Three‐arms off‐clamp robot‐assisted partial nephrectomy with the new Hugo robot‐assisted surgery system

Abstract

Robot-assisted surgery (RAS) has taken the upper hand over open and laparoscopic approaches for the main urological procedures due to the established benefits in terms of perioperative and functional outcomes, while showing comparable oncological results [1]. After the introduction of the first Da Vinci platform, novel generations of robotic systems equipped with innovative technical refinements have emerged as alternative solutions to overcome intrinsic platforms limitations [2]. In this context, the Hugo™ RAS system (Medtronic plc, Dublin, Ireland) was introduced as a modular robotic platform with four independent arm-carts, enabling highly customised procedures by adapting the surgical strategy. Additionally, notable technical benefits include a more ergonomic trocar position, an expanded working space for the bed-side assistant, and cost-effectiveness for single procedures. The development of the Hugo RAS system arose as an alternative robotic platform designed to fulfil the requirements of a more ergonomic and customised working environment. Another objective of this system is to enhance the accessibility of RAS for a larger number of patients by improving the cost-effectiveness of each individual procedure, thus alleviating the strain on healthcare systems. Only one pre-clinical study has been published on the Hugo RAS system, conducted at the ORSI Academy (Aalst, Belgium) between August and October 2021 on four cadavers [3]. The authors performed total hysterectomy, radical hysterectomy, pelvic exenteration, pelvic and para-aortic lymphadenectomy, and omentectomy. Moreover, several tests were carried out to identify the best configurations for all gynaecological surgical scenarios. Regarding first in human studies, the main procedures performed on a few patients were: right and left colectomy, radical prostatectomy, and lateral transabdominal adrenalectomy [4, 5]. All the authors reported the feasibility of the Hugo RAS system, with satisfactory intra- and perioperative outcomes without the need for conversion. Robot-assisted partial nephrectomy (RAPN) represents a core urological procedure under continuous evolution and improvement. If on the one hand on-clamp RAPN represents the most popular approach due to the better control of intraoperative bleeding during tumour excision, on the other hand clamping of renal hilum exposes healthy renal parenchyma to potential ischaemic injury. Furthermore, all published off-clamp series have not shown worse results in terms of surgical and postoperative outcomes in comparison to the on-clamp technique [6, 7]. While the application of the Hugo RAS system to radical prostatectomy is rapidly gaining in popularity [8, 9], its potential in the setting of PN has experienced difficulties in achieving success. With this background, we aimed to describe the first experience and surgical setting for off-clamp RAPN with a three-arms configuration using the new Hugo RAS system. The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of Campus Bio-Medico University (number: PAR 113.22 OSS). Informed consent was obtained from all patients involved in the study. Between October 2022 and March 2023, 18 consecutive patients underwent off-clamp RAPN for renal tumour using the Hugo RAS system at our Institution, a high-volume centre for off-clamp laparoscopic PN. Moreover, we gained experience and became familiar with the Hugo RAS system through an initial series of robot-assisted radical prostatectomies during the same time period, which slowed down the accrual of RAPNs. Postoperative complications were reported according to the Clavien–Dindo classification [10]. Continuous variables are presented as medians and interquartile ranges (IQRs), while frequencies are used to report categorical variables. First surgeon, bed-assistants and all surgical staff taking part in the operations had all completed the technical training on the Hugo RAS system provided by Medtronic at the ORSI Academy (Aalst, Belgium) before performing surgeries using the system. A modified extended flank position was used, and patients were placed at the margin of the surgical bed with a slight flexion (45°) to increase the operating space between the costal margin and iliac spine. The first 11-mm robotic trocar (camera port) was positioned along the pararectal line at 14 ± 2 cm from the umbilicus, using an open access technique. The pneumoperitoneum was then induced through the AirSeal™ system (SurgiQuest, Milford, CT, USA) with a standard intra-abdominal pressure of 12 mmHg. Two more 8-mm operative robotic ports were placed under direct vision caudally from the costal margin and cranially from the iliac spine at 9 ± 1 cm from the camera port (Fig. 1). Two 12-mm laparoscopic ports for the bed-assistant were placed between the robotic ports and below the camera port to avoid unintentional clashes with the robotic instruments, maintaining a distance from the robotic ports of ≥ 8 cm. All procedures were performed by a single surgeon (R.P.) with extensive experience in minimally invasive PN and the off-clamp technique through a conventional transperitoneal route, using monopolar curved shears, fenestrated grasper, and large needle driver in a three-instruments configuration. The main steps of our off-clamp procedures involved complete mobilisation of the kidney, isolation from the surrounding peri-renal fat tissue, and a direct approach to the renal mass without hilum identification. Bleeding from the resection bed was controlled with monopolar energy and renorrhaphy using a 2/0 poliglecaprone 25 (Monocryl®, Ethicon Inc., Somerville, NJ, USA) single-running suture with sliding-clips technique. Haemostasis was improved through the application of haemostatic agents on the renal rim (TABOTAMP fibrillar™ [Ethicon Inc.] and TachoSil® [Corza Medical, Westwood, MA, USA]). After normotensive control of haemostasis, Gerota's fascia was closed, and a drain placed. Off-clamp RAPN was successfully performed in 18 patients with renal masses (Table S1). Of the 18 patients enrolled in the study, 13 were male (72.2%) and five were female (27.8%). The median (IQR) age and body mass index (BMI) were 69 (60.5–73.5) years and 26.3 (24.9–27.8) kg/m2, respectively. The median (IQR) preoperative haemoglobin, creatinine and estimated GFR (eGFR) were 148 (133–155) g/L, 79.56 (68.95–89.23) μmol/L and 81.2 (66.4–91.3) mL/min/1.73 m2, respectively. Seven (38.9%) patients in our cohort had a left-side renal mass and 11 (61.1%) had a right-side tumour, all with cT1 renal masses while two (11.1%) of them presented with cT2a renal tumours. The median (IQR) tumour size was 31.5 (26–34.7) mm and median (IQR) R.E.N.A.L. (Radius, Exophytic/Endophytic, Nearness, Anterior/Posterior, Location) Nephrometry Score was 5 (5–7). The median (IQR) docking time was 7 (5–9) min, with a slight reduction of time needed during the second half of the procedures. No intraoperative complications occurred. No additional port placement was necessary. No robotic instruments clashed inside the abdomen, nor were there any clashes between the robotic arms and the bed-side assistant. No technical failures of the system occurred. The median (IQR) console time was 100 (68–125) min. The median (IQR) estimated blood loss was 250 (90–400) mL, and the median (IQR) hospital stay was 3 (2–4) days. Only two patients (11.1%) presented postoperative Clavien–Dindo Grade II complications: one developed fever that was treated with intravenous antibiotics administration, while the other needed a single-unit blood transfusion due to postoperative anaemia. Before discharge, the median (IQR) haemoglobin, creatinine and eGFR were 115 (100–125) g/L, 77.79 (64.53–87.52) μmol/L and 84 (63.9–93.1) mL/min/1.73 m2, respectively. Pathological reports showed one angiomyolipoma (5.5%), four oncocytomas (22.3%), 10 clear cell carcinomas (55.6%), two papillary carcinomas (11.1%), and one chromophobe carcinoma (5.5%). Negative surgical margins were reported in all cases. Our study can be classified as a prospective evaluation of the Hugo RAS system for off-clamp RAPN, conducted within the Idea, Development, Exploration, Assessment, Long-term follow-up study (IDEAL) Stage 1/2a study framework. The primary outcome was the successful completion of cases without any Clavien–Dindo complications above Grade II and without the need for conversion. Secondary outcomes assessed included operative times, docking times, perioperative outcomes, and functional outcomes at the 3-month mark. All cases were completed successfully and safely without requiring conversion. All oncological cases had negative surgical margins, indicating successful cancer resection. This IDEAL Stage 1/2a evaluation demonstrates the feasibility and safety of off-clamp RAPN using the Hugo RAS system with a unique trocar configuration and a three-arm setting. The Hugo RAS system currently represents the most comprehensive alternative to the standard Da Vinci system with a greater potential for application in the field of minimally invasive urological surgery. This system showed an enhanced