention. Trial registration: NCT00816881. [Zhang X-y, Wang Q, Zhang S, Tan W, Wang Z, Li J (2015 The use of a modified, oscillating positive expiratory pressure device reduced fever and

  20. The Effectiveness of Manual Therapy Versus Surgery on Self-reported Function, Cervical Range of Motion, and Pinch Grip Force in Carpal Tunnel Syndrome: A Randomized Clinical Trial.

    Science.gov (United States)

    Fernández-de-Las-Peñas, César; Cleland, Joshua; Palacios-Ceña, María; Fuensalida-Novo, Stella; Pareja, Juan A; Alonso-Blanco, Cristina

    2017-03-01

    Study Design Randomized parallel-group trial. Background Carpal tunnel syndrome (CTS) is a common pain condition that can be managed surgically or conservatively. Objective To compare the effectiveness of manual therapy versus surgery for improving self-reported function, cervical range of motion, and pinch-tip grip force in women with CTS. Methods In this randomized clinical trial, 100 women with CTS were randomly allocated to either a manual therapy (n = 50) or a surgery (n = 50) group. The primary outcome was self-rated hand function, assessed with the Boston Carpal Tunnel Questionnaire. Secondary outcomes included active cervical range of motion, pinch-tip grip force, and the symptom severity subscale of the Boston Carpal Tunnel Questionnaire. Patients were assessed at baseline and 1, 3, 6, and 12 months after the last treatment by an assessor unaware of group assignment. Analysis was by intention to treat, with mixed analyses of covariance adjusted for baseline scores. Results At 12 months, 94 women completed the follow-up. Analyses showed statistically significant differences in favor of manual therapy at 1 month for self-reported function (mean change, -0.8; 95% confidence interval [CI]: -1.1, -0.5) and pinch-tip grip force on the symptomatic side (thumb-index finger: mean change, 2.0; 95% CI: 1.1, 2.9 and thumb-little finger: mean change, 1.0; 95% CI: 0.5, 1.5). Improvements in self-reported function and pinch grip force were similar between the groups at 3, 6, and 12 months. Both groups reported improvements in symptom severity that were not significantly different at all follow-up periods. No significant changes were observed in pinch-tip grip force on the less symptomatic side and in cervical range of motion in either group. Conclusion Manual therapy and surgery had similar effectiveness for improving self-reported function, symptom severity, and pinch-tip grip force on the symptomatic hand in women with CTS. Neither manual therapy nor surgery resulted

  1. Trials

    Directory of Open Access Journals (Sweden)

    Michele Fornaro

    2010-01-01

    Full Text Available Mental Retardation (MR is a developmental disability characterized by impairments in adaptive daily life skills and difficulties in social and interpersonal functioning. Since multiple causes may contribute to MR, associated clinical pictures may vary accordingly. Nevertheless, when psychiatric disorders as Treatment Resistant Depression (TRD and/or alcohol abuse co-exist, their proper detection and management is often troublesome, essentially due to a limited vocabulary MR people could use to describe their symptoms, feelings and concerns, and the lack of reliable screening tools. Furthermore, MR people are among the most medicated subjects, with (over prescription of antidepressants and/or typical antipsychotics being the rule rather than exception. Thus, treatment resistance or even worsening of depression, constitute frequent occurrences. This report describes the case of a person with MR who failed to respond to repetitive trials of antidepressant monotherapies, finally recovering using aripiprazole to fluvoxamine augmentation upon consideration of a putative bipolar diathesis for “agitated” TRD. Although further controlled investigations are needed to assess a putative bipolar diathesis in some cases of MR associated to TRD, prudence is advised in the long-term prescription of antidepressant monotherapies in such conditions.

  2. Breast-conserving surgery with or without radiotherapy in women with ductal carcinoma in situ: a meta-analysis of randomized trials

    Directory of Open Access Journals (Sweden)

    Leon Paola G

    2007-08-01

    Full Text Available Abstract Background To investigate whether Radiation therapy (RT should follow breast conserving surgery in women with ductal carcinoma in situ from breast cancer (DCIS with objective of decreased mortality, invasive or non invasive recurrence, distant metastases and contralateral breast cancer rates. We have done a meta-analysis of these results to give a more balanced view of the total evidence and to increase statistical precision. Methods A meta-analysis of randomized controlled trials (RCT was performed comparing RT treatment for DCIS of breast cancer to observation. The MEDLINE, EMBASE, CANCERLIT, Cochrane Library databases, Trial registers, bibliographic databases, and recent issues of relevant journals were searched. Relevant reports were reviewed by two reviewers independently and the references from these reports were searched for additional trials, using guidelines set by QUOROM statement criteria. Results The reviewers identified four large RCTs, yielding 3665 patients. Pooled results from this four randomized trials of adjuvant radiotherapy showed a significant reduction of invasive and DCIS ipsilateral breast cancer with odds ratio (OR of 0.40 (95% CI 0.33 – 0.60, p Conclusion The conclusion from our meta-analysis is that the addition of radiation therapy to lumpectomy results in an approximately 60% reduction in breast cancer recurrence, no benefit for survival or distant metastases compared to excision alone. Patients with high-grade DCIS lesions and positive margins benefited most from the addition of radiation therapy. It is not yet clear which patients can be successfully treated with lumpectomy alone; until further prospective studies answer this question, radiation should be recommended after lumpectomy for all patients without contraindications.

  3. Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study.

    Science.gov (United States)

    Potter, Shelley; Mills, Nicola; Cawthorn, Simon J; Donovan, Jenny; Blazeby, Jane M

    2014-03-14

    Well-designed randomised clinical trials (RCTs) provide the best evidence to inform decision-making and should be the default option for evaluating surgical procedures. Such trials can be challenging, and surgeons' preferences may influence whether trials are initiated and successfully conducted and their results accepted. Preferences are particularly problematic when surgeons' views play a key role in procedure selection and patient eligibility. The bases of such preferences have rarely been explored. Our aim in this qualitative study was to investigate surgeons' preferences regarding the feasibility of surgical RCTs and their understanding of study design issues using breast reconstruction surgery as a case study. Semistructured qualitative interviews were undertaken with a purposive sample of 35 professionals practicing at 15 centres across the United Kingdom. Interviews were transcribed verbatim and analysed thematically using constant comparative techniques. Sampling, data collection and analysis were conducted concurrently and iteratively until data saturation was achieved. Surgeons often struggle with the concept of equipoise. We found that if surgeons did not feel 'in equipoise', they did not accept randomisation as a method of treatment allocation. The underlying reasons for limited equipoise were limited appreciation of the methodological weaknesses of data derived from nonrandomised studies and little understanding of pragmatic trial design. Their belief in the value of RCTs for generating high-quality data to change or inform practice was not widely held. There is a need to help surgeons understand evidence, equipoise and bias. Current National Institute of Health Research/Medical Research Council investment into education and infrastructure for RCTs, combined with strong leadership, may begin to address these issues or more specific interventions may be required.

  4. Time to be BRAVE: is educating surgeons the key to unlocking the potential of randomised clinical trials in surgery? A qualitative study

    Science.gov (United States)

    2014-01-01

    Background Well-designed randomised clinical trials (RCTs) provide the best evidence to inform decision-making and should be the default option for evaluating surgical procedures. Such trials can be challenging, and surgeons’ preferences may influence whether trials are initiated and successfully conducted and their results accepted. Preferences are particularly problematic when surgeons’ views play a key role in procedure selection and patient eligibility. The bases of such preferences have rarely been explored. Our aim in this qualitative study was to investigate surgeons’ preferences regarding the feasibility of surgical RCTs and their understanding of study design issues using breast reconstruction surgery as a case study. Methods Semistructured qualitative interviews were undertaken with a purposive sample of 35 professionals practicing at 15 centres across the United Kingdom. Interviews were transcribed verbatim and analysed thematically using constant comparative techniques. Sampling, data collection and analysis were conducted concurrently and iteratively until data saturation was achieved. Results Surgeons often struggle with the concept of equipoise. We found that if surgeons did not feel ‘in equipoise’, they did not accept randomisation as a method of treatment allocation. The underlying reasons for limited equipoise were limited appreciation of the methodological weaknesses of data derived from nonrandomised studies and little understanding of pragmatic trial design. Their belief in the value of RCTs for generating high-quality data to change or inform practice was not widely held. Conclusion There is a need to help surgeons understand evidence, equipoise and bias. Current National Institute of Health Research/Medical Research Council investment into education and infrastructure for RCTs, combined with strong leadership, may begin to address these issues or more specific interventions may be required. PMID:24628821

  5. Hydroxyethyl starch reduces coagulation competence and increases blood loss during major surgery: results from a randomized controlled trial.

    Science.gov (United States)

    Rasmussen, Kirsten C; Johansson, Pär I; Højskov, Michael; Kridina, Irina; Kistorp, Thomas; Thind, Peter; Nielsen, Henning B; Ruhnau, Birgitte; Pedersen, Tom; Secher, Niels H

    2014-02-01

    This study evaluated whether administration of hydroxyethyl starch (HES) 130/0.4 affects coagulation competence and influences the perioperative blood loss. Artificial colloids substitute blood volume during surgery; with the administration of HES 130/0.4 (Voluven, Fresenius Kabi, Uppsala, Sweden) only a minor effect on coagulation competence is expected. Eighty patients were scanned for enrollment in the study, and 40 patients fulfilled the inclusion criteria. Two patients withdrew their consent to participate in the study, and 5 patients were excluded. Thus, 16 patients were randomized to receive lactated Ringer's solution and 17 to receive HES 130/0.4. Among the patients receiving HES 130/0.4, thrombelastography indicated reduced clot strength (P Administration of HES 130/0.4 reduced clot strength and perioperative hemorrhage increased by more than 50%, while administration of lactated Ringer's solution provoked an approximately 2.5 times greater positive volume balance at the end of surgery.

