RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-01-03
Study Completion:2026-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06511414

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * • Patients undergoing ileostomy closure after surgery for cancer All patients with a stoma (independent of diagnosis)
  2. * Age 18 or greater
  3. * Surgical oncology patient where routine radiologic surveillance for malignancy is planned
  4. * Patient accepts participation and gives informed consent
  1. * • Pregnancy
  2. * Prior mesh hernia repair at laparotomy site
  3. * Life expectancy less than 1 years
  4. * Patient is unable / unwilling to provide informed consent
  5. * Patient is unable to comply with the protocol or proposed follow-up visits
  6. * Patient is enrolled in another hernia study
  7. * Non-English-speaking participants
  8. * Data from children will not analyzed in this study.
  9. * Cognitively Impaired Adults: Data from cognitively impaired adults will not analyzed in this study.
  10. * Adults Unable to Consent: Data from adults unable to consent will not analyzed in this study.

Contacts and Locations

Study Contact

tomek wojtasik
CONTACT
312.503.5291
tomasz.wojtasik@northwestern.edu

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Northwestern University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-03
Study Completion Date2026-12

Study Record Updates

Study Start Date2024-01-03
Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

  • duramesh,

Additional Relevant MeSH Terms

  • Incisional Hernia
  • Ileostomy - Stoma