- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03622281
Quality Improvement Intervention in Colonoscopy Using Artificial Intelligence
February 10, 2020 updated by: Yanqing Li, Shandong University
Quality measures in colonoscopy are important guides for improving the quality of patient care.
But quality improvement intervention is not taking place, primarily because of the inconvenience and expense.
To address the difficulties above, we used artificial intelligence for quality control of colonoscopy.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
676
Phase
- Not Applicable
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
-
-
Shandong
-
Jinan, Shandong, China, 250012
- Department of Gastroenterology, Qilu Hospital, Shandong University
-
-
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
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- aged between 18 and 80;
- agree to give written informed consent.
Exclusion Criteria:
- patients with the contraindications to colonoscopy examination;
- patients with a history of inflammatory bowel disease (IBD), CRC, colorectal surgery;
- patients with prior failed colonoscopy and high suspicion of polyposis syndromes, IBD and typical advanced CRC;
- patients refused to participate in the trial;
- the colonoscopyprocedure cannot be completed due to stenosis, obstruction, huge occupying lesions, or solid stool;
- the colonoscopy procedure have to be terminated due to complications of anaesthesia.
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
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Colonoscopists who received quality intervention
|
Colonoscopists received performance measure monitoring and feedback
|
|
No Intervention: Colonoscopists who did not received quality intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adenoma detection rate
Time Frame: 8 months
|
Adenoma detection rate was defined as the number of exams with findings of adenoma divided by the total number of exams.
|
8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
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)
October 20, 2018
Primary Completion (Actual)
May 31, 2019
Study Completion (Actual)
May 31, 2019
Study Registration Dates
First Submitted
July 16, 2018
First Submitted That Met QC Criteria
August 4, 2018
First Posted (Actual)
August 9, 2018
Study Record Updates
Last Update Posted (Actual)
February 12, 2020
Last Update Submitted That Met QC Criteria
February 10, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 2018SDU-QILU-716
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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