Clinical Trial: Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional




Official Title: Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas

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