ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair

NCT06367309 | Recruiting DMC

• 1 other identifier: 2023 - 02357
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventral Hernia; Abdominal Wall Defect

Outcome Measures

Primary Outcomes (2)

• primary outcome: pain numeric rating scale (NRS)

  pain, measured on the numeric rating scale (NRS) 0 - 10 24 hours after the surgical procedure.

  24 hours

• pain outcome using the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form 3a

  pain, measured using the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form 3a 24 hours after the surgical procedure

  24 hours

Secondary Outcomes (6)

• pain mid-term

  12 months

• recurrence and reoperation

  5 years

• LOS

  30 days

• Functional recovery

  5 years

• Adverse events

  30 days

Study Arms (2)

eTEP (Extended totally extraperitoneal repair)

EXPERIMENTAL

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: Extended totally extraperitoneal repair

IPOM (intraperitoneal onlay mesh)

ACTIVE COMPARATOR

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.

Procedure: Intraperitoneal onlay mesh

Interventions

Extended totally extraperitoneal repair PROCEDURE

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.

eTEP (Extended totally extraperitoneal repair)

Intraperitoneal onlay mesh PROCEDURE

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.

IPOM (intraperitoneal onlay mesh)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead
• St. Clara Hospital, Basel, Switzerland: collaborator
• Innklinikum Altötting, Germany: collaborator

Study Sites (1)

St. Clara Hospital

Basel, Canton of Basel-City, 4058, Switzerland

RECRUITING

MeSH Terms

Conditions

Hernia, Ventral

Condition Hierarchy (Ancestors)

Hernia, Abdominal; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Julian Süsstrunk, MD

  Clarunis - Universitäres Bauchzentrum Basel

  PRINCIPAL INVESTIGATOR

• Johannes Baur, MD

  Clarunis - Universitäres Bauchzentrum Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fiorenzo Angehrn, MD

CONTACT

0041 61 777 73 17; fiorenzo.angehrn@clarunis.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The trial participants and the assessors (trained investigators not involved in the operative procedures) of the primary outcome are blinded regarding the performed procedure during the first seven days after the procedure to reduce bias. The blinding is guaranteed by not sharing the detailed operation report with anyone involved in the aftercare of the patient or in the assessment of study outcomes.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 16, 2024
• Study Start: July 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: April 11, 2025

Record last verified: 2025-04

Locations

CH (1)