Fistula-in-ano in Infants and Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: placement of non-cutting seton (silicone).
- Who it may be relevant to
- Registry conditions: Fistula in Ano. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Fistula-in-ano in Infants and Children: Prospective, Randomized Clinical Trail on the Duration of Non-cutting Seton Placement
Overview
In this prospective, randomized trail, duration of non-cutting seton placement in patients with fistula-in-ano is evaluated.
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.
Interventions
- 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 an
Primary outcome measures
- Recurrent fistula in ano [Time frame: 6 months after initial surgery]
- Recurrent perianal abscess [Time frame: 6 months after initial surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Germany · 1 center
- Friedrich-Alexander-Universität Erlangen-Nürnberg, Pediatric Surgery — Erlangen
Identifiers
NCT: NCT05666609 · FIA2023-7