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

Colonic Neoplasms Clinical Trial

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02385552
• Other study ID #: H-1502-003-644
• Status: Recruiting
• Phase: N/A
• First received: March 1, 2015
• Last updated: May 19, 2015
• Start date: March 2011
• Est. completion date: December 2019

Study information

• Verified date: May 2015
• Source: Seoul National University Hospital
• Contact: Ji Yeon Seo, M.D.
• Phone: 82-2-2112-5641
• Email: sjy[@]snuh.org
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 17
• Est. completion date: December 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colonic Neoplasms
• Colonic Polyps

Intervention

Behavioral:
• Feedback
Experienced endoscopists will receive feedbacks from investigators about their own adenoma detection rates.

Locations

Country	Name	City	State
Korea, Republic of	Healthcare System Gangnam Center, Seoul National University Hospital	Seoul
Korea, Republic of	Ji Yeon Seo	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adenoma detection rate	(total, right, transverse, left)	8 years	No
Secondary	Colonoscopy performance indicators	Colonoscopy withdrawal time in negative complete colonoscopy	8 years	No
Secondary	Colonoscopy performance indicators	The number of taken pictures in negative complete colonoscopy	8 years	No
Secondary	Colonoscopy performance indicators	The position changes during colonoscope insertion and withdrawal	8 years	No
Secondary	Colonoscopy quality indicators	Colorectal cancer detection rate	8 years	No
Secondary	Colonoscopy quality indicators	Advanced adenoma detection rate	8 years	No
Secondary	Colonoscopy quality indicators	Adenoma detection rate plus	8 years	No
Secondary	Colonoscopy quality indicators	Polyp detection rate (total, right, transverse, left)	8 years	No
Secondary	Colonoscopy quality indicators	Multiple adenoma detection rate	8 years	No
Secondary	Colonoscopy quality indicators	Serrated polyp detection rate (total, right, transverse, left)	8 years	No
Secondary	Colonoscopy quality indicators	Complication rate (bleeding, perforation, pain)	8 years	No