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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02385552

Collaborator

(none)

Enrollment

Locations

105

Duration (Months)

8.5

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Colonic Polyps Colonic Neoplasms	Behavioral: Feedback

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

17 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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.

Study Start Date :

Mar 1, 2011

Anticipated Primary Completion Date :

Mar 1, 2019

Anticipated Study Completion Date :

Dec 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experienced endoscopists All of the experienced endoscopists will receive feedbacks from investigators about their own adenoma detection rate every 3 months	Behavioral: Feedback Experienced endoscopists will receive feedbacks from investigators about their own adenoma detection rates.

Arm

Intervention/Treatment

Experienced endoscopists

All of the experienced endoscopists will receive feedbacks from investigators about their own adenoma detection rate every 3 months

Behavioral: Feedback

Experienced endoscopists will receive feedbacks from investigators about their own adenoma detection rates.

Outcome Measures

Primary Outcome Measures

Adenoma detection rate [8 years]
(total, right, transverse, left)

Secondary Outcome Measures

Colonoscopy performance indicators [8 years]
Colonoscopy withdrawal time in negative complete colonoscopy
Colonoscopy performance indicators [8 years]
The number of taken pictures in negative complete colonoscopy
Colonoscopy performance indicators [8 years]
The position changes during colonoscope insertion and withdrawal
Colonoscopy quality indicators [8 years]
Colorectal cancer detection rate
Colonoscopy quality indicators [8 years]
Advanced adenoma detection rate
Colonoscopy quality indicators [8 years]
Adenoma detection rate plus
Colonoscopy quality indicators [8 years]
Polyp detection rate (total, right, transverse, left)
Colonoscopy quality indicators [8 years]
Multiple adenoma detection rate
Colonoscopy quality indicators [8 years]
Serrated polyp detection rate (total, right, transverse, left)
Colonoscopy quality indicators [8 years]
Complication rate (bleeding, perforation, pain)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Healthcare System Gangnam Center, Seoul National University Hospital	Seoul		Korea, Republic of
2	Ji Yeon Seo	Seoul		Korea, Republic of

Sponsors and Collaborators

Seoul National University Hospital

Investigators

Principal Investigator: Su Jin Chung, M.D., Ph.D., Department of Internal Medicine and Healthcare Research Institute, Healthcare System Gangnam Center, Seoul National University Hospital