Fistula-in-ano in Infants and Children

Friedrich-Alexander-Universität Erlangen-Nürnberg

Status: Enrolling

Conditions: Fistula in Ano

Treatments: Procedure: placement of non-cutting seton (silicone)

Study type: Interventional

Funder types: Other

Identifiers

NCT05666609

FIA2023-7

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

20 participants in 2 patient groups

Group 4weeks

Active Comparator group

Description:

Duration of placed seton 4 weeks

Treatment:

Procedure: placement of non-cutting seton (silicone)

Group 12weeks

Active Comparator group

Description:

Duration of placed seton 12 weeks

Treatment:

Procedure: placement of non-cutting seton (silicone)