Assessment of the training program for Versius, a new innovative robotic system for use in minimal access surgery

ObjectivesThe Versius surgical system has been developed for use in robot-assisted minimal access surgery (MAS). This study aimed to evaluate the effectiveness of the Versius training program.DesignA 3.5-day program following 10 hours of online didactic training. Participants were assessed during the technical training using the Global Evaluative Assessment of Robotic Skills (GEARS).SettingDry box exercises were conducted in classrooms, and wet lab sessions simulated an operating room environment using cadaveric specimens.ParticipantsSeventeen surgical teams participated; surgeons represented general, colorectal, obstetrics/gynecology, and urology specialties. All surgeons had previous laparoscopic MAS experience, while experience with robotics varied.Main outcomes measuresParticipants were scored on a five-point Likert Scale for each of six validated GEARS domains (depth perception, bimanual dexterity, efficiency, force sensitivity, autonomy, and robotic control). Additional metrics used to chart surgeon performance included: combined instrument path length; combined instrument angular path; and time taken to complete each task.ResultsParticipants demonstrated an overall improvement in performance during the study, with a mean GEARS Score of 21.0 (SD: 1.9) in Assessment 1 increasing to 23.4 (SD: 2.9) in Validation. Greatest improvements were observed in the depth perception and robotic control domains. Greatest differences were observed when stratifying by robotic experience; those with extensive experience consistently scored higher than those with some or no experience.ConclusionsThe Versius training program is effective; participants were able to successfully operate the system by program completion, and more surgeons achieved intermediate-level and expert-level GEARS scores in Validation compared with Assessment 1.

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Usability assessment of Versius, a new robot-assisted surgical device for use in minimal access surgery

BMJ Surgery, Interventions, & Health Technologies ◽

10.1136/bmjsit-2019-000028 ◽

2020 ◽

Vol 2 (1) ◽

pp. e000028 ◽

Cited By ~ 1

Author(s):

Fiona Haig ◽

Ana Cristina Barbosa Medeiros ◽

Karen Chitty ◽

Mark Slack

Keyword(s):

Minimal Access Surgery ◽

Minimal Access ◽

Usability Assessment ◽

Surgical Device ◽

Critical Task ◽

Surgical Teams ◽

Robotic Surgeries ◽

Access Surgery ◽

Upper Gastrointestinal ◽

Cadaveric Model

ObjectivesVersius is a teleoperated surgical robotic system intended for use in minimal access surgery. This study aimed to validate the safety and effectiveness of the Versius user interface in the hands of trained users and identify and address the causes of any user errors.DesignSurgical teams completed a commercially representative training program over 3.5 days. After training was completed, the usability-related aspects of the system were assessed.SettingA simulated operating room using a cadaveric model.ParticipantsSurgical teams consisting of a lead surgeon, assistant surgeon, scrub nurse and circulating nurse.Main outcome measuresUsability-related aspects of the system were assessed through the completion of critical and non-critical tasks. A critical task was defined according to the Food and Drug Administration’s definition, as a user task which, if performed incorrectly or not performed at all, would or could cause serious harm to the patient or user, where harm is defined to include compromised medical care.ResultsIn total, 17 surgical teams participated in the study and all were experienced in laparoscopic surgery. The number of robotic surgeries performed by the participants per month ranged from 0 to 100. Surgical specialties were similarly represented from obstetrics and gynecology, colorectal, urology and upper gastrointestinal. No critical task failures were observed. Of all the tasks completed, 98% were recorded as a pass or a pass with difficulty.ConclusionsThese results demonstrate that in a simulated clinical setting, Versius can be safely used by both laparoscopically and robotically trained healthcare professionals. These results support the progression to assessment of Versius in preclinical studies.

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Using end-user feedback to optimize the design of the Versius Surgical System, a new robot-assisted device for use in minimal access surgery

BMJ Surgery, Interventions, & Health Technologies ◽

10.1136/bmjsit-2019-000019 ◽

2019 ◽

Vol 1 (1) ◽

pp. e000019 ◽

Cited By ~ 5

Author(s):

Luke Hares ◽

Paul Roberts ◽

Keith Marshall ◽

Mark Slack

Keyword(s):

Surgical Procedures ◽

Surgical Robot ◽

Minimal Access Surgery ◽

Minimal Access ◽

Robot Assisted ◽

Robot System ◽

Long Term Study ◽

Surgical Teams ◽

Access Surgery ◽

Surgical System

BackgroundRobot-assisted minimal access surgery (MAS) reduces blood loss, recovery time, intraoperative and postoperative complications and pain. However, uptake of robotic MAS remains low, suggesting there are barriers to its use. To overcome these barriers, a new surgical robot system, Versius, was developed based on the needs and feedback of surgeons and surgical teams.MethodsThe surgical robot prototype was designed based on observations in the operating room (OR) and previous interviews with surgeons. Formative studies with surgeons and surgical teams were used to refine the prototype design, resulting in modifications to all components, including the arms, instruments, handgrips and surgeon console. Proof-of-concept cadaver studies were used to further optimize its design by assessing its usability during surgical procedures.ResultsFeedback led to the development of a novel, mobile design with independent arm carts and surgical console, linked by supported serial or parallel connections, providing maximum flexibility in the OR. Instrument tips were developed based on surgeons’ preferred designs and wristed at the tip providing seven degrees of freedom within the patient. Multiple handgrip designs were assessed by surgeons; of these, a ‘game controller’ design was rated most popular and usable. An open surgical console design allowing multiple working positions was rated highest by surgeons and the surgical teams.ConclusionsThis surgical robot system has been developed using feedback from end users throughout the design process and aims to minimize barriers to robotic MAS uptake. Additionally, these studies demonstrate system success in the surgical procedures it was designed for. The studies reported here, and further studies of the Versius Surgical System, are intended to align with IDEAL (Idea, Development, Exploration, Assessment, Long-term study) Framework guidance.

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