Primary Prevention of Peristomial Hernias Via Parietal Prostheses: a Randomized, Multicentric Study
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention
Presence/absence of a peristomal hernia
The occurrence of peristomal hernias is determined in both groups every three months up until 24 months. The presence of absence of a hernia is detected by clinical exam, and at 24 months by an additional radiology exam. The primary outcome concerns rates at 24 months, primo-events only.
24 months
Yes
Michel Prudhomme, MD, PhD
Principal Investigator
Centre Hospitalier Universitaire de Nîmes
France: Agence Nationale de Sécurité du Médicament et des produits de santé
PHRC-N/2011/MP-01
NCT01380860
November 2012
November 2015
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