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New minimally invasive surgery aims to heal stubborn anal fistulas with less pain

NCT ID NCT06484660

Disease control Sponsor: Hospital Son Llatzer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jul 08, 2026 · Updated 2 times

Summary

This trial tests a less invasive surgical technique for complex perianal fistula, a painful condition. The new approach uses lower power and causes less tissue damage. Researchers will compare healing rates, pain, and quality of life in 40 adults over six months.

What this could mean

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

Active substance
minimally invasive mucosal advancement flap procedure
What this could lead to
If successful, this could offer a more effective, less painful surgical option for complex perianal fistula, potentially improving healing rates and quality of life.
What could go wrong
This is a small, early-stage trial with only 40 participants. The new technique may not prove better than standard surgery, and risks like infection or incontinence remain.

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 40 people

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

Started

Aug 2021

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: * Age older than 18. * Present with a complex perianal fistula not surgically treated with curative intention. * Present only one main fistulous tract. * Mucosal advancement flap as the chosen technique for the treatment of the fistula. * Patient has given informed consent to participate in the study. Exclusion Criteria: * Non-cryptoglandular internal fistulous orifice (IFO). * Extrasphincteric fistula. * Coexistence of anal fissure. * Coexistence of hemorrhoids tributary to surgery. * Coexistence of anal or rectal prolapse. * Coexistence of inflammatory bowel disease. * Coexistence of anal or colorrectal cancer.

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Conditions

The condition(s) this trial relates to.

anal fistula

As listed by the trial registrant

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

Fistula perianal

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital Son Llatzer

    RECRUITING

    Palma de Mallorca, Balearic Islands, 07198, Spain