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负压吸引微创经皮肾镜碎石术一期治疗结石性脓肾:前瞻性随机研究
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注册号:

Registration number:

ChiCTR-IOR-16008490 

最近更新日期:

Date of Last Refreshed on:

2016-05-18 

注册时间:

Date of Registration:

2016-05-18 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

负压吸引微创经皮肾镜碎石术一期治疗结石性脓肾:前瞻性随机研究 

Public title:

Minimally Invasive Percutaneous Nephrolithotomy (MPCNL) with the Aid of a Patented Suctioning Sheath for calculus pyonephrosisy: a Prospective Randomized Study  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

负压吸引微创经皮肾镜碎石术一期治疗结石性脓肾的对比研究 

Scientific title:

A Comparative Study of Minimally Invasive Percutaneous Nephrolithotomy (MPCNL) with the Aid of a Patented Suctioning Sheath in the Treatment of Renal Calculus Complicated by Pyonephrosis by One Surgery 

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:

邓小林 

研究负责人:

宋乐明 

Applicant:

Xiaolin Deng 

Study leader:

Leming Song 

申请注册联系人电话:

Applicant telephone:

+86 18770738881 

研究负责人电话:

Study leader's telephone:

+86 13507078922 

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:

dengxiaolin@hsc.pku.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

slm631@sina.cn 

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:

江西省赣州市红旗大道17号 

研究负责人通讯地址:

江西省赣州市红旗大道17号 

Applicant address:

17 Hongqi Avenue, Ganzhou, Jjiangxi, China 

Study leader's address:

17 Hongqi Avenue, Ganzhou, Jjiangxi, 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:

赣州市人民医院 

Applicant's institution:

Ganzhou People's Hospital  

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:

2011-03-11 

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:

赣州市人民医院伦理审查委员会 

Name of the ethic committee:

Ganzhou People's Hospital Ethical Commitment  

伦理委员会批准日期:

Date of approved by ethic committee:

 

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:

赣州市人民医院 

Primary sponsor:

Ganzhou People's Hospital 

研究实施负责(组长)单位地址:

江西省赣州市红旗大道17号 

Primary sponsor's address:

17 Hongqi Avenue Ganzhou ganzhou jiangxi, 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):

江西

市(区县):

Country:

China

Province:

jiangxi

City:

单位(医院):

赣州市人民医院

具体地址:

江西省赣州市红旗大道17号

Institution
hospital:

Ganzhou People's Hospital

Address:

17 Hongqi Avenue Ganzhou ganzhou jiangxi

经费或物资来源:

江西省科技厅 

Source(s) of funding:

Science and Technology Department of Jiangxi Province 

研究疾病:

肾结石 

Target disease:

renal stone 

研究疾病代码:

 

Target disease code:

 

研究类型:

干预性研究 

Study type:

Interventional study 

研究所处阶段:

其它 

Study phase:

Other 

研究目的:

探讨微造瘘经皮肾镜负压吸引碎石清石鞘治疗结石性脓肾的价值 

Objectives of Study:

To explore the value of a patented suctioning sheath assisted minimally invasive percutaneous nephrolithotomy lithotripsy (MPCNL) in the treatment of calculus pyonephrosis. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照试验 

Study design:

Randomized parallel controlled trial 

纳入标准:

年龄在18-85岁的结石性脓肾 

Inclusion criteria

Subject of Renal Calculus Complicated by Pyonephrosis is 18-85 yrs of age 

排除标准:

(1)严重心脑血管疾病患者,(2)患者依从性差不能进行随访,(3)患有严重血液系统疾病或者不能暂停抗凝和抗血小板治疗3-5天者。 

Exclusion criteria:

(1)Patients who had serious cardiovascular or cerebrovascular disease; (2)Poor compliance; (3)Subject has a disorder of the coagulation cascade system or is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (3-5 days). 

研究实施时间:

Study execute time:

From2011-03-01To 2013-04-30 

干预措施:

Interventions:

组别:

A

样本量:

91

Group:

A

Sample size:

干预措施:

负压吸引MPCNL

干预措施代码:

Intervention:

MPCNL with the Aid of a Patented Suctioning Sheath

Intervention code:

组别:

B

样本量:

91

Group:

B

Sample size:

干预措施:

无负压吸引MPCNL

干预措施代码:

Intervention:

MPCNL with peel-away sheath

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

测量指标:

Outcomes:

指标中文名:

结石清除率

指标类型:

主要指标 

Outcome:

stone free rate

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

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:

出血量

指标类型:

主要指标 

Outcome:

bleeding amount

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

并发症发生率

指标类型:

主要指标 

Outcome:

Incidence of complication

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:

结石

组织:

Sample Name:

stone

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 85 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):

随机数字表

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

random number table

盲法:

Blinding:

试验完成后的统计结果(上传文件):

点击下载

Calculated Results after
the Study Completed(upload file):

download

原始数据公开时间:

The time of sharing IPD:

即时公开/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):

通过ResMan查询

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

via 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:

用ResMan共享原始数据

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

Public access will be allowed via ResMan.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2016-05-18
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