Laparoscopic Skills AcquisitionNCT06184854
Assessing the Efficacy of Enhanced Versus Standard 3D Training Models in Laparoscopic Skills Acquisition: A Randomised Controlled Trial
A study testing 3D-Enhanced Training Models and Standard 3D LapPass Training Models in people with Laparoscopic Skills Acquisition, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
The goal of this trial is to compare the effect of using 3D-enhanced versus standard 3D (three-dimensional) training models when novice medical students practise certain laparoscopic tasks. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Skills Acquisition
- What is being tested?
- 3D-Enhanced Training Models and Standard 3D LapPass Training Models
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 18 May 2022to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (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
Who cannot join
- (1) Undertaken at least one session of laparoscopic skills training
- (2) Uncommitted to the completion of the study
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Barts Cancer Institute, Queen Mary University of London
London, EC1M 6BE
About this study
Official title: Assessing the Efficacy of Enhanced Versus Standard Three-Dimensional Training Models in Laparoscopic Skills Acquisition: A Randomised Controlled Trial of Novice Medical Students
The goal of this trial is to compare the effect of using 3D-enhanced versus standard 3D (three-dimensional) training models when novice medical students practise certain laparoscopic tasks. The main question our trial aims to answer is:
-Are the 3D-enhanced training models used superior compared to the existing standard 3D LapPass training models for laparoscopic skills learning in novice medical students?
Participants will be assigned in one of the 2 groups and practise laparoscopic tasks in 2 separate sessions.
Read the detailed description
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 systems 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-enhanced training models with increased dimensionality and spatial complexity to expedite training and skill acquisition in 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 3D training models used in LapPass for training and assessment purposes lack variable contours and spatial complexity. 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, 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 3D training model for suturing and approximation of slightly indented circles on a flat suturing pad. Perhaps, the adoption of these standard 3D 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, compared to other improved alternatives. 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 increasing the dimensionality of the tasks, a more realistic surgical environment could be achieved, addressing this potential technical skills gap and leading to faster, more cost-effective training.
In this study, the polo task will be converted using a 3D-enhanced Jenga polo model developed in our institution. 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-enhanced 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.
Literature describing a direct comparison between 3D-enhanced and standard 3D 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-enhanced 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-enhanced training models in novice medical students when compared to the standard 3D LapPass training models in two distinct laparoscopic tasks.
PICOS criteria
- Population = Novice medical students from Year 1-5 including intercalating students
- Intervention = 3D-enhanced training models for polo manipulation and suturing tasks
- Comparator = Standard 3D 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
- Conditions
- Laparoscopic Skills Acquisition
- Being tested
- 3D-Enhanced Training Models, Standard 3D LapPass Training Models
- Keywords
- 3D-enhanced training models, Standard 3D training models, laparoscopic skills, randomised controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D-Enhanced Training ModelsOther
3D-enhanced Jenga polo model for task 1 and 3D-enhanced suturing model for task 2
Standard 3D LapPass Training ModelsOther
Standard 3D LapPass polo model for task 1 and standard 3D LapPass model for task 2
| Study group | Role | What they receive |
|---|---|---|
| Standard 3D LapPass Training Models | Active comparator | Participants in the standard 3D group practised laparoscopic skills using the standard 3D LapPass training models for polo manipulation and intracorporeal suturing Receives: Other: Standard 3D LapPass Training Models |
| 3D-Enhanced Training Models | Experimental | Participants in the 3D-enhanced group practised laparoscopic skills using the 3D-enhanced training models for polo manipulation and intracorporeal suturing Receives: Other: 3D-Enhanced Training Models |
What is being measured
The primary outcome is the main question the study is designed to answer.
GOALS score ranging from 5 to 25
The GOALS tool serves as a 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.
Measured: 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''.
Measured: 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''
Measured: 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 outcomes (1)
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 3D-enhanced versus standard 3D training models on participant-perceived performance and confidence
Measured: Immediately after study completion (average 1 week from enrolment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2023
- Study start18 May 2022
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic Skills AcquisitionStudies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georgios Alampritis, Queen Mary University of London
- Investigators
- Georgios Alampritis, Principal investigator, Queen Mary University of London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06184854
- Sponsor's protocol ID
- QMERC22.110
- Status last verified
- Jul 2024
- First submitted
- 7 Dec 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study Protocol, Informed Consent, Surveys and Study Report
Publications
Alampritis G, Rossou C, Patel B. Assessing the Efficacy of Enhanced Versus Standard Three-Dimensional Training Models in Laparoscopic Skills Acquisition: A Randomized Controlled Trial of Novice Medical Students. J Surg Educ. 2024 Dec;81(12):103278. doi: 10.1016/j.jsurg.2024.08.028. Epub 2024 Oct 11.
