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NCT03919487

Surrogate Quality Indicators for Adenoma Detection Rate (ADR)

Completed Last updated 10 March 2021
What this trial tests

trial testing Back to back colonoscopy in Colon Adenoma in 400 participants. Completed in 18 December 2020.

Timeline
1 July 2018
Primary endpoint
30 June 2020
18 December 2020

Quick facts

Lead sponsorSoonchunhyang University Hospital
StatusCompleted
Study typeOBSERVATIONAL
Enrollment400
Start date1 July 2018
Primary completion30 June 2020
Estimated completion18 December 2020
Sites1 location across South Korea

Drugs / interventions tested

Conditions studied

Sponsor

Soonchunhyang University Hospital

Who can join

Adults 50 to 75, any sex, with Colon Adenoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Correlation between Surrogate Quality Indicators for Adenoma Detection Rate and Adenoma Miss Rate in Qualified Colonoscopy, CORE Study: KASID Multicenter Study.
    Han JH, Kim HG, Ahn EM, Park S, et al · · 2022 · cited 7× · PMID 34933279 · DOI 10.5009/gnl210287

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Other recruiting trials for Colon Adenoma

Currently open trials in the same condition.

Other Soonchunhyang University Hospital trials

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Data sources for this page

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