Evaluating long-term outcomes of colostomy with and without mesh placement

Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh: Material-epidemiology Study

This study looks at how well colostomy patients do over time with or without a special mesh to see if it helps prevent hernias.

Quick facts

• Study type: Observational
• Enrollment: 134 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Centre Hospitalier Universitaire de Nīmes (Academic / other)
• Locations: 16 sites (Besançon and 15 other locations)
• Trial ID: NCT04282473 on ClinicalTrials.gov

What this trial studies

This observational study follows patients from the GRECCAR 07 cohort to assess the long-term outcomes of terminal colostomy performed five years ago, specifically focusing on the rates of parastomal hernia in patients who received mesh versus those who did not. The study aims to gather data on the effectiveness and complications associated with the use of the Parietex TCM parietal prosthesis in colostomy procedures. By comparing these two groups, the study seeks to provide insights into the best practices for managing colostomy patients.

Who should consider this trial

Good fit: Ideal candidates for this study are patients who were part of the GRECCAR 07 cohort and underwent a terminal colostomy five years ago.

Not a fit: Patients currently participating in other interventional studies or those who are pregnant or breastfeeding may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for patients undergoing colostomy, potentially reducing the incidence of parastomal hernias.

How similar studies have performed: While this study builds on previous research, the specific approach of comparing outcomes with and without mesh in this cohort is relatively novel.

Eligibility criteria

Inclusion Criteria:

* The patient must be affiliated with a health insurance programme
* Patient was included in the GRECCAR 07 cohort (PHRC National 2011; N° RCB: 2011-A01572-39 - ClinicalTrials.gov ID: NCT01380860)
* Patient received colostomy 5 years ago

Exclusion Criteria:

* The subject is participating in another category I interventional study, or is in a period of exclusion determined by a previous study
* The subject signals opposition to participating in the study
* The patient is under safeguard of justice or state guardianship
* The patient is pregnant or breastfeeding

Where this trial is running

Besançon and 15 other locations

• L'Hôpital Jean Minjoz — Besançon, France (Recruiting)
• CHU de Bordeaux — Bordeaux, France (Not_yet_recruiting)
• CHRU Clermont- Ferrand Hôtel -Dieu — Clermont-Ferrand, France (Recruiting)
• Hôpital Beaujon (AP-HP) — Clichy, France (Not_yet_recruiting)
• Hôpital Albert Michallon — Grenoble, France (Not_yet_recruiting)
• Centre Oscar Lambret — Lille, France (Recruiting)
• Centre Hospitalier Lyon-Sud — Lyon, France (Recruiting)
• Centre Régional de Lutte contre le Cancer Institut Paoli-Calmettes — Marseille, France (Not_yet_recruiting)
• Hôpital La Timone, AP-HM — Marseille, France (Not_yet_recruiting)
• CRLC Val d'Aurelle - Paul Lamarque — Montpellier, France (Not_yet_recruiting)
• Centre Hospitalier Universitaire Hôtel-Dieu - CHU de Nantes — Nantes, France (Recruiting)
• CHU de Nimes — Nîmes, France (Recruiting)
• Hôpital Saint Antoine (AP-HP) — Paris, France (Not_yet_recruiting)
• Hôpital Pontchaillou — Rennes, France (Not_yet_recruiting)
• Hôpital Charles-Nicolle — Rouen, France (Recruiting)
• Hôpital Purpan - CHU de Toulouse — Toulouse, France (Recruiting)

Study contacts

• Principal investigator: Michel Prudhomme, MD — CHU Nimes
• Study coordinator: Michel Prudhomme, MD

Conditions Colostomy Stoma; Parastomal Hernia