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Anal fistula surgery: which technique works best? new study aims to find out

NCT ID NCT07477496

Knowledge-focused Sponsor: National and Kapodistrian University of Athens 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This study follows 100 adults who need surgery for an anal fistula. Researchers will track healing, recurrence, and quality of life for one year after the procedure. The goal is to see which surgical methods work best in real-world settings. No new treatments are being tested—only standard care techniques.

What this could mean

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

What this could lead to
If successful, this study could help doctors choose the best surgical approach for perianal fistulas, improving patient outcomes and quality of life.
What could go wrong
This is an observational study, not a controlled trial, so results may not prove one surgery is better than another. It is small (100 people) and only follows patients for one year.

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.

Participants

About 100 people

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

Started

Jan 2026

Expected to finish

Jan 2030

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.

Who is studied

The study will enroll adult patients with cryptoglandular perianal fistulas who are scheduled for elective surgical repair. Participants will be free of inflammatory bowel disease and major anorectal resections, and they will be able to provide informed consent, complete validated patient-reported outcome measures, and comply with the scheduled 12-month follow-up protocol.

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 ≥ 18 years. * Clinically and/or radiologically confirmed perianal fistula (primary or recurrent). * Planned definitive surgical treatment (any sphincter-dividing or sphincter-preserving technique). * Ability to understand and complete study questionnaires. * Commitment to attend follow-up visits at 1, 3, 6, and 12 months (or to complete remote assessments). * Signed written informed consent. Exclusion Criteria: * Diagnosed inflammatory bowel disease (Crohn's disease or ulcerative colitis). * Active perianal sepsis requiring emergency drainage after enrolment and before definitive surgery. * Prior abdominoperineal resection or permanent colostomy. * Pregnancy or planned pregnancy during the 12-month follow-up. * Severe uncontrolled systemic disease (e.g., decompensated heart failure, end-stage renal disease, uncontrolled diabetes). * Cognitive impairment or psychiatric disorder precluding reliable consent or questionnaire completion. * Lack of reliable contact information or inability to attend at least one scheduled follow-up visit.

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Conditions

The condition(s) this trial relates to.

anal fistula Fistula

As listed by the trial registrant

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

Anal fistula Anal fistula surgery Perianal fistula

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

  • Ippokrateio Hospital

    RECRUITING

    Athens, Greece

More trials for these conditions

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