Evaluating non-cutting seton placement for fistula-in-ano in children
Fistula-in-ano in Infants and Children: Prospective, Randomized Clinical Trail on the Duration of Non-cutting Seton Placement
NA · Friedrich-Alexander-Universität Erlangen-Nürnberg · NCT05666609
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Friedrich-Alexander-Universität Erlangen-Nürnberg (other) |
| Locations | 1 site (Erlangen, Bavaria) |
| Trial ID | NCT05666609 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are infants and children aged 0-18 years diagnosed with fistula-in-ano.
Not a fit: Patients with conditions unrelated to fistula-in-ano or those outside the age range may not benefit from this study.
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 performed: While there may be limited studies on non-cutting seton placement specifically in children, similar approaches have shown promise in adult populations.
Eligibility criteria
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 this trial is running
Erlangen, Bavaria
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Fistula in Ano