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Is it Necessary to Drain in Contact With the Prostheses During a Cure of a Ventricle With Retromuscular Prosthesis?

France113 participantsStarted 2022-07-31

Plain-language summary

Is there an indication for drainage in contact with a prosthesis placed in a retromuscular position, during a cure for abdominal wall ventration in adults? This procedure is very frequent in digestive surgery and can be associated with serious complications, notably prosthesis infection.

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: * Adult patient (≥18 years old) * Patient operated on at HUS between 01/01/2018 and 12/31/2020 * Patient who has undergone surgical cure of anterior or lateral abdominal wall eventration of any width with placement during the procedure of a prosthetic mesh in a prefascial retromuscular position. * Patient not objecting to the reuse of their data for scientific research purposes. Exclusion criteria: * Patient who has expressed opposition to the reuse of his or her data for scientific research purposes. * Particular clinical forms of the disease: absence of previous surgical intervention (and thus absence of ventration: umbilical hernia, diastasis) * Absence of prosthesis during the operation or prosthesis placed in intraperitoneal position

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

infection after drainage in contact with a retromuscular prosthesis

Timeframe: 1 day after surgery

Trial details

NCT IDNCT05534503

SponsorUniversity Hospital, Strasbourg, France

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-09-10

Contact for this trial

Benoit ROMAIN, MD, PhD

33 3 88 12 72 37 benoit.romain@chru-strasbourg.fr

View on ClinicalTrials.gov More Eventration of the Abdominal Wall 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.