Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000806167
Ethics application status
Approved
Date submitted
12/05/2019
Date registered
3/06/2019
Date last updated
4/02/2020
Date data sharing statement initially provided
3/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Costs of complications following rectal resection surgery
Scientific title
The health costs of complications following rectal resection surgery
Secondary ID [1] 298173 0
None
Universal Trial Number (UTN)
U1111-1232-9829
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rectal resection 312734 0
Complications following rectal resection 312751 0
Inflammatory Bowel Disease 312752 0
Diverticulitis 312754 0
Rectal Cancer
 312756 0
Condition category
Condition code
Surgery 311235 311235 0 0
Surgical techniques
Oral and Gastrointestinal 311238 311238 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Anaesthesiology 311241 311241 0 0
Anaesthetics
Cancer 311459 311459 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Oral and Gastrointestinal 311460 311460 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
ICD Codes that were included were:
32026-00 Ultra low anterior resection of rectum
32024-00 High anterior resection of rectum
32030-00 Rectosigmoidectomy with formation of stoma
32028-00 Ultra low anterior resection of rectum with hand sutured coloanal anastomosis
32030-01 Laparoscopic rectosigmoidectomy with formation of stoma
32051-00 Total proctocolectomy with ileo-anal anastomosis
32039-00 Abdominoperineal proctectomy
32025-00 Low anterior resection of rectum
92208-00 Anterior resection of rectum, level unspecified
32015-00 Total proctocolectomy with ileostomy
32051-01 Total proctocolectomy with ileo-anal anastomosis and formation of temporary ileostomy
32112-00 Perineal rectosigmoidectomy
32047-00 Perineal proctectomy

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] 314405 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319993 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 rectal 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] 319993 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] 370131 0
Costs of rectal resection

All costs related to the index admission for rectal 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] 370131 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] 370132 0
Complications following rectal 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.
Timepoint [2] 370132 0
Complications are considered retrospectively at discharge from the completion of surgery to hospital discharge for the index admission only.
Secondary outcome [3] 370133 0
Cost of Open rectal resection

All costs related to the index admission for rectal 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] 370133 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] 370134 0
Cost of Laparoscopic rectal resection

All costs related to the index admission for rectal 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] 370134 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] 370765 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
Timepoint [5] 370765 0
From completion of surgery (last surgical stitch) to hospital discharge

Eligibility
Key inclusion criteria
Patients who undergo a rectal resection for any indication at the Austin Hospital were considered. Rectal resection will be defined as any procedure which involves partial or full removal of the rectum. All surgical techniques will be considered. Any indication for a rectal 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 rectal 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
350
Accrual to date
Final
389
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13714 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 26409 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 302708 0
Hospital
Name [1] 302708 0
Department of Anaesthesia, Austin Health
Country [1] 302708 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] 302641 0
None
Name [1] 302641 0
Address [1] 302641 0
Country [1] 302641 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303318 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 303318 0
Ethics committee country [1] 303318 0
Australia
Date submitted for ethics approval [1] 303318 0
15/08/2018
Approval date [1] 303318 0
16/08/2018
Ethics approval number [1] 303318 0
LNR/18/Austin/358

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

Contacts
Principal investigator
Name 93254 0
A/Prof Laurence Weinberg
Address 93254 0
145 Studley Road Heidelberg VIC 3084
Department of Anaesthesia, Austin Health
Country 93254 0
Australia
Phone 93254 0
+61 03 94965000
Fax 93254 0
Email 93254 0
[email protected]
Contact person for public queries
Name 93255 0
Laurence Weinberg
Address 93255 0
145 Studley Road Heidelberg VIC 3084
Department of Anaesthesia, Austin Health
Country 93255 0
Australia
Phone 93255 0
+61 03 94965000
Fax 93255 0
Email 93255 0
[email protected]
Contact person for scientific queries
Name 93256 0
Laurence Weinberg
Address 93256 0
145 Studley Road Heidelberg VIC 3084
Department of Anaesthesia, Austin Health
Country 93256 0
Australia
Phone 93256 0
+61 03 94965000
Fax 93256 0
Email 93256 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
6730Ethical approval  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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