Gastrointestinal Fistula Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Greece
Ippokrateio Hospital
RECRUITING
Athens
Contact Information
Primary
George Theodoropoulos
georgetheocrs@live.com
+30 213 208.8000
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2030-01-01
Participants
Target number of participants: 100
Treatments
Perianal-Fistula Surgical Cohort
Adults (≥ 18 y) undergoing any elective surgical repair for a primary or recurrent perianal fistula (simple or complex) in our center. All participants are followed prospectively for a minimum of 12 months with standardized clinician- and patient-reported outcome assessments.
Related Therapeutic Areas
Sponsors
Leads: National and Kapodistrian University of Athens

This content was sourced from clinicaltrials.gov