Recurrence and Anal Fistula Patient Reported Outcomes Trial
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational and Kapodistrian University of Athens
About this 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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Perianal fistula surgical repair
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov