今天是:2019-01-16 星期三

双能量CT单能量技术对成人腕管的解剖学研究
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注册号:

Registration number:

ChiCTR1900020653 

最近更新日期:

Date of Last Refreshed on:

2019-01-11 

注册时间:

Date of Registration:

2019-01-11 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

双能量CT单能量技术对成人腕管的解剖学研究 

Public title:

Anatomic study of the carpal tunnel in adults using monoenergetic reconstruction of dual-energy computed tomography 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

双能量CT单能量技术对成人腕管的解剖学研究 

Scientific title:

Anatomic study of the carpal tunnel in adults using monoenergetic reconstruction of dual-energy computed tomography 

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:

彭飞 

研究负责人:

赵衡 

Applicant:

Fei Peng 

Study leader:

Heng Zhao 

申请注册联系人电话:

Applicant telephone:

+86 17607476826 

研究负责人电话:

Study leader's telephone:

+86 18974735009 

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:

690943880@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

angerh9@126.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:

中国湖南省衡阳市常胜西路28号 

研究负责人通讯地址:

中国湖南省衡阳市常胜西路28号 

Applicant address:

28 Changsheng Road West, Hengyang, Hu'nan, China 

Study leader's address:

28 Changsheng Road West, Hengyang, Hu'nan, 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:

南华大学附属第一医院 

Applicant's institution:

The First Affiliated Hospital of University of South 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:

USC20151206001 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

南华大学医学伦理委员会 

Name of the ethic committee:

Medical Ethic Committee of USC 

伦理委员会批准日期:

Date of approved by ethic committee:

2015-12-06 

伦理委员会联系人:

南华大学医学伦理委员会工作室 

Contact Name of the ethic committee:

The Office of Medical Ethic Committee of USC 

伦理委员会联系地址:

中国湖南省衡阳市常胜西路28号 

Contact Address of the ethic committee:

28 Changsheng Road West, Hengyang, Hu'nan, 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:

南华大学附属第一医院 

Primary sponsor:

The First Affiliated Hospital of University of South China 

研究实施负责(组长)单位地址:

湖南省衡阳市船山路69号 

Primary sponsor's address:

69 Chuanshan Road, Hengyang, Hu'nan, 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):

湖南

市(区县):

衡阳

Country:

China

Province:

Hu'nan

City:

Hengyang

单位(医院):

南华大学附属第一医院

具体地址:

湖南省衡阳市船山路69号

Institution
hospital:

The First Affiliated Hospital of University of South China

Address:

69 Chuanshan Road, Hengyang, Hu'nan, China

国家:

中国

省(直辖市):

辽宁

市(区县):

沈阳

Country:

China

Province:

Liaoning

City:

Shenyang

单位(医院):

中国医科大学附属盛京医院

具体地址:

中国辽宁省沈阳市和平区三好街36号

Institution
hospital:

Shengjing Hospital of China Medical University

Address:

36 Sanhao Street, Heping District, Shenyang, Liaoning, China

经费或物资来源:

国家重点研发计划、国家自然科学基金、湖南省自然科学基金 

Source(s) of funding:

the National Key Research and Development Program of China, the National Natural Science Foundation of China, Hu'nan Provincial Natural Science Foundation of China 

研究疾病:

成人腕管 

Target disease:

carpal tunnel of adult 

研究疾病代码:

 

Target disease code:

 

研究类型:

相关因素研究 

Study type:

Relative factors research 

研究所处阶段:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

本研究的目的是应用双能量CT的单能量技术对成人腕管进行影像解剖学研究,寻找最佳显示腕管结构的能量keV值,了解腕管内软组织结构的解剖学特征,并探讨腕管骨性结构与软组织结构在解剖学上的相关性。 

Objectives of Study:

To seek optimal keV settings for imaging the carpal tunnel in adults by monoenergetic dual-energy computed tomography (DECT) and to describe the anatomic characteristics of and correlation between the bony and soft tissue structures of the carpal tunnel. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续病例 

Study design:

Case series 

纳入标准:

1、对侧腕关节外伤的年轻成人患者;2、外伤侧具有可疑骨结构损伤或骨结构病变;3、对非外伤侧腕关节行CT扫描做对比 

Inclusion criteria

we chose patients with acute single wrist trauma and suspicion of bony injury on initial CT scan. DECT was performed on the contralateral (uninjured) wrist for comparison 

排除标准:

正中神经变异为两束 图像质量差 

Exclusion criteria:

bifid median nerve; poor-quality images 

研究实施时间:

Study execute time:

From2016-01-01To 2017-02-28 

干预措施:

Interventions:

组别:

Case series

样本量:

24

Group:

Case series

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):

湖南 

市(区县):

衡阳 

Country:

China 

Province:

Hu'nan 

City:

Hengyang 

单位(医院):

南华大学附属第一医院 

单位级别:

三甲 

Institution
hospital:

The First Affiliated Hospital of University of South China  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

腕管的软组织与骨性结构

指标类型:

主要指标 

Outcome:

bony and soft tissue structures of the carpal tunnel

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:

未取

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:

结束

Completed

年龄范围:

Participant age:

最小 Min age 23 years
最大 Max age 28 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):

N/A

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

N/A

盲法:

N/A

Blinding:

N/A

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):

2019年6月30日前,上传中国临床试验注册中心网站,网址:http://www.chictr.org.cn

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

Before June 30, 2019, upload the website of China Clinical Trials Registry Website: http://www.chictr.org.cn

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:

所有数据采用SPSS 17.0汇总,相关的电子记录存入专门的硬盘,所有的相关数据由研究组负责人保管。

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

All data were transcribed by using SPSS 17.0, and the relevant electronic records were stored in a dedicated hard disk. All relevant data were kept by the research team leader.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-01-11
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