Laparoscopic SurgeryCAMELs-RCTNCT07276022
Laparoscopic Skills Acquisition Using an AI-enhanced Game-based Simulation Tool Compared With a Laparoscopic Simulator Box Trainer
A study testing AI-enhanced game-based simulation tool (Laptitude) and Laparoscopic simulator box trainer (SurgTrac) in people with Laparoscopic Surgery, run by University of Edinburgh at 3 sites in 3 countries.
Trial summary
The goal of this clinical trial is to learn whether an AI-enhanced, game-based laparoscopic simulation tool can improve laparoscopic skills training and help increase surgical capacity in surgical trainees and other healthcare professionals learning laparoscopic surgery. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Laparoscopic Surgery
- What is being tested?
- AI-enhanced game-based simulation tool (Laptitude) and Laparoscopic simulator box trainer (SurgTrac)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 19 Nov 2025to 31 Jul 2026
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Novice medical students: no previous experience previous simulation training and/or operative experience.
- Novice medically-qualified doctors (MDs): no previous experience previous simulation training and/or operative experience.
- Intermediate experience medical students: previously used laparoscopic simulator box trainer.
- Intermediate experience medically-qualified doctors (MDs): previously used laparoscopic simulator box trainer.
Who cannot join
- Inability to provide informed consent.
- Inability to attend for training and assessment.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
About this study
Official title: Creating New Models of Laparoscopic Surgery Skills Acquisition and Assessment: Randomised-controlled Trial of Laparoscopic Skills Acquisition Using an AI-enhanced Game-based Simulation Tool Compared With a Laparoscopic Simulator Box Trainer
The goal of this clinical trial is to learn whether an AI-enhanced, game-based laparoscopic simulation tool can improve laparoscopic skills training and help increase surgical capacity in surgical trainees and other healthcare professionals learning laparoscopic surgery. The main questions it aims to answer are:
- Does an AI-enhanced game-based simulator lead to faster and/or higher quality acquisition of laparoscopic technical skills than a standard box trainer?
- Is AI-enhanced game-based simulation a feasible and scalable model for laparoscopic skills training across diverse healthcare settings?
- Researchers will compare training with the Laptitude AI-enhanced game-based simulator to training with a standard laparoscopic box trainer to see if the AI-enhanced approach results in better performance on validated laparoscopic skills assessments and more efficient training.
Read more
Participants will:
- Be randomly assigned to train using either the Laptitude AI-enhanced game-based simulator or a standard box trainer.
- Complete a structured programme of laparoscopic training tasks.
- Undergo standardized assessments of laparoscopic skills performance during and/or after the training period.
Read the detailed description
Surgery is an indispensable part of healthcare but it is lacking resources. It is estimated that an additional 143 million additional surgical operations are needed each year and that 1.5 million deaths would be prevented if these operations were available. Over the next decade, the lack of surgery is projected to cost $10 billion in lost global gross domestic product (GDP).
There is an urgent need to train surgeons as this expertise is scarce. However, experience is unpredictable, skills remain unquantified, trainees require supervision, and surgeons undergo long periods of training following medical school. Surgical training which is based on graduated responsibility, defined as the progressive accumulation of skill by surgical residents that allows for the granting of greater involvement and independence by senior surgeons, forms much of the groundwork for surgical residency training.
Laparoscopic techniques have transformed surgery, being associated with less pain, lower infection rates and shorter length of stay. Of the 143 million additional operations required to meet basic needs and save lives, 28 million (20%) could be done using minimally invasive techniques. Surgeons need comprehensive training in this area through skill-based models and measurable assessment of skill acquisition to effectively track and understand the development of competencies. There is an added interest in understanding if non-MDs (non-medical doctors), undergoing similar training in laparoscopic procedures can reproduce the skills of conventionally trained surgeons.
Simulator training is a skills-based model for developing effective laparoscopic surgical skills, but existing simulators may not accurately represent real life conditions. There is a need to identify and develop high-fidelity simulators which can substitute for operative time in skill-acquisition.
The creation and deployment of complex interventions like laparoscopic skills training is challenging. Technological innovations are often complex in themselves, and they necessitate expertise and backing from a broad group of stakeholders. Furthermore, these interventions must be sufficiently flexible to meet needs across a diverse range of healthcare settings. The successful delivery of health technology programs, including laparoscopic skills training, necessitates the strong and early engagement of patients, practitioners, and policy makers. This shifts the focus from a binary question of effectiveness, to whether interventions can be acceptable, implementable, cost-effective, scalable, and transportable across settings.
This study will therefore evaluate approaches to increase surgical capacity based on the creation of new models for laparoscopic surgical skills acquisition, including this randomised controlled trial comparing of an AI-enhanced game-based simulation tool (Laptitude, Grendel Games) compared with a standard laparoscopic simulator box trainer.
