Recurrence and Anal Fistula Patient Reported Outcomes Trial

NCT07477496 | Recruiting

• 1 other identifier: 99/18-12-2025
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anal Fistula Surgery; Anal Fistula; Perianal Fistula

Keywords

perianal; fistula; anal; PROMs; patient-reported outcomes; quality of life

Outcome Measures

Primary Outcomes (2)

• Proportion of patients with complete fistula healing (clinical examination)

  No clinically detectable perianal discharge, no signs of infection or inflammation, and no palpable/visible fistulous tract on physical examination.

  1, 3, 6, 12 and 24 months

• Quality of Life (QoL)

  Anal Fistula Quality of Life (AF-QoL) questionnaire (0 = worst QoL, 100 = best QoL; higher scores indicate better health-related QoL)

  1, 3, 6, 12 and 24 months

Secondary Outcomes (7)

• Recurrence rate

  12 and 24 months

• Incontinence symptoms

  1, 3, 6, 12 and 24 months

• Complications, Re-interventions, Readmission, Mortality

  1, 3, 6, 12 and 24 months

• Clavien-Dindo classification of complications

  1, 3, 6, 12 and 24 months

• Patient satisfaction

  1, 3, 6, 12 and 24 months

Study Arms (1)

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.

Procedure: Perianal fistula surgical repair

Interventions

Perianal fistula surgical repair PROCEDURE

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.

Perianal-Fistula Surgical Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will enroll adult patients with cryptoglandular perianal fistulas who are scheduled for elective surgical repair. Participants will be free of inflammatory bowel disease and major anorectal resections, and they will be able to provide informed consent, complete validated patient-reported outcome measures, and comply with the scheduled 12-month follow-up protocol.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National and Kapodistrian University of Athens: lead

Study Sites (1)

Ippokrateio Hospital

Athens, Greece

RECRUITING

MeSH Terms

Conditions

Rectal Fistula; Fistula

Condition Hierarchy (Ancestors)

Intestinal Fistula; Digestive System Fistula; Digestive System Diseases; Intestinal Diseases; Gastrointestinal Diseases; Rectal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Central Study Contacts

George Theodoropoulos

CONTACT

+30 213 208.8000; georgetheocrs@live.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 24 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Study Record Dates

• First Submitted: March 11, 2026
• First Posted: March 17, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

GR (1)