Status:
RECRUITING
Effect of Duramesh™ on Hernia Formation After Ileostomy Closure, Randomized Controlled Trial
Lead Sponsor:
Northwestern University
Conditions:
Incisional Hernia
Ileostomy - Stoma
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- • 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
- • 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.
Key Trial Info
Start Date :
January 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT06511414
Start Date
January 3 2024
End Date
December 1 2026
Last Update
July 22 2024
Active Locations (1)
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1
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611