ANZCTR - Registration

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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]

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

Complications following cystectomy

Bladder cancer

Condition category

Condition code

Surgery

Surgical techniques

Renal and Urogenital

Other renal and urogenital disorders

Anaesthesiology

Anaesthetics

Cancer

Bladder

Intervention/exposure

Study type

Observational

Patient registry

True

Target follow-up duration

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]

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]

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]

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]

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]

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]

Patient mortality after radical cystectomy.

Timepoint [2]

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?

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]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Austin Health

Address [1]

Department of Anaesthesia, Austin Hospital
145 Studley Road, Heidelberg VIC, 3084

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin Health Human Research Ethics Committee

Ethics committee address [1]

L8 Harold Stokes Building 145 Studley Road Heidelberg Victoria Australia 3084 PO Box 5555

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

31/03/2021

Approval date [1]

07/04/2021

Ethics approval number [1]

Audit/21/Austin/26

Summary

Brief summary

There has been recent interest in understanding the costs associated with post-operative complications of patients undergoing radical cystectomy (removal of the entire bladder). 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 radical cystectomy.

Who is it for?
You may be eligible for this study if you are an adult who underwent a radical cystectomy.

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 Jan 2012 and 31st July 2021.

It is hoped that this research will help to provide a better understanding of the costs associated with major surgery.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Laurence Weinberg

Address

Department of Anaesthesia, Austin Health,, 145 Studley Road, Heidelberg, VIC, 3084

Country

Australia

Phone

+61 3 94963800

Fax

laurence.weinberg@austin.org.au

Contact person for public queries

Name

Laurence Weinberg

Address

Department of Anaesthesia, Austin Health,, 145 Studley Road, Heidelberg, VIC, 3084

Country

Australia

Phone

+61 3 94963800

Fax

laurence.weinberg@austin.org.au

Contact person for scientific queries

Name

Laurence Weinberg

Address

Department of Anaesthesia, Austin Health,, 145 Studley Road, Heidelberg, VIC, 3084

Country

Australia

Phone

+61 3 94963800

Fax

laurence.weinberg@austin.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
14575	Ethical approval			laurence.weinberg@austin.org.au		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

Source	Title	Year of Publication	DOI
Embase	Postoperative complications and hospital costs following open radical cystectomy: A retrospective study.	2023	https://dx.doi.org/10.1371/journal.pone.0282324

N.B. These documents automatically identified may not have been verified by the study sponsor.

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