NCT03131297

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 6, 2017

Completed
11 days until next milestone

Study Start

First participant enrolled

April 17, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 27, 2017

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2020

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2022

Completed
Last Updated

February 23, 2024

Status Verified

February 1, 2024

Enrollment Period

3.5 years

First QC Date

April 6, 2017

Last Update Submit

February 22, 2024

Conditions

Anal Fistula

Keywords

anal fistulasevaluation of radiofrequency

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (9)

  • Clinical healing of an anal fistula,

    12 months

  • evaluate anal continuation

    12 months

  • Assessment of Feasibility of anal fistula treatment by radiofrequency

    day 0 at inclusion

  • Determination of the optimal settings

    12 months

  • Patient satisfaction

    6 months

  • +4 more secondary outcomes

Study Arms (1)

Anal fistula treated by radiofrequency

EXPERIMENTAL

treatment by radiofrequency: patient with anal fistula treated by radiofrequency

Procedure: treatment by radiofrequency

Interventions

treatment by radiofrequencyPROCEDURE

Radiofrequency might destroy fistula tract without lesion of anal sphincter.

Anal fistula treated by radiofrequency

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Chu Nantes

Nantes, France

Location

Clinique Blomet

Paris, 75015, France

Location

CHU Pontchaillou

Rennes, France

Location

Hopital Bagatelle

Talence, France

Location

MeSH Terms

Conditions

Rectal Fistula

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Laurent Abramowitz, MD

    Clinique Blomet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2017

First Posted

April 27, 2017

Study Start

April 17, 2017

Primary Completion

October 5, 2020

Study Completion

October 5, 2022

Last Updated

February 23, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)