NCT03131297

Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: F Care Systems NV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anal Fistula

Interventions

Type	Name	Description
PROCEDURE	treatment by radiofrequency	Radiofrequency might destroy fistula tract without lesion of anal sphincter.

Timeline

• Start date: 2017-04-17
• Primary completion: 2020-10-05
• Completion: 2022-10-05
• First posted: 2017-04-27
• Last updated: 2024-02-23

Locations

4 sites across 1 country: France