Evaluation of the Efficacy and Safety of Radiofrequency Ablation (RFA) for the Treatment of perianal Fistula: A Prospective Multicenter Single-Arm Study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0011583

Enrollment

Registered

2026-02-06

Start date

2026-06-01

Completion date

Unknown

Last updated

2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : The intervention in this study is radiofrequency ablation (RFA) applied to the fistula tract in patients with perianal fistula. All enrolled participants will undergo the procedure in

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Able and willing to provid-e written informed consent after receiving an explanation of the study purpose, procedures, potential benefits, and risks - Diagnosed with at least one of the following fistula types/conditions: 1) High trans-sphincteric fistula 2) Low trans-sphincteric fistula with a high risk of fecal incontinence 3) Fistula with seton placement 4) Fistula associated with Crohn’s disease 5)Considered a complex fistula, such as those with a history of perineal or gynecologic surgery, or recurrent fistula

Exclusion criteria

Exclusion criteria: - Superficial fistula that can be adequately treated with fistulotomy with minimal risk of sphincter injury - Fistula related to malignancy - Pregnancy - Contraindications to RFA, including: 1) History of stapled hemorrhoidopexy 2) Presence of endoscopic clips or similar devices within the anal canal 3) Fecal diversion due to a stoma

Design outcomes

Primary

Measure	Time frame
Clinical fistula closure: Closure is defined by (1) absence of the external opening on inspection with complete epithelialization, (2) absence of drainage/discharge spontaneously or on gentle pressure, and (3) no clinically apparent internal opening or persistent tract findings on digital rectal examination (DRE). Improvement in pain is collected as supportive symptom information but is not required for closure.	—

Measure

Time frame

Clinical fistula closure: Closure is defined by (1) absence of the external opening on inspection with complete epithelialization, (2) absence of drainage/discharge spontaneously or on gentle pressure, and (3) no clinically apparent internal opening or persistent tract findings on digital rectal examination (DRE). Improvement in pain is collected as supportive symptom information but is not required for closure.

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Secondary

Measure	Time frame
Recurrence: Recurrence is defined as reappearance of an external opening, recurrent drainage/discharge, or clinical evidence of fistula during follow-up after initial clinical closure.;Adverse events (AEs) and serious adverse events (SAEs): All medical events occurring after the procedure are recorded and categorized by frequency, severity, and relatedness to the intervention.;Need for additional fistula-related interventions: Any additional management such as reintervention/reoperation, drainage procedures, or seton placement is recorded as an indicator of treatment failure or recurrence requiring further care.;PROMIS Pain Interference Short Form 8a: Pain-related impact on daily function is assessed using the standardized questionnaire, and changes in scores over time are evaluated.;Wexner Incontinence Score: Continence-related symptoms are assessed using the Wexner score, and changes in scores and any worsening are evaluated longitudinally.;Patient Global Impression of Improvement (PGI-I): Overall perceived improvement is measured using the 7-point PGI-I scale at follow-up.;Procedural feasibility/technical success: Completion of the planned RFA ablation per protocol and any device-related issues (eg, malfunction) are documented.	—

Measure

Time frame

Recurrence: Recurrence is defined as reappearance of an external opening, recurrent drainage/discharge, or clinical evidence of fistula during follow-up after initial clinical closure.;Adverse events (AEs) and serious adverse events (SAEs): All medical events occurring after the procedure are recorded and categorized by frequency, severity, and relatedness to the intervention.;Need for additional fistula-related interventions: Any additional management such as reintervention/reoperation, drainage procedures, or seton placement is recorded as an indicator of treatment failure or recurrence requiring further care.;PROMIS Pain Interference Short Form 8a: Pain-related impact on daily function is assessed using the standardized questionnaire, and changes in scores over time are evaluated.;Wexner Incontinence Score: Continence-related symptoms are assessed using the Wexner score, and changes in scores and any worsening are evaluated longitudinally.;Patient Global Impression of Improvement (PGI-I): Overall perceived improvement is measured using the 7-point PGI-I scale at follow-up.;Procedural feasibility/technical success: Completion of the planned RFA ablation per protocol and any device-related issues (eg, malfunction) are documented.

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Countries

Korea, Republic of

Contacts

Public ContactDayoung Park

Korea University Ansan Hospital

poppdy@naver.com+82-31-412-5114

Outcome results