Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000014651
Ethics application status
Approved
Date submitted
25/11/2013
Date registered
6/01/2014
Date last updated
6/01/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the incidence of preoperative frailty and its correlation with recovery from anaesthesia
Scientific title
In patients aged over 70 undergoing minor surgery, does the presence of preoperative frailty compared to absence of preoperative frailty correlate with poorer recovery from anaesthesia?
Secondary ID [1] 283588 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Preoperative frailty 290498 0
Postoperative recovery from anaesthesia 290836 0
Condition category
Condition code
Anaesthesiology 290892 290892 0 0
Anaesthetics
Surgery 291201 291201 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
Frailty as determined using the Edmonton Frail Scale will be measured preoperatively and compared with postoperative recovery at Day 1 as measured by the Postoperative Quality Recovery Scale
Intervention code [1] 288275 0
Not applicable
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290878 0
Recovery from anaesthesia determined by postoperative quality of recovery (PQRS) score
Timepoint [1] 290878 0
Postoperative day 1
Secondary outcome [1] 305528 0
n/a
Timepoint [1] 305528 0
n/a

Eligibility
Key inclusion criteria
Age 70 and over.
Undergoing day case surgery or an overnight stay involving sedation or general anaesthesia at Peter MacCallum Cancer Centre (PMCC).
Minimum age
70 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-english speaking

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/02/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 288268 0
Self funded/Unfunded
Name [1] 288268 0
Country [1] 288268 0
Primary sponsor type
Individual
Name
Dr Jonathan Hiller
Address
Department of Surgical Oncology
Peter MacCallum Cancer Centre,
A'Beckett Street
East Melbourne
Victoria 8006
Country
Australia
Secondary sponsor category [1] 286983 0
None
Name [1] 286983 0
Address [1] 286983 0
Country [1] 286983 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290365 0
Peter MacCallum Cancer Centre Ethics Committee
Ethics committee address [1] 290365 0
Peter MacCallum Cancer Centre Ethics Committee
Locked Bag 1 A'Beckett Street
Victoria 8006 Australia
Ethics committee country [1] 290365 0
Australia
Date submitted for ethics approval [1] 290365 0
Approval date [1] 290365 0
28/10/2013
Ethics approval number [1] 290365 0
13/132L

Summary
Brief summary
This project aims to estimate the incidence of preoperative frailty in patients undergoing minor surgery at Peter MacCallum Cancer Centre, and to explore the correlation between preoperative frailty and recovery from surgery. It will also explore the practicality of assessing frailty using the Edmonton Frail Scale in a preanaesthetic environment.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 44298 0
Dr Jonathan Hiller
Address 44298 0
Department of Surgical Oncology
Peter MacCallum Cancer Centre,
A'Beckett Street
East Melbourne
Victoria 8006
Country 44298 0
Australia
Phone 44298 0
+61 3 9656 3662
Fax 44298 0
Email 44298 0
[email protected]
Contact person for public queries
Name 44299 0
Jonathan Hiller
Address 44299 0
Department of Surgical Oncology
Peter MacCallum Cancer Centre,
A'Beckett Street
East Melbourne
Victoria 8006
Country 44299 0
Australia
Phone 44299 0
+61 3 9656 3662
Fax 44299 0
Email 44299 0
[email protected]
Contact person for scientific queries
Name 44300 0
Jonathan Hiller
Address 44300 0
Department of Surgical Oncology
Peter MacCallum Cancer Centre,
A'Beckett Street
East Melbourne
Victoria 8006
Country 44300 0
Australia
Phone 44300 0
+61 3 9656 3662
Fax 44300 0
Email 44300 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.