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Trial registered on ANZCTR


Registration number
ACTRN12620001208998
Ethics application status
Approved
Date submitted
5/10/2020
Date registered
13/11/2020
Date last updated
13/11/2020
Date data sharing statement initially provided
13/11/2020
Date results information initially provided
13/11/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Measuring the impact of anaesthetic drug volume during surgery
Scientific title
MEasuring the impact of Anaesthetic drug volumeS on intra-operative flUid balance duRing prolonged abdominal surgEry (MEASURE)
Secondary ID [1] 302469 0
Nil known
Universal Trial Number (UTN)
U1111-1259-2094
Trial acronym
MEASURE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Pancreaticoduodenectomy 319300 0
Anaesthesia medications 319301 0
Condition category
Condition code
Anaesthesiology 317267 317267 0 0
Anaesthetics
Surgery 317268 317268 0 0
Other surgery
Cancer 317269 317269 0 0
Pancreatic
Oral and Gastrointestinal 317270 317270 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
There is no participant involvement. Only the de-identified hospital medical record of patients who have undergone pancreaticoduodenectomy (Whipple's operation) at the Austin Hospital from 1st Jan 2010 to 1st June 2020 will be reviewed.
Intervention code [1] 318761 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325326 0
The primary outcome will be the volume (measured in milliliters) of intravenous anaesthesia medications and infusions administered intraoperatively in adult patients undergoing pancreaticoduodenectomy. This outcome will be obtained by extracting this data from the intraoperative anaesthesia medical record.
Timepoint [1] 325326 0
During the intraoperative period i.e. from anaesthesia induction to completion of surgery.
Secondary outcome [1] 387511 0
The secondary outcome will be the intraoperative fluid balance (measured in milliliters).

Intraoperative fluid balance will be calculated using the following formula: Fluid input (sum of all anaesthesia medications + crystalloids + colloids + blood or blood products) minus Fluid output (sum of all fluid loses i.e. urine output + blood loss + nasogastric loss). This outcome will be obtained by extracting this data from the intraoperative anaesthesia medical record.

Timepoint [1] 387511 0
During the intraoperative period i.e. form anaesthesia induction to completion of surgery.
Secondary outcome [2] 387512 0
To analyse the association of anaesthesia medications on the development of postoperative complications.

Complications will be assessed using the Clavien-Dindo system, a validated tool for grading complications. This outcome will be obtained by reviewing data-linkage to the Austin hospital's medical records.
Timepoint [2] 387512 0
From completion of surgery (last surgical stitch) to hospital discharge.
Secondary outcome [3] 387513 0
To analyse the association of anaesthesia medications and hospital length of stay.

This outcome will be obtained by reviewing data-linkage to the Austin hospital's medical records.
Timepoint [3] 387513 0
Hospital length of stay will be calculated in days from completion of surgery to discharge from hospital. This outcome will be obtained by reviewing data-linkage to the Austin hospital's medical records.

Eligibility
Key inclusion criteria
Adult patients who underwent a pancreaticoduodenectomy between 1st January 2010 to 1st June 2020 for any indication at the Austin Hospital will be eligible. Any indication for pancreaticoduodenectomy will be considered. Both emergent and elective procedures will also be considered.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
We will exclude the following patients:
1. Distal pancreatectomy
2. Central pancreatectomy
3. Total pancreatectomy

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Collected data will be arranged using Microsoft Excel (Microsoft Office 365 version 2008, Microsoft corp., WA, USA).

Statistical analysis will be performed using R version 4.0.0 (R Development Core Team, Vienna, Austria, 2020).

Missing data analysis will be applied to detect a greater than 5% missing rate of all variables. For variables with a missing rate lower than 5%, cases will be analysed as planned. For variables with a missing rate of over 5%, the multiple imputation method will be applied.

Normality tests will then be performed for all continuous variables using Q-Q plot. If these tests are violated, non-parametric statistical methods or log-transformation will be applied.

Paired and unpaired t-test, Spearman’s correlation analysis, and receiver-operator characteristic curve (ROC) analysis will be used to investigate the primary and secondary outcomes. The R packages of “pROC” and “plotROC” will be used for ROC analysis.

Data will be presented as mean ± standard deviation (SD) or median (IQR)[Max:Min] 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 or a Bonferonni’s corrected value will be considered to be statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 17736 0
Austin Health - Austin Hospital - Heidelberg

Funding & Sponsors
Funding source category [1] 306894 0
Hospital
Name [1] 306894 0
Department of Anaesthesia, Austin Health
Address [1] 306894 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg VIC, 3084
Country [1] 306894 0
Australia
Primary sponsor type
Hospital
Name
Department of Anaesthesia, Austin Health
Address
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg VIC, 3084
Country
Australia
Secondary sponsor category [1] 307451 0
None
Name [1] 307451 0
Address [1] 307451 0
Country [1] 307451 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307050 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 307050 0
L8 Harold Stokes Building 145 Studley Road Heidelberg Victoria Australia 3084
PO Box 5555
Ethics committee country [1] 307050 0
Australia
Date submitted for ethics approval [1] 307050 0
02/10/2020
Approval date [1] 307050 0
28/10/2020
Ethics approval number [1] 307050 0

Summary
Brief summary
There has been recent interest in fluid balance during surgery and the impact on patient recovery. However, it is currently unknown whether any anaesthetic drugs substantially impact upon fluid balance during surgery. The aim of this study is to provide a thorough analysis of the medications and infusions provided to patients during a pancreaticoduodenectomy (also known as a Whipple procedure).

Who is it for?
You may be eligible for this study if you are an adult who underwent a pancreaticoduodenectomy (Whipple procedure) at the Austin Hospital between January 2011 and June 2020.

Study details
This study will be conducted using a review of medical records, and no patient contact is required. The study will review the medical records of adult patients who underwent a pancreaticoduodenectomy at the Austin Hospital between 1st January 2011 and 1st June 2020.

It is hoped that this research will help to provide a better understanding of fluid balance during surgery and the impact of fluid balance on complications and outcomes after surgery.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 105850 0
A/Prof Laurence Weinberg
Address 105850 0
145 Studley Road, Heidelberg , VIC, 3084, Department of Anaesthesia, Austin Health
Country 105850 0
Australia
Phone 105850 0
+61 3 94963800
Fax 105850 0
Email 105850 0
laurence.weinberg@austin.org.au
Contact person for public queries
Name 105851 0
A/Prof Laurence Weinberg
Address 105851 0
145 Studley Road, Heidelberg , VIC, 3084, Department of Anaesthesia, Austin Health
Country 105851 0
Australia
Phone 105851 0
+61 3 94963800
Fax 105851 0
Email 105851 0
laurence.weinberg@austin.org.au
Contact person for scientific queries
Name 105852 0
A/Prof Laurence Weinberg
Address 105852 0
145 Studley Road, Heidelberg , VIC, 3084, Department of Anaesthesia, Austin Health
Country 105852 0
Australia
Phone 105852 0
+61 3 94963800
Fax 105852 0
Email 105852 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 a retrospective observational study, patients have not provided consent for their data to be shared.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary