PROphylactic MESH (PROMESH) for stoma closure: does it reduce the incidence of incisional hernia? Protocol for a triple-blinded randomised controlled trial

INTRODUCTION: Application of a prophylactic mesh during stoma closure was shown to reduce the incidence of incisional hernia at the site of stoma closure. Our objective is to provide high quality evidence to validate this finding. METHODS AND ANALYSIS: The study will be a randomised controlled triple-blinded superiority parallel monocentric trial. Patients undergoing elective ileostomy or colostomy closure after surgery for digestive cancer will be eligible for inclusion. Patients allergic to the mesh, immunosuppressed or refusing to participate will be excluded. Randomisation will be performed based on a 1:1 allocation ratio between stoma closure with application of a non-absorbable mesh in the sublay position (intervention) and stoma closure without a mesh (control). The primary outcome will be the 1-year incidence of incisional hernia at the site of stoma closure, determined clinically and by CT. Secondary outcomes will be the 31-day incidence of surgical site infection and the modified Carolinas Comfort Scale. Patients, radiologists and investigators performing the assessment at 1 year will be blinded for the allocated study group. Analysis will be performed in intention-to-treat. The trial will include 68 patients (34 with mesh, 34 without mesh). ETHICS AND DISSEMINATION: The present randomised controlled trial was registered into clinicaltrials.gov (NCT 04510558) and was accepted by the local ethic committee (Geneva, Switzerland: CCER 2021-00053). The results will be presented at national and international congresses in the fields of colorectal surgery and general surgery, and published in a peer-reviewed journal.