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Could a staged fistula treatment be safely skipped?

NCT ID NCT07807319

Disease control Sponsor: Proctos Kliniek 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

This trial compares two ways to treat a single-tract cryptoglandular anal fistula, a condition that can cause pain and discharge. One group receives a loose seton for about 8 weeks before definitive sphincter-preserving surgery, while the other goes straight to surgery without a seton. Researchers want to see if skipping the seton is not inferior in terms of fistula closure at 26 weeks after the final surgery. The study includes 277 adults and also tracks recurrence, complications, pain, quality of life, and costs.

What this could mean

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

Active substance
Loose seton placement before surgery versus no seton placement before sphincter-preserving surgery
What this could lead to
If skipping the seton works as well, patients could avoid an extra procedure, shorten their treatment time, and reduce healthcare costs.
What could go wrong
The trial is testing non-inferiority, so there is a risk that skipping the seton leads to slightly lower healing rates. Results are not yet available, and the outcome depends on careful patient selection.

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 277 people

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

Started

Jan 2026

Expected to finish

Jan 2029

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

Accepted

You do not need to have the condition being studied to take part.

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 or older * Single-tract non-purulent mid-high or high cryptoglandular anal fistula * Eligible for sphincter-preserving surgical treatment * Able to complete Dutch-language questionnaires sent by email * Written informed consent provided Exclusion Criteria: * Anorectal abscess * Multiple or complex anorectal fistulas * Inflammatory bowel disease or clinical suspicion requiring further investigation * History of anorectal malignancy * Use of immunosuppressive medication at the time of surgery * History of pelvic radiation * Pregnancy or lactation

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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.

Cryptoglandular 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

    2 sites. 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

  • Proctos Kliniek

    RECRUITING

    Bilthoven, North Holland, 3723 MB, Netherlands

  • Ziekenhuis Amstelland

    RECRUITING

    Amstelveen, North Holland, 1186 AM, Netherlands

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