Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas (RADIOFIST)
Primary Purpose
Anal Fistula
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
treatment by radiofrequency
Sponsored by
About this trial
This is an interventional other trial for Anal Fistula focused on measuring anal fistulas, evaluation of radiofrequency
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).
Sites / Locations
- Chu Nantes
- Clinique BlometRecruiting
- CHU Pontchaillou
- Hopital Bagatelle
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Anal fistula treated by radiofrequency
Arm Description
treatment by radiofrequency: patient with anal fistula treated by radiofrequency
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
evaluate anal continuation
evaluate anal continuation with SELF-EVALUATION QUESTIONNAIRE
Assessment of Feasibility of anal fistula treatment by radiofrequency
Assessment of feasibility by measurement of anal fistula drying
Determination of the optimal settings
Evaluate the parameters of the probe (25 watts, 120 ° C, power 150 joules / 0,5 cm)
Patient satisfaction
self-assessment questionnaire with numerical scales
Patient satisfaction
self-assessment questionnaire with numerical scales
the rate and nature of post-operative complications
Number of Participants With Abnormal Values in MRI and Adverse Events That Are Related to Treatment
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.
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03131297
Brief Title
Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas
Acronym
RADIOFIST
Official Title
Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 17, 2017 (Actual)
Primary Completion Date
April 2019 (Anticipated)
Study Completion Date
October 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
F Care Systems NV
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anal Fistula
Keywords
anal fistulas, evaluation of radiofrequency
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Anal fistula treated by radiofrequency
Arm Type
Experimental
Arm Description
treatment by radiofrequency: patient with anal fistula treated by radiofrequency
Intervention Type
Procedure
Intervention Name(s)
treatment by radiofrequency
Intervention Description
Radiofrequency might destroy fistula tract without lesion of anal sphincter.
Primary Outcome Measure Information:
Title
Clinical healing of an anal fistula
Description
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.
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Clinical healing of an anal fistula,
Description
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.
Time Frame
12 months
Title
evaluate anal continuation
Description
evaluate anal continuation with SELF-EVALUATION QUESTIONNAIRE
Time Frame
12 months
Title
Assessment of Feasibility of anal fistula treatment by radiofrequency
Description
Assessment of feasibility by measurement of anal fistula drying
Time Frame
day 0 at inclusion
Title
Determination of the optimal settings
Description
Evaluate the parameters of the probe (25 watts, 120 ° C, power 150 joules / 0,5 cm)
Time Frame
12 months
Title
Patient satisfaction
Description
self-assessment questionnaire with numerical scales
Time Frame
6 months
Title
Patient satisfaction
Description
self-assessment questionnaire with numerical scales
Time Frame
12 months
Title
the rate and nature of post-operative complications
Description
Number of Participants With Abnormal Values in MRI and Adverse Events That Are Related to Treatment
Time Frame
12 months
Title
Evolution in MRI
Description
If the MRI has eliminated an undrained pathway, a diverticulum greater than 10 mm, a hyper-intensity in T2 and after injection of Gadolinium.
Time Frame
12 month
Title
Prognostic factors
Description
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
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent Abramowitz, MD
Phone
1 40 25 72 02
Ext
+33
Email
laurent.abramowitz@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurent Abramowitz, MD
Organizational Affiliation
Clinique Blomet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Nantes
City
Nantes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GUILLAUME MEURETTE, Pr MD PhD
First Name & Middle Initial & Last Name & Degree
guillaume MEURETTE, Pr MD PhD
Facility Name
Clinique Blomet
City
Paris
ZIP/Postal Code
75015
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
laurent abramowitz, md
Facility Name
CHU Pontchaillou
City
Rennes
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent SIPROUDHIS, Pr MD PhD
First Name & Middle Initial & Last Name & Degree
Laurent SIPROUDHIS, Pr MD PhD
Facility Name
Hopital Bagatelle
City
Talence
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
DOMINIQUE BOUCHARD, MD
First Name & Middle Initial & Last Name & Degree
FRANCOIS PIGOT
12. IPD Sharing Statement
Plan to Share IPD
No
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Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas
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