Use of the new Versius Surgical Robotic System in surgical interventions on children: Russia’s clinical trials results

Abstract

Authors represent the Russia’s first research demonstrating the results of the use of the Versius modular & portable surgical robot by “CMR Surgical,” Ltd. (Cambridge, Cambridgeshire, United Kingdom) in surgical interventions on pediatric patients that they’ve obtained as part of the clinical trials complex approved by the Federal Service for Surveillance in Healthcare of Russia (“Roszdravnadzor”). The purpose of this research was to obtain practical evidence of the clinical safety and effectiveness of the use of the new Versius® Surgical Robotic System in minimally invasive surgical interventions on children. The criteria for the safety and effectiveness of the method were the absence of complications caused by the Surgical Robotic System (SRS) operation or the surgical technique as well as the absence of dropping into either laparoscopy or open surgery technique. Material and methods used: non-randomized single-center controlled trial had been carried out in children aged 1 to 18 y/o. Areas of application for surgical procedures included urology, abdominal and thoracic surgeries. Results: the number of patients who had undergone the robot-assisted surgeries had totaled 55 (27 (49%) m/28 (51%) f). The patient’s median age of the surgical intervention was 11.5 [7.0; 15.0] y/o; the median weight was 45.5 [27.0; 59.0] kilograms; the median surgical intervention duration was 140.0 [85.0; 175.0] minutes; patients’ stay in the intensive care unit had averaged for 23.0 [19.0; 24.0] hours; the average hospitalization duration was 8.0 [4.0; 14.0] days. Surgical interventions weren’t accompanied by any of the intraoperative complications such as bleeding, organ perforation and/or injury to adjacent anatomical structures. Conversions to either laparoscopic or open surgery technique also weren’t recorded. The equipment technical problems with SRS such as sudden system power-off, synchronous interaction of joysticks/manipulators interruption, robotic arms blocking, manipulators’ uncontrolled movement and/or traumatic effects on the tissues of the abdominal wall/chest weren’t recorded as well. Conclusion: the preliminary results obtained from the clinical trials complex affirm the potential ability of the Versius® Surgical Robotic System to performing robotic surgical interventions on pediatric patients aged 1 to 18 years old.