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Trial registered on ANZCTR
Registration number
ACTRN12624000793516
Ethics application status
Approved
Date submitted
2/06/2024
Date registered
27/06/2024
Date last updated
27/06/2024
Date data sharing statement initially provided
27/06/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Long term survival in adult patients undergoing major abdominal surgery
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Scientific title
Long term survival in adult patients undergoing major abdominal surgery: a retrospective observational single centre audit
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Secondary ID [1]
311982
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Major abdominal surgery
333594
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Mortality
334191
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Post-operative complications
334192
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Condition category
Condition code
Anaesthesiology
330278
330278
0
0
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Anaesthetics
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Surgery
330279
330279
0
0
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Surgical techniques
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Oral and Gastrointestinal
330280
330280
0
0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Public Health
330850
330850
0
0
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Health service research
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
In this study we will use patient data from a single centre to investigate the association of post-operative complications and mortality in adult patients undergoing major abdominal surgery. In using routinely collected in-hospital data, this study will also identify independent risk factors for post-operative complications including (but not limited to) mortality, length of stay, and new co-morbidities. There is no direct patient involvement, only the retrospective collection of patient data from their electronic medical records.
Each patients' data will only be collected once and the period for which the data will be collected will from the start of their major abdominal surgery (surgical incision) to their date of hospital discharge. All patients who underwent major abdominal surgery between July 2010 to April 2021 will have their data collected. In addition, through the electronic medical records and the Births and Deaths registry Victoria, date of death will be established. There will be no prospective collection of any other data. Patients will not be contacted at any point.
The types of data collected will be data-linkage only. From the data collected from the electronic medical records, we will describe the baseline characteristics of those patients who. We will seek to summarise their intraoperative course and collect data on their postoperative outcomes, including complications.
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Intervention code [1]
328444
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Not applicable
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Mortality
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Assessment method [1]
338022
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Patient medical records and the Victorian Births and Death Registry
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Timepoint [1]
338022
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From time to admission to death
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Primary outcome [2]
338023
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Postoperative complications. Complications will be assessed as a composite primary outcome and will defined as any deviation from the normal postoperative course, guided by the European Perioperative Clinical Outcome definitions. Complications will be graded using Clavien-Dindo Classification - a widely used and validated approach to surgical outcome assessment that assigns severity grades to surgical complications. These data will be collected from the electronic medical records.
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Assessment method [2]
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These data will be collected from the electronic medical records.
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Timepoint [2]
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Data for days 1-30 post surgery
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Secondary outcome [1]
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Length of hospital stay
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Assessment method [1]
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Correlation with medical records
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Timepoint [1]
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Time to admission to time of discharge (or death, if applicable)
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Secondary outcome [2]
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Readmission to the hospital
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Assessment method [2]
434167
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Patient medical records
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Timepoint [2]
434167
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Time from discharge to 30 days post surgery
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Eligibility
Key inclusion criteria
1. Adult patients
2. Undergoing major abdominal surgery (colorectal surgery, cystectomy, distal pancreatectomy, hepatobiliary (HPB) and pancreatic surgery, and small bowel surgeries)
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Paediatric patients
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Study design
Purpose
Screening
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Duration
Longitudinal
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Selection
Defined population
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Timing
Retrospective
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Statistical methods / analysis
Based on a preliminary search, we expect the total sample size for the project to be approximately 2000 patients.
This sample size is sufficient to meet the research aims and answer the research questions because it provides accurate data that facilitates understanding of the extent of association between post-operative outcomes, complications, and mortality in adult patients undergoing major abdominal surgery.
The statistical analysis plan has been designed with a biostatistician.
All statistical analysis will be performed with R 4.3.2( R: A language and environment for statistical computing, R core Team (2023), Vienna, Austria). Continuous variables will be evaluated for normality assumption using Shapiro’s test and visual check of Q-Q plots. Data will be presented with mean ± standard deviation(SD), median (1st to 3rd quartiles) [Min:Max], or number of cases (percentile) for the descriptive statistics, and any estimated values will be described with 95% confidence intervals (CI).
Statistical results will be presented with P values and corresponding effect sizes. A 2-sided P value below 0.05 will be considered statistical significance based on the null hypothesis significance testing, and the number of effects will be evaluated with the estimated effect sizes.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
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Actual
12/06/2024
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Date of last participant enrolment
Anticipated
16/07/2024
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Actual
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Date of last data collection
Anticipated
1/08/2024
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Actual
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Sample size
Target
2000
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Accrual to date
569
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
26420
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Austin Health - Austin Hospital - Heidelberg
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Recruitment postcode(s) [1]
42399
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3084 - Heidelberg
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Funding & Sponsors
Funding source category [1]
316331
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Hospital
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Name [1]
316331
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Austin Health - Department of Anaesthesia
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Address [1]
316331
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Country [1]
316331
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Australia
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Primary sponsor type
Hospital
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Name
Austin Health - Department of Anaesthesia
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Address
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
318512
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Address [1]
318512
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Country [1]
318512
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
315141
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
315141
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https://www.austin.org.au/Office-for-Research/
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Ethics committee country [1]
315141
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Australia
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Date submitted for ethics approval [1]
315141
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19/04/2024
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Approval date [1]
315141
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11/06/2024
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Ethics approval number [1]
315141
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HREC/107644/Austin-2024
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Summary
Brief summary
This study will use electronic medical records from the Austin Health database to evaluate the outcomes and complications in patients undergoing major abdominal surgery. These results may be used to aid prognostication of post-operative major abdominal surgery patients, as well as identify, and therefore modify, factors that may predispose patients to poorer post-operative outcomes and ultimately reduce overall morbidity and mortality in this patient cohort.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Laurence Weinberg
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Address
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Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg VIC 3084
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Country
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Australia
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Phone
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+61 3 9496 3800
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Fax
133794
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Email
133794
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[email protected]
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Contact person for public queries
Name
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Laurence Weinberg
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Address
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Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg VIC 3084
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Country
133795
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Australia
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Phone
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+61 3 9496 3800
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Fax
133795
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Email
133795
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[email protected]
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Contact person for scientific queries
Name
133796
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Laurence Weinberg
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Address
133796
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Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg VIC 3084
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Country
133796
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Australia
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Phone
133796
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+61 3 9496 3800
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Fax
133796
0
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Email
133796
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Participant confidentiality will be maintained by only reporting aggregate results.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
23846
Ethical approval
2024
[email protected]
387684-(Uploaded-21-06-2024-23-03-32)-Austin-2024_Major Abdominal Surgery.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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