Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas (RADIOFIST)

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

Study Overview

• Status: Completed
• Conditions: Anal Fistula
• Intervention / Treatment: Procedure: treatment by radiofrequency

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nantes, France
    • CHU Nantes
  • Paris, France, 75015
    • Clinique Blomet
  • Rennes, France
    • CHU Pontchaillou
  • Talence, France
    • Hopital Bagatelle

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Anal fistula treated by radiofrequency; treatment by radiofrequency: patient with anal fistula treated by radiofrequency	Procedure: treatment by radiofrequency; Radiofrequency might destroy fistula tract without lesion of anal sphincter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
evaluate anal continuation	evaluate anal continuation with SELF-EVALUATION QUESTIONNAIRE	12 months
Assessment of Feasibility of anal fistula treatment by radiofrequency	Assessment of feasibility by measurement of anal fistula drying	day 0 at inclusion
Determination of the optimal settings	Evaluate the parameters of the probe (25 watts, 120 ° C, power 150 joules / 0,5 cm)	12 months
Patient satisfaction	self-assessment questionnaire with numerical scales	6 months
Patient satisfaction	self-assessment questionnaire with numerical scales	12 months
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
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
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

Collaborators and Investigators

• Sponsor: F Care Systems NV
• Investigators: Principal Investigator: Laurent Abramowitz, MD, Clinique Blomet

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2017
• Primary Completion (Actual): October 5, 2020
• Study Completion (Actual): October 5, 2022

Study Registration Dates

• First Submitted: April 6, 2017
• First Submitted That Met QC Criteria: April 24, 2017
• First Posted (Actual): April 27, 2017

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: anal fistulas; evaluation of radiofrequency
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Rectal Diseases; Intestinal Fistula; Digestive System Fistula; Fistula; Rectal Fistula
• Other Study ID Numbers: 17LAZ_RadioFist

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No