Actively Recruiting
Recurrence and Anal Fistula Patient Reported Outcomes Trial
Led by National and Kapodistrian University of Athens · Updated on 2026-03-19
100
Participants Needed
1
Research Sites
208 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Recurrence and Anal Fistula Patient Reported Outcomes Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Clinically or radiologically confirmed perianal fistula (primary or recurrent)
- Planned definitive surgical treatment using any sphincter-dividing or sphincter-preserving technique
- Ability to understand and complete study questionnaires
- Willingness to attend follow-up visits at 1, 3, 6, and 12 months or complete remote assessments
- Signed written informed consent
You will not qualify if you...
- Diagnosed inflammatory bowel disease (Crohn's disease or ulcerative colitis)
- Active perianal infection requiring emergency drainage after enrollment and before surgery
- Previous abdominoperineal resection or permanent colostomy
- Pregnancy or planned pregnancy during the 12-month follow-up
- Severe uncontrolled systemic diseases such as decompensated heart failure, end-stage renal disease, or uncontrolled diabetes
- Cognitive impairment or psychiatric disorder preventing reliable consent or questionnaire completion
- Lack of reliable contact information or inability to attend at least one scheduled follow-up visit
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Ippokrateio Hospital
Athens, Greece
Actively Recruiting
Research Team
G
George Theodoropoulos
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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