Clinical trial NCT01380860: Primary Prevention of Peristomial Hernias Via Parietal Prostheses
Official title: Primary Prevention of Peristomial Hernias Via Parietal Prostheses: a Randomized, Multicentric Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parastomal Hernia
Keywords: mesh
hernia
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2011-06-27
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Presence/absence of a peristomal hernia
timeFrame: 24 months
Secondary outcomes:
measure: Presence/absence of peristomal hernia
timeFrame: 12 months
measure: Days of hospitalisation
timeFrame: 1 month
measure: Operating time (minutes)
timeFrame: Day 1
measure: Estimation of blood loss during the operation (ml)
timeFrame: Day 1
measure: Was stomal repair necessary for the patient? yes/no
timeFrame: 24 months
measure: Was relocation of the colostomy required? yes/no
timeFrame: 24 months
measure: Presence/absence of complications
timeFrame: 24 months
measure: Patient difficulty for fitting his/her colostomy with the appropriate sac.
timeFrame: 24 months
measure: Pain around the colostomy
timeFrame: 24 months
measure: Abdominal pain
timeFrame: 24 months
measure: Pain medication consumption
timeFrame: 24 months
measure: Number of colostomy leaks per day
timeFrame: 24 months
measure: Number of colostomy sac changes per day
timeFrame: 24 months
measure: Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
timeFrame: 24 months
measure: Questionnaire Stoma-QOL
timeFrame: 24 months
measure: Exposition of the prothesis (mesh): yes/no
timeFrame: 24 months
measure: Questionnaire Stoma-QOL
timeFrame: 12 months
measure: Questionnaire Stoma-QOL
timeFrame: 1 month
measure: Presence/absence of peri-operative complications
timeFrame: Day 1
measure: Pain around the colostomy
timeFrame: Day 1
measure: Pain around the colostomy
timeFrame: 1 month
measure: Pain around the colostomy
timeFrame: 3 months
measure: Pain around the colostomy
timeFrame: 6 months
measure: Pain around the colostomy
timeFrame: 9 months
measure: Pain around the colostomy
timeFrame: 12 months
measure: Pain around the colostomy
timeFrame: 15 months
measure: Pain around the colostomy
timeFrame: 18 months
measure: Pain around the colostomy
timeFrame: 21 months
measure: Abdominal pain
timeFrame: Day 1
measure: Abdominal pain
timeFrame: 1 month
measure: Abdominal pain
timeFrame: 3 months
measure: Abdominal pain
timeFrame: 6 months
measure: Abdominal pain
timeFrame: 9 months
measure: Abdominal pain
timeFrame: 12 months
measure: Abdominal pain
timeFrame: 15 months
measure: Abdominal pain
timeFrame: 18 months
measure: Abdominal pain
timeFrame: 21 months
measure: Presence/absence of peristomal hernia
timeFrame: 1 month
measure: Presence/absence of peristomal hernia
timeFrame: 3 months
measure: Presence/absence of peristomal hernia
timeFrame: 6 months
measure: Presence/absence of peristomal hernia
timeFrame: 9 months
measure: Presence/absence of peristomal hernia
timeFrame: 15 months
measure: Presence/absence of peristomal hernia
timeFrame: 18 months
measure: Presence/absence of peristomal hernia
timeFrame: 21 months
measure: Presence/absence of complications
timeFrame: 1 month
measure: Presence/absence of complications
timeFrame: 3 months
measure: Presence/absence of complications
timeFrame: 6 months
measure: Presence/absence of complications
timeFrame: 9 months
measure: Presence/absence of complications
timeFrame: 12 months
measure: Presence/absence of complications
timeFrame: 15 months
measure: Presence/absence of complications
timeFrame: 18 months
measure: Presence/absence of complications
timeFrame: 21 months
measure: Patient difficulty for fitting his/her colostomy with the appropriate sac.
timeFrame: Day 1
measure: Patient difficulty for fitting his/her colostomy with the appropriate sac.
timeFrame: 1 month
measure: Patient difficulty for fitting his/her colostomy with the appropriate sac.
timeFrame: 3 months
measure: Patient difficulty for fitting his/her colostomy with the appropriate sac.
timeFrame: 6 months
measure: Patient difficulty for fitting his/her colostomy with the appropriate sac.
timeFrame: 9 months
measure: Patient difficulty for fitting his/her colostomy with the appropriate sac.
timeFrame: 12 months
measure: Patient difficulty for fitting his/her colostomy with the appropriate sac.
timeFrame: 15 months
measure: Patient difficulty for fitting his/her colostomy with the appropriate sac.
timeFrame: 18 months
measure: Patient difficulty for fitting his/her colostomy with the appropriate sac.
timeFrame: 21 months
measure: Pain medication consumption
timeFrame: Day 1
measure: Pain medication consumption
timeFrame: 1 month
measure: Pain medication consumption
timeFrame: 3 months
measure: Pain medication consumption
timeFrame: 6 months
measure: Pain medication consumption
timeFrame: 9 months
measure: Pain medication consumption
timeFrame: 12 months
measure: Pain medication consumption
timeFrame: 15 months
measure: Pain medication consumption
timeFrame: 18 months
measure: Pain medication consumption
timeFrame: 21 months
measure: Number of colostomy leaks per day
timeFrame: Day 1
measure: Number of colostomy leaks per day
timeFrame: 1 month
measure: Number of colostomy leaks per day
timeFrame: 3 months
measure: Number of colostomy leaks per day
timeFrame: 6 months
measure: Number of colostomy leaks per day
timeFrame: 9 months
measure: Number of colostomy leaks per day
timeFrame: 12 months
measure: Number of colostomy leaks per day
timeFrame: 18 months
measure: Number of colostomy leaks per day
timeFrame: 15 months
measure: Number of colostomy leaks per day
timeFrame: 21 months
measure: Number of colostomy sac changes per day
timeFrame: Day 1
measure: Number of colostomy sac changes per day
timeFrame: 1 month
measure: Number of colostomy sac changes per day
timeFrame: 3 months
measure: Number of colostomy sac changes per day
timeFrame: 6 months
measure: Number of colostomy sac changes per day
timeFrame: 9 months
measure: Number of colostomy sac changes per day
timeFrame: 12 months
measure: Number of colostomy sac changes per day
timeFrame: 15 months
measure: Number of colostomy sac changes per day
timeFrame: 18 months
measure: Number of colostomy sac changes per day
timeFrame: 21 months
measure: Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
timeFrame: Day 1
measure: Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
timeFrame: 1 month
measure: Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
timeFrame: 3 months
measure: Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
timeFrame: 6 months
measure: Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
timeFrame: 9 months
measure: Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
timeFrame: 12 months
measure: Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
timeFrame: 15 months
measure: Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
timeFrame: 18 months
measure: Does the patient consider fitting a sac to his/her colostomy to be a difficult task? yes/no
timeFrame: 21 months
measure: Exposition of the prothesis (mesh): yes/no
timeFrame: 1 month
measure: Exposition of the prothesis (mesh): yes/no
timeFrame: 3 months
measure: Exposition of the prothesis (mesh): yes/no
timeFrame: 6 months
measure: Exposition of the prothesis (mesh): yes/no
timeFrame: 9 months
measure: Exposition of the prothesis (mesh): yes/no
timeFrame: 12 months
measure: Exposition of the prothesis (mesh): yes/no
timeFrame: 15 months
measure: Exposition of the prothesis (mesh): yes/no
timeFrame: 18 months
measure: Exposition of the prothesis (mesh): yes/no
timeFrame: 21 months
measure: Presence/absence of a complication potentially linked to the presence of a mesh?
timeFrame: 1 month
measure: Presence/absence of a complication potentially linked to the presence of a mesh?
timeFrame: 3 months
measure: Presence/absence of a complication potentially linked to the presence of a mesh?
timeFrame: 6 months
measure: Presence/absence of a complication potentially linked to the presence of a mesh?
timeFrame: 9 months
measure: Presence/absence of a complication potentially linked to the presence of a mesh?
timeFrame: 12 months
measure: Presence/absence of a complication potentially linked to the presence of a mesh?
timeFrame: 15 months
measure: Presence/absence of a complication potentially linked to the presence of a mesh?
timeFrame: 18 months
measure: Presence/absence of a complication potentially linked to the presence of a mesh?
timeFrame: 21 months
measure: Presence/absence of a complication potentially linked to the presence of a mesh?
timeFrame: 24 months
measure: Ablation of the mesh: yes/no
timeFrame: 1 month
measure: Ablation of the mesh: yes/no
timeFrame: 3 months
measure: Ablation of the mesh: yes/no
timeFrame: 6 months
measure: Ablation of the mesh: yes/no
timeFrame: 9 months
measure: Ablation of the mesh: yes/no
timeFrame: 12 months
measure: Ablation of the mesh: yes/no
timeFrame: 15 months
measure: Ablation of the mesh: yes/no
timeFrame: 18 months
measure: Ablation of the mesh: yes/no
timeFrame: 21 months
measure: Ablation of the mesh: yes/no
timeFrame: 24 months
measure: Evaluation of colostomy healing by the clinician
timeFrame: Day 1
measure: Evaluation of colostomy healing by the clinician
timeFrame: 1 month
measure: Evaluation of colostomy healing by the clinician
timeFrame: 3 months
measure: Evaluation of colostomy healing by the clinician
timeFrame: 6 months
measure: Evaluation of colostomy healing by the clinician
timeFrame: 9 months
measure: Evaluation of colostomy healing by the clinician
timeFrame: 12 months
measure: Evaluation of colostomy healing by the clinician
timeFrame: 15 months
measure: Evaluation of colostomy healing by the clinician
timeFrame: 18 months
measure: Evaluation of colostomy healing by the clinician
timeFrame: 21 months
measure: Evaluation of colostomy healing by the clinician
timeFrame: 24 months
measure: Duration of postoperative fever (hours)
timeFrame: 10 days
measure: Presence/absence of postoperative fever > 37.2°C
timeFrame: Day 1
Other outcomes:
Locations:
city: Besancon
country: France
facility: CHRU de Besancon
city: Bordeaux
country: France
facility: CHU de Bordeaux
city: Clermont Ferrand
country: France
facility: CHRU de Clermont Ferrand
city: Clichy
country: France
facility: APHP - Hôpital Beaujon
city: Grenoble
country: France
facility: Hôpital Albert Michallon, CHU de Grenoble
city: Le Kremlin Bicêtre Cedex
country: France
facility: APHP - Centre Hospitalier Universitaire de Bicêtre
city: Lille Cedex
country: France
facility: CHRU de Lille - Hôpital Claude Huriez
city: Lille
country: France
facility: Centre de Lutte Contre le Cancer - Centre Oscar Lambret
city: Lyon
country: France
facility: CHU de Lyon
city: Marseille
country: France
facility: Centre Régional de Lutte Contre le Cancer - Institut Paoli-Calmettes
city: Marseille
country: France
facility: APHM - Hôpital La Timone Adultes
city: Montpellier
country: France
facility: Centre Régional de Lutte Contre le Cancer Val d'Aurelle - Paul Lamarque
city: Nantes
country: France
facility: CHU de Nantes
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes
city: Paris Cedex 12
country: France
facility: APHP - Hôpital Saint-Antoine
city: Paris Cedex 13
country: France
facility: APHP - Groupe Hospitalier Pitié-Salpetrière
city: Paris
country: France
facility: APHP - Hôpital Lariboisière
city: Rennes
country: France
facility: Hôpital Pontchailou
city: Rouen
country: France
facility: CHU de Rouen
city: Strasbourg
country: France
facility: Centre Régional de Lutte contre le Cancer Centre Paul Strauss
city: Toulouse
country: France
facility: CHU de Toulouse
city: Vichy
country: France
facility: CH de Vichy - Jacques Larin
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Michel Prudhomme, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.