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A Nested Case–Control Study on the Risk of Subcapsular Renal Hematoma After Extracorporeal Shock Wave Lithotripsy
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注册号:

Registration number:

ChiCTR2200055454 

最近更新日期:

Date of Last Refreshed on:

2022-01-10 

注册时间:

Date of Registration:

2022-01-10 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

请于伦理委员会批准后才开始征募参试者,并与我们联系上传伦理批件。 体外冲击波碎石术后肾包膜下血肿风险的巢式病例对照研究 

Public title:

A Nested Case–Control Study on the Risk of Subcapsular Renal Hematoma After Extracorporeal Shock Wave Lithotripsy 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

体外冲击波碎石术后肾包膜下血肿风险的巢式病例对照研究 

Scientific title:

A Nested Case–Control Study on the Risk of Subcapsular Renal Hematoma After Extracorporeal Shock Wave Lithotripsy 

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:

李云鹏 

研究负责人:

吕建林 

Applicant:

Yunpeng Li 

Study leader:

Jianlin Lv 

申请注册联系人电话:

Applicant telephone:

18251816469 

研究负责人电话:

Study leader's telephone:

13770631917 

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:

928214141@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

ljlxx01@163.com 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

Department of Urology, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing Me 

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:

Hushan Road, Jiangning District, Nanjing 21000, China 

研究负责人通讯地址:

Hushan Road, Jiangning District, Nanjing 21000, China 

Applicant address:

Hushan Road, Jiangning District, Nanjing 21000, China 

Study leader's address:

Hushan Road, Jiangning District, Nanjing 21000, China 

申请注册联系人邮政编码:

Applicant postcode:

210000 

研究负责人邮政编码:

Study leader's postcode:

210000 

申请人所在单位:

Department of Urology, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing Medical University 

Applicant's institution:

Department of Urology, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing Medical University 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

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:

 

Name of the ethic committee:

 

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:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

Department of Urology, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing Medical University 

Primary sponsor:

None 

研究实施负责(组长)单位地址:

Hushan Road, Jiangning District, Nanjing 21000, China 

Primary sponsor's address:

None 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

China

市(区县):

Nanjing

Country:

china

Province:

China

City:

Nanjing

单位(医院):

Department of Urology, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing Medical University

具体地址:

Hushan Road, Jiangning District, Nanjing 21000, China

Institution
hospital:

nanjing

Address:

Hushan Road, Jiangning District, Nanjing 21000, China

经费或物资来源:

None 

Source(s) of funding:

None 

研究疾病:

输尿管结石 

Target disease:

ureter stone 

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:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

体外冲击波碎石术(ESWL)后肾包膜下血肿(SRH)发生率低,但仍有可能发生。本研究旨在探讨ESWL术后SRH的可能危险因素。 

Objectives of Study:

The probability of subcapsular renal hematoma (SRH)after extracorporeal shock wave lithotripsy(ESWL) is low, but it may still occur.We designed this study to investigate the possible risk factors for SRH after ESWL. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

析因分组(即根据危险因素或暴露因素分组) 

Study design:

Factorial 

纳入标准:

ESWL后出现严重背痛及血尿,CT提示肾包膜下血肿,且无外伤史。 

Inclusion criteria

Severe back pain and hematuria after ESWL with CT suggestive of subcapsular renal hematoma and no history of trauma.  

排除标准:

伴有外伤史,无肾包膜下血肿 

Exclusion criteria:

There was a history of trauma and no subcapsular hematoma 

研究实施时间:

Study execute time:

From2022-01-05To  

征募观察对象时间:

Recruiting time:

From2022-06-05To  

干预措施:

Interventions:

组别:

2

样本量:

50

Group:

2

Sample size:

干预措施:

干预措施代码:

Intervention:

none

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

China 

市(区县):

Nanjing 

Country:

china 

Province:

China 

City:

Nanjing 

单位(医院):

Department of Urology, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing Medical University 

单位级别:

Department of Urology, The Affiliated Jiangning Hospital of Nanjing Medical University, Nanjing Medical University 

Institution
hospital:

nanjing  

Level of the institution:

Province 

测量指标:

Outcomes:

指标中文名:

比值比

指标类型:

主要指标 

Outcome:

OR

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 65 years

性别:

男性

Gender:

Male

随机方法(请说明由何人用什么方法产生随机序列):

No

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

No

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):

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

no

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:

数据来自南京医科大学附属江宁医院。

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

Data were collected from the Affiliated Jiangning Hospital of Nanjing Medical University.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-01-10
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