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Mesh may stop hernias after stoma closure, but study halted early

NCT ID NCT04916067

Prevention Sponsor: Dartmouth-Hitchcock Medical Center 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 pilot study tested whether placing a special mesh during ileostomy closure surgery could prevent hernias in people with inflammatory bowel disease. Only 8 patients were enrolled before the study was stopped. The main goal was to check safety, like infections or wound problems, within 30 days. Researchers also looked at hernia rates and quality of life up to 6 months.

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

8 people

The number who actually took part.

Started

Dec 2021

Finished

Aug 2024

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: 1. Age \> 18years. 2. Patient is undergoing closure of loop ileostomy. 3. Patient has a diagnosis of Inflammatory bowel disease treated with resection and diverting loop ileostomy. 4. Patient has been evaluated by a qualified surgeon and found to be a suitable candidate for surgery. Exclusion Criteria: 1. Pre-existing systemic infection at the time of ileostomy takedown 2. Cirrhosis, chronic renal failure requiring dialysis, or collagen disorder 3. Previous abdominal hernia repair with mesh placement 4. Concurrent surgical procedures in addition to closure of diverting loop ileostomy 5. Ileostomy closure not completed through the previous stoma site (i.e. those requiring exploratory laparotomy for closure)

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Conditions

The condition(s) this trial relates to.

Hernia inflammatory bowel disease

As listed by the trial registrant

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

Ileostomy - stoma Inflammatory bowel diseases

Contacts and locations

Locations

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

More trials for these conditions

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