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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
Scientific title
The financial burden of complications associated with surgical lung resection for non small cell lung cancer: a retrospective observational single centre study
Secondary ID [1] 313688 0
None
Universal Trial Number (UTN)
U1111-1317-5877
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical removal/resection of the lung 336262 0
Complications following lung resection surgery 336263 0
Lung cancer 336264 0
Non small cell lung cancer 336500 0
Condition category
Condition code
Surgery 332805 332805 0 0
Other surgery
Anaesthesiology 332806 332806 0 0
Other anaesthesiology
Cancer 333010 333010 0 0
Lung - Non small cell

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 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.
Intervention code [1] 330372 0
Diagnosis / Prognosis
Comparator / control treatment
Patients undergoing lung resection without complications with be considered the control group. Patients with lung complications will be the comparator group.
Control group
Active

Outcomes
Primary outcome [1] 340468 0
Costs of complications as a composite outcome defined as the hospital costs associated with the index surgery.
Timepoint [1] 340468 0
Costs will be calculated from day of surgery to hospital discharge. Readmissions will be considered within 30 days of discharge from the index admission.
Secondary outcome [1] 444187 0
Complications following any type of lung resection.
Timepoint [1] 444187 0
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.
Secondary outcome [2] 444188 0
NSCLC patient mortality after any type of lung resection.
Timepoint [2] 444188 0
This will result in an observation follow up period of at least months post index surgery.

Eligibility
Key inclusion criteria
Inclusion criteria will include:

1. Any type of lung resection
2. Adult patient with non-small cell lung cancer
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
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).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/02/2025
Actual
Date of last participant enrolment
Anticipated
25/02/2025
Actual
Date of last data collection
Anticipated
3/03/2025
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 318154 0
Hospital
Name [1] 318154 0
Austin Health - Department of Anaesthesia
Country [1] 318154 0
Australia
Primary sponsor type
Hospital
Name
Austin Health - Department of Anaesthesia
Address
Country
Australia
Secondary sponsor category [1] 320535 0
None
Name [1] 320535 0
Address [1] 320535 0
Country [1] 320535 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316800 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 316800 0
Ethics committee country [1] 316800 0
Australia
Date submitted for ethics approval [1] 316800 0
27/01/2025
Approval date [1] 316800 0
Ethics approval number [1] 316800 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 139046 0
Prof Laurence Weinberg
Address 139046 0
Department of Anaesthesia, Austin Health,, 145 Studley Road, Heidelberg, VIC, 3084
Country 139046 0
Australia
Phone 139046 0
+61 3 94965249
Fax 139046 0
Email 139046 0
laurence.weinberg@austin.org.au
Contact person for public queries
Name 139047 0
Laurence Weinberg
Address 139047 0
Department of Anaesthesia, Austin Health,, 145 Studley Road, Heidelberg, VIC, 3084
Country 139047 0
Australia
Phone 139047 0
+61 3 94965249
Fax 139047 0
Email 139047 0
laurence.weinberg@austin.org.au
Contact person for scientific queries
Name 139048 0
Laurence Weinberg
Address 139048 0
Department of Anaesthesia, Austin Health,, 145 Studley Road, Heidelberg, VIC, 3084
Country 139048 0
Australia
Phone 139048 0
+61 3 94965249
Fax 139048 0
Email 139048 0
laurence.weinberg@austin.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24479Ethical approval  laurence.weinberg@austin.org.au



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.