Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000322932
Ethics application status
Approved
Date submitted
9/02/2020
Date registered
9/03/2020
Date last updated
9/03/2020
Date data sharing statement initially provided
9/03/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The hospital costs associated with postoperative complications following small bowel resection surgery
Scientific title
The hospital costs associated with postoperative complications following small bowel resection surgery: a cohort study
Secondary ID [1] 298906 0
None
Universal Trial Number (UTN)
U1111-1237-8840
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Small bowel resection 316104 0
Complications following small bowel resection 316105 0
Inflammatory Bowel Disease 316109 0
Small Bowel Cancer 316110 0
Condition category
Condition code
Surgery 314390 314390 0 0
Surgical techniques
Oral and Gastrointestinal 314391 314391 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Oral and Gastrointestinal 314392 314392 0 0
Inflammatory bowel disease
Anaesthesiology 314393 314393 0 0
Anaesthetics
Cancer 314394 314394 0 0
Bowel - Small bowel (duodenum and ileum)

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
There is no participant involvement. Only the de-identified hospital medical record of patients who have undergone surgery will be reviewed.

We will review the following ICD Codes:
30515-03 Ileocolic resection with anastomosis
30515-04 Laparoscopic ileocolic resection with anastomosis
30515-05 Ileocolic resection with formation of stoma
30515-06 Laparoscopic ileocolic resection with formation of stoma
30565-00 Resection of small intestine with formation of stoma
30566-00 Resection of small intestine with anastomosis

The procedures were performed at the Austin Hospital, a tertiary hospital with small bowel 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 re-admissions 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] 316736 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 322748 0
Costs of complications as a composite outcome defined as cost of patients with complications less the cost of patients without complications (i.e. by comparison of patients with and without complications).

All costs related to the index admission for small bowel resections 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] 322748 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] 379559 0
Costs of small bowel resection

All costs related to the index admission for small bowel resection and any consequent readmissions are included. Costs related to preoperative course are not considered. Costs are 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] 379559 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] 379561 0
Complications following small bowel resection

Complications were 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 [2] 379561 0
Complications are considered retrospectively at discharge from the completion of surgery to hospital discharge for the index admission only.
Secondary outcome [3] 379562 0
Cost of Open small bowel resection

All costs related to the index admission for small bowel resection and any consequent readmissions are included. Costs related to preoperative course are not considered. Costs are 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] 379562 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] 379563 0
Cost of Laparoscopic small bowel resection

All costs related to the index admission for small bowel resection and any consequent readmissions are included. Costs related to preoperative course are not considered. Costs are 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 [4] 379563 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 [5] 379564 0
Severity of complications. This outcomes will be defined by a validated grading classification for surgical complications i.e. Clavien-Dindo grading system for surgical complications. This outcome will be obtained by reviewing data-linkage to the Austin hospital's medical records.
Timepoint [5] 379564 0
From completion of surgery (last surgical stitch) to hospital discharge

Eligibility
Key inclusion criteria
Patients who undergo a small bowel resection for any indication at the Austin Hospital were considered. Small bowel resection will be defined as any procedure which involves partial or full removal of the small bowel. All surgical techniques will be considered. Any indication for a small bowel resection will be considered. Both emergent and elective would 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 undergoing small bowel 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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
5/09/2019
Date of last participant enrolment
Anticipated
Actual
28/01/2020
Date of last data collection
Anticipated
Actual
28/01/2020
Sample size
Target
350
Accrual to date
Final
395
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15774 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 29207 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 303454 0
Hospital
Name [1] 303454 0
Department of Anaesthesia, Austin Health
Country [1] 303454 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] 303505 0
None
Name [1] 303505 0
Address [1] 303505 0
Country [1] 303505 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303984 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 303984 0
Ethics committee country [1] 303984 0
Australia
Date submitted for ethics approval [1] 303984 0
23/08/2019
Approval date [1] 303984 0
04/09/2019
Ethics approval number [1] 303984 0
Audit/19/Austin/88

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

Contacts
Principal investigator
Name 95458 0
A/Prof Laurence Weinberg
Address 95458 0
145 Studley Road Heidelberg VIC 3084
Department of Anaesthesia, Austin Health
Country 95458 0
Australia
Phone 95458 0
+61 03 94965000
Fax 95458 0
Email 95458 0
[email protected]
Contact person for public queries
Name 95459 0
Laurence Weinberg
Address 95459 0
145 Studley Road Heidelberg VIC 3084
Department of Anaesthesia, Austin Health
Country 95459 0
Australia
Phone 95459 0
+61 03 94965000
Fax 95459 0
Email 95459 0
[email protected]
Contact person for scientific queries
Name 95460 0
Laurence Weinberg
Address 95460 0
145 Studley Road Heidelberg VIC 3084
Department of Anaesthesia, Austin Health
Country 95460 0
Australia
Phone 95460 0
+61 03 94965000
Fax 95460 0
Email 95460 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 has not provided consent for their data to be shared.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
6749Ethical approval  [email protected] 378100-(Uploaded-09-02-2020-20-03-10)-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
SourceTitleYear of PublicationDOI
EmbasePostoperative complications and hospital costs following small bowel resection surgery.2020https://dx.doi.org/10.1371/journal.pone.0241020
N.B. These documents automatically identified may not have been verified by the study sponsor.