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OpenTrials
Completed

NCT Number: NCT03131297

Multicenter Prospective Evaluation of Radiofrequency for Anal Fistulas

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

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Key information

Conditions

Anal Fistula Digestive System Diseases Digestive System Fistula Fistula Gastrointestinal Diseases Intestinal Diseases Intestinal Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Rectal Diseases Rectal Fistula

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Nantes, Nantes, France

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About this study

: 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

treatment by radiofrequency

Procedure

Radiofrequency might destroy fistula tract without lesion of anal sphincter.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

F Care Systems NV

Industry

Registry information

Acronym: RADIOFIST

Important dates

Study start
2017
Primary completion
2020
Study completion
2022
First posted
Apr 27, 2017
Registry last updated
Feb 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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