Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000979752
Ethics application status
Approved
Date submitted
20/08/2013
Date registered
3/09/2013
Date last updated
28/10/2021
Date data sharing statement initially provided
28/10/2021
Date results information initially provided
28/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Waist circumference and postoperative adverse effects in patients undergoing elective non-cardiac surgeries
Scientific title
Waist circumference as a predictor of major postoperative adverse outcomes following elective non-cardiac surgeries
Secondary ID [1] 283043 0
None
Universal Trial Number (UTN)
U1111-1146-9654
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity
 289877 0
postoperative adverse outcomes 289976 0
Condition category
Condition code
Anaesthesiology 290240 290240 0 0
Other anaesthesiology
Diet and Nutrition 290349 290349 0 0
Obesity
Surgery 290350 290350 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Measuring waist circumference along with neckcircumference in patients coming for noncardiac surgeries
Intervention code [1] 287762 0
Not applicable
Comparator / control treatment
Measurement of BMI along with neckcircumference in patients coming for noncardiac surgeries
Control group
Active

Outcomes
Primary outcome [1] 290261 0
Major adverse outcomes as listed below:

1. Cardiac complications:
AMI Cardiac arrest Congestive cardiac failure Significant arrhythmias
2. Pulmonary complications:
Pneumonia Re-intubation Acute respiratory failure Failure to wean >24 hours post op
3. Acute kidney injury
4. Pulmonary embolism
5. Stroke
6. Sepsis/septic shock
7. Wound infections
8. Reoperation
9. Excess bleeding
10. Death
Timepoint [1] 290261 0
within 30 days of the index operation
Secondary outcome [1] 304220 0
Length of stay from the day of surgery till discharge would be obtained from the discharge summary associated with primary admission
Timepoint [1] 304220 0
during primary hospital admission
Secondary outcome [2] 304386 0
Health care costs per patient would be obtained from the data provided by the funding, activity and costing team of the hospital respectively. Total costs will be estimated by using clinical costing systems that links patient’s hospital identification number with the individual utilisation of in-patient services and reported in Australian Dollars.
Timepoint [2] 304386 0
associated with primary admission

Eligibility
Key inclusion criteria
Adults>/=18 years age, ASA I -III undergoing intermediate to high risk noncardiac elective surgeries requiring atleast an overnight stay in the hospital.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Procedures done under local anaesthesia or monitored anaesthesia care or sedation only, patients who have been on ventilation in ICU at least 48 hours preoperative, repeat operations within 30 days( only the prime operation is considered) ,pregnancy.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
For this analysis, the predictor variables, waist circumference and BMI will be considered as both continuous and categorical variables, with cut-off values for overweight and obese as specified by the World Health Organisation. Descriptive statistics will be computed by frequency and percentage distribution for categorical data and mean with standard deviation for continuous data. A univariate logistic regression analysis of the predictor variables to the primary outcome, namely 30-day major adverse events will be performed followed by multivariate logistic regression after adjusting for the covariates namely demographics, preoperative comorbidities, preoperative laboratory values and intraoperative data including the complexity of surgeries, classified as either intermediate or high risk. Multiple least squares regression of length of stay and costs incurred on waist circumference and BMI will be separately performed both as univariate and multivariate models. These analyses will be repeated with neck circumference and waist to hip ratio to compare their association with the outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2013
Actual
9/04/2014
Date of last participant enrolment
Anticipated
Actual
10/06/2014
Date of last data collection
Anticipated
Actual
10/06/2014
Sample size
Target
200
Accrual to date
Final
153
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 1448 0
The Prince Charles Hospital - Chermside
Recruitment postcode(s) [1] 7281 0
4032 - Chermside

Funding & Sponsors
Funding source category [1] 287808 0
Other
Name [1] 287808 0
Australian Newzealand College of Anaesthetists( ANZCA) Trials group pilot grant scheme
Country [1] 287808 0
Australia
Primary sponsor type
Individual
Name
Dr.Usha Gurunathan
Address
The Prince Charles Hospital, Rode Road, Chermside, QLD 4032
Country
Australia
Secondary sponsor category [1] 286535 0
None
Name [1] 286535 0
Address [1] 286535 0
Country [1] 286535 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Many recent studies have shown that overweight and mildly obese individuals have marginally better outcomes compared to individuals with normal weight following surgery or even nonsurgical situations such as heart related problems. However, body mass index (BMI) is not an accurate measure of body fat composition. We therefore need a measure that can be used at the bedside as well as one that can accurately predict the body fat composition and hence the risk associated with surgery. This pilot study is a miniature version of a future multicentre prospective cohort study to assess if waist circumference is a predictor of postoperative major adverse outcomes after elective non-cardiac surgeries. If that is so, we would like to know if it is better predictor than the currently popular predictor, BMI. We are also testing if other measures like waist to hip ratio, neck circumference are equally useful predictors or not.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42262 0
Dr Usha Gurunathan
Address 42262 0
The Prince Charles Hospital,Rode Road, Chermside, QLD 4032
Country 42262 0
Australia
Phone 42262 0
+ 61 7 3139 4000
Fax 42262 0
Email 42262 0
[email protected]
Contact person for public queries
Name 42263 0
Usha Gurunathan
Address 42263 0
The Prince Charles Hospital,Rode Road, Chermside, QLD 4032
Country 42263 0
Australia
Phone 42263 0
+ 61 7 3139 4000
Fax 42263 0
Email 42263 0
[email protected]
Contact person for scientific queries
Name 42264 0
Usha Gurunathan
Address 42264 0
The Prince Charles Hospital,Rode Road, Chermside, QLD 4032
Country 42264 0
Australia
Phone 42264 0
+ 61 7 3139 4000
Fax 42264 0
Email 42264 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
Individual participant detail would not make any difference to their clinical care.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Plain language summaryNo This was a small study on 153 patients could n... [More Details]

Documents added automatically
No additional documents have been identified.