  6. Overview of data acquisition and central control system of steady state superconducting Tokamak (SST-1)

    Energy Technology Data Exchange (ETDEWEB)

    Pradhan, S., E-mail: pradhan@ipr.res.in; Mahajan, K.; Gulati, H.K.; Sharma, M.; Kumar, A.; Patel, K.; Masand, H.; Mansuri, I.; Dhongde, J.; Bhandarkar, M.; Chudasama, H.

    2016-11-15

    Highlights: • The paper gives overview on SST-1 data acquisition and central control system and future upgrade plans. • The lossless PXI based data acquisition of SST-1 is capable of acquiring around 130 channels with sampling frequency ranging from 10 KHz to 1 MHz sampling frequency. • Design, architecture and technologies used for central control system (CCS) of SST-1. • Functions performed by CCS. - Abstract: Steady State Superconducting Tokamak (SST-1) has been commissioned successfully and has been carrying out limiter assisted ohmic plasma experiments since the beginning of 2014 achieving a maximum plasma current of 75 kA at a central field of 1.5 T and the plasma duration ∼500 ms. In near future, SST-1 looks forward to carrying out elongated plasma experiments and stretching plasma pulses beyond 1 s. The data acquisition and central control system (CCS) for SST-1 are distributed, modular, hierarchical and scalable in nature The CCS has been indigenously designed, developed, implemented, tested and validated for the operation of SST-1. The CCS has been built using well proven technologies like Redhat Linux, vxWorks RTOS for deterministic control, FPGA based hardware implementation, Ethernet, fiber optics backbone for network, DSP for real-time computation & Reflective memory for high-speed data transfer etc. CCS in SST-1 controls & monitors various heterogeneous SST-1 subsystems dispersed in the same campus. The CCS consists of machine control system, basic plasma control system, GPS time synchronization system, storage area network (SAN) for centralize data storage, SST-1 networking system, real-time networks, SST-1 control room infrastructure and many other supportive systems. Machine Control System (MCS) is a multithreaded event driven system running on Linux based servers, where each thread of the software communicates to a unique subsystem for monitoring and control from SST-1 central control room through network programming. The CCS hardware

  7. Effect of Vitamin C on adrenal suppression by etomidate induction in patients undergoing cardiac surgery: A randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Deepanwita Das

    2016-01-01

    Full Text Available Introduction: Etomidate is usually preferred in the induction of cardiac compromised patients due to its relative cardiovascular stability. However, the use of this drug has been limited as etomidate induces suppression of cortisol biosynthesis as a result of blockade of 11-beta-hydroxylation in the adrenal gland, mediated by the imidazole radical of etomidate. This study was carried out to observe the effect of Vitamin C on adrenal suppression after etomidate induction in patients undergoing cardiac surgery. Materials and Methods: A total of 78 patients were randomly distributed into two groups. Group-I received oral Vitamin C (500 mg twice daily and Group-II received antacid tablet as placebo twice daily instead of Vitamin C for 7 consecutive days prior to surgery till morning of surgery. Patients of both the groups induced with etomidate (0.1-0.3 mg/kg. Blood cortisol was estimated at different points of time till 24 th postinduction hour/blood lactate, glucose, hemodynamic parameters, and perioperative outcomes were assessed. Results: Data of seventy patients (n = 35 in each group were finally analyzed. Cortisol level is statistically significantly higher in Group-I (69.51 ± 7.65 as compared to Group-II (27.74 ± 4.72 (P < 0.05 in the 1 st postinduction hour. In Group-II, cortisol was consistently lower for 1 st 24 postinduction hour. Total adrenaline requirement was statistically significantly high in Group-II. Time of extubation, length of Intensive Care Unit stay arrhythmia was similar in both the groups. Conclusion: Vitamin C effectively inhibits etomidate-induced adrenal suppression in cardiac patients, thereby etomidate can be used as a safe alternative for induction in cardiac surgery under cardiopulmonary bypass when pretreated with Vitamin C.

  8. Back school or brain school for patients undergoing surgery for lumbar radiculopathy? Protocol for a randomised, controlled trial

    OpenAIRE

    Kelly Ickmans; Maarten Moens; Koen Putman; Ronald Buyl; Lisa Goudman; Eva Huysmans; Ina Diener; Tine Logghe; Adriaan Louw; Jo Nijs

    2016-01-01

    Introduction: Despite scientific progress with regard to pain neuroscience, perioperative education tends to stick to the biomedical model. This may involve, for example, explaining the surgical procedure or ‘back school’ (education that focuses on biomechanics of the lumbar spine and ergonomics). Current perioperative education strategies that are based on the biomedical model are not only ineffective, they can even increase anxiety and fear in patients undergoing spinal surgery. Therefore, ...

  9. Comparing primary and secondary wound healing discomfort after mandibular third molar surgery: a randomized, double-blind clinical trial.

    Science.gov (United States)

    Refo'a, Youshiaho; Ouatik, Nabil; Golchin, Foroogh; Mahboobi, Nima

    2011-01-01

    Extraction of impacted mandibular third molars is one of the most common procedures in the oral cavity and often is followed by pain, swelling, and postextraction alveolitis and trismus. It has been suggested that postoperative discomfort is in relation to the type of surgical wound healing. The aim of this study was to compare pain, swelling, and maximum mouth opening in two groups of patients with primary and secondary wound healing after impacted mandibular third molar surgery. Thirty-two patients were enrolled in this study and randomly divided into two equal groups, quantitatively and by gender. After the surgical procedures, 16 patients received primary wound closure, while the other 16 participants received secondary wound closure. A visual analog scale was used to collect pain data three days after the surgeries. A checklist was used to record data regarding swelling size and maximum mouth opening before, immediately following, three days after, and one week after surgery. Frequency tests and a t-test were used for statistical analysis and a P value of complications such as pain, maximal mouth opening, and swelling size after impacted mandibular third molar extractions.

  10. Percutaneous coronary intervention versus bypass surgery for left main coronary artery disease: A meta-analysis of randomised trials

    NARCIS (Netherlands)

    G. Ferrante (Giuseppe); P. Presbitero (Patrizia); M. Valgimigli (Marco); M-C. Morice (Marie-Claude); P. Pagnotta (Paolo); G. Belli (Guido); E. Corrada (Elena); Y. Onuma (Yoshinobu); P. Barlis (Peter); D. Locca (Didier); E. Eeckhout; C. di Mario (Carlo); P.W.J.C. Serruys (Patrick)

    2011-01-01

    textabstractAims: We performed a meta-analysis of randomised trials comparing percutaneous coronary intervention (PCI) with stent implantation to coronary artery bypass grafting (CABG) for the treatment of unprotected left main coronary artery stenosis (ULMCA). Methods and results: Pubmed and other

  11. Phosphorylation of threonine 333 regulates trafficking of the human sst5 somatostatin receptor.

    Science.gov (United States)

    Petrich, Aline; Mann, Anika; Kliewer, Andrea; Nagel, Falko; Strigli, Anne; Märtens, Jan Carlo; Pöll, Florian; Schulz, Stefan

    2013-04-01

    The frequent overexpression of the somatostatin receptors sst2 and sst5 in neuroendocrine tumors provides the molecular basis for therapeutic application of novel multireceptor somatostatin analogs. Although the phosphorylation of the carboxyl-terminal region of the sst2 receptor has been studied in detail, little is known about the agonist-induced regulation of the human sst5 receptor. Here, we have generated phosphosite-specific antibodies for the carboxyl-terminal threonines 333 (T333) and 347 (T347), which enabled us to selectively detect either the T333-phosphorylated or the T347-phosphorylated form of sst5. We show that agonist-mediated phosphorylation occurs at T333, whereas T347 is constitutively phosphorylated in the absence of agonist. We further demonstrate that the multireceptor somatostatin analog pasireotide and the sst5-selective ligand L-817,818 but not octreotide or KE108 were able to promote a detectable T333 phosphorylation. Interestingly, BIM-23268 was the only sst5 agonist that was able to stimulate T333 phosphorylation to the same extent as natural somatostatin. Agonist-induced T333 phosphorylation was dose-dependent and selectively mediated by G protein-coupled receptor kinase 2. Similar to that observed for the sst2 receptor, phosphorylation of sst5 occurred within seconds. However, unlike that seen for the sst2 receptor, dephosphorylation and recycling of sst5 were rapidly completed within minutes. We also identify protein phosphatase 1γ as G protein-coupled receptor phosphatase for the sst5 receptor. Together, we provide direct evidence for agonist-selective phosphorylation of carboxyl-terminal T333. In addition, we identify G protein-coupled receptor kinase 2-mediated phosphorylation and protein phosphatase 1γ-mediated dephosphorylation of T333 as key regulators of rapid internalization and recycling of the human sst5 receptor.

  12. Induction chemotherapy before chemoradiotherapy and surgery for locally advanced rectal cancer. Is it time for a randomized phase III trial?

