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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Friedrich-Alexander-Universität Erlangen-Nürnberg Academic / other |
| Locations | 1 site (Erlangen, Bavaria) |
| Status | Recruiting |
| Started | January 1, 2023 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | September 8, 2025 |
| Trial ID | NCT05666609 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
- Principal investigator: Sonja Diez, MD — Friedrich-Alexander-Universität Erlangen-Nürnberg
- Study coordinator: Sonja Diez, MD
- Email: sonja.diez@uk-erlangen.de
- Phone: 004991318532923
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.