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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:
Participants will:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI-enhanced game-based simulation tool | Experimental | Laptitude tool. |
|
| Laparoscopic simulator box trainer | Active Comparator | eoSim tool. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-enhanced game-based simulation tool (Laptitude) | Device | A surgical simulation game-based platform comprising controllers and software delivered via a laptop computer |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Final assessment is conducted after a total of 4 hours training time |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ewen M Harrison, PhD | University of Edinburgh | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital General San Juan de Dios | Guatemala City | Guatemala | ||||
| Christian Medical College (CMC), Ludhiana |
Full anonymised individual participant data will be available for sharing with bona fide research teams upon application to the Principal Investigator.
Data will be made available 6 months after completion of the study and will be available indefinitely.
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| Laparoscopic simulator box trainer (SurgTrac) | Device | eoSim SurgTrac box trainer platform |
|
| 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. | 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. | 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. | 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. | Final assessment is conducted after a total of 4 hours training time |
| Ludhiana |
| Punjab |
| 141003 |
| India |
| Obafemi Awolowo University (OAU) | Ile-Ife | Nigeria |