ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair (ALPINE)

University Hospital Basel

Status: Enrolling

Conditions: Ventral Hernia; Abdominal Wall Defect

Treatments: Procedure: Extended totally extraperitoneal repair; Procedure: Intraperitoneal onlay mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT06367309

2023 - 02357

Details and patient eligibility

About

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.

Enrollment: 138 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

138 participants in 2 patient groups

eTEP (Extended totally extraperitoneal repair)

Experimental group

Description:

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.

Treatment:

Procedure: Extended totally extraperitoneal repair

IPOM (intraperitoneal onlay mesh)

Active Comparator group

Description:

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.

Treatment:

Procedure: Intraperitoneal onlay mesh