Development and Validation of Virtual Laparoscopic Hiatal Hernia Simulator

Predictive Validity of VLaHHS

Virtual Laparoscopic Hiatal Hernia Simulator (VLaHHS), GS Residents

Part 3 Phase III of this protocol is the interventional portion and is the reason why only this Part is registered and reported within this record. The goal of this phase of the study is to establish the learning curve and predictive validity of the VLaHHS. The study population includes GS residents. The hypothesis is that the subject trained in VLaHHS will improve their skills compared to control with no training and show better transfer of skills on to an actual procedure.

The learning curve of VLaHHS will be established by training subjects in the task over extended period until they reach a plateau. The predictive validity will be established by comparing the training group with a control group with no training by testing their skills on a simulated surgical task using a crural repair silicone model and porcine fundoplication model. The experimental design is a between-subjects design with two groups to which participants will be randomly assigned: (1) Group 1 (Simulation Group): training with VLaHHS, (2) Group 2 (Control Group): no training. The Crural closure tasks of VLaHHS will be tested (10 subjects per task). Before the testing session begins, all participants will receive a guided, hands-on orientation to the task that is being tested. They will then take a pre-test in which they will be asked to perform the task once to mark their baseline performance (i.e. initialize their learner profile). For the training phase, participants in Group 1 will perform the tasks on VLaHHS for an hour a day for a maximum of no more than three weeks (3 weeks' x 5 days = 15 sessions). In each session of no more than an hour, subjects will repeat the task five times. Participants in Group 2 will continue with their normal residency training but will not participate in VLaHHS training at all. Two aspects of learning will then be assessed post-training: skill learning and transfer-of-training. For the Simulation Group, skill learning will be measured immediately following training (post-test) and again after two weeks to measure retention. For the Control Group, skill learning will be measured four weeks after orientation and again two weeks later to measure retention. Finally, immediately after post-test, transfer-of-training will be assessed using simulated crural repair or fundoplication model. The transfer study will be conducted either at the UT Southwestern (UTSW) Simulation Center or at the Artificial Intelligence and Medical Simulation (AIMS) Lab in south campus. Dependent measures for learning curve and retention will be the score computed from completion time and errors on the VLaHHS and the workload assessment measured using the NASA-TLX (Task Load Index) questionnaire after each session. For the transfer task, Subjects performance on the crural repair task will be video recorded and evaluated by a minimum of three experts using Global Assessment Tools for Intraoperative Laparoscopic Skills (GOALS) subjective evaluation method. The videotaping will focus only on subjects hand and any Identifying information such as subjects face will not be captured.

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