Primary Prevention of Peristomial Hernias Via Parietal Prostheses

NCT01380860 | Completed DMC

• 2 other identifiers: PHRC-N/2011/MP-012011-A01572-39
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 22

Brief 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.

Conditions

Parastomal Hernia

Keywords

mesh; hernia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (135)

• Presence/absence of peristomal hernia

  12 months

• Days of hospitalisation

  1 month

• Operating time (minutes)

  Day 1

• Estimation of blood loss during the operation (ml)

  Day 1

• Was stomal repair necessary for the patient? yes/no

  24 months

Study Arms (2)

Mesh

EXPERIMENTAL

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.

Procedure: Colostomy with mesh implantation

No mesh

ACTIVE COMPARATOR

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

Procedure: Simple colostomy

Interventions

Colostomy with mesh implantation PROCEDURE

Colostomy with mesh implantation

Mesh

Simple colostomy PROCEDURE

Colostomy with no mesh implantation.

No mesh

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• The patient is currently participating in another interventional 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (22)

CHRU de Besancon

Besançon, 25030, France

Location

CHU de Bordeaux

Bordeaux, 33075, France

Location

CHRU de Clermont Ferrand

Clermont-Ferrand, 63058, France

Location

APHP - Hôpital Beaujon

Clichy, 92110, France

Location

Hôpital Albert Michallon, CHU de Grenoble

Grenoble, 38043, France

Location

APHP - Centre Hospitalier Universitaire de Bicêtre

Le Kremlin-Bicêtre, 94275, France

Location

Centre de Lutte Contre le Cancer - Centre Oscar Lambret

Lille, 59020, France

Location

CHRU de Lille - Hôpital Claude Huriez

Lille, 59037, France

Location

CHU de Lyon

Lyon, 69317, France

Location

Centre Régional de Lutte Contre le Cancer - Institut Paoli-Calmettes

Marseille, 13009, France

Location

APHM - Hôpital La Timone Adultes

Marseille, 13385, France

Location

Centre Régional de Lutte Contre le Cancer Val d'Aurelle - Paul Lamarque

Montpellier, 34298, France

Location

CHU de Nantes

Nantes, 44093, France

Location

Centre Hospitalier Universitaire de Nîmes

Nîmes, 30029, France

Location

APHP - Hôpital Lariboisière

Paris, 75010, France

Location

APHP - Hôpital Saint-Antoine

Paris, 75571, France

Location

APHP - Groupe Hospitalier Pitié-Salpetrière

Paris, 75651, France

Location

Hôpital Pontchailou

Rennes, 35033, France

Location

CHU de Rouen

Rouen, 76038, France

Location

Centre Régional de Lutte contre le Cancer Centre Paul Strauss

Strasbourg, 67065, France

Location

CHU de Toulouse

Toulouse, France

Location

CH de Vichy - Jacques Larin

Vichy, 03207, France

Location

Related Publications (2)

• Prudhomme M, Rullier E, Lakkis Z, Cotte E, Panis Y, Meunier B, Rouanet P, Tuech JJ, Jafari M, Portier G, Dubois A, Sielezneff I, Parc Y, Faucheron JL, Meurette G, Lelong B, Piessen G, Karoui M, Fabbro-Peray P, Demattei C, Bertrand MM; GRECCAR research group. End Colostomy With or Without Mesh to Prevent a Parastomal Hernia (GRECCAR 7): A Prospective, Randomized, Double Blinded, Multicentre Trial. Ann Surg. 2021 Dec 1;274(6):928-934. doi: 10.1097/SLA.0000000000004371.

  PMID: 33201089 RESULT

• Prudhomme M, Alline M, Chauvat J, Fabbro-Perray P, Ripoche J, Bertrand MM; French Research Group of Rectal Cancer Surgery (GRECCAR). Primary prevention of peristomial hernias via parietal prostheses: A randomized, multicentric study (GRECCAR 7 trial). Dig Liver Dis. 2016 Jul;48(7):812-6. doi: 10.1016/j.dld.2016.03.020. Epub 2016 Apr 5.

  PMID: 27130912 DERIVED

MeSH Terms

Conditions

Hernia

Interventions

Colostomy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Enterostomy; Digestive System Surgical Procedures; Surgical Procedures, Operative; Ostomy

Study Officials

• Michel Prudhomme, MD, PhD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2011
• First Posted: June 27, 2011
• Study Start: November 1, 2012
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: December 1, 2025

Record last verified: 2020-08

Locations

FR (22)