Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000948897
Ethics application status
Approved
Date submitted
5/05/2021
Date registered
20/07/2021
Date last updated
20/07/2021
Date data sharing statement initially provided
20/07/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
Training gynaecology trainees using an integrated Visual Reality Stimulator curriculum
Scientific title
We live in a virtual world: Impact of training the gynaecology trainee using an integrated Visual Reality Stimulator curriculum
Secondary ID [1] 304132 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical performance 321820 0
Condition category
Condition code
Surgery 319554 319554 0 0
Other surgery
Public Health 319985 319985 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: Virtual-reality integrated training curriculum in addition to standard training for the period of 6months.
The curriculum included didactic teaching (online anatomy tutorials, journal articles, and slideshows provided by gynaecologists), two 3-hour consultant-led workshops (one at study commencement and another at 3months), and 24-hour access to traditional box trainers and the LapSim® VRS. Lapsim is an advanced surgical simulation technology that allows users to practice laparoscopic skills on an advanced computer. The high-fidelity simulator was programed with four modules, each with multiple exercises of graded complexity. Two investigators were available for simulation supervision at different times each week. Log-book reviews were undertaken at 3-monthly intervals to assess surgical progress, and the VRS stored information regarding trainee usage.

The intervention group (Groups 'novice-trained' and 'experienced-trained') were given access to the VRS-integrated training curriculum. The intervention group was made up of trainees at a specific training hospital. Controls were employed at other training hospitals in the same city.
Intervention code [1] 320470 0
Treatment: Other
Intervention code [2] 321137 0
Treatment: Devices
Comparator / control treatment
Standard gynaecological surgical training. This involves on-the-job / apprenticeship style learning, where gynaecology trainees receive surgical skill tuition while performing live surgeries on patients. Trainees may be guided towards other resources (books, YouTube, journal articles) but these are not standardised. Tuition is delivered by a range of tutors, from senior trainees to consultants, and time periods of training are varied depending on the clinical cases. Trainees were assessed after 6months of standard training.
Control group
Active

Outcomes
Primary outcome [1] 327416 0
Live-operating performance for novice trainees.

At the end of the 6-months, participants in all groups completed the structured feedback questionnaire, log-book review (simulation and live-operating logbooks for the intervention group, and live-operating logbook alone for the controls), and a single LapSim® salpingectomy (marked by in-built computer metrics) paired with a video-recorded laparoscopic salpingectomy. The 6-month video-recorded laparoscopic salpingectomy cases were assessed using the OSATS-LS framework by blinded assessors.
Timepoint [1] 327416 0
6 months following commencement of VRS-integrated curriculum.
Secondary outcome [1] 395058 0
Time spent on the LapSim VRS, and quantified but logged time (minutes) by trainee.
Timepoint [1] 395058 0
6 months following commencement of VRS-integrated curriculum.
Secondary outcome [2] 395059 0
LapSim VRS scores
Timepoint [2] 395059 0
Pre-intervention and 6 months following commencement of VRS-integrated curriculum.
Secondary outcome [3] 395060 0
Live operating performance for experienced trainees.

At the end of the 6-months, participants in all groups completed the structured feedback questionnaire, log-book review (simulation and live-operating logbooks for the intervention group, and live-operating logbook alone for the controls), and a single LapSim® salpingectomy (marked by in-built computer metrics) paired with a video-recorded laparoscopic salpingectomy. The 6-month video-recorded laparoscopic salpingectomy cases were assessed using the OSATS-LS framework by blinded assessors.
Timepoint [3] 395060 0
6-months post commencement of intervention.

Eligibility
Key inclusion criteria
1. Gynaecology junior doctor
2. Employed at a training institution in metropolitan Melbourne
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Unwilling to participate in training curriculum
2. Unwilling to consent to video assessment and/or completion of questionnaires

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)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data was summarized as mean(SD), median(25th–75th percentiles) and number(%) according to type and distribution. Between group differences were tested using Wilcoxon Ranksum test. Change in LapSim® scores were adjusted for baseline VRS by including the later as a covariate in a linear regression model. The significance level was two-sided and set at 0.05 for all comparisons with raw p-values adjusted for multiple comparisons using the Holm-Sidak adjustment. Statistical analysis was performed using Stata v15 (StataCorp. 2017. Stata Statistical Software: Release 15. College Station, TX, USA)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
30/05/2018
Date of last participant enrolment
Anticipated
Actual
29/06/2018
Date of last data collection
Anticipated
Actual
18/01/2019
Sample size
Target
30
Accrual to date
Final
35
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 19287 0
Mercy Hospital for Women - Heidelberg
Recruitment hospital [2] 19288 0
The Royal Women's Hospital - Parkville
Recruitment hospital [3] 19289 0
Sunshine Hospital - St Albans
Recruitment hospital [4] 19290 0
Monash Medical Centre - Clayton campus - Clayton
Recruitment postcode(s) [1] 33868 0
3084 - Heidelberg
Recruitment postcode(s) [2] 33869 0
3052 - Parkville
Recruitment postcode(s) [3] 33870 0
3021 - St Albans
Recruitment postcode(s) [4] 33871 0
3168 - Clayton

Funding & Sponsors
Funding source category [1] 308510 0
Charities/Societies/Foundations
Name [1] 308510 0
Australian Gynaecological and Endoscopy Surgery (AGES) Society Ltd
Country [1] 308510 0
Australia
Primary sponsor type
Hospital
Name
Mercy Hospital for Women
Address
163 Studley Road
Heidelberg VIC 3068
Country
Australia
Secondary sponsor category [1] 309363 0
None
Name [1] 309363 0
Address [1] 309363 0
Country [1] 309363 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308468 0
Mercy Health Human Research Ethics Committee
Ethics committee address [1] 308468 0
Ethics committee country [1] 308468 0
Australia
Date submitted for ethics approval [1] 308468 0
01/11/2017
Approval date [1] 308468 0
16/04/2018
Ethics approval number [1] 308468 0
2018-003

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

Contacts
Principal investigator
Name 110794 0
Dr Samantha S Mooney
Address 110794 0
Mercy Hospital for Women
163 Studley Road
Heidelberg, VIC, 3084
Country 110794 0
Australia
Phone 110794 0
+61 3 8458 4022
Fax 110794 0
Email 110794 0
[email protected]
Contact person for public queries
Name 110795 0
Samantha S Mooney
Address 110795 0
Mercy Hospital for Women
163 Studley Road
Heidelberg, VIC, 3084
Country 110795 0
Australia
Phone 110795 0
+61 3 8458 4022
Fax 110795 0
Email 110795 0
[email protected]
Contact person for scientific queries
Name 110796 0
Samantha S Mooney
Address 110796 0
Mercy Hospital for Women
163 Studley Road
Heidelberg, VIC, 3084
Country 110796 0
Australia
Phone 110796 0
+61 3 8458 4022
Fax 110796 0
Email 110796 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
Confidential individual training 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.