Recurrence and Anal Fistula Patient Reported Outcomes Trial
Greece100 participantsStarted 2026-01-01
Plain-language 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 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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., 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Proportion of patients with complete fistula healing (clinical examination)
Timeframe: 1, 3, 6, 12 and 24 months
2
Quality of Life (QoL)
Timeframe: 1, 3, 6, 12 and 24 months
Trial details
NCT IDNCT07477496
SponsorNational and Kapodistrian University of Athens