Randomized Study on the Type and Location of Mesh Implantation in Abdominal Wall Hernias
Résumé de l'étude
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 étudiée
Mesh-reinforced, minimally invasive extraperitoneal abdominal wall repair
(BASEC)
Maladie en cours d'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)
Critères d'exclusion
Very high (subxyphoid) or very low (suprapubic) abdominal wall hernias
Previous mesh implantation
Liver or kidney disease in advanced stage
Pregnancy
Emergency surgeries
(BASEC)
Lieu de l’étude
Bâle, Sion, Autre
(BASEC)
Altötting, Deutschland Visp (Sion), Schweiz
(BASEC)
Sponsor
Clarunis - University Digestive Health Care Center
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Fiorenzo Angehrn
+41 61 777 73 17
fiorenzo.angehrn@clutterclarunis.chClarunis - University Digestive Health Care Center
(BASEC)
Informations générales
Clarunis - Universit?res Bauchzentrum Basel,Clarunis - Universit?res Bauchzentrum Basel,
0041 61 777 73 17;
fiorenzo.angehrn@clutterclarunis.ch(ICTRP)
Informations générales
Clarunis - Universitres Bauchzentrum BaselClarunis - Universitres Bauchzentrum Basel
0041 61 777 73 17
fiorenzo.angehrn@clutterclarunis.chfiorenzo.angehrn@clutterclarunis.ch(ICTRP)
Informations scientifiques
Clarunis - Universit?res Bauchzentrum Basel,Clarunis - Universit?res Bauchzentrum Basel,
0041 61 777 73 17;
fiorenzo.angehrn@clutterclarunis.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Ethikkommission Nordwest- und Zentralschweiz EKNZ
(BASEC)
Date d'approbation du comité d'éthique
21.05.2024
(BASEC)
Identifiant de l'essai ICTRP
NCT06367309 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair (ALPINE) (BASEC)
Titre académique
ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair - the Randomized Controlled ALPINE Trial (ICTRP)
Titre public
ExtrAperitoneaL Plasty vs Intraperitoneal oNlay mEsh in Ventral Hernia Repair (ICTRP)
Maladie en cours d'investigation
Ventral HerniaAbdominal Wall Defect
(ICTRP)
Intervention étudiée
Procedure: Extended totally extraperitoneal repairProcedure: Intraperitoneal onlay mesh
(ICTRP)
Type d'essai
Interventional (ICTRP)
Plan de l'étude
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor).
(ICTRP)
Critères d'inclusion/exclusion
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 disponible
Critères d'évaluation principaux et secondaires
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)
Date d'enregistrement
non disponible
Inclusion du premier participant
non disponible
Sponsors secondaires
St. Clara Hospital, Basel, Switzerland;Innklinikum Alt�tting, Germany (ICTRP)
Contacts supplémentaires
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 secondaires
2023 - 02357 (ICTRP)
Résultats-Données individuelles des participants
non disponible
Informations complémentaires sur l'essai
https://clinicaltrials.gov/ct2/show/NCT06367309 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible