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

April 14, 2016 updated by: Su Jin Chung, Seoul National University Hospital

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

17

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Healthcare System Gangnam Center, Seoul National University Hospital
        • Contact:
          • Ji Yeon Seo, M.D.
          • Phone Number: 82-2-2112-5641
          • Email: sjy@snuh.org
        • Contact:
      • Seoul, Korea, Republic of
        • Recruiting
        • Ji Yeon Seo
        • Contact:
          • Ji Yeon Seo, M.D.
          • Phone Number: 82-2-2112-5641
          • Email: sjy@snuh.org
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adenoma detection rate
Time Frame: 8 years
(total, right, transverse, left)
8 years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

March 1, 2015

First Submitted That Met QC Criteria

March 5, 2015

First Posted (Estimate)

March 11, 2015

Study Record Updates

Last Update Posted (Estimate)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 14, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-1502-003-644

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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