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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ventral Hernia; Abdominal Wall Defect
• Intervention / Treatment: Procedure: Extended totally extraperitoneal repair; Procedure: Intraperitoneal onlay mesh

• Study Type: Interventional
• Enrollment (Estimated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fiorenzo Angehrn, MD; Phone Number: 0041 61 777 73 17; Email: fiorenzo.angehrn@clarunis.ch

Study Locations

• Switzerland
  • Basel-Stadt
    • Basel, Basel-Stadt, Switzerland, 4058
      • Recruiting
      • St. Clara Hospital
      • Contact: Fiorenzo Angehrn, MD; Email: fiorenzo.angehrn@clarunis.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: eTEP (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: 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.
Active Comparator: IPOM (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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain mid-term	pain, measured on the visual analog scale (NRS) 0 - 10 and using the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form 3a after 7days, 14 days, 6 weeks, 6 and 12 months (NRS 0-10)	12 months
recurrence and reoperation	Long-term outcome at 3 and 5 years with assessment of the number of patients with clinical and / or radiological recurrences and with assessment of the number of patients who needed reoperations for either recurrences or other reasons such as mechanical bowel obstructions	5 years
LOS	Length of hospital stay	30 days
Functional recovery	Functional recovery measured using the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) Questionnaire at 7 and 14 days, 6 weeks, 6 months, 1, 3 and 5 years. The questionnaire uses 5 questions describing the patients health & abilities on that particular day and a visual analogue scale question (0 = worst, 100 = best) on the patients health on that particular day.	5 years
Adverse events	Intraoperative adverse events (Bleeding, conversion rate, injury to bowel structures) Postoperative adverse events (ileus, seroma, hematoma, Surgical site infections (SSI), pulmonary embolism) according to Clavien-Dindo Classification and scored according to the Comprehensive Complication Index (CCI) up to 30 days after surgery.	30 days
Quality of life (SF 12)	Quality of life using the short form-12 (SF-12) questionnaire at 7 and 14 days, 6 weeks, 6 months, 1, 3 and 5 years. The 12-item Short Form Survey (SF-12) is a general health questionnaire that was first published in 1995 as part of the Medical Outcomes Study (MOS). The SF-12 was constructed using questions drawn from each of the 8 dimensions of the MOS 36 item Short Form Survey (SF-36). Two summary scores are reported from the SF-12 - a mental component score (MCS-12) and a physical component score (PCS-12). The score ranges from 0 - 100, with a higher score indicating better physical and mental health functioning.	5 years

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Collaborators: St. Clara Hospital, Basel, Switzerland; Innklinikum Altötting, Germany
• Investigators: Principal Investigator: Johannes Baur, MD, Clarunis - Universitäres Bauchzentrum Basel; Principal Investigator: Julian Süsstrunk, MD, Clarunis - Universitäres Bauchzentrum Basel

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: March 27, 2024
• First Submitted That Met QC Criteria: April 11, 2024
• First Posted (Actual): April 16, 2024

Study Record Updates

• Last Update Posted (Actual): April 11, 2025
• Last Update Submitted That Met QC Criteria: April 8, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Ventral
• Other Study ID Numbers: 2023 - 02357

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD may be shared upon reasonable request. Only anonymised data shall be shared.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No