Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas

Anal Fistula Clinical Trial

— RADIOFIST  

Official title:

Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03131297
• Other study ID #: 17LAZ_RadioFist
• Status: Completed
• Phase: N/A
• Start date: April 17, 2017
• Est. completion date: October 5, 2022

Study information

• Verified date: February 2024
• Source: F Care Systems NV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 5, 2022
• Est. primary completion date: October 5, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult Patient agreeing to participate in the study and signing the consent to participate
• Patients with an anal fistula previously drained, without diverticulum> 10 mm in MRI after drainage.
• For women of childbearing age, they must have a negative urine pregnancy test

Exclusion Criteria:

• Patient minor,
• Patients who are linguistically or psychologically unable to understand the information given and to give informed consent,
• Patient incapable, in the opinion of the investigator, to complete the self-questionnaires,
• Against-indication to radiofrequency treatment (infectious anal pathologies, anal fissures, residual staples of previous treatment Longo,
• Pregnant woman,
• Patient carrying a pacemaker,
• Patients participating in another clinical study,
• Against indication to the realization of an MRI,
• Patient with a fistula with insufficient drainage, against indicating the removal of the stem (congestive fistula, oozing, with internal and / or external congestive orifices).

Related Conditions & MeSH terms

• Anal Fistula
• Fistula
• Rectal Fistula

Intervention

Procedure:
• treatment by radiofrequency
Radiofrequency might destroy fistula tract without lesion of anal sphincter.

Locations

Country	Name	City	State
France	Chu Nantes	Nantes
France	Clinique Blomet	Paris
France	CHU Pontchaillou	Rennes
France	Hopital Bagatelle	Talence

Sponsors (1)

Lead Sponsor	Collaborator
F Care Systems NV

Country where clinical trial is conducted

France, 

Outcome

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