NCT06367309 ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair
| NCT ID | NCT06367309 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Basel, Switzerland |
| Condition | Ventral Hernia |
| Study Type | INTERVENTIONAL |
| Enrollment | 138 participants |
| Start Date | 2024-07-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 138 participants in total. It began in 2024-07-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Julian Süsstrunk, MD
PRINCIPAL INVESTIGATOR
Clarunis - Universitäres Bauchzentrum Basel
Frequently Asked Questions
Who can join the NCT06367309 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Ventral Hernia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06367309 currently recruiting?
Yes, NCT06367309 is actively recruiting participants. Contact the research team at fiorenzo.angehrn@clarunis.ch for enrollment information.
Where is the NCT06367309 trial being conducted?
This trial is being conducted at Basel, Switzerland.
Who is sponsoring the NCT06367309 clinical trial?
NCT06367309 is sponsored by University Hospital, Basel, Switzerland. The principal investigator is Julian Süsstrunk, MD at Clarunis - Universitäres Bauchzentrum Basel. The trial plans to enroll 138 participants.