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临床试验/NCT02385552
NCT02385552Unknown不适用

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.

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2011年3月最近更新:
适应症

试验速览

阶段
不适用
入组人数
17
试验地点
2
主要终点
Adenoma detection rate

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Adenoma detection rate

时间窗: 8 years

(total, right, transverse, left)

次要结局

  • Colonoscopy performance indicators(8 years)
  • Colonoscopy quality indicators(8 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Su Jin Chung

Associate Professor

Seoul National University Hospital

研究点 (2)

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