Recurrence and Patient-Reported Outcomes after Anal Fistula Surgery

Prospective Study of Functional Disorders and Quality of Life Following Surgical Management of Perianal Fistulas

This observational project will see if different surgical treatments for perianal fistulas lead to better healing, continence, and quality of life for adults having definitive fistula surgery.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: National and Kapodistrian University of Athens (Academic / other)
• Locations: 1 site (Athens)
• Trial ID: NCT07477496 on ClinicalTrials.gov

What this trial studies

This prospective observational cohort enrolls adults undergoing definitive surgical repair for perianal fistulas at Ippokrateio Hospital in Athens. The study will collect clinician-reported outcomes and patient-reported outcome measures (PROMs) at 1, 3, 6, and 12 months to capture healing, recurrence, postoperative complications, continence, symptom burden, and health-related quality of life. Participants may receive any sphincter-dividing or sphincter-preserving technique per the treating surgeon, and the protocol aims to harmonize outcome definitions and measurement tools across cases. Patients with inflammatory bowel disease, active uncontrolled sepsis, prior permanent colostomy, pregnancy, or severe uncontrolled comorbidity are excluded to focus on non-IBD perianal fistulas.

Who should consider this trial

Good fit: Adults (≥18 years) with clinically or radiologically confirmed perianal fistula scheduled for definitive surgical repair who can complete questionnaires and attend follow-up visits are ideal candidates.

Not a fit: Patients with Crohn's disease or ulcerative colitis, active uncontrolled perianal sepsis, prior abdominoperineal resection or permanent colostomy, pregnancy, severe uncontrolled systemic disease, cognitive impairment, or inability to complete follow-up are unlikely to benefit from this observational cohort.

Why it matters

Potential benefit: If successful, the project could provide real-world outcome and PROM data to help surgeons choose surgical techniques and standardize how recovery and quality of life are measured.

How similar studies have performed: Previous observational cohorts and randomized trials have reported outcomes for specific techniques, but high-quality, standardized head-to-head comparisons using consistent PROMs remain limited.

Eligibility criteria

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.

Where this trial is running

Athens

• Ippokrateio Hospital — Athens, Greece (Recruiting)

Study contacts

• Study coordinator: George Theodoropoulos

Conditions Anal Fistula Surgery; Anal Fistula; Perianal Fistula; perianal; fistula; anal; PROMs; patient-reported outcomes