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

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

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.

Study Overview

• Status: Completed
• Conditions: Parastomal Hernia
• Intervention / Treatment: Procedure: Colostomy with mesh implantation; Procedure: Simple colostomy

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Besançon, France, 25030
    • CHRU De Besancon
  • Bordeaux, France, 33075
    • CHU de Bordeaux
  • Clermont-Ferrand, France, 63058
    • CHRU de Clermont Ferrand
  • Clichy, France, 92110
    • APHP - Hôpital Beaujon
  • Grenoble, France, 38043
    • Hôpital Albert Michallon, CHU de Grenoble
  • Le Kremlin-Bicêtre, France, 94275
    • APHP - Centre Hospitalier Universitaire de Bicêtre
  • Lille, France, 59037
    • CHRU de Lille - Hopital Claude Huriez
  • Lille, France, 59020
    • Centre de Lutte contre le Cancer - Centre Oscar Lambret
  • Lyon, France, 69317
    • CHU de Lyon
  • Marseille, France, 13385
    • APHM - Hôpital La Timone Adultes
  • Marseille, France, 13009
    • Centre Régional de Lutte Contre le Cancer - Institut Paoli-Calmettes
  • Montpellier, France, 34298
    • Centre Régional de Lutte Contre le Cancer Val d'Aurelle - Paul Lamarque
  • Nantes, France, 44093
    • CHU de Nantes
  • Nîmes, France, 30029
    • Centre Hospitalier Universitaire de Nîmes
  • Paris, France, 75010
    • APHP - Hôpital Lariboisière
  • Paris, France, 75651
    • APHP - Groupe Hospitalier Pitié-Salpetrière
  • Paris, France, 75571
    • APHP - Hôpital Saint-Antoine
  • Rennes, France, 35033
    • Hôpital Pontchailou
  • Rouen, France, 76038
    • CHU de Rouen
  • Strasbourg, France, 67065
    • Centre Régional de Lutte contre le Cancer Centre Paul Strauss
  • Toulouse, France
    • CHU de Toulouse
  • Vichy, France, 03207
    • CH de Vichy - Jacques Larin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mesh; 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; Colostomy with mesh implantation
Active Comparator: No mesh; The patients allocated to this arm of the protocol will not receive mesh implantation with their colostomy.	Procedure: Simple colostomy; Colostomy with no mesh implantation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence/absence of peristomal hernia	The presence of absence of a hernia is detected by clinical exam.	12 months
Days of hospitalisation	The number of days spent in the hospital after the surgical intervention.	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
Was relocation of the colostomy required? yes/no		24 months
Presence/absence of complications	Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration	24 months
Patient difficulty for fitting his/her colostomy with the appropriate sac.	A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.	24 months
Pain around the colostomy	A visual analog scale is used to assess the patient's perception of pain around the stomy site.	24 months
Abdominal pain	A visual analog scale is used to assess the patient's perception of abdominal pain.	24 months
Pain medication consumption		24 months
Number of colostomy leaks per day		24 months
Number of colostomy sac changes per day		24 months
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no		24 months
Questionnaire Stoma-QOL	Validated assessment of quality of life.	24 months
Exposition of the prothesis (mesh): yes/no		24 months
Questionnaire Stoma-QOL	Validated assessment of quality of life.	12 months
Questionnaire Stoma-QOL	Validated assessment of quality of life.	1 month
Presence/absence of peri-operative complications		Day 1
Pain around the colostomy	A visual analog scale is used to assess the patient's perception of pain around the stomy site.	Day 1
Pain around the colostomy	A visual analog scale is used to assess the patient's perception of pain around the stomy site.	1 month
Pain around the colostomy	A visual analog scale is used to assess the patient's perception of pain around the stomy site.	3 months
Pain around the colostomy	A visual analog scale is used to assess the patient's perception of pain around the stomy site.	6 months
Pain around the colostomy	A visual analog scale is used to assess the patient's perception of pain around the stomy site.	9 months
Pain around the colostomy	A visual analog scale is used to assess the patient's perception of pain around the stomy site.	12 months
Pain around the colostomy	A visual analog scale is used to assess the patient's perception of pain around the stomy site.	15 months
Pain around the colostomy	A visual analog scale is used to assess the patient's perception of pain around the stomy site.	18 months
Pain around the colostomy	A visual analog scale is used to assess the patient's perception of pain around the stomy site.	21 months
