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New study probes hidden side effects of common bowel surgery

NCT ID NCT02052063

Knowledge-focused Sponsor: University Hospital, Rouen 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 a surgery called STARR, used to treat severe constipation caused by a rectocele or intussusception, affects the anal sphincter's ability to stretch and hold. Nine patients were tested before and 3 months after surgery using a special balloon device (EndoFLIP) and other standard tests. The goal was to understand why some patients develop leakage or urgency after the procedure, which could lead to safer surgical techniques in the future.

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

9 people

The number who actually took part.

Started

Sep 2014

Finished

Sep 2018

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 to 65 years

Sex

Female participants only

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 \>18 years old * Patient is not under any type of guardianship * Patient has a rectocele \> 3 cm during defecography * Patient has persistent defecatory troubles despite medical treatment (laxatives for at least 1 month) * Patient received information and signed the consent form * Patients having social security coverage Exclusion Criteria: * Patient has an asymptomatic rectocele * Patient with an enterocele at rest upon defecography, with opacification of the small bowel * Faecal incontinence * Anal sphincter insufficiency detected by rectal manometry * Patient with non-rehabilitated anorectal asynchrony * Patient has previously had rectal surgery or pelvic radiotherapy * Patient has a anal or rectal lesion, intestinal inflammatory disease * Anal or rectal tumor * Immunocompromised subjects * Positive pregnancy test, by urine * Psychological condition which would impair participation in the study * Coagulation disorders * Patients using anticoagulants * Participation in any other device or drug study within 30 days prior to enrollment. * Patient cannot read French * Patient is under any type of guardianship

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Conditions

The condition(s) this trial relates to.

intussusception Rectocele

As listed by the trial registrant

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

Intussusception Rectocele Sphincter ani incontinence Surgery

Contacts and locations

Locations

  • UH Rouen

    Rouen, 76031, France

More trials for these conditions

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