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 ]
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