Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas

NCT ID: NCT03131297

Last Updated: 2024-02-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-17
• Study Completion Date: 2022-10-05

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 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.

Conditions

Anal Fistula

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Anal fistula treated by radiofrequency

treatment by radiofrequency: patient with anal fistula treated by radiofrequency

Group Type: EXPERIMENTAL

treatment by radiofrequency

Intervention Type: PROCEDURE

Radiofrequency might destroy fistula tract without lesion of anal sphincter.

Interventions

treatment by radiofrequency

Radiofrequency might destroy fistula tract without lesion of anal sphincter.

Intervention Type: PROCEDURE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

F Care Systems NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Laurent Abramowitz, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Blomet

Locations

Chu Nantes

Nantes, , France

Clinique Blomet

Paris, , France

CHU Pontchaillou

Rennes, , France

Hopital Bagatelle

Talence, , France

Countries

France

Other Identifiers

17LAZ_RadioFist

Identifier Type: -

Identifier Source: org_study_id