Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001021268
Ethics application status
Approved
Date submitted
16/05/2018
Date registered
19/06/2018
Date last updated
13/08/2019
Date data sharing statement initially provided
13/08/2019
Date results information initially provided
13/08/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hospital costs of complications following liver resection surgery
Scientific title
Health economic impact of postoperative complications following liver resection surgery
Secondary ID [1] 294880 0
None
Universal Trial Number (UTN)
U1111-1214-0405
Trial acronym
Not applicable
Linked study record
Not applicable

Health condition
Health condition(s) or problem(s) studied:
Liver resection 307832 0
Complications following liver resection 307833 0
Costs of liver resection 307834 0
Condition category
Condition code
Surgery 306879 306879 0 0
Surgical techniques
Oral and Gastrointestinal 307293 307293 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Elective or emergent liver resection, defined using the procedural ICD-10 codes: ‘30414-00: Excision of lesion of liver’, ‘30415-00: Segmental resection of liver’, ‘30418-00: Lobectomy of liver’, ‘30421-00: Trisegmental resection of liver’, ‘30427-00: Segmental resection of liver for trauma’, ‘30428-00: Lobectomy of liver for trauma’, and ‘30430-00: Trisegmental resection of live for trauma’.

The procedures were performed at the Austin Hospital, a tertiary hospital with hepato-biliary expertise, over the period of July 2010 and June 2017. Patients were followed-up for 30 days following discharge from the index admission. If no subsequent readmissions occurred within this period, follow-up ceased. If a patient was readmitted within the 30-day period, then the readmission was included, and following discharge from the readmission or end of the originial 30-day period, whichever was later, follow-up ceased.
Intervention code [1] 301195 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305870 0
Costs of complications following liver resection.

Costs of complications defined as cost of patients with complications less the cost of patients without complications (ie by comparison of patients with and without complications), and further subdivided by Clavien-Dindo grade of complication.

All costs related to the index admission for liver resection and any consequent readmissions are included. Costs related to preoperative course are not considered. Allocation of costs will be done based on service volume, and costs 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] 305870 0
Costs will be calculated from day of surgery to hospital discharge. Readmissions are considered within 30 days of discharge from the index admission.
Secondary outcome [1] 346853 0
Costs of major liver resection, defined as 4 or more liver segments resected.

All costs related to the index admission for liver resection and any consequent readmissions are included. Costs related to preoperative course are not considered. Allocation of costs will be done based on service volume, and costs 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] 346853 0
Costs will be calculated from day of surgery to hospital discharge. Readmissions are considered within 30 days of discharge from the index admission.
Secondary outcome [2] 346857 0
Costs of minor liver resection, defined as less than 4 liver segments resected.

All costs related to the index admission for liver resection and any consequent readmissions are included. Costs related to preoperative course are not considered. Allocation of costs will be done based on service volume, and costs 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 [2] 346857 0
Costs will be calculated from day of surgery to hospital discharge. Readmissions are considered within 30 days of discharge from the index admission.
Secondary outcome [3] 346858 0
Complications following major liver resection

Complications were assessed using the Clavien-Dindo system, a previously validated tool for grading complications. Possible complications include bile leak, infection, haemorrhage, liver failure, death, etc.
Timepoint [3] 346858 0
Complications are considered retrospectively at discharge from the completion of surgery to hospital discharge for the index admission only.
Secondary outcome [4] 346859 0
Complications following minor liver resection

Complications were assessed using the Clavien-Dindo system, a previously validated tool for grading complications. Possible complications include bile leak, infection, haemorrhage, etc
Timepoint [4] 346859 0
Complications are considered retrospectively at discharge from the completion of surgery to hospital discharge for the index admission only.
Secondary outcome [5] 347975 0
Cost of open liver resection

All costs related to the index admission for liver resection and any consequent readmissions are included. Costs related to preoperative course are not considered. Allocation of costs will be done based on service volume, and costs 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 [5] 347975 0
Costs will be calculated from day of surgery to hospital discharge. Readmissions are considered within 30 days of discharge from the index admission.
Secondary outcome [6] 347976 0
Cost of laparoscopic liver resection

All costs related to the index admission for liver resection and any consequent readmissions are included. Costs related to preoperative course are not considered. Allocation of costs will be done based on service volume, and costs 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 [6] 347976 0
Costs will be calculated from day of surgery to hospital discharge. Readmissions are considered within 30 days of discharge from the index admission.
Secondary outcome [7] 347977 0
Complications following open liver resection

Complications were assessed using the Clavien-Dindo system, a previously validated tool for grading complications. Possible complications include bile leak, infection, haemorrhage, liver failure, death, etc
Timepoint [7] 347977 0
Complications are considered retrospectively at discharge from the completion of surgery to hospital discharge for the index admission only.
Secondary outcome [8] 347978 0
Complications following laparoscopic liver resection

Complications were assessed using the Clavien-Dindo system, a previously validated tool for grading complications. Possible complications include bile leak, infection, haemorrhage, liver failure, death, etc
Timepoint [8] 347978 0
Complications are considered retrospectively at discharge from the completion of surgery to hospital discharge for the index admission only.

