First experience with the Hugo™ robot‐assisted surgery system for endometriosis: A descriptive study

RGO: conceptualization; methodology; software; formal analysis; investigation; data curation; writing – original draft; project administration. DH: methodology; investigation; resources; writing – review & editing. TD: investigation; resources; writing – review & editing. MEM: methodology; software; writing – review & editing. FB: conceptualization; methodology; writing – review & editing; supervision. LK: conceptualization; methodology; writing – review & editing; supervision. AR: conceptualization; methodology; writing – review & editing; supervision.

All patients were informed of the study and the use of the new robotic platform before signing a written informed consent form. The prospective study was reviewed and approved by the Danish Data Protection Agency (P‐2022‐341). No approval from the ethical committee or IRB was needed according to Danish guidelines.

This research did not receive any funding from Medtronic (Minneapolis, MN, USA) but they did provide technical support as described above. Mette Elkjær Madsen reports funding from Ferring Pharmaceuticals through a grant to the institution. The funders had no role in the design or conduct of the study, or the manuscript development. None of the other authors received any specific grant from public, commercial or not‐for‐profit funding agencies.

Twelve patients underwent surgery with the Medtronic Hugo™ RAS system. No patients declined to participate in the study. Four surgeries were re‐scheduled to the Davinci® system due to the unexpected unavailability of the surgical team. Patient characteristics are described in Table  1 . The indication for surgery was dysmenorrhea (92%) and/or fertility wishes (17%). The median age was 38 years (range 24–52 years), the median body mass index (BMI) was 23.4 kg/m 2 (range 21.5–33.1 kg/m 2 ) and most women were receiving hormone treatment (75%) with either oral desogestrel, GnRH agonist or a levonorgestrel‐releasing intrauterine device before surgery. All patients had American Society of Anesthesiology (ASA) score ≤2. Seven patients had received surgery for endometriosis, but not within the past year. An overview of patient demographics; most patients had severe endometriosis. GnRH agonist Oral desogestrel GnRH agonist Oral desogestrel GnRH agonist Levonorgestrel‐releasing intrauterine device Oral desogestrel GnRH agonist Oral Levonorgestrel +ethinylestradiol Abbreviations: ASA score, American Society of Anesthesiology score; BMI, body mass index; N, None; Y, Yes. Six patients underwent a total hysterectomy with salpingo‐oophorectomy and five patients underwent ovarian cystectomy (Table  2 ). The extent of endometriosis varied between the patients from no visible residual endometriosis to severe endometriosis (stage IV) classified according to the revised American Society for Reproductive Medicine (r‐ASRM) classification of endometriosis. 14 Seven patients had deep infiltrating endometriosis classified according to the Enzian score 15 with removal of endometriosis removed from the rectovaginal septum, sacrouterine ligaments, rectum and/or ureter (Table  3 ). Images of stage IV endometriosis are shown in Figure  3 and Video  S1 . The median docking time was 17 minutes (range 11–37 minutes), the median console time was 87.5 minutes (range 48–185 minutes) and the median undocking time was 3 minutes (range 2–5 minutes). No procedures were converted. The median blood loss was 40 mL (range 10–75 mL). Summary of the intraoperative procedures and technical errors. There was no conversion of the procedure to open surgery or conventional laparoscopy. Total hysterectomy; Bilateral salpingo‐oophorectomy Trouble with calibration of arm cart 1 Error message at the surgeon's console Restarting the calibration system. No issues with the arm afterward Removal of all instruments in the patient and rebooting of the surgeon console. No error messages afterwards No Total hysterectomy; Bilateral salpingo‐oophorectomy Total hysterectomy; Unilateral salpingo‐oophorectomy Total hysterectomy; Bilateral salpingo‐oophorectomy; Endometriosis resection of the peritoneum; Ovarian cystectomy: Endometriosis resection of the ovaries, peritoneum and septum rectovaginale; Adhesiolysis Total hysterectomy; Bilateral salpingo‐oophorectomy; Endometriosis resection of the peritoneum, septum rectovaginale, rectum; Adhesiolysis Total hysterectomy; Bilateral salpingo‐oophorectomy; Endometriosis resection of the peritoneum, rectum; Adhesiolysis Ovarian cystectomy; endometriosis resection of the ovaries, peritoneum; Adhesiolysis Ovarian cystectomy; ENDOMETRIOSIS resection of the ovaries, peritoneum, septum rectovaginale; Adhesiolysis Trouble with calibration of arm cart 1 The tip cover of the monopolar sheer breaks The arm cart is changed to a new arm cart. No issues with the arm afterwards The tip cover is replaced No No Bilateral salpingo‐oophorectomy; Endometriosis resection of the peritoneum; Adhesiolysis Unilateral salpingo‐oophorectomy; Ovarian cystectomy; Endometriosis resection of the ovaries, peritoneum; Adhesiolysis The extent of endometriosis classified according to the revised American Society for Reproductive Medicine (r‐ASRM) 14 classification with a detailed description of the extent of deep infiltrating endometriosis (DIE) classified with Enzian score. 15 Abbreviations: A, Septum rectovaginale; B, sacrouterine ligaments, cardinal ligaments, pelvic sidewall; C, rectum; F, invasion of other organs in the pelvic cavity and distant organs; FU, intrinsic ureter involvement; O, ovary; P, peritoneum; T, tube. Images of stage IV endometriosis in patients A (A–E) and B (F–I). (A) Severe endometriosis. (B) Mobilization of the rectum. (C) Excision of bladder peritoneum. (D) Ureterolysis, left side. (E) Salpingectomy, left side. (F) Endometrioma, left ovary. (G) Ovarian cystectomy, left ovary. (H) Excision of peritoneum. (I) End of surgery. We experienced minor technical issues in 10 procedures including arm calibration issues ( n  = 2), surgeon console calibration issues ( n  = 1), arm collisions ( n  = 3), unresponsiveness of monopolar curved shear scissors ( n  = 1) and small perforations of the tip cover ( n  = 5). None of the technical issues led to the conversion of the robotic procedures or affected patient safety. All procedures were completed successfully with no complications during surgery (Table  4 ) and all but one patient were discharged the same day or the day after surgery. Four patients experienced minor postoperative complications, all CD grade 1 (nausea, residual urine and IV infiltration of the arm). No patients were readmitted within 30 days, and only three patients contacted the Department of Gynecology within 30 days: two patients with minor issues of CD grade 1 (wound pain and leg cramps) that did not require treatment, and one patient with minor issue of CD grade 2 (urinary tract infection), which was treated with oral antibiotics. Summary of patient outcome data showing minor surgical complications postoperatively and within 30 days. Wound pain, CD grade 1 Nausea, CD grade 1 Nausea, CD grade 1 Leg cramps, CD grade 1 Abbreviations: CD, Clavien–Dindo; N, none.

