Validation of a Simulator Set Up Entirely in an Academic Setting: Low-Cost Surgical Trainer Rather than High-Cost Videogame

Michele N Minuto*¹, Gianluca Marcocci¹, Domenico Soriero¹, Gregorio Santori¹, Marco Sguanci¹, Francesca Mandolfino¹, Marco Casaccia¹, Rosario Fornaro¹, Cesare Stabilini¹, Gianni Vercelli², Simone Marcutti², Marco Gaudina², Francesca Stratta¹, Marco Frascio¹

Received: May 29, 2018;   Published: June 11, 2018

DOI: 10.26717/BJSTR.2018.05.001190

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Abstract

Laparoscopic surgery is the standard approach for most surgical operations because of its benefits for the patients, although it requires a significant learning curve. For this reason, the FDA established the need for certified laparoscopic training programs, supported by validated surgical simulators. Our multidisciplinary team developed a virtual surgical simulator (eLap4D) based on: a low-cost and a realistic haptic feedback. This study presents the validation process of the eLap4D, performed through the construct and face validities.

The authors preliminarily analyzed and excluded the possible impact of videogame experience on eLap4D users. The construct validity was used to objectively assess the surgical value of five basic skills by comparing the performances between two groups with different levels of laparoscopy experience. The presence of a learning curve was also evaluated by comparing the results of the first and second attempts. The difference among exercises was investigated in terms of the difficulty and kind of basic gestures, comparing the completion rates of every task in the three difficulty levels each. Face validation was performed using a specific questionnaire investigating the realism and accuracy of the simulator. This last survey was administered only to experienced surgeons. The validation process indicated that eLap4D can measure surgical ability and not just videogame experience. It also positively affects the learning curve and reproduces different basic gestures and levels of difficulty. Face validity confirmed that its structural features and ergonomics are satisfactory. In conclusion, eLap4D seems suitable and useful for learning basic laparoscopy skills.

Keywords: Surgical Simulator, Virtual Reality, Training, Haptic Feedback, Validation, Face Validity, Construct Validity

Abbreviations: EUSTM: European Society for Translational Medicine; TM : Translational Medicine; TS : Translational Science; SBME: SimulationBased Medical Education; FDA: Food & Drug Administration; FLS: Fundamentals of Laparoscopic Surgery; HEC: Hand Eye Coordination

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