hernia cicatricalis incisional hernia
Conditions
Interventions
One group (standard arm) receives standard stoma closure and the other group
(intervention arm) will have a preventive synthetic mesh placed in addition to
standard stoma closure
Sponsors
Meander Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Age >18 years Signed informed consent
Exclusion criteria
Exclusion criteria: Not able to sign informed consent Connective tissue disorder Intraperitoneal dialysis Immunodeficiency Use of immunosupressive medication (including high dose corticosteroids) Previous intraperitoneal mesh placement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incisional hernia rate as detected by abdominal ultrasound at 1 year following stoma closure. An incisional hernia was defined as an opening or defect in the abdominal wall with protruding tissue trough it at the stomal incision site. | — |
Secondary
| Measure | Time frame |
|---|---|
| - Clinical diagnosis of incisional hernia at 1 year follow-up - Number of patients requiring surgical intervention for correction of a incisional hernia - Postoperative pain - 30-day mortality, cause of death - 30-day morbidity, specifically focussing on infectious complications. - 30-day re-admission and re-operation rate - Quality of life - Cost-effectiveness | — |
Countries
Netherlands
Outcome results
None listed