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Trial registered on ANZCTR


Registration number
ACTRN12620001377921
Ethics application status
Approved
Date submitted
20/11/2020
Date registered
22/12/2020
Date last updated
22/12/2020
Date data sharing statement initially provided
22/12/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Costs of complications following oesophageal resection surgery
Scientific title
The health costs of complications following oesophageal resection surgery
Secondary ID [1] 299235 0
None
Universal Trial Number (UTN)
U1111-1239-9745
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oesophageal resections 319813 0
Complications following oesophagectomy 319814 0
Oesophageal cancer 319815 0
Condition category
Condition code
Surgery 317744 317744 0 0
Surgical techniques
Anaesthesiology 317745 317745 0 0
Anaesthetics
Cancer 317746 317746 0 0
Oesophageal (gullet)
Oral and Gastrointestinal 317747 317747 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
In this study we will be observing complications after oesophagectomy and the associated hospital costs. As this is a retrospective study, there is no participant involvement. Only the de-identified hospital medical record of patients who have oesophagectomy will be reviewed.

We will review the following ICD Codes:

30294-00 Cervical oesophagectomy
30535-00 Oesophagectomy by abdominal and transthoracic mobilisation, with thoracic oesophagogastric anastomosis
30536-00 Oesophagectomy by abdominal and transthoracic mobilisation, with cervical oesophagogastric anastomosis
30536-01 Oesophagectomy by abdominal and transthoracic mobilisation, with cervical oesophagostomy
30541-00 Trans-hiatal oesophagectomy by abdominal and cervical mobilisation, with oesophagogastric anastomosis
30541-01 Trans-hiatal oesophagectomy by abdominal and cervical mobilisation, with oesophagojejunal anastomosis
30545-00 Oesophagectomy by abdominal and thoracic mobilisation with thoracic anastomosis, large intestine interposition and anastomosis
30545-01 Oesophagectomy by abdominal and thoracic mobilisation with thoracic anastomosis using Roux-en-Y reconstruction
30550-00 Oesophagectomy by abdominal and thoracic mobilisation with cervical anastomosis, large intestine interposition and anastomosis
30550-01 Oesophagectomy by abdominal and thoracic mobilisation with cervical anastomosis using Roux-en-Y reconstruction
30554-00 Oesophagectomy with reconstruction by free jejunal flap
30554-01 Oesophagectomy with reconstruction by other free flap
43903-00 Replacement of oesophagus using intestine, paediatric
43906-00 Partial resection of oesophagus with anastomosis, paediatric
43906-01 Total resection of oesophagus with anastomosis, paediatric

The procedures were performed at the Austin Hospital, a tertiary hospital with oesophagectomy expertise over the period of 1 January 2010 to 31 December 2019 (10-year period). Patients were followed-up following discharge from their index admission. Readmissions for up to 90 days postoperatively will be collected.
Intervention code [1] 319115 0
Not applicable
Comparator / control treatment
There are two patient cohorts that will be compared:- those wth complications and those patients without complications.
Control group
Active

Outcomes
Primary outcome [1] 325776 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 esophageal resections 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] 325776 0
Costs will be calculated from day of surgery to hospital discharge. Readmissions will be considered within 90 days of discharge from the index admission.
Secondary outcome [1] 389112 0
Complications following oesophageal resection.

Complications will be assessed using the Clavien-Dindo system, a previously validated tool for grading complications. Possible complications include anastomotic leak, infection, haemorrhage, death, etc. This outcome will be obtained by reviewing data-linkage to the Austin hospital's medical records.
Timepoint [1] 389112 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 who undergo oesophagectomy for any indication at the Austin Hospital will be considered.

Oesophagectomy be defined as any procedure which involves partial or full removal of the oesophagus. All surgical techniques will be considered. Any indication for a oesophagectomy will be considered.

