Randomized Study on the Type and Location of Mesh Implantation in Abdominal Wall Hernias
Descrizione riassuntiva dello studio
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)
Intervento studiato
Mesh-reinforced, minimally invasive extraperitoneal abdominal wall repair
(BASEC)
Malattie studiate
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)
Criteri di esclusione
Very high (subxyphoid) or very low (suprapubic) abdominal wall hernias
Previous mesh implantation
Liver or kidney disease in advanced stage
Pregnancy
Emergency surgeries
(BASEC)
Luogo dello studio
Basilea, Sion, Altro
(BASEC)
Altötting, Deutschland Visp (Sion), Schweiz
(BASEC)
Sponsor
Clarunis - University Digestive Health Care Center
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Fiorenzo Angehrn
+41 61 777 73 17
fiorenzo.angehrn@clutterclarunis.chClarunis - University Digestive Health Care Center
(BASEC)
Informazioni generali
Clarunis - Universit?res Bauchzentrum Basel,Clarunis - Universit?res Bauchzentrum Basel,
0041 61 777 73 17;
fiorenzo.angehrn@clutterclarunis.ch(ICTRP)
Informazioni generali
Clarunis - Universitres Bauchzentrum BaselClarunis - Universitres Bauchzentrum Basel
0041 61 777 73 17
fiorenzo.angehrn@clutterclarunis.chfiorenzo.angehrn@clutterclarunis.ch(ICTRP)
Informazioni scientifiche
Clarunis - Universit?res Bauchzentrum Basel,Clarunis - Universit?res Bauchzentrum Basel,
0041 61 777 73 17;
fiorenzo.angehrn@clutterclarunis.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione d'etica svizzera nord-ovest/centrale EKNZ
(BASEC)
Data di approvazione del comitato etico
21.05.2024
(BASEC)
ID di studio ICTRP
NCT06367309 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair (ALPINE) (BASEC)
Titolo accademico
ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair - the Randomized Controlled ALPINE Trial (ICTRP)
Titolo pubblico
ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair (ICTRP)
Malattie studiate
Ventral HerniaAbdominal Wall Defect
(ICTRP)
Intervento studiato
Procedure: Extended totally extraperitoneal repairProcedure: Intraperitoneal onlay mesh
(ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
(ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
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)
Data di registrazione
non disponibile
Inclusione del primo partecipante
non disponibile
Sponsor secondari
St. Clara Hospital, Basel, Switzerland;Innklinikum Alt�tting, Germany (ICTRP)
Contatti aggiuntivi
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)
ID secondari
2023 - 02357 (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06367309 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile