RecruitingNCT07477496

Recurrence and Anal Fistula Patient Reported Outcomes Trial

Prospective Study of Functional Disorders and Quality of Life Following Surgical Management of Perianal Fistulas

Sponsor

National and Kapodistrian University of Athens

Enrollment

100 participants

Start Date

Jan 1, 2026

Study Type

OBSERVATIONAL

Conditions

Anal Fistula Perianal Fistula Anal Fistula Surgery

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria7

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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Interventions

PROCEDUREPerianal fistula surgical repair

Patients undergo the operative procedure that their treating colorectal surgeon selects as routine clinical care for a primary or recurrent perianal fistula. The operative approach may be a sphincter-dividing technique (e.g., fistulotomy or fistulectomy) or a sphincter-preserving technique (e.g., ligation of the intersphincteric fistula tract \[LIFT\], mucosal advancement flap, laser fistula treatment, fistula plug, autologous biologic product injection, or seton placement). No investigational devices or experimental protocols are used; the study records the specific technique, intra-operative details, and any adjunctive measures (draining seton, pre-operative imaging, antibiotics, etc.) to allow comparison of real-world outcomes across all accepted surgical modalities for perianal fistulas.