Over the past two decades, we have witnessed one of the most significant revolutions in the surgical field, the introduction of robotic-assisted surgery (RAS)25. RAS has matured and has proven to be safe and effective in multiple specialties. The technology is constantly evolving, and besides the mechanical improvements, in the last few years robotic surgery is keeping the promise to integrate surgery with computer based intelligent features powered by AI and Machine Learning, opening up new and unexplored possibilities26–29.
One of the controversial and unresolved aspects of robotic surgery is the high economic burden associated with these technologies, leading to increased healthcare costs, especially when compared to open and laparoscopic surgery. This poses challenges in terms of adoption, both for low reimbursement procedures and in low-income countries or those with entirely public health care systems30–33.
The field has recently seen the introduction of new players34. In Europe, two commercially available options include the Senhance® Surgical System (Asensus Surgical, North Carolina, USA) and the Cambridge CMR Versius, whereas only the Senhance has received FDA approval in the USA35,36. Both platforms adopt a modular design for their operative arms, but they exhibit significant difference in their designs.
In this scenario, Medtronic has introduced the new Hugo™ RAS System, which is also based on cart mounted modular arms.
The innovative concept of four independent arm-carts, as opposed to a boom mounted system, offers the potential for various docking configurations. The open console design facilitates direct interaction between the lead surgeon and the bedside assistants, contributing to a reconfiguration of the surgical workspace based on enhanced communication and new troubleshooting ability. However, these novel features might rise some new challenges, such as, docking times, efficiency, and reliability13.
Hence, the innovative Hugo™ RAS requires new applicative models that need to be tested and standardized, along with new training pathways, for novice robotic surgeons as well as experienced robotic surgeons. The purpose of our work has been to address these needs.
While Hugo™ RAS has not yet received FDA approval, it has already been used outside of the United States for clinical cases in General Surgery, Urology, and Gynaecology. The very first clinical application of the Hugo™ RAS was performed in Urology by Mottrie et al. (5 patients who underwent radical prostatectomy)37. The use of this platform is also spreading in General Surgery. Bianchi et al. published the first three colectomies with Hugo™ RAS (one left colectomy, two right colectomies with complete mesocolic excision [CME] and high vascular ligation [HVL]). Mean docking and console times were 8 and 259 min, respectively. Neither intraoperative complications, nor conversions to open surgery were recorded38. Raffaelli et al. reported the first five transabdominal adrenalectomies performed with the Hugo™ RAS: median docking time was 5 min and median console time was 55 min. Procedures were performed without intraoperative complications and no conversions or additional ports were needed. Each procedure was uneventful39. Ciccoritti et al published the first 4 patients that underwent to Roux-en-Y-Bypass, with median docking time of 8 min and median console time was 127.5 min. Nor complications, neither technical issues were recorded14. Mintz et al came out with his series of 13 inguinal hernia repair performed with the Hugo™ RAS. Mean docking time was 9.5 min and mean console time was 50.3 min and 74.7 min for unilateral and bilateral inguinal hernia repair, respectively. No intraoperative or postoperative complications occurred. There was one conversion to laparoscopic surgery due to a technical issue with the robot (a rare event of communication loss between the console and the camera arm). Since this occurred just before the final stage of suturing the peritoneum, they decided to undock the robot and suture the peritoneum laparoscopically40. Caruso et al. reported the first Nissen fundoplication for hiatal hernia. No intraoperative complications or technical failures of the system were recorded. The operative time was 97 min, the docking time was 3 min15. Gangemi et al. published the current largest case series of alimentary tract surgeries performed with the Hugo™ RAS: it’s a combination of 17 procedure including cholecystectomies, hiatal hernia repair and Nissen fundoplication, right and left hemicolectomy, sleeve gastrectomy16.
Initial clinical experiences with Hugo™ RAS indicate that the docking times and operative data are comparable to those of the DaVinci Xi System41. Some limitations arise from Hugo's current lack of advanced energy devices, requiring the placement of accessory laparoscopic trocars. Further testing will be necessary once advanced energy devices become available.
As mentioned by Alletti et al, the overall footprint of the system is larger than the boom mounted counterpart42. In our work we aimed at optimizing the cart placement to reduce the space occupancy and limit it to the areas around the patient where the space is less needed. The “butterfly” configuration in fact allows wide range of movements for the bedside assistant and the anaesthesiologist. Furthermore, concerns have been raised by the length of the arms and related fast “flag-waving” movements, potentially interfering with the bedside work. Although we also noticed this potential problem at the beginning of our experience, we were able to increase the working space for the assistant by utilizing more often a 0 degree camera and optimizing the distance of the ports from the target anatomy42. This distance is generally recommended to be in between 16 to 18 cm as this distance allows the instruments to work better and to increase space at the bed side reducing collisions.
We have observed that the robotic arms possess an increased range of motion, extending not only along the longitudinal axis but also across the lateral axis. To the extent that, when the carts are positioned perpendicular to the patient's side, they can reach from the hiatus all the way down to the pelvis. This extended reach has also allowed us to perform procedures in the LUQ (Nissen fundoplication and left hepatectomy) while using the setup for RUQ. This might allow, as clinical experience develops, to adopt a single dock configuration for both RUQ and LUQ for many procedures simplifying and streamlining the OR workflow.
A criticism to the open console configuration is the risk that being able to see the surrounding environment in the OR could be a potential distraction for the first operator. It's worth noting that although the system allows the surgeon to look at the surgical field while operating, it halts the motion of the robotic arms if the operator is not actively engaged with the screen. In our experience the open architecture actually fostered a more direct connection between the lead surgeon and the bedside assistants, and allowed the lead surgeon to quickly understand and overcome collisions and limitations of the arms simply by glancing at the operative field. This possibility has the potential to speed up the learning curve. Additionally, the open console allows multiple surgeons to share the same 3D vision simultaneously, making it an opportunity to easily train and interact on the same images at the same time. Another favourable innovative aspect is the working position during surgery, that appears to be more ergonomic with increased back support and overall comfort. The impressions provided by the first surgeon and the assistant, recorded at the end of each procedure through the aforementioned questionnaires, allowed us to objectively confirm these positive aspects43–45.
To date, two other papers have been published on the preclinical application of Hugo in performing prostatectomies and gynaecological procedure42,45. The strength of our paper lies in the high number of training sessions (22) that led to the development of final models, as well as the final tests on two cadavers with opposite BMIs (95th and 5th percentile). Although it is a preclinical study, our data and results can be easily transferred to real clinical practice.
We started our lab work with some general instructions provided by the company, following those instructions we developed and tested the set-up guides here presented. These set up guides have now been officially adopted by Medtronic to support new installations and clinical applications in the described surgical fields.
Our study represents the most comprehensive preclinical investigation published to date on Hugo™ RAS application in surgical procedures of upper gastrointestinal tract. Its purpose has been to test the efficiency and safety of Hugo™ RAS, optimize the overall setup, and develop standardized and easily replicable models for new users. The data we have generated support the hypothesis of the platform's effectiveness and reliability. These findings allowed us to finally deliver reliable, reproducible, and standardized docking configuration and port setup for upper gastrointestinal surgeries.
The study presents some limitations: despite our efforts to replicate the operating room environment as closely as possible, there are some inherent limitations to conducting these sessions in a laboratory setting. Another limitation is related to using cadavers, which lack all the physiological features found in real patients. Nevertheless, as mentioned earlier, our models have already been successfully applied in clinical settings14–16.