Luca Morelli1,2, Matteo Palmeri3, Tommaso Simoncini4, Vito Cela4, Alessandra Perutelli4, Cesare Selli5, Piero Buccianti6, Francesco Francesca7, Massimo Cecchi8, Cristina Zirafa9, Luca Bastiani10, Alfred Cuschieri11, Franca Melfi9. 1. General Surgery Unit, Department of Surgery, Translational and new Technologies in Medicine, University of Pisa, Via Paradisa 2, 56124, Pisa, Italy. luca.morelli@unipi.it. 2. EndoCAS (Center for Computer Assisted Surgery), University of Pisa, Pisa, Italy. luca.morelli@unipi.it. 3. General Surgery Unit, Department of Surgery, Translational and new Technologies in Medicine, University of Pisa, Via Paradisa 2, 56124, Pisa, Italy. 4. Division of Obstetrics and Gynecology, Department of Experimental and Clinical Medicine, University of Pisa, Pisa, Italy. 5. Division of Urology, Department of Translational Research, University of Pisa, Pisa, Italy. 6. General Surgery, Department of Surgery, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy. 7. Urology Unit, Department of Endocrinology, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy. 8. General Surgery Unit, Versilia Hospital, Viareggio, Italy. 9. Multidisciplinary Robotic Center, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy. 10. Institute of Clinical Physiology, National Council of Research, Pisa, Italy. 11. Institute for Medical Science and Technology, University of Dundee, Dundee, Scotland, UK.
Abstract
BACKGROUND: The da Vinci® Table Motion (dVTM) comprises a combination of a unique operating table (Trumpf Medical™ TruSystem® 7000dV) capable of isocenter motion connected wirelessly with the da Vinci Xi® robotic platform, thereby enabling patients to be repositioned without removal of instruments and or undocking the robot. MATERIALS AND METHODS: Between May 2015 to October 2015, the first human use of dVTM was carried out in this prospective, single-arm, post-market study in the EU, for which 40 patients from general surgery (GS), urology (U), or gynecology (G) were enrolled prospectively. Primary endpoints of the study were dVTM feasibility, efficacy, and safety. RESULTS: Surgeons from the three specialties obtained targeting success and the required table positioning in all cases. Table movement/repositioning was necessary to gain exposure of the operating field in 106/116 table moves (91.3%), change target in 2/116 table moves (1.7%), achieve hemodynamic relief in 4/116 table moves (3.5%), and improve external access for tumor removal in 4/116 table moves (3.5%). There was a significantly higher use of tilt and tilt plus Trendelenburg in GS group (GS vs. U p = 0.055 and GS vs. G p = 0.054). There were no dVTM safety-related or adverse events. CONCLUSIONS: The dVTM with TruSystem 7000dV operating table in wireless communication with the da Vinci Xi is a perfectly safe and effective synergistic combination, which allows repositioning of the patient whenever needed without imposing any delay in the execution of the operation. Moreover, it is helpful in avoiding extreme positions and enables the anesthesiologist to provide immediate and effective hemodynamic relief to the patient when needed.
BACKGROUND: The da Vinci® Table Motion (dVTM) comprises a combination of a unique operating table (Trumpf Medical™ TruSystem® 7000dV) capable of isocenter motion connected wirelessly with the da Vinci Xi® robotic platform, thereby enabling patients to be repositioned without removal of instruments and or undocking the robot. MATERIALS AND METHODS: Between May 2015 to October 2015, the first human use of dVTM was carried out in this prospective, single-arm, post-market study in the EU, for which 40 patients from general surgery (GS), urology (U), or gynecology (G) were enrolled prospectively. Primary endpoints of the study were dVTM feasibility, efficacy, and safety. RESULTS: Surgeons from the three specialties obtained targeting success and the required table positioning in all cases. Table movement/repositioning was necessary to gain exposure of the operating field in 106/116 table moves (91.3%), change target in 2/116 table moves (1.7%), achieve hemodynamic relief in 4/116 table moves (3.5%), and improve external access for tumor removal in 4/116 table moves (3.5%). There was a significantly higher use of tilt and tilt plus Trendelenburg in GS group (GS vs. U p = 0.055 and GS vs. G p = 0.054). There were no dVTM safety-related or adverse events. CONCLUSIONS: The dVTM with TruSystem 7000dV operating table in wireless communication with the da Vinci Xi is a perfectly safe and effective synergistic combination, which allows repositioning of the patient whenever needed without imposing any delay in the execution of the operation. Moreover, it is helpful in avoiding extreme positions and enables the anesthesiologist to provide immediate and effective hemodynamic relief to the patient when needed.
Entities:
Keywords:
Robotic surgery; da Vinci Table Motion (dVTM); da Vinci Xi