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An observational cohort study to evaluate volume and severity of emergency general surgery admissions during the COVID-19 pandemic: is there a “lockdown” effect?
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注册号：

Registration number：

 ChiCTR2000034588 

最近更新日期：

Date of Last Refreshed on：

 2020-07-11 04:45:09 

注册时间：

Date of Registration：

 2020-07-11 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

An observational cohort study to evaluate volume and severity of emergency general surgery admissions during the COVID-19 pandemic: is there a “lockdown” effect?

Public title：

An observational cohort study to evaluate volume and severity of emergency general surgery admissions during the COVID-19 pandemic: is there a “lockdown” effect?

注册题目简写：

English Acronym：

COVID Severity

研究课题的正式科学名称：

An observational cohort study to evaluate volume and severity of emergency general surgery admissions during the COVID-19 pandemic: is there a “lockdown” effect?

Scientific title：

An observational cohort study to evaluate volume and severity of emergency general surgery admissions during the COVID-19 pandemic: is there a “lockdown” effect?

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：

Ross McLean 

研究负责人：

Kevin Etherson 

Applicant：

Ross McLean 

Study leader：

Kevin Etherson 

申请注册联系人电话：

Applicant telephone：

 +44 01642 383444

研究负责人电话：

Study leader's
telephone：

+44 01642 383444

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：

 rossmclean@nhs.net

研究负责人电子邮件：

Study leader's E-mail：

 kevin.etherson1@nhs.net

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 Colorectal Surgery, University Hospital of North Tees, Hardwick Road, Stockton-On-Tees, TS19 8PE, England, United Kingdom

研究负责人通讯地址：

Department of Colorectal Surgery, University Hospital of North Tees, Hardwick Road, Stockton-On-Tees, TS19 8PE, England, United Kingdom

Applicant address：

Department of Colorectal Surgery, University Hospital of North Tees, Hardwick Road, Stockton-On-Tees, TS19 8PE, England, United Kingdom

Study leader's address：

Department of Colorectal Surgery, University Hospital of North Tees, Hardwick Road, Stockton-On-Tees, TS19 8PE, England, United Kingdom

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：

联合王国英格兰北部蒂斯大学医院

Applicant's institution：

University Hospital of North Tees, England, United Kingdom

研究负责人所在单位：

联合王国英格兰北部蒂斯大学医院

Affiliation of the Leader：

University Hospital of North Tees, England, United Kingdom

是否获伦理委员会批准：

否

Approved by ethic committee：

No

伦理委员会批件文号：

Approved No. of ethic committee：

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：

Name of the ethic committee：

伦理委员会批准日期：

Date of approved by ethic committee：

 2013-08-26 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

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：

英格兰北部蒂斯大学医院

Primary sponsor：

University Hospital of North Tees

研究实施负责（组长）单位地址：

Department of Colorectal Surgery, University Hospital of North Tees, Hardwick Road, Stockton-On-Tees, TS19 8PE, England, United Kingdom

Primary sponsor's address：

Department of Colorectal Surgery, University Hospital of North Tees, Hardwick Road, Stockton-On-Tees, TS19 8PE, England, United Kingdom

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Nil

Source(s) of funding：

Nil

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：

The aim of this study was to investigate the impact of the UK Governments lockdown’ on the volume and severity of surgical admissions during the COVID-19 pandemic by evaluating changes in the aetiology of presentations, management approach and short-term outcomes for these patients. These observations may be utilised to inform future surgical practice during subsequent COVID-19 surges locally and may help to inform surgical decisions across the NHS.  

Objectives of Study：

The aim of this study was to investigate the impact of the UK Governments lockdown on the volume and severity of surgical admissions during the COVID-19 pandemic by evaluating changes in the aetiology of presentations, management approach and short-term outcomes for these patients. These observations may be utilised to inform future surgical practice during subsequent COVID-19 surges locally and may help to inform surgical decisions across the NHS.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

N/A 

纳入标准：

Inclusion criteria

排除标准：

Patients were excluded from the study if they were admitted and transferred to urological services, admitted for less than 24 hours, or under 16 years of age.

Exclusion criteria：

Patients were excluded from the study if they were admitted and transferred to urological services, admitted for less than 24 hours, or under 16 years of age.

研究实施时间：

Study execute time：

从 From 2020-02-16 00:00:00至 To 2020-05-15 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2020-02-16 00:00:00 至 To 2020-04-15 00:00:00

干预措施：

Interventions：

组别：

Case series

样本量：

 207

Group：

Case series

Sample size：

干预措施：

Post-lockdown

干预措施代码：

Intervention：

Post-lockdown

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 联合王国

省(直辖市)：

 蒂斯 

市(区县)：

  

Country：

United Kingdom

Province：

Teeside

City：

单位(医院)：

 英格兰北部蒂斯大学医院 

单位级别：

 大学医院 

Institution
hospital：

UHNT

Level of the institution：

University Hospital

测量指标：

Outcomes：

指标中文名：

病死率

指标类型：

主要指标

Outcome：

Death at 30 days

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

30 days mortality

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

N/A

组织：

Sample Name：

Nil

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 16 岁 years
最大 Max age 88 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 randomisation

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

No randomisation

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：

N/A

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）：

Not available as the local registry prohibits data sharing

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

Not available as the local registry prohibits data sharing

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：

Included patients had their anonymised data extracted from prospectively maintained electronic medical records, TrakCare? (Intersystems, Cambridge, MA, USA) using a standardised data collection form. These included demographic, clinical, laboratory, treatment, and surgical outcomes. Data were collected retrospectively for the historical cohort, and prospectively for the study cohort. These were entered and maintained within an encrypted spreadsheet on a secure Trust computer.

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

Included patients had their anonymised data extracted from prospectively maintained electronic medical records, TrakCare? (Intersystems, Cambridge, MA, USA) using a standardised data collection form. These included demographic, clinical, laboratory, treatment, and surgical outcomes. Data were collected retrospectively for the historical cohort, and prospectively for the study cohort. These were entered and maintained within an encrypted spreadsheet on a secure Trust computer.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2020-07-11 04:31:53
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