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A prospective multicenter, self-controlled study of artificial intelligence-assisted colonoscopy quality assessment system
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注册号:

Registration number:

ChiCTR2200059134 

最近更新日期:

Date of Last Refreshed on:

2022-04-26 

注册时间:

Date of Registration:

2022-04-26 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

人工智能辅助肠镜质量评估体系的前瞻性多中心、自身对照研究 

Public title:

A prospective multicenter, self-controlled study of artificial intelligence-assisted colonoscopy quality assessment system 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

人工智能辅助肠镜质量评估体系的前瞻性多中心、自身对照研究 

Scientific title:

A prospective multicenter, self-controlled study of artificial intelligence-assisted colonoscopy quality assessment system 

研究课题代号(代码):

Study subject ID:

 

在二级注册机构或其它机构的注册号:

The registration number of the Partner Registry or other register:

 

申请注册联系人:

韩泽龙 

研究负责人:

刘思德 

Applicant:

Zelong Han 

Study leader:

Side Liu 

申请注册联系人电话:

Applicant telephone:

18925061960 

研究负责人电话:

Study leader's telephone:

13902212459 

申请注册联系人传真 :

Applicant Fax:

 

研究负责人传真:

Study leader's fax:

 

申请注册联系人电子邮件:

Applicant E-mail:

hzl198886@163.com 

研究负责人电子邮件:

Study leader's E-mail:

liuside2011@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

 

申请注册联系人通讯地址:

广东省广州市白云区广州大道北1838号南方医院 

研究负责人通讯地址:

广东省广州市白云区广州大道北1838号南方医院 

Applicant address:

1838 North Guangzhou Avenue, Baiyun District,Guangzhou, Guangdong, China 

Study leader's address:

1838 North Guangzhou Avenue, Baiyun District,Guangzhou, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

 

研究负责人邮政编码:

Study leader's postcode:

 

申请人所在单位:

南方医科大学南方医院 

Applicant's institution:

Nanfang Hospital, Southern Medical University 

是否获伦理委员会批准:

是 

Approved by ethic committee:

Yes 

伦理委员会批件文号:

Approved No. of ethic committee:

NFEC-2021-365 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

南方医科大学南方医院医学伦理委员会 

Name of the ethic committee:

Medical Ethics Committee of Nanfang Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

2021-11-05 

伦理委员会联系人:

沈少林 

Contact Name of the ethic committee:

Shaolin Shen 

伦理委员会联系地址:

广东省广州市白云区广州大道北1838号南方医院 

Contact Address of the ethic committee:

1838 North Guangzhou Avenue, Baiyun District,Guangzhou, Guangdong, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

 

研究实施负责(组长)单位:

南方医科大学南方医院 

Primary sponsor:

Nanfang Hospital, Southern Medical University 

研究实施负责(组长)单位地址:

广东省广州市白云区广州大道北1838号南方医院 

Primary sponsor's address:

1838 North Guangzhou Avenue, Baiyun District,Guangzhou, Guangdong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

广州

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

南方医科大学南方医院

具体地址:

广东省广州市白云区广州大道北1838号南方医院

Institution
hospital:

Nanfang Hospital, Southern Medical University

Address:

1838 North Guangzhou Avenue, Baiyun District,Guangzhou, Guangdong, China

经费或物资来源:

NA 

Source(s) of funding:

NA 

研究疾病:

大肠息肉 

Target disease:

colorectal polyps 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

1、通过多中心前瞻性、自身对照研究探究AI辅助肠镜质量控制系统对肠镜质量控制指标的有效性,以协助内镜医师提高肠镜检查质量。 2、结合新提出的质控指标—AI识别的退镜超速百分比、滑镜已回镜次数/滑镜未回镜次数比及肠道准备清洁度评分,评价肠镜腺瘤检出率的有效性,提出更全面、更客观的肠镜规范操作标准。 

Objectives of Study:

1. To explore the effectiveness of the AI-assisted colonoscopy quality control system on colonoscopy quality control indicators through a multi-center prospective and self-controlled study, so as to assist endoscopists to improve the quality of colonoscopy. 2. To evaluate the effectiveness of adenomas detection rate by combining the newly proposed quality control indicators-the percentage of AI-identified retraction overspeed,the ratio of the number of successful retractions after slidoscope to the number of unreturned slidoscopes and the score of bowel preparation cleanliness,thereby putting forward to a more comprehensive and objective colonoscopic operating standard.  

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

单臂 

Study design:

Single arm 

纳入标准:

1) 年龄≥50 岁的中国人群; 2) 受试者自愿签署知情同意书; 3) 受试者拟行肠镜检查。 

Inclusion criteria

1) Chinese people aged ≥50 years; 2) The subjects voluntarily signed the informed consent; 3) The subjects plan to undergo colonoscopy. 

