Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas

Study Overview
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Brief Summary
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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
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: 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.

Official Title
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Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas

Conditions
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Anal Fistula

Intervention / Treatment
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* Procedure: treatment by radiofrequency


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anal fistula treated by radiofrequency<br>treatment by radiofrequency: patient with anal fistula treated by radiofrequency | Procedure: treatment by radiofrequency<br>* Radiofrequency might destroy fistula tract without lesion of anal sphincter.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 
| evaluate anal continuation | evaluate anal continuation with SELF-EVALUATION QUESTIONNAIRE | 12 months | 
| Assessment of Feasibility of anal fistula treatment by radiofrequency | Assessment of feasibility by measurement of anal fistula drying | 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) | 12 months | 
| Patient satisfaction | self-assessment questionnaire with numerical scales | 6 months | 
| Patient satisfaction | self-assessment questionnaire with numerical scales | 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 | 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. | 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 | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anal fistulas, evaluation of radiofrequency