NCT03878498

Brief Summary

The management of anal fistula in Crohn Disease is complex. In aim to obtain the healing of the anal fistula, different approaches can be proposed but the best strategy is not yet determined. The aim was to describe the therapeutic management of anal fistula in Crohn Disease.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
212

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

June 19, 2018

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 18, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 19, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 19, 2019

Completed
Last Updated

March 18, 2019

Status Verified

March 1, 2019

Enrollment Period

1.3 years

First QC Date

March 14, 2019

Last Update Submit

March 14, 2019

Conditions

Anal FistulaCrohn Disease

Keywords

Crohn diseaseanal fistulaanal surgery

Outcome Measures

Primary Outcomes (1)

  • Description of the therapeutic management of anal fistula in Crohn Disease

    Therapeutic management of anal fistula in Crohn Disease, including medical and surgical treatments

    The inclusion day

Interventions

therapeutic managementOTHER

therapeutic management of anal fistula in Crohn Disease

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with anal fistula in Crohn Disease and needed fistula drainage or surgery

You may qualify if:

  • Patient over 18 years of age
  • Crohn's disease with fistulizing anoperineal lesion
  • Operated at least once for this reason

You may not qualify if:

  • Adult person protected under the Public Health Code
  • Minor person

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Rennes

Rennes, 35033, France

Location

MeSH Terms

Conditions

Rectal FistulaCrohn Disease

Condition Hierarchy (Ancestors)

Intestinal FistulaDigestive System FistulaDigestive System DiseasesIntestinal DiseasesGastrointestinal DiseasesRectal DiseasesFistulaPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsInflammatory Bowel DiseasesGastroenteritis

Study Officials

  • Charlène BROCHARD, MD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2019

First Posted

March 18, 2019

Study Start

June 19, 2018

Primary Completion

September 19, 2019

Study Completion

September 19, 2019

Last Updated

March 18, 2019

Record last verified: 2019-03

Locations

FR(1)