Fistula-in-ano in Infants and Children
ConditionFistula in Ano
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorFriedrich-Alexander-Universität Erlangen-Nürnberg
About this trial
In this prospective, randomized trail, duration of non-cutting seton placement in patients with fistula-in-ano is evaluated.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
any patient with FIA and treatment with non-cutting seton placement in our institution
regardless of underlying diagnoses
age 0-18 years
Disqualifiers
none
Trial design
Design model
Parallel
Treatments tested in this trial
placement of non-cutting seton (silicone)
Procedure/SurgeryTreatment 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.
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Group 4weeksActive comparator 1 intervention
Group B: Group 12weeksActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Recurrent fistula in ano
Time frame
6 months after initial surgery2
Recurrent perianal abscess
Time frame
6 months after initial surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov