ChiCTR2600116355 版本V1.0 版本创建时间2026/01/08 15:11:36 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2600116355 

最近更新日期：

Date of Last Refreshed on：

2026-01-08 15:11:30 

注册时间：

Date of Registration：

2026-01-08 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

结肠镜检查肠道准备质量的智能自评体系构建与验证研究

Public title：

Construction and verification of intelligent self-evaluation system for the quality of intestinal preparation for colonoscopy

注册题目简写：

English Acronym：

研究课题的正式科学名称：

结肠镜检查肠道准备质量的智能自评体系构建与验证研究

Scientific title：

Construction and verification of intelligent self-evaluation system for the quality of intestinal preparation for colonoscopy

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：

黄茜 

研究负责人：

黄茜 

Applicant：

Huang Xi 

Study leader：

Huang Xi 

申请注册联系人电话：

Applicant telephone：

+86 137 6797 2188

研究负责人电话：

Study leader's telephone：

+86 791 8869 4287

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：

13767972188@163.com

研究负责人电子邮件：

Study leader's E-mail：

13767972188@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：

江西省南昌市东湖区永外正街17号

研究负责人通讯地址：

南昌市东湖区永外正街17号

Applicant address：

No.17 Yongwaizheng Street, donghu district, Nanchang City, Jiangxi Province

Study leader's address：

17# Yongwai Zhengjie, Nanchang City, Jiangxi Province, 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：

南昌大学第一附属医院

Applicant's institution：

the first affiliated hospital of nanchang university

研究负责人所在单位：

南昌大学第一附属医院

Affiliation of the Leader：

The first affiliated hostipal of nanchang university

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

HIT[2025]临伦审第920号

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：

南昌大学第一附属医院医学伦理委员会（IIT分会）

Name of the ethic committee：

The First Affiliated Hospital of Nanchang University Institutional Review Board (IIT)

伦理委员会批准日期：

Date of approved by ethic committee：

2025-12-24 00:00:00

伦理委员会联系人：

舒展

Contact Name of the ethic committee：

Shu Zhan

伦理委员会联系地址：

南昌市东湖区永外正街17号

Contact Address of the ethic committee：

17# Yongwai Zhengjie, Nanchang City, Jiangxi Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 791 8869 2201

伦理委员会联系人邮箱：

Contact email of the ethic committee：

493831410@qq.com

研究实施负责（组长）单位：

南昌大学第一附属医院

Primary sponsor：

The first affiliated hostipal of nanchang university

研究实施负责（组长）单位地址：

南昌市东湖区永外正街17号

Primary sponsor's address：

17# Yongwai Zhengjie, Nanchang City, Jiangxi Province, 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)：

江西省

市(区县)：

Country：

China

Province：

Jiangxi

City：

单位(医院)：

南昌大学第一附属医院

具体地址：

南昌市东湖区永外正街17号

Institution
hospital：

The first affiliated hostipal of nanchang university

Address：

17# Yongwai Zhengjie, Nanchang City, Jiangxi Province, China

经费或物资来源：

南昌大学第一附属医院临床研究培育项目

Source(s) of funding：

Clinical research and cultivation project of the First Affiliated Hospital of Nanchang University

Target disease：

Colorectal cancer

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

研究设计：

队列研究 

Study design：

Cohort study 

研究目的：

本研究旨在编制结肠镜检查患者肠道准备自评量表，通过自评量表形式验证患者根据末次直肠流出物的评估与真实肠道准备情况的一致性，通过统计学方法确定自评量表的“优秀、一般、差”等多分类cut-off值，用于评估肠道准备质量；构建基于该量表及多分类标准值的AI辅助评估模型，让患者在肠道准备过程中上传直肠流出物照片进行动态化评估，并生成相应的指导方案,优化结肠镜检查前肠道准备质量的评价。  

Objectives of Study：

The purpose of this study is to compile the self-rating scale of intestinal preparation for colonoscopy patients, verify the consistency between the patient's assessment based on the last rectal effluent and the real intestinal preparation through the form of the self-rating scale, and determine the multi-classification cut-off values of the self-rating scale such as "excellent, average and poor" through statistical methods to evaluate the quality of intestinal preparation; An AI-assisted evaluation model based on the scale and multi-classification standard values was constructed, so that patients could upload photos of rectal exudates for dynamic evaluation in the process of intestinal preparation, and generate corresponding guidance programs to optimize the evaluation of intestinal preparation quality before colonoscopy.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.年龄18-75周岁，性别不限； 2.拟行择期结肠镜检查的门诊或住院患者； 3.意识清楚，无严重认知或精神障碍，能够理解并配合完成量表填写及图像采集流程； 4.自愿参与本研究，并签署伦理委员会批准的书面知情同意书；

Inclusion criteria

1. Age 18-75 years old, regardless of gender;
2. Outpatients or inpatients who plan to undergo elective colonoscopy;
3. Clear consciousness, no serious cognitive or mental disorders, able to understand and cooperate with the completion of the scale filling and image acquisition process;
4. Voluntarily participate in this study and sign the written informed consent approved by the Ethics Committee;

排除标准：

1.严重认知障碍、精神疾病或无法配合者； 2.合并严重心肺肝肾功能障碍，不能耐受肠道准备或肠镜者； 3.使用智能设备困难者； 4.未完成肠镜检查或肠道狭窄、肿瘤阻塞影响评分者； 5.研究过程退出或关键数据缺失者。

Exclusion criteria：

1. Serious cognitive impairment, mental illness or inability to cooperate;
2. Patients with severe heart, lung, liver and kidney dysfunction who cannot tolerate intestinal preparation or colonoscopy;
3. Those who have difficulty in using smart devices;
4. Those who have not completed colonoscopy or whose scores are affected by intestinal stenosis or tumor obstruction;
5. The research process is withdrawn or key data is missing.

