Recurrence and Anal Fistula Patient Reported Outcomes Trial
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational and Kapodistrian University of Athens
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Perianal fistula surgical repair
Procedure/SurgeryPatients 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Perianal-Fistula Surgical Cohort1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
1, 3, 6, 12 and 24 months2
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)
Time frame
1, 3, 6, 12 and 24 monthsSecondary outcomes
1
Recurrence rate
Re-appearance of any fistulous tract (clinical or imaging confirmation) after a documented period of ≥ 6months of complete healing, or identification of a new, distinct fistulous tract that was not present at baseline
Time frame
12 and 24 months2
Incontinence symptoms
Vaizey / St Mark's Incontinence Score (0 = perfect continence, 24 = complete incontinence)
Time frame
1, 3, 6, 12 and 24 months3
Complications, Re-interventions, Readmission, Mortality
Any adverse events (yes/no). Includes surgical site infection, wound dehiscence, bleeding, urinary retention. Any need for radiological or surgical re-intervention (yes/no), unplanned readmission (yes/no), or mortality (yes/no).
Time frame
1, 3, 6, 12 and 24 months4
Clavien-Dindo classification of complications
Complication, graded by Clavien-Dindo classification (I-V)
Time frame
1, 3, 6, 12 and 24 monthsSponsors and contacts
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Source ClinicalTrials.gov