Recurrence and Anal Fistula Patient Reported Outcomes Trial

Perianal fistulas are a chronic anorectal condition associated with significant morbidity, including pain, persistent discharge, infection, and impaired continence, all of which can substantially affect patients' quality of life. Surgical management aims to eradicate the fistulous tract while preserving anal sphincter function and continence. Despite numerous available surgical techniques, high-quality comparative evidence regarding optimal management remains limited. This prospective observational study aims to evaluate clinical outcomes, functional outcomes, and patient-reported quality of life following surgical treatment of perianal fistulas. The study will collect both clinician-reported and patient-reported outcomes over a 12-month follow-up period. Outcomes of interest include fistula healing, recurrence, postoperative complications, continence status, symptom burden, and health-related quality of life. The findings are expected to provide real-world data that may inform clinical decision-making and contribute to improved patient-centered care.

NCT Number	NCT07477496
Lead Sponsor	National and Kapodistrian University of Athens
Conditions	Anal Fistula Surgery, Anal Fistula, Perianal Fistula
Enrollment	100 participants
Start Date	2026-01-01
Primary Completion	2028-01-01 (estimated)
Study Completion	2030-01-01 (estimated)
Updated on ClinicalTrials.gov	2026-03-19