    Energy Technology Data Exchange (ETDEWEB)

    Roedel, Claus [Frankfurt Univ. (Germany). Klinik fuer Strahlentherapie und Onkologie; Arnold, Dirk [Halle Univ. (Germany). Klinik und Poliklinik fuer Innere Medizin IV; Becker, Heinz; Ghadimi, Michael; Liersch, Torsten [Goettingen Univ. (Germany). Klinik fuer Allgemein- und Visceralchirurgie; Fietkau, Rainer; Sauer, Rolf [Erlangen Univ. (Germany). Strahlenklinik; Graeven, Ullrich [Kliniken Maria Hilf GmbH, Moenchengladbach (Germany). Klinik fuer Haematologie, Onkologie und Gastroenterologie; Hess, Clemens [Goettingen Univ. (Germany). Klinik fuer Strahlentherapie und Radioonkologie; Hofheinz, Ralf [Universitaetsmedizin Mannheim (Germany). III. Medizinische Klinik Haematologie und Internistische Onkologie; Hohenberger, Werner [Erlangen Univ. (Germany). Chirurgische Klinik; Post, Stefan [Universitaetsmedizin Mannheim (Germany). Chirurgische Klinik; Raab, Rudolf [Klinikum Oldenburg (Germany). Klinik fuer Allgemein- und Visceralchirurgie; Wenz, Frederick [Universitaetsmedizin Mannheim (Germany). Klinik fuer Strahlentherapie und Radioonkologie

    2010-12-15

    Background: In the era of preoperative chemoradiotherapy (CRT) and total mesorectal excision (TME), the development of distant metastases is the predominant mode of failure in rectal cancer patients today. Integrating more effective systemic therapy into combined modality programs is the challenge. The question that needs to be addressed is how and when to apply systemic treatment with adequate dose and intensity. Material and Methods: This review article focuses on phase II-III trials designed to improve 5-fluorouracil (5-FU)-based combined modality treatment for rectal cancer patients through the inclusion of concurrent, adjuvant or, most recently, induction combination chemotherapy. Computerized bibliographic searches of PubMed were supplemented with hand searches of reference lists and abstracts of ASCO/ASTRO/ESTRO meetings. Results: After preoperative CRT and surgical resection, approximately one third of patients do not receive adjuvant chemotherapy, mainly due to surgical complications, patients' refusal, or investigator's discretion. In order to be able to apply chemotherapy with sufficient dose and intensity, an innovative approach is to deliver systemic therapy prior to preoperative CRT rather than adjuvant chemotherapy. Emerging evidence from several phase II trials and, recently, randomized phase II trials indicate that induction chemotherapy is feasible, does not compromise CRT or surgical resection, and enables the delivery of chemotherapy in adequate dose and intensity. Although this approach did not increase local efficacy in recent trials (e.g., pathological complete response rates, tumor regression, R0 resection rates, local control), it may help to improve control of distant disease. Conclusion: Whether this improvement in applicability and dose density of chemotherapy will ultimately translate into improved disease-free survival will have to be tested in a larger phase III trial. (orig.)

  13. The effect of foot reflexology on physiologic parameters and mechanical ventilation weaning time in patients undergoing open-heart surgery: A clinical trial study.

    Science.gov (United States)

    Ebadi, Abbas; Kavei, Parastoo; Moradian, Seyyed Tayyeb; Saeid, Yaser

    2015-08-01

    The aim of this study was to investigate the efficacy of foot reflexology on physiological parameters and mechanical ventilation weaning time in patients undergoing open-heart surgery. This was a double blind three-group randomized controlled trial. Totally, 96 patients were recruited and randomly allocated to the experimental, placebo, and the control groups. Study groups respectively received foot reflexology, simple surface touching, and the routine care of the study setting. Physiological parameters (pulse rate, respiratory rate, systolic and diastolic blood pressures, mean arterial pressure, percutaneous oxygen saturation) and weaning time were measured. The study groups did not differ significantly in terms of physiological parameters (P value > 0.05). However, the length of weaning time in the experimental group was significantly shorter than the placebo and the control groups (P value reflexology in shortening the length of weaning time.

  14. The effect of ranitidine on postoperative infectious complications following emergency colorectal surgery: a randomized, placebo-controlled, double-blind trial

    DEFF Research Database (Denmark)

    Moesgaard, F; Jensen, L S; Christiansen, P M

    1998-01-01

    OBJECTIVE AND DESIGN: To study the potential effect of ranitidine on postoperative infectious complications following emergency colorectal surgery. A randomized, placebo-controlled, double-blind trial was carried out in three university clinics and two county hospitals in Denmark. PATIENTS...... patients were withdrawn from the study (for reasons such as other diagnosis, refused to continue, medication not given as prescribed). MAIN OUTCOME MEASURES: Patients were observed for signs of infectious complications; such as wound infection, intra-abdominal abscess, septicemia, and pneumonia. RESULTS...... pneumonia were 12.9%, 5.2%, 3.8% and 14%, respectively in group I. In group II, the infectious complications were 16.1%, 6.8%, 6.9% and 22%, respectively. Twelve patients (13.8%) in the placebo group developed more than one complication...

  15. Comparably improved health-related quality of life after total arterial revascularization versus conventional coronary surgery--Copenhagen arterial revascularization randomized patency and outcome trial

    DEFF Research Database (Denmark)

    Damgaard, Sune; Lund, Jens T; Lilleør, Nikolaj B

    2011-01-01

    OBJECTIVE: We compared health-related quality of life up to 11 months after coronary artery bypass grafting using total arterial revascularization versus conventional coronary surgery. METHODS: In this randomized single-center trial, 161 patients underwent total arterial revascularization using.......01). For total arterial revascularization, there were also not statistically significant improvements for 'physical component summary' (P=0.09), 'bodily pain' (P=0.07) and 'vitality' (P=0.08). CONCLUSION: Health-related quality of life up to 1 year after total arterial revascularization is equal or slightly...... of the general Danish population. On all scales of the SF-36, there was statistically significant improvement at 3 and 11 months in both groups. For 'social functioning', the improvement following total arterial revascularization was significantly higher than following conventional revascularization (P=0...

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

    Science.gov (United States)

    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 (Spinal anaesthesia is an effective as well as a safe modality to anaesthetize the patient for day care urological procedures. This study shows lignocaine + butorphanol is preferable over bupivacaine for spinal anesthesia for day care

  17. The CURE-AF trial: a prospective, multicenter trial of irrigated radiofrequency ablation for the treatment of persistent atrial fibrillation during concomitant cardiac surgery.

    Science.gov (United States)

    Damiano, Ralph J; Badhwar, Vinay; Acker, Michael A; Veeragandham, Ramesh S; Kress, David C; Robertson, Jason O; Sundt, Thoralf M

    2014-01-01

    Ablation technology has been introduced to replace the surgical incisions of the Cox-Maze procedure in order to simplify the operation. However, the efficacy of these ablation devices has not been prospectively evaluated. The purpose of this study was to examine the efficacy and safety of irrigated unipolar and bipolar radiofrequency ablation for the treatment of persistent and long-standing persistent atrial fibrillation (AF) during concomitant cardiac surgical procedures. Between May 2007 and July 2011, 150 consecutive patients were enrolled at 15 U.S. centers. Patients were followed for 6 to 9 months, at which time a 24-hour Holter recording and echocardiogram were obtained. Recurrent AF was defined as any atrial tachyarrhythmia (ATA) lasting over 30 seconds on the Holter monitor. The safety end-point was the percent of patients who suffered a major adverse event within 30 days of surgery. All patients underwent a biatrial Cox-Maze lesion set. Operative mortality was 4%, and there were 4 (3%) 30-day major adverse events. Overall freedom from ATAs was 66%, with 53% of patients free from ATAs and also off antiarrhythmic drugs at 6 to 9 months. Increased left atrial diameter, shorter total ablation time, and an increasing number of concomitant procedures were associated with recurrent AF (P cardiac surgery was associated with a low complication rate. No device-related complications occurred. The Cox-Maze lesion set was effective at restoring sinus rhythm and had higher success rates in patients with smaller left atrial diameters and longer ablation times. © 2013 Heart Rhythm Society Published by Heart Rhythm Society All rights reserved.

  18. Scapula alata in early breast cancer patients enrolled in a randomized clinical trial of post-surgery short-course image-guided radiotherapy

    Directory of Open Access Journals (Sweden)

    Adriaenssens Nele

    2012-05-01

    Full Text Available Abstract Background Scapula alata (SA is a known complication of breast surgery associated with palsy of the serratus anterior, but it is seldom mentioned. We evaluated the risk factors associated with SA and the relationship of SA with ipsilateral shoulder/arm morbidity in a series of patients enrolled in a trial of post-surgery radiotherapy (RT. Methods The trial randomized women with completely resected stage I-II breast cancer to short-course image-guided RT, versus conventional RT. SA, arm volume and shoulder-arm mobility were measured prior to RT and at one to three months post-RT. Shoulder/arm morbidities were computed as a post-RT percentage change relative to pre-RT measurements. Results Of 119 evaluable patients, 13 (= 10.9% had pre-RT SA. Age younger than 50 years old, a body mass index less than 25 kg/m2, and axillary lymph node dissection were significant risk factors, with odds ratios of 4.8 (P = 0.009, 6.1 (P = 0.016, and 6.1 (P = 0.005, respectively. Randomization group was not significant. At one to three months’ post-RT, mean arm volume increased by 4.1% (P = 0.036 and abduction decreased by 8.6% (P = 0.046 among SA patients, but not among non-SA patients. SA resolved in eight, persisted in five, and appeared in one patient. Conclusion The relationship of SA with lower body mass index suggests that SA might have been underestimated in overweight patients. Despite apparent resolution of SA in most patients, pre-RT SA portended an increased risk of shoulder/arm morbidity. We argue that SA warrants further investigation. Incidentally, the observation of SA occurring after RT in one patient represents the second case of post-RT SA reported in the literature.

  19. Effectiveness of computer-navigated minimally invasive total hip surgery compared to conventional total hip arthroplasty: design of a randomized controlled trial

    Directory of Open Access Journals (Sweden)

    Bulstra Sjoerd K

    2007-01-01

    Full Text Available Abstract Background Moderate to severe osteoarthrosis is the most common indication for Total Hip Arthroplasty (THA. Minimally Invasive Total Hip Surgery (MIS and computer-navigated surgery were introduced several years ago. However, the literature lacks well-designed studies that provide evidence of superiority of computer-navigated MIS over a conventional THA technique. Hence, the purpose of this study is to compare (costeffectiveness of computer-navigated MIS with a conventional technique for THA. It is our hypothesis that computer-navigated MIS will lead to a quicker recovery during the early postoperative period (3 months, and to an outcome at least as good 6 months postoperatively. We also hypothesize that computer-navigated MIS leads to fewer perioperative complications and better prosthesis positioning. Furthermore, cost advantages of computer-navigated MIS over conventional THA technique are expected. Methods/design A cluster randomized controlled trial will be executed. Patients between the ages of 18 and 75 admitted for primary cementless unilateral THA will be included. Patients will be stratified using the Charnley classification. They will be randomly allocated to have computer-navigated MIS or conventional THA technique. Measurements take place preoperatively, perioperatively, and 6 weeks and 3 and 6 months postoperatively. Degree of limping (gait analysis, self-reported functional status and health-related quality of life (questionnaires will be assessed preoperatively as well as postoperatively. Perioperative complications will be registered. Radiographic evaluation of prosthesis positioning will take place 6 weeks postoperatively. An evaluation of costs within and outside the healthcare sector will focus on differences in costs between computer-navigated MIS and conventional THA technique. Discussion Based on studies performed so far, few objective data quantifying the risks and benefits of computer-navigated MIS are available

  20. The Effect of Mobile App Follow-up Care on the Number of In-person Visits Following Ambulatory Surgery: A Randomized Control Trial.

