Hernia
Conditions
Keywords
colostomy, parastomal, peristomal, hernia, mesh, surgery, Indication for permanent end colostomy
Brief summary
The study aims to prove differences or equalities in outcome for patients operated with or without a peristomal mesh in the sublay position when establishing a permanent colostomy.
Detailed description
Patients are randomized to 2 groups equal in number: a group with mesh implantation and a control group without mesh implantation. Primary endpoint is Parastomal hernia. Secondary endpoints are operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy. Patients are followed 4 years after operation with clinical examination
Interventions
DEVICEMesh in permanent colostomy
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Condition with indication for establishing a permanent end-colostomy.
Exclusion criteria
* Age under 18 * ASA score above 3
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Parastomal hernia | at 3, 12, 24, 36 and 48 months |
Secondary
| Measure | Time frame |
|---|---|
| Operating time, infection, obstruction, stenosis, retraction, fistulae, skin related problems and reoperations. Endpoints are correlated to body mass index, previous hernia, age, concurrent illness and cause for colostomy | 4 years |
Countries
Norway
Outcome results
None listed