Acute Care Surgery during novel coronavirus pneumonia (COVID-19) pandemic in Spain

注册号:

Registration number:

ChiCTR2000033052 

最近更新日期:

Date of Last Refreshed on:

2020-05-19 08:29:45 

注册时间:

Date of Registration:

2020-05-19 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

Acute Care Surgery during novel coronavirus pneumonia (COVID-19) pandemic in Spain

Public title:

Acute Care Surgery during novel coronavirus pneumonia (COVID-19) pandemic in Spain

注册题目简写:

English Acronym:

研究课题的正式科学名称:

Acute Care Surgery during COVID-19 pandemic in Spain: changes in the volume, causes and complications. A multicentre retrospective cohort study.

Scientific title:

Acute Care Surgery during COVID-19 pandemic in Spain: changes in the volume, causes and complications. A multicentre retrospective cohort 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:

Oscar Cano-Valderrama 

研究负责人:

Oscar Cano-Valderrama 

Applicant:

Oscar Cano-Valderrama 

Study leader:

Oscar Cano-Valderrama 

申请注册联系人电话:

Applicant telephone:

+34 9 13303184

研究负责人电话:

Study leader's
telephone:

+34 9 13303184

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:

oscarcanovalderrama@hotmail.com

研究负责人电子邮件:

Study leader's E-mail:

oscarcanovalderrama@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:

Hospital Clínico San Carlos, C/Profesor Martin Lagos SN, Madrid, Spain

研究负责人通讯地址:

Hospital Clínico San Carlos, C/Profesor Martin Lagos SN, Madrid, Spain

Applicant address:

Hospital Clínico San Carlos, C/Profesor Martin Lagos SN, Madrid, Spain

Study leader's address:

Hospital Clínico San Carlos, C/Profesor Martin Lagos SN, Madrid, Spain

申请注册联系人邮政编码:

Applicant postcode:

28040

研究负责人邮政编码:

Study leader's postcode:

28040

申请人所在单位:

西班牙圣.卡洛斯医院

Applicant's institution:

Hospital Clínico San Carlos

研究负责人所在单位:

西班牙圣.卡洛斯医院

Affiliation of the Leader:

Hospital Clínico San Carlos

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

20/282-E_COVID

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:

CEIC Hospital Clínico San Carlos

Name of the ethic committee:

CEIC Hospital Clínico San Carlos

伦理委员会批准日期:

Date of approved by ethic committee:

2020-04-03 00:00:00

伦理委员会联系人:

Mar García Arenillas

Contact Name of the ethic committee:

Mar García Arenillas

伦理委员会联系地址:

CEIC Hospital Clínico San Carlos, C/ Profesor Martin Lagos SN, 28040, Madrid, Spain

Contact Address of the ethic committee:

CEIC Hospital Clínico San Carlos, C/ Profesor Martin Lagos SN, 28040, Madrid, Spain

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:

Oscar Cano-Valderrama

Primary sponsor:

Oscar Cano-Valderrama

研究实施负责(组长)单位地址:

Hospital Clínico San Carlos, C/Profesor Martin Lagos SN, Madrid, Spain

Primary sponsor's address:

Hospital Clínico San Carlos, C/Profesor Martin Lagos SN, Madrid, Spain

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

西班牙

省(直辖市):

马德里

市(区县):

Country:

Spain

Province:

Madrid

City:

Madrid

单位(医院):

Hospital Clinico San Carlos

具体地址:

Hospital Clínico San Carlos, C/Profesor Martin Lagos SN, Madrid, Spain

Institution
hospital:

Hospital Clinico San Carlos

Address:

Hospital Clínico San Carlos, C/Profesor Martin Lagos SN, Madrid, Spain

经费或物资来源:

None

Source(s) of funding:

None

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:

队列研究 

Study design:

Cohort study 

研究目的:

Describe reduction in acute care surgery during COVID-19 pandemic  

Objectives of Study:

Describe reduction in acute care surgery during COVID-19 pandemic

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

None 

纳入标准:

Inclusion criteria

排除标准:

Minor surgery procedures

Exclusion criteria:

Minor surgery procedures

研究实施时间:

Study execute time:

From 2020-03-16 00:00:00 To 2020-05-11 00:00:00  

征募观察对象时间:

Recruiting time:

From 2020-03-16 00:00:00 To 2020-04-26 00:00:00

干预措施:

Interventions:

组别:

Control

样本量:

250

Group:

Control

Sample size:

干预措施:

Number of Acute Care Surgery

干预措施代码:

Intervention:

Number of Acute Care Surgery

Intervention code:

组别:

Pandemic

样本量:

150

Group:

Pandemic

Sample size:

干预措施:

Number of Acute Care Surgery

干预措施代码:

Intervention:

Number of Acute Care Surgery

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

西班牙

省(直辖市):

马德里 

市(区县):

 

Country:

Spain

Province:

Madrid

City:

Madrid

单位(医院):

Hospital Clinico San Carlos 

单位级别:

三级医院 

Institution
hospital:

Hospital Clinico San Carlos

Level of the institution:

Tertiary Hospital

测量指标:

Outcomes:

指标中文名:

Number of acute care surgeries per day

指标类型:

主要指标

Outcome:

Number of acute care surgeries per day

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:

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 18 years
最大 Max age 90 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):

None

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:

N/A

Blinding:

NONE

是否共享原始数据:

IPD sharing

是Yes

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:

Data were collected in an excel database

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

Data were collected in an excel database

数据与安全监察委员会:

Data and Safety Monitoring Committee:

无/No

注册人:

Name of Registration:

 2020-05-19 08:29:45