    Science.gov (United States)

    Armstrong, Kathleen; Coyte, Peter; Semple, John

    2015-01-01

    Women's College Hospital (WCH) in Toronto offers specialized ambulatory surgical procedures. A feasibility study using a mobile appliciation (app) to supplement in-person follow-up care after surgery suggests that the mobile app adequately detects postoperative complications, eliminates the need for in-person follow-up care and is cost-effective. This is concordant with other postoperative telemedicine studies. The purpose of this study is to determine if we can avert in-person follow-up care through the use of mobile app compared to conventional, in-person follow-up care in the first month following surgery amongst breast reconstruction patients at WCH. This will be a pragmatic, single-centre, open, controlled, 2-arm parallel-group superiority randomized trial. Mobile app follow-up care is a novel approach to managing patients postoperatively with the potential to avert in-person follow-up and generate cost-savings for the healthcare system and patient.

  1. Granisetron versus Granisetron-Dexamethasone for Prevention of Postoperative Nausea and Vomiting in Pediatric Strabismus Surgery: A Randomized Double-Blind Trial

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    Renu Sinha

    2016-01-01

    Full Text Available Aim. Efficacy of granisetron and combination of granisetron and dexamethasone was evaluated for prevention of postoperative nausea and vomiting (PONV in children undergoing elective strabismus surgery. Methods. A total of 136 children (1–15 years were included. Children received either granisetron (40 mcg/kg [group G] or combination of granisetron (40 mcg/kg and dexamethasone (150 mcg/kg [group GD]. Intraoperative fentanyl requirement and incidence and severity of oculocardiac reflex were assessed. PONV severity was assessed for first 24 hours and if score was >2, it was treated with metoclopramide. Postoperative analgesia was administered with intravenous fentanyl and ibuprofen. Results. The demographic profile, muscles operated, and fentanyl requirement were comparable. Complete response to PONV in first 24 hours was observed in 75% (51/68 of children in group G and 76.9% (50/65 of children in group GD, which was comparable statistically (p=0.96, Fisher exact test; OR 1.11, 95% CI 0.50, 2.46. Incidence of PONV between 0 and 24 hours was comparable. One child in group G required rescue antiemetic in first 24 hours and none of the children had severe PONV in group GD. There was no significant difference in incidence or severity of oculocardiac reflex. Conclusion. Dexamethasone did not increase efficacy of granisetron for prevention of PONV in elective pediatric strabismus surgery. Registration number of clinical trial was CTRI/2009/091/001000.

  2. The Influence of Oral Ginger before Operation on Nausea and Vomiting after Cataract Surgery under General Anesthesia: A double-blind placebo-controlled randomized clinical trial

    Science.gov (United States)

    Seidi, Jamal; Ebnerasooli, Shahrokh; Shahsawari, Sirous; Nzarian, Simin

    2017-01-01

    Background According to Iranian traditional medicine, using safe ginger may contribute to taking less chemical medicines and result in fewer side effects. Objective To determine the influence of using ginger before operation on nausea and vomiting, after cataract surgery under general anesthesia. Methods This study was a double-blind placebo-controlled randomized clinical trial conducted at Kurdistan University of Medical Sciences in 2015. 122 candidates of cataract surgery were randomly allocated in three groups. The first group received a ginger capsule in a single 1 g dose, the second received two separate doses of ginger capsule each containing 500 mg and the third group received placebo capsule before operation. The patients were examined and studied for the level of nausea and occurrence of vomiting for 6 hours after the operation. The intensity of nausea was scored from zero to ten, based upon Visual Analog Scale. SPSS version 20 was used to analyze the data. We used Chi square and Kruskal-Wallis test for the analyses of outcomes. Results The frequency and intensity of nausea and the frequency of vomiting after operation among those who had taken the ginger capsule in 2 separate 500 mg doses was less than the other 2 groups. This difference was significant (pKurdistan University of Medical Sciences, Sanandaj, Iran. PMID:28243400

  3. The effect of oral clonidine premedication on blood loss and the quality of the surgical field during endoscopic sinus surgery: a placebo-controlled clinical trial.

    Science.gov (United States)

    Mohseni, Masood; Ebneshahidi, Amin

    2011-08-01

    Bleeding during functional endoscopic sinus surgery (FESS) remains a challenge for both surgeons and anesthesiologists despite several modalities available for improving the surgical field. This study was conducted to evaluate the effect of oral clonidine premedication on blood loss and the quality of the surgical field in FESS. In a placebo-controlled clinical trial, a total of 84 American Society of Anesthesiologists (ASA) physical status I-II patients undergoing endoscopic sinus surgery for chronic sinusitis were randomly allocated to receive either oral clonidine 0.2 mg or identical-looking placebo tablets 90 min before arrival at the operating room. Blood loss in the clonidine group was 214 ± 67 ml on average and that in the placebo group was 276 ± 78 ml (mean ± SD, p clonidine group was significantly lower than that in the placebo group (2 (1-3) vs. 2.5 (2-4), p clonidine group than with that in the placebo group (median score, 4 (3-5) vs. 3 (1-5), p premedication with oral clonidine 0.2 mg can effectively reduce bleeding during FESS.

  4. Granisetron versus Granisetron-Dexamethasone for Prevention of Postoperative Nausea and Vomiting in Pediatric Strabismus Surgery: A Randomized Double-Blind Trial.

    Science.gov (United States)

    Sinha, Renu; Shende, Dilip; Maitra, Souvik; Kumar, Neeraj; Ray, Bikash Ranjan; Mohan, Virender Kumar

    2016-01-01

    Aim. Efficacy of granisetron and combination of granisetron and dexamethasone was evaluated for prevention of postoperative nausea and vomiting (PONV) in children undergoing elective strabismus surgery. Methods. A total of 136 children (1-15 years) were included. Children received either granisetron (40 mcg/kg) [group G] or combination of granisetron (40 mcg/kg) and dexamethasone (150 mcg/kg) [group GD]. Intraoperative fentanyl requirement and incidence and severity of oculocardiac reflex were assessed. PONV severity was assessed for first 24 hours and if score was >2, it was treated with metoclopramide. Postoperative analgesia was administered with intravenous fentanyl and ibuprofen. Results. The demographic profile, muscles operated, and fentanyl requirement were comparable. Complete response to PONV in first 24 hours was observed in 75% (51/68) of children in group G and 76.9% (50/65) of children in group GD, which was comparable statistically (p = 0.96, Fisher exact test; OR 1.11, 95% CI 0.50, 2.46). Incidence of PONV between 0 and 24 hours was comparable. One child in group G required rescue antiemetic in first 24 hours and none of the children had severe PONV in group GD. There was no significant difference in incidence or severity of oculocardiac reflex. Conclusion. Dexamethasone did not increase efficacy of granisetron for prevention of PONV in elective pediatric strabismus surgery. Registration number of clinical trial was CTRI/2009/091/001000.

  5. The Effect of Sufentanil Administration on Remifentanil-Based Anaesthesia during Laparoscopic Gynaecological Surgery: A Double-Blind Randomized Controlled Trial

    Directory of Open Access Journals (Sweden)

    Ilsoon Son

    2014-01-01

    Full Text Available This study assessed the effect of sufentanil administered before conclusion of remifentanil-based anaesthesia on postoperative hyperalgesia and haemodynamic stability in patients undergoing laparoscopic gynaecological surgery. The patients were randomly allocated to a sufentanil administration group (S group or a normal saline administration group (C group. Anaesthesia was induced and maintained with controlled administration of remifentanil at 10 ng·mL−1 and propofol under bispectral index guidance. Once the surgical specimen was procured, sufentanil or normal saline was administered at 0.15 ng·mL−1 and maintained until extubation. The haemodynamic status during anaesthetic emergence was evaluated. The pain and postoperative nausea and vomiting (PONV were assessed for 72 h following postanaesthetic care unit (PACU discharge. The S group had significantly lower mean systemic arterial blood pressure and heart rate changes between the start of drug administration and extubation. Postoperative pain was significantly lower in the S group until 24 h following PACU discharge. There were no significant differences in PONV incidence and severity 72 h after PACU discharge between the two groups. Sufentanil administration before concluding remifentanil-based anaesthesia improved postoperative hyperalgesia and achieved haemodynamic stability at extubation without delaying recovery or increasing PONV during laparoscopic gynaecological surgery. Clinical trial registration is found at KCT0000785.

  6. Gabapentin Does Not Appear to Improve Postoperative Pain and Sleep Patterns in Patients Who Concomitantly Receive Regional Anesthesia for Lower Extremity Orthopedic Surgery: A Randomized Control Trial

    Science.gov (United States)

    Amin, Shawn; Reilly, Mark C.; Shulman, Steven

    2017-01-01

    In recent years, gabapentin has gained popularity as an adjuvant therapy for the treatment of postoperative pain. Numerous studies have shown a decrease in pain score, even with immediate postoperative activity, which is significant for early post-op ambulation and regaining functionality sooner. However, studies have been in conclusive in patients undergoing lower extremity orthopedic surgery. For this reason, we hoped to study the effect of gabapentin on postoperative pain in patients undergoing total knee arthroplasty, total hip arthroplasty, or a hip fracture repair. This was done in the setting of ensuring adequate postoperative analgesia with regional blocks and opioid PCA, as is protocol at our institution. Given the sedative effects of gabapentin and the potential for improving postoperative sleep patterns, we also studied the drug's effect on this aspect of our patient's postoperative course. We utilized the Pittsburg Sleep Quality Index and Visual Analog Scale for pain to obtain a more objective standardized score amongst our study population. Our results indicate that gabapentin does not offer any additional relief in pain or improve sleep habits in patients who have received either a femoral or lumbar plexus block for lower extremity orthopedic surgery. This trial is registered with NCT01546857.

