Groupe Hospitalier Diaconesses Croix Saint Simon
Paris, 75020, France
NCT Number: NCT03865823
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Paris, 75020, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 2 years
Healing is defined by the absence of anal pain, pus discharge and anal swelling reported by the patient.
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.
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.
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:
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.
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.
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).
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.
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).
Groupe Hospitalier Diaconesses Croix Saint-Simon
Other
Acronym: PROFIL
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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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