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中国人群胃镜检查耐受性预测模型研究
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注册号:

Registration number:

ChiCTR1800020236 

最近更新日期:

Date of Last Refreshed on:

2018-12-20 

注册时间:

Date of Registration:

2018-12-20 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

中国人群胃镜检查耐受性预测模型研究 

Public title:

Prediction of Tolerance in Chinese Patients Undergoing Esophagogastroduodenoscopy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

中国人群胃镜检查耐受性预测模型研究 

Scientific title:

Prediction of Tolerance in Chinese Patients Undergoing Esophagogastroduodenoscopy 

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:

袁金秋 

研究负责人:

杨曼 

Applicant:

YUAN Jin-Qiu 

Study leader:

Yang Man 

申请注册联系人电话:

Applicant telephone:

+86 13169902651 

研究负责人电话:

Study leader's telephone:

+86 15818709496 

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:

yuanjinqiu06@gmail.com 

研究负责人电子邮件:

Study leader's E-mail:

man442114238@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:

广东省东莞市长安镇陶然豪园5栋 

研究负责人通讯地址:

广东省深圳市宝安区松岗街道沙江路2号 

Applicant address:

5th Building, Taoranhaoyuan, Changan, Dongguan, Guangdong, China 

Study leader's address:

2 Shajiang Road, Songgang Street, Bao'an District, Shanzhen, 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:

中山大学第七附属医院 

Applicant's institution:

The First Affiliated Hospital of Sun Yat-sen 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:

SGPHE201704G 

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:

松岗人民医院伦理委员会 

Name of the ethic committee:

The Ethics Committee of Songgang People’s Hospital  

伦理委员会批准日期:

Date of approved by ethic committee:

2018-03-04 

伦理委员会联系人:

王威 

Contact Name of the ethic committee:

WANG Wei 

伦理委员会联系地址:

广东省深圳市宝安区沙江路松岗人民医院 

Contact Address of the ethic committee:

Songgang People's Hospital, 2 Shajiang Road, Songgang Street, Bao'an District, Shanzhen, 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:

雷平光 

Primary sponsor:

LEI Ping-Guang 

研究实施负责(组长)单位地址:

广东省深圳市宝安区沙江路松岗人民医院 

Primary sponsor's address:

2 Shajiang Road, Songgang Street, Bao'an District, Shanzhen, 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):

Country:

China

Province:

Guangdong

City:

单位(医院):

松岗人民医院

具体地址:

广东省深圳市宝安区沙江路松岗人民医院

Institution
hospital:

Songgang People's Hospital

Address:

2 Shajiang Road, Songgang Street, Bao'an District, Shanzhen, Guangdong, China

经费或物资来源:

深圳市宝安区重点专科基金 

Source(s) of funding:

Funding of the Key Department of Baoan, Shenzhen 

研究疾病:

上消化道内镜检查 

Target disease:

Esophagogastroduodenoscopy 

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:

为了给患者以及内镜医师提供个体化地决策辅助工具,本研究拟通过在中国人群中收集诊断性上消化道内镜检查患者的临床特征资料,以及内镜检查过程中患者的不适感、耐受度及对操作的满意程度等资料,建立患者对内镜检查不适感以及耐受程度的预测模型。 

Objectives of Study:

We undertake the present study to develop and validate a model to predict the discomfort, tolerance, panic/fear, and willingness to repeat unsedated endoscopy in the future, in Chinese patients undergoing unsedated EGD. 

药物成份或治疗方案详述:

不适用 

Description for medicine or protocol of treatment in detail:

Not applicable 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

1)年龄18周岁或以上; 2)符合上消化道内镜检查适应症,拟行上消化道诊断性内镜检查; 3)首次接受上消化道内镜检查; 4)患者意识清楚认知完全,可独立完成相关研究问卷调查; 5)同意参加本研究并签署知情同意。 

Inclusion criteria

1) aged 18 years or over; 2) scheduled to undergo routine, diagnostic non-advanced EGD, for any reasons; 3) undergoing EGD for the first time; 4) could finish the survey independently; 5) agree to participant in this study and sign the consent form. 

排除标准:

1)有恶心、呕吐等妊娠反应的怀孕期妇女; 2)确诊患有食管狭窄、上消化道畸形等; 3)既往接受过口腔、咽喉、食管等手术; 4)其它某些特殊患者经试验者判断不适合纳入本研究的患者。 

Exclusion criteria:

1) pregnant women with nausea or vomiting; 2) patients with self-reported esophageal stenosis, upper gastrointestinal tract anomalies; 3) with a history of upper gastrointestinal surgery; 4) other patients who are not appropriate for EGD. 

研究实施时间:

Study execute time:

From2018-02-01To 2019-07-31 

征募观察对象时间:

Recruiting time:

From2019-01-01To 2019-03-31 

干预措施:

Interventions:

组别:

Case series

样本量:

1500

Group:

Case series

Sample size:

干预措施:

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):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

松岗人民医院 

单位级别:

2甲 

Institution
hospital:

Songgang People's Hospital  

Level of the institution:

Second A Hospital 

测量指标:

Outcomes:

指标中文名:

不适度

指标类型:

主要指标 

Outcome:

Discomfort

Type:

Primary indicator 

测量时间点:

内镜检查术后10-20分钟

测量方法:

视觉模拟评分

Measure time point of outcome:

10 to 20 minutes after endoscopy

Measure method:

visual analogue scale

指标中文名:

耐受度

指标类型:

主要指标 

Outcome:

Tolerance

Type:

Primary indicator 

测量时间点:

内镜检查术后10-20分钟

测量方法:

视觉模拟评分

Measure time point of outcome:

10 to 20 minutes after endoscopy

Measure method:

visual analogue scale

指标中文名:

恐慌/焦虑度

指标类型:

次要指标 

Outcome:

panic/fear

Type:

Secondary indicator 

测量时间点:

内镜检查术后10-20分钟

测量方法:

视觉模拟评分

Measure time point of outcome:

10 to 20 minutes after endoscopy

Measure method:

visual analogue scale

指标中文名:

再次接受相同检查意愿

指标类型:

次要指标 

Outcome:

Willingness to repeat unsedated endoscopy in the future

Type:

Secondary indicator 

测量时间点:

内镜检查术后10-20分钟

测量方法:

问卷

Measure time point of outcome:

10 to 20 minutes after endoscopy

Measure method:

Questionnaire

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

na

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

不适于预测模型研究

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

Not applicable for predictive modeling study

盲法:

不适于预测模型研究

Blinding:

Not applicable for predictive modeling study

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):

有兴趣的研究人员可通过联系研究主管人(杨曼:man442114238@163.com ),提交研究计划,通过邮件等方式获得研究数据

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

Data from this study are available upon request for research purposes. Data requests should be sent to the PI (Dr. Yang Man:man442114238@163.com). Anonymous data will be provided after evaluation of t

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:

病例记录表, WJX Online.

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

Case Record Form, WJX Online

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:

 2018-12-20
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