Actively Recruiting
Effect of Duramesh™ on Hernia Formation After Ileostomy Closure, Randomized Controlled Trial
Led by Northwestern University · Updated on 2024-07-22
106
Participants Needed
1
Research Sites
151 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Effect of Duramesh™ on Hernia Formation After Ileostomy Closure, Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing ileostomy closure after surgery for cancer or with a stoma regardless of diagnosis
- Age 18 years or older
- Surgical oncology patients with planned routine radiologic surveillance for malignancy
- Patient accepts participation and provides informed consent
You will not qualify if you...
- Pregnancy
- Prior mesh hernia repair at laparotomy site
- Life expectancy less than 1 year
- Unable or unwilling to provide informed consent
- Unable to comply with the protocol or follow-up visits
- Enrolled in another hernia study
- Non-English-speaking participants
- Data from children will not be analyzed
- Data from cognitively impaired adults will not be analyzed
- Data from adults unable to consent will not be analyzed
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States, 60611
Actively Recruiting
Research Team
T
tomek wojtasik
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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