A Randomized Controlled Trial of a Robotic Simulation Curriculum to Teach Robotic Suturing

BACKGROUND AND RATIONALE

A number of pressures make it challenging to learn robotic suturing in the operating room including budgetary constraints necessitating near maximum operating room efficiency, concerns about patient safety, and decreased trainee working hours. Robotic surgery is a novel surgical technique which has significantly decreased surgical morbidity compared to open surgery.

Robotic simulation is a technique that enables skill acquisition in robotic surgery without the constraints of the operating room. The Mimic® dv-Trainer TM is a novel virtual reality robotic surgery simulator which first became available in 2007. Further refinements and developments led to incorporation of the Mimic software into the da Vinci® Skills Simulator. This simulator has been shown to have face validity (appears realistic to experienced surgeons) and construct validity (surgeons with more experience in robotic surgery score higher than less experienced surgeons when performing the simulation exercises). The impact of training using the da Vinci® Skills Simulator on performance using the actual surgical robot (da Vinci® Surgical System) has started to be studied. One study assessed the impact of training using the da Vinci® Skills Simulator on performance of three animal tissue based tasks using the da Vinci® Si HD TM Surgical System (Hung, A.J., et al., Concurrent and predictive validation of a novel robotic surgery simulator: a prospective, randomized study. Journal of Urology, 2012. 187(2): p. 630-7). One of three tasks assessed was suturing closed a hole in an injured animal bladder. This study showed statistically significant improvement in the animal tissue exercises for the subgroup of participants who started with scores in the lower 50th percent for those exercises.

Our study will differ from this study in several ways. First, we will be focusing on a more select group of simulation exercises focusing on robotic suturing (six exercises rather than seventeen). Second, we will be developing a proficiency curriculum rather than one based on time spent training. Third, our primary outcome will be performance of suturing, using the actual surgical robot (da Vinci® Surgical System), of a vaginal cuff model made out of inanimate materials rather than an animal tissue model. Due to logistic reasons, the suturing of the inanimate model will be performed with the da Vinci® S Surgical System at the March 23rd testing date (pretest for group 1) and with the da Vinci® Si Surgical System at the April 27 testing date (pretest for group 2 and post-test 1 for group 1) and at the June 1 testing date (post-test for group 2 and post-test 2 for group 1 controls who then cross over to training in May). Our study will be open to trainees and surgeons from obstetrics and gynecology, general surgery, urology, and cardiac surgery rather than just urology.

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