Efficacy and safety of the C-Qur Film Adhesion Barrier for the prevention of surgical adhesions (CLIPEUS Trial): study protocol for a randomized controlled trial
| العنوان: | Efficacy and safety of the C-Qur Film Adhesion Barrier for the prevention of surgical adhesions (CLIPEUS Trial): study protocol for a randomized controlled trial |
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| المؤلفون: | Martijn W J Stommel, Chema Strik, Harry van Goor, Richard P. G. ten Broek |
| المصدر: | Trials, 15 Trials |
| سنة النشر: | 2014 |
| مصطلحات موضوعية: | Glycerol, medicine.medical_specialty, Time Factors, Digestive System Diseases, medicine.medical_treatment, C-Qur™ film, Adhesion (medicine), Medicine (miscellaneous), Biocompatible Materials, Tissue Adhesions, Study Protocol, anti-adhesive barrier, Ileostomy, Clinical Protocols, Double-Blind Method, Colostomy, Fatty Acids, Omega-3, medicine, Humans, Pharmacology (medical), Prospective Studies, adhesion prevention, Colectomy, Netherlands, business.industry, Other Research Radboud Institute for Health Sciences [Radboudumc 0], Adhesion barrier, adhesions, medicine.disease, Colorectal surgery, Surgery, Bowel obstruction, Treatment Outcome, Reconstructive and regenerative medicine Radboud Institute for Molecular Life Sciences [Radboudumc 10], Incision Site, Research Design, Carboxymethylcellulose Sodium, colorectal surgery, Laparoscopy, business |
| الوصف: | Contains fulltext : 137909.pdf (Publisher’s version ) (Open Access) BACKGROUND: Adhesions develop in over 90% of patients after intra-abdominal surgery. Adhesion barriers are rarely used despite the high morbidity caused by intra-abdominal adhesions. Only one of the currently available adhesion barriers has demonstrated consistent evidence for reducing adhesions in visceral surgery. This agent has limitations through poor handling characteristics because it is sticky on both sides. C-Qur Film is a novel thin film adhesion barrier and it is sticky on only one side, resulting in better handling characteristics. The objective of this study is to assess efficacy and safety of C-Qur Film to decrease the incidence of adhesions after colorectal surgery. METHODS/DESIGN: This is a prospective, investigator initiated, randomized, double-blinded, multicenter trial. Eligible patients undergoing colorectal resection requiring temporary loop ileostomy or loop/split colostomy by laparotomy or hand assisted laparoscopy will be included in the trial. Before closure, patients are randomized 1:1 to either the treatment arm (C-Qur Film) or control arm (no adhesion barrier). Patients will return 8 to 16 weeks post-colorectal resection for take down of their ostomy. During ostomy takedown, adhesions will be evaluated for incidence, extent, and severity. The primary outcome evaluation will be assessment of adhesions to the incision site. It is hypothesized that the use of C-Qur Film underneath the primary incision reduces the incidence of adhesion at the incision by 30%. To demonstrate 30% reduction in the incidence of adhesions, a sample size of 84 patients (32 + 10 per group (25% drop out)) is required (two-sided test, alpha = 0.05, 80% power). DISCUSSION: Results of this study add to the evidence on the use of anti-adhesive barriers in open and laparoscopic 'hand-assisted' colorectal surgery. We chose incidence of adhesions to the incision site as primary outcome measure since clinical outcomes such as small bowel obstruction, secondary infertility and adhesiolysis related complications are considered multifactorial and difficult to interpret. Incidence of adhesions at repeat surgery is believed to be the most valuable surrogate endpoint for clinically relevant adhesion prevention, since small bowel obstruction and adhesiolysis at repeat surgery are not likely to occur when complete adhesion reduction in a patient is accomplished. TRIAL REGISTRATION: ClinicalTrials.gov Identifier NCT01872650, registration date 6 June 2013. |
| وصف الملف: | application/pdf |
| تدمد: | 1745-6215 |
| الوصول الحر: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::36c7101575ff1f25dad35c96d15cd3e9Test https://hdl.handle.net/2066/137909Test |
| حقوق: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....36c7101575ff1f25dad35c96d15cd3e9 |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 17456215 |
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