Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
20 participants
INTERVENTIONAL
2023-01-01
2027-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 4weeks
Duration of placed seton 4 weeks
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.
Group 12weeks
Duration of placed seton 12 weeks
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* regardless of underlying diagnoses
* age 0-18 years
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Friedrich-Alexander-Universität Erlangen-Nürnberg
OTHER
Responsible Party
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Dr. med. Sonja Diez
Medical Doctor
Principal Investigators
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Sonja Diez, MD
Role: PRINCIPAL_INVESTIGATOR
Friedrich-Alexander-Universität Erlangen-Nürnberg
Locations
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Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery
Erlangen, Bavaria, Germany
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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FIA2023-7
Identifier Type: -
Identifier Source: org_study_id
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