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ClinicalTrials.gov ID

NCT02385552

Lead Sponsor

Seoul National University HospitalOTHER

Overall Status

Unknown status

Study Type

Observational

Enrollment

17Estimated

Last Update Posted

Apr 18, 2016Estimated

Start Date

Mar 2011

Primary Completion Date

Mar 2019Estimated

Completion Date

Dec 2019Estimated

Official Title

Seoul National University Hospital Healthcare System Gangnam Center Colonoscopy Quality Upgrade Project (Gangnam-CUP): Development of Quality Indicators and Quality Improvement Plan of Colonoscopy in Experienced Endoscopist.

Brief Summary

The purpose of this study is to determine clinical factors affecting quality indicators of colonoscopy including adenoma detection rate, and whether quality of colonoscopy could be elevated by improving related factors.

Detailed Description

This study is an extension of quality assurance program in Seoul National University Hospital Healthcare System Gangnam Center. This study is composed of five periods. First, quality indicators of colonoscopy in experienced endoscopists will be analyzed retrospectively from January 2011 to december 2014. Individual differences and changes of quality indicators in every endoscopist will be verified. In second period, from January 2015 to March 2015, quality assurance program will be activated. Endoscopists will be educated by EQUIP (Endoscopic Quality Improvement Program). Also split-regimen bowel preparation instead of same-day regimen and Boston bowel preparation scale will be introduced to standardize disparity of grading. Third, prospective trial starts from April 2015 to March 2018. All endoscopists will receive feedbacks of their own adenoma detection rates in every 3 months. Changes of quality indicators for each endoscopist will be investigated, and annually monitored by institutional review board. If there is a significant improvement of quality indicators in interim assessment, prospective trial will be extended until April 2018. Fourth is wash-out period from April 2018 to march 2019. Feedbacks will be stopped and adenoma detection rates and quality indicators of endoscopists will be compared with those from prospective period. Finally, cumulative rate and mortality rate of colorectal cancers will be investigated until December 2019.

• Colonic Polyps
• Colonic Neoplasms

• Feedback

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

Inclusion Criteria:

• Customers who received colonoscopy in Seoul National University Hospital Healthcare System Gangnam Center from 2011 to 2019.

Exclusion Criteria:

• Age <18 years
• Customers who refused to offer their health check up data
• History of inflammatory bowel disease
• History of familial adenomatous polyposis
• Customers who received Incomplete colonoscopy
• History of previous colorectal resection

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Seoul National University HospitalOTHER

sjy@snuh.org82-2-2112-5641