Recurrence and Patient-Reported Outcomes after Anal Fistula Surgery
Official title: Prospective Study of Functional Disorders and Quality of Life Following Surgical Management of Perianal Fistulas
Run by National and Kapodistrian University of Athens · NCT07477496 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | National and Kapodistrian University of Athens Academic / other |
| Locations | 1 site (Athens) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | January 1, 2028 |
| Study ends | January 1, 2030 |
| Registry record updated | March 19, 2026 |
| Trial ID | NCT07477496 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
Show full inclusion / exclusion 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 it's running
-
Ippokrateio Hospital
Athens, Greece Recruiting
Study contacts
- Study coordinator: George Theodoropoulos
- Email: georgetheocrs@live.com
- Phone: +30 213 208.8000
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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We will see if giving a second dose of liposomal bupivacaine 72 hours after anal fistula surgery reduces postoperative pain in adults.
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.