ANZCTR - Registration

Registration number

ACTRN12619001169134

Ethics application status

Approved

Date submitted

14/07/2019

Date registered

20/08/2019

Date last updated

11/02/2021

Date data sharing statement initially provided

20/08/2019

Type of registration

Retrospectively registered

Titles & IDs

Public title

An observational study of general surgery models in Australia

Scientific title

An Australian observational study of general surgery models of care for emergency patients, including Traditional, Hybrid and Acute Surgical Unit models.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Emergency general surgery model

Condition category

Condition code

Surgery

Other surgery

Public Health

Health service research

Intervention/exposure

Study type

Observational

Description of intervention(s) / exposure

This is an observational study of the model of care used by general surgical departments for the care of emergency aka non-elective patients. The exposure assessed will be the type of emergency general surgery model in place at each hospital.
Acute Surgical Units were defined as those with a surgeon dedicated solely to EGS patients for greater than 50% of business hours. A Hybrid model lacked such surgeon allocation, but provided a registrar rostered solely to EGS patients for greater than 50% of business hours, or two or more half-day protected EGS theatre lists per week. Hospitals with a Traditional model had none of these features.
Data will be gained by staff questionnaires. Emergency departments are not part of this study.

Intervention code [1]

Not applicable

Comparator / control treatment

Use of the Traditional model of structuring care for emergency general surgery patients.
Acute Surgical Units were defined as those with a surgeon dedicated solely to EGS patients for greater than 50% of business hours. A Hybrid model lacked such surgeon allocation, but provided a registrar rostered solely to EGS patients for greater than 50% of business hours, or two or more half-day protected EGS theatre lists per week. Hospitals with a Traditional model had none of these features.

Control group

Active

Outcomes

Primary outcome [1]

Proportion of Australian medium- to large-sized hospitals using each emergency general surgery model.
This outcome will be assessed by inviting surgical staff at all such hospitals to complete a questionnaire, and reporting the proportion of hospitals utilising each model.

Timepoint [1]

This data will be collected once only for each hospital. Surgical staff will be invited to complete the questionnaire in March-April 2019. There is no baseline time, as hospitals may have changed to the Acute Surgical Unit model (or another model) many years prior. This study is intended as a snapshot of current practice.

Secondary outcome [1]

Bed number of hospitals utilising each emergency general surgery model, as assessed by study specific staff questionnaire, combined with freely available data on hospital characteristics from the Australian Institute of Health and Welfare.
This questionnaire has not been externally validated, and was designed specifically for this study.
Categorical measures will be summarized as proportions and assessed with Pearson’s chi-square test. All tests will be two-tailed and significance assessed at the 5% alpha level.

Timepoint [1]

This data will be collected once only for each hospital. Surgical staff will be invited to complete the questionnaire in March-April 2019. There is no baseline time, as hospitals may have changed to the Acute Surgical Unit model (or another model) many years prior. This study is intended as a snapshot of current practice.

Secondary outcome [2]

Secondary study outcomes will include reporting average subjective staff satisfaction amongst involved general surgery consultants and registrars, of hospitals utilising each emergency general surgery model, as assessed by study specific staff questionnaire.

Categorical data will be compared with Pearson’s chi-square test, or the Fisher exact test when zero values are encountered. Continuous data will be compared using either the Mann-Whitney U test for continuous data in two categories, or the Kruskal Wallis test for continuous data in three or more categories. All statistical tests will be two-tailed. The 5% alpha level will be used to assess significance.

Timepoint [2]

This data will be collected once only for each hospital. Surgical staff will be invited to complete the questionnaire in March-April 2019. There is no baseline time, as hospitals may have changed to the Acute Surgical Unit model (or another model) many years prior. This study is intended as a snapshot of current practice.

Secondary outcome [3]

Mean number of general surgeons in hospitals utilising each emergency general surgery model, as assessed by study specific staff questionnaire. This questionnaire has not been externally validated, and was designed specifically for this study.
Categorical measures will be summarized as proportions and assessed with Pearson’s chi-square test. All tests will be two-tailed and significance assessed at the 5% alpha level.

