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Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas (RADIOFIST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03131297
Recruitment Status : Unknown
Verified April 2017 by F Care Systems NV.
Recruitment status was:  Recruiting
First Posted : April 27, 2017
Last Update Posted : April 27, 2017
Sponsor:
Information provided by (Responsible Party):
F Care Systems NV

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

Condition or disease Intervention/treatment Phase
Anal Fistula Procedure: treatment by radiofrequency Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas
Actual Study Start Date : April 17, 2017
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : October 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

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.




Primary Outcome Measures :
  1. Clinical healing of an anal fistula [ Time Frame: 6 month ]
    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 :
  1. Clinical healing of an anal fistula, [ Time Frame: 12 months ]
    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.

  2. evaluate anal continuation [ Time Frame: 12 months ]
    evaluate anal continuation with SELF-EVALUATION QUESTIONNAIRE

  3. Assessment of Feasibility of anal fistula treatment by radiofrequency [ Time Frame: day 0 at inclusion ]
    Assessment of feasibility by measurement of anal fistula drying

  4. Determination of the optimal settings [ Time Frame: 12 months ]
    Evaluate the parameters of the probe (25 watts, 120 ° C, power 150 joules / 0,5 cm)

  5. Patient satisfaction [ Time Frame: 6 months ]
    self-assessment questionnaire with numerical scales

  6. Patient satisfaction [ Time Frame: 12 months ]
    self-assessment questionnaire with numerical scales

  7. the rate and nature of post-operative complications [ Time Frame: 12 months ]
    Number of Participants With Abnormal Values in MRI and Adverse Events That Are Related to Treatment

  8. Evolution in MRI [ Time Frame: 12 month ]
    If the MRI has eliminated an undrained pathway, a diverticulum greater than 10 mm, a hyper-intensity in T2 and after injection of Gadolinium.

  9. Prognostic factors [ Time Frame: 12 month ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131297


Contacts
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Contact: Laurent Abramowitz, MD 1 40 25 72 02 ext +33 laurent.abramowitz@aphp.fr

Locations
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France
Chu Nantes Not yet recruiting
Nantes, France
Contact: GUILLAUME MEURETTE, Pr MD PhD         
Principal Investigator: guillaume MEURETTE, Pr MD PhD         
Clinique Blomet Recruiting
Paris, France, 75015
Contact: laurent abramowitz, md         
CHU Pontchaillou Not yet recruiting
Rennes, France
Contact: Laurent SIPROUDHIS, Pr MD PhD         
Principal Investigator: Laurent SIPROUDHIS, Pr MD PhD         
Hopital Bagatelle Not yet recruiting
Talence, France
Contact: DOMINIQUE BOUCHARD, MD         
Contact: FRANCOIS PIGOT         
Sponsors and Collaborators
F Care Systems NV
Investigators
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Principal Investigator: Laurent Abramowitz, MD CLINIQUE BLOMET
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Responsible Party: F Care Systems NV
ClinicalTrials.gov Identifier: NCT03131297    
Other Study ID Numbers: 17LAZ_RadioFist
First Posted: April 27, 2017    Key Record Dates
Last Update Posted: April 27, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by F Care Systems NV:
anal fistulas
evaluation of radiofrequency
Additional relevant MeSH terms:
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Rectal Fistula
Fistula
Pathological Conditions, Anatomical
Intestinal Fistula
Digestive System Fistula
Digestive System Diseases
Intestinal Diseases
Gastrointestinal Diseases
Rectal Diseases