abdominal hernia incisional hernia
Conditions
Interventions
The intervention in the experimental arm consists of suturing an acellular
biological mesh derived from porcine dermis in the abdominal wall defect,
followed by closure of the skin, fascia and subcu
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Require an elective closure of an ileostomy or a colostomy. Those patients undergoing a Stoma closure involving both a colostomy and an ileostomy element are eligible and should be Stratified as colostomy patients. Be able and willing to provide written informed consent for the study Be aged 18 years or over.
Exclusion criteria
Exclusion criteria: Taking part in another clinical study which is related to the surgical procedure. Allergic to any porcine or collagen products. Unable or unwilling to provide written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of clinically detectable hernias at two years post closure | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Radiological hernia rate at one year post closure. An exploratory analysis will compare radiological hernia rate at 1 year with clinical hernia rate at 2 years to assess the value of using a CT scan as an early diagnostic tool of incisional hernias. 2. Surgical re-intervention rate. 3. Surgical complications at 30 days and 1 year. 4. Quality of life and post-operative pain. 5. Cost-benefit analysis. | — |
Countries
Netherlands
Outcome results
None listed