今天是:2017-06-24 星期六

一项针对输尿管内支架拔除使用器械疗效评估的随机对照研究:输尿管硬镜VS膀胱软镜
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注册号:

Registration number:

ChiCTR-IOR-17010986 

最近更新日期:

Date of Last Refreshed on:

2017-03-27 

注册时间:

Date of Registration:

2017-03-27 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

一项针对输尿管内支架拔除使用器械疗效评估的随机对照研究:输尿管硬镜VS膀胱软镜 

Public title:

A prospective and randomized comparison of rigid ureteroscopic to flexible cystoscopic retrieval of ureteral stents 

研究课题的正式科学名称:

一项针对输尿管内支架拔除使用器械疗效评估的随机对照研究:输尿管硬镜VS膀胱软镜 

Scientific title:

A prospective and randomized comparison of rigid ureteroscopic to flexible cystoscopic retrieval of ureteral stents 

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:

赖德辉 

研究负责人:

赖德辉 

Applicant:

Dehui Lai 

Study leader:

Dehui Lai 

申请注册联系人电话:

Applicant telephone:

+86 13570508863 

研究负责人电话:

Study leader's telephone:

+86 18922186874 

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:

dehuilai@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

dehuilai@hotmail.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:

广州市黄埔区港湾路621号广州医科大学附属第五医院泌尿外科 

研究负责人通讯地址:

广州医科大学附属第五医院泌尿外科 

Applicant address:

621 Gangwan Road, Huangpu District, Guangzhou, Guangdong, China 

Study leader's address:

621 Gangwan Road, Huangpu District, Guangzhou, Guangdong, 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:

广州医科大学附属第五医院 

Applicant's institution:

5th Affiliated Hospital, Guangzhou Medical University 

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:

2012GWEB01-17 

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:

广州医科大学附属第五医院 

Name of the ethic committee:

5th Affiliated Hospital, Guangzhou Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

研究实施负责(组长)单位:

广州医科大学附属第五医院 

Primary sponsor:

5th Affiliated Hospital,Guangzhou Medical University 

研究实施负责(组长)单位地址:

广州市黄埔区港湾路621号 

Primary sponsor's address:

621 Gangwan Road, Huangpu District, Guangzhou, Guangdong, 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):

广东省

市(区县):

Country:

China

Province:

Guangdong

City:

单位(医院):

广州医科大学附属第五医院

具体地址:

广州市黄埔区港湾路621号广州医科大学附属第五医院泌尿外科

Institution
hospital:

5th Affiliated Hospital,Guangzhou Medical University

Address:

621 Gangwan Road, Huangpu District, Guangzhou, Guangdong, China

国家:

中国

省(直辖市):

广东省

市(区县):

Country:

China

Province:

Guangdong

City:

单位(医院):

中信惠州医院

具体地址:

广东省惠州市仲恺大道346号中信惠州医院

Institution
hospital:

Citic Huizhou Hospital

Address:

346 Zhongkai Avenue, Huizhou, Guangdong, China

经费或物资来源:

自筹 

Source(s) of funding:

self-collected 

研究疾病:

输尿管内支架管置取出术 

Target disease:

ureteral stent retrival 

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:

We compared rigid ureteroscopic to flexible cystoscopic retrieval of ureteral stents in a prospective and randomized clinical trial.  

Objectives of Study:

We compared rigid ureteroscopic to flexible cystoscopic retrieval of ureteral stents in a prospective and randomized clinical trial.  

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:

from July 2012 to July 2013, 300 adult patients with unilateral 6 Fr. double-J ureteral stents were accrued for the study.  

Inclusion criteria

from July 2012 to July 2013, 300 adult patients with unilateral 6 Fr. double-J ureteral stents were accrued for the study.  

排除标准:

Patients with residual stones, chronic renal failure, diabetes, solitary kidney, history of sepsis, febrile infection, or migrated stents were excluded. 

Exclusion criteria:

Patients with residual stones, chronic renal failure, diabetes, solitary kidney, history of sepsis, febrile infection, or migrated stents were excluded. 

研究实施时间:

Study execute time:

From2012-03-01To 2014-03-04 

干预措施:

Interventions:

组别:

rigid ureteroscopic group

样本量:

150

Group:

A

Sample size:

干预措施:

rigid ureteroscope

干预措施代码:

Intervention:

rigid ureteroscopic retrieval of ureteral stents

Intervention code:

组别:

flexible cystoscope

样本量:

150

Group:

flexible cystoscop

Sample size:

干预措施:

flexible cystoscopic retrieval of ureteral stents

干预措施代码:

Intervention:

flexible cystoscopic retrieval of ureteral stents

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

China 

省(直辖市):

Guangdong 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

5th Affiliated Hospital,Guangzhou Medical University 

单位级别:

tertiary 

Institution
hospital:

5th Affiliated Hospital,Guangzhou Medical University  

Level of the institution:

teriary 

国家:

China 

省(直辖市):

Guangdong 

市(区县):

 

Country:

China 

Province:

Guangdong 

City:

 

单位(医院):

Citic Huizhou Hospital 

单位级别:

tertiary 

Institution
hospital:

Citic Huizhou Hospital  

Level of the institution:

tertiary 

测量指标:

Outcomes:

指标中文名:

operative time

指标类型:

主要指标 

Outcome:

operative 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:

perioperative and postoperative pain

指标类型:

主要指标 

Outcome:

perioperative and postoperative pain

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

postoperative hematuria

指标类型:

主要指标 

Outcome:

postoperative hematuria

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

irritable bladder symptoms

指标类型:

主要指标 

Outcome:

irritable bladder symptoms

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:

不需要

组织:

Sample Name:

NA

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:

暂停或中断

Suspending

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):

Using the random number table by staff

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

Using the random number table staff

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:

试验完成后6个月内公开/Within six months after the trial complete

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提供原始数据查询

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

IPD will be public accessable via ResMan

数据保存和管理(说明:数据包括原始记录、病例记录表等数据,采用什么数据库):

EXCEL

The repository and management of the data(Please specify what repository will be used for management of the metadata):

EXCEL

注册人:

Name of Registration:

 2017-03-27
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