Anal FistulaPROFILNCT03865823
Evaluation of the Recovery Rate and Postoperative Incontinence of Surgical Fistulas in a Cohort of a Reference Centre
An observational study of Anal Fistula, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Fistula
- What is being tested?
- pus sample
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2019to Mar 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with an anus fistula with indication for surgical treatment
Who may be able to join
- Patient over the age of 18, patient with an anus fistula with indication for surgical treatment
Who cannot join
- Cutaneous Suppuration, without fistula (e.g., Verneuil disease, boil)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Anal Fistula
- Being tested
- pus sample
- Keywords
- anal fistula, anal infection
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pus sampleProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| anal Fistula | patient with anal fistula with indication to surgical treatment Receives: Procedure: pus sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2019
- Study start1 Mar 2019
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-Simon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03865823
- Sponsor's protocol ID
- D_ELK_2018_2
- Acronym
- PROFIL
- Status last verified
- Sep 2025
- First submitted
- 4 Mar 2019
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Recovery Rate and Postoperative Incontinence of Surgical Fistulas in a Cohort of a Reference Centre
- ClinicalTrials.gov ID
- NCT03865823
- Acronym / sponsor ID
- PROFIL / D_ELK_2018_2
- Conditions
- Anal Fistula
- Keywords
- anal fistula, anal infection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Groupe Hospitalier Diaconesses Croix Saint-SimonUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 7 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anal Fistula | – | Procedure: pus samplepatient with anal fistula with indication to surgical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with an anus fistula with indication for surgical treatment
Key inclusion criteria (1 listed)
- Patient over the age of 18, patient with an anus fistula with indication for surgical treatment
Key exclusion criteria (1 listed)
- Cutaneous Suppuration, without fistula (e.g., Verneuil disease, boil)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pus sampleA pus sample from the fistula will be taken by the doctor during this first consultation or, failing that, in the operating room before disinfection. | Procedure or surgery | anal Fistula |
Primary outcome
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.
8 secondary outcomes
Anal incontinence rate in participants operated for anal fistula, 2 years after initial care.
Time frame: Year 2
Healing rate in participants operated for anal fistula, at 6, 12 and 24 months after initial care.
Time frame: Month 6, 12, 24
Assessment of time to consolidated recovery.
Time frame: Month 24
Description of the number of surgeries required to obtain a cure.
Time frame: 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.
Time frame: 2 weeks
Quality of life of participants at 2 years.
Time frame: 2 years
Quantitative assessment of sphincter function using anorectal manometry
Time frame: 2 years
Evolution of anatomical lesions of the anal sphincter on endoanal ultrasound
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Fistula, run by Groupe Hospitalier Diaconesses Croix Saint-Simon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing rate at 2 years after initial surgical management of anal fistula. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.