This pilot study indicates that the Medtronic Hugo™ RAS system is safe and feasible for robot‐assisted endometriosis surgery. All surgeries were completed successfully with all surgical steps carried out according to plan and no unexpected complications. Several new robotic systems have emerged in the market since the introduction of the Senhance® Telerobotic system at the end of 2016. 16 , 17 , 18 , 19 The introduction of new surgical systems has given rise to several practical, technical and patient considerations. The technical setup with the Medtronic Hugo™ RAS system is significantly different from the DaVinci® Surgical System and we explored the consequences of this with three measurements of team performance: docking, console time and undocking. The average median docking time was 17 minutes, which is slightly longer than the reported 5–15 minutes for the DaVinci® Surgical System. 20 , 21 , 22 One explanation is that different docking setups were used (Figure  1 ) and since these were the first 12 procedures, the docking of the system had not yet become routine for the surgeons and might be reduced with more procedures. Further, we experienced that the Medtronic Hugo™ RAS system required more personalization according to patient anatomy compared with the DaVinci® Surgical System. This is important to avoid arm collisions and secure smooth surgical flow. The console time varied significantly (range 48–185 minutes) according to the complexity of the procedure; this is well known in endometriosis surgery, where four studies using the DaVinci® Surgical System have reported a mean console time of 106–227 minutes. 21 , 22 , 23 , 24 Any comparisons should be made with caution due to the small number of cases in our study, but no unexpected long console time was found. Lastly, we experienced a very short undocking time, which was stable during the 12 procedures. Overall, we conclude the technical implementation was successful with no apparent difficulties that unnecessarily extended the time used in the OR. We did experience minor technical issues which were corrected before or during the procedure. The malfunction of the surgeon console during surgery was corrected with a re‐start of the system and did not compromise patient safety. Arm collisions were observed and could be a result of the long surgical arms and the need for familiarization with the system; however, reconfiguration of the arms was easily achieved during surgery. The most notable issue was the unresponsiveness of the monopolar curved shear scissor and the tip covers. We noted that the tip covers sustained small perforations and had to be changed frequently to avoid the theoretical risk of current unexpectedly traveling through the patient, although this was not observed in any case. All tip covers were from the same batch, and the issue was solved after switching to another batch. We have previously reported on similar technical issues on the Hugo™ RAS system from the same surgical facility, and therefore the same Hugo™ RAS system. 11 No other studies have reported on technical issues; we can only speculate on whether they did not experience any technical issues or just did not include them as an outcome. Technical issues are not uncommon in robotic surgery and the amount we encountered was anticipated in this introductory phase. 25 , 26 In the patient follow‐up, we did not find blood loss or length of hospital stay to be higher than in other studies. 21 , 23 , 24 , 27 Half of the patients had deep infiltrating endometriosis, which is often more difficult to remove than peritoneal endometriosis. This patient group only had minor complications (CD grade 1), which is in accordance with previous literature. 28 , 29 , 30 , 31 No serious adverse events were observed in any of the patients, which is surprising as previous studies have reported CD grade ≥3 in 2%–16% of all endometriosis cases in short‐term follow‐ups. 32 , 33 , 34 , 35 We believe our data support the continued use of the Medtronic Hugo™ RAS system, as we did not experience major complications or conversion of the surgery caused by the robotic system. We look forward to studies with larger patient cohorts to illuminate further the safety and use of the system. The primary limitation was the small number of patients. The Medtronic Hugo™ RAS system is more resource‐demanding in the implementation process compared with the DaVinci® system. It requires the presence of an extra OR nurse and a senior robotic surgeon as assistant, which was made difficult due to staff shortages at the surgical facility. Further, we experienced periods of instrument shortages and it was not possible to perform surgeries during those periods. Another limitation is all patients underwent surgery performed by an experienced robotic surgical team and the results may therefore not translate into inexperienced robotic surgical teams. There are many interesting aspects beyond patient safety we believe should be explored as new robotic technologies emerge in the coming years. We plan on examining the experience of the nursing staff, as it is unknown how skills from one robotic system are transferred to another for the surgical team and if the proficiency is temporarily restricted by this. There will always be a learning curve when a surgeon transfers skills to another operating system. 36 , 37 In this study, it seems that the learning curve is steep and short, as our surgeons are experienced and the two robotic systems are similar. In this early implementation phase, we did not find any improvements in surgery time or patient outcomes with the Medtronic Hugo™ RAS system. The system does have an open console, which might have the advantage of easier supervision, as other surgeons can see the same 3D image as the surgeon. Robotic systems with an open console could transform the training of novice surgeons. At this point, we do not know whether one robotic system is better, but comparative and even randomized studies could be performed in the future. Hopefully, competition in the market will drive innovation and reduce the costs of robot‐assisted surgery, but cost analysis of the different robotic systems is lacking, making it difficult to compare the cost‐effectiveness of the systems. The introduction of new robotic systems could make robotic surgery even more attractive with the integration of other technologies such as imaging, warning systems or even automated surgery.

