RecruitingNot ApplicableNCT05666609

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

Sponsor

Friedrich-Alexander-Universität Erlangen-Nürnberg

Enrollment

20 participants

Start Date

Jan 1, 2023

Study Type

INTERVENTIONAL

Conditions

Fistula in Ano

Summary

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

Eligibility

Max Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is collecting data on a condition called fistula-in-ano (an abnormal tunnel that forms between the inside of the bowel and the skin around the anus) in infants and children. Researchers will follow patients who have been treated with a non-cutting seton — a surgical thread placed through the fistula to gradually heal it — regardless of the underlying cause. You may be eligible if... - You are a patient from birth up to 18 years old - You have been diagnosed with fistula-in-ano - You have received treatment with non-cutting seton placement at the participating institution - You have any underlying diagnosis (there is no disease-specific restriction) You may NOT be eligible if... - There are no specific exclusion criteria for this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREplacement 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.