CompletedNot Applicable

Endoscopic eTEP Versus Open Rives-Stoppa

Belgium60 participantsStarted 2022-06-09

Plain-language summary

Observational cohort study (partially retrospective, partially prospective) comparing the endoscopic extended totally extraperitoneal prosthesis (eTEP) repair for midline abdominal hernias to open Rives-Stoppa repair (control).

Who can participate

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: Group 1 (eTEP): * Participants who underwent an eTEP procedure in the investigators' center * Preoperative existence of one or more midline abdominal wall hernias * Preoperative existence of rectus abdominis diastasis Group 2 (Rives-Stoppa, control group): \- Participants who underwent an open Rives-Stoppa (midline repair with sublay mesh) in the investigators' center Exclusion Criteria: Group 1 (eTEP): * Preoperative absence of midline abdominal wall hernias * Preoperative absence of rectus abdominis diastasis * Intraoperative performance of transverse abdominis release (TAR) * Intraoperative inguinal hernia repair Group 2 (Rives-Stoppa, control group): * Intraoperative performance of transverse abdominis release (TAR) * Intraoperative performance of anterior component separation * Intraoperative inguinal hernia repair

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

Length of hospital stay

Timeframe: From the date of operation until the date of discharge from the hospital, assessed up to 30 days.

Postoperative pain management

Timeframe: From the end of surgery (moment of the end of operation) until the date of discharge from the hospital, assessed up to 30 days.

Trial details

NCT IDNCT05446675

SponsorAZ Alma

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2022-08-30

View on ClinicalTrials.gov More Hernia, Ventral trials