PubMed 39393177
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Efficacy of Enhanced Versus Standard Three-Dimensional Training Models in Laparoscopic Skills Acquisition: A Randomised Controlled Trial of Novice Medical Students
- ClinicalTrials.gov ID
- NCT06184854
- Acronym / sponsor ID
- QMERC22.110
- Conditions
- Laparoscopic Skills Acquisition
- Keywords
- 3D-enhanced training models, Standard 3D training models, laparoscopic skills, randomised controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 18 May 2022 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 28 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this trial is to compare the effect of using 3D-enhanced versus standard 3D (three-dimensional) training models when novice medical students practise certain laparoscopic tasks. The main question our trial aims to answer is:
-Are the 3D-enhanced training models used superior compared to the existing standard 3D LapPass training models for laparoscopic skills learning in novice medical students?
Participants will be assigned in one of the 2 groups and practise laparoscopic tasks in 2 separate sessions.
Detailed description
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 systems 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-enhanced training models with increased dimensionality and spatial complexity to expedite training and skill acquisition in 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 3D training models used in LapPass for training and assessment purposes lack variable contours and spatial complexity. 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, 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 3D training model for suturing and approximation of slightly indented circles on a flat suturing pad. Perhaps, the adoption of these standard 3D 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, compared to other improved alternatives. 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 increasing the dimensionality of the tasks, a more realistic surgical environment could be achieved, addressing this potential technical skills gap and leading to faster, more cost-effective training.
In this study, the polo task will be converted using a 3D-enhanced Jenga polo model developed in our institution. 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-enhanced 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.
Literature describing a direct comparison between 3D-enhanced and standard 3D 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-enhanced 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-enhanced training models in novice medical students when compared to the standard 3D LapPass training models in two distinct laparoscopic tasks.
PICOS criteria
- Population = Novice medical students from Year 1-5 including intercalating students
- Intervention = 3D-enhanced training models for polo manipulation and suturing tasks
- Comparator = Standard 3D 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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomised Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Standard 3D LapPass Training Models | Active comparator | Other: Standard 3D LapPass Training ModelsParticipants in the standard 3D group practised laparoscopic skills using the standard 3D LapPass training models for polo manipulation and intracorporeal suturing |
| 3D-Enhanced Training Models | Experimental | Other: 3D-Enhanced Training ModelsParticipants in the 3D-enhanced group practised laparoscopic skills using the 3D-enhanced training models for polo manipulation and intracorporeal suturing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- (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
Key exclusion criteria (2 listed)
- (1) Undertaken at least one session of laparoscopic skills training
- (2) Uncommitted to the completion of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D-Enhanced Training Models3D-enhanced Jenga polo model for task 1 and 3D-enhanced suturing model for task 2 | Other | 3D-Enhanced Training Models |
| Standard 3D LapPass Training ModelsStandard 3D LapPass polo model for task 1 and standard 3D LapPass model for task 2 | Other | Standard 3D LapPass Training Models |
Primary outcome
GOALS score ranging from 5 to 25
Time frame: 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)
The GOALS tool serves as a 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.
Task completion time in minutes
Time frame: 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)
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''.
Number of Erros
Time frame: 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)
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''
1 secondary outcome
Post-study survey questions on participant perceived pre- and post-training confidence and overall performance with a Likert scale of 1-5
Time frame: Immediately after study completion (average 1 week from enrolment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Derived from this study: PubMed 39393177Alampritis G, Rossou C, Patel B. Assessing the Efficacy of Enhanced Versus Standard Three-Dimensional Training Models in Laparoscopic Skills Acquisition: A Randomized Controlled Trial of Novice Medical Students. J Surg Educ. 2024 Dec;81(12):103278. doi: 10.1016/j.jsurg.2024.08.028. Epub 2024 Oct 11.
- Individual participant dataSharing planned: Yes. Study Protocol, Informed Consent, Surveys and Study Report
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Georgios Alampritis principal investigator
Queen Mary University of London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D-Enhanced Training Models and Standard 3D LapPass Training Models in people with Laparoscopic Skills Acquisition, run by Queen Mary University of London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GOALS score ranging from 5 to 25 (time frame: 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)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06184854, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.