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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 :
: 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 :
Schedule :
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anal fistula treated by radiofrequency | Experimental | treatment by radiofrequency: patient with anal fistula treated by radiofrequency |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| treatment by radiofrequency | Procedure | Radiofrequency might destroy fistula tract without lesion of anal sphincter. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| evaluate anal continuation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurent Abramowitz, MD | Clinique Blomet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Nantes | Nantes | France | ||||
| Clinique Blomet |
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| ID | Term |
|---|---|
| D012003 | Rectal Fistula |
| ID | Term |
|---|---|
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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evaluate anal continuation with SELF-EVALUATION QUESTIONNAIRE |
| 12 months |
| Assessment of Feasibility of anal fistula treatment by radiofrequency | Assessment of feasibility by measurement of anal fistula drying | day 0 at inclusion |
| Determination of the optimal settings | Evaluate the parameters of the probe (25 watts, 120 ° C, power 150 joules / 0,5 cm) | 12 months |
| Patient satisfaction | self-assessment questionnaire with numerical scales | 6 months |
| Patient satisfaction | self-assessment questionnaire with numerical scales | 12 months |
| the rate and nature of post-operative complications | Number of Participants With Abnormal Values in MRI and Adverse Events That Are Related to Treatment | 12 months |
| 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. | 12 month |
| 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 | 12 month |
| Paris |
| 75015 |
| France |
| CHU Pontchaillou | Rennes | France |
| Hopital Bagatelle | Talence | France |
| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |