Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000081516p
Ethics application status
Submitted, not yet approved
Date submitted
21/11/2023
Date registered
30/01/2024
Date last updated
30/01/2024
Date data sharing statement initially provided
30/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Using a motion-tracking headset to objectively assess surgical performance - A transition to the operating theatre
Scientific title
Using objective metrics from a motion-tracking headset to differentiate between varying surgical skill levels in a live operating theatre environment.
Secondary ID [1] 310996 0
None
Universal Trial Number (UTN)
Trial acronym
Motion-tracking in the Operating Room (MoTOR 3)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post-operative complications 332099 0
Condition category
Condition code
Surgery 328822 328822 0 0
Surgical techniques
Public Health 329165 329165 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The HoloLens 2 augmented reality device is one that has the capabilities to track hand movements. The headset has in-built sensors that are able to track the movements of surgeons. There are specific patterns of movement that are associated with increased expertise.

The project will involve surgical registrars and consultants performing operations as they normally would whilst wearing the motion-tracking headset. A transition to the operating theatre will allow us to further identify whether this headset can be used in a clinical environment and continue to provide objective assessment data. We aim to video tape the procedures to allow for further post-hoc analysis of the footage. The study will involve the use of the HoloLens 2 in the operating room during operations not involving the use of surgical loupes including open inguinal hernia repairs, orchidopexies, hydrocele repairs, circumcisions and others. All surgeons will have comp[eted a 1 hour session using the headset while performing a simulated surgery. This will allow for acclimatisation for the surgeon and allow for the research team to answer any questions for the surgeon. The surgeons, if consent is provided by both the surgeon and patient, will wear the headset during the appropriate procedure until the target number has been reached. The frequency that a surgeon will use the headset during surgery will depend on their surgical schedule and patient consent.

Prior to the procedure, the operating surgeon will have an opportunity to get accustomed to the headset. During the procedure, the operating surgeon will be wearing the HoloLens 2, which will be tracking their hand movements with a focus on path length, total time, and speed of movement to provide an overall gauge of proficiency. A camera that is mounted on the HoloLens will be used to capture video only footage. This will be de-identified and will be from the surgeons point-of-view and will largely capture their hand movements and the operative field.

Upon analysis of the data, the research team will access the device's analytic report which will provide an insight into the quality of the data that has been obtained and to monitor for any technical issues that arise.
Intervention code [1] 327438 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 336627 0
Efficiency of movement
Timepoint [1] 336627 0
Data will be collected once after completion of each procedure.
Primary outcome [2] 336999 0
Total path length collected via the HoloLens 2 device and software
Timepoint [2] 336999 0
Data will be collected upon completion of each procedure.
Primary outcome [3] 337004 0
Velocity of movement. collected via the HoloLens 2 device and software
Timepoint [3] 337004 0
Data will be collected after completion of each procedure.
Secondary outcome [1] 429053 0
User satisfaction with the headset used
Timepoint [1] 429053 0
The questionnaire will be completed once after each procedure.
Secondary outcome [2] 430347 0
Comparison between surgical performance between junior surgeons and senior surgeons.
Timepoint [2] 430347 0
Upon reaching the target number of procedures (50), this will be compared.

Eligibility
Key inclusion criteria
Paediatric surgical registrars and consultants at our hospital site are eligible. There is no specific age limit for the registrars or consultants to participate.

The specific operations that will be include operations not involving the use of surgical loupes including open inguinal hernia repairs, orchidopexies, hydrocele repairs, circumcisions and others.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Operations that use surgical loupes will not be included.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2024
Actual
Date of last participant enrolment
Anticipated
1/12/2024
Actual
Date of last data collection
Anticipated
1/12/2024
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25970 0
Monash Children’s Hospital - Clayton
Recruitment postcode(s) [1] 41812 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 315259 0
Other Collaborative groups
Name [1] 315259 0
Monash Children's Simulation
Country [1] 315259 0
Australia
Primary sponsor type
Hospital
Name
Monash Children's Hospital
Address
246 Clayton road, clayton 3148, VIC
Country
Australia
Secondary sponsor category [1] 317293 0
None
Name [1] 317293 0
Address [1] 317293 0
Country [1] 317293 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314177 0
Monash Health Human Research Ethics Comittee
Ethics committee address [1] 314177 0
Ethics committee country [1] 314177 0
Australia
Date submitted for ethics approval [1] 314177 0
06/10/2023
Approval date [1] 314177 0
Ethics approval number [1] 314177 0

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

Contacts
Principal investigator
Name 130686 0
A/Prof Ramesh Mark Nataraja
Address 130686 0
Monash Children's Hospital, 248 Clayton Road, Clayton, VIC 3168
Country 130686 0
Australia
Phone 130686 0
+61 3 8572 3838
Fax 130686 0
Email 130686 0
[email protected]
Contact person for public queries
Name 130687 0
Ramesh Mark Nataraja
Address 130687 0
Monash Children's Hospital, 248 Clayton Road, Clayton, VIC 3168
Country 130687 0
Australia
Phone 130687 0
+61 3 8572 3838
Fax 130687 0
Email 130687 0
[email protected]
Contact person for scientific queries
Name 130688 0
Ramesh Mark Nataraja
Address 130688 0
Monash Children's Hospital, 248 Clayton Road, Clayton, VIC 3168
Country 130688 0
Australia
Phone 130688 0
+61 3 8572 3838
Fax 130688 0
Email 130688 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20992Study protocol    386907-(Uploaded-29-01-2024-09-26-23)-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.