Today is 2019-12-13

A prospective study to investigate the effect of stepwise voltage escalation on treatment outcome in extracorporeal shockwave lithotripsy of renal calculi
download

注册号:

Registration number:

ChiCTR-TRC-14004710 

最近更新日期:

Date of Last Refreshed on:

2016-11-06 

注册时间:

Date of Registration:

2014-05-28 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

能量逐步遞增治療方案對體外碎石沖擊波治療腎結石成效的前瞻性研究 

Public title:

A prospective study to investigate the effect of stepwise voltage escalation on treatment outcome in extracorporeal shockwave lithotripsy of renal calculi 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

能量逐步遞增治療方案對體外碎石沖擊波治療腎結石成效的前瞻性研究 

Scientific title:

A prospective study to investigate the effect of stepwise voltage escalation on treatment outcome in extracorporeal shockwave lithotripsy of renal calculi 

研究课题代号(代码):

Study subject ID:

CRE-2014.096-T 

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:

CUHK_CCT00414 

申请注册联系人:

NG CHI FAI 

研究负责人:

NG CHI FAI 

Applicant:

NG CHI FAI 

Study leader:

NG CHI FAI 

申请注册联系人电话:

Applicant telephone:

+852 2632 1663 

研究负责人电话:

Study leader's telephone:

+852 2632 1663 

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:

ngcf@surgery.cuhk.edu.hk 

研究负责人电子邮件:

Study leader's E-mail:

ngcf@surgery.cuhk.edu.hk 

申请单位网址(自愿提供):

Applicant website(voluntary supply):

http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00414 

研究负责人网址(自愿提供):

Study leader's website(voluntary supply):

http://www.cct.cuhk.edu.hk/registry/publictrialrecord.aspx?trialid=CUHK_CCT00414 

申请注册联系人通讯地址:

4/F., LCW Clinical Science Building, Prince of Wales Hospital 

研究负责人通讯地址:

4/F., LCW Clinical Science Building, Prince of Wales Hospital 

Applicant address:

4/F., LCW Clinical Science Building, Prince of Wales Hospital 

Study leader's address:

4/F., LCW Clinical Science Building, Prince of Wales Hospital 

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:

The Chinese University of Hong Kong 

Applicant's institution:

The Chinese University of Hong Kong 

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:

NA 

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:

The Chinese University of Hong Kong 

Name of the ethic committee:

The Chinese University of Hong Kong 

伦理委员会批准日期:

Date of approved by ethic committee:

2014-03-31 

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:

The Chinese University of Hong Kong 

Primary sponsor:

The Chinese University of Hong Kong 

研究实施负责(组长)单位地址:

The Chinese University of Hong Kong 

Primary sponsor's address:

The Chinese University of Hong Kong 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中國

省(直辖市):

香港特別行政區

市(区县):

Country:

China

Province:

Hong Kong SAR

City:

单位(医院):

Chinese University of Hong Kong

具体地址:

Chinese University of Hong Kong

Institution
hospital:

Chinese University of Hong Kong

Address:

The Chinese University of Hong Kong

经费或物资来源:

The Chinese University of Hong Kong 

Source(s) of funding:

The Chinese University of Hong Kong 

研究疾病:

Renal stone 

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:

IV期临床试验 

Study phase:

研究目的:

能量逐步遞增治療方案對體外碎石沖擊波治療腎結石成效 

Objectives of Study:

To investigate the effect of stepwise voltage escalation on treatment outcome in extracorporeal shockwave lithotripsy of renal calculi. 

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 

Study design:

Parallel 

纳入标准:

Adult patient (aged >=18 years old). Solitary radio-opaque renal stones of size 5-15mm in maximal diameter as measured from plain radiography. Clinically decided for primary ESWL. 

Inclusion criteria

Adult patient (aged >=18 years old). Solitary radio-opaque renal stones of size 5-15mm in maximal diameter as measured from plain radiography. Clinically decided for primary ESWL. 

排除标准:

Stones associated with renal or ureteric anatomical abnormality. Patients with ureteric stent or nephrostomy tube inserted. History of cystine stone. Multiple stones in the same calyx. Currently taking alpha-blocker or calcium-channel blocker or systemic corticosteroids. History of allergy or any abnormal reaction with alfentanil. 

Exclusion criteria:

Stones associated with renal or ureteric anatomical abnormality. Patients with ureteric stent or nephrostomy tube inserted. History of cystine stone. Multiple stones in the same calyx. Currently taking alpha-blocker or calcium-channel blocker or systemic corticosteroids. History of allergy or any abnormal reaction with alfentanil. 

研究实施时间:

Study execute time:

From2014-06-15To  

干预措施:

Interventions:

组别:

Two groups

样本量:

220

Group:

Two groups

Sample size:

干预措施:

Stepwise voltage escalation in extracorporeal shockwave lithotripsy 30 - 60 minutes versus Standard fixed voltage with 30-60 minutes duration

干预措施代码:

Intervention:

Stepwise voltage escalation in extracorporeal shockwave lithotripsy 30 - 60 minutes versus Standard fixed voltage with 30-60 minutes duration

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中國 

省(直辖市):

香港特別行政區 

市(区县):

 

Country:

China 

Province:

Hong Kong SAR 

City:

 

单位(医院):

Chinese University of Hong Kong 

单位级别:

Chinese University of Hong Kong 

Institution
hospital:

Chinese University of Hong Kong  

Level of the institution:

Chinese University of Hong Kong 

测量指标:

Outcomes:

指标中文名:

Treatment successfulness at 12 week

指标类型:

主要指标 

Outcome:

Treatment successfulness at 12 week

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Degree of renal injury. Maximal pain score. Analge

指标类型:

次要指标 

Outcome:

Degree of renal injury. Maximal pain score. Analge

Type:

Secondary 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:

征募研究对象情况:

Recruiting status:

暂停或中断

Suspending

年龄范围:

Participant age:

最小 Min age 18 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):

RCT

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

RCT

盲法:

Blinding:

Double-blind

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

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):

Not stated

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

Not stated

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:

Not stated

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

Not stated

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2014-05-28
return list