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Does the thread itself matter? testing seton material against patient comfort

NCT ID NCT07818642

Symptom relief Sponsor: Acibadem Kent Hospital Source: ClinicalTrials.gov ↗

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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)

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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This status has not been confirmed recently, so it may be out of date.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 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

A loose seton is a thread surgeons place through a complex anal fistula to keep it draining. This pilot study follows 50 adults who already have a polypropylene seton and whose surgeon decides, as part of routine care, to replace it with a braided polyester one. Researchers ask each participant to rate their quality of life, pain, comfort, and hygiene before the swap and again 4 and 12 weeks after, so each person acts as their own comparison. The goal is to see whether the material of the thread is linked to how people feel day to day.

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 biomaterial (a surgical thread placed through an anal fistula to keep it draining)
What this could lead to
If the thread material matters, this could guide surgeons toward a seton that patients find more comfortable and easier to live with. It could also set up a larger study to confirm any difference.
What could go wrong
This is a small, single-center pilot with 50 people and no separate control group, so any change in comfort could stem from time, surgery, or expectations rather than the material itself. The results may not hold in a larger or more varied group.

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 50 people

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

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Feb 2028

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

Consecutive adult patients with recurrent or persistent complex cryptoglandular anal fistula who present to a tertiary referral colorectal surgery center with an existing polypropylene loose seton and for whom replacement with a braided polyester loose seton is clinically indicated as part of routine management will be screened for eligibility. Participants must have clinically stable disease without acute perianal sepsis requiring emergency intervention and must be able to complete patient-reported outcome questionnaires. Eligible patients providing written informed consent will be prospectively enrolled.

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 or older * Recurrent or persistent complex cryptoglandular anal fistula * Existing polypropylene loose seton in situ * Clinically indicated replacement of the polypropylene loose seton with a braided polyester loose seton as part of routine clinical management * Sufficient previous experience with the polypropylene loose seton to permit baseline assessment of patient-reported outcomes * Ability to understand and complete the study questionnaires * Provision of written informed consent Exclusion Criteria: * Anal fistula associated with Crohn's disease * Anal malignancy * Rectovaginal fistula * Acute perianal abscess or acute perianal sepsis requiring emergency surgical intervention * Cognitive impairment preventing completion of patient-reported outcome questionnaires * Inability to complete the study questionnaires * Pregnancy

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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.

Complex anal fistula Cryptoglandular anal fistula

How to take part

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  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

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Contacts and locations

Locations

  • Acibadem Kent Hospital

    Izmir, 35630, Turkey (Türkiye)

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