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Trial registered on ANZCTR


Registration number
ACTRN12622000057785
Ethics application status
Approved
Date submitted
25/12/2021
Date registered
18/01/2022
Date last updated
18/01/2022
Date data sharing statement initially provided
18/01/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hospital costs of complications following cystectomy
Scientific title
The healthcosts of postoperative complications following radical cystectomy
Secondary ID [1] 306111 0
Nil Known
Universal Trial Number (UTN)
U1111-1272-7973
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical removal of the bladder 324785 0
Complications following cystectomy 324786 0
Bladder cancer 324787 0
Condition category
Condition code
Surgery 322236 322236 0 0
Surgical techniques
Renal and Urogenital 322237 322237 0 0
Other renal and urogenital disorders
Anaesthesiology 322238 322238 0 0
Anaesthetics
Cancer 322239 322239 0 0
Bladder

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
6
Target follow-up type
Months
Description of intervention(s) / exposure
In this study we will be observing complications after radical cystectomy and the associated hospital costs for patients undergoing this surgery between 1 July 2012 and 31st July 2021. As this is a retrospective study, there is no participant involvement. Only the de-identified hospital medical record of patients who have undergone radical cystectomy will be reviewed.

We will review all the International Classification for Diseases (ICD) codes relevant to cystectomy or radical cystectomy inclusive of:

1. ICD-10-Procedure Coding System for bladder removal and neobladder
2. ICD-10-Procedure Coding System for an open or laparoscopic surgical approach
Intervention code [1] 322528 0
Diagnosis / Prognosis
Comparator / control treatment
There are two patient cohorts that will be compared:- those patients undergoing radical cystectomy who develop a postoperative complication, and those patients undergoing radical cystectomy without complications.
Control group
Active

Outcomes
Primary outcome [1] 330011 0
Costs of complications as a composite outcome defined as the hospital costs associated with the index surgery.

All costs related to the index admission for radical cystectomy 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.
Timepoint [1] 330011 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] 404580 0
Complications following radical cystectomy. 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.
Timepoint [1] 404580 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] 404581 0
Patient mortality after radical cystectomy.
Timepoint [2] 404581 0
Any observed mortality will be recorded after surgery until the last observation day which will be set a-priori as 31 Oct 2021. 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. Radical cystectomy with or without ileal conduit
2. Radical cystoprostatectomy with or without ileal/sigmoid conduit
3. Radical cystectomy with neobladder
4. Radical cystoprostatectomy with neobladder

Both open and laparoscopic techniques will be included. All reconstructions of the urinary tract will be included (e.g., ileal conduit, neobladder reconstruction or continent urinary reservoir).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Excluded patients will include:

1. Patients who have undergone a partial cystectomy
2. If the cystectomy was secondary to another major procedure (e.g., pelvic exenteration, cystectomy with hysterectomy and oophorectomy)
3. Cystectomy secondary to trauma.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Statistical analysis will be performed using IBM SPSS Statistics for Windows, version 23 (IBM Corp., 2015, Armonk, NY, USA) and R version 4.1.2 (R Development Core Team, Vienna, Austria, 2021). Missing data analysis will be performed to detect more than a 5% missing rate for all variables. In case of a higher missing rate than 5%, the multiple imputations method will be applied to the corresponding variable if the missing patterns are completely at random. For variables with less than 5% of missing values, appropriate statistical analysis will be undertaken.

All continuous variables will be tested for normality using the Q-Q plot. If a variable violates the normality assumption, we will apply the variable transformation and re-evaluate the normality, or alternatively consider non-parametric statistical methods.

Wilcoxon rank-sum test and Kruskal-Wallis one-way analysis of variance on ranks will be used to evaluate the unadjusted hospital cost analysis. In addition, Dunn’s all pairwise multiple comparison procedures will be considered as a post hoc test, if deemed to be appropriate by the statistician.

Adjusted hospital cost analysis will be performed according to the characteristics of the variables and the results of the assumption test made. Pearson’s or Spearman’s correlation analysis will be performed to evaluate the relationship between the hospital cost and other pre, intra, and postoperative variables.

Linear regression modeling will also be applied to understand the effects of postoperative complications on hospital costs. Autocorrelation of the values of the hospital cost will be evaluated using Durbin-Watson statistics, and the multicollinearity between covariates will be tested with the variance-inflation factor and collinearity diagnostics using the eigenvalues. Homoscedasticity will be assessed using residual plots.

Mortality in the cystectomy cohort will be evaluated with survival analysis. We will use Kaplan-Meier survival curves. Among the collected variables, mortality-related variables will be assessed using Pearson’s or Spearman’s correlation. Adjusted effect of complications on postoperative mortality will be appreciated using time-dependent coefficient Cox’s proportional hazard regression model. The constant hazard ratio assumption will be evaluated with Schöenfeldt residual test.

All data will be presented as mean ± standard deviation (SD) or median [IQR] for continuous variables and number (percentile) for categorical variables. Comparative results will be presented with a P-value and corresponding effect size. A two-tailed P-value below 0.050 will be considered to be statistically significant. P-values will be adjusted by Bonferroni’s correction method as required.

Costs will be inflated to 31 August 2021 based on the end-of-fiscal-quarter Australian Consumer Price Index. Costs will also be converted to United States dollars (USD) based on the market rate on 31 August 2021. In-hospital costs will be calculated according to an activity-based costing methodology that allocates costs based on service volume.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
8/04/2021
Date of last participant enrolment
Anticipated
Actual
31/08/2021
Date of last data collection
Anticipated
Actual
1/11/2021
Sample size
Target
154
Accrual to date
Final
147
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 21423 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 36322 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 310465 0
Hospital
Name [1] 310465 0
Austin Health
Country [1] 310465 0
Australia
Primary sponsor type
Hospital
Name
Austin Health
Address
Department of Anaesthesia, Austin Hospital
145 Studley Road, Heidelberg VIC, 3084
Country
Australia
Secondary sponsor category [1] 311615 0
None
Name [1] 311615 0
Address [1] 311615 0
Country [1] 311615 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310096 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 310096 0
Ethics committee country [1] 310096 0
Australia
Date submitted for ethics approval [1] 310096 0
31/03/2021
Approval date [1] 310096 0
07/04/2021
Ethics approval number [1] 310096 0
Audit/21/Austin/26

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

Contacts
Principal investigator
Name 116454 0
A/Prof Laurence Weinberg
Address 116454 0
Department of Anaesthesia, Austin Health,, 145 Studley Road, Heidelberg, VIC, 3084
Country 116454 0
Australia
Phone 116454 0
+61 3 94963800
Fax 116454 0
Email 116454 0
[email protected]
Contact person for public queries
Name 116455 0
Laurence Weinberg
Address 116455 0
Department of Anaesthesia, Austin Health,, 145 Studley Road, Heidelberg, VIC, 3084
Country 116455 0
Australia
Phone 116455 0
+61 3 94963800
Fax 116455 0
Email 116455 0
[email protected]
Contact person for scientific queries
Name 116456 0
Laurence Weinberg
Address 116456 0
Department of Anaesthesia, Austin Health,, 145 Studley Road, Heidelberg, VIC, 3084
Country 116456 0
Australia
Phone 116456 0
+61 3 94963800
Fax 116456 0
Email 116456 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
As this is an observational study, patients have not provided consent for their data to be shared.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14575Ethical approval  [email protected] 383349-(Uploaded-25-12-2021-20-22-01)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePostoperative complications and hospital costs following open radical cystectomy: A retrospective study.2023https://dx.doi.org/10.1371/journal.pone.0282324
N.B. These documents automatically identified may not have been verified by the study sponsor.