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Trial registered on ANZCTR
Registration number
ACTRN12625000112460p
Ethics application status
Submitted, not yet approved
Date submitted
23/01/2025
Date registered
31/01/2025
Date last updated
31/01/2025
Date data sharing statement initially provided
31/01/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
The costs of complications after lung resection surgery
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Scientific title
The financial burden of complications associated with surgical lung resection for non small cell lung cancer: a retrospective observational single centre study
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Secondary ID [1]
313688
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None
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Universal Trial Number (UTN)
U1111-1317-5877
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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:
Lung cancer
336264
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Non small cell lung cancer
336500
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Complications following lung resection surgery
336263
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Surgical removal/resection of the lung
336262
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Condition category
Condition code
Surgery
332805
332805
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0
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Other surgery
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Anaesthesiology
332806
332806
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0
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Other anaesthesiology
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Cancer
333010
333010
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0
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Lung - Non small cell
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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 be observing complications after any type of lung resection and the associated hospital costs for adult patients with non-small cell lung cancer (NSCLC) undergoing this surgery between 1 January 2011 and 31st December 2023.
There are two patient cohorts that will be compared:- those patients undergoing lung resection who develop a postoperative complication, and those patients undergoing lung resection without complications.
As this is a retrospective study, there is no participant involvement. Only the de-identified hospital medical record of NSCLC adult patients who have undergone lung resection will be reviewed.
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Intervention code [1]
330372
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Diagnosis / Prognosis
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Comparator / control treatment
Patients undergoing lung resection without complications with be considered the control group. Patients with lung complications will be the comparator group.
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Control group
Active
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Outcomes
Primary outcome [1]
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Costs of complications as a composite outcome defined as the hospital costs associated with the index surgery.
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Assessment method [1]
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All costs related to the index admission for lung resection surgery and any consequent readmissions will be included. Costs related to preoperative course are not considered. Allocation of costs will be done based on service volume, and costs will be calculated using an activity-based costing methodology. Only in-hospital costs are considered, with both direct and indirect costs assessed to produce a total cost for each patient. Costs for each patient will be obtained from the Austin Health Department of Finance, which maintain an itemised prospective database of all hospital expenses related to each patient.
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Timepoint [1]
340468
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Costs will be calculated from day of surgery to hospital discharge. Readmissions will be considered within 30 days of discharge from the index admission.
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Secondary outcome [1]
444187
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Complications following any type of lung resection.
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Assessment method [1]
444187
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Complications will be assessed using the Clavien-Dindo system, a previously validated tool for grading complications. Possible complications include infection, haemorrhage, death, etc. This outcome will be obtained by reviewing data-linkage to the Austin hospital's medical records.
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Timepoint [1]
444187
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Complications will be retrospectively collected from the patient medical records at hospital discharge. The duration period over which complications will be collected are from the completion of surgery to hospital discharge for the index admission.
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Secondary outcome [2]
444188
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NSCLC patient mortality after any type of lung resection.
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Assessment method [2]
444188
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Any observed mortality will be recorded after surgery until the last observation day which will be set a-priori as 31 Dec 2023. This will result in an observation follow up period of at least months post index surgery.
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Timepoint [2]
444188
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This will result in an observation follow up period of at least months post index surgery.
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Eligibility
Key inclusion criteria
Inclusion criteria will include:
1. Any type of lung resection
2. Adult patient with non-small cell lung cancer
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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
We will exclude patients undergoing the following procedure
1. Pleurodesis
2. Pulmonary decortication including mesothelioma surgery
3. Other procedures on the pleura
4. Tracheal and bronchial (parenchyma sparing resection)
5. Oesophagectomy
6. Mediastinal tumour resections/mediastinoscopy
7. Endobronchial procedures on bronchus and trachea
8. Chest wall surgery of rib/s
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Study design
Purpose
Natural history
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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
The statistical analysis will be performed using IBM SPSS Statistics for Windows, version 23 (IBM Corp., Armonk, NY, USA) and R, version 4.1.2 (R Core Team, Vienna, Austria, 2021). A missing data analysis will be conducted to identify variables with a missing rate greater than 5%. For variables exceeding this threshold, multiple imputations will be applied as if the missing patterns are completely random. Variables with a missing rate below 5% will be excluded on a case-by-case basis during analysis.
