Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000170729
Ethics application status
Approved
Date submitted
26/12/2021
Date registered
2/02/2022
Date last updated
2/02/2022
Date data sharing statement initially provided
2/02/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Predicting perioperative risk in patients in aged 90-100 years.
Scientific title
A modified Aged-Adjusted Charlson Comoribidy Index risk score in predicting perioperative outcomes in nonagenarian patients.
Secondary ID [1] 306116 0
None
Universal Trial Number (UTN)
U1111-1272-8075
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 324788 0
Surgical procedures 324789 0
Complications after surgery 324790 0
Mortality after surgery 324791 0
Condition category
Condition code
Surgery 322240 322240 0 0
Other surgery
Anaesthesiology 322241 322241 0 0
Other anaesthesiology

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
1
Target follow-up type
Years
Description of intervention(s) / exposure
In this study we will first be observing postoperative complications in patients aged 90-100 years who have undergone any surgical procedure or intervention at Austin Health between 1 January 2012 to 31 December 2019. As this is a retrospective study, there is no participant involvement. Only the de-identified hospital medical record of patients who have had surgery will be reviewed.

Second, we will then assess if the age-adjusted Charlson Comorbidity Index (CCI) can be applied to the nonagenarian surgical population. Our study presents the validity of age-adjusted CCI for nonagenarian patients across multiple surgical and endoscopic streams, whilst proposing a modified score in improving perioperative risk assessment for this vulnerable population.

The Charlson Comorbidity Index is a validated risk score for clinicians in predicting perioperative mortality and morbidity in comorbid patients. First introduced by Professor Mary Charlson and her peers in 1987, the CCI assesses comorbidity level through the number and severity of 19 pre-defined comorbid conditions. Scores are weighted accordingly for each disease and their severity. Charlson et al, subsequently established a refined tool with the Age-Adjusted Charlson Comorbidity Index (ACCI) in 1994, adjusting the existing CCI score for increasing age. The ACCI has subsequently been validated in predicting short term and long-term outcomes including mortality, function outcomes and hospital length of stay across different surgical populations. The CCI has since become one the most widely used scoring system for comorbidities by clinical researches for longitudinal studies and by point of care clinicians.
Intervention code [1] 322529 0
Diagnosis / Prognosis
Comparator / control treatment
This study has no control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 330012 0
The primary outcome is to assess the accuracy of revised age-adjusted CCI risk score for quantifying peri-operative risk. This will be assessed using data from the patient medical records.
Timepoint [1] 330012 0
This will be calculated retrospectively from the completion of surgery to hospital discharge for the index admission only.
Secondary outcome [1] 404582 0
Complications following any surgical procedure. Complications will be assessed using the Clavien-Dindo system, a previously validated tool for grading complications. Possible complications include anastomotic leak, infection, haemorrhage, death, etc. This outcome will be obtained by reviewing data-linkage to the Austin hospital's medical records.
Timepoint [1] 404582 0
Complications are considered retrospectively at discharge from the completion of surgery to hospital discharge for the index admission only.

Eligibility
Key inclusion criteria
Patients aged 90-100 years undergoing any surgical or interventional procedure. All operative and anaesthetic techniques will be considered.

We will include the following types of surgeries:
1. cardiac and non-cardiac surgery
2. endoscopic procedures
3. superficial skin surgery under local anaesthesia
4. any radiological intervention requiring anaesthesia
5. cardiac procedures requiring anaesthesia (insertion of permanent pacemakers, electrical cardioversion, coronary angiograms, or any coronary intervention including transcatheter aortic valve replacements)
6. cataract extractions under topical, retrobulbar, or peribulbar eye blocks.
Minimum age
90 Years
Maximum age
100 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any patients aged less than 90 years or great than 100 years, or a patient who does not undergo a surgical procedure.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Retrospective
Statistical methods / analysis
Statistical analysis will be performed using IBM SPSS Statistics for Windows, version 23 (IBM Corp., 2015, Armonk, NY, USA) and Stata/SE 13.0 for Windows (StataCorp LP, Texas, USA, 2013). Data will be deidentified, and the variable names encrypted. All data will be coded with numerical values to blind the collected variables’ characteristics to the statistician.

Data will be presented as mean ± standard deviation or median (1st?3rd quartiles) [Min:Max], or the number (percentile) for descriptive statistics. Estimated values will be described with 95% confidence intervals (CI) and presented with P-values. Any two-sided P value below 0.05 will be considered as statistically significant. In case of multiple pairwise comparisons, Bonferroni’s correction will be applied for significance. Prior to statistical analysis, normality will be assessed for continuous variables using the Quantile-Quantile plot. If normality criteria are violated, non-parametric statistical methods will be applied for that variable.

We will develop a postoperative complication and survival prediction score system based on the ACCI. When validating this prognostic model, calibration and discrimination will be evaluated and applied to establish any relevant relationship between preoperative parameters and postoperative complications. . Receiver-Operating Characteristic curves (ROC curve) will be applied to compare the performance of each scoring system in predicting postoperative complication development.

Overall mortality will also be evaluated with the Cox proportional hazard regression.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/04/2021
Date of last participant enrolment
Anticipated
Actual
31/07/2021
Date of last data collection
Anticipated
Actual
1/11/2021
Sample size
Target
3100
Accrual to date
Final
3103
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 21425 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 36326 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 310467 0
Hospital
Name [1] 310467 0
Austin Health - Austin Hospital - Heidelberg
Country [1] 310467 0
Australia
Primary sponsor type
Hospital
Name
Austin Health - Austin Hospital - Heidelberg
Address
Department of Anaesthesia, Austin Hospital
145 Studley Road, Heidelberg VIC, 3084
Country
Australia
Secondary sponsor category [1] 311617 0
None
Name [1] 311617 0
Address [1] 311617 0
Country [1] 311617 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310098 0
Austin Health Human Research Ethics Committee
Ethics committee address [1] 310098 0
Ethics committee country [1] 310098 0
Australia
Date submitted for ethics approval [1] 310098 0
01/04/2021
Approval date [1] 310098 0
08/04/2021
Ethics approval number [1] 310098 0
Audit/21/Austin/30

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

Contacts
Principal investigator
Name 116462 0
A/Prof Laurence Weinberg
Address 116462 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg, VIC, 3084
Country 116462 0
Australia
Phone 116462 0
+61 394963800
Fax 116462 0
Email 116462 0
[email protected]
Contact person for public queries
Name 116463 0
Laurence Weinberg
Address 116463 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg, VIC, 3084
Country 116463 0
Australia
Phone 116463 0
+61 394963800
Fax 116463 0
Email 116463 0
[email protected]
Contact person for scientific queries
Name 116464 0
Laurence Weinberg
Address 116464 0
Department of Anaesthesia, Austin Health, 145 Studley Road, Heidelberg, VIC, 3084
Country 116464 0
Australia
Phone 116464 0
+61 394963800
Fax 116464 0
Email 116464 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 have not provided consent for their data to be shared.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
14577Ethical approval    383351-(Uploaded-26-12-2021-20-19-33)-Study-related document.pdf



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.