Clinical trial Recruiting at 1 site Interventional Ages Any age to 18

Evaluating non-cutting seton placement for fistula-in-ano in children

Official title: Fistula-in-ano in Infants and Children: Prospective, Randomized Clinical Trail on the Duration of Non-cutting Seton Placement

Run by Friedrich-Alexander-Universität Erlangen-Nürnberg · NCT05666609 · Data updated 2026-11-12

This study tests how long a special thread, called a seton, should be used to treat fistula-in-ano in children to see which duration helps them feel better.

More Fistula in Ano trials

Quick facts

Study typeInterventional
AgesAny age to 18 Years
SexAll
Enrollment20 (estimated)
SponsorFriedrich-Alexander-Universität Erlangen-Nürnberg
Academic / other
Locations1 site (Erlangen, Bavaria)
StatusRecruiting
StartedJanuary 1, 2023
Main results expectedDecember 31, 2027
Study endsDecember 31, 2027
Registry record updatedSeptember 8, 2025
Trial IDNCT05666609 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are infants and children aged 0-18 years diagnosed with fistula-in-ano.

Probably not a fit

Patients with conditions unrelated to fistula-in-ano or those outside the age range may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effectiveness of non-cutting seton placement in treating fistula-in-ano in infants and children. Participants are randomly assigned to two groups: one receiving a seton for 4 weeks and the other for 12 weeks. The goal is to determine the optimal duration for seton placement to improve patient outcomes. Informed consent is obtained from all participants before enrollment.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment protocols for children suffering from fistula-in-ano.

How similar studies have gone: While there may be limited studies on non-cutting seton placement specifically in children, similar approaches have shown promise in adult populations.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* any patient with FIA and treatment with non-cutting seton placement in our institution
* regardless of underlying diagnoses
* age 0-18 years

Exclusion Criteria:

* none

Where it's running

  • Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery
    Erlangen, Bavaria, Germany
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.