Abdominal pain	A visual analog scale is used to assess the patient's perception of abdominal pain.	Day 1
Abdominal pain	A visual analog scale is used to assess the patient's perception of abdominal pain.	1 month
Abdominal pain	A visual analog scale is used to assess the patient's perception of abdominal pain.	3 months
Abdominal pain	A visual analog scale is used to assess the patient's perception of abdominal pain.	6 months
Abdominal pain	A visual analog scale is used to assess the patient's perception of abdominal pain.	9 months
Abdominal pain	A visual analog scale is used to assess the patient's perception of abdominal pain.	12 months
Abdominal pain	A visual analog scale is used to assess the patient's perception of abdominal pain.	15 months
Abdominal pain	A visual analog scale is used to assess the patient's perception of abdominal pain.	18 months
Abdominal pain	A visual analog scale is used to assess the patient's perception of abdominal pain.	21 months
Presence/absence of peristomal hernia	The presence of absence of a hernia is detected by clinical exam.	1 month
Presence/absence of peristomal hernia	The presence of absence of a hernia is detected by clinical exam.	3 months
Presence/absence of peristomal hernia	The presence of absence of a hernia is detected by clinical exam.	6 months
Presence/absence of peristomal hernia	The presence of absence of a hernia is detected by clinical exam.	9 months
Presence/absence of peristomal hernia	The presence of absence of a hernia is detected by clinical exam.	15 months
Presence/absence of peristomal hernia	The presence of absence of a hernia is detected by clinical exam.	18 months
Presence/absence of peristomal hernia	The presence of absence of a hernia is detected by clinical exam.	21 months
Presence/absence of complications	Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration	1 month
Presence/absence of complications	Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration	3 months
Presence/absence of complications	Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration	6 months
Presence/absence of complications	Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration	9 months
Presence/absence of complications	Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration	12 months
Presence/absence of complications	Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration	15 months
Presence/absence of complications	Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration	18 months
Presence/absence of complications	Complications include: retraction, stenosis, prolapse, disunion, necrosis, abcess, infections, occlusion, strangulation, perforation, eczema, dermatitis, erythema, ulceration	21 months
Patient difficulty for fitting his/her colostomy with the appropriate sac.	A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.	Day 1
Patient difficulty for fitting his/her colostomy with the appropriate sac.	A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.	1 month
Patient difficulty for fitting his/her colostomy with the appropriate sac.	A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.	3 months
Patient difficulty for fitting his/her colostomy with the appropriate sac.	A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.	6 months
Patient difficulty for fitting his/her colostomy with the appropriate sac.	A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.	9 months
Patient difficulty for fitting his/her colostomy with the appropriate sac.	A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.	12 months
Patient difficulty for fitting his/her colostomy with the appropriate sac.	A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.	15 months
Patient difficulty for fitting his/her colostomy with the appropriate sac.	A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.	18 months
Patient difficulty for fitting his/her colostomy with the appropriate sac.	A visual analog scale is used to determine how difficult it is for a patient to fit his/her colostomy with an appropriate device. 0: perfect adhesion; 10: the device does not adjust to the shape of my skin, and I have permanent leakage.	21 months
Pain medication consumption		Day 1
Pain medication consumption		1 month
Pain medication consumption		3 months
Pain medication consumption		6 months
Pain medication consumption		9 months
Pain medication consumption		12 months
Pain medication consumption		15 months
Pain medication consumption		18 months
Pain medication consumption		21 months
Number of colostomy leaks per day		Day 1
Number of colostomy leaks per day		1 month
Number of colostomy leaks per day		3 months
Number of colostomy leaks per day		6 months
Number of colostomy leaks per day		9 months
Number of colostomy leaks per day		12 months
Number of colostomy leaks per day		18 months
