NCT01380860

Primary Prevention of Peristomial Hernias Via Parietal Prostheses

Primary Prevention of Peristomial Hernias Via Parietal Prostheses: a Randomized, Multicentric Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Centre Hospitalier Universitaire de Nīmes · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare rates of hernia formation between colostomies created with no hernia preventing mesh versus colostomies created with a particular mesh.

Detailed description

Previous studies indicate that implanting mesh for peristomal hernia repair may efficiently prevent hernia relapse. However, mesh provides a good infection site, which is not a desirable characteristic for a material adjacent to a colostomy "port". Our goal is to implement a high-quality, randomized trial to demonstrate whether or not systematic mesh implantation upon primary hernia creation is an effective means of avoiding this common and troublesome complication.

Conditions

• Parastomal Hernia

Interventions

Type	Name	Description
PROCEDURE	Colostomy with mesh implantation	Colostomy with mesh implantation
PROCEDURE	Simple colostomy	Colostomy with no mesh implantation.

Timeline

• Start date: 2012-11-01
• Primary completion: 2018-12-31
• Completion: 2018-12-31
• First posted: 2011-06-27
• Last updated: 2025-12-01

Locations

22 sites across 1 country: France