Laparoscopic Skills Acquisition Using an AI-enhanced Game-based Simulation Tool Compared With a Laparoscopic Simulator Box Trainer

NCT07276022 | Active Not Recruiting

• 1 other identifier: 24-EMREC-003
• Study Type: interventional
• Target: 157
• Locations: 3 countries
• Sites: 3

Brief 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. 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.

Conditions

Laparoscopic Surgery

Keywords

surgery; global health; simulation; skills acquisition; training; artificial intelligence; machine learning; serious gaming

Outcome Measures

Primary Outcomes (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.

  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

  Final assessment is conducted after a total of 4 hours training time

• Flow measure across five laparoscopic simulator tasks

  Final assessment is conducted after a total of 4 hours training time

• Handling measure across five laparoscopic simulator tasks

  Final assessment is conducted after a total of 4 hours training time

• Respect measure across five laparoscopic simulator tasks

  Final assessment is conducted after a total of 4 hours training time

• Qualitative questionnaire and interview

  Final assessment is conducted after a total of 4 hours training time

Study Arms (2)

AI-enhanced game-based simulation tool

EXPERIMENTAL

Laptitude tool.

Device: AI-enhanced game-based simulation tool (Laptitude)

Laparoscopic simulator box trainer

ACTIVE COMPARATOR

eoSim tool.

Device: Laparoscopic simulator box trainer (SurgTrac)

Interventions

AI-enhanced game-based simulation tool (Laptitude) DEVICE

A surgical simulation game-based platform comprising controllers and software delivered via a laptop computer

AI-enhanced game-based simulation tool

Laparoscopic simulator box trainer (SurgTrac) DEVICE

eoSim SurgTrac box trainer platform

Laparoscopic simulator box trainer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Inability to provide informed consent.
• Inability to attend for training and assessment.

Sponsors & Collaborators

• University of Edinburgh: lead

Study Sites (3)

Hospital General San Juan de Dios

Guatemala City, Guatemala

Location

Christian Medical College (CMC), Ludhiana

Ludhiana, Punjab, 141003, India

Location

Obafemi Awolowo University (OAU)

Ile-Ife, Nigeria

Location

Study Officials

• Ewen M Harrison, PhD

  University of Edinburgh

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 10, 2025
• Study Start: November 19, 2025
• Primary Completion: January 23, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be made available 6 months after completion of the study and will be available indefinitely.

Locations

GU (1); IN (1); NG (1)