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Trial registered on ANZCTR


Registration number
ACTRN12615001264572
Ethics application status
Approved
Date submitted
13/11/2015
Date registered
19/11/2015
Date last updated
1/09/2020
Date data sharing statement initially provided
1/09/2020
Date results information initially provided
1/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Use of the six minute walk test to predict recovery and complications in morbidly obese patients undergoing elective surgery
Scientific title
In severely obese patients presenting for elective surgery, can the six minute walk test predict recovery and medical complications?
Secondary ID [1] 287886 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Severe obesity 296771 0
Post-operative functional recovery and medical complications 296772 0
Condition category
Condition code
Diet and Nutrition 297006 297006 0 0
Obesity
Surgery 297017 297017 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Performance of the six minute walk test. This measures the distance that a patient can walk in 6 minutes and is follows steps delineated by a standard operating procedure. This will occur in the pre-operative assessment clinic and be supervised by a research assistant who will be trained in supervision of the test..
Performance of spirometry, measurement of waist and hip circumferences, and of serum NT pro-BNP will also occur in the pre-operative assessment clinic. These are study measures and are not measured routinely.
Patients visit the pre-operative assessment clinics between one day and 6 weeks prior to their scheduled date of surgery.
Intervention code [1] 293252 0
Early detection / Screening
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 296602 0
Functional recovery as measured by the WHODAS 2.0 and QOR-15 tools.
Timepoint [1] 296602 0
The recovery measurement surveys will occur at the following times after surgery: QOR-15 at 3 and 30 days, WHODAS 2.0 at 30 days and at 6 months.
Secondary outcome [1] 318892 0
Medical complications will be measured using a standard checklist with standard measures and definitions. Data will be gathered by a research assistant searching the medical record, and confirming with the patient at the 30 day post-operative interview.
Timepoint [1] 318892 0
Within first 30 days post-operatively.

Eligibility
Key inclusion criteria
Consent
Age => 18 years
BMI => 35 at pre-admission clinic
Booked for elective non-cardiac surgery at Wollongong hospital
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Inadequate time to complete the 6MWT pre-operatively
Presence of medical contra-indications to the 6MWT test as per American Thoracic Society guidelines
Pregnancy

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Follow-up to 6 months post-operatively
The aim of this trial is to test the predictive value of a pre-operative screening tool for risk assessment and stratification in a specific patient population group.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Correlation statistics: mainly receiver operating characteristic (ROC) method, with linear regression and use of t-tests where appropriate. Sample size was determined using published tables. We estimated the correlation co-efficient to be 0.5 as the outcomes are somewhat nut not completely correlated. We chose confidence intervals to be no wider than -/+ 0.1. A sample size of 219 met these requirements. We added c 10% extra to this to account for losses between study recruitment and completion to give an overall sample size of 250. Based on an audit of numbers of severely obese patients presenting to the Wollongong pre-operative clinic, we estimated that up to 18 months should be sufficient to recruit this sample size.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/02/2016
Actual
8/02/2017
Date of last participant enrolment
Anticipated
1/08/2017
Actual
1/12/2017
Date of last data collection
Anticipated
Actual
1/06/2018
Sample size
Target
250
Accrual to date
Final
285
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 4629 0
Wollongong Hospital - Wollongong
Recruitment postcode(s) [1] 12219 0
2500 - Wollongong

Funding & Sponsors
Funding source category [1] 292382 0
Other
Name [1] 292382 0
ANZCA (Australia and New Zealand College of Anaesthetists) Research Committee
Country [1] 292382 0
Australia
Funding source category [2] 306628 0
University
Name [2] 306628 0
Illawarra Health and Medical Research Institute: University of Wollongong
Country [2] 306628 0
Australia
Primary sponsor type
Individual
Name
Natalie Smith
Address
c/- Department of Anaesthesia
Wollongong Hospital
Crown St, Wollongong
NSW 2500
Country
Australia
Secondary sponsor category [1] 291071 0
None
Name [1] 291071 0
Address [1] 291071 0
Country [1] 291071 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293852 0
UOW and ISLHD Health and Medical Research Ethics Committee
Ethics committee address [1] 293852 0
Ethics Unit, Research Services Office
University of Wollongong
Northfields Ave, Wollongong
NSW 2522
Ethics committee country [1] 293852 0
Australia
Date submitted for ethics approval [1] 293852 0
16/09/2015
Approval date [1] 293852 0
15/12/2015
Ethics approval number [1] 293852 0
Ethics number HE15/379

Summary
Brief summary
Wollongong Hospital is a large regional hospital that performs approximately 13 000 episodes of operative care per year. The range of surgery performed covers all areas apart from cardio-thoracic, including neurosurgery, vascular, orthopaedics, urology, ENT general, colo-rectal, endoscopy, imaging, obstetrics and gynaecology, general paediatrics, and plastic surgery. The anaesthesia department at Wollongong Hospital has an audit and research focus particularly in the fields of education, obesity, and geriatric care.

