Surrogate Quality Indicators for Adenoma Detection Rate (ADR)
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|ClinicalTrials.gov Identifier: NCT03919487|
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
This study is to evaluate the correlation of adenoma missing rate and quality indicators of colonoscopy including adenoma detection ratee (ADR), polyp detection rate (PDR), adenoma per colonoscopy rate (APC), adenoma per positive participant (APP), ADR-Plus, and to find out the surrogate indicators of ADR. This study is a prospective observational multi-center study. Correlation between AMR and quality indicators of colonoscopy based on the previous studies, 8 endoscopists participated in this study and will enroll 50 screening colonoscopies respectively.
Recruit research participants who want to participate in research in outpatient clinics. Perform colonoscopy in the morning after colon cleansing with split method. Colonoscopy is performed by back-to-back two consecutive colonoscopies. When the first colonoscopy is performed, the colonoscope is retracted after inserting the cecum, and all colon polyps are removed. After retracting to the anus of the first colonoscopy, the second colonoscopy is performed immediately. In case of newly detected colon polyps except for the small polyps and S-colon and rectal polyps which were left as photographs during the first colonoscopy with the second colonoscopy, we regard them as an overlooked lesion during the first colonoscopy. After the procedure, the histologic examination is confirmed and classified as benign lesions (all adenomas, advanced adenomas, dysplasia, and colorectal cancer) and non-lesion lesions.
Using the back-to-back colonoscopy results of the participants during the study period, calculate the quality indicators including ADR, PDR, APC, ADR-plus, APP and AMR for each endoscopist. And then, evaluate the correlation between AMR and other quality indicators.
|Condition or disease||Intervention/treatment|
|Colon Adenoma||Procedure: Back to back colonoscopy|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Correlation Between Surrogate Quality Indicators for Adenoma Detection Rate (ADR) and Adenoma Miss Rate (AMR) in Qualified Colonoscopy: CORE Study|
|Actual Study Start Date :||January 1, 2017|
|Estimated Primary Completion Date :||May 31, 2019|
|Estimated Study Completion Date :||June 30, 2019|
Back-to-back colonoscopy group
As I described the study method in the protocol, the experimental group will be a screening colonoscopy cohort with back to back method. In fact, this study is to evaluate the correlation between quality indicators of colonoscopy and adenoma miss rate (AMR), and intervention is a single arm for back-to-back colonoscopy.
Procedure: Back to back colonoscopy
After first colonoscopy performing with polypectomy, the 2nd colonoscopy will be performed right after the 1st colonoscopy, and if the missed lesion during the 1st colonoscopy will be found, it should be removed.
Other Name: colonoscopy
- Correlation between adenoma missing rate during the colonoscopy and other colonoscopy quality indicators in each endoscopist. [ Time Frame: Within 1 year ]colonoscopy quality indicators including adenoma detection rate, polyp detection rate, adenoma per colonoscopy, adenoma detection rate-plus, adenoma per positive participant
- Evaluation of surrogate indicators of ADR [ Time Frame: Within 1 year ]Correlation between ADR and other substitute indicators including PDR, APC, ADR-P
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03919487
|Contact: Hyun GUn Kim, Professorfirstname.lastname@example.org|
|Korea, Republic of|
|Soonchunhyang univerisity hospital||Recruiting|
|Seoul, Korea, Republic of, 140-743|
|Contact: Hyun Gun Kim, MD., PhD. email@example.com|
|Principal Investigator: Hyun Gun Kim, MD., PhD.|
|Study Director:||Hyun Gun Kim, Professor||Soonchunhyang University College of Medicine|