ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Extended totally extraperitoneal repair, Intraperitoneal onlay mesh.
- Who it may be relevant to
- Registry conditions: Ventral Hernia, Abdominal Wall Defect. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Switzerland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair - the Randomized Controlled ALPINE Trial
Overview
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.
Interventions
- 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 preper - 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 orif
Primary outcome measures
- primary outcome: pain numeric rating scale (NRS) [Time frame: 24 hours]
- pain outcome using the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form 3a [Time frame: 24 hours]
Secondary outcome measures (6)
- pain mid-term [Time frame: 12 months]
- recurrence and reoperation [Time frame: 5 years]
- LOS [Time frame: 30 days]
- Functional recovery [Time frame: 5 years]
- Adverse events [Time frame: 30 days]
- Quality of life (SF 12) [Time frame: 5 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
Switzerland · 1 center
- St. Clara Hospital — Basel
Identifiers
NCT: NCT06367309 · 2023 - 02357