Actively Recruiting
ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair - the Randomized Controlled ALPINE Trial
Led by University Hospital, Basel, Switzerland · Updated on 2025-04-11
138
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Basel, Switzerland
Lead Sponsor
S
St. Clara Hospital, Basel, Switzerland
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating two surgical techniques, eTEP (Extended totally extraperitoneal repair) and IPOM (Intraperitoneal onlay mesh), for treating abdominal wall hernias. This clinical trial aims to determine which method leads to better outcomes in terms of pain after surgery, complication rates, recurrence and reoperation rates, and quality of life for patients with ventral hernias. Participants will undergo hernia repair using either the eTEP technique, where the retromuscular space is accessed and a synthetic mesh is placed with minimal fixation, or the IPOM technique, involving laparoscopic placement of a coated mesh inside the peritoneal cavity with sutures and absorbable tackers for fixation. Both procedures involve laparoscopic ports and closure of the hernia orifice with barbed sutures. After surgery, participants will be followed up through in-person visits, phone calls, or emails at multiple time points including day 1, 7, 14, 6 weeks, 6 months, and then 1, 3, and 5 years. Researchers will assess pain using numeric rating scales and PROMIS tools within 24 hours, as well as monitor pain mid-term, recurrence, reoperation, length of hospital stay, functional recovery, adverse events, and quality of life over the follow-up period.
CONDITIONS
Brief Title
ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants undergo one of two surgical techniques for ventral hernia repair: Extended totally extraperitoneal repair (eTEP) or Intraperitoneal onlay mesh (IPOM). This includes the surgical procedure and immediate recovery period.
1 surgical visit (in-person)
Duration - 30 days
Participants are monitored for recovery, pain, adverse events, and functional outcomes after surgery.
Approximately 3 post-operative visits (in-person)
Duration - Up to 5 years
Participants are followed for long-term outcomes including pain, recurrence, reoperation, functional recovery, and quality of life over several years.
Periodic visits over 5 years (in-person or remote)
Trial Site Locations
Total: 1 location
1
St. Clara Hospital
Basel, Canton of Basel-City, Switzerland, 4058
Actively Recruiting
Research Team
F
Fiorenzo Angehrn, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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