Fistula in Ano
Conditions
Brief summary
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
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.
Sponsors
Study design
Masking description
Masking is not possible due to study design.
Intervention model description
Group A: duration of placed seton 4 weeks Group B: duration of placed seton 12 weeks
Eligibility
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Recurrent fistula in ano | 6 months after initial surgery |
| Recurrent perianal abscess | 6 months after initial surgery |
Countries
Germany