Effect of Duramesh™ on Hernia Formation After Ileostomy Closure, Randomized Controlled Trial
Northwestern University
106 participants
Jan 3, 2024
INTERVENTIONAL
Conditions
Summary
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. Duramesh™ 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 Duramesh™ suture vs standard closure on rates of hernia formation after ileostomy closure.
Eligibility
Inclusion Criteria4
- • Patients undergoing ileostomy closure after surgery for cancer All patients with a stoma (independent of diagnosis)
- Age 18 or greater
- Surgical oncology patient where routine radiologic surveillance for malignancy is planned
- Patient accepts participation and gives informed consent
Exclusion Criteria10
- • Pregnancy
- Prior mesh hernia repair at laparotomy site
- Life expectancy less than 1 years
- Patient is unable / unwilling to provide informed consent
- Patient is unable to comply with the protocol or proposed follow-up visits
- Patient is enrolled in another hernia study
- Non-English-speaking participants
- Data from children will not analyzed in this study.
- Cognitively Impaired Adults: Data from cognitively impaired adults will not analyzed in this study.
- Adults Unable to Consent: Data from adults unable to consent will not analyzed in this study.
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Interventions
Duramesh™ 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
standard closure of fascia
Locations(1)
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NCT06511414