Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000202763
Ethics application status
Approved
Date submitted
14/01/2022
Date registered
7/02/2022
Date last updated
7/02/2022
Date data sharing statement initially provided
7/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hospital costs of complications following distal pancreatectomy
Scientific title
Costs of postoperative complications following distal pancreatectomy
Secondary ID [1] 306211 0
None
Universal Trial Number (UTN)
U1111-1273-2780
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical removal of the distal pancreas 324920 0
Complications following distal pancreatectomy 324921 0
Pancreatic cancer 324922 0
Condition category
Condition code
Surgery 322354 322354 0 0
Other surgery
Oral and Gastrointestinal 322355 322355 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Anaesthesiology 322356 322356 0 0
Other anaesthesiology
Cancer 322357 322357 0 0
Pancreatic

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 distal pancreatectomy and the associated hospital costs. As this is a retrospective study, there is no participant involvement. We will review the medical records of adult patients who underwent a distal pancreatectomy at the Austin Hospital between 1 Jan 2012 and 31 July 2021.

We will review all the International Classification Diseases (ICD) codes relevant to distal pancreatectomy. These include:

1. 2022 ICD-10-Procedure Coding System 0FBG0ZZ Excision of Pancreas, Open Approach

2. 2022 ICD-10-Procedure Coding System 0FBG3ZZ Excision of Pancreas, Percutaneous Approach

3. 2022 ICD-10-PCS 0FBG4ZZ Excision of Pancreas, Percutaneous Endoscopic Approach

4. 2022 ICD-10-PCS 0FBG8ZZ Excision of Pancreas, Via Natural or Artificial Opening Endoscopic
Intervention code [1] 322613 0
Diagnosis / Prognosis
Comparator / control treatment
There are two patient groups that will be compared:- those patients undergoing distal pancreatectomy who develop a postoperative complication, and those patients undergoing distal pancreatectomy without complications.
Control group
Active

Outcomes
Primary outcome [1] 330120 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 distal pancreatectomy 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] 330120 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] 404942 0
Complications following distal pancreatectomy. 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] 404942 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] 404943 0
Patient mortality after distal pancreatectomy
Timepoint [2] 404943 0
Any observed mortality will be recorded after surgery until the last observation day which will be set a-priori as 31 Dec 2021. This will result in an observation follow up period of at least six months post index surgery.

Eligibility
Key inclusion criteria
Inclusion criteria will include
1. Distal pancreatectomy with splenectomy
2.. Distal pancreatectomy with spleen preserving technique
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients who have undergone a total pancreatectomy
2. Patients who have undergone a central pancreatectomy
3. Patients who have undergone a Whipples procedure
4. If the distal pancreatectomy was secondary to another major procedure (e.g., pelvic exenteration, cystectomy etc. )
5. Distal pancreatectomy 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.

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
8/08/2021
Date of last data collection
Anticipated
Actual
31/12/2021
Sample size
Target
62
Accrual to date
Final
62
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 310560 0
Hospital
Name [1] 310560 0
Austin Health - Austin Hospital - Heidelberg
Country [1] 310560 0
Australia
Primary sponsor type
Hospital
Name
Austin Health - Austin Hospital - Heidelberg
Address
Department of Anaesthesia, Austin Hospital, 145 Studley Road, Heidelberg VIC, 3084
Country
Australia
Secondary sponsor category [1] 311930 0
None
Name [1] 311930 0
Address [1] 311930 0
Country [1] 311930 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310168 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 310168 0
Ethics committee country [1] 310168 0
Australia
Date submitted for ethics approval [1] 310168 0
31/03/2021
Approval date [1] 310168 0
07/04/2021
Ethics approval number [1] 310168 0
Audit/21/Austin/26

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

Contacts
Principal investigator
Name 116730 0
A/Prof Laurence Weinberg
Address 116730 0
Department of Anaesthesia, Austin Health,, 145 Studley Road, Heidelberg, VIC, 3084
Country 116730 0
Australia
Phone 116730 0
+61394963800
Fax 116730 0
Email 116730 0
[email protected]
Contact person for public queries
Name 116731 0
Laurence Weinberg
Address 116731 0
Department of Anaesthesia, Austin Health,, 145 Studley Road, Heidelberg, VIC, 3084
Country 116731 0
Australia
Phone 116731 0
+61394963800
Fax 116731 0
Email 116731 0
[email protected]
Contact person for scientific queries
Name 116732 0
Laurence Weinberg
Address 116732 0
Department of Anaesthesia, Austin Health,, 145 Studley Road, Heidelberg, VIC, 3084
Country 116732 0
Australia
Phone 116732 0
+61394963800
Fax 116732 0
Email 116732 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
14661Ethical approval  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
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