Australian Bureau of Statistics data report that 62.8% of adult Australians were overweight or obese in 2011-12. Of this number, approximately 12% had a body mass index (BMI) greater than or equal to 35, which, in the presence of comorbidities, has been defined as morbid obesity. Local data show that at least 13% of patients undergoing elective surgery at Wollongong Hospital each year are morbidly obese. Most of the literature suggests that morbidly obese patients have higher rates of clinical complications in the post-operative period than the non-obese although this finding has not been universally reported. Assessment of risk in obese patients cannot accurately be based on the presence of obesity alone.

Measurement of functional capacity pre-operatively is considered essential for useful risk stratification and prediction of post-operative outcomes. Cardiopulmonary exercise testing (CPET) is the gold standard for assessing cardio-respiratory fitness. However, CPET is expensive, resource-intensive, and requires a dedicated specialist laboratory and trained technicians. In contrast, the six minute walk test (6MWT) is a simple and cheap test for evaluation of cardio-respiratory function that has compared well to CPEX in previous studies. It may be ideal for assessing functional capacity in morbidly obese patients as it can be performed by existing staff in a pre-operative assessment area and has been shown to be safe for morbidly obese patients in multiple papers. There are currently no published data on the use of the 6MWT as a screening tool to predict high risk in obese patients undergoing surgery.

The aim of this study is to assess the ability of the 6MWT to predict postoperative functional recovery and medical complications in morbidly obese patients in Wollongong Hospital who attend a pre-admission assessment clinic (PAC). Identification of this subset of patients would allow peri-operative teams to target further investigations, optimise surgical planning, and stratify the intensity of intra-operative and post-operative care. With these strategies, it may be possible to decrease morbidity and mortality and the associated healthcare costs to the community.
Trial website
nil
Trial related presentations / publications
nil
Public notes

Contacts
Principal investigator
Name 61522 0
A/Prof Natalie Smith
Address 61522 0
c/- Department of Anaesthesia
Wollongong Hospital
Crown St, Wollongong, NSW 2500
Country 61522 0
Australia
Phone 61522 0
+61 2 4255 1560
Fax 61522 0
Email 61522 0
natasmith@hotmail.com
Contact person for public queries
Name 61523 0
A/Prof Natalie Smith
Address 61523 0
c/- Department of Anaesthesia
Wollongong Hospital
Crown St, Wollongong, NSW 2500
Country 61523 0
Australia
Phone 61523 0
+61 2 4255 1560
Fax 61523 0
Email 61523 0
natasmith@hotmail.com
Contact person for scientific queries
Name 61524 0
A/Prof Natalie Smith
Address 61524 0
c/- Department of Anaesthesia
Wollongong Hospital
Crown St, Wollongong, NSW 2500
Country 61524 0
Australia
Phone 61524 0
+61 2 4255 1560
Fax 61524 0
Email 61524 0
natasmith@hotmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
De-idientified individual participant data after publication
When will data be available (start and end dates)?
Start date: After publication
End date: no end date determined
Available to whom?
Researchers who provide a sound proposal at the discretion of the chief investigator
Available for what types of analyses?
To achieve aims in a proposal, for meta-analysis
How or where can data be obtained?
By contacting the chief investigator by email: natalieanne.smith@health.nsw.gov.au


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9014Study protocol    The protocol will be available as part of the main... [More Details]
9015Statistical analysis plan  natalieanne.smith@health.nsw.gov.au
9016Informed consent form  natalieanne.smith@health.nsw.gov.au
9017Clinical study report  natalieanne.smith@health.nsw.gov.au
9018Ethical approval  natalieanne.smith@health.nsw.gov.au



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 clinical, functional and disability characteristics of patients with severe obesity presenting for non-bariatric surgery.2019https://dx.doi.org/10.1177/0310057X19887976
EmbasePredicting recovery and disability after surgery in patients with severe obesity: The role of the six-minute walk test.2022https://dx.doi.org/10.1177/0310057X20981969
N.B. These documents automatically identified may not have been verified by the study sponsor.