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
| Condition(s) | Anal Fistula Surgery, Anal Fistula, Perianal Fistula |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | 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 fistu |
| Who can participate | Inclusion Criteria: * Age ≥ 18 years. * Clinically and/or radiologically confirmed perianal fistula (primary or recurrent). * Planned definitive surgical treatment (any sphincter-dividing or sphincter-preserving technique). * Ability to understand and complete study questionnaires. * Commitment to attend follow-up visits at 1, 3, 6, and 12 months (or to complete remote assessments). * Signed written informed consent. Exclusion Criteria: * Diagnosed inflammatory bowel disease (Crohn's disease or ulcerative colitis). * Active perianal sepsis requiring emergency drainage after enrolment and before definitive surgery. * Prior abdominoperineal resection or permanent colostomy. * Pregnancy or planned pregnancy during the 12-month follow-up. * Severe uncontrolled systemic disease (e.g., decompens |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | National and Kapodistrian University of Athens |
| Locations | Athens, Greece |
| Start date | 2026-01-01 |
| NCT ID | NCT07477496 |
| Official listing | https://clinicaltrials.gov/study/NCT07477496 |