Randomized Study on the Type and Location of Mesh Implantation in Abdominal Wall Hernias
Zusammenfassung der Studie
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)
Untersuchte Intervention
Mesh-reinforced, minimally invasive extraperitoneal abdominal wall repair
(BASEC)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
Very high (subxyphoid) or very low (suprapubic) abdominal wall hernias
Previous mesh implantation
Liver or kidney disease in advanced stage
Pregnancy
Emergency surgeries
(BASEC)
Studienstandort
Basel, Sion, Andere
(BASEC)
Altötting, Deutschland Visp (Sion), Schweiz
(BASEC)
Sponsor
Clarunis - University Digestive Health Care Center
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Fiorenzo Angehrn
+41 61 777 73 17
fiorenzo.angehrn@clutterclarunis.chClarunis - University Digestive Health Care Center
(BASEC)
Allgemeine Auskünfte
Clarunis - Universit?res Bauchzentrum Basel,Clarunis - Universit?res Bauchzentrum Basel,
0041 61 777 73 17;
fiorenzo.angehrn@clutterclarunis.ch(ICTRP)
Allgemeine Auskünfte
Clarunis - Universitres Bauchzentrum BaselClarunis - Universitres Bauchzentrum Basel
0041 61 777 73 17
fiorenzo.angehrn@clutterclarunis.chfiorenzo.angehrn@clutterclarunis.ch(ICTRP)
Wissenschaftliche Auskünfte
Clarunis - Universit?res Bauchzentrum Basel,Clarunis - Universit?res Bauchzentrum Basel,
0041 61 777 73 17;
fiorenzo.angehrn@clutterclarunis.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Datum der Bewilligung durch die Ethikkommission
21.05.2024
(BASEC)
ICTRP Studien-ID
NCT06367309 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair (ALPINE) (BASEC)
Wissenschaftlicher Titel
ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair - the Randomized Controlled ALPINE Trial (ICTRP)
Öffentlicher Titel
ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair (ICTRP)
Untersuchte Krankheit(en)
Ventral HerniaAbdominal Wall Defect
(ICTRP)
Untersuchte Intervention
Procedure: Extended totally extraperitoneal repairProcedure: Intraperitoneal onlay mesh
(ICTRP)
Studientyp
Interventional (ICTRP)
Studiendesign
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
(ICTRP)
Ein-/Ausschlusskriterien
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)
nicht verfügbar
Primäre und sekundäre Endpunkte
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)
Registrierungsdatum
nicht verfügbar
Einschluss des ersten Teilnehmers
nicht verfügbar
Sekundäre Sponsoren
St. Clara Hospital, Basel, Switzerland;Innklinikum Alt�tting, Germany (ICTRP)
Weitere Kontakte
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)
Sekundäre IDs
2023 - 02357 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
nicht verfügbar
Weitere Informationen zur Studie
https://clinicaltrials.gov/ct2/show/NCT06367309 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar