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Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas — RADIOFIST  

Anal Fistula Clinical Trial

Official title:
Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas

Clinical Trial 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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT03131297
Study type Interventional
Source F Care Systems NV
Contact
Status Completed
Phase N/A
Start date April 17, 2017
Completion date October 5, 2022
View Details
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