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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prophylactic stoma mesh | Experimental | Mesh |
|
| No mesh prophylaxis | Active Comparator | No mesh |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesh in permanent colostomy | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Parastomal hernia | at 3, 12, 24, 36 and 48 months |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan Lambrecht, MD | Rikshospitalet-Radiumhospitalet HF, Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rikshospitalet-Radiumhospitalet HF | Oslo | NO-0027 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32222841 | Derived | Lambrecht JR. Diagnostic methods in parastomal hernia; research and clinical relevance. Hernia. 2021 Jun;25(3):817-820. doi: 10.1007/s10029-020-02177-8. Epub 2020 Mar 28. No abstract available. |
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| ID | Term |
|---|---|
| D006547 | Hernia |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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