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The follow-up study of capsule endoscopy applied in digestive system disease in children in China
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注册号:

Registration number:

ChiCTR1900026558 

最近更新日期:

Date of Last Refreshed on:

2019-10-14 

注册时间:

Date of Registration:

2019-10-14 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

胶囊内镜在儿童消化系统疾病中应用的系列研究 

Public title:

The follow-up study of capsule endoscopy applied in digestive system disease in children in China 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

胶囊内镜在儿童消化系统疾病中应用的系列研究 

Scientific title:

The follow-up study of capsule endoscopy applied in digestive system disease in children in China 

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:

张顺先 

研究负责人:

耿岚岚 

Applicant:

Zhang Shunxian 

Study leader:

Geng Lanlan 

申请注册联系人电话:

Applicant telephone:

+86 15221364706 

研究负责人电话:

Study leader's telephone:

+86 13622237569 

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:

zhangshunxian110@163.com 

研究负责人电子邮件:

Study leader's E-mail:

13622237569@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:

广东省广州市天河区金穗路9号 

研究负责人通讯地址:

广东省广州市天河区金穗路9号 

Applicant address:

9 Jinsui Road, Tianhe District, Guangzhou, Guangdong, China 

Study leader's address:

9 Jinsui Road, Tianhe District, Guangzhou, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

510623 

研究负责人邮政编码:

Study leader's postcode:

510623 

申请人所在单位:

广州市妇女儿童医疗中心 

Applicant's institution:

Guangzhou Women and Children's Medical Center 

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:

40601 

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:

广州市妇女儿童医疗中心伦理学委员会 

Name of the ethic committee:

The ethic committee of Guangzhou Women and Children's Medical Center 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

李庆丰 

Contact Name of the ethic committee:

Li Qingfeng 

伦理委员会联系地址:

广东省广州市天河区金穗路9号 

Contact Address of the ethic committee:

9 Jinsui Road, Tianhe 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:

广州市妇女儿童医疗中心 

Primary sponsor:

Guangzhou Women and Children's Medical Center 

研究实施负责(组长)单位地址:

广东省广州市天河区金穗路9号 

Primary sponsor's address:

9 Jinsui Road, Tianhe District, Guangzhou, Guangdong, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

自筹资金 

Source(s) of funding:

Self-financing 

研究疾病:

各种消化道疾病 

Target disease:

Various digestive tract diseases 

研究疾病代码:

 

Target disease code:

 

研究类型:

病因学/相关因素研究 

Study type:

Cause/Relative factors study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

本研究尝试探索影响胶囊内镜应用的因素、揭示影响胶囊内镜在肠道中运行的时间,为制定精准的个体化诊疗方案提供科学参考、为肠道疾病的预防和控制提供科学参考。 

Objectives of Study:

This study aim to explore the factors that affect the application of capsule endoscopy, reveal the time that affects the operation of capsule endoscopy in the intestinal tract, and provide scientific reference for the formulation of precise individualized diagnosis and treatment programs, as well as for the prevention and control of intestinal diseases. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

于2016年1月1日到2025年12月31日期间,在广州市妇女儿童医疗中心门诊就诊和住院的患者中,进行胶囊内镜检查的<18岁的患者,且取得家长知情同意, 患儿配合治疗,签属知情同意书。 

Inclusion criteria

From 91-January-2016 to 31-December-2025, patients under the age of 18 who underwent capsule endoscopy in outpatient and inpatient clinics of Guangzhou Women's and Children's Medical Center received informed consent from their parents, cooperated with the treatment and signed an informed consent. 

排除标准:

(1)吞咽困难; (2)明显的消化道出血; (3)已知或怀疑消化道梗阻、畸形、瘘管; (4)既往胃肠道手术; (5)一般情况差,无法耐受检查; (6)体内有心脏起搏器等植入物; (7)检查录像和报告资料缺失; (8)未获得知情同意者; (9)正参加其它临床试验的患者; (10)研究人员认为其他原因不适合临床试验者。 

Exclusion criteria:

(1) Dysphagia; (2) Obvious gastrointestinal bleeding; (3) known or suspected gastrointestinal obstruction, malformation, fistula; (4) previous gastrointestinal surgery; (5) poor general condition, intolerable examination; (6) implants such as cardiac pacemaker in vivo; (7) lack of video and report data; (8) persons without informed consent; (9) are participating in other clinical trials. Patients; (10) Researchers believe that other reasons are not suitable for clinical trials. 

研究实施时间:

Study execute time:

From2016-01-01To 2025-12-31 

干预措施:

Interventions:

组别:

Case series

样本量:

1000

Group:

Case series

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

身高

指标类型:

主要指标 

Outcome:

height

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

体重

指标类型:

主要指标 

Outcome:

weight

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

发育

指标类型:

主要指标 

Outcome:

Development

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

营养水平

指标类型:

主要指标 

Outcome:

Nutrition level

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

胶囊运行时间

指标类型:

主要指标 

Outcome:

Capsule Running Time

Type:

Primary 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:

粪便

组织:

Sample Name:

stool

Tissue:

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

标本中文名:

血液

组织:

Sample Name:

blood

Tissue:

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:

正在进行

Recruiting

年龄范围:

Participant age:

最小 Min age 0 years
最大 Max age 18 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):

不进行随访分组

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

N/A

盲法:

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

整个研究结束后(2026年1月1日后),由研究者公布,以EXCEL文件的方式; ResMan

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

When the end of this study (After 01-Jan-2026), it was published by the researchers in the form of EXCEL documents; ResMan

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:

数据采集和管理采用excel软件

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

Excel software is used for data collection and management

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2019-10-14
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