Randomized Study on the Type and Location of Mesh Implantation in Abdominal Wall Hernias
Summary description of the study
In this study, two different techniques for the surgery of an abdominal wall hernia are compared. In the technique to be studied, the mesh, which is introduced to reinforce the hernia closure, is planned outside the abdominal cavity. In the comparison technique, the mesh is introduced inside the abdominal cavity.
Which procedure is applied to the respective study participants is decided by lottery, and the study participant learns at the earliest 7 days after the operation which technique was used.
Surgical techniques are established and are routinely applied at all three study centers. Which technique is superior, however, remains unclear according to current literature.
The primary endpoint of the study is the occurrence of pain 24 hours after the operation. Other endpoints to be investigated include pain after 7 days, 2 and 6 weeks, complications, the duration of the operation and hospital stay, and costs.
(BASEC)
Intervention under investigation
Mesh-reinforced, minimally invasive extraperitoneal abdominal wall repair
(BASEC)
Disease under investigation
Abdominal wall hernias
(BASEC)
Age > 18 years
Primary or secondary abdominal wall hernia
Single hernia defect </= 4cm or sum of hernia defects </= 4cm
Minimally invasive surgery possible
Consent of the study participant
(BASEC)
Exclusion criteria
Very high (subxyphoid) or very low (suprapubic) abdominal wall hernias
Previous mesh implantation
Liver or kidney disease in advanced stage
Pregnancy
Emergency surgeries
(BASEC)
Trial sites
Basel, Sion, Other
(BASEC)
Altötting, Deutschland Visp (Sion), Schweiz
(BASEC)
Sponsor
Clarunis - University Digestive Health Care Center
(BASEC)
Contact
Contact Person Switzerland
Fiorenzo Angehrn
+41 61 777 73 17
fiorenzo.angehrn@clutterclarunis.chClarunis - University Digestive Health Care Center
(BASEC)
General Information
Clarunis - Universit?res Bauchzentrum Basel,Clarunis - Universit?res Bauchzentrum Basel,
0041 61 777 73 17;
fiorenzo.angehrn@clutterclarunis.ch(ICTRP)
General Information
Clarunis - Universitres Bauchzentrum BaselClarunis - Universitres Bauchzentrum Basel
0041 61 777 73 17
fiorenzo.angehrn@clutterclarunis.chfiorenzo.angehrn@clutterclarunis.ch(ICTRP)
Scientific Information
Clarunis - Universit?res Bauchzentrum Basel,Clarunis - Universit?res Bauchzentrum Basel,
0041 61 777 73 17;
fiorenzo.angehrn@clutterclarunis.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee northwest/central Switzerland EKNZ
(BASEC)
Date of authorisation
21.05.2024
(BASEC)
ICTRP Trial ID
NCT06367309 (ICTRP)
Official title (approved by ethics committee)
ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair (ALPINE) (BASEC)
Academic title
ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair - the Randomized Controlled ALPINE Trial (ICTRP)
Public title
ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair (ICTRP)
Disease under investigation
Ventral HerniaAbdominal Wall Defect
(ICTRP)
Intervention under investigation
Procedure: Extended totally extraperitoneal repairProcedure: Intraperitoneal onlay mesh
(ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
(ICTRP)
Inclusion/Exclusion 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.
(ICTRP)
not available
Primary and secondary end points
primary outcome: pain numeric rating scale (NRS);pain outcome using the Patient-Reported Outcome Measurement Information System (PROMIS) Pain Intensity Short Form 3a
(ICTRP)
pain mid-term;recurrence and reoperation;LOS;Functional recovery;Adverse events;Quality of life (SF 12)
(ICTRP)
Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
St. Clara Hospital, Basel, Switzerland;Innklinikum Alt�tting, Germany (ICTRP)
Additional contacts
Julian S?sstrunk, MD;Johannes Baur, MD;Fiorenzo Angehrn, MD;Fiorenzo Angehrn, MD, fiorenzo.angehrn@clarunis.ch, 0041 61 777 73 17;, Clarunis - Universit?res Bauchzentrum Basel,Clarunis - Universit?res Bauchzentrum Basel, (ICTRP)
Secondary trial IDs
2023 - 02357 (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06367309 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available