  7. Comparison of volume controlled ventilation and pressure controlled ventilation in patients undergoing robot-assisted pelvic surgeries: An open-label trial

    Science.gov (United States)

    Jaju, Rishabh; Jaju, Pooja Bihani; Dubey, Mamta; Mohammad, Sadik; Bhargava, AK

    2017-01-01

    Background and Aims: Although volume controlled ventilation (VCV) has been the traditional mode of ventilation in robotic surgery, recently pressure controlled ventilation (PCV) has been used more frequently. However, evidence on whether PCV is superior to VCV is still lacking. We intended to compare the effects of VCV and PCV on respiratory mechanics and haemodynamic in patients undergoing robotic surgeries in steep Trendelenburg position. Methods: This prospective, randomized trial was conducted on sixty patients between 20 and 70 years belonging to the American Society of Anesthesiologist Physical Status I–II. Patients were randomly assigned to VCV group (n = 30), where VCV mode was maintained through anaesthesia, or the PCV group (n = 30), where ventilation mode was changed to PCV after the establishment of 40° Trendelenburg position and pneumoperitoneum. Respiratory (peak and mean airway pressure [APpeak, APmean], dynamic lung compliance [Cdyn] and arterial blood gas analysis) and haemodynamics variables (heart rate, mean blood pressure [MBP] central venous pressure) were measured at baseline (T1), post-Trendelenburg position at 60 min (T2), 120 min (T3) and after resuming supine position (T4). Results: Demographic profile, haemodynamic variables, oxygen saturation and minute ventilation (MV) were comparable between two groups. Despite similar values of APmean, APpeak was significantly higher in VCV group at T2 and T3 as compared to PCV group (P < 0.001). Cdyn and PaCO2 were also better in PCV group than in VCV group (P < 0.001 and 0.045, respectively). Conclusion: PCV should be preferred in robotic pelvic surgeries as it offers lower airway pressures, greater Cdyn and a better-preserved ventilation-perfusion matching for the same levels of MV. PMID:28216699

  8. Comparison of volume controlled ventilation and pressure controlled ventilation in patients undergoing robot-assisted pelvic surgeries: An open-label trial

    Directory of Open Access Journals (Sweden)

    Rishabh Jaju

    2017-01-01

    Full Text Available Background and Aims: Although volume controlled ventilation (VCV has been the traditional mode of ventilation in robotic surgery, recently pressure controlled ventilation (PCV has been used more frequently. However, evidence on whether PCV is superior to VCV is still lacking. We intended to compare the effects of VCV and PCV on respiratory mechanics and haemodynamic in patients undergoing robotic surgeries in steep Trendelenburg position. Methods: This prospective, randomized trial was conducted on sixty patients between 20 and 70 years belonging to the American Society of Anesthesiologist Physical Status I–II. Patients were randomly assigned to VCV group (n = 30, where VCV mode was maintained through anaesthesia, or the PCV group (n = 30, where ventilation mode was changed to PCV after the establishment of 40° Trendelenburg position and pneumoperitoneum. Respiratory (peak and mean airway pressure [APpeak, APmean], dynamic lung compliance [Cdyn] and arterial blood gas analysis and haemodynamics variables (heart rate, mean blood pressure [MBP] central venous pressure were measured at baseline (T1, post-Trendelenburg position at 60 min (T2, 120 min (T3 and after resuming supine position (T4. Results: Demographic profile, haemodynamic variables, oxygen saturation and minute ventilation (MV were comparable between two groups. Despite similar values of APmean,APpeakwas significantly higher in VCV group at T2 and T3 as compared to PCV group (P < 0.001. Cdynand PaCO2were also better in PCV group than in VCV group (P < 0.001 and 0.045, respectively. Conclusion: PCV should be preferred in robotic pelvic surgeries as it offers lower airway pressures, greater Cdynand a better-preserved ventilation-perfusion matching for the same levels of MV.

  9. Comparison of calcium alginate and carboxymethyl cellulose for nasal packing after endoscopic sinus surgery: a prospective, randomised, controlled single-blinded trial.

    Science.gov (United States)

    Park, D-Y; Chung, H J; Sim, N S; Jo, K H; Kim, D H; Kim, C-H; Yoon, J-H

    2016-06-01

    Calcium alginate is a biodegradable gel-transforming agent widely used for nasal packing. It can reduce pain and improve comfort. However, few randomised controlled trials have compared the efficacy of calcium alginate nasal packing with that of other biodegradable gel-transforming materials. Prospective, randomised, single-blinded controlled study. Yonsei University Severance Hospital, a tertiary academic medical centre. Twenty-seven patients (54 nostrils) with chronic rhinosinusitis who were scheduled for bilateral endoscopic sinus surgery were enrolled. After surgery, one nostril was packed with calcium alginate and the other with carboxymethyl cellulose. Only patients with an intersinus chronic rhinosinusitis severity score difference of ≤1 were included. Visual analogue scale (VAS) scores for postoperative pain, discomfort from nasal discharge and pain during packing removal were analysed. Two independent rhinologists who were blinded to the assessments separately scored adhesions, oedema and infection by endoscopic digital photography at 1, 4 and 8 weeks postoperatively. There were no significant differences in VAS scores for postoperative pain, discomfort from nasal discharge or pain during packing removal between calcium alginate packings and carboxymethyl cellulose packings. Inter-rater variability of adhesion, oedema and infection scores was acceptable. Adhesion severity and oedema scores at 4 weeks were significantly lower with calcium alginate packing than with carboxymethyl cellulose. Infection severity scores also tended to be lower with calcium alginate than with carboxymethyl cellulose, but the difference was not significant. Calcium alginate nasal packing is associated with reduced severity of oedema and adhesions after endoscopic sinus surgery. © 2015 John Wiley & Sons Ltd.

  10. Comparison of the analgesic effect of ibuprofen with mesalamine after discectomy surgery in patients with lumbar disc herniation: A double-blind randomized controlled trial

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    Toroudi Hamidreza

    2009-01-01

    Full Text Available Background: Pain management is an important component in the postoperative period following discectomy. Aims: We hypothesized that mesalamine considering its better safety profile, is likely to be a better choice, if it would be as effective as ibuprofen in controlling post-discectomy pain. Settings and Design: A double-blind randomized controlled trial was performed on patients who underwent lumbar discectomy surgery. Materials and Methods: Of the 58 patients who had lumbar discectomy, 27 patients were randomized to oral ibuprofen 500 mg and 31 patients to mesalamine 400 mg, three times a day for nine days following surgery. There was no placebo group. Severity of pain was assessed by using 10- cm visual analogue scale (VAS, once before operation and for nine days after. Statistical Analysis: Mean ± SD pain scores were compared between groups and the statistical difference was estimated by Student′s test using SPSS (Version 13. We also calculated the power of each t-test. Repeated measure ANOVA was performed for measuring the effect of time. Results: The age range of the patients was 35 to 60 years (mean: 42.2 years. Mean ± SD preoperative pain scores for ibuprofen or mesalamine-treated groups were 7.852 ± 2.441 and 7.806 ± 2.892, respectively. At the end of day 9, mean ± SD of pain score was 2.704 ± 2.284 and 2.717 ± 2.273 for ibuprofen and mesalamine-treated groups respectively. Both drugs significantly reduced postoperative pain and there was no statistically significant difference between the two groups.Conclusions: Since both drugs showed almost equal analgesic effect, considering its safety profile mesalamine, seems to be the preferred choice to alleviate post-discectomy surgery pain.

  11. Ultrasound-Assisted Thoracic Paravertebral Block Reduces Intraoperative Opioid Requirement and Improves Analgesia after Breast Cancer Surgery: A Randomized, Controlled, Single-Center Trial.

    Directory of Open Access Journals (Sweden)

    Lijian Pei

    Full Text Available The contribution of ultrasound-assisted thoracic paravertebral block to postoperative analgesia remains unclear. We compared the effect of a combination of ultrasound assisted-thoracic paravertebral block and propofol general anesthesia with opioid and sevoflurane general anesthesia on volatile anesthetic, propofol and opioid consumption, and postoperative pain in patients having breast cancer surgery.Patients undergoing breast cancer surgery were randomly assigned to ultrasound-assisted paravertebral block with propofol general anesthesia (PPA group, n = 121 or fentanyl with sevoflurane general anesthesia (GA group, n = 126. Volatile anesthetic, propofol and opioid consumption, and postoperative pain intensity were compared between the groups using noninferiority and superiority tests.Patients in the PPA group required less sevoflurane than those in the GA group (median [interquartile range] of 0 [0, 0] vs. 0.4 [0.3, 0.6] minimum alveolar concentration [MAC]-hours, less intraoperative fentanyl requirements (100 [50, 100] vs. 250 [200, 300]μg,, less intense postoperative pain (median visual analog scale score 2 [1, 3.5] vs. 3 [2, 4.5], but more propofol (median 529 [424, 672] vs. 100 [100, 130] mg. Noninferiority was detected for all four outcomes; one-tailed superiority tests for each outcome were highly significant at P<0.001 in the expected directions.The combination of propofol anesthesia with ultrasound-assisted paravertebral block reduces intraoperative volatile anesthetic and opioid requirements, and results in less post operative pain in patients undergoing breast cancer surgery.ClinicalTrial.gov NCT00418457.

  12. Play distraction versus pharmacological treatment to reduce anxiety levels in children undergoing day surgery: a randomized controlled non-inferiority trial.

    Science.gov (United States)

    Al-Yateem, N; Brenner, M; Shorrab, A A; Docherty, C

    2016-07-01

    Perioperative experience can be one of the most distressful experiences in a child's life if not managed properly by healthcare professionals. Its consequences can extend well beyond surgery and recovery into the child's future life. Healthcare professionals have a responsibility to decrease the anxiety associated with this experience, improve the child's and the parent's experience and prevent negative consequences. This has traditionally been performed through pharmacological treatment which might have negative side effects. More developmentally appropriate distraction methods are currently being trialled globally to augment the evidence that supports their use as a similarly efficient alternative. The aim of this study was to explore the efficiency of storytelling, pictures and colouring activities as an anxiolytic intervention in comparison to the traditional pharmacological premedication technique in a non-inferiority study. A randomized non-inferiority controlled trial was carried out in 168 children scheduled for day surgery. Children's perioperative anxiety was assessed by a trained anaesthetist using the modified Yale Preoperative Assessment Scale and by parents using the State-Trait Anxiety Inventory for Children. Children's vital signs were also collected preoperatively during the induction period and during the recovery period. The primary endpoint, which is non-inferiority in terms of anxiety as per Yale Preoperative Assessment Scale survey between play distraction and preoperative medication, was met [average score 10.95 vs. 10.94, respectively, 95% confidence interval (-0.35; 0.37); P = 0.941]. Moreover, anxiety scores of both the intervention and the control group were quite comparable as per STAIC survey [20.90 vs. 20.73, respectively, 95% confidence interval (-0.52; 0.88); P = 0.708] and in terms of vital signs. The results indicate that the distraction technique employed can be considered as an efficient alternative to traditional

  13. Comparison the effect of stump closure by endoclips versus endoloop on the duration of surgery and complications in patients under laparoscopic appendectomy: A randomized clinical trial

    Science.gov (United States)

    Sadat-Safavi, Seyed Abas; Nasiri, Shirzad; Shojaiefard, Abolfazl; Jafari, Mehdi; Abdehgah, Ali Ghorbani; Notash, Aidin Yghoobi; Soroush, Ahmadreza

    2016-01-01

    Background: Laparoscopic appendectomy is a well-described surgical technique. However, concerns still exist regarding whether the closure of the appendiceal stump should be done with a clip, an endoloop, or other techniques. In this study, the effect of stump closure on duration of surgery and complications by endoclips was compared with endoloop in patients under laparoscopic appendectomy. The study was carried out as a prospective randomized clinical trial between 2013 and 2015 in Shariati Hospital of Tehran. Materials and Methods: Seventy-six patients under laparoscopic appendectomy were enrolled and randomly assigned to receive either endoclips or endoloop for stump closure. The results in terms of the operating time, length of hospital stay, and the complications were compared and analyzed between two groups. After collecting the essential data by using a checklist and examination of patients, the data were analyzed with SPSS. Results: The mean age was 23.13 ± 5.07 years and 44.7% of the patients were male. Moreover, in this study, it was seen that the mean duration of surgery was 23.2 min versus 21.5 min in endoloop and endoclips groups, respectively (P = 0.021). There was no difference between hospital stay among two groups (P > 0.05). Furthermore, the complications were same in two groups (P > 0.05). Conclusion: The effect of stump closure with endoloop versus endoclips is not different for complications, but the duration of surgery was shorter in endoclips method. Both methods could be used based on the opinion of the surgeon without expecting a statistically significant difference in the results. PMID:28163733

  14. Rainfall variability over Alagoas under the influences of SST anomalies

    Science.gov (United States)

    Lyra, G. B.; Oliveira-Júnior, J. F.; Gois, G.; Cunha-Zeri, G.; Zeri, M.

    2017-04-01

    The rainfall variability for the state of Alagoas, Northeast of Brazil, was evaluated based on the Standardized Precipitation Index (SPI). Harmonic decomposition was applied to 31 years-long (1960-1990) series of SPI, from 33 stations, to relate their modes of variability to El Niño-Southern Oscillation (ENSO) and the Atlantic Ocean sea surface temperature (SST). The most important harmonics identified by the spectral analysis had periods of 10-15 and 2-3 years, followed by other oscillations with smaller periods. The 10-15 years harmonic was associated with the Atlantic interhemispheric SST gradient (AITG), a cross-equatorial dipole which impacts the northeast region of Brazil by influencing the position of the intertropical convergence zone (ITCZ), leading to dry or wet conditions. The 2-3 years harmonic was consistent with the variability of ENSO events. The harmonic analysis is a powerful tool to identify the principal modes of variability of SPI. Although the magnitude of SPI is underestimated in some cases, this tool significantly increases the knowledge of the main drivers of rainfall and droughts in the region.

  15. Assembly & Metrology of First Wall Components of SST-1

    Science.gov (United States)

    Parekh, Tejas; Santra, Prosenjit; Biswas, Prabal; Patel, Hiteshkumar; Paravastu, Yuvakiran; Jaiswal, Snehal; Chauhan, Pradeep; Babu, Gattu Ramesh; A, Arun Prakash; Bhavsar, Dhaval; Raval, Dilip C.; Khan, Ziauddin; Pradhan, Subrata

    2017-04-01

    First Wall Components (FWC) of SST-1 tokamak, which are in the immediate vicinity of plasma comprises of limiters, divertors, baffles, passive stabilizers are designed to operate long duration (1000 s) discharges of elongated plasma. All FWC consists of a copper alloy heat sink modules with SS cooling tubes brazed onto it, graphite tiles acting as armour material facing the plasma, and are mounted to the vacuum vessels with suitable Inconel support structures at ring & port locations. The FWC are very recently assembled and commissioned successfully inside the vacuum vessel of SST-1 undergoing a meticulous planning of assembly sequence, quality checks at every stage of the assembly process. This paper will present the metrology aspects & procedure of each FWC, both outside the vacuum vessel, and inside the vessel, assembly tolerances, tools, equipment and jig/fixtures, used at each stage of assembly, starting from location of support bases on vessel rings, fixing of copper modules on support structures, around 3800 graphite tile mounting on 136 copper modules with proper tightening torques, till final toroidal and poloidal geometry of the in-vessel components are obtained within acceptable limits, also ensuring electrical continuity of passive stabilizers to form a closed saddle loop, electrical isolation of passive stabilizers from vacuum vessel.

  16. Development of a Virtual Reality Exposure Tool as Psychological Preparation for Elective Pediatric Day Care Surgery: Methodological Approach for a Randomized Controlled Trial.

    Science.gov (United States)

    Eijlers, Robin; Legerstee, Jeroen S; Dierckx, Bram; Staals, Lonneke M; Berghmans, Johan; van der Schroeff, Marc P; Wijnen, Rene Mh; Utens, Elisabeth Mwj

    2017-09-11

    Preoperative anxiety in children is highly prevalent and is associated with adverse outcomes. Existing psychosocial interventions to reduce preoperative anxiety are often aimed at distraction and are of limited efficacy. Gradual exposure is a far more effective way to reduce anxiety. Virtual reality (VR) provides a unique opportunity to gradually expose children to all aspects of the operating theater. The aims of our study are (1) to develop a virtual reality exposure (VRE) tool to prepare children psychologically for surgery; and (2) to examine the efficacy of the VRE tool in a randomized controlled trial (RCT), in which VRE will be compared to care as usual (CAU). The VRE tool is highly realistic and resembles the operating room environment accurately. With this tool, children will not only be able to explore the operating room environment, but also get accustomed to general anesthesia procedures. The PREoperative Virtual reality Intervention to Enhance Wellbeing (PREVIEW) study will be conducted. In this single-blinded RCT, 200 consecutive patients (aged 4 to 12 years) undergoing elective day care surgery for dental, oral, or ear-nose-throat problems, will be randomly allocated to the preoperative VRE intervention or CAU. The primary outcome is change in child state anxiety level between baseline and induction of anesthesia. Secondary outcome measures include child's postoperative anxiety, emergence delirium, postoperative pain, use of analgesics, health care use, and pre- and postoperative parental anxiety. The VRE tool has been developed. Participant recruitment began March 2017 and is expected to be completed by September 2018. To our knowledge, this is the first RCT evaluating the effect of a VRE tool to prepare children for surgery. The VRE intervention is expected to significantly diminish preoperative anxiety, postoperative pain, and the use of postoperative analgesics in pediatric patients. The tool could create a less stressful experience for both

  17. Central corneal thickness changes in bevel-up versus bevel-down phacoemulsification cataract surgery: study protocol for a randomised, triple-blind, parallel group trial.

