ChiCTR2000038865 版本V1.0 版本创建时间2020/10/07 22:52:58 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2000038865 

最近更新日期：

Date of Last Refreshed on：

 2020-10-07 22:51:39 

注册时间：

Date of Registration：

 2020-10-07 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Does elective orthopaedic surgery in the pandemic era increase the risk of developing COVID-19? A combined analysis of retrospective and prospective study at a national tertiary hospital in Jakarta, Indonesia

Public title：

Does elective orthopaedic surgery in the pandemic era increase the risk of developing COVID-19? A combined analysis of retrospective and prospective study at a national tertiary hospital in Jakarta, Indonesia

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Does elective orthopaedic surgery in the pandemic era increase the risk of developing COVID-19? A combined analysis of retrospective and prospective study at a national tertiary hospital in Jakarta, Indonesia

Scientific title：

Does elective orthopaedic surgery in the pandemic era increase the risk of developing COVID-19? A combined analysis of retrospective and prospective study at a national tertiary hospital in Jakarta, Indonesia

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：

I Wayan Arya Mahendra Karda 

研究负责人：

Achmad Fauzi Kamal 

Applicant：

I Wayan Arya Mahendra Karda 

Study leader：

Achmad Fauzi Kamal 

申请注册联系人电话：

Applicant telephone：

 +62 87788408163

研究负责人电话：

Study leader's
telephone：

+6281511450189

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：

 arya961mahendra@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

 fauzikamal@yahoo.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：

Department of Orthopaedic and Traumatology, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo Hospital Jl. Diponegoro no. 71, Jakarta, Indonesia

研究负责人通讯地址：

Department of Orthopaedic and Traumatology, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo Hospital Jl. Diponegoro no. 71, Jakarta, Indonesia

Applicant address：

Department of Orthopaedic and Traumatology, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo Hospital Jl. Diponegoro no. 71, Jakarta, Indonesia

Study leader's address：

Department of Orthopaedic and Traumatology, Faculty of Medicine Universitas Indonesia, Dr. Cipto Mangunkusumo Hospital Jl. Diponegoro no. 71, Jakarta 10430

申请注册联系人邮政编码：

Applicant postcode：

 10430

研究负责人邮政编码：

Study leader's postcode：

 10430

申请人所在单位：

印度尼西亚雅加达印度尼西亚大学医学院附属Cipto Mangunkusumo医院

Applicant's institution：

Department of Orthopaedics and Traumatology, Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia

研究负责人所在单位：

印度尼西亚雅加达印度尼西亚大学医学院附属Cipto Mangunkusumo医院

Affiliation of the Leader：

Department of Orthopaedics and Traumatology, Faculty of Medicine, Universitas Indonesia, Cipto Mangunkusumo Hospital, Jakarta, Indonesia

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：

 KET-809/UN2.F1/ETIK/PPM.00.02/2020, protocol no. 20-05-0558

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：

The Ethics Committee of the Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital

Name of the ethic committee：

The Ethics Committee of the Faculty of Medicine, University of Indonesia - Cipto Mangunkusumo Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2020-07-27 00:00:00

伦理委员会联系人：

Prof. Dr. Rita Sita Sitorus, Ph.D., Sp.M(K)

Contact Name of the ethic committee：

Prof. Dr. Rita Sita Sitorus, Ph.D., Sp.M(K)

伦理委员会联系地址：

Gedung Fakultas Kedokteran UI JI. Salemba Raya No.6, Jakarta 10430

Contact Address of the ethic committee：

Gedung Fakultas Kedokteran UI JI. Salemba Raya No.6, Jakarta 10430

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：

None

Primary sponsor：

None

研究实施负责（组长）单位地址：

None

Primary sponsor's address：

None

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

The authors report no external source of funding during the writing of this article.

Source(s) of funding：

The authors report no external source of funding during the writing of this article.

研究疾病：

新型冠状病毒肺炎(COVID-19)  

Target disease：

Novel Coronavirus Pneumonia (COVID-19)

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

研究设计：

连续入组 

Study design：

Sequential 

研究目的：

This study aims to investigate whether elective orthopaedic surgery will increase the risk of developing COVID-19.  

Objectives of Study：

This study aims to investigate whether elective orthopaedic surgery will increase the risk of developing COVID-19.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Subjects were patients who underwent elective orthopaedic surgeries at our institution from April to May 2020

Inclusion criteria

Subjects were patients who underwent elective orthopaedic surgeries at our institution from April to May 2020

排除标准：

Those who were previously infected with COVID-19 from polymerase chain reaction (PCR) reverse transcriptase (RT) examination obtained via nasopharynx and oropharynx swab, as well as those who were reluctant to participate, were excluded from the study.

Exclusion criteria：

Those who were previously infected with COVID-19 from polymerase chain reaction (PCR) reverse transcriptase (RT) examination obtained via nasopharynx and oropharynx swab, as well as those who were reluctant to participate, were excluded from the study.

研究实施时间：

Study execute time：

从 From 2020-07-01 00:00:00至 To 2020-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-06-01 00:00:00 至 To 2020-07-01 00:00:00

干预措施：

Interventions：

组别：

Case series

样本量：

 35

Group：

Case series

Sample size：

干预措施：

Nil

干预措施代码：

Intervention：

None

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 印度尼西亚

省(直辖市)：

 雅加达 

市(区县)：

 Central Jakarta 

Country：

Indonesia

Province：

Jakarta

City：

Central Jakarta

单位(医院)：

 Cipto Mangunkusumo National Central Hospital 

单位级别：

 National Hospital 

Institution
hospital：

Cipto Mangunkusumo National Central Hospital

Level of the institution：

National Hospital

测量指标：

Outcomes：

指标中文名：

COVID-19

指标类型：

主要指标

Outcome：

COVID-19

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

length of stay

指标类型：

次要指标

Outcome：

length of stay

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

duration of surgery

指标类型：

次要指标

Outcome：

duration of surgery

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

comorbid

指标类型：

次要指标

Outcome：

comorbid

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：

标本中文名：

Nil

组织：

Sample Name：

None

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 2 岁 years
最大 Max age 67 岁 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）：

No randomization was performed

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

No randomization was performed

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

No blinding was performed

Blinding：

No blinding was performed

是否共享原始数据：

IPD sharing

否No

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）：

By request

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

By request

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：

By request

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

By request

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2020-10-07 22:51:39