NCT06367309

ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair

ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair - the Randomized Controlled ALPINE Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 138 (estimated)
• Sponsor: University Hospital, Basel, Switzerland · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ventral Hernia
• Abdominal Wall Defect

Interventions

Type	Name	Description
PROCEDURE	Extended totally extraperitoneal repair	The anterior rectus sheath is incised and the retromuscular space is entered through the rectus muscle fibres. The capnopreperitoneum is established and blunt dissection of the retromuscular space is performed. Two additional laparoscopic ports are established 8-10cm lateral to the linea alba caudally to the initial port. The medial border of the rectus sheath is incised and the preperitoneal space below the linea alba is dissected. The hernia orifice is also dissected from peritoneum and preperitoneal fatty tissue. The medial border of the right retromuscular space is then incised and blunt dissection is performed. The hernia orifice is closed with barbed suture and a synthetic mesh is placed on the posterior sheath of the dissected space (intended Mesh-defect ratio 16). The mesh is fixed non-traumatically using glubran glue or no fixation at all.
PROCEDURE	Intraperitoneal onlay mesh	Capnoperitoneum is established through left sided subcostal Veress-Needle punction. Three laparoscopic ports are placed 8-10cm lateral to the linea alba usually on the patient's left side. The peritoneum is incised and detached from the umbilical and supraumbilical linea alba. The peritoneum including the hernia sac and preperitoneal fat is resected. The hernia orifice is then closed using a barbed suture. A coated mesh is than placed to the ventral abdominal wall covering the closed hernia orifices (intended mesh-defect-ratio: 16). The mesh is fixed with two transfacial absorbable sutures and several absorbable tackers placed in double crown technique around the hernia orifice. The capnoperitoneum is released, the trocars removed and the fascia closed with an absorbable suture. The skin is sutured with absorbable sutures.

Timeline

• Start date: 2024-07-01
• Primary completion: 2025-12-31
• Completion: 2030-12-31
• First posted: 2024-04-16
• Last updated: 2025-04-11

Locations

1 site across 1 country: Switzerland