Timepoint [3]

This data will be collected once only for each hospital. Surgical staff will be invited to complete the questionnaire in March-April 2019. There is no baseline time, as hospitals may have changed to the Acute Surgical Unit model (or another model) many years prior. This study is intended as a snapshot of current practice.

Secondary outcome [4]

Trauma service sophistication in hospitals utilising each emergency general surgery model. Data will be obtained by study specific staff questionnaire, combined with freely available data on hospital characteristics from the Australian Institute of Health and Welfare.
This questionnaire has not been externally validated, and was designed specifically for this study.
Categorical measures will be summarized as proportions and assessed with Pearson’s chi-square test. All tests will be two-tailed and significance assessed at the 5% alpha level.

Timepoint [4]

This data will be collected once only for each hospital. Surgical staff will be invited to complete the questionnaire in March-April 2019. There is no baseline time, as hospitals may have changed to the Acute Surgical Unit model (or another model) many years prior. This study is intended as a snapshot of current practice.

Eligibility

Key inclusion criteria

Eligible centres were Australian public hospitals offering elective general surgery, medium (>2,000 patient separations per-annum) or greater peer group, who offered an emergency general surgery service.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

No

Key exclusion criteria

Centres were excluded if they were located outside Australia, private hospitals, did not offer both elective and emergency general surgery services or declined to participate.

Study design

Statistical methods / analysis

Hospitals were grouped based on EGS structure as Traditional versus Hybrid or ASU. Categorical data were displayed as proportions and compared with Pearson’s chi-square test, or the Fisher exact test when zero values were encountered. Continuous data were reported as means. Given their expected non-normal distribution, these were compared using either the Mann-Whitney U test for continuous data in two categories, or the Kruskal Wallis test for continuous data in three or more categories. All statistical tests were two-tailed. The 5% alpha level was used to assess significance.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

Actual

4/03/2019

Date of last participant enrolment

Anticipated

Actual

19/04/2019

Date of last data collection

Anticipated

Actual

19/04/2019

Sample size

Target

120

Accrual to date

Final

119

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Country [1]

Australia

Funding source category [2]

University

Name [2]

University of Adelaide post-graduate scholarship

Country [2]

Australia

Funding source category [3]

Charities/Societies/Foundations

Name [3]

The Hospital Research Foundation

Country [3]

Australia

Primary sponsor type

Individual

Name

Dr Ned Kinnear

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Adelaide

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Adelaide Local Health Network Human Research Ethics Committee

Ethics committee address [1]

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

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

12/08/2018

Approval date [1]

20/11/2018

Ethics approval number [1]

HREC/18/CALHN/529

Summary

Brief summary

To date, a total of sixteen Australian public hospitals have published their uptake of the Acute Surgical Unit (ASU) model, while another two have documented successful persistence with Traditional models. However, for the great majority of public hospitals in Australia, the emergency general surgery (EGS) model in use remains unknown. In 2010, General Surgery Australia’s ‘12 Point Plan for Emergency General Surgery’ recommended separation of emergency and elective activity. However, these were non-binding recommendations and explicitly expected variation in EGS models. Departments remain free to choose their preferred system and no national registry or automated reporting of structure exists. This lack of information regarding EGS models in the large majority of Australian hospitals is problematic. A national survey could be used to guide other hospitals considering commencing an ASU, or by health bodies to inform future policy. 

We aimed therefore to survey the structure of EGS care of adults in all Australian medium to major public hospitals, with particular regard to the chronological and geographical spread of EGS models, the impact of trauma care and other variables on choice of EGS model, reasons for or against commencing an ASU model, staff satisfaction, registrar operative exposure and safe working hours.

Trial website

Public notes

Contacts

Principal investigator

Name

Dr Ned Kinnear

Address

Western Health, 160 Gordon St, Footscray VIC 3011

Country

Australia

Phone

+61 3 9496 5000

Email

[email protected]

Contact person for public queries

Name

James Moore

Address

Royal Adelaide Hospital
North Tce, Adelaide SA 5000

Country

Australia

Phone

+61 8 7074 2315

Email

[email protected]

Contact person for scientific queries

Name

Ned Kinnear

Address

Western Health, 160 Gordon St, Footscray VIC 3011

Country

Australia

Phone

+61 3 9496 5000

Email

[email protected]

Trial Review

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