Clinical trial NCT06367309: ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair
Official title: ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair - the Randomized Controlled ALPINE Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Ventral Hernia
Abdominal Wall Defect
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: St. Clara Hospital, Basel, Switzerland
name: Innklinikum Altötting, Germany
First posted: 2024-04-16
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: primary outcome: pain numeric rating scale (NRS)
timeFrame: 24 hours
measure: pain outcome using the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form 3a
timeFrame: 24 hours
Secondary outcomes:
measure: pain mid-term
timeFrame: 12 months
measure: recurrence and reoperation
timeFrame: 5 years
measure: LOS
timeFrame: 30 days
measure: Functional recovery
timeFrame: 5 years
measure: Adverse events
timeFrame: 30 days
measure: Quality of life (SF 12)
timeFrame: 5 years
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: St. Clara Hospital
state: Basel-Stadt
Study officials:
affiliation: Clarunis - Universitäres Bauchzentrum Basel
name: Julian Süsstrunk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clarunis - Universitäres Bauchzentrum Basel
name: Johannes Baur, MD
role: PRINCIPAL_INVESTIGATOR
References: