Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05666609

Fistula-in-ano in Infants and Children

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

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

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery

Erlangen, Bavaria, 91054, Germany

Location status: Recruiting

Location contact

Sonja Diez, M.D.

CONTACT

[email protected]

0049 09131 85 32923

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Recurrent fistula in ano

    Time frame: 6 months after initial surgery

  2. Recurrent perianal abscess

    Time frame: 6 months after initial surgery

Study contacts

Contact information is provided by the study sponsor or research team.

Manuel Besendörfer, MD

CONTACT

[email protected]

004991318532923

Sonja Diez, MD

CONTACT

[email protected]

004991318532923

Sponsors and collaborators

Lead sponsor

Friedrich-Alexander-Universität Erlangen-Nürnberg

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Dec 28, 2022
Registry last updated
Sep 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.