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

Detailed 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

Schedule :

  • First inclusion march 2017
  • Last inclusion march 2018
  • Evaluations until march 2019.

Sponsor: F Care Systems NV

Current Primary Outcome: Clinical healing of an anal fistula [ Time Frame: 6 month ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Clinical healing of an anal fistula, [ Time Frame: 12 months ]
    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.
  • evaluate anal continuation [ Time Frame: 12 months ]
    evaluate anal continuation with SELF-EVALUATION QUESTIONNAIRE
  • Assessment of Feasibility of anal fistula treatment by radiofrequency [ Time Frame: day 0 at inclusion ]
    Assessment of feasibility by measurement of anal fistula drying
  • Determination of the optimal settings [ Time Frame: 12 months ]
    Evaluate the parameters of the probe (25 watts, 120 ° C, power 150 joules / 0,5 cm)
  • Patient satisfaction [ Time Frame: 6 months ]
    self-assessment questionnaire with numerical scales
  • Patient satisfaction [ Time Frame: 12 months ]
    self-assessment questionnaire with numerical scales
  • the rate and nature of post-operative complications [ Time Frame: 12 months ]
    Number of Participants With Abnormal Values in MRI and Adverse Events That Are Related to Treatment
  • Evolution in MRI [ Time Frame: 12 month ]
    If the MRI has eliminated an undrained pathway, a diverticulum greater than 10 mm, a hyper-intensity in T2 and after injection of Gadolinium.
  • Prognostic factors [ Time Frame: 12 month ]
    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


Original Secondary Outcome: Same as current

Information By: F Care Systems NV

Dates:
Date Received: April 6, 2017
Date Started: April 17, 2017
Date Completion: October 2019
Last Updated: April 24, 2017
Last Verified: April 2017