The Effect of 3D Versus 2D Training Models in Laparoscopic Skills Acquisition: A Randomised Controlled Trial

Study Overview
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Brief Summary
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The goal of this trial is to compare the effect of using 3D (three-dimensional) versus 2D (two-dimensional) training models when novice medical students practise certain laparoscopic tasks. The main question our trial aims to answer is: -Are the 3D training models used superior compared to the existing 2D LapPass training models for laparoscopic skills learning in novel medical students? Participants will be assigned in one of the 2 groups and practise laparoscopic tasks in 2 separate sessions.

Detailed Description
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There is ample evidence supporting the use of low-fidelity surgical simulators, often referred to as benchtop models, for fundamental laparoscopic skills acquisition using both basic and advanced tasks. The purpose of using low-fidelity training models is mainly skills acquisition rather than recreation of in situ anatomy. Benchtop models have the potential to be low-cost compared to other high-fidelity simulators, whilst enhancing transferability of those vital skills to the operative room. It has been demonstrated in the literature that the use of the 3D visual modality in laparoscopy is associated with an improved depth perception providing an enhanced visuo-spatial context and performance in the surgical or simulation setting, facilitating the execution of complex laparoscopic tasks. The use of this technology is often associated with certain limitations of adaptability to personnel, practicalities and financial considerations of its introduction to the everyday teaching curriculum of novice individuals. Hence, there is potential of following a differential approach by utilising low-fidelity 3D training models of varying depth, height and width to expedite training and skill acquisition using the 2D visual modality, which is most commonly used both in the simulation and operative settings. Monocular cues are important to compensate for lack of depth perception in 2D vision. These include motion parallax through movement of the laparoscope, shading of light and dark, texture grading, relative position and instrument and anatomic structure size. Depth perception can be improved through experience as processing of monocular cues is enhanced and adaptation, which is a learning process, ultimately results to improved performance. Experienced surgeons have mastered the skill of identifying indirect monocular cues and gain depth perception by utilising them, resulting to accurate and efficient movements. The training models used in LapPass for training and assessment purposes are relatively flat, 2D models. In the current model for the polo manipulation and grasping task, all the posts are on the same height and mounted on a flat surface, thus lacking contours and depth. This is the first exercise performed and heavily practised by novices to develop the fundamental laparoscopic skills of depth perception, hand-eye coordination and bimanual dexterity, which are vital for smooth progression to the other tasks. The laparoscopic suturing and intracorporeal knot tying task, similarly, introduces a 2-dimensional training model for suturing and approximation of circles on a flat suturing pad without variable contours. The adoption of 2D training models could act as a limiting factor in technical skills acquisition and ultimately prolong the training time to achieve a higher level of expertise. Achieving proficiency in basic laparoscopic skills can result in faster acquisition of more complex laparoscopic skills such as suturing and ultimately results to a more cost-effective training. By converting the tasks to the 3-dimensions using low-fidelity 3D training models with varying heights, widths and depths, the simulation of a more realistic surgical environment could be achieved and bridge a potential technical laparoscopic skills gap created by training on flat models compared to three-dimensional landmarks. In our study, the polo task will be converted using a 3D polo model developed in our institution, which demonstrated face and construct validity to differentiate between various levels of expertise. The model was initially developed for the FLS program's simpler peg transfer task and the equipment will be adjusted to simulate the LapPass polo grasping and manipulation task, a more technically demanding task. In addition, the suturing task will be converted using a 3D suturing model by Inovus Medical (Saint Helens, England, UK) attached on a platform providing limited stability to the model, which simulates sufficiently complexities in surgical practise. The use of a 3D suturing model with varying contours has been demonstrated to be an effective simulation teaching tool for the advanced task of laparoscopic suturing. Literature describing a direct comparison between 3D and 2D training models of LapPass basic and advanced laparoscopic tasks is absent, despite the potential of fast-tracking laparoscopic skills acquisition in novices. We postulate that the use of 3D training models at the onset of laparoscopic skills training of novices could accelerate the adaptation to indirect cues related to depth perception, as well as other core skills of laparoscopic skills training, enhancing performance. The aim of this study is to determine if laparoscopic technical skills acquisition will be superior with the use of 3D training models in novice medical students when compared to the current 2D LapPass training models in 2 separate laparoscopic tasks. PICOS criteria Population = Novice medical students from Year 1-5 including intercalating students Intervention = 3D training models for polo manipulation and suturing tasks Comparator = 2D LapPass training models for polo manipulation and suturing tasks Outcomes = Laparoscopic skill acquisition (GOALS score, Task completion time, Errors, Survey data) Setting = Simulation lab in Barts Cancer Institute

Official Title
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The Effect of 3D Versus 2D Training Models in Laparoscopic Skills Acquisition: A Randomised Controlled Trial of Novice Medical Students

Conditions
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Laparoscopic Skills Acquisition

Intervention / Treatment
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* Other: 3D Training Models
* Other: 2D LapPass Training Models


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: (1) Medical students from Year 1 to Year 5 including intercalating students (2) Novices in laparoscopic surgery defined as having no formal laparoscopic skills training beyond camera navigation Exclusion Criteria: (1) Undertaken at least one session of laparoscopic skills training (2) Uncommitted to the completion of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised Controlled Trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 2D LapPass Training Models<br>Participants in the 2D group practised laparoscopic skills using the 2D LapPass training models for polo manipulation and intracorporeal suturing | Other: 2D LapPass Training Models<br>* 2D LapPass polo model for task 1 and 2D LapPass model for task 2<br>|
| Experimental: 3D Training Models<br>Participants in 3D group practised laparoscopic skills using the 3D training models for polo manipulation and intracorporeal suturing | Other: 3D Training Models<br>* 3D Jenga polo model for task 1 and 3D suturing model for task 2<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GOALS score ranging from 5 to 25 | The GOALS tool serves as a valid and reliable technique- specific method to assess the technical performance of novice medical students, with extensive evidence in the literature. GOALS tool is comprised of 5 domains: (1) depth perception, (2) bimanual dexterity, (3) efficiency, (4) tissue handling and (5) autonomy scored with a 5-points scale for each domain according to the level of technical skills demonstrated with the total score ranging from 5-25. | Baseline assessment after 20 minutes of task and equipment familiarisation (A1), Interim assessment at 1-hour of training and Post-training assessment at 2-hours of training (A3) | 
| Task completion time in minutes | Completion time is defined as 'time to task completion with start time being the moment instruments are in view on the monitor and end time being the moment the task is completed with instruments removed or reaching the time limit of 10 minutes''. | Baseline assessment after 20 minutes of task and equipment familiarisation (A1), Interim assessment at 1-hour of training and Post-training assessment at 2-hours of training (A3) | 
| Number of Erros | Errors for the polo task are defined as '' dropping a polo'' and intracorporeal suturing task as ''poor approximation, insecure knot, incomplete knot or slipping knot'' | Baseline assessment after 20 minutes of task and equipment familiarisation (A1), Interim assessment at 1-hour of training and Post-training assessment at 2-hours of training (A3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-study survey questions on participant perceived pre- and post-training confidence and overall performance with a Likert scale of 1-5 | The secondary outcome measure includes post-study survey questions to measure the effect of training on 2D versus 3D training models on participant-perceived performance and confidence | Immediately after study completion (average 1 week from enrolment) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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3D training models, 2D training models, laparoscopic skills, randomised controlled trial