Actively Recruiting
Prospective Study of Functional Disorders and Quality of Life Following Surgical Management of Perianal Fistulas
Led by National and Kapodistrian University of Athens · Updated on 2026-03-19
100
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Perianal fistulas are a chronic condition that causes pain, discharge, infection, and difficulty controlling bowel movements, significantly impacting quality of life. This prospective observational study aims to evaluate clinical and functional outcomes, as well as patient-reported quality of life, following surgical treatment of perianal fistulas. The research focuses on comparing different surgical techniques to better understand their effects on healing and continence over a 12-month period. Participants undergoing elective surgery for either simple or complex perianal fistulas will be enrolled and followed for 12 months. The surgical approaches include sphincter-dividing techniques like fistulotomy or fistulectomy, and sphincter-preserving techniques such as ligation of the intersphincteric fistula tract (LIFT), mucosal advancement flap, laser treatment, fistula plugs, or seton placement. No experimental procedures are used; instead, real-world surgical methods are recorded and compared. During the study, participants will provide information through clinical examinations and questionnaires at 1, 3, 6, and 12 months after surgery. Researchers will assess fistula healing, recurrence, complications, continence status, symptom burden, quality of life, and patient satisfaction using validated tools. These comprehensive assessments aim to provide detailed insights into the effectiveness of different surgical treatments and their impact on patients' daily lives.
CONDITIONS
Brief Title
Recurrence and Anal Fistula Patient Reported Outcomes Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 63 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
You will not qualify if you...
- 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 such as decompensated heart failure, end-stage renal disease, or 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
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for eligibility confirmation and consent
Duration - Day of surgery plus immediate recovery period
Participants undergo elective surgical repair of their perianal fistula using either sphincter-dividing or sphincter-preserving techniques as part of routine clinical care. Operative details and intra-operative findings are recorded.
1 surgical visit (in-person)
Duration - 12 months
Participants are followed for 12 months after surgery with standardized assessments of healing, recurrence, continence, complications, and quality of life using clinician- and patient-reported outcome measures.
Follow-up visits at 1, 3, 6, and 12 months post-operatively (in-person or remote)
Trial Site Locations
Total: 1 location
1
Ippokrateio Hospital
Athens, Greece
Actively Recruiting
Research Team
G
George Theodoropoulos
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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