ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair (NCT06367309) | Clinical Trial Compass
RecruitingNot Applicable
ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair
Switzerland138 participantsStarted 2024-07-01
Plain-language summary
This study investigates on the effect of two different operative techniques to treat abdominal wall hernias.
The goal of this clinical trial is to learn if the eTEP (Extended totally extraperitoneal repair) technique leads to a better outcome than the IPOM (Intraperitoneal onlay mesh) technique.
The main questions it aims to answer are:
* pain after the operation
* rate of complications
* rate of recurrence and reoperations
* quality of life.
Participants will:
Either be operated using the eTEP or the IPOM technique. Be followed up either in person or via email / phone call at day 1, day 7, day 14, 6 weeks, 6 months, 1, 3 and 5 years after the surgery to asses the above-stated main and some more outcomes.
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:
* Patient age \>18 years
* Informed consent obtained
* Primary or incisional ventral hernia
* Epigastric, umbilical or infraumbilical ventral hernias with transversal diameter \>1cm and \</= 4cm, +/- rectus diastasis which doesn't demand specific treatment
* If multiple hernias: cumulative transversal diameter \</= 4cm
* Considered eligible for minimally-invasive approach
Exclusion Criteria:
* Subxyphoidal or suprapubic hernias
* precedent hernia treatment with mesh placement in the retromuscular space
* liver disease defined by the presence of ascites
* end-stage renal disease requiring dialysis
* need of an emergency surgery
* pregnancy
* need of rectus diastasis treatment intraoperatively
Criteria for participating surgeons
\- Each participating surgeon has performed 20 or more laparoscopic IPOM procedures and 20 or more eTEP procedures.
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
1
primary outcome: pain numeric rating scale (NRS)
Timeframe: 24 hours
2
pain outcome using the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form 3a