To Evaluate the Performance and Efficiency of Robotic Surgery in Children and Adults

Overview

Robotic minimally invasive surgery has been rapidly adopted for a wide variety of surgical procedures in adult patients across a broad spectrum of surgical specialties. This has occurred despite the high costs and uncertain benefits of surgical robots. In contrast, Children's Hospitals and pediatric surgical disciplines have been much slower to embrace the surgical robot. Many children's hospitals do not even possess a surgical robot, and many of those that do borrow them from the adult operating room within the same medical facility. Since the first case of robotic minimally invasive surgery in children in 2000, robotic procedures have been slowly adopted by select pediatric surgical specialists. Advocates of robotic minimally invasive surgical systems add many useful features that include improved dexterity, motion scaling, tremor filtration, greater optical magnification (up to 10x), stereoscopic vision, operator-controlled camera movement, and the elimination of the fulcrum effect when compared to conventional laparoscopy. The wristed laparoscopic instruments used in robotic surgery provide seven degrees of freedom. For the surgeon, these features may allow for more precise dissection with increased magnification and visibility. The intuitive controls of the robot are purported as providing the ability to perform laparoscopic procedures in an "open" fashion. In pediatric surgical procedures, these technical abilities may have the potential to surpass the physical capabilities of human performance in the tight operative fields encountered in children. This study aims to evaluate the clinical safety, effectiveness, and cost-effectiveness of robot-assisted minimally invasive surgery in both pediatric and adult patients. Robotic surgery was developed to overcome key limitations of conventional laparoscopy, including 2D visualization, limited instrument mobility, poor ergonomics, and long learning curves. The trial will assess clinical outcomes, postoperative pain, length of stay, return to daily activities, access to minimally invasive surgery, and the impact of robotic surgery on surgical training. Specific indications, such as pyeloplasty, will also be compared with open and conventional laparoscopic approaches.

Minimally invasive surgery (MIS) has transformed surgical practice since the 1980s, offering reduced postoperative pain, shorter hospitalization, faster recovery, and improved cosmetic outcomes. However, conventional laparoscopy is limited by rigid instruments, 2D imaging, non-intuitive motion, and challenging ergonomics, resulting in long learning curves, especially in pediatric surgery where operative spaces are smaller. Robot-assisted surgery, introduced in 1999 with the Da Vinci system, was designed to overcome these limitations by providing 3D high-definition visualization, articulated instruments with seven degrees of freedom, tremor filtration, intuitive movements, surgeon-controlled camera operation, and improved ergonomics. Its dual-console configuration also enhances surgical training. Despite widespread adoption in adults, pediatric use remains limited. This multicenter study will evaluate robot-assisted surgery across several specialties (urology, gynecology, visceral surgery, thoracic surgery, pediatric surgery, and ENT), in accordance with CE-marked indications. The study will assess: clinical outcomes and quality of life, postoperative pain, length of stay, and return to daily activities, access to MIS for patients with comorbidities or complex multidisciplinary needs, reduction of the learning curve compared with laparoscopy, benefits for resident and fellow training, and, for pyeloplasty, comparison with open and laparoscopic techniques. Interim analyses will be performed and may generate hypotheses for future research.