Ventral and Ventral Insicional Hernia Clinical Trial
Official title:
Randomized Controlled National Multicenter Study for Evaluation of Two Different Ways of Fixation of Mesh-implants and Differences With or Without Approximation of Herniadefects at Laparoscopic Operation for Incisional and Ventral Hernia
The study aims to prove differences or equalities in outcome for patients operated with laparoscopic ventral hernia repair with different methods of fixation of mesh and with or without approximation of defect prior to meshfixation.
Patients are randomized to 4 groups: non-absorbable suture fixation and hernia
approximation, double crown mesh fixation with titanium spiral tacks with hernia
approximation and the same fixations without hernia approximation.
Primary endpoint is recurrence. Secondary endpoints are operating time, adhesion score, mode
of entering abdominal cavity, time to recovery, pain durance, seroma formation, aesthetic
result (protrusion), organ traumatization infection. Endpoints are correlated to hernia
size, body mass index, previous recurrence, age, concurrent illness. Patients are followed 3
years after operation with clinical examination.
300 patients are planned included in primary study. A subgroup of organ transplanted
patients is evaluated in a separate study with identical criteria for inclusion.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment