Fistula-in-ano in Infants and Children

Not Applicable

Recruiting

• Conditions: Fistula in Ano
• Interventions: Procedure: placement of non-cutting seton (silicone)

• Registration Number: NCT05666609
• Lead Sponsor: Friedrich-Alexander-Universität Erlangen-Nürnberg

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 Timeline

• Study First Submitted: 2022-12-18
• Study First Submitted QC: 2022-12-18
• Study First Posted: 2022-12-28
• Study Start: 2023-01-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-25
• Last Update Posted: 2024-02-28
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 12weeks	placement of non-cutting seton (silicone)	Duration of placed seton 12 weeks
Group 4weeks	placement of non-cutting seton (silicone)	Duration of placed seton 4 weeks

Primary Outcome Measures

Name	Time	Method
Recurrent fistula in ano	6 months after initial surgery
Recurrent perianal abscess	6 months after initial surgery

Trial Locations

Locations (1)

Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery; 🇩🇪 Erlangen, Bavaria, Germany