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| Name | Class |
|---|---|
| Centre Hospitalier Universitaire Vaudois | OTHER |
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Stoma closure has been associated with a high rate of surgical site infection (SSI). The rate for SSI following stoma closure has been noted to be 7-41%; a rate that is higher than expected for a clean-contaminated operative classification. The ideal stoma site closure technique is still debated in the current literature. The aim of this study was to compare the rate of SSI following two different stoma closure techniques, primary closure versus a skin approximating purse string closure, in a multi-center randomized controlled trial. The investigators hypothesize that purse string closure technique will have a lower rate of SSI than primary closure technique.
The investigators will randomize ileostomy takedown patients to either a primary closure or purse string closure technique intraoperatively. Surgeons at both the University of Minnesota and the CHUV hospital in Switzerland will participate in the this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Purse string closure | Active Comparator | Patients undergo a purse string closure of their old stoma site. |
|
| Primary closure | Active Comparator | Patients have their stoma sites close primarily with staples. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Purse string closure | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| surgical site infection | 30 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| delayed wound healing | Evidence of delayed wound-healing at stoma takedown site | 30 days postoperatively |
| patient satisfaction | We are measuring subject satisfaction with wound healing and cosmetic outcome |
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Inclusion Criteria:
Subjects eligible are those with either a colostomy or ileostomy (end or loop) who are deemed by their surgeon to be appropriate candidates for ostomy closure. There will be no limitations based upon initial indication for formation of the ostomy. Indications for initial ostomy formation for fecal diversion can include: infection (e.g. diverticulitis) and protection of an anastomosis. (following resection for inflammatory bowel disease, benign diseases, or cancer)
Exclusion Criteria:
Subjects will be excluded from the study if:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25285695 | Derived | Lee JT, Marquez TT, Clerc D, Gie O, Demartines N, Madoff RD, Rothenberger DA, Christoforidis D. Pursestring closure of the stoma site leads to fewer wound infections: results from a multicenter randomized controlled trial. Dis Colon Rectum. 2014 Nov;57(11):1282-9. doi: 10.1097/DCR.0000000000000209. |
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| ID | Term |
|---|---|
| D014946 | Wound Infection |
| D013530 | Surgical Wound Infection |
| ID | Term |
|---|---|
| D007239 | Infections |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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|
| Primary closure | Procedure |
|
|
| 30 days postoperatively |