Fistula-in-ano in Infants and Children

Fistula in Ano Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05666609
• Other study ID #: FIA2023-7
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: February 2024
• Source: Friedrich-Alexander-Universität Erlangen-Nürnberg
• Contact: Sonja Diez, MD
• Phone: 004991318532923
• Email: sonja.diez[@]uk-erlangen.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Fistula in Ano
• Rectal Fistula

Intervention

Procedure:
• placement 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.

Locations

Country	Name	City	State
Germany	Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Friedrich-Alexander-Universität Erlangen-Nürnberg

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrent fistula in ano		6 months after initial surgery
Primary	Recurrent perianal abscess		6 months after initial surgery