Peristomal Hernia Rate 5 Years After a Terminal Colostomy With the Parietex ™ TCM Parietal Prosthesis Versus Without Mesh

Launched by CENTRE HOSPITALIER UNIVERSITAIRE DE NĪMES · Feb 21, 2020

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ClinConnect Summary

**Clinical Trial Summary:**

This clinical trial is looking at the long-term effects of using a special mesh (called the Parietex™ TCM Parietal Prosthesis) during a terminal colostomy surgery. A colostomy is a procedure where part of the bowel is brought out through the abdomen, often needed for patients with certain health conditions. The goal of this study is to see how many patients develop a parastomal hernia (a type of bulge that can occur around the stoma) five years after their surgery—comparing those who had the mesh placed with those who did not.

To be eligible for this trial, you must be part of a health insurance program and have had a colostomy for five years as part of the earlier GRECCAR 07 study. Participants will be closely monitored to assess their health and any complications related to the colostomy. This study is currently recruiting participants, and it's important to know that you cannot join if you are part of another study or if you are pregnant or breastfeeding. This research aims to improve the understanding of how mesh may help prevent hernias after colostomy surgery, which can help doctors make better treatment decisions in the future.

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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