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Communication and management of incidental pathology in 1,214 consecutive appendicectomies: a cohort study
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注册号:

Registration number:

ChiCTR1900024372 

最近更新日期:

Date of Last Refreshed on:

2020-01-08 

注册时间:

Date of Registration:

2019-07-07 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

Communication and management of incidental pathology in 1,214 consecutive appendicectomies: a cohort study 

Public title:

Communication and management of incidental pathology in 1,214 consecutive appendicectomies: a cohort study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

Communication and management of incidental pathology in 1,214 consecutive appendicectomies: a cohort study 

Scientific title:

Communication and management of incidental pathology in 1,214 consecutive appendicectomies: a 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:

Ned Kinnear 

研究负责人:

Ned Kinnear 

Applicant:

Ned Kinnear 

Study leader:

Ned Kinnear 

申请注册联系人电话:

Applicant telephone:

+61383456666 

研究负责人电话:

Study leader's telephone:

+61383456666 

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:

ned.kinnear@adelaide.edu.au 

研究负责人电子邮件:

Study leader's E-mail:

ned.kinnear@adelaide.edu.au 

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:

160 Gordon St, Footscray 3011 VIC Australia 

研究负责人通讯地址:

160 Gordon St, Footscray 3011 VIC Australia 

Applicant address:

160 Gordon St, Footscray 3011 VIC Australia 

Study leader's address:

160 Gordon St, Footscray 3011 VIC Australia 

申请注册联系人邮政编码:

Applicant postcode:

3011 

研究负责人邮政编码:

Study leader's postcode:

3011 

申请人所在单位:

澳大利亚维多利亚省西部卫生 

Applicant's institution:

Western Health, VIC Australia 

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:

Q20180805 

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:

Central Adelaide Local Health Network Human Research Ethics Committee 

Name of the ethic committee:

Central Adelaide Local Health Network Human Research Ethics Committee 

伦理委员会批准日期:

Date of approved by ethic committee:

2019-03-15 

伦理委员会联系人:

Jan-Louise Durrand 

Contact Name of the ethic committee:

Jan-Louise Durrand 

伦理委员会联系地址:

Royal Adelaide Hospital Clinical Trial Centre Wayfinder 3D460.02 Level 3 Port Road ADELAIDE SA 5000 

Contact Address of the ethic committee:

Royal Adelaide Hospital Clinical Trial Centre Wayfinder 3D460.02 Level 3 Port Road ADELAIDE SA 5000 

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:

jan-louise.durand@sa.gov.au 

研究实施负责(组长)单位:

Dr Ned Kinnear 

Primary sponsor:

Dr Ned Kinnear 

研究实施负责(组长)单位地址:

160 Gordon St, Footscray 3011 VIC Australia 

Primary sponsor's address:

160 Gordon St, Footscray 3011 VIC Australia 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

澳大利亚

省(直辖市):

南澳大利亚

市(区县):

Adelaide

Country:

Australia

Province:

South Australia

City:

Adelaide

单位(医院):

University of Adelaide

具体地址:

North Terrace

Institution
hospital:

University of Adelaide

Address:

North Terrace

经费或物资来源:

N Kinnear received funding in relation to this work from the University of Adelaide, the Hospital Research Foundation and the National Health and Medical Research Council. 

Source(s) of funding:

N Kinnear received funding in relation to this work from the University of Adelaide, the Hospital Research Foundation and the National Health and Medical Research Council. 

研究疾病:

Important incidental pathology on appendicectomy speciment.  

Target disease:

Important incidental pathology on appendicectomy speciment.  

研究疾病代码:

Nil 

Target disease code:

Nil 

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:

Important incidental pathology requiring further action is commonly found during appendicectomy, macro- and microscopically. This study aims to assess whether the introduction of an acute surgical unit impacted the disclosure and management of patients with important incidental findings during appendicectomy. 

Objectives of Study:

Important incidental pathology requiring further action is commonly found during appendicectomy, macro- and microscopically. This study aims to assess whether the introduction of an acute surgical unit impacted the disclosure and management of patients with important incidental findings during appendicectomy. 

药物成份或治疗方案详述:

This study compares appendicectomy patients in the 2.5 years before and after introduction of an acute surgical unit (ASU) model. Traditionally, general surgery departments allocated their surgeons and trainees to elective duties. Emergency general surgery (EGS) patients were managed ad-hoc, either after long delays, or through the interruption of elective patients. An alternative ASU model was introduced at our hospital on 01/08/2012. Compared with the Traditional model of managing emergency general surgical referrals, the ASU provides an on-site registrar, on-call consultant and ready emergency theatre, all available 24 hours a day.  

