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NCT Number: NCT03865823

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Diaconesses Croix Saint Simon

Paris, 75020, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

pus sample

Procedure

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.

Primary outcomes

  1. Healing rate at 2 years after initial surgical management of anal fistula.

    Time frame: 2 years

    Healing is defined by the absence of anal pain, pus discharge and anal swelling reported by the patient.

Secondary outcomes

  1. Anal incontinence rate in participants operated for anal fistula, 2 years after initial care.

    Time frame: Year 2

    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.

  2. Healing rate in participants operated for anal fistula, at 6, 12 and 24 months after initial care.

    Time frame: Month 6, 12, 24

    Healing is defined by the absence of anal pain, pus discharge and anal swelling reported by the patient at 6, 12 and 24 months.

  3. Assessment of time to consolidated recovery.

    Time frame: Month 24

    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.
  4. Description of the number of surgeries required to obtain a cure.

    Time frame: 2 years

    Description of the number and type of anal fistula surgeries performed during the participant's follow-up, at 6, 12 and 24 months.

  5. 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.

    Time frame: 2 weeks

    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.

  6. Quality of life of participants at 2 years.

    Time frame: 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).

  7. Quantitative assessment of sphincter function using anorectal manometry

    Time frame: 2 years

    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.

  8. Evolution of anatomical lesions of the anal sphincter on endoanal ultrasound

    Time frame: 2 years

    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).

Sponsors and collaborators

Lead sponsor

Groupe Hospitalier Diaconesses Croix Saint-Simon

Other

Registry information

Acronym: PROFIL

Important dates

Study start
2019
Primary completion
2026
Study completion
2026
First posted
Mar 7, 2019
Registry last updated
Sep 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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