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

Last updated: July 16, 2024
Sponsor: Northwestern University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Hernia

Treatment

Control

duramesh

Clinical Study ID

NCT06511414
STU00220106
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • • Patients undergoing ileostomy closure after surgery for cancer All patients with astoma (independent of diagnosis)

  • Age 18 or greater

  • Surgical oncology patient where routine radiologic surveillance for malignancyis planned

  • Patient accepts participation and gives informed consent

Exclusion

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 notanalyzed in this study.

  • Adults Unable to Consent: Data from adults unable to consent will not analyzedin this study.

Study Design

Total Participants: 106
Treatment Group(s): 2
Primary Treatment: Control
Phase:
Study Start date:
January 03, 2024
Estimated Completion Date:
December 31, 2026

Connect with a study center

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois 60611
    United States

    Active - Recruiting

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