Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06367309

ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Ventral Hernia Abdominal Wall Defect Hernia Hernia, Abdominal Hernia, Ventral Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Clara Hospital

Basel, Canton of Basel-City, 4058, Switzerland

Location status: Recruiting

Location contact

Fiorenzo Angehrn, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. primary outcome: pain numeric rating scale (NRS)

    Time frame: 24 hours

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

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

    Time frame: 24 hours

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

Secondary outcomes

  1. pain mid-term

    Time frame: 12 months

    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)

  2. recurrence and reoperation

    Time frame: 5 years

    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

  3. LOS

    Time frame: 30 days

    Length of hospital stay

  4. Functional recovery

    Time frame: 5 years

    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. Adverse events

    Time frame: 30 days

    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.

  6. Quality of life (SF 12)

    Time frame: 5 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Fiorenzo Angehrn, MD

CONTACT

[email protected]

0041 61 777 73 17

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Collaborators

  • Hôpital du Valais
  • Innklinikum Altötting, Germany
  • St. Clara Hospital, Basel, Switzerland

Registry information

Official study title

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

Acronym: ALPINE

Important dates

Study start
2024
Primary completion
2026
Study completion
2031
First posted
Apr 16, 2024
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.