排除标准:

1)多发性息肉综合征者; 2)炎症性肠病病史; 3)确诊或高度怀疑肠道狭窄、堵塞、穿孔、梗阻或结直肠肿瘤; 4)结直肠手术史; 5)既往失败的结肠镜检查病史; 6)研究者评估不适合结肠镜检查的其他高危因素。 

Exclusion criteria:

1)The subjects with multiple polyposis syndrome; 2)The subjects have a history of inflammatory bowel disease; 3)The subjects have confirmed or highly suspected intestinal stricture, blockage, perforation, obstruction or colorectal tumor; 4)The subjects have a history of colorectal surgery; 5)The subjects have a history of failed colonoscopy; 6)Investigators assess other high-risk factors for subjects who are not suitable for colonoscopy. 

研究实施时间:

Study execute time:

From2021-09-01To 2023-12-31 

征募观察对象时间:

Recruiting time:

From2022-05-06To 2023-11-30 

干预措施:

Interventions:

组别:

NA

样本量:

968

Group:

NA

Sample size:

干预措施:

NA

干预措施代码:

Intervention:

NA

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

南方医科大学南方医院 

单位级别:

三级甲等医院 

Institution
hospital:

Nanfang Hospital, Southern Medical University  

Level of the institution:

Grade A class three hospital  

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广州医科大学附属第一医院 

单位级别:

三级甲等医院 

Institution
hospital:

The First Affiliated Hospital of Guangzhou Medical University  

Level of the institution:

Grade A class three hospital  

国家:

中国 

省(直辖市):

广东 

市(区县):

广州 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广东省中医院 

单位级别:

三级甲等医院 

Institution
hospital:

Guangdong Provincial Hospital of traditional Chinese medicine  

Level of the institution:

Grade A class three hospital  

国家:

中国 

省(直辖市):

广东 

市(区县):

东莞 

Country:

China 

Province:

Guangdong 

City:

Dongguan 

单位(医院):

东莞市人民医院 

单位级别:

三级甲等医院 

Institution
hospital:

Dongguan People's Hospital  

Level of the institution:

Grade A class three hospital  

测量指标:

Outcomes:

指标中文名:

腺瘤检出率

指标类型:

主要指标 

Outcome:

Adenomas detection rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

退镜超速百分比

指标类型:

主要指标 

Outcome:

the percentage of AI-identified retraction overspeed

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

滑镜回镜/ 滑镜未回镜次数比

指标类型:

主要指标 

Outcome:

the ratio of the number of successful retractions after slidoscope to the number of unreturned slidoscopes

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

实时肠道清洁度评分

指标类型:

主要指标 

Outcome:

Real-time bowel cleanliness score

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

晚期腺瘤检出率

指标类型:

次要指标 

Outcome:

Advanced adenoma detection rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

息肉检出率

指标类型:

次要指标 

Outcome:

Polyp detection rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

退镜时间

指标类型:

次要指标 

Outcome:

Take-off time

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

达盲率

指标类型:

次要指标 

Outcome:

Blinding rate

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

不良事件发生率

指标类型:

次要指标 

Outcome:

Incidence of adverse events

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

结直肠息肉病理标本

组织:

大肠

Sample Name:

Pathological specimens of colorectal polyps

Tissue:

Large intestine

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

征募研究对象情况:

Recruiting status:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 50 years
最大 Max age 75 years

性别:

男女均可

Gender:

Both

随机方法(请说明由何人用什么方法产生随机序列):

NA

Randomization Procedure (please state who generates the random number sequence and by what method):

NA

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

No

共享原始数据的方式(说明:请填入公开原始数据日期和方式,如采用网络平台,需填该网络平台名称和网址):

上传至医院科研科数据管理中心

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url):

Upload to data Management Center of Scientific Research Department of hospital

数据采集和管理(说明:数据采集和管理由两部分组成,一为病例记录表(Case Record Form, CRF),二为电子采集和管理系统(Electronic Data Capture, EDC),如ResMan即为一种基于互联网的EDC:

研究者根据受试者的原始观察记录、将数据及时、完整、正确、清晰地载入病例报告表。录入采用相应的数据库系统双人双机录入,之后对数据库进行两遍比对。电子数据文件分类保存,并有多个备份保存于不同磁盘或记录介质上,妥善保存,防止损坏。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture:

Based on the original observation records, researchers will completely write accurate data into case report forms in time. Input the data into corresponding database system by two special researchers with two computers respectively. After that, researchers compare two database twice and electronic data will be conserved and backup.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-04-26
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