Both emergent and elective procedures will also be considered.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have the following procedures will be excluded:
1. Reconstructive oesophageal procedures without any resection eg. colonic interposition or any interposition graft. without resection.
2. Oesophageal biopsies
3. Laryngectomy with oesophagectomy as a secondary procedure

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, Armonk, NY, USA) and R version 4.0.0 (R Development Core Team, Vienna, Austria, 2020). Study patients will be classified into two groups: the ‘no complication group for patients who did not experience postoperative complications and the ‘complication group for patients who experienced one or more postoperative complications.

Before statistical analysis, missing data analysis will be performed to detect more than 5% missing values for all variables. For variables with less than 5% of missing values, statistical analysis excluding cases by analysis will be planned. The multiple imputation method will be performed in cases of missing values of more than 5%. All continuous variables will be tested for normality using the Q-Q plot. If the normality assumption is violated, non-parametric statistical methods will be considered.

Comparative statistics will be estimated using Student’s t-test, Mann–Whitney U test, Chi-square test, Cochran–Armitage test, and Fisher’s exact test, depending on the characteristics of the variables and the results of the required assumption tests. 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.

Total hospital costs in relation to complications will be analyzed using unadjusted and adjusted hospital costs. For the adjusted analyses, costs will be analyzed according to the occurrence, number, and severity of complications using covariates of both clinical and statistical importance. To evaluate the unadjusted relationship between postoperative complications and hospital costs, the Mann–Whitney U test and the Kruskal–Wallis H test will be used. If the Kruskal–Wallis H test reveals significant differences, all multiple pairwise comparisons will be performed under a Bonferroni adjusted P-value. Detailed cost items will be compared by the groups and the number and severity of complications using the Mann–Whitney U and the Kruskal–Wallis H tests.

For the adjusted hospital cost analysis as the primary outcome, we will use a bootstrapped quantile regression model. The independent variable will be the presence, number, and severity of complications; the dependent variable will be hospital cost. The a priori selected covariates will be defined a-priori. If hospital cost have a severely positively skewed distribution we will use quantile regression modeling to investigate the cost-driving effects of complications according to low (25th quantile), median (50th quantile), and high (75th quantile) cost brackets. Spearman’s correlation analysis will be performed to clarify which variables were in a relationship with complications and hospital costs. To assess multicollinearity, variance inflation factors will be used. The estimated values will be expressed with a 95% confidence interval (95% CI). To correct for multiple comparisons, the Bonferroni correction will be applied where necessary.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
10/10/2019
Date of last participant enrolment
Anticipated
Actual
19/10/2020
Date of last data collection
Anticipated
Actual
19/11/2020
Sample size
Target
120
Accrual to date
Final
110
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18066 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 32054 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 303776 0
Hospital
Name [1] 303776 0
Austin Health - Austin Hospital - Heidelberg
Country [1] 303776 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] 303895 0
None
Name [1] 303895 0
Address [1] 303895 0
Country [1] 303895 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304295 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 304295 0
Ethics committee country [1] 304295 0
Australia
Date submitted for ethics approval [1] 304295 0
10/09/2019
Approval date [1] 304295 0
23/11/2019
Ethics approval number [1] 304295 0
HREC/19/Austin/103

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

Contacts
Principal investigator
Name 96434 0
A/Prof Laurence Weinberg
Address 96434 0
Department of Anaesthesia, Austin Health,, 145 Studley Road, Heidelberg, VIC, 3084
Country 96434 0
Australia
Phone 96434 0
+61 03 94963800
Fax 96434 0
Email 96434 0
laurence.weinberg@austin.org.au
Contact person for public queries
Name 96435 0
Laurence Weinberg
Address 96435 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg, VIC, 3084
Country 96435 0
Australia
Phone 96435 0
+61 03 94963800
Fax 96435 0
Email 96435 0
laurence.weinberg@austin.org.au
Contact person for scientific queries
Name 96436 0
Laurence Weinberg
Address 96436 0
Department of Anaesthesia, Austin Health, 145 Studley Road Heidelberg VIC 3084
Country 96436 0
Australia
Phone 96436 0
+61 03 94963800
Fax 96436 0
Email 96436 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
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
9813Ethical approval  laurence.weinberg@austin.org.au 378344-(Uploaded-20-11-2020-17-59-56)-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
No additional documents have been identified.