研究实施时间：

Study execute time：

从 From 2026-01-01 00:00:00至 To 2028-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2026-01-08 00:00:00 至 To 2027-12-31 00:00:00  

干预措施：

Interventions：

组别：

观察组

样本量：

950

Group：

Observation group

Sample size：

干预措施：

无

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江西省 

市(区县)：

  

Country：

China 

Province：

Jiangxi 

City：

 

单位(医院)：

南昌大学第一附属医院 

单位级别：

三级甲等 

Institution
hospital：

The first affiliated hostipal of nanchang university

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 陕西省 

市(区县)：

  

Country：

China 

Province：

Shaanxi 

City：

 

单位(医院)：

西安市红会医院 

单位级别：

三级甲等 

Institution
hospital：

Xi'an Honghui Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

  

Country：

China 

Province：

Guangdong 

City：

 

单位(医院)：

南方医科大学深圳医院 

单位级别：

三级甲等 

Institution
hospital：

Shenzhen Hospital of Southern Medical Unversity

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 湖南省 

市(区县)：

  

Country：

China 

Province：

Hunan 

City：

 

单位(医院)：

中南大学湘雅医院 

单位级别：

三级甲等 

Institution
hospital：

Xiangya Hospital Central South University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

AI模型的综合性能

指标类型：

次要指标

Outcome：

Comprehensive performance of AI model

Type：

Secondary indicator

测量时间点：

智能自评体系构建后

测量方法：

使用外部数据集进行模型测试的准确率及ROC曲线下面积(AUC)，检测肠道准备不足的灵敏度为90%。

Measure time point of outcome：

After the construction of intelligent self-evaluation system

Measure method：

The accuracy of model test and the area under ROC curve (AUC) using external data sets, and the sensitivity of detecting intestinal hypoplasia are 90%.

指标中文名：

自评量表的评估准确性

指标类型：

主要指标

Outcome：

Evaluation accuracy of self-rating scale

Type：

Primary indicator

测量时间点：

结肠镜检查

测量方法：

以波士顿肠道准备量表（BBPS）评分作为金标准，通过受试者工作特征曲线下面积（AUC）评估自评量表区分“肠道准备合格”与“不合格”的判别能力

Measure time point of outcome：

Colonoscopy

Measure method：

Taking the score of the Boston Bowel Preparation Scale (BBPS) as the gold standard, the ability to distinguish between "qualified bowel preparation" and "unqualified bowel preparation" was evaluated by the receiver operating characteristic curve area (AUC).

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

NA

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

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 18 岁 years
最大 Max age 75 岁 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）：

无

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

None

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

无

Blinding：

None

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）：

不共享

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

Not sharing

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：

本研究采用电子化数据采集方式（EDC），建立专用研究数据库，由项目组统一创建病例信息表、量表录入表及影像数据管理模块。所有原始数据（自评量表、BBPS评分、临床资料及图像文件）由研究人员现场核实后录入数据库，并采用双人独立录入与交叉核对方式，减少录入差错。图像资料由系统按编号自动存储并脱敏管理，不包含患者身份信息。 在数据录入阶段实时设置逻辑校验规则，对缺失数据、异常值进行提示与核查；数据清洗完成后由数据管理员进行数据库锁定，确保后续数据不可随意更改。所有研究数据按伦理与隐私要求加密储存，定期进行云备份及本地镜像备份，防止丢失。研究结束后数据归档并保存至少5年，便于验证与追溯，期间仅授权研究团队使用。

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

In this study, electronic data acquisition (EDC) was used to establish a special research database, and the project team created a case information table, a scale entry table and an image data management module. All the original data (self-rating scale, BBPS score, clinical data and image files) were recorded in the database after on-site verification by researchers, and the two-person independent entry and cross-checking were adopted to reduce the input errors. Image data are automatically stored and desensitized by the system according to the number, and do not contain patient identity information.In the data entry stage, logical verification rules are set in real time to prompt and check missing data and abnormal values; After the data cleaning is completed, the data administrator locks the database to ensure that the subsequent data cannot be changed at will. All research data are encrypted and stored according to ethical and privacy requirements, and cloud backup and local mirror backup are carried out regularly to prevent loss. After the research, the data should be archived and kept for at least 5 years, which is convenient for verification and traceability. During this period, only the research team is authorized to use it.In this study, electronic data acquisition (EDC) was used to establish a special research database, and the project team created a case information table, a scale entry table and an image data management module. All the original data (self-rating scale, BBPS score, clinical data and image files) were recorded in the database after on-site verification by researchers, and the two-person independent entry and cross-checking were adopted to reduce the input errors. Image data are automatically stored and desensitized by the system according to the number, and do not contain patient identity information.In the data entry stage, logical verification rules are set in real time to prompt and check missing data and abnormal values; After the data cleaning is completed, the data administrator locks the database to ensure that the subsequent data cannot be changed at will. All research data are encrypted and stored according to ethical and privacy requirements, and cloud backup and local mirror backup are carried out regularly to prevent loss. After the research, the data should be archived and kept for at least 5 years, which is convenient for verification and traceability. During this period, only the research team is authorized to use it.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-01-08 15:11:30