Trial Review

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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
Scientific title
Long term survival in adult patients undergoing major abdominal surgery: a retrospective observational single centre audit
Secondary ID [1] 311982 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Major abdominal surgery 333594 0
Mortality 334191 0
Post-operative complications 334192 0
Condition category
Condition code
Anaesthesiology 330278 330278 0 0
Anaesthetics
Surgery 330279 330279 0 0
Surgical techniques
Oral and Gastrointestinal 330280 330280 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Public Health 330850 330850 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 328444 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338022 0
Mortality
Timepoint [1] 338022 0
From time to admission to death
Primary outcome [2] 338023 0
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.
Timepoint [2] 338023 0
Data for days 1-30 post surgery
Secondary outcome [1] 434166 0
Length of hospital stay
Timepoint [1] 434166 0
Time to admission to time of discharge (or death, if applicable)
Secondary outcome [2] 434167 0
Readmission to the hospital
Timepoint [2] 434167 0
Time from discharge to 30 days post surgery

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)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Paediatric patients

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
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.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
12/06/2024
Date of last participant enrolment
Anticipated
16/07/2024
Actual
Date of last data collection
Anticipated
1/08/2024
Actual
Sample size
Target
2000
Accrual to date
569
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 26420 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 42399 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 316331 0
Hospital
Name [1] 316331 0
Austin Health - Department of Anaesthesia
Country [1] 316331 0
Australia
Primary sponsor type
Hospital
Name
Austin Health - Department of Anaesthesia
Address
Country
Australia
Secondary sponsor category [1] 318512 0
None
Name [1] 318512 0
Address [1] 318512 0
Country [1] 318512 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315141 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 315141 0
https://www.austin.org.au/Office-for-Research/
Ethics committee country [1] 315141 0
Australia
Date submitted for ethics approval [1] 315141 0
19/04/2024
Approval date [1] 315141 0
11/06/2024
Ethics approval number [1] 315141 0
HREC/107644/Austin-2024

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 133794 0
Prof Laurence Weinberg
Address 133794 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg VIC 3084
Country 133794 0
Australia
Phone 133794 0
+61 3 9496 3800
Fax 133794 0
Email 133794 0
[email protected]
Contact person for public queries
Name 133795 0
Laurence Weinberg
Address 133795 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg VIC 3084
Country 133795 0
Australia
Phone 133795 0
+61 3 9496 3800
Fax 133795 0
Email 133795 0
[email protected]
Contact person for scientific queries
Name 133796 0
Laurence Weinberg
Address 133796 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg VIC 3084
Country 133796 0
Australia
Phone 133796 0
+61 3 9496 3800
Fax 133796 0
Email 133796 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participant confidentiality will be maintained by only reporting aggregate results.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23846Ethical approval2024 [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.