ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Technical difficulty of surgery

Condition category

Condition code

Surgery

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]

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]

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]

Immediately after the end of surgery

Secondary outcome [1]

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]

At discharge

Secondary outcome [2]

Duration of operation, as assessed by passage of time on a clock at the time of the surgery.

Timepoint [2]

At completion of surgery

Secondary outcome [3]

Blood loss, assessed at the time of completion of surgery by contents of sucker canister(s) minus any lavage.

Timepoint [3]

At completion of surgery

Secondary outcome [4]

Transfusion requirement, from hospital record.

Timepoint [4]

At discharge

Secondary outcome [5]

Conversion to open surgery, which is self explanatory at the completion of the operation.

Timepoint [5]

At completion of operation

Secondary outcome [6]

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]

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?

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

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD,VIC

Recruitment hospital [1]

The Alfred - Melbourne

Recruitment hospital [2]

Cabrini Hospital - Malvern - Malvern

Recruitment hospital [3]

The Avenue Private Hospital - Windsor

Recruitment hospital [4]

Frankston Hospital - Frankston

Recruitment hospital [5]

Peninsula Private Hospital - Frankston - Frankston

Recruitment hospital [6]

Sydney Adventist Hospital - Wahroonga

Recruitment hospital [7]

Holy Spirit Northside - Chermside

Recruitment hospital [8]

Royal Brisbane & Womens Hospital - Herston

Recruitment postcode(s) [1]

3004 - Melbourne

Recruitment postcode(s) [2]

3144 - Malvern

Recruitment postcode(s) [3]

3181 - Windsor

Recruitment postcode(s) [4]

3199 - Frankston

Recruitment postcode(s) [5]

2076 - Wahroonga

Recruitment postcode(s) [6]

4032 - Chermside

Recruitment postcode(s) [7]

4029 - Herston

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University

Address [1]

99 Commercial Rd Prahran, Victoria, 3181

Country [1]

Australia

Primary sponsor type

University

Name

Monash University Dept of Surgery

Address

99 Commercial Rd
Prahran, Victoria 3181

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital

Ethics committee address [1]

Alfred Hospital
99 Commercial Rd 
Prahran, Victoria, 3181

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/02/2020

Approval date [1]

27/03/2020

Ethics approval number [1]

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

Dr Stephen Bell

Address

Alfred Hospital 99 Commercial Rd Prahran, 3181 Victoria

Country

Australia

Phone

+61 3 92762000

Fax

nil

[email protected]

Contact person for public queries

Name

Stephen Bell

Address

Alfred Hospital 99 Commercial Rd Prahran, 3181 Victoria

Country

Australia

Phone

+61 3 90762000

Fax

nil

[email protected]

Contact person for scientific queries

Name

Stephen Bell

Address

Alfred Hospital 99 Commercial Rd Prahran, 3181 Victoria

Country

Australia

Phone

+61 3 92762000

Fax

nil

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

Yes

Will there be any conditions when requesting access to individual participant data?

Persons/groups eligible to request access:
• Only researchers with a methodologically sound proposal

Conditions for requesting access:
• -

What individual participant data might be shared?

• All de-identified data

What types of analyses could be done with individual participant data?

• Any analyses that has been reviewed and approved by the principal investigator.

When can requests for individual participant data be made (start and end dates)?

From:
After data analysis, no end date

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?

• All requests may by made to the principal investigator: [email protected]

Are there extra considerations when requesting access to individual participant data?

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.

Trial Review

Documents added manually

Documents added automatically