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

Northwestern University

Status: Enrolling

Conditions: Ileostomy - Stoma; Incisional Hernia

Treatments: Device: Control; Device: duramesh

Study type: Interventional

Funder types: Other

Identifiers

NCT06511414

STU00220106

Details and patient eligibility

About

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.

Enrollment: 106 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Duramesh

Experimental group

Description:

using duramesh suture for ileostomy fascial closure

Treatment:

Device: duramesh

Control

Active Comparator group

Description:

standard ileostomy fascial closure

Treatment:

Device: Control