Description for medicine or protocol of treatment in detail:

This study compares appendicectomy patients in the 2.5 years before and after introduction of an acute surgical unit (ASU) model. Traditionally, general surgery departments allocated their surgeons and trainees to elective duties. Emergency general surgery (EGS) patients were managed ad-hoc, either after long delays, or through the interruption of elective patients. An alternative ASU model was introduced at our hospital on 01/08/2012. Compared with the Traditional model of managing emergency general surgical referrals, the ASU provides an on-site registrar, on-call consultant and ready emergency theatre, all available 24 hours a day.  

研究设计:

连续入组 

Study design:

Sequential 

纳入标准:

Patients undergoing appendicectomy at our institution between 01/02/2010 and 31/01/2015. 

Inclusion criteria

Patients undergoing appendicectomy at our institution between 01/02/2010 and 31/01/2015. 

排除标准:

Patients with incomplete data. 

Exclusion criteria:

Patients with incomplete data. 

研究实施时间:

Study execute time:

From2010-02-01To 2015-07-31 

征募观察对象时间:

Recruiting time:

From2010-02-01To 2015-07-31 

干预措施:

Interventions:

组别:

Appendicectomy patients

样本量:

1200

Group:

Appendicectomy patients

Sample size:

干预措施:

Introduction of an acute surgical unit

干预措施代码:

Intervention:

Introduction of an acute surgical unit

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

澳大利亚 

省(直辖市):

南澳大利亚 

市(区县):

阿德莱德 

Country:

Australia 

Province:

South Australia 

City:

Adelaide 

单位(医院):

Lyell McEwin Hospital 

单位级别:

Tertiary referral 

Institution
hospital:

Lyell McEwin Hospital  

Level of the institution:

Tertiary referral 

测量指标:

Outcomes:

指标中文名:

Rates of documentation of communication of important incidental findings to the patient

指标类型:

主要指标 

Outcome:

Rates of documentation of communication of important incidental findings to the patient

Type:

Primary indicator 

测量时间点:

Rates of documentation of communication of important incidental findings to the patient

测量方法:

Documentation in hard copy or electronic case notes.

Measure time point of outcome:

Rates of documentation of communication of important incidental findings to the patient

Measure method:

Documentation in hard copy or electronic case notes.

指标中文名:

Rates of documentation of communication of important incidental findings to the patient's general practitioner

指标类型:

主要指标 

Outcome:

Rates of documentation of communication of important incidental findings to the patient's general practitioner

Type:

Primary indicator 

测量时间点:

Within three months of operation

测量方法:

Documentation in hard copy or electronic case notes.

Measure time point of outcome:

Within three months of operation

Measure method:

Documentation in hard copy or electronic case notes.

指标中文名:

Rates of documentation of appropriate management

指标类型:

主要指标 

Outcome:

Rates of documentation of appropriate management

Type:

Primary indicator 

测量时间点:

Within six months of operation

测量方法:

Documentation in hard copy or electronic case notes.

Measure time point of outcome:

Within six months of operation

Measure method:

Documentation in hard copy or electronic case notes.

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

组织:

Sample Name:

Nil

Tissue:

Nil

人体标本去向

使用后销毁 

说明

Fate of sample:

Destruction after use 

Note:

Nil

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 100 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):

Nil; this is a retrospective cohort study.

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

Nil; this is a retrospective cohort study.

盲法:

Nil; this is a retrospective cohort study.

Blinding:

Nil; this is a retrospective cohort study.

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:

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):

Publication in a peer reviewed journal

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

Publication in a peer reviewed journal

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:

The authors will examine the case notes of all eligible patients, to identify those with important incidental pathology. During data collection and cross-linking, patient details will be identifiable to the primary investigator (NK). Patient data will be stored in a password-protected spreadsheet, on a password-protected hard drive. Once combined by Dr Kinnear, de-identified summary results generated. Only Dr Kinnear will have access to the full dataset.

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

The authors will examine the case notes of all eligible patients, to identify those with important incidental pathology. During data collection and cross-linking, patient details will be identifiable to the primary investigator (NK). Patient data will be stored in a password-protected spreadsheet, on a password-protected hard drive. Once combined by Dr Kinnear, de-identified summary results generated. Only Dr Kinnear will have access to the full dataset. All authors will have access to the de-identified summary results. After the study, all other personnel will destroy their files. Dr Kinnear will keep a copy of the raw data for seven years, again in a password protected spreadsheet, on a password protected laptop. He will then also destroy the files.

数据管理委员会:

Data Managemen Committee:

无/No

注册人:

Name of Registration:

 2019-07-07
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