Federico Gheza, MD, Mario A Masrur, MD, Simone Crivellaro, MD. UIC
Introduction: Robotic instruments provides a better ergonomics during suturing compared to standard laparoscopy. Minimally invasive procedures with limited need of few suture may benefit from an economically affordable device able to overcome some limitations of laparoscopic suturing. FlexDex surgical recently obtained the FDA approval for human use of its articulated laparoscopic needle driver. The official training provided by the Company (available at https://flexdex.com/register-for-training) is a 3 hour basic dry lab. The training curriculum as well as the accreditation process is not well structured. No literature is available today on this matter. Our goal was building a dedicated training, to allow a safe and predictable early use in humans.
Methods and Procedures: The training module design and implementation was done in our minimally invasive laboratory. In the preliminary phase we define with a small group of residents and research specialists a short list of mandatory concepts to detail showing the instrument. A simple suturing task was then performed by the same group with the new device, laparoscopically and with the robot, available in our lab for training only. A more complex task, based on a dedicated self-designed high-fidelity model of urethral anastomosis was then proposed, exploring different options (one FlexDex only vs two FlexDex, surgeon vs assistant holding the camera). Lastly, we applied the new device in animals to evaluate the usefulness of including simple tasks or entire procedures in the training curriculum.
Results: We were able to define a multilevel, adaptable training module including a basic information session, a dry lab with inanimate low- and high-fidelity models and a pig lab. Subjects with different level of expertise (medical student, resident, fellow, expert and very expert surgeon) were involved to have an extensive feedback. However, our main focus was to design a training module for laparoscopic and robotic surgeons, to safely introduce the FlexDex in their practice. The only outcome for this preliminary work was collected through a “post exposure” survey. The expert surgeon that did the entire training was able to give feedback after his first application of the device in humans as well.
Conclusions: FlexDex is a promising device, available in the United States in approved facilities only. A minimally invasive lab with high laparoscopic and robotic training experience is the ideal setting to build a curriculum. A first adaptable, multilevel, original, high-fidelity training is proposed to be validated with further studies and could be implementable for accreditation purposes
Presented at the SAGES 2017 Annual Meeting in Houston, TX.
Abstract ID: 88500
Program Number: P504
Presentation Session: iPoster Session (Non CME)
Presentation Type: Poster