Primary prevention of peristomial hernias via parietal prostheses: A randomized, multicentric study (GRECCAR 7 trial).

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.

CONCLUSION: 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.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01380860.