Primary Prevention of Peristomial Hernias Via Parietal Prostheses (GRECCAR 07)

Centre Hospitalier Universitaire de Nīmes

Status: Completed

Conditions: Parastomal Hernia

Treatments: Procedure: Colostomy with mesh implantation; Procedure: Simple colostomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01380860

2011-A01572-39 (Other Identifier)

PHRC-N/2011/MP-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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200 participants in 2 patient groups

Mesh

Experimental group

Description:

The patients allocated to this arm of the study will have mesh (Covidien France: mono filament polyester bidimensional knit) implanted in association with their colostomy.

Treatment:

Procedure: Colostomy with mesh implantation

No mesh

Active Comparator group

Description:

The patients allocated to this arm of the protocol will not receive mesh implantation with their colostomy.

Treatment:

Procedure: Simple colostomy