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Recurrence and Anal Fistula Patient Reported Outcomes Trial

Recruitingn/aAges 18 Years - anyAllNational and Kapodistrian University of Athens
NCT07477496 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Perianal fistula surgical repair
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Where

1 site
Ippokrateio Hospital
Athens, Greece
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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