    Science.gov (United States)

    Kaup, Soujanya; Shivalli, Siddharudha; Ks, Divyalakshmi; Arunachalam, Cynthia; Varghese, Rejitha Chinnu

    2016-09-29

    Corneal endothelial damage following phacoemulsification is still one of the major concerns of modern day cataract surgery. Although many techniques have been proposed, the risks of posterior capsular rupture and corneal endothelium damage persist. In theory, damage to the corneal endothelium is minimised by delivering the lowest phaco energy only in the direction necessary to emulsify the lens nucleus. Hence, it is believed that the bevel of the needle should be turned towards the nucleus or the nuclear fragment (ie, bevel-down. However, there is a difference of opinion among ophthalmologists with reference to the phaco tip's position (bevel-up vs bevel-down) during phacoemulsification. This subject has not been extensively studied earlier. This is a prospective, triple-blinded (trial participant, outcome assessor and the data analyst), randomised controlled trial with 2 parallel groups and with an allocation ratio of 1:1. It will be conducted in a tertiary care hospital, Mangaluru, India. The objective is to compare the postoperative central corneal thickness changes between the bevel-up and bevel-down techniques of phacoemulsification. Patients aged >18 years with immature cataract undergoing phacoemulsification will be selected for the study. The important exclusion criteria are the history of previous significant ocular trauma or intraocular surgery, corneal pathology, pseudoexfoliation syndrome, intraocular inflammation, a preoperative fully dilated pupil 4. After randomisation, patients will undergo phacoemulsification surgery either by a bevel-up or bevel-down procedure. With an estimated power of 80%, the calculated sample size is 55 patients in each group. The recruitment will start from April 2016. Yenepoya University Ethics Committee, India has approved the study protocol (YUEC/148/2016 on 18 February 2016). It complies with the Declaration of Helsinki, local laws and the International Council for Harmonization-good clinical practices. CTRI/2016

  18. Sevoflurane Versus Propofol for Myocardial Protection in Patients Undergoing Coronary Artery Bypass Grafting Surgery:a Meta-analysis of Randomized Controlled Trials

    Institute of Scientific and Technical Information of China (English)

    Yun-tai Yao; Li-huan Li

    2009-01-01

    Objective To systematically review randomized controlled trials to compare myocardial protection profiles of sevoflurane with propofol in patients undergoing coronary artery bypass grafting(CABG)surgery.Methods Electronic databases were searched to identify all randomized controlled trials comparing sevoflurane with propofol for protecting myocardiurn in adult patients undergoing CABG surgery.Two authors independently extracted patients' perioperative data,including patients' baseline characteristics,surgical variables,and outcome data.For continuous variables,treatment effects were calculated as weighted mean difference(WMD)and 95% confidential interval(C0.For dichotomous data,treatment effects were calculated as odds ratio(OR)and 95% CI.Each outcome was tested for heterogeneity,and randomized-effects or fixed-effects model was used in the presence or absence of significant heterogeneity(Q test P<0.05).Sensitivity analyses were done by examining the influence of statistical model on estimated treatment effects.Publication bias was explored through visual inspection of funnel plots of the outcomes.Statistical significance was defined as P<0.05.Results Our search yielded 13 studies including 696 patients,and 402 patients were allocated into sevoflurane group and 294 into propofol group.There was no significant difference in postoperative mechanical ventilation time,inotropic support,mortality,myocardial infarction,and atrial fibrillation between the two groups(all P>0.05).Patients randomized into sevoflurane group had higher post-bypass cardiac index(WMD=0.39,95% CI:0.18 to 0.60,P=0.0003),lower troponin I level(WMD=-0.82,95% CI:-0.87 to-0.85,P=0.0002),lower incidence of myocardial ischemia(OR=0.37,95% CI:0.16 to 0.83,P=0.02),shorter ICU and hospital stay length(WMD=-10.99,95% CI:-12.97 to-9.01,P<0.00001;WMD=-0.78,95% CI:-1.00 to-0.56,P<0.00001,respectively).Conclusion This meta-analysis has found some evidence showing that sevoflurane has better myocardial

  19. Ethanol lock therapy (E-Lock in the prevention of catheter-related bloodstream infections (CR-BSI after major heart surgery (MHS: a randomized clinical trial.

    Directory of Open Access Journals (Sweden)

    María Jesús Pérez-Granda

    Full Text Available Lock-therapy with antimicrobials has been used for the treatment and prevention of catheter-related bloodstream infections (CR-BSI. Experiences with Ethanol-Locks (E-locks have included therapeutic interventions with variable results. Patients undergoing Major Heart Surgery (MHS are a high-risk population for CR-BSI.The aim of this study was to assess the efficacy and tolerance to E-Locks in the prevention of CR-BSI of patients undergoing MHS.This is an academic, prospective, randomized, non-blinded and controlled clinical trial assessing the incidence of CR-BSI of patients with E-locks (E-lock and the tolerance to the procedure in comparison with patients receiving conventional catheter-care (CCC. Patients undergoing MHS with intravascular catheters for more than 48 hours were randomly assigned into treatment or control group by a computer-generated list of randomly assigned numbers. In the treatment group, all their catheter lumens were locked with an ethanol solution at 70% for two hours, every three days (E-Locks. The control group received conventional catheter-care (CCC. Overall, 200 patients with 323 catheters were included in the study, which was stopped after 10 months due to adverse events. Of them, 179 catheters (113 patients had E-Locks and 144 catheters (87 patients were CCC. Euroscore Surgical Risk in both groups was 4.04 vs 4.07 p = 0.94 respectively. The results for the E-Locks and CCC were as follows: Incidence of CR-BSI/1000 days of exposure 2.1 vs 5.2 (p = 0.33, catheter tip colonization 14 (7.8% vs 6 (4.2% patients (p = 0.17, median length of hospital stay, 15 vs 16 days (p = 0.77. Seven patients (6.19%, all in the ethanol branch, had to discontinue the trial due to intolerance or adverse events.We do not recommend prophylaxis of CR-BSI with ethanol-lock on a routine basis in patients undergoing Major Heart Surgery.Clinical Trials.gov NCT01229592.

  20. Stopping versus continuing acetylsalicylic acid before coronary artery bypass surgery: A systematic review and meta-analysis of 14 randomized controlled trials with 4499 patients.

    Science.gov (United States)

    Sá, Michel Pompeu Barros Oliveira; Soares, Artur Freire; Miranda, Rodrigo Gusmão Albuquerque; Araújo, Mayara Lopes; Menezes, Alexandre Motta; Silva, Frederico Pires Vasconcelos; Lima, Ricardo Carvalho

    2017-08-16

    This study aimed to evaluate the efficacy and safety of continuing versus stopping aspirin [acetylsalicylic acid (ASA)] preoperatively in patients undergoing coronary artery bypass graft surgery. MEDLINE, EMBASE, CENTRAL/Cochrane Controlled Trials Register (CCTR), ClinicalTrials.gov, Scientific Electronic Library Online (SciELO), Literatura Latino Americana em Ciências da Saúde (LILACS), Google Scholar and reference lists of relevant articles were searched for randomized controlled trials that reported efficacy outcomes of myocardial infarction and mortality, and safety outcomes of blood loss, packed red blood cell transfusion and surgical re-exploration were compared between groups. Fourteen studies fulfilled our eligibility criteria and included a total of 4499 patients (2329 for 'continuing ASA' and 2170 for 'stopping ASA'). In the pooled analysis, continuing aspirin therapy did not reduce the risk of myocardial infarction [risk ratio 0.834, 95% confidence interval (CI) 0.688-1.010; P = 0.063] or operative mortality (risk ratio 1.384, 95% CI 0.727-2.636; P = 0.323). Preoperative ASA increased postoperative chest tube drainage (mean difference 143 ml, 95% CI 39-248 ml; P = 0.007) and packed red blood cell transfusion (mean difference 142 ml, 95% CI 55-228; P = 0.001) but did not increase the risk of surgical re-exploration (risk ratio 1.316, 95% CI 0.910-1.905; P = 0.145). This meta-analysis found no statistically significant difference regarding the risk of operative mortality and myocardial infarction between the 'continuing ASA' and 'stopping ASA' strategies. On the other hand, the mean volume of blood loss and packed red blood cell transfusion was higher in the 'continuing ASA' group, but this finding did not translate into higher risk of reoperation for bleeding.

  1. SST THERMAL FORCING - A DISCUSSION ON THE MECHANISM OF ATMOSPHERIC LOW-FREQUENCY OSCILLATION

    Institute of Scientific and Technical Information of China (English)

    2001-01-01

    Dynamic and numerical methods are used to discuss the atmospheric response to SST thermal forcing. The results show that for planetary scale systems, the standing SST thermal forcing can quickly excite a stable atmospheric equilibrium state response, which is characterized by obvious large-scale teleconnection oscillation in east-west and south-north directions. For synoptic scale systems, the SST thermal forcing mainly excites the atmospheric low-frequency oscillation. Some basic relation and dynamic processes between SST thermal forcing and atmospheric response pattern are revealed and some new viewpoints are presented.

  2. EFFICACY OF MUSIC THERAPY IN THE REDUCTION OF REQUIREMENT OF SEDATIVE AGENTS, IN SURGERIES PERFORMED UNDER CAUDAL ANAESTHESIA: A ONE YEAR DOUBLE BLINDED RANDOMIZED CONTROLLED TRIAL

    Directory of Open Access Journals (Sweden)

    Manjunath C

    2014-09-01

    Full Text Available CONTEXT: Paediatric patients undergoing surgeries under regional anaesthesia require adequate sedation. Various intravenous agents and inhalational anaesthetics have been used for this purpose. The purpose of this study is to establish a relationship between music and intra operative requirement of sedative agents (inhalational and intravenous agents in pediatric patients undergoing surgeries under caudal epidural anaesthesia. AIM: The aim of this study is to establish a relationship between music and reduction in intra operative requirement of sedative agents (inhalational and intravenous agents in pediatric patients undergoing surgeries under caudal epidural anaesthesia. SETTINGS AND DESIGN: One year hospital based double blinded randomized clinical controlled trial. MATERIALS AND METHODS: 50 ASA grade I and II children in the age group of 1 to 6 years who were scheduled for herniotomy were included in this study. Children were randomly divided into two groups A and B. All the children received 1 ml/kg body weight of 0.25% bupivacaine in caudal epidural space, in addition all the a head phone was applied in all the children, the children in Group A were played a classical Indian music via head phone whereas children in Group B were devoid of any music in the intra operative period. SpO2, ECG, NIBP were monitored intra operatively. Level of sedation using “Ramsay Sedation Scale”. If the sedation scale was < 3, Inj.midazolam-0.03 mg/kg was administered i.v. as and when required, so that the maximum dose did not cross 0.6mg/kg4. If the midazolam requirement exceeded the maximum dose then adequate sedation scores were achieved using sevoflurane. The total number of doses of sedatives required and the total dose required were noted. STASTICAL ANALYSIS: The data was analyzed using the Mann Whitney test and Student’s t test comparing the sedation scores of between the two groups. RESULTS: The demographic parameters, duration of surgery were

  3. Immediate function on the day of surgery compared with a delayed implant loading process in the mandible: a randomized clinical trial over 5 years.

