RecruitingNot Applicable

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

France134 participantsStarted 2022-05-24

Plain-language summary

This study is a follow-up of the GRECCAR 07 cohort (NCT01380860). Patients will be evaluated 5 years following terminal colostomy to observe patient long-term patient outcomes from colostomy with and without mesh placement.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Rate of parastomal hernia between groups

Timeframe: 5 years after colostomy formation

Date of parastomal hernia

Timeframe: 5 years after colostomy formation

Trial details

NCT IDNCT04282473

SponsorCentre Hospitalier Universitaire de Nīmes

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-05

Contact for this trial

Michel Prudhomme, MD

06.43.50.35.22 michel.prudhomme@chu-nimes.fr

View on ClinicalTrials.gov More Colostomy Stoma trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.