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阳性咳嗽-反流相关性对胃食管反流病相关性咳嗽手术疗效的预测性
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注册号:

Registration number:

ChiCTR1800016444 

最近更新日期:

Date of Last Refreshed on:

2018-06-01 

注册时间:

Date of Registration:

2018-06-01 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

阳性咳嗽-反流相关性对胃食管反流病相关性咳嗽手术疗效的预测性 

Public title:

the predictive effect of positive cough-reflux association on outcome of antireflux surgery of GERD related cough  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

反流和症状相关性对胃食管反流病相关性咳嗽手术疗效的预测性 

Scientific title:

the predictive effect of symptom-reflux association on outcome of antireflux surgery of GERD related cough  

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:

陈冬 

研究负责人:

陈冬 

Applicant:

Dong CHEN 

Study leader:

Dong CHEN 

申请注册联系人电话:

Applicant telephone:

+86 18701180920 

研究负责人电话:

Study leader's telephone:

+86 18701180920 

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:

739353406@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

739353406@qq.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:

北京市西城区新街口外大街16号 

研究负责人通讯地址:

北京市西城区新街口外大街16号 

Applicant address:

16 Xinjiekouwai Street, Xicheng District, Beijing, China 

Study leader's address:

16 Xinjiekouwai Street, Xicheng District, Beijing, 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:

中国人民解放军火箭军总医院 

Applicant's institution:

The General Hospital of the PLA Rocket Force 

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:

KY2018021 

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:

中国人民解放军第二炮兵总医院伦理委员会 

Name of the ethic committee:

Ethics committee of the general hospital of the PLA rocket force 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-05-21 

伦理委员会联系人:

姜卫剑 

Contact Name of the ethic committee:

Weijian JIANG 

伦理委员会联系地址:

北京市西城区新街口外大街16号 

Contact Address of the ethic committee:

16 Xinjiekouwai Street, Xicheng District, Beijing, 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:

中国人民解放军火箭军总医院 

Primary sponsor:

The General Hospital of the PLA Rocket Force 

研究实施负责(组长)单位地址:

北京市西城区新街口外大街16号 

Primary sponsor's address:

16 Xinjiekouwai Street, Xicheng District, Beijing, 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):

北京

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国人民解放军火箭军总医院

具体地址:

北京市西城区新街口外大街16号

Institution
hospital:

The General Hospital of the PLA Rocket Force

Address:

16 Xinjiekouwai Street, Xicheng District, Beijing

经费或物资来源:

无 

Source(s) of funding:

None 

研究疾病:

胃食管反流病 

Target disease:

gastroesophageal reflux disease 

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:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

研究反流和症状相关性对胃食管反流病相关性咳嗽手术疗效的预测性,用于指导临床实践,提高食管外症状的手术疗效。 

Objectives of Study:

To study the predictive effect of symptom-reflux association on outcome of antireflux surgery of GERD related cough,so as to guide clinical practice,and improve outcome of antireflux surgery of extraesophageal symptom. 

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:

① 符合胃食管反流病相关性咳嗽的诊断标准; a)符合胃食管反流病的诊断(胃镜下食管炎、食管阻抗联合pH监测阳性、症状+PPI治疗有效); b)慢性咳嗽持续超过8周; ②完成了食管24h多通道腔内阻抗PH监测; ③患者知情同意。 

Inclusion criteria

1. Meet the diagnostic criteria of GERD related cough; (1) meet the diagnostic criteria of GERD(endoscopic esophagitis or positive 24h MII-pH mornitoring or symptom response to PPI threapy); (2) chronic cough lasting longer than 8 weeks; 2. complete 24h MII-pH mornitoring; 3. informed consent. 

排除标准:

①存在目前吸烟、近期上呼吸道感染、使用ACEI类药物等; ②上消化道手术史; ③恶性肿瘤 

Exclusion criteria:

1. current smoker/recently upper respiratory infection/ACEI use; 2. history of upper gastrointestinal surgery; 3. malignancy. 

研究实施时间:

Study execute time:

From2018-06-01To  

征募观察对象时间:

Recruiting time:

From2018-06-01To  

干预措施:

Interventions:

组别:

咳嗽-反流相关性阳性组

样本量:

72

Group:

positive cough-reflux association

Sample size:

干预措施:

干预措施代码:

Intervention:

None

Intervention code:

组别:

咳嗽-反流相关性阴性组

样本量:

72

Group:

Negative relationship cough-reflux association

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:

国家:

中国 

省(直辖市):

北京 

市(区县):

 

Country:

China 

Province:

Beijing 

City:

 

单位(医院):

中国人民解放军火箭军总医院 

单位级别:

三级甲等 

Institution
hospital:

The General Hospital of the PLA Rocket Force  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

咳嗽治愈流率

指标类型:

主要指标 

Outcome:

cure rate of cough

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:

组织:

Sample Name:

None

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 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):

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

None

盲法:

Blinding:

是否共享原始数据:

IPD sharing

否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):

2019-12-30, 相关SCI发表

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

Before 30 december 2019, related SCI articles published will share the data.

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:

采用病例记录与Excel表格记录的形式。

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

The data will be recorded with case reports and Excel table.

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:

 2018-06-01
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