Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000803190
Ethics application status
Approved
Date submitted
12/05/2019
Date registered
3/06/2019
Date last updated
3/06/2019
Date data sharing statement initially provided
3/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Hospital costs of complications following bowel resection surgery
Scientific title
Financial burden of postoperative complications following colonic resection surgery
Secondary ID [1] 295959 0
None
Universal Trial Number (UTN)
U1111-1219-7232
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colon cancer 309590 0
Inflammatory Bowel Disease 312743 0
Diverticulitis 312753 0
Condition category
Condition code
Surgery 308409 308409 0 0
Surgical techniques
Oral and Gastrointestinal 308410 308410 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Anaesthesiology 311249 311249 0 0
Anaesthetics
Cancer 311461 311461 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Oral and Gastrointestinal 311462 311462 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Elective or emergent colonic resection, defined using the procedural ICD-10 codes:
32000-00 Limited excision of large intestine with formation of stoma
32000-01 Right hemicolectomy with formation of stoma
32000-02 Laparoscopic limited excision of large intestine with formation of stoma
32000-03 Laparoscopic right hemicolectomy with formation of stoma
32003-00 Limited excision of large intestine with anastomosis
32003-01 Right hemicolectomy with anastomosis
32003-02 Laparoscopic limited excision of large intestine with anastomosis
32003-03 Laparoscopic right hemicolectomy with anastomosis
32004-00 Subtotal colectomy with formation of stoma
32004-01 Extended right hemicolectomy with formation of stoma
32004-02 Laparoscopic subtotal colectomy with formation of stoma
32004-03 Laparoscopic extended right hemicolectomy with formation of stoma
32005-00 Subtotal colectomy with anastomosis
32005-01 Extended right hemicolectomy with anastomosis
32005-02 Laparoscopic subtotal colectomy with anastomosis
32005-03 Laparoscopic extended right hemicolectomy with anastomosis
32006-00 Left hemicolectomy with anastomosis
32006-01 Left hemicolectomy with formation of stoma
32006-02 Laparoscopic left hemicolectomy with anastomosis
32006-03 Laparoscopic left hemicolectomy with formation of stoma
32009-00 Total colectomy with ileostomy
32009-01 Laparoscopic total colectomy with ileostomy
32012-00 Total colectomy with ileorectal anastomosis
32012-01 Laparoscopic total colectomy with ileorectal anastomosis


The procedures were performed at the Austin Hospital, a tertiary hospital with colorectal expertise, over the period of January 2013 and June 2018. 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 original 30-day period, whichever was later, follow-up ceased.
Intervention code [1] 312380 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307376 0
Costs of complications (as a composite outcome) following Colon resections.

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). All costs related to the index admission for colon resection and any consequent readmissions are included. Costs related to preoperative course are not considered. Allocation of 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] 307376 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] 351697 0
Costs of colon resection, defined as complete excision of any part of the large bowel (excluding rectum) and includes the following procedures: cecectomy, right hemicolectomy, left hemicolectomy, sigmoidectomy, transverse colectomy, partial and total colectomy. All costs related to the index admission for colon resection and any consequent readmissions are included. Costs related to preoperative course are not considered. Allocation of 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] 351697 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] 351698 0
Costs of laparoscopic colon resection.

All costs related to the index admission for colon resection and any consequent readmissions are included. Costs related to preoperative course are not considered. Allocation of 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 [2] 351698 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] 351699 0
Costs of open colon resection.

All costs related to the index admission for colon resection and any consequent readmissions are included. Costs related to preoperative course are not considered. Allocation of 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 [3] 351699 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 [4] 351701 0
Complications following colonic resection.

Complications were assessed using the Clavien-Dindo system, a previously validated tool for grading complications. Possible complications include anastomotic leak, infection, haemorrhage, Ileus, death, etc.
Timepoint [4] 351701 0
Complications are considered retrospectively at discharge from the completion of surgery to hospital discharge for the index admission only.
Secondary outcome [5] 370766 0
Severity of complications defined by the validated Clavien-Dindo classification for the grading of surgical complications.
Timepoint [5] 370766 0
From completion of surgery (last surgical stitch) to hospital discharge.

Eligibility
Key inclusion criteria
Adult patients (>18 years of age) undergoing any form of colon resection at the Austin Hospital were included. Colonic resection will be defined as complete excision of any part of the large bowel (excluding rectum) and includes the following procedures: cecectomy, right hemicolectomy, left hemicolectomy, sigmoidectomy, transverse colectomy, partial and total colectomy. All surgical techniques will be included. Any indication for colon resection will be included. Both emergent and elective patients will be included.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients undergoing colon resection that was minor and secondary to another concomitant major procedure were excluded.

Study design
Purpose
Natural history
Duration
Longitudinal
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
4/03/2019
Date of last participant enrolment
Anticipated
Actual
6/05/2019
Date of last data collection
Anticipated
Actual
6/05/2019
Sample size
Target
450
Accrual to date
Final
497
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 12962 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 25440 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 300555 0
Hospital
Name [1] 300555 0
Department of Anaesthesia, Austin Health
Country [1] 300555 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] 300039 0
None
Name [1] 300039 0
Address [1] 300039 0
Country [1] 300039 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301349 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 301349 0
Ethics committee country [1] 301349 0
Australia
Date submitted for ethics approval [1] 301349 0
02/08/2018
Approval date [1] 301349 0
14/08/2018
Ethics approval number [1] 301349 0
LNR/18/Austin/350

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

Contacts
Principal investigator
Name 86698 0
A/Prof Laurence Weinberg
Address 86698 0
145 Studley Road Heidelberg VIC 3084 Department of Anaesthesia, Austin Health
Country 86698 0
Australia
Phone 86698 0
+61 03 94965000
Fax 86698 0
Email 86698 0
[email protected]
Contact person for public queries
Name 86699 0
Laurence Weinberg
Address 86699 0
145 Studley Road Heidelberg VIC 3084 Department of Anaesthesia, Austin Health
Country 86699 0
Australia
Phone 86699 0
+61 03 94965000
Fax 86699 0
Email 86699 0
[email protected]
Contact person for scientific queries
Name 86700 0
Laurence Weinberg
Address 86700 0
145 Studley Road Heidelberg VIC 3084 Department of Anaesthesia, Austin Health
Country 86700 0
Australia
Phone 86700 0
+61 03 94965000
Fax 86700 0
Email 86700 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 informed consent 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
SourceTitleYear of PublicationDOI
EmbaseThe hospital costs of complications following colonic resection surgery: A retrospective cohort study.2020https://dx.doi.org/10.1016/j.amsu.2020.03.013
N.B. These documents automatically identified may not have been verified by the study sponsor.