Recurrence and Anal Fistula Patient Reported Outcomes Trial (RAPPORT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Anal Fistula; Perianal Fistula; Anal Fistula Surgery
• Intervention / Treatment: Procedure: Perianal fistula surgical repair

Detailed Description

Background

Perianal fistulas are abnormal tracts that connect the anal canal or rectum to the perianal skin, most often developing after a perianal abscess that originates near the anal glands at the dentate line. The majority of fistulas arise secondary to an abscess. Treatment aims to eradicate the tract, prevent recurrence, and preserve continence by protecting the sphincter mechanism. Fistulas are classified anatomically (Parks) and, more clinically, as simple (low) or complex. Simple fistulas involve only the distal third of the external sphincter and are usually cured with sphincter-dividing procedures such as fistulotomy or fistulectomy, which have high healing rates and low continence risk. Complex fistulas-those that affect a larger portion of the sphincter, have multiple tracts, or are recurrent-require sphincter-preserving techniques (e.g., mucosal advancement flap, LIFT, laser treatment, plugs, or setons), although these approaches often carry higher recurrence rates. Current guidelines are hampered by limited high-quality evidence and marked heterogeneity in outcome definitions, measurement tools, and reporting practices, highlighting the need for standardized prospective data.

Study Objective and Design

The primary aim is to generate high-quality, real-world observational data on surgical management of perianal fistulas. The study will conduct a prospective cohort enrolling adult participants at the time of definitive fistula surgery and will follow them for 12 months. The cohort will be stratified by fistula complexity (simple vs. complex) and by surgical strategy (partially sphincter-dividing versus sphincter-preserving). The study will capture demographic, clinical, imaging, and operative information to explore how these variables relate to healing, recurrence, continence preservation, and patient-reported quality of life.

Data Collection and Analysis

Baseline data will include age, sex, comorbidities, pre-operative imaging, and any preceding seton placement or previous surgery. Operative details-type of technique, extent of sphincter involvement, intra-operative findings-will be recorded in a standardized case-report form. Follow-up assessments will occur at 1, 3, 6, and 12 months post-operatively and will collect clinician-reported endpoints (clinical and radiological healing, recurrence, complications graded by Clavien-Dindo) and patient-reported outcomes (continence status, symptom burden, health-related quality of life, psychological impact, and satisfaction) using validated instruments. Descriptive statistics will summarize patient and treatment characteristics; multivariable logistic and Cox regression models will evaluate associations between surgical approach, imaging findings, and outcomes, adjusting for confounders such as age, comorbidity, and fistula complexity. Subgroup analyses will compare outcomes across the two surgical strategy groups.

Anticipated Impact

By employing uniform outcome definitions and integrating both clinician- and patient-centered metrics, the study will fill a critical evidence gap regarding the comparative effectiveness of current fistula surgeries. The findings are expected to clarify which techniques achieve optimal healing while minimizing continence loss and to provide robust data that can refine clinical guidelines, inform shared-decision making, and ultimately improve functional and quality-of-life outcomes for patients with perianal fistulas.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: George Theodoropoulos; Phone Number: +30 213 208.8000; Email: georgetheocrs@live.com

Study Locations

• Greece
  • Athens, Greece
    • Recruiting
    • Ippokrateio Hospital
    • Contact: George Theodoropoulos; Phone Number: +30 213 208.8000; Email: georgetheocrs@live.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 and 24 months
Incontinence symptoms	Vaizey / St Mark's Incontinence Score (0 = perfect continence, 24 = complete incontinence)	1, 3, 6, 12 and 24 months
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).	1, 3, 6, 12 and 24 months
Clavien-Dindo classification of complications	Complication, graded by Clavien-Dindo classification (I-V)	1, 3, 6, 12 and 24 months
Patient satisfaction	Numerical Rating Scale (NRS: 0-10; 0 indicating no pain, 10 worse pain)	1, 3, 6, 12 and 24 months
EQ-5D-5L	Quality of Life descriptive system comprising of five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels (0: no problems, 5: severe problems)	1, 3, 6, 12 and 24 months
EQ VAS	The EQ VAS records the patient's self-rated health on a vertical visual analogue scale (0: worse health you can imagine and 100: best health you can imagine)	1, 3, 6, 12 and 24 months

Collaborators and Investigators

• Sponsor: National and Kapodistrian University of Athens

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: March 11, 2026
• First Submitted That Met QC Criteria: March 12, 2026
• First Posted (Actual): March 17, 2026

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 17, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: quality of life; patient-reported outcomes; fistula; PROMs; perianal; anal
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Digestive System Fistula; Intestinal Fistula; Pathological Conditions, Signs and Symptoms; Fistula; Rectal Fistula
• Other Study ID Numbers: 99/18-12-2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No