Fistula-in-ano in Infants and Children

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

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

Study Overview

• Status: Recruiting
• Conditions: Fistula in Ano
• Intervention / Treatment: Procedure: placement of non-cutting seton (silicone)

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 Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sonja Diez, MD; Phone Number: 004991318532923; Email: sonja.diez@uk-erlangen.de
• Study Contact Backup: Name: Manuel Besendörfer, MD; Phone Number: 004991318532923; Email: manuel.besendoerfer@uk-erlangen.de

Study Locations

• Germany
  • Bavaria
    • Erlangen, Bavaria, Germany, 91054
      • Recruiting
      • Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery
      • Contact: Sonja Diez, M.D.; Phone Number: 0049 09131 85 32923; Email: sonja.diez@uk-erlangen.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group 4weeks; Duration of placed seton 4 weeks	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.
Active Comparator: Group 12weeks; Duration of placed seton 12 weeks	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Recurrent fistula in ano	6 months after initial surgery
Recurrent perianal abscess	6 months after initial surgery

Collaborators and Investigators

• Sponsor: Friedrich-Alexander-Universität Erlangen-Nürnberg
• Investigators: Principal Investigator: Sonja Diez, MD, Friedrich-Alexander-Universität Erlangen-Nürnberg

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 18, 2022
• First Submitted That Met QC Criteria: December 18, 2022
• First Posted (Actual): December 28, 2022

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 25, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Rectal Fistula
• Other Study ID Numbers: FIA2023-7

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No