Ventral and Ventral Insicional Hernia
Conditions
Keywords
Laparoscopy, ventral, hernia, repair, surgery
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.
Interventions
PROCEDURELaparoscopic ventral hernia repair
Sponsors
Tyco Healthcare Group
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* secondary or primary ventral hernia
Exclusion criteria
* Loss of domain, Giant hernia with need of abdominal plastic operation, ASA score above 3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Operating time | 30-180 min |
| Adhesion score | — |
| Mode of entering abdominal cavity | — |
| Pain durance | 8 weeks |
| Seroma formation | — |
| Aesthetic result (protrusion) | 3 years |
| Infection | 8 weeks |
Countries
Norway
Outcome results
None listed