Primary Prevention of Peristomial Hernias Via Parietal Prostheses
NCT ID: NCT01380860
Last Updated: 2025-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
200 participants
INTERVENTIONAL
2012-11-30
2018-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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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.
Colostomy with mesh implantation
Colostomy with mesh implantation
No mesh
The patients allocated to this arm of the protocol will not receive mesh implantation with their colostomy.
Simple colostomy
Colostomy with no mesh implantation.
Interventions
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Colostomy with mesh implantation
Colostomy with mesh implantation
Simple colostomy
Colostomy with no mesh implantation.
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire de Nīmes
OTHER
Responsible Party
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Principal Investigators
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Michel Prudhomme, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Centre Hospitalier Universitaire de Nîmes
Locations
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CHRU de Besancon
Besançon, , France
CHU de Bordeaux
Bordeaux, , France
CHRU de Clermont Ferrand
Clermont-Ferrand, , France
APHP - Hôpital Beaujon
Clichy, , France
Hôpital Albert Michallon, CHU de Grenoble
Grenoble, , France
APHP - Centre Hospitalier Universitaire de Bicêtre
Le Kremlin-Bicêtre, , France
Centre de Lutte Contre le Cancer - Centre Oscar Lambret
Lille, , France
CHRU de Lille - Hôpital Claude Huriez
Lille, , France
CHU de Lyon
Lyon, , France
Centre Régional de Lutte Contre le Cancer - Institut Paoli-Calmettes
Marseille, , France
APHM - Hôpital La Timone Adultes
Marseille, , France
Centre Régional de Lutte Contre le Cancer Val d'Aurelle - Paul Lamarque
Montpellier, , France
CHU de Nantes
Nantes, , France
Centre Hospitalier Universitaire de Nîmes
Nîmes, , France
APHP - Hôpital Lariboisière
Paris, , France
APHP - Hôpital Saint-Antoine
Paris, , France
APHP - Groupe Hospitalier Pitié-Salpetrière
Paris, , France
Hôpital Pontchailou
Rennes, , France
CHU de Rouen
Rouen, , France
Centre Régional de Lutte contre le Cancer Centre Paul Strauss
Strasbourg, , France
CHU de Toulouse
Toulouse, , France
CH de Vichy - Jacques Larin
Vichy, , France
Countries
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References
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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.
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.
Other Identifiers
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2011-A01572-39
Identifier Type: OTHER
Identifier Source: secondary_id
PHRC-N/2011/MP-01
Identifier Type: -
Identifier Source: org_study_id
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