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Fistula-in-ano in Infants and Children

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05666609
Enrollment
20
Registered
2022-12-28
Start date
2023-01-01
Completion date
2027-12-31
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fistula in Ano

Brief summary

In this prospective, randomized trail, duration of non-cutting seton placement in patients with fistula-in-ano is evaluated.

Detailed description

In this prospective, randomized trail, patients are treated in case of fistula-in-ano with non-cutting seton placement. They are then randomized 1:1 in either Group A (duration of placed seton for 4 weeks) or Group B (duration of placed seton for 12 weeks). Patients are participating after informed consent is obtained.

Interventions

PROCEDUREplacement of non-cutting seton (silicone)

Treatment of Fistula in ano is conducted according to the institution's treatment guidelines. Silicon seton placement is conducted under general anesthesia. Identification of the FIA is secured by the insertion of a bulb-headed lacrimal probe, on which a silicon vessel loop is attached and pulled through the entire fistulous tract. In case of a perianal abscess, drainage and sphincter-sparing debridement is performed followed by secondary wound healing. The loop is ligated loosely outside the anus without any additional tension to the skin. Duration of placed seton is depending on group assignment and is set to either 4 or 12 weeks.

Sponsors

Friedrich-Alexander-Universität Erlangen-Nürnberg
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Masking description

Masking is not possible due to study design.

Intervention model description

Group A: duration of placed seton 4 weeks Group B: duration of placed seton 12 weeks

Eligibility

Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Recurrent fistula in ano6 months after initial surgery
Recurrent perianal abscess6 months after initial surgery

Countries

Germany

Contacts

Primary ContactSonja Diez, MD
sonja.diez@uk-erlangen.de004991318532923
Backup ContactManuel Besendörfer, MD
manuel.besendoerfer@uk-erlangen.de004991318532923

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026