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AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Guatemala1 site
  • Hospital General San Juan de Dios

    Guatemala City

Other trials in Guatemala

India1 site
  • Christian Medical College (CMC), Ludhiana

    Ludhiana, Punjab, 141003

Other trials in India

Nigeria1 site
  • Obafemi Awolowo University (OAU)

    Ile-Ife

Other trials in Nigeria

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.

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 groups in NCT07276022
Study groupRoleWhat they receive
AI-enhanced game-based simulation toolExperimentalLaptitude tool.
Receives: Device: AI-enhanced game-based simulation tool (Laptitude)
Laparoscopic simulator box trainerActive comparatoreoSim 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  1. First posted10 Dec 2025
  2. Study start19 Nov 2025
  3. Primary completion23 Jan 2026
  4. Study completion31 Jul 2026

Resources

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)
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.

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.

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