NCT05666609RecruitingNot Applicable
Fistula-in-ano in Infants and Children: Prospective, Randomized Clinical Trail on the Duration of Non-cutting Seton Placement
Friedrich-Alexander-Universität Erlangen-Nürnberg2 sites in 1 country20 target enrollmentStarted: January 1, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 20
- Locations
- 2
- Primary Endpoint
- Recurrent fistula in ano
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Masking Description
Masking is not possible due to study design.
Eligibility Criteria
- Ages
- — to 18 Years (Child, Adult)
- Sex
- All
- Accepts 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
- Not provided
Outcomes
Primary Outcomes
Recurrent fistula in ano
Time Frame: 6 months after initial surgery
Recurrent perianal abscess
Time Frame: 6 months after initial surgery
Secondary Outcomes
No secondary outcomes reported
Investigators
Dr. med. Sonja Diez
Medical Doctor
Friedrich-Alexander-Universität Erlangen-Nürnberg
Study Sites (2)
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