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Fistula-in-ano in Infants and Children

Primary Purpose

Fistula in Ano

Status

Recruiting

Phase

Not Applicable

Locations

Germany

Study Type

Interventional

Intervention

placement of non-cutting seton (silicone)

About this trial

This is an interventional treatment trial for Fistula in Ano

Eligibility Criteria

undefined - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric SurgeryRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Group 4weeks

Group 12weeks

Arm Description

Duration of placed seton 4 weeks

Duration of placed seton 12 weeks

Outcomes

Primary Outcome Measures

Recurrent fistula in ano

Recurrent perianal abscess

Secondary Outcome Measures

Full Information

NCT ID

NCT05666609

First Posted

December 18, 2022

Last Updated

February 2, 2023

Sponsor

Friedrich-Alexander-Universität Erlangen-Nürnberg

1. Study Identification

Unique Protocol Identification Number

NCT05666609

Brief Title

Fistula-in-ano in Infants and Children

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Recruiting

Study Start Date

January 1, 2023 (Actual)

Primary Completion Date

December 31, 2027 (Anticipated)

Study Completion Date

December 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Friedrich-Alexander-Universität Erlangen-Nürnberg

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Fistula in Ano

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

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

Masking

None (Open Label)

Masking Description

Masking is not possible due to study design.

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 4weeks

Arm Type

Active Comparator

Arm Description

Duration of placed seton 4 weeks

Arm Title

Group 12weeks

Arm Type

Active Comparator

Arm Description

Duration of placed seton 12 weeks

Intervention Type

Procedure

Intervention Name(s)

placement of non-cutting seton (silicone)

Intervention Description

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 Outcome Measure Information:

Title

Recurrent fistula in ano

Time Frame

6 months after initial surgery

Title

Recurrent perianal abscess

Time Frame

6 months after initial surgery

10. Eligibility

Sex

All

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sonja Diez, MD

Phone

004991318532923

sonja.diez@uk-erlangen.de

First Name & Middle Initial & Last Name or Official Title & Degree

Manuel Besendörfer, MD

Phone

004991318532923

manuel.besendoerfer@uk-erlangen.de

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sonja Diez, MD

Organizational Affiliation

Friedrich-Alexander-Universität Erlangen-Nürnberg

Official's Role

Principal Investigator

Facility Information:

Facility Name

Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery

City

Erlangen

State/Province

Bavaria

ZIP/Postal Code

91054

Country

Germany

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sonja Diez, M.D.

Phone

0049 09131 85 32923

sonja.diez@uk-erlangen.de

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Fistula-in-ano in Infants and Children

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