Eligibility
Key inclusion criteria
- Patients undergoing hepatic resection at the Austin Hospital.
- Included procedural ICD-10 codes were ‘30414-00: Excision of lesion of liver’, ‘30415-00: Segmental resection of liver’, ‘30418-00: Lobectomy of liver’, ‘30421-00: Trisegmental resection of liver’, ‘30427-00: Segmental resection of liver for trauma’, ‘30428-00: Lobectomy of liver for trauma’, and ‘30430-00: Trisegmental resection of live for trauma’
- elective and emergent cases
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients admitted more than one day prior to liver resection were excluded, to ensure cost data accurately reflected only operative and postoperative costs
Patients undergoing liver resection that was minor and secondary to another concomitant major procedure were excluded.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
The Mann-Whitney U, Student t, 1-way ANOVA, and Kruskal-Wallis tests will be used to compare continuous variables where relevant. The Fisher exact and Pearson’s Chi-square test will be used to compare proportions as appropriate. All calculated p-values will be two-sided. A p-value of =0.05 will be considered significant, however, given that multiple comparisons will be used when comparing cost categories, we will apply the Bonferroni correction and consider statistical significance as a p-value of =0.005 when comparing costs. GraphPad Prism 7 (version 7.04) and Stata Statistical Software (Release 15) will be used for all analyses.

Additional analysis will be completed using cluster based analysis with Kohonen’s self-organized feature maps as implemented in Viscovery SOMine software.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
26/02/2018
Date of last participant enrolment
Anticipated
Actual
16/04/2018
Date of last data collection
Anticipated
Actual
16/04/2018
Sample size
Target
300
Accrual to date
Final
317
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10891 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 22652 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 299465 0
Hospital
Name [1] 299465 0
Department of Anaesthesia, Austin Health
Country [1] 299465 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia, Austin Health
Address
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg VIC, 3084, Australia
Country
Australia
Secondary sponsor category [1] 298765 0
None
Name [1] 298765 0
Address [1] 298765 0
Country [1] 298765 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300372 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 300372 0
L8 Harold Stokes Building 145 Studley Road Heidelberg Victoria Australia 3084
PO Box 5555
Ethics committee country [1] 300372 0
Australia
Date submitted for ethics approval [1] 300372 0
Approval date [1] 300372 0
17/03/2017
Ethics approval number [1] 300372 0
LNR/17/Austin/78

Summary
Brief summary
Hepatic resection remains the standard of care for both malignant and benign tumours of the liver, despite numerous advances in tumour ablation, targeted radiation therapy, immunotherapy, and chemotherapy for liver cancers and related pathologies. As perioperative outcomes have improved over the last two decades, along with developments in the diagnosis and management of liver tumours, indications for hepatic resection have broadened. Accordingly, increasing knowledge of liver anatomy and physiology, alongside improving outcomes following hepatic resection, has fostered an increase in the complexity and extent of disease that is considered operable, with repeat and two-stage resections becoming increasingly more common. Increasing complexity and extent of hepatic resection carries an increase in the incidence and severity of postoperative complications, with typically more than 50% of patients experiencing complications even in high volume centres.

Complications following liver resection not only carry a substantial clinical burden, they also place a growing economic burden upon healthcare providers. Complications present the greatest contribution to increased costs following hepatic resection, and consequently provide an important target for interventions seeking to reduce healthcare expenditure. As the demand for healthcare grows, utilising limited resources in an era of mounting costs is becoming paramount in maintaining an effective and universally available healthcare system. Despite this, there is limited health economic data available on the topic of hepatic resection, and even less so quantifying the cost of complications.

Aiming to address this need, we aim to identify the relationship between the extent of liver resection, the incidence and severity of complications, and the ensuing costs. Additionally, we seek to examine the sources of cost differentials between complicated and uncomplicated patients. Secondary objectives aim to assess the impact of surgical technique on the incidence and severity of complications and associated costs. We also aim to identify patient and anaesthetic factors associated with the clinical and economic outcomes.

We hypothesised that as more extensive hepatic resection was performed the incidence and severity of complications would increase, and accordingly an increase in costs would be associated.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83442 0
A/Prof Laurence Weinberg
Address 83442 0
145 Studley Road Heidelberg VIC 3084
Department of Anaesthesia, Austin Health
Country 83442 0
Australia
Phone 83442 0
+61 03 94965000
Fax 83442 0
Email 83442 0
[email protected]
Contact person for public queries
Name 83443 0
A/Prof Laurence Weinberg
Address 83443 0
145 Studley Road Heidelberg VIC 3084
Department of Anaesthesia, Austin Health
Country 83443 0
Australia
Phone 83443 0
+61 03 94965000
Fax 83443 0
Email 83443 0
[email protected]
Contact person for scientific queries
Name 83444 0
A/Prof Laurence Weinberg
Address 83444 0
145 Studley Road Heidelberg VIC 3084
Department of Anaesthesia, Austin Health
Country 83444 0
Australia
Phone 83444 0
+61 03 94965000
Fax 83444 0
Email 83444 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 a retrospective study, participants have not not consented for their data to be shared.


What supporting documents are/will be available?

No Supporting Document Provided



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.