Effect of Duramesh™ on Hernia Formation After Ileostomy Closure, Randomized Controlled Trial

Launched by NORTHWESTERN UNIVERSITY · Jul 16, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a special type of suture called Duramesh™ in preventing hernias after a surgical procedure known as ileostomy closure. An ileostomy is a surgery that creates an opening in the abdomen to allow waste to exit the body. Sometimes, after this surgery is reversed, patients can develop a hernia at the stoma site, which can cause pain and affect their quality of life. The trial aims to see if using Duramesh™ instead of standard sutures helps reduce the chances of developing these hernias.

To participate in the trial, individuals must be at least 18 years old and undergoing ileostomy closure after surgery for cancer. They should also be able to provide informed consent, meaning they understand the trial and agree to take part. Participants can expect to receive either the Duramesh™ suture or standard closure and will be monitored for hernia formation afterward. This study is currently recruiting participants, and it’s important to note that those who are pregnant, have had previous hernia repairs at the same site, or are unable to consent will not be eligible.

Gender

ALL

Eligibility 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.