FISTULA-RFA Trial: Radiofrequency Ablation for Perianal Fistula

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-74
SponsorKorea University Ansan Hospital

About this trial

The goal of this pilot clinical study is to learn whether radiofrequency ablation (RFA) can safely and effectively treat perianal fistulas in adults. It will also evaluate procedure-related safety and changes in symptoms over time. The main questions it aims to answer are:

* How many participants achieve fistula closure by 6 months after RFA treatment? * How often do fistulas recur during follow-up? * What medical problems or adverse events occur after the RFA procedure (for example, pain, bleeding, infection, urinary retention, or changes in continence)? * How do patient-reported outcomes (such as pain and quality of life) change after treatment? This is a prospective, multicenter, single-arm pilot study. All participants will receive RFA treatment; there is no comparison (control) group.

Participants will:

* Be screened and enrolled at one of the participating hospitals * Undergo a standardized RFA procedure for the perianal fistula * Attend follow-up visits with clinical assessments at regular time points up to 6 months (including key assessments around 3 and 6 months) * Report symptoms and any adverse events during the follow-up period

Eligibility criteria

Qualifiers

Adults aged 20 to 74 years

Able and willing to provide written informed consent after receiving explanation of the study purpose, procedures, potential benefits, and risks

High trans-sphincteric fistula

Low trans-sphincteric fistula with high risk of fecal incontinence (sphincter injury risk)

Disqualifiers

Superficial fistula that is expected to be curable with simple fistulotomy with minimal risk of sphincter injury

Fistula related to malignancy

Any contraindication to RFA, including: History of stapled hemorrhoidopexy, Presence of endoscopic clips (or similar metallic clips) within the anal canal, Fecal diversion with stoma (diverting stoma in place), Pregnancy

Trial design

Treatments tested in this trial

  • Radiofrequency Ablation (RFA) for Perianal Fistula

Treatment groups

80 Participants
are divided into 1 treatment group

Locations

This trial has no locations