Fistula-in-ano in Infants and Children

NCT05666609 | Recruiting DMC

• 1 other identifier: FIA2023-7
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Fistula in Ano

Outcome Measures

Primary Outcomes (2)

• Recurrent fistula in ano

  6 months after initial surgery

• Recurrent perianal abscess

  6 months after initial surgery

Study Arms (2)

Group 4weeks

ACTIVE COMPARATOR

Duration of placed seton 4 weeks

Procedure: placement of non-cutting seton (silicone)

Group 12weeks

ACTIVE COMPARATOR

Duration of placed seton 12 weeks

Procedure: placement of non-cutting seton (silicone)

Interventions

placement of non-cutting seton (silicone) PROCEDURE

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.

Group 12weeks; Group 4weeks

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• any patient with FIA and treatment with non-cutting seton placement in our institution
• regardless of underlying diagnoses
• age 0-18 years

You may not qualify if:

• none

Sponsors & Collaborators

• Friedrich-Alexander-Universität Erlangen-Nürnberg: lead

Study Sites (1)

Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery

Erlangen, Bavaria, 91054, Germany

RECRUITING

MeSH Terms

Conditions

Rectal Fistula

Interventions

Silicones

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Fistula; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Siloxanes; Organosilicon Compounds; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Sonja Diez, MD

  Friedrich-Alexander-Universität Erlangen-Nürnberg

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sonja Diez, MD

CONTACT

004991318532923; sonja.diez@uk-erlangen.de

Manuel Besendörfer, MD

CONTACT

004991318532923; manuel.besendoerfer@uk-erlangen.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Masking is not possible due to study design.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

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

Study Record Dates

• First Submitted: December 18, 2022
• First Posted: December 28, 2022
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)