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New stitch may stop hernias after stoma reversal surgery

NCT ID NCT06511414

Disease control Sponsor: Northwestern University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a special suture called Duramesh™ can prevent hernias at the stoma site after ileostomy closure. About 106 adults who had a temporary ileostomy for cancer surgery will be randomly assigned to receive either Duramesh™ or standard suture during closure. The main goal is to compare hernia rates and check for side effects like infection.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 106 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Incisional Hernia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Ileostomy - stoma Incisional hernia

Contacts and locations

Locations

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.