- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04397120
The Factors Affecting ADR of Screening Colonoscopy
May 19, 2020 updated by: The First Affiliated Hospital of Zhejiang Chinese Medical University
Comprehensive Analysis of Multilevel Factors Affecting Adenoma Detection Rates of Screening Colonoscopy
The purpose of this study is to assess the impact of multilevel factors on the quality of screening colonoscopy, reflected mainly by adenoma detection rate (ADR).
Study Overview
Status
Completed
Conditions
Detailed Description
The subjects will include patients who need to screening colonoscopies by 21 endoscopists between January 2019 and December 2019 were retrospectively enrolled in this unit.
Multilevel factors, including patient-, proceduralist-, and procedure-level characteristics were analyzed for the relationship with ADR.
Study Type
Observational
Enrollment (Actual)
13495
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Zhejiang
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Hangzhou, Zhejiang, China, 310006
- First Affiliated Hospital of Zhejiang Chinese Medical University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Endoscopy Department of a university Hospital
Description
Inclusion Criteria:
- Patients were retrospectively included in this study if they had undergone a completed colonoscopy.
Exclusion Criteria:
- prior colonoscopy within 3 years;
- medical history of inflammatory bowel disease (IBD), CRC, or abdominal surgery;
- fair or poor quality of bowel preparation (fair quality: some semisolid stool that could be suctioned or washed away but >90% of mucosal surface seen; poor quality: semisolid stool that could not be suctioned or washed away with <90% of mucosal surface seen);
- failure in cecal intubation;
- withdrawal time without removing<6 min.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adenoma detection rate
Time Frame: After histopathologically examined, reviewed, and confirmed, an average of 7 days.
|
the proportion of colonoscopies in which at least one adenoma was detected
|
After histopathologically examined, reviewed, and confirmed, an average of 7 days.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bin Lu, M.D., First Affiliated Hospital of Zhejiang Chinese Medical University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
April 30, 2020
Study Registration Dates
First Submitted
May 16, 2020
First Submitted That Met QC Criteria
May 19, 2020
First Posted (Actual)
May 21, 2020
Study Record Updates
Last Update Posted (Actual)
May 21, 2020
Last Update Submitted That Met QC Criteria
May 19, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CADR-HuY-2005
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
IPD Plan Description
Individual participant data sharing will be consider after study
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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