- Conditions
- Laparoscopic Surgery
- Being tested
- AI-enhanced game-based simulation tool (Laptitude), Laparoscopic simulator box trainer (SurgTrac)
- Keywords
- surgery, global health, simulation, skills acquisition, training, artificial intelligence, machine learning, serious gaming
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI-enhanced game-based simulation tool (Laptitude)Device
A surgical simulation game-based platform comprising controllers and software delivered via a laptop computer
Laparoscopic simulator box trainer (SurgTrac)Device
eoSim SurgTrac box trainer platform
| Study group | Role | What they receive |
|---|---|---|
| AI-enhanced game-based simulation tool | Experimental | Laptitude tool. Receives: Device: AI-enhanced game-based simulation tool (Laptitude) |
| Laparoscopic simulator box trainer | Active comparator | eoSim tool. Receives: Device: Laparoscopic simulator box trainer (SurgTrac) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite measure of flow, handling and respect across five laparoscopic simulator tasks
A proportional odds mixed model of the domains: flow, handling and respect, measured on a 7-level Likert scale for five tasks (peg transfer, suture with extracorproeal knot, suture with intracorporeal knot, precision cutting, and ligating loop) specifying an interaction between arm and task and including participant and rater as random effects.
Measured: Final assessment is conducted after a total of 4 hours training time
Secondary outcomes (5)
Sensitivity analyais: Composite measure of flow, handling and respect across five laparoscopic simulator tasks
Sensitivity analysis: A linear mixed model of the domains: flow, handling and respect, measured on a 7-level Likert scale for five tasks (peg transfer, suture with extracorproeal knot, suture with intracorporeal knot, precision cutting, and ligating loop) specifying an interaction between arm and task and including participant and rater as random effects.
Measured: Final assessment is conducted after a total of 4 hours training time
Flow measure across five laparoscopic simulator tasks
Flow domain measured on a 7-level Likert scale for five tasks (peg transfer, suture with extracorproeal knot, suture with intracorporeal knot, precision cutting, and ligating loop) specifying an interaction between arm and task and including participant and rater as random effects.
Measured: Final assessment is conducted after a total of 4 hours training time
Handling measure across five laparoscopic simulator tasks
Handling domain measured on a 7-level Likert scale for five tasks (peg transfer, suture with extracorproeal knot, suture with intracorporeal knot, precision cutting, and ligating loop) specifying an interaction between arm and task and including participant and rater as random effects.
Measured: Final assessment is conducted after a total of 4 hours training time
Respect measure across five laparoscopic simulator tasks
Respect domain measured on a 7-level Likert scale for five tasks (peg transfer, suture with extracorproeal knot, suture with intracorporeal knot, precision cutting, and ligating loop) specifying an interaction between arm and task and including participant and rater as random effects.
Measured: Final assessment is conducted after a total of 4 hours training time
Qualitative questionnaire and interview
At the end of the assessment, all participants will be invited to complete a qualitative questionnaire gathering their feedback on the use of the technology they were randomised to. A small subset of participants will be invited to take part in a qualitative research focus group.
Measured: Final assessment is conducted after a total of 4 hours training time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start19 Nov 2025
- Primary completion23 Jan 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic SurgeryStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ewen M Harrison, PhD, Study chair, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07276022
- Sponsor's protocol ID
- 24-EMREC-003
- Acronym
- CAMELs-RCT
- Status last verified
- Mar 2026
- First submitted
- 18 Nov 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Full anonymised individual participant data will be available for sharing with bona fide research teams upon application to the Principal Investigator.
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Creating New Models of Laparoscopic Surgery Skills Acquisition and Assessment: Randomised-controlled Trial of Laparoscopic Skills Acquisition Using an AI-enhanced Game-based Simulation Tool Compared With a Laparoscopic Simulator Box Trainer
- ClinicalTrials.gov ID
- NCT07276022
- Acronym / sponsor ID
- CAMELs-RCT / 24-EMREC-003
- Conditions
- Laparoscopic Surgery
- Keywords
- surgery, global health, simulation, skills acquisition, training, artificial intelligence, machine learning, serious gaming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- 19 Nov 2025 (actual)
- Primary completion
- 23 Jan 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 10 Dec 2025 (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 clinical trial is to learn whether an AI-enhanced, game-based laparoscopic simulation tool can improve laparoscopic skills training and help increase surgical capacity in surgical trainees and other healthcare professionals learning laparoscopic surgery. The main questions it aims to answer are:
- Does an AI-enhanced game-based simulator lead to faster and/or higher quality acquisition of laparoscopic technical skills than a standard box trainer?
- Is AI-enhanced game-based simulation a feasible and scalable model for laparoscopic skills training across diverse healthcare settings?
- Researchers will compare training with the Laptitude AI-enhanced game-based simulator to training with a standard laparoscopic box trainer to see if the AI-enhanced approach results in better performance on validated laparoscopic skills assessments and more efficient training.
Participants will:
- Be randomly assigned to train using either the Laptitude AI-enhanced game-based simulator or a standard box trainer.
- Complete a structured programme of laparoscopic training tasks.
- Undergo standardized assessments of laparoscopic skills performance during and/or after the training period.
