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Bridge device for stoma: does it help or hinder?

NCT ID NCT02756273

Symptom relief Sponsor: Centre Hospitalier Universitaire, Amiens 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 looked at whether placing a bridge device during loop ileostomy creation reduces complications like infections or stoma problems. 166 adults having elective colorectal surgery took part. The goal was to see if the device improves outcomes or just adds difficulty to care.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bridge device
What this could lead to
If successful, using a bridge device could reduce wound infections and other stoma problems after colorectal surgery.
What could go wrong
This is a completed trial with 166 participants, but the device may not reduce complications and could make nursing care harder.

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

166 people

The number who actually took part.

Started

May 2016

Finished

Dec 2025

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: * colorectal disease (cancer; diverticulitis; Crohn disease; inflammatory bowel disease) * requiring elective surgery with an ileostomy * patient having given his consent before the enrollment Exclusion Criteria: * patient with early closure of the stoma (within 10 days after the colorectal surgery) * long term corticoids * emergency surgery * history of stoma in the side of the stoma placement planned for the study * BMI \>50 * No signature of the consent to participate in the study * Physical or mental state not allowing participation in the study * Contraindication to surgery * ASA classification (American Society of Anesthesiologists) IV-V or life expectancy \<48h * Pregnancy or breastfeeding * Patient under guardianship or guardianship or patient deprived of liberty by a judicial or administrative decision (in accordance with articles L1121-6 and L1121-8 of the Public Health Code) * Minor patient * Patient without social protection Peroperative exclusion criteria: * no anastomosis * no ileostomy * Spontaneous stomal retraction

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Conditions

The condition(s) this trial relates to.

colorectal cancer Crohn disease diverticulitis inflammatory bowel disease

As listed by the trial registrant

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

Elective colorectal surgery

Contacts and locations

Locations

  • Amiens Universitary Hospital

    Amiens, France

  • Beauvais hospital

    Beauvais, France

  • Chu Rouen

    Rouen, France, 76000, France

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