Comparing two surgical techniques for ventral hernia repair
ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair - the Randomized Controlled ALPINE Trial
NA · University Hospital, Basel, Switzerland · NCT06367309
This study tests which of two surgical methods for fixing ventral hernias, eTEP or IPOM, helps patients recover better and have fewer problems after surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 138 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland (other) |
| Locations | 1 site (Basel, Canton of Basel-City) |
| Trial ID | NCT06367309 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of two surgical techniques, Extended Totally Extraperitoneal Repair (eTEP) and Intraperitoneal Onlay Mesh (IPOM), in treating ventral hernias. The study aims to evaluate outcomes such as postoperative pain, complication rates, recurrence of hernias, and overall quality of life for patients. Participants will be randomly assigned to one of the two surgical approaches and will be followed up for several years to assess their recovery and any long-term effects. The trial seeks to determine which technique offers better results for patients undergoing hernia repair.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with primary or incisional ventral hernias that meet specific size criteria.
Not a fit: Patients with certain types of hernias, liver disease, end-stage renal disease, or those requiring emergency surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical outcomes and quality of life for patients undergoing ventral hernia repair.
How similar studies have performed: Previous studies have shown varying success with similar surgical techniques, but this specific comparison is novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Basel, Canton of Basel-City
- St. Clara Hospital — Basel, Canton of Basel-City, Switzerland (RECRUITING)
Study contacts
- Principal investigator: Julian Süsstrunk, MD — Clarunis - Universitäres Bauchzentrum Basel
- Study coordinator: Fiorenzo Angehrn, MD
- Email: fiorenzo.angehrn@clarunis.ch
- Phone: 0041 61 777 73 17
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Ventral Hernia, Abdominal Wall Defect