Detailed description
Surgery is an indispensable part of healthcare but it is lacking resources. It is estimated that an additional 143 million additional surgical operations are needed each year and that 1.5 million deaths would be prevented if these operations were available. Over the next decade, the lack of surgery is projected to cost $10 billion in lost global gross domestic product (GDP).
There is an urgent need to train surgeons as this expertise is scarce. However, experience is unpredictable, skills remain unquantified, trainees require supervision, and surgeons undergo long periods of training following medical school. Surgical training which is based on graduated responsibility, defined as the progressive accumulation of skill by surgical residents that allows for the granting of greater involvement and independence by senior surgeons, forms much of the groundwork for surgical residency training.
Laparoscopic techniques have transformed surgery, being associated with less pain, lower infection rates and shorter length of stay. Of the 143 million additional operations required to meet basic needs and save lives, 28 million (20%) could be done using minimally invasive techniques. Surgeons need comprehensive training in this area through skill-based models and measurable assessment of skill acquisition to effectively track and understand the development of competencies. There is an added interest in understanding if non-MDs (non-medical doctors), undergoing similar training in laparoscopic procedures can reproduce the skills of conventionally trained surgeons.
Simulator training is a skills-based model for developing effective laparoscopic surgical skills, but existing simulators may not accurately represent real life conditions. There is a need to identify and develop high-fidelity simulators which can substitute for operative time in skill-acquisition.
The creation and deployment of complex interventions like laparoscopic skills training is challenging. Technological innovations are often complex in themselves, and they necessitate expertise and backing from a broad group of stakeholders. Furthermore, these interventions must be sufficiently flexible to meet needs across a diverse range of healthcare settings. The successful delivery of health technology programs, including laparoscopic skills training, necessitates the strong and early engagement of patients, practitioners, and policy makers. This shifts the focus from a binary question of effectiveness, to whether interventions can be acceptable, implementable, cost-effective, scalable, and transportable across settings.
This study will therefore evaluate approaches to increase surgical capacity based on the creation of new models for laparoscopic surgical skills acquisition, including this randomised controlled trial comparing of an AI-enhanced game-based simulation tool (Laptitude, Grendel Games) compared with a standard laparoscopic simulator box trainer.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI-enhanced game-based simulation tool | Experimental | Device: AI-enhanced game-based simulation tool (Laptitude)Laptitude tool. |
| Laparoscopic simulator box trainer | Active comparator | Device: Laparoscopic simulator box trainer (SurgTrac)eoSim tool. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Novice medical students: no previous experience previous simulation training and/or operative experience.
- Novice medically-qualified doctors (MDs): no previous experience previous simulation training and/or operative experience.
- Intermediate experience medical students: previously used laparoscopic simulator box trainer.
- Intermediate experience medically-qualified doctors (MDs): previously used laparoscopic simulator box trainer.
Key exclusion criteria (2 listed)
- Inability to provide informed consent.
- Inability to attend for training and assessment.
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 |
|---|---|---|
| AI-enhanced game-based simulation tool (Laptitude)A surgical simulation game-based platform comprising controllers and software delivered via a laptop computer | Device | AI-enhanced game-based simulation tool |
| Laparoscopic simulator box trainer (SurgTrac)eoSim SurgTrac box trainer platform | Device | Laparoscopic simulator box trainer |
Primary outcome
Composite measure of flow, handling and respect across five laparoscopic simulator tasks
Time frame: Final assessment is conducted after a total of 4 hours training time
A proportional odds mixed model of the domains: flow, handling and respect, measured on a 7-level Likert scale for five tasks (peg transfer, suture with extracorproeal knot, suture with intracorporeal knot, precision cutting, and ligating loop) specifying an interaction between arm and task and including participant and rater as random effects.
5 secondary outcomes
Sensitivity analyais: Composite measure of flow, handling and respect across five laparoscopic simulator tasks
Time frame: Final assessment is conducted after a total of 4 hours training time
Flow measure across five laparoscopic simulator tasks
Time frame: Final assessment is conducted after a total of 4 hours training time
Handling measure across five laparoscopic simulator tasks
Time frame: Final assessment is conducted after a total of 4 hours training time
Respect measure across five laparoscopic simulator tasks
Time frame: Final assessment is conducted after a total of 4 hours training time
Qualitative questionnaire and interview
Time frame: Final assessment is conducted after a total of 4 hours training time
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 9 Sep 2026.
- Individual participant dataSharing planned: Yes. Full anonymised individual participant data will be available for sharing with bona fide research teams upon application to the Principal Investigator.
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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.
Ewen M Harrison, PhD study chair
University of Edinburgh
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI-enhanced game-based simulation tool (Laptitude) and Laparoscopic simulator box trainer (SurgTrac) in people with Laparoscopic Surgery, run by University of Edinburgh at 3 sites in 3 countries.
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 4 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 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Guatemala, India, Nigeria. 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?
Composite measure of flow, handling and respect across five laparoscopic simulator tasks (time frame: Final assessment is conducted after a total of 4 hours training time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Sep 2026.