Development of Quality Indicators and Quality Improvement Plan of Colonoscopy in Experienced Endoscopist

• Conditions: Colonic Neoplasms; Colonic Polyps
• Interventions: Behavioral: Feedback

• Registration Number: NCT02385552
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2015-03-01
• Study First Submitted QC: 2015-03-05
• Study First Posted: 2015-03-11
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-14
• Last Update Posted: 2016-04-18
• Primary Completion: 2019-03
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Experienced endoscopists	Feedback	All of the experienced endoscopists will receive feedbacks from investigators about their own adenoma detection rate every 3 months

Primary Outcome Measures

Name	Time	Method
Adenoma detection rate	8 years	(total, right, transverse, left)

Secondary Outcome Measures

Name	Time	Method
Colonoscopy performance indicators	8 years	The position changes during colonoscope insertion and withdrawal
Colonoscopy quality indicators	8 years	Complication rate (bleeding, perforation, pain)

Trial Locations

Locations (2)

Healthcare System Gangnam Center, Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Ji Yeon Seo; 🇰🇷 Seoul, Korea, Republic of