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Surrogate Quality Indicators for Adenoma Detection Rate (ADR)

NCT03919487 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2021-03-10

No results posted yet for this study

Summary

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.

Conditions

  • Colon Adenoma

Interventions

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.

Sponsors & Collaborators

  • Soonchunhyang University Hospital

    lead OTHER

Principal Investigators

  • Hyun Gun Kim, Professor · Soonchunhyang University College of Medicine

Eligibility

Min Age
50 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-01
Primary Completion
2020-06-30
Completion
2020-12-18

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03919487 on ClinicalTrials.gov