今天是:2020-08-03 星期一

Iatrogenic Peripheral Nerve Injuries - Common Causes and Treatment: A Medical Records Based Study
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注册号:

Registration number:

ChiCTR2000032799 

最近更新日期:

Date of Last Refreshed on:

2020-05-11 

注册时间:

Date of Registration:

2020-05-11 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

Iatrogenic Peripheral Nerve Injuries - Common Causes and Treatment: A Medical Records Based Study 

Public title:

Iatrogenic Peripheral Nerve Injuries - Common Causes and Treatment: A Medical Records Based Study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

Iatrogenic Peripheral Nerve Injuries - Common Causes and Treatment: A Medical Records Based Study 

Scientific title:

Iatrogenic Peripheral Nerve Injuries - Common Causes and Treatment: A Medical Records Based Study 

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:

Tatsuya Hara 

研究负责人:

Tatsuya Hara 

Applicant:

Tatsuya Hara 

Study leader:

Tatsuya Hara 

申请注册联系人电话:

Applicant telephone:

+81 566 752111 

研究负责人电话:

Study leader's telephone:

+81 566 752111 

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:

hara17jp@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

hara17jp@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:

日本愛知県安城市安城町東広畔28番地 

研究负责人通讯地址:

日本愛知県安城市安城町東広畔28番地 

Applicant address:

28 Higashihirokute, Anjo-cho, Anjo-city 446-8602, Japan 

Study leader's address:

28 Higashihirokute, Anjo-cho, Anjo-city 446-8602, Japan 

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:

日本愛知県安城市安城町安城更生病院 

Applicant's institution:

Department of Orthopaedic Surgery, Anjo Kosei 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:

2019-049017872 

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:

Nagoya university hospital institutional review board 

Name of the ethic committee:

Nagoya university hospital institutional review board 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-04-01 

伦理委员会联系人:

小寺泰弘 

Contact Name of the ethic committee:

Yasuhiro KODERA 

伦理委员会联系地址:

65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan 

Contact Address of the ethic committee:

65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+81 52 7442957 

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:

日本愛知県安城市安城町安城更生病院 

Primary sponsor:

Department of Orthopaedic Surgery, Anjo Kosei Hospital 

研究实施负责(组长)单位地址:

日本愛知県安城市安城町東広畔28番地 

Primary sponsor's address:

28 Higashihirokute, Anjo-cho, Anjo-city 446-8602, Japan 

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

none 

Source(s) of funding:

none 

研究疾病:

医源性神经损伤 

Target disease:

Iatrogenic Peripheral Nerve Injuries  

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:

The objective of this study was to investigate the most common causes of iatrogenic nerve injuries surgically treated at our hospital, especially the surgical procedures with the highest risk of causing such injuries, so as to raise awareness among physicians of the risks and ensure that such cases can be readily identified and treated in a more timely manner than is generally the case today. 

Objectives of Study:

The objective of this study was to investigate the most common causes of iatrogenic nerve injuries surgically treated at our hospital, especially the surgical procedures with the highest risk of causing such injuries, so as to raise awareness among physicians of the risks and ensure that such cases can be readily identified and treated in a more timely manner than is generally the case today. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

Between January 2006 and December 2017, we selected the cases diagnosed with nerve injury or paralysis from our surgical patients database and excluded cases of spontaneous nerve palsy such as carpal tunnel syndrome. In total, 232 cases of "traumatic" nerve injury/paralysis were included. Then, we reviewed the medical records and identified 57 cases of iatrogenic nerve injuries in the 232 patients caused after undergoing primary surgical procedures.  

Inclusion criteria

Between January 2006 and December 2017, we selected the cases diagnosed with nerve injury or paralysis from our surgical patients database and excluded cases of spontaneous nerve palsy such as carpal tunnel syndrome. In total, 232 cases of "traumatic" nerve injury/paralysis were included. Then, we reviewed the medical records and identified 57 cases of iatrogenic nerve injuries in the 232 patients caused after undergoing primary surgical procedures.  

排除标准:

Three patients with malignant tumors were excluded because they underwent resection surgery including the peripheral nerve intentionally. Finally, 54 patients with iatrogenic nerve injuries were included in this study. 

Exclusion criteria:

Three patients with malignant tumors were excluded because they underwent resection surgery including the peripheral nerve intentionally. Finally, 54 patients with iatrogenic nerve injuries were included in this study. 

研究实施时间:

Study execute time:

From2020-04-01To 2021-03-31 

征募观察对象时间:

Recruiting time:

From2020-04-01To 2021-03-31 

干预措施:

Interventions:

组别:

Iatrogenic Peripheral Nerve Injuries

样本量:

54

Group:

Iatrogenic Peripheral Nerve Injuries

Sample size:

干预措施:

Nil

干预措施代码:

Intervention:

Nil

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

日本 

省(直辖市):

愛知県 

市(区县):

名古屋 

Country:

Japan 

Province:

Aichi 

City:

Nagoya 

单位(医院):

名古屋大学医院 

单位级别:

 

Institution
hospital:

Nagoya university hospital  

Level of the institution:

 

测量指标:

Outcomes:

指标中文名:

The cases of iatrogenic nerve injuries

指标类型:

主要指标 

Outcome:

The cases of iatrogenic nerve injuries

Type:

Primary indicator 

测量时间点:

确诊时

测量方法:

外科

Measure time point of outcome:

When diagnosed

Measure method:

Surgical findings

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

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 9 years
最大 Max age 80 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:

N/A

Blinding:

N/A

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):

PC rocked with password and also we can not identify the all patients.

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

PC rocked with password and also we can not identify the all patients.

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:

Department of Hand Surgery, Nagoya University Graduate School of Medicine, Japan

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

Department of Hand Surgery, Nagoya University Graduate School of Medicine, Japan

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-05-11
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