MedTrace Logo

Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas

NCT03131297 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2024-02-23

No results posted yet for this study

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

Conditions

  • Anal Fistula

Interventions

PROCEDURE

treatment by radiofrequency

Radiofrequency might destroy fistula tract without lesion of anal sphincter.

Sponsors & Collaborators

  • F Care Systems NV

    lead INDUSTRY

Principal Investigators

  • Laurent Abramowitz, MD · Clinique Blomet

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-17
Primary Completion
2020-10-05
Completion
2022-10-05

Countries

  • France

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03131297 on ClinicalTrials.gov