Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000961943
Ethics application status
Approved
Date submitted
14/04/2020
Date registered
25/09/2020
Date last updated
25/09/2020
Date data sharing statement initially provided
25/09/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
The NASA Task Load Index study measuring the technical difficulty of performing an operation.
Scientific title
The NASA Task Load Index study measuring the technical difficulty of performing an operation in those undergoing elective surgery for right hemicolectomy or repeat bariatric surgery.
Secondary ID [1] 301010 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Technical difficulty of surgery 317049 0
Condition category
Condition code
Surgery 315216 315216 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
Using the NASA TLX to measure the technical difficulty of performing an operation. Surgeons will complete the NASA TLX survey upon completion of an operation. This produces a numerical score of the technical difficulty encountered. This is compared to other surrogate measures of difficulty including clinical outcomes and complications. Each surgeon will enrol 20 patients. The encounter will not differ from normal for the patients.
Intervention code [1] 317328 0
Not applicable
Comparator / control treatment
Clinical outcomes are being used as comparators to the NASA TLX score.
NASA TLX scores will be correlated with clinical outcome parameters. These include:
1. Duration of operation
2. Blood loss
3. Transfusion requirement
4. Intra-operative complications
5. Conversion to open surgery
6. In-hospital complications (Clavien-Dindo)
7. Length of stay
Control group
Active

Outcomes
Primary outcome [1] 323473 0
The NASA TLX score. The tool being measured is the NASA Task Load Index, and this is being compared to clinical outcomes to assess if this tool can measure the technical difficulty of an operation.
NASA TLX scores will be correlated with clinical outcome parameters. These include:
1. Duration of operation
2. Blood loss
3. Transfusion requirement
4. Intra-operative complications
5. Conversion to open surgery
6. In-hospital complications (Clavien-Dindo)
7. Length of stay
These are relatively blunt measures of technical difficulty and are not very useful in a research setting. If the NASA TLX can be shown to accurately measure technical difficulty it would be a beneficial tool in future research.
Timepoint [1] 323473 0
Immediately after the end of surgery
Secondary outcome [1] 382019 0
The NASA TLX score. The tool being measured is the NASA Task Load Index, and this is being compared to clinical outcomes to assess if this tool can measure the technical difficulty of an operation.
At discharge the NASA TLX scores will be correlated with the following clinical outcome parameter:
In-hospital complications (Clavien-Dindo)
These are relatively blunt measures of technical difficulty and are not very useful in a research setting. If the NASA TLX can be shown to accurately measure technical difficulty it would be a beneficial tool in future research.
Timepoint [1] 382019 0
At discharge
Secondary outcome [2] 385508 0
Duration of operation, as assessed by passage of time on a clock at the time of the surgery.
Timepoint [2] 385508 0
At completion of surgery
Secondary outcome [3] 385509 0
Blood loss, assessed at the time of completion of surgery by contents of sucker canister(s) minus any lavage.
Timepoint [3] 385509 0
At completion of surgery
Secondary outcome [4] 385510 0
Transfusion requirement, from hospital record.
Timepoint [4] 385510 0
At discharge
Secondary outcome [5] 385511 0
Conversion to open surgery, which is self explanatory at the completion of the operation.
Timepoint [5] 385511 0
At completion of operation
Secondary outcome [6] 385512 0
Length of stay, which is self explanatory at the time of patient's discharge, and obtainable at any later date by review of the hospital record.
Timepoint [6] 385512 0
At discharge

Eligibility
Key inclusion criteria
Elective surgery for right hemicolectomy and re-do bariatric surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Emergency surgery
Complex surgery requiring ICU/HDU

