NCT03288961

Brief Summary

This study aims to develop a self-screening tool for Crohn's perianal fistula.

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
146

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2017

Typical duration for all trials

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

May 1, 2017

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 19, 2017

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 20, 2017

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 13, 2019

Status Verified

August 1, 2019

Enrollment Period

2.6 years

First QC Date

September 19, 2017

Last Update Submit

August 12, 2019

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

  • Perianal fistula

    perianal fistula rate confirmed by MRI

    1 day

Eligibility Criteria

Age10 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Crohn's disease patients are asked to fill out survey of their perianal symptoms. Survey score is compared with MRI results as the gold standard.

You may qualify if:

  • Crohn's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyungpook National University Hospital

Daegu, 41944, South Korea

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 19, 2017

First Posted

September 20, 2017

Study Start

May 1, 2017

Primary Completion

December 1, 2019

Study Completion

December 1, 2019

Last Updated

August 13, 2019

Record last verified: 2019-08

Locations

KR(1)