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Diverting ileostomy is frequently utilized to protect high-risk anastomoses, though it is not shown to reduce the leak rate it may reduce the severe consequences of an anastomotic leak. Ileostomy will be reversed with restoration of continuity in majority of patients. Stoma site incisional hernias after ileostomy closure are complex hernias that can be associated with abdominal pain, discomfort, and a diminished quality of life. Durameshâ„¢ non-absorbable polypropylene suture is a hollow core, microporous, cylindrical suture made off in polypropylene filaments that are loosely braided and bonded to each other with heat and pressure. The Aim of this study is to evaluate Durameshâ„¢ suture vs standard closure on rates of hernia formation after ileostomy closure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duramesh | Experimental | using duramesh suture for ileostomy fascial closure |
|
| Control | Active Comparator | standard ileostomy fascial closure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| duramesh | Device | Durameshâ„¢ non-absorbable polypropylene suture is a hollow core, microporous, cylindrical suture made off in polypropylene filaments that are loosely braided and bonded to each other with heat and pressure |
| Measure | Description | Time Frame |
|---|---|---|
| hernia rates | Compare hernia rates after ileostomy closure between Durameshâ„¢ and standard monofilament closure | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| infection rate | Evaluate potential side effects including infections and need for re intervention associated with Durameshâ„¢ vs standard closure | 1 year |
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Inclusion Criteria:
• Patients undergoing ileostomy closure after surgery for cancer All patients with a stoma (independent of diagnosis)
Exclusion Criteria:
• Pregnancy
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
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| ID | Term |
|---|---|
| D000069290 | Incisional Hernia |
| ID | Term |
|---|---|
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
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randomized controlled trial
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| Control | Device | standard closure of fascia |
|
| D010335 | Pathologic Processes |