Clinical trial NCT03131297: Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas
Official title: Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anal Fistula
Keywords: anal fistulas
evaluation of radiofrequency
Lead sponsor: F Care Systems NV
Sponsor class: INDUSTRY
First posted: 2017-04-27
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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).

Primary outcomes:
measure: Clinical healing of an anal fistula
timeFrame: 6 month
Secondary outcomes:
measure: Clinical healing of an anal fistula,
timeFrame: 12 months
measure: evaluate anal continuation
timeFrame: 12 months
measure: Assessment of Feasibility of anal fistula treatment by radiofrequency
timeFrame: day 0 at inclusion
measure: Determination of the optimal settings
timeFrame: 12 months
measure: Patient satisfaction
timeFrame: 6 months
measure: Patient satisfaction
timeFrame: 12 months
measure: the rate and nature of post-operative complications
timeFrame: 12 months
measure: Evolution in MRI
timeFrame: 12 month
measure: Prognostic factors
timeFrame: 12 month
Other outcomes:
Locations:
city: Nantes
country: France
facility: Chu Nantes
city: Paris
country: France
facility: Clinique Blomet
city: Rennes
country: France
facility: CHU Pontchaillou
city: Talence
country: France
facility: Hopital Bagatelle
Study officials:
affiliation: Clinique Blomet
name: Laurent Abramowitz, MD
role: PRINCIPAL_INVESTIGATOR
References: