ChiCTR2600120437 版本V1.0 版本创建时间2026/03/13 17:23:47 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:

ChiCTR2600120437 

最近更新日期:

Date of Last Refreshed on:

2026-03-13 17:23:35 

注册时间:

Date of Registration:

2026-03-13 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

接受肠镜检查人群生活习惯的调查-多中心横断面研究

Public title:

Survey of Lifestyle Habits Among Individuals Undergoing Colonoscopy: A Multicentre Cross-Sectional Study

注册题目简写:

English Acronym:

研究课题的正式科学名称:

接受肠镜检查人群生活习惯的调查

Scientific title:

Survey on Lifestyle Habits of Individuals Undergoing 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:

黄昌伟 

研究负责人:

郭瑾陶 

Applicant:

Changwei Huang 

Study leader:

Jintao Guo 

申请注册联系人电话:

Applicant telephone:

+86 131 3081 7919

研究负责人电话:

Study leader's
telephone:

+86 189 4025 6654

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:

hcwdoctor@163.com

研究负责人电子邮件:

Study leader's E-mail:

guojt@sj-hospital.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:

辽宁省沈阳市和平区三好街36号

研究负责人通讯地址:

辽宁省沈阳市和平区三好街36号

Applicant address:

No. 36 Sanhao Street, Heping District,Shengyang,Liaoning

Study leader's address:

No. 36 Sanhao Street, Heping District,Shengyang,Liaoning

申请注册联系人邮政编码:

Applicant postcode:

110004

研究负责人邮政编码:

Study leader's postcode:

110004

申请人所在单位:

中国医科大学附属盛京医院

Applicant's institution:

Shengjing Hospital of China Medical University

研究负责人所在单位:

中国医科大学附属盛京医院

Affiliation of the Leader:

Shengjing Hospital of China Medical University

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

2024PS1029K

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:

中国医科大学附属盛京医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Shengjing Hospital Affiliated to China Medical University

伦理委员会批准日期:

Date of approved by ethic committee:

2024-04-29 00:00:00

伦理委员会联系人:

郭传骥

Contact Name of the ethic committee:

Chuanji Guo

伦理委员会联系地址:

辽宁省沈阳市和平区三好街36号

Contact Address of the ethic committee:

No. 36 Sanhao Street, Heping District,Shengyang,Liaoning

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 966 1510027

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:

中国医科大学附属盛京医院

Primary sponsor:

Shengjing Hospital Affiliated to China Medical University

研究实施负责(组长)单位地址:

辽宁省沈阳市和平区三好街36号

Primary sponsor's address:

No. 36 Sanhao Street, Heping District,Shengyang,Liaoning

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

辽宁省

市(区县):

沈阳

Country:

China

Province:

Liaoning

City:

Shenyang

单位(医院):

中国医科大学附属盛京医院

具体地址:

辽宁省沈阳市和平区三好街36号

Institution
hospital:

Shengjing Hospital Affiliated to China Medical University

Address:

No. 36 Sanhao Street, Heping District,Shengyang,Liaoning

经费或物资来源:

国家优秀青年医师 (V025/MV025);植树计划(M1595);国家卫生健康委能力建设和继续教育中心慢病管理研究课题(GWJJMB202510022196);

Source(s) of funding:

This study was supported by the National High-Level Talent Program (Outstanding Young Physicians) (V025/MV025);Chronic Disease Management Research Project of National Health Commission Capacity Building and Continuing Education Center(GWJJMB202510022196), The Tree Planting Program of Shengjing Hospital (M1595);

研究疾病:

肠息肉  

Target disease:

Colonic 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

研究设计:

横断面 

Study design:

Cross-sectional 

研究目的:

识别结直肠息肉的高危人群,并指导高危人群的生活习惯。  

Objectives of Study:

Identify high-risk populations for colorectal polyps and provide lifestyle guidance for those at elevated risk.

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.年龄为20-80岁 2.经过肠镜确诊为没有息肉和有息肉的 3.无炎症性肠病 4.没有特殊的饮食禁忌以及特殊饮食人群(运动员,孕妇等)

Inclusion criteria

1.Aged between 20 and 80 years; 2. Confirmed via colonoscopy to be either polyp-free or polyp-bearing; 3. No inflammatory bowel disease; 4. No specific dietary restrictions or special dietary requirements (e.g. athletes, pregnant women).

排除标准:

1.未签署知情同意 2.严重的内外科病变 3.有食物过敏史 4.黑色素瘤

Exclusion criteria:

1.Failure to sign informed consent; 2. Severe internal or surgical pathology; 3. History of food allergies; 4. Melanoma.

研究实施时间:

Study execute time:

From 2024-05-07 00:00:00 To 2030-02-01 00:00:00  

征募观察对象时间:

Recruiting time:

From 2024-05-07 00:00:00 To 2030-02-01 00:00:00

干预措施:

Interventions:

组别:

观察组

样本量:

1153

Group:

Observation group

Sample size:

干预措施:

不涉及

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):

福建 

市(区县):

 

Country:

China

Province:

Fujian

City:

单位(医院):

厦门大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of Xiamen University

Level of the institution:

Tertiary A

国家:

中国

省(直辖市):

广东 

市(区县):

 

Country:

China

Province:

Guangdong

City:

单位(医院):

遵义医科大学附属第五医院 

单位级别:

三甲 

Institution
hospital:

The Fifth Affiliated Hospital of Zunyi Medical University

Level of the institution:

Tertiary A

测量指标:

Outcomes:

指标中文名:

膳食等生活习惯

指标类型:

主要指标

Outcome:

Dietary habits and other lifestyle practices

Type:

Primary indicator

测量时间点:

测量方法:

问卷调查

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

不涉及

组织:

Sample Name:

N/A

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 20 years
最大 Max age 80 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):

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

NA

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results after
the Study Completed(upload file):

是否共享原始数据:

IPD sharing

是Yes

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):

试验全部完成,数据完成清洗后;http://www.medresman.org.cn/login.aspx

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

After all tests are completed and data cleaning is finished;:http://www.medresman.org.cn/login.aspx

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:

CRF

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

CRF

数据与安全监察委员会:

Data and Safety Monitoring Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2026-03-13 17:23:35