FISTULA-RFA Trial: Radiofrequency Ablation for Perianal Fistula
ConditionRectal Fistulas
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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
Radiofrequency Ablation (RFA) for Perianal Fistula
DeviceRadiofrequency ablation (RFA) will be delivered to the fistula tract using a dedicated RFA catheter introduced through the external opening under standardized technique. The procedure aims to apply controlled thermal energy along the tract to promote tract closure while minimizing injury to surrounding sphincter structures. Participants will receive a single RFA treatment per protocol, with post-procedure care and safety monitoring during scheduled follow-up.
Treatment groups
80 Participants
are divided into 1 treatment groupGroup A: Radiofrequency Ablation (RFA) Treatment ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Fistula Closure (Clinical Healing)
Fistula closure will be determined by clinical assessment, defined as: (1) complete epithelialization/absence of the external opening on inspection, (2) no drainage/discharge (spontaneous or on gentle pressure), and (3) no clinically apparent fistula tract opening on digital rectal examination (DRE). Symptom improvement (including reduced pain) will be recorded as supportive patient-reported information.
Time frame
Baseline(post-procedure) and at 3 and 6 months after RFASecondary outcomes
1
Fistula Recurrence
Recurrence after initial clinical closure, defined as reappearance of an external opening, recurrent drainage/discharge, or clinical evidence of a fistula tract on examination during follow-up.
Time frame
Up to 6 months after RFA (assessed at 3 and 6 months)2
Time to Fistula Closure
Time from the RFA procedure to first documented clinical closure as defined in the primary outcome criteria.
Time frame
Up to 6 months after RFA3
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number and proportion of participants experiencing procedure- or device-related AEs/SAEs (eg, bleeding, infection/abscess, urinary retention, severe pain requiring intervention, hospitalization, or reoperation), graded by severity and relationship to the procedure/device.
Time frame
From the day of procedure through 6 months after RFA4
Change in Pain Severity
Change in patient-reported pain interference compared with baseline, assessed using the PROMIS® Pain Interference - Short Form 8a. The instrument includes 8 items, each scored on a 5-point Likert scale (1=not at all to 5=very much). Item scores are summed to generate a raw total score ranging from 8 to 40, with higher scores indicating worse pain interference. The outcome will be reported as the change in raw total score from baseline at each follow-up time point.
Time frame
Baseline (pre-procedure), 3 months, and 6 months after RFAOther outcomes
1
Patient Global Impression of Improvement (PGI-I)
Patient-reported global improvement using a single-item global rating (PGI-I)
Time frame
3 months and 6 months after RFA2
Procedural Feasibility and Technical Success
Successful completion of the planned RFA procedure per protocol (eg, ability to access the tract and deliver energy as intended) without intra-procedural device failure.
Time frame
During the procedure (day of RFA)3
Procedure Duration
Procedure duration, defined as the time recorded in the operative report from the start of the fistula procedure to completion (minutes).
Time frame
Day of procedure4
Same-day Discharge
Proportion of participants discharged on the day of the procedure (post-procedure day 0), recorded as Yes/No.
Time frame
Day of procedure (post-procedure day 0)Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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