title: Primary prevention of peristomial hernias via parietal prostheses: A randomized, multicentric study (GRECCAR 7 trial).
abstract: BACKGROUND
  Peristomal hernia (PH) is a common complication of colostomy. It often leads to a decrease in the patient's quality of life. Surgical procedures for PH are difficult and present high failure and morbidity rates. This randomized, double blind, multicentre trial was conducted to determine the benefits and risks of mesh reinforcement vs conventional stoma formation in preventing PH.
  
  
  METHODS
  200 patients undergoing a permanent end colostomy are randomized into two groups. In the mesh group an end-colostomy is created inserting a lightweight (<50g/m(2)) monofilament mesh in a sublay location, and compared to a group with traditional stoma creation. The presence or absence of a PH is determined by another practitioner by clinical exam and by a CT scan or MRI after 24 months of follow-up. 19 university hospitals participate during a 3-year inclusion period. The primary endpoint is the comparison of the PH incidence. To find a difference of 20% with a power of 80% a total number of 174 patients must be included.
  
  
  CONCLUSIONS
  This GRECCAR study is a multicentre, double blind, and randomized trial conducted to determine whether a preventive insertion of a prosthetic mesh decreases the incidence of a PH with an acceptable morbidity.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01380860.
authors.affiliation: Digestive Surgery Department, CHU Nîmes, Nîmes, France. Electronic address: Michel.prudhomme@chu-nimes.fr.
authors.forename: Michel
authors.initials: M
authors.lastname: Prudhomme
authors.affiliation: Digestive Surgery Department, CHU Nîmes, Nîmes, France.
authors.forename: Mathias
authors.initials: M
authors.lastname: Alline
authors.affiliation: Digestive Surgery Department, CHU Nîmes, Nîmes, France.
authors.forename: John
authors.initials: J
authors.lastname: Chauvat
authors.affiliation: DECBSPIM, Clinical Epidemiology Department, CHU Nîmes, Nîmes, France.
authors.forename: Pascale
authors.initials: P
authors.lastname: Fabbro-Perray
authors.affiliation: Digestive Surgery Department, CHU Nîmes, Nîmes, France.
authors.forename: Jérémie
authors.initials: J
authors.lastname: Ripoche
authors.affiliation: Digestive Surgery Department, CHU Nîmes, Nîmes, France.
authors.forename: Martin Marie
authors.initials: MM
authors.lastname: Bertrand
mesh_terms: D015179:Colorectal Neoplasms / Q000601:surgery*; D003125:Colostomy / Q000009:adverse effects*; D004311:Double-Blind Method; D005260:Female; D005602:France; D006547:Hernia / Q000517:prevention & control*; D006801:Humans; D015994:Incidence; D008279:Magnetic Resonance Imaging; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D011322:Primary Prevention / Q000379:methods*; D011788:Quality of Life; D013526:Surgical Mesh; D054047:Surgical Stomas; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome
keywords: Peristomal hernia; Prevention; Prosthetic mesh