Anal Fistula
Conditions
Keywords
anal fistulas, evaluation of radiofrequency
Brief summary
Anal fistula treatment is associated with increasing risk of anal incontinence until 40% of cases. New and alternative treatments (glue, advancement flap, plug…) decrease this risk, but with fistula efficacy treatment in 40 to 60% of cases. Radiofrequency might destroy fistula tract without lesion of anal sphincter. Objective : Fistula healing rate and anal continence, 6 and 12 months after radiofrequency procedure. Methods : Clinical and MRI evaluation before, 6 and 12 months after treatment. Patients : 50 patients with low, high, complex and Crohn disease fistula. An intermediate analysis is expected after the first 20 patients, to verify morbidity. Evaluations : * Fistula clinical healing 6 and 12 months after procedure * Fistula MRI healing 12 months after procedure * Anal continence before and after procedure * Feasibility og radiofrequency procedure * Morbidity * Success and failure prognostics factors of this procedure
Detailed description
: Anal fistula treatment is associated with increasing risk of anal incontinence until 40% of cases. New and alternative treatments (glue, advancement flap, plug…) decrease this risk, but with fistula efficacy treatment in 40 to 60% of cases. Radiofrequency might destroy fistula tract without lesion of anal sphincter. Objective : Fistula healing rate and anal continence, 6 and 12 months after radiofrequency procedure. Methods : Clinical and MRI evaluation before, 6 and 12 months after treatment. Patients : 50 patients with low, high, complex and Crohn disease fistula. An intermediate analysis is expected after the first 20 patients, to verify morbidity. Evaluations : * Fistula clinical healing 6 and 12 months after procedure * Fistula MRI healing 12 months after procedure * Anal continence before and after procedure * Feasibility og radiofrequency procedure * Morbidity * Success and failure prognostics factors of this procedure Schedule : * First inclusion march 2017 * Last inclusion march 2018 * Evaluations until march 2019.
Interventions
PROCEDUREtreatment by radiofrequency
Radiofrequency might destroy fistula tract without lesion of anal sphincter.
Sponsors
F Care Systems NV
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult Patient agreeing to participate in the study and signing the consent to participate * Patients with an anal fistula previously drained, without diverticulum\> 10 mm in MRI after drainage. * For women of childbearing age, they must have a negative urine pregnancy test
Exclusion criteria
* Patient minor, * Patients who are linguistically or psychologically unable to understand the information given and to give informed consent, * Patient incapable, in the opinion of the investigator, to complete the self-questionnaires, * Against-indication to radiofrequency treatment (infectious anal pathologies, anal fissures, residual staples of previous treatment Longo, * Pregnant woman, * Patient carrying a pacemaker, * Patients participating in another clinical study, * Against indication to the realization of an MRI, * Patient with a fistula with insufficient drainage, against indicating the removal of the stem (congestive fistula, oozing, with internal and / or external congestive orifices).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical healing of an anal fistula | 6 month | Clinical healing of an anal fistula, 6 months after radiofrequency treatment: A fistula is clinically healed if there is no drain, the external and internal openings are non-inflammatory, clogged, and without flow. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction | 6 months | self-assessment questionnaire with numerical scales |
| the rate and nature of post-operative complications | 12 months | Number of Participants With Abnormal Values in MRI and Adverse Events That Are Related to Treatment |
| Evolution in MRI | 12 month | If the MRI has eliminated an undrained pathway, a diverticulum greater than 10 mm, a hyper-intensity in T2 and after injection of Gadolinium. |
| Determination of the optimal settings | 12 months | Evaluate the parameters of the probe (25 watts, 120 ° C, power 150 joules / 0,5 cm) |
| evaluate anal continuation | 12 months | evaluate anal continuation with SELF-EVALUATION QUESTIONNAIRE |
| Assessment of Feasibility of anal fistula treatment by radiofrequency | day 0 at inclusion | Assessment of feasibility by measurement of anal fistula drying |
| Prognostic factors | 12 month | Evaluate the prognostic factors of good or bad response to this treatment: type of fistula, settings of the probe and the drying of the fistula |
| Clinical healing of an anal fistula, | 12 months | Clinical healing of an anal fistula, 12 months after radiofrequency treatment: A fistula is clinically healed if there is no drain, the external and internal openings are non-inflammatory, clogged, and without flow. |
Countries
France
Outcome results
None listed