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Comparing the NASA TLX scores with other measures of technical difficulty such as duration of operation and blood loss. An assessment of correlation will be made.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
7/08/2020
Date of last participant enrolment
Anticipated
31/12/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
180
Accrual to date
5
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 16463 0
The Alfred - Melbourne
Recruitment hospital [2] 16464 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [3] 16465 0
The Avenue Private Hospital - Windsor
Recruitment hospital [4] 16466 0
Frankston Hospital - Frankston
Recruitment hospital [5] 16467 0
Peninsula Private Hospital - Frankston - Frankston
Recruitment hospital [6] 16468 0
Sydney Adventist Hospital - Wahroonga
Recruitment hospital [7] 16469 0
Holy Spirit Northside - Chermside
Recruitment hospital [8] 16470 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 30004 0
3004 - Melbourne
Recruitment postcode(s) [2] 30005 0
3144 - Malvern
Recruitment postcode(s) [3] 30006 0
3181 - Windsor
Recruitment postcode(s) [4] 30007 0
3199 - Frankston
Recruitment postcode(s) [5] 30008 0
2076 - Wahroonga
Recruitment postcode(s) [6] 30009 0
4032 - Chermside
Recruitment postcode(s) [7] 30010 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 305456 0
University
Name [1] 305456 0
Monash University
Country [1] 305456 0
Australia
Primary sponsor type
University
Name
Monash University Dept of Surgery
Address
99 Commercial Rd
Prahran, Victoria 3181
Country
Australia
Secondary sponsor category [1] 305853 0
None
Name [1] 305853 0
Address [1] 305853 0
Country [1] 305853 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305772 0
Alfred Hospital
Ethics committee address [1] 305772 0
Alfred Hospital
99 Commercial Rd
Prahran, Victoria, 3181
Ethics committee country [1] 305772 0
Australia
Date submitted for ethics approval [1] 305772 0
27/02/2020
Approval date [1] 305772 0
27/03/2020
Ethics approval number [1] 305772 0
61221

Summary
Brief summary
The technical difficulty each individual operation creates for a surgeon is difficult to measure. Each surgeon knows after an operation how easy or hard it was, but there are no accurate measures of this difficulty. In a research setting and in a teaching setting it would be valuable to be able to accurately measure this degree of difficulty. Any new surgical technique or intervention needs to be measured for improvements in clinical outcomes. It would also be beneficial to measure any improvement in technical difficulty for the surgeon. The ability of a trainee to learn a new operation, and the ability to measure a trainees progress is also beneficial.

This project will measure the NASA Task Load Index (NASA TLX) and correlate this against other current, relatively weak, measures of technical difficulty. The NASA TLX produces a numerical score for each operation, and this can be measured against clinical outcome parameters. The study does not alter the clinical or operative management of the patient, but merely has the surgeon complete a survey immediately after the operation, along with other clinical outcome parameters.

The project will study eight surgeons from both upper gastrointestinal and colorectal surgery, and at two levels of experience: consultant surgeons and post-fellowship advanced trainees. Each surgeon will enrol 20 patients to the study, giving an adequate volume per surgeon to detect a correlation, plus a total of 160 operations overall to produce overall power of the study.
Trial website
Nil
Trial related presentations / publications
Nil so far
Public notes

Contacts
Principal investigator
Name 101542 0
Dr Stephen Bell
Address 101542 0
Alfred Hospital
99 Commercial Rd
Prahran, 3181
Victoria
Country 101542 0
Australia
Phone 101542 0
+61 3 92762000
Fax 101542 0
nil
Email 101542 0
[email protected]
Contact person for public queries
Name 101543 0
Dr Stephen Bell
Address 101543 0
Alfred Hospital
99 Commercial Rd
Prahran, 3181
Victoria
Country 101543 0
Australia
Phone 101543 0
+61 3 90762000
Fax 101543 0
nil
Email 101543 0
[email protected]
Contact person for scientific queries
Name 101544 0
Dr Stephen Bell
Address 101544 0
Alfred Hospital
99 Commercial Rd
Prahran, 3181
Victoria
Country 101544 0
Australia
Phone 101544 0
+61 3 92762000
Fax 101544 0
nil
Email 101544 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified data
When will data be available (start and end dates)?
After data analysis, no end date
Available to whom?
Only researchers with a methodologically sound proposal
Available for what types of analyses?
Any analyses that has been reviewed and approved by the principal investigator.
How or where can data be obtained?
All requests may by made to the principal investigator: [email protected]


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.