Evaluating Duramesh™ for preventing hernias after ileostomy closure
Effect of Duramesh™ on Hernia Formation After Ileostomy Closure, Randomized Controlled Trial
This study is testing if using a special type of suture called Duramesh™ can help prevent hernias in patients who are having their ileostomy reversed after cancer surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 106 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Northwestern University Academic / other |
| Locations | 1 site (Chicago, Illinois) |
| Trial ID | NCT06511414 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of Duramesh™, a specialized non-absorbable polypropylene suture, in reducing the incidence of incisional hernias following ileostomy closure. Patients undergoing ileostomy reversal after cancer surgery will be randomly assigned to receive either Duramesh™ or standard closure techniques. The study aims to assess the rates of hernia formation and associated complications, thereby providing insights into the potential benefits of using Duramesh™ in surgical practice.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older who are undergoing ileostomy closure after surgery for cancer.
Not a fit: Patients who are pregnant, have a prior mesh hernia repair, or are unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the occurrence of hernias and improve the quality of life for patients after ileostomy closure.
How similar studies have performed: While the use of specialized sutures in hernia repair is a common practice, the specific application of Duramesh™ in this context is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * • 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 Criteria: * • 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.
Where this trial is running
Chicago, Illinois
- Northwestern University Feinberg School of Medicine — Chicago, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: tomek wojtasik
- Email: tomasz.wojtasik@northwestern.edu
- Phone: 312.503.5291
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.