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

18 Years
Open (Enrolling)
Parastomal Hernia

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Trial Information

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.

Inclusion Criteria:

- The patient has given informed consent

- The patient must be affiliated with a health insurance programme

- The patient must be available for 24 months of follow-up

- The patient requires a colostomy (primo-event, ie first colostomies only)

Exclusion Criteria:

- The patient is currently participating in another interventional study

- The patient is in an exclusion period determined by a previous study

- The patient is under guardianship

- The patient refuses to sign the consent

- It is impossible to communicate information to the patient (does not read French)

- The patient is pregnant

- The patient is breastfeeding

- There is a contra-indication for any treatment used in this study

- The subject has already had a colostomy

- The subject has peritonitis

- The subject needs a colostomy for infectious reasons

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Outcome Measure:

Presence/absence of a peristomal hernia

Outcome Description:

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.

Outcome Time Frame:

24 months

Safety Issue:


Principal Investigator

Michel Prudhomme, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Hospitalier Universitaire de Nîmes


France: Agence Nationale de Sécurité du Médicament et des produits de santé

Study ID:




Start Date:

November 2012

Completion Date:

November 2015

Related Keywords:

  • Parastomal Hernia
  • mesh
  • hernia
  • Hernia