Evaluation of the Recovery Rate and Postoperative Incontinence of Surgical Fistulas in a Cohort of a Reference Centre
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 600
- Locations
- 1
- Primary Endpoint
- Healing rate at 2 years after initial surgical management of anal fistula.
Study Overview
Brief 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. 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
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
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
- Anal incontinence rate in participants operated for anal fistula, 2 years after initial care.(Year 2)
- Healing rate in participants operated for anal fistula, at 6, 12 and 24 months after initial care.(Month 6, 12, 24)
- Assessment of time to consolidated recovery.(Month 24)
- Description of the number of surgeries required to obtain a cure.(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.(2 weeks)
- Quality of life of participants at 2 years.(2 years)
- Quantitative assessment of sphincter function using anorectal manometry(2 years)
- Evolution of anatomical lesions of the anal sphincter on endoanal ultrasound(2 years)