Continuous variables will be assessed for normality using quantile-quantile (Q-Q) plots. When normality assumptions are violated, non-parametric tests or transformations will be applied. Unadjusted hospital cost analysis will be performed according to the presence, number, and severity of complications as well as surgical techniques, using the Wilcoxon rank-sum test or the Kruskal-Wallis one-way analysis of variance on ranks. Dunn’s post-hoc test will be employed in cases in which the Kruskal-Wallis test indicated statistical significance.
For adjusted cost analysis, Pearson’s or Spearman’s correlation analysis will be performed to assess relationships between hospital costs and perioperative variables. Variables with significant correlation coefficients and an absolute value greater than 0.2 will be selected for further evaluation. Clinically significant variables and those with high correlations will be chosen as adjusting factors for the final models. Linear regression models will be applied to explore the effects of postoperative complications on hospital costs. Autocorrelation will be assessed using Durbin-Watson statistics, and multicollinearity will be evaluated using variance inflation factors and eigenvalues. Homoscedasticity will be evaluated using residual plots and Cook’s distance will be used to detect influential outliers. Kaplan-Meier survival curves will be generated to analyze mortality outcomes, and Pearson’s or Spearman’s correlation coefficients will be used to assess associations between key variables. Cox proportional hazards models with time-dependent covariates will be applied to evaluate the effect of complications on mortality, with the proportional hazards assumption tested using Schoenfeld residuals.
Results will be reported as median (interquartile range [IQR]) for continuous variables, and as numbers (percentages) for categorical variables. Inferential statistics will be presented with 95% confidence intervals (CIs) and p-values. A two-tailed p-value below 0.05 will be considered statistically significant. Bonferroni correction was applied for multiple comparisons when necessary.
All costs were adjusted to the Australian Consumer Price Index (CPI) as of December 31, 2023, and converted to United States dollars (USD) using an exchange rate of 1 Australian dollar (AUD) = 0.67 USD (June 2024).
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
17/02/2025
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Actual
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Date of last participant enrolment
Anticipated
25/02/2025
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Actual
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Date of last data collection
Anticipated
3/03/2025
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Actual
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Sample size
Target
800
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
318154
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Hospital
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Name [1]
318154
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Austin Health - Department of Anaesthesia
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Address [1]
318154
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Country [1]
318154
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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]
320535
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None
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Name [1]
320535
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Address [1]
320535
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Country [1]
320535
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
316800
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Austin Health Human Research Ethics Committee
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Ethics committee address [1]
316800
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https://www.austin.org.au/Office-for-Research/
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Ethics committee country [1]
316800
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Australia
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Date submitted for ethics approval [1]
316800
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27/01/2025
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Approval date [1]
316800
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Ethics approval number [1]
316800
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Summary
Brief summary
There has been recent interest in understanding the costs associated with post-operative complications of adult non small cell lung cancer (NSCLC) patients undergoing lung resection. Accurately defining the costs of complications allows institutions to make more informed decisions as to what these costs are, and then implement strategies to reduce the incidence of complications, thereby mitigating hospital costs. The aim of this study is to provide a detailed costs analysis for patients who undergo any type of lung resection. Who is it for? You may be eligible for this study if you are an adult with NSCLC who underwent any type of lung resection. Study details This study will be conducted using a review of medical records, and no patient contact is required. The study will review the medical records of adult patients who underwent a radical cystectomy at the Austin Hospital between 1 January 2011 and 31st December 2023. It is hoped that this research will help to provide a better understanding of the costs associated with any type of lung resection surgery.
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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
139046
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Department of Anaesthesia, Austin Health,, 145 Studley Road, Heidelberg, VIC, 3084
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Country
139046
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Australia
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Phone
139046
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+61 3 94965249
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Fax
139046
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Email
139046
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[email protected]
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Contact person for public queries
Name
139047
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Laurence Weinberg
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Address
139047
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Department of Anaesthesia, Austin Health,, 145 Studley Road, Heidelberg, VIC, 3084
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Country
139047
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Australia
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Phone
139047
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+61 3 94965249
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Fax
139047
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Email
139047
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[email protected]
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Contact person for scientific queries
Name
139048
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Laurence Weinberg
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Address
139048
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Department of Anaesthesia, Austin Health,, 145 Studley Road, Heidelberg, VIC, 3084
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Country
139048
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Australia
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Phone
139048
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+61 3 94965249
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Fax
139048
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Email
139048
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[email protected]
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Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Type
Citation
Link
Email
Other Details
Attachment
Ethical approval
[email protected]
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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