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临床试验/NCT04487626
NCT04487626已完成不适用

Development and Validation of an Artificial Intelligence System for Bowel Preparation Quality Scoring

National Cancer Center, Korea2 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2020年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
accuracy of bowel preparation score

研究概览

简要总结

The purpose of this study is to develop and validate the accuracy and reliability of an artificial intelligence(AI) system for bowel preparation quality scoring based of Boston Bowel preparation Scoring(BBPS). Then evaluate whether this AI system can help endoscopists to improve the quality of colonoscopy in clinical practice.

详细描述

Bowel preparation is one of the most important factors which decide the quality of colonoscopy. Adequate bowel preparation is essential to guarantee a clear vision of colonic mucosa, complete inspection of entire colon and improves the adenoma detection rates(ADRs). Therefore, the quality of bowel preparation should be evaluated accurately and objectively. However, current bowel preparation quality scales depend on memories and subjective decision of endoscopists. Recently, articifial intelligence system based on deep learning algorithm has been used widely in medical fields. But, few studies have been reported to evaluate the performance of AI system based on deep learning in bowel preparation quality scoring. This study aims to develop and train an AI system to assess bowel preparation quality using the BBPS, and validate the AI system to improve the quality of colonoscopy.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 20-80 years undergoing elective colonoscopy

排除标准

  • Patients received colon or rectal surgery

结局指标

主要结局

accuracy of bowel preparation score

时间窗: 6 months

Bowel preparation quality was measured by BBPS. After fully washing or suctioning of colonic contents, three segments including right colon (containing cecum and ascending colon), transvers colon (containing hepatic and splenic flexures) and left colon (containing descending and sigmoid colon) were individually scored from 0 to 3. Point 0 refers to unprepared colon segment with obscured solid stool making mucosa cannot be seen; Point 1 refers to part of mucosa can be seen, but some areas are covered by staining, residual stool, and/or opaque liquid; Point 2 refers to entire mucosa is well-seen; Point 3 refers to clean colon segment without staining, fecal materials or liquids. A sub-score of each colon segment was used, ranging from minimum 0 to maximum 3. The highest score means the excellent bowel preparation. Adequate bowel preparation was defined as a total BBPS≥6 and sub-BBPS≥2 per segment.

次要结局

未报告次要终点

研究者

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

Dae Kyung Sohn

Staff surgeon

National Cancer Center, Korea

研究点 (2)

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