LVHR Multicenter Study
- Conditions
- Ventral and Ventral Insicional Hernia
- Registration Number
- NCT00455299
- Lead Sponsor
- Oslo University Hospital
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 156
- secondary or primary ventral hernia
- Loss of domain, Giant hernia with need of abdominal plastic operation, ASA score above 3
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Primary Outcome Measures
Name Time Method Mode of entering abdominal cavity Operating time 30-180 min Pain durance 8 weeks Infection 8 weeks Adhesion score Seroma formation Aesthetic result (protrusion) 3 years
- Secondary Outcome Measures
Name Time Method
Related Research Topics
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Trial Locations
- Locations (2)
SIHF Gjøvik
🇳🇴Gjøvik, Norway
Ullevål University Hospital
🇳🇴Oslo, Norway
SIHF Gjøvik🇳🇴Gjøvik, Norway