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Comparison of Effect of different Procedure in Treating Pectus Excavatum
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注册号:

Registration number:

ChiCTR2100047696 

最近更新日期:

Date of Last Refreshed on:

2021-06-22 

注册时间:

Date of Registration:

2021-06-22 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

请与我们联系上传伦理批件。 不同手术方式治疗漏斗胸的疗效分析 

Public title:

Comparison of Effect of different Procedure in Treating Pectus Excavatum 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

不同手术方式治疗漏斗胸的疗效分析 

Scientific title:

Comparison of Effect of different Procedure in Treating Pectus Excavatum 

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:

陈辉 

研究负责人:

李文超 

Applicant:

Hui Chen 

Study leader:

Wenchao Li 

申请注册联系人电话:

Applicant telephone:

18810365133 

研究负责人电话:

Study leader's telephone:

15801302889 

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:

chenhui301@126.com 

研究负责人电子邮件:

Study leader's E-mail:

liwenchao301@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:

北京市东城区南门仓5号 

研究负责人通讯地址:

北京市东城区南门仓5号 

Applicant address:

5 Nanmencang Road, Dongcheng District, Beijing 100700, China.  

Study leader's address:

5 Nanmencang Road, Dongcheng District, Beijing 100700, 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:

解放军总医院第七医学中心儿科医学部 

Applicant's institution:

the Faculty of Pediatrics, the Seventh Medical Center of PLA General Hospital,Beijing 100700, China.  

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:

2021-40 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

解放军总医院第七医学中心伦理委员会 

Name of the ethic committee:

The ethics Committee of the Seventh Medical Center of PLA General Hospital 

伦理委员会批准日期:

Date of approved by ethic committee:

 

伦理委员会联系人:

杨蓉娅 

Contact Name of the ethic committee:

Rongya Yang 

伦理委员会联系地址:

北京市东城区南门仓5号 

Contact Address of the ethic committee:

5 Nanmencang Road, Dongcheng District, Beijing 100700, 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:

解放军总医院第七医学中心儿科医学部 

Primary sponsor:

the Faculty of Pediatrics, the Seventh Medical Center of PLA General Hospital,Beijing 100700, China.  

研究实施负责(组长)单位地址:

北京市东城区南门仓5号 

Primary sponsor's address:

5 Nanmencang Road, Dongcheng District, Beijing 100700, 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):

东城区

Country:

China

Province:

Beijing

City:

Dongcheng District

单位(医院):

解放军总医院第七医学中心

具体地址:

北京市东城区南门仓5号

Institution
hospital:

the Seventh Medical Center of PLA General Hospital

Address:

5 Nanmencang Road, Dongcheng District, Beijing 100700, China.

经费或物资来源:

自筹 

Source(s) of funding:

Self-financing 

研究疾病:

漏斗胸 

Target disease:

Pectus Excavatum 

研究疾病代码:

 

Target disease code:

 

研究类型:

预后研究 

Study type:

Prognosis study 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

对比不同手术方式治疗先天性漏斗胸的效果,以提高漏斗胸的手术疗效。 

Objectives of Study:

To compare the effect of different procedures in order to improve the curative effect of pectus excavatum. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

病例对照研究 

Study design:

Case-Control study 

纳入标准:

3岁以上儿童,由外观明确诊断为漏斗胸,胸廓两侧对称。 

Inclusion criteria

Over 3 years old,the patient was clearly diagnosed as ectus excavatum,and the thoracic cage is symmetrical on both sides 

排除标准:

3岁以下儿童,胸廓两侧不对称。 

Exclusion criteria:

Under the age of three,and the thoracic cage is not symmetrical on both sides, 

研究实施时间:

Study execute time:

From2021-07-01To 2022-07-01 

征募观察对象时间:

Recruiting time:

From2021-07-01To 2022-07-01 

干预措施:

Interventions:

组别:

病例组

样本量:

15

Group:

case group

Sample size:

干预措施:

干预措施代码:

Intervention:

no

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):

东城区 

Country:

China 

Province:

Beijing 

City:

Dongcheng District 

单位(医院):

解放军总医院第七医学中心儿科医学部 

单位级别:

解放军总医院第七医学中心儿科医学部 

Institution
hospital:

the Seventh Medical Center of PLA General Hospital  

Level of the institution:

5 Nanmencang Road, Dongcheng District, Beijing 100700, China. 

测量指标:

Outcomes:

指标中文名:

手术时间

指标类型:

主要指标 

Outcome:

operation time

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术中出血量

指标类型:

主要指标 

Outcome:

blood loss

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后住院时间

指标类型:

主要指标 

Outcome:

duration of postoperative hospitalization

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

术后并发症发生率

指标类型:

主要指标 

Outcome:

postoperative complications

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

矫治效果优良率

指标类型:

主要指标 

Outcome:

excellent and good rate of correct outcomes

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:

no

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 3 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):

非随机方法

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

Non-random method

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

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):

原始数据公开日期:2022.12.01;数据上传至百度网盘

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

Original data publication date: 2022.12.01; data uploaded to Baidu Netdisk

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:

1.病例资料来源于电子病历系统;2.分析结果保存于word或excel文件。

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

1.The case data comes from the electronic medical record system; 2. The analysis results are saved in word or excel files.

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2021-06-22
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