Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas

F Care Systems NV50 enrolled

Overview

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

: 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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Clinical healing of an anal fistula

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.

Time frame: 6 month

Secondary Outcomes

Clinical healing of an anal fistula,

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.

Time frame: 12 months

evaluate anal continuation

evaluate anal continuation with SELF-EVALUATION QUESTIONNAIRE

Time frame: 12 months

Assessment of Feasibility of anal fistula treatment by radiofrequency

Assessment of feasibility by measurement of anal fistula drying

Time frame: day 0 at inclusion

Determination of the optimal settings

Evaluate the parameters of the probe (25 watts, 120 ° C, power 150 joules / 0,5 cm)

Time frame: 12 months

Patient satisfaction

self-assessment questionnaire with numerical scales

Time frame: 6 months

Patient satisfaction

self-assessment questionnaire with numerical scales

Time frame: 12 months

the rate and nature of post-operative complications

Number of Participants With Abnormal Values in MRI and Adverse Events That Are Related to Treatment

Time frame: 12 months

Evolution in MRI

If the MRI has eliminated an undrained pathway, a diverticulum greater than 10 mm, a hyper-intensity in T2 and after injection of Gadolinium.

Time frame: 12 month

Prognostic factors

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

Time frame: 12 month

Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas

Overview

Conditions

Interventions

Eligibility

Locations (4)

Outcomes

Primary Outcomes

Secondary Outcomes