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Scientific article
Open access
English

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

Published inBMJ open, vol. 11, no. 12, e053751
Publication date2021-12-14
First online date2021-12-14
Abstract

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 (NCT04510558) 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.

eng
Keywords
  • Adult surgery
  • Colorectal surgery
  • Surgery
Citation (ISO format)
MEYER, Jérémy et al. PROphylactic MESH (PROMESH) for stoma closure: does it reduce the incidence of incisional hernia? Protocol for a triple-blinded randomised controlled trial. In: BMJ open, 2021, vol. 11, n° 12, p. e053751. doi: 10.1136/bmjopen-2021-053751
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Article (Published version)
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ISSN of the journal2044-6055
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Technical informations

Creation12/22/2021 2:01:00 PM
First validation12/22/2021 2:01:00 PM
Update time03/16/2023 2:49:28 AM
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