Postoperative Pain, Ventral Hernia
Conditions
Keywords
Ventral Hernia, Postoperative Pain, Ventral Hernia Pain Questionnaire, Postoperative Abdominal wall and muscle function, Biodex
Brief summary
This is a prospective randomized study to compare surgical methods for the repair of large abdominal hernia.
Detailed description
Patients with giant (\>10 cm in diameter) abdominal wall hernia are included in a prospective randomized study comparing conventional mesh repair with the best possible method to onlay full thickness skin grafts.
Interventions
PROCEDUREVentral hernia repair using full thickness skin graft
25 patients
PROCEDUREVentral hernia repair using mesh
25 patients
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* ventral hernia \> 10 centimeters, abdominal wall pain or discomfort, desire hernia repair.
Exclusion criteria
* \< 18 years of age, ongoing pregnancy or nursing, ongoing immunosuppressive treatment,ongoing smoking.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of complication | 3 month, 1 year and 3 year post-operative clinical follow-up | Complications will be assessed over a 3 year period of regular follow-up by an objective surgeon who is unaware of which surgical method which was used. Eventual complications may include infection, bleeding, seroma and fistula formation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventral Hernia Pain Questionnaire (VHPQ) | 1 year period of follow-up | All subjects will complete the VHPQ which will be used to assess their pre- and postoperative pain. |
| Abdominal wall function | 3 year period of follow up | All subjects will undergo testing of abdominal wall function and strength using the Biodex. |
Countries
Sweden
Outcome results
None listed