Recurrence and Anal Fistula Patient Reported Outcomes Trial
Recruiting now
Conditions studied: Anal Fistula Surgery, Anal Fistula, Perianal Fistula
In brief
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.
Key facts
- Study ID
- NCT07477496
- Run by
- National and Kapodistrian University of Athens
- People needed
- 100
- Starts
- 2026-01-01
- Expected to finish
- 2030-01-01
- Last updated by the study team
- 2026-03-19
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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., decompensated heart failure, end-stage renal disease, uncontrolled diabetes).
- Cognitive impairment or psychiatric disorder precluding reliable consent or questionnaire completion.
- Lack of reliable contact information or inability to attend at least one scheduled follow-up visit.
Where it is running
- Ippokrateio Hospital — Athens, Greece (enrolling)
Full record on ClinicalTrials.gov
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