Evaluation of the Recovery Rate and Postoperative Incontinence of Surgical Fistulas in a Cohort of a Reference Centre (PROFIL)

Fistula is a pathology that can be complex and lead to treatment difficulties for the proctologist.

The proctologist's objective is to treat the infection (anal fistula and abscess) with the minimum impact on anal continence. Drainage of the fistula pathway(s) and removal of infected tissue during initial surgery are essential. The treatment of upper trans-sphincterial fistulas, i. e. those that span more than half the height of the anal sphincter, poses risks to anal continence. It sometimes requires several times of surgical treatment.

The study aim to investigate the fate of all patients treated for anal fistula in an expert team, in terms of impact on healing and anal continence and according to the type of anal fistula, the co-morbidity, the surgical techniques used and the bacterial flora responsible.

Study Overview

• Status: Active, not recruiting
• Conditions: Anal Fistula
• Intervention / Treatment: Procedure: pus sample

• Study Type: Observational
• Enrollment (Estimated): 600

Contacts and Locations

Study Locations

• France
  • Paris, France, 75020
    • Groupe Hospitalier Diaconesses Croix Saint Simon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patient with an anus fistula with indication for surgical treatment

Description

Inclusion Criteria:

• Patient over the age of 18, patient with an anus fistula with indication for surgical treatment

Exclusion Criteria:

• Cutaneous Suppuration, without fistula (e.g., Verneuil disease, boil)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
anal Fistula; patient with anal fistula with indication to surgical treatment	Procedure: pus sample; A pus sample from the fistula will be taken by the doctor during this first consultation or, failing that, in the operating room before disinfection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healing rate at 2 years after initial surgical management of anal fistula.	Healing is defined by the absence of anal pain, pus discharge and anal swelling reported by the patient.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anal incontinence rate in participants operated for anal fistula, 2 years after initial care.	Rate of anal incontinence and degree of continence impairment assessed by the change in the Vaizey score preoperatively and postoperatively at 2 years after initial treatment. Anal incontinence is defined by a Vaizey score > 4 reported by the participant during a phone interview. The Vaizey score ranges from 0 to 24/24, with the higher the score, the greater the loss of continence. Perfect continence therefore corresponds to 0/24. Normal" continence can be defined as continence ranging from 0 to 4/24.	Year 2
Healing rate in participants operated for anal fistula, at 6, 12 and 24 months after initial care.	Healing is defined by the absence of anal pain, pus discharge and anal swelling reported by the patient at 6, 12 and 24 months.	Month 6, 12, 24
Assessment of time to consolidated recovery.	Time (in days) between the start of treatment (date of the first operation) and the 'end of follow-up' consultation, at which the surgeon considers the participant to be cured (consolidated cure). Consolidated healing is defined by the surgeon: On examination, by the absence of anal pain, pus discharge and anal swelling reported by the participant.; On clinical examination, by the complete closure of the scar with re-epithelialisation and the absence of pus discharge.	Month 24
Description of the number of surgeries required to obtain a cure.	Description of the number and type of anal fistula surgeries performed during the participant's follow-up, at 6, 12 and 24 months.	2 years
Bacteriological profile at the level of the fistula at the time of diagnosis and research into a possible role in the cure rate, the surgical technique used and the rate of post-operative incontinence.	Description of the bacteriological profile found in the fistula when the pus was sampled at the time of the first consultation or, if this could not be done, when a sample was taken in the operating theatre before starting the surgical procedure.	2 weeks
Quality of life of participants at 2 years.	Changes in quality of life after surgical treatment will be assessed at 6, 12 and 24 months using the FIQL (Fecal Incontinence Quality of Life) score. The FIQL questionnaire comprises 29 items grouped into four dimensions: lifestyle, behaviour, depression and self-image, and embarrassment in relation to others. Each item was given a score from 1 to 4 (1 being the worst).	2 years
Quantitative assessment of sphincter function using anorectal manometry	Evolution of anal sphincter pressure measurements in people at risk or developing incontinence during follow-up, measured by anorectal manometry: resting pressure below 60mmHg, maximum and mean voluntary contraction in mmHg, length of canal in mm, maximum tolerated volume and perception threshold in ml.	2 years
Evolution of anatomical lesions of the anal sphincter on endoanal ultrasound	Evolution of lesions on EndoAnal Ultrasound measured before the first surgery and at 24 months in patients at risk or developing incontinence during follow-up (defined by a worsening of the Vaizey score greater than 4/24) Description of lesions: Presence of a collection with its size (defined as a heterogeneous hypoechoic area with hyperechoic spot, measured in mm, length of the anal fistula in mm, description of the type of fistula (trans-sphincter, inter-sphincter or horseshoe, anterior, posterior, right, left). Measurement of defects in terms of angle, height and volume, specifying internal sphincter, external sphincter and puborectal strap (Stark classification).	2 years

Collaborators and Investigators

• Sponsor: Groupe Hospitalier Diaconesses Croix Saint-Simon

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): March 1, 2026

Study Registration Dates

• First Submitted: March 4, 2019
• First Submitted That Met QC Criteria: March 4, 2019
• First Posted (Actual): March 7, 2019

Study Record Updates

• Last Update Posted (Estimated): September 23, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: anal fistula; anal infection
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Rectal Diseases; Digestive System Fistula; Fistula; Intestinal Fistula; Pathological Conditions, Signs and Symptoms; Rectal Fistula
• Other Study ID Numbers: D_ELK_2018_2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No