title: 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.
abstract: 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
  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, α = 0.05, 80% power).
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier NCT01872650, registration date 6 June 2013.
authors.affiliation: Department of Surgery, Radboud University Medical Center, P,O, Box 9101, 6500 HB Nijmegen, The Netherlands. Martijn.Stommel@radboudumc.nl.
authors.forename: Martijn W J
authors.initials: MW
authors.lastname: Stommel
authors.forename: Chema
authors.initials: C
authors.lastname: Strik
authors.forename: Richard P G
authors.initials: RP
authors.lastname: ten Broek
authors.forename: Harry
authors.initials: H
authors.lastname: van Goor
mesh_terms: D001672:Biocompatible Materials / Q000009:adverse effects / Q000627:therapeutic use*; D002266:Carboxymethylcellulose Sodium / Q000009:adverse effects / Q000627:therapeutic use*; D002985:Clinical Protocols; D003082:Colectomy / Q000009:adverse effects*; D003125:Colostomy / Q000009:adverse effects*; D004066:Digestive System Diseases / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D004311:Double-Blind Method; D015525:Fatty Acids, Omega-3 / Q000009:adverse effects / Q000627:therapeutic use*; D005990:Glycerol / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007081:Ileostomy / Q000009:adverse effects*; D010535:Laparoscopy / Q000009:adverse effects*; D009426:Netherlands; D011446:Prospective Studies; D012107:Research Design; D013997:Time Factors; D000267:Tissue Adhesions; D016896:Treatment Outcome
chemical_list: D001672:Biocompatible Materials; D015525:Fatty Acids, Omega-3; D002266:Carboxymethylcellulose Sodium; D005990:Glycerol