modularity provided by separated arm-carts that could either reduce the docking time or the intraoperative accidental clashing effect between robotic and laparoscopic instruments. These technical nuances may potentially find a natural application in the context of RAPN whereas the synergy between master surgeon and bed-side assistant represents a critical factor to avoid significative intraoperative bleeding [11]. Moreover, the Hugo RAS independent cart docking system provides a real-time, adjustable working-space for the bed-assistant that can be tailored to patients in complex conditions such as increased BMI, previous abdominal surgery, or anatomical kidney variability where the lack of hilar control may be discouraging even in expert hands [6]. Another modular system is the Versius, developed by CMR in Cambridge (UK). Similarly to Hugo RAS system, it comprises an open console with three-dimensional glasses, along with three or four separate bed-side units to allow the surgeon a more tailored surgical planning. One notable distinction from the da Vinci console is that the controls of the Versius system are exclusively hand controlled. Initial clinical series have demonstrated the feasibility of performing minor or intermediate gynaecological and general surgery procedures using this system. Recently, a few clinical reports have emerged regarding the utilisation of Versius for urological applications [12]. The use of the Hugo RAS system for RAPN has already been published using the standard four-arms approach and one case was performed as an off-clamp RAPN [13]. The majority of patients in that series presented with small renal masses. Moreover, in one case the use of four robotic arms resulted in suboptimal trocar placement compromising the safety of the procedure and the authors were forced to convert to laparoscopy. Indeed, even in experienced hands, the use of all four robotic arms could be troublesome potentially leading to unexpected clashes between robotic instruments or with bed-assistant laparoscopic ports. In our experience, the alternative three-arms setting with a novel trocar-placement configuration allowed us to safely carry out all surgeries, without major complications, instrument clashing, or the need to convert to laparoscopy, displaying satisfactory docking and operative times. To the best of our knowledge, this is the first study describing a novel configuration using a three-arms setting describing the feasibility and safety of the largest series of RAPN using the Hugo RAS system, including two patients with T2 renal tumours. The rationale behind this innovative arrangement is to enable the bed-side assistant to use dual suction during off-clamp renal mass enucleation, resulting in a precise surgical plane for the first surgeon and point-to-point haemostasis after resection. Moreover, by reducing the number of robotic arms involved in the procedure we minimised the risk of unexpected collisions that could potentially cause the robotic system to freeze, a troublesome event if happening during off-clamp RAPN. Notwithstanding the satisfactory outcomes and the quick docking of the Hugo RAS system, we must acknowledge that the procedures were performed by a team with extensive experience in purely off-clamp laparoscopic PN. Consequently, the results described may not be generalisable and need to be investigated by further studies with more procedures and longer follow-up. Nonetheless, the application of the Hugo RAS system for a challenging surgical procedure, such as PN for highly complex renal masses, seems promising. This novel robotic platform showed a user-friendly docking system. The three-arms approach was feasible, providing satisfactory intra- and perioperative outcomes without any unexpected collisions during surgery. Further procedures are needed to confirm the feasibility and safety of RAPN using the Hugo RAS system in the setting of complex renal masses, and to externally validate bed-side features such as docking or tilt angles. None. None of the authors have any disclosures or conflicts of interest to report. None. The study was conducted in accordance with the Declaration of Helsinki and approved by the Institutional Review Board of Campus Bio-Medico University (Number: PAR 113.22 OSS). Informed consent was obtained from all subjects involved in the study. Written informed consent has been obtained from the patients to publish this manuscript. Table S1. Baseline and perioperative data. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article.

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