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

Description

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

Incisional Hernia, Ileostomy - Stoma

Study Overview

Study Details

Study overview

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.

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

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

Condition
Incisional Hernia
Intervention / Treatment

-

Contacts and Locations

Chicago

Northwestern University Feinberg School of Medicine, Chicago, Illinois, United States, 60611

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * • 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Northwestern University,

Study Record Dates

2026-12