Number of colostomy leaks per day		15 months
Number of colostomy leaks per day		21 months
Number of colostomy sac changes per day		Day 1
Number of colostomy sac changes per day		1 month
Number of colostomy sac changes per day		3 months
Number of colostomy sac changes per day		6 months
Number of colostomy sac changes per day		9 months
Number of colostomy sac changes per day		12 months
Number of colostomy sac changes per day		15 months
Number of colostomy sac changes per day		18 months
Number of colostomy sac changes per day		21 months
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no		Day 1
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no		1 month
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no		3 months
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no		6 months
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no		9 months
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no		12 months
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no		15 months
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no		18 months
Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no		21 months
Exposition of the prothesis (mesh): yes/no		1 month
Exposition of the prothesis (mesh): yes/no		3 months
Exposition of the prothesis (mesh): yes/no		6 months
Exposition of the prothesis (mesh): yes/no		9 months
Exposition of the prothesis (mesh): yes/no		12 months
Exposition of the prothesis (mesh): yes/no		15 months
Exposition of the prothesis (mesh): yes/no		18 months
Exposition of the prothesis (mesh): yes/no		21 months
Presence/absence of a complication potentially linked to the presence of a mesh?		1 month
Presence/absence of a complication potentially linked to the presence of a mesh?		3 months
Presence/absence of a complication potentially linked to the presence of a mesh?		6 months
Presence/absence of a complication potentially linked to the presence of a mesh?		9 months
Presence/absence of a complication potentially linked to the presence of a mesh?		12 months
Presence/absence of a complication potentially linked to the presence of a mesh?		15 months
Presence/absence of a complication potentially linked to the presence of a mesh?		18 months
Presence/absence of a complication potentially linked to the presence of a mesh?		21 months
Presence/absence of a complication potentially linked to the presence of a mesh?		24 months
Ablation of the mesh: yes/no		1 month
Ablation of the mesh: yes/no		3 months
Ablation of the mesh: yes/no		6 months
Ablation of the mesh: yes/no		9 months
Ablation of the mesh: yes/no		12 months
Ablation of the mesh: yes/no		15 months
Ablation of the mesh: yes/no		18 months
Ablation of the mesh: yes/no		21 months
Ablation of the mesh: yes/no		24 months
Evaluation of colostomy healing by the clinician	The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.	Day 1
Evaluation of colostomy healing by the clinician	The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.	1 month
Evaluation of colostomy healing by the clinician	The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.	3 months
Evaluation of colostomy healing by the clinician	The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.	6 months
Evaluation of colostomy healing by the clinician	The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.	9 months
Evaluation of colostomy healing by the clinician	The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.	12 months
Evaluation of colostomy healing by the clinician	The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.	15 months
Evaluation of colostomy healing by the clinician	The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.	18 months
Evaluation of colostomy healing by the clinician	The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.	21 months
Evaluation of colostomy healing by the clinician	The evaluating clinician (blind to the procedure) will evaluate the healing progress of the colostomy using a visual analog scale.	24 months
Duration of postoperative fever (hours)		10 days
Presence/absence of postoperative fever > 37.2°C		Day 1

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Michel Prudhomme, MD, PhD, Centre Hospitalier Universitaire de Nîmes

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: June 22, 2011
• First Submitted That Met QC Criteria: June 23, 2011
• First Posted (Estimated): June 27, 2011

Study Record Updates

• Last Update Posted (Estimated): December 1, 2025
• Last Update Submitted That Met QC Criteria: November 24, 2025
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: hernia; mesh
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Hernia; Surgical Procedures, Operative; Digestive System Surgical Procedures; Ostomy; Enterostomy; Colostomy
• Other Study ID Numbers: PHRC-N/2011/MP-01; 2011-A01572-39 (Other Identifier: ANSM)