NCT07477496 Recurrence and Anal Fistula Patient Reported Outcomes Trial
| NCT ID | NCT07477496 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National and Kapodistrian University of Athens |
| Condition | Anal Fistula Surgery |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2028-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-01-01 with a primary completion date of 2028-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07477496 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Anal Fistula Surgery. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07477496 currently recruiting?
Yes, NCT07477496 is actively recruiting participants. Contact the research team at georgetheocrs@live.com for enrollment information.
Where is the NCT07477496 trial being conducted?
This trial is being conducted at Athens, Greece.
Who is sponsoring the NCT07477496 clinical trial?
NCT07477496 is sponsored by National and Kapodistrian University of Athens. The trial plans to enroll 100 participants.