The Impact of a Colonoscopy Monitoring Program on Endoscopists' Performance
The goal of this clinical trial is to learn if colonoscopy monitoring program works to adenoma detection rate in endoscopists. It will also learn about the impact on sessile serrated lesion detection rate, adenomas per colonoscopy, sessile serrated lesions per colonoscopy, advanced adenoma detection rate. The main questions it aims to answer are:
Does colonoscopy monitoring program effect on adenoma detection rate in endoscopists?
Participants will:
Receive result of colonoscopy monitoring program or not every 3 months for 1 year
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Endoscopists with at least 1 year of colonoscopy experience
Exclusion Criteria:
- Endoscopists with less than 1 year of colonoscopy experience
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Feedback group
The feedback group will be notified of the colonoscopy performances.
|
Adenoma detection rate feedback from colonoscopy monitoring programs
|
|
No Intervention: Control group
The control group will not be notified of the colonoscopy performances.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
adenoma detection rate
Time Frame: 1 year
|
the percentage of patients with at least one histologically proven adenoma
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
sessile serrated lesion detection rate
Time Frame: 1 year
|
the percentage of patients with at least one histologically proven sessile serrated lesion
|
1 year
|
|
adenomas per colonoscopy
Time Frame: 1 year
|
the number of detected adenomas divided by the total number of screening colonoscopies
|
1 year
|
|
sessile serrated lesions per colonoscopy
Time Frame: 1 year
|
the number of detected sessile serrated lesions divided by the total number of screening colonoscopies
|
1 year
|
|
advanced adenoma detection rate
Time Frame: 1 year
|
the percentage of patients with at least one histologically proven advanced adenoma
|
1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2406-162-1549
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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