    Science.gov (United States)

    Jokstad, Asbjorn; Alkumru, Hassan

    2014-12-01

    To appraise the feasibility of loading four implants with a pre-existing denture converted to a fixed dental prosthesis (FDP) on the day of implant surgery compared with waiting for 3- to 4-month healing. Patients with an edentulous, fully healed mandible were recruited in a faculty clinic to partake in a blinded two-arm parallel randomized controlled trial (RCT). The participants received four parallel intraforamina mandibular implants with a moderately rough titanium surface (Brånemark System Mk III or Mk IV TiUnite; Nobel Biocare AB, Göteborg, Sweden). The implants were loaded on the same day by converting the participants' pre-existing denture in the experimental group. The implants were placed using a one-stage surgery procedure, and the participants' pre-existing denture were soft-relined in the control group. For both groups, the permanent 10- to 12-unit FDP consisting of a type-3 cast precious alloy veneered with acrylic and artificial teeth was placed 3-4 months after implant surgery. All participants have been recalled annually for 5 years for appraisal of bone loss and registration of adverse events. Thirty-five of the original 42 participants (83%) returned for clinical and radiological examinations at the 5-year follow-up recall. No selective dropout or specific reasons for dropout was identified in the two study arms; leaving n = 17 (Intention-to-treat group, ITT) in the experimental group, alternatively n = 13 as per protocol group (PP), and n = 18 participants in the control group (ITT = PP). At study commencement, five of the participants assigned to the experimental group did not receive their planned intervention. In the control group, one implant failed to osseointegrate and another failed due to bone loss after 5 years. The crestal bone level changes over 5 years were identical in the experimental and control groups, that is, 1.2 mm (SD = 0.7). There were no differences between the two study arms with regard to incidence of biological and

  4. Immediate function on the day of surgery compared with a delayed implant loading process in the mandible: a randomized clinical trial over 5 years

    Science.gov (United States)

    Jokstad, Asbjorn; Alkumru, Hassan

    2014-01-01

    Objectives To appraise the feasibility of loading four implants with a pre-existing denture converted to a fixed dental prosthesis (FDP) on the day of implant surgery compared with waiting for 3- to 4-month healing. Methods Patients with an edentulous, fully healed mandible were recruited in a faculty clinic to partake in a blinded two-arm parallel randomized controlled trial (RCT). The participants received four parallel intraforamina mandibular implants with a moderately rough titanium surface (Brånemark System Mk III or Mk IV TiUnite; Nobel Biocare AB, Göteborg, Sweden). The implants were loaded on the same day by converting the participants' pre-existing denture in the experimental group. The implants were placed using a one-stage surgery procedure, and the participants' pre-existing denture were soft-relined in the control group. For both groups, the permanent 10- to 12-unit FDP consisting of a type-3 cast precious alloy veneered with acrylic and artificial teeth was placed 3–4 months after implant surgery. All participants have been recalled annually for 5 years for appraisal of bone loss and registration of adverse events. Results Thirty-five of the original 42 participants (83%) returned for clinical and radiological examinations at the 5-year follow-up recall. No selective dropout or specific reasons for dropout was identified in the two study arms; leaving n = 17 (Intention-to-treat group, ITT) in the experimental group, alternatively n = 13 as per protocol group (PP), and n = 18 participants in the control group (ITT = PP). At study commencement, five of the participants assigned to the experimental group did not receive their planned intervention. In the control group, one implant failed to osseointegrate and another failed due to bone loss after 5 years. The crestal bone level changes over 5 years were identical in the experimental and control groups, that is, 1.2 mm (SD = 0.7). There were no differences between the two study arms

  5. Bari-Active: A randomized controlled trial of a preoperative intervention to increase physical activity in bariatric surgery patients

    Science.gov (United States)

    Bond, Dale S.; Vithiananthan, Sivamainthan; Thomas, J. Graham; Trautvetter, Jennifer; Unick, Jessica L.; Jakicic, John M.; Pohl, Dieter; Ryder, Beth A.; Roye, G. Dean; Sax, Harry C.; Wing, Rena R.

    2014-01-01

    Background: Habitual physical activity (PA) may help to optimize bariatric surgery outcomes; however objective PA measures show that most patients have low PA preoperatively and make only modest PA changes postoperatively. Patients require additional support to adopt habitual PA. Objectives: Test the efficacy of a preoperative PA intervention (PAI) versus standard pre-surgical care (SC) for increasing daily moderate-to-vigorous PA (MVPA) in bariatric surgery patients. Setting: University Hospital, United States. Methods: Outcomes analysis included 75 participants (86.7% women; 46.0±8.9 years; Body Mass Index [BMI]=45.0±6.5 kg/m2) who were randomly assigned preoperatively to 6 weeks of PAI (n=40) or SC (n=35). PAI received weekly individual face-to-face sessions with tailored instruction in behavioral strategies (e.g., self-monitoring, goal-setting) to increase home-based walking exercise. The primary outcome, pre- to post-intervention change in daily bout-related (≥10-min bouts) and total (≥1-minute bouts) MVPA minutes, was assessed objectively via a multi-sensor monitor worn for 7 days at baseline- and post-intervention. Results: Retention was 84% at the post-intervention primary end point. In intent-to-treat analyses with baseline value carried forward for missing data and adjusted for baseline MVPA, PAI achieved a mean increase of 16.6±20.6 minutes/day in bout-related MVPA (baseline: 4.4±5.5 to post-intervention: 21.0±21.4 minutes/day) compared to no change (−0.3±12.7 minutes/day; baseline: 7.9±16.6 to post-intervention: 7.6±11.5 minutes/day) for SC (p=0.001). Similarly, PAI achieved a mean increase of 21.0±26.9 minutes/day in total MVPA (baseline: 30.9±21.2 to post-intervention: 51.9±30.0 minutes/day), whereas SC demonstrated no change (− 0.1±16.3 minutes/day; baseline: 33.7±33.2 to post-intervention: 33.6±28.5 minutes/day) (p=0.001). Conclusions: With behavioral intervention, patients can significantly increase MVPA before bariatric

  6. {sup 68}Ga-DOTATOC PET/CT and somatostatin receptor (sst1-sst5) expression in normal human tissue: correlation of sst2 mRNA and SUV{sub max}

    Energy Technology Data Exchange (ETDEWEB)

    Boy, Christian; Poeppel, Thorsten D.; Jentzen, Walter; Brandau, Wolfgang; Bockisch, Andreas [University Hospital Essen, University of Duisburg-Essen, Department of Nuclear Medicine, Essen (Germany); Heusner, Till A.; Antoch, Gerald [University Hospital Essen, University of Duisburg-Essen, Department of Diagnostic and Interventional Radiology and Neuroradiology, Essen (Germany); Redmann-Bischofs, Anja; Unger, Nicole; Mann, Klaus; Petersenn, Stephan [University of Duisburg-Essen, Department of Endocrinology and Division of Laboratory Research, Essen (Germany)

    2011-07-15

    By targeting somatostatin receptors (sst) radiopeptides have been established for both diagnosis and therapy. For physiologically normal human tissues the study provides a normative database of maximum standardized uptake value (SUV{sub max}) and sst mRNA. A total of 120 patients were subjected to diagnostic {sup 68}Ga-DOTATOC positron emission tomography (PET)/CT (age range 19-83 years). SUV{sub max} values were measured in physiologically normal tissues defined by normal morphology, absence of surgical intervention and absence of metastatic spread during clinical follow-up. Expression of sst subtypes (sst1-sst5) was measured independently in pooled adult normal human tissue by real-time reverse transcriptase polymerase chain reaction (RT-PCR). SUV{sub max} revealed a region-specific pattern (e.g., mean {+-} SD, spleen 31.1 {+-} 10.9, kidney 16.9 {+-} 5.3, liver 12.8 {+-} 3.6, stomach 7.0 {+-} 3.1, head of pancreas 6.2 {+-} 2.3, small bowel 4.8 {+-} 1.8, thyroid 4.7 {+-} 2.2, bone 3.9 {+-} 1.3, large bowel 2.9 {+-} 0.8, muscle 2.1 {+-} 0.5, parotid gland 1.9 {+-} 0.6, axillary lymph node 0.8 {+-} 0.3 and lung 0.7 {+-} 0.3). SUV{sub max} was age independent. Gender differences were evident within the thyroid (female/male: 3.7 {+-} 1.6/5.5 {+-} 2.4, p < 0.001; Mann-Whitney U test) and the pancreatic head (5.5 {+-} 1.9/6.9 {+-} 2.2, p < 0.001). The sst mRNA was widely expressed and heterogeneous, showing sst1 to be most abundant. SUV{sub max} values exclusively correlated with sst2 expression (r = 0.846, p < 0.001; Spearman rank correlation analysis), whereas there was no correlation of SUV{sub max} with the expression of the other four subtypes. In normal human tissues {sup 68}Ga-DOTATOC imaging has been related to the expression of sst2 at the level of mRNA. The novel normative database may improve diagnostics, monitoring and therapy of sst-expressing tumours or inflammation on a molecular basis. (orig.)

  7. Influence of gum chewing on postoperative bowel activity after complete staging surgery for gynecological malignancies: a randomized controlled trial.

    Science.gov (United States)

    Ertas, Ibrahim Egemen; Gungorduk, Kemal; Ozdemir, Aykut; Solmaz, Ulas; Dogan, Askin; Yildirim, Yusuf

    2013-10-01

    To investigate whether gum chewing affects the return of bowel function after complete staging surgery for gynecologic malignancies. A total of 149 patients undergoing abdominal complete surgical staging for various gynecological cancers were randomized into a gum-chewing group (n=74) or a control group (n=75). The patients chewed sugarless gum three times from the first postoperative morning until the first passage of flatus. Each chewing session lasted 30 min. Total abdominal hysterectomy with systematic pelvic and para-aortic lymphadenectomy was performed on all patients a