In this pilot study, we found the Medtronic Hugo™ RAS system safe and feasible for robot‐assisted surgery for endometriosis. The advent of new robotic systems is welcomed to accelerate the development of technology that will improve surgical care for patients across the globe.

Robot‐assisted surgery (RAS) has gained widespread use within the gynecological community and the number of procedures performed using RAS has increased over the last decades. Robot‐assisted surgery has gained popularity over laparoscopy due to the three‐dimensional vision, tremor filtration, articulated instruments with more degrees of freedom, and improvement of ergonomics for the surgeon. 1 , 2 , 3 , 4 , 5 , 6 Until recently, the DaVinci® Surgical System was the only robotic system available. Several new robotic systems are now being promoted for clinical use and the Medtronic Hugo™ RAS system was launched in late 2021. This system offers a new “open” surgeon console, including a 3D screen, a system tower and four individual arm carts. 3 The safety and feasibility of the Medtronic Hugo™ RAS system were previously demonstrated in human cadaver studies and clinical studies in urology, gynecology and general surgery. 3 , 7 , 8 , 9 , 10 , 11 Rigshospitalet in Denmark was one of Europe's first hospitals to receive the Medtronic Hugo™ RAS system. We described the peri‐ and postoperative complications for the first patient series operated for endometriosis using the new Hugo™ RAS system. The primary outcome was safe case completion in all surgical steps required for completion without major surgical complications (Clavien–Dindo [CD] grade ≤2) and no conversion of the procedures. Our secondary outcomes included analysis of the surgical procedure, reporting of technical challenges, in‐hospital complications, length of hospital stay and readmission within 30 days.

The authors have stated explicitly that there are no conflicts of interest in connection with this article.

In a collaboration between surgical teams from urology, gynecology and general surgery, we began the implementation of the Medtronic Hugo™ RAS system and performed the first case in 2022. In the implementation process, we focused on patient safety and reported this using the IDEAL framework stage 1/2a recommendations for reporting surgical innovation. 12 All patients undergoing surgery with the Medtronic Hugo™ RAS system in gynecology, urology or general surgery are included in a prospective study investigating the surgical outcomes and training of surgeons. Here, we report on a subgroup of patients with endometriosis enrolled between 29 August 2022 and 4 June 2023. Two experienced gynecological robotic surgeons (>1000 cases performed) performed all procedures together. Both surgeons had >20 years’ experience with laparoscopic resection of endometriosis and >10 years’ experience with robotic resection of endometriosis on the DaVinci® system. The Department of Gynecology, Rigshospitalet, is one of two tertiary centers in Denmark which specializes in the surgical treatment of severe endometriosis. On average, the Department of Gynecology, Rigshospitalet, performs 10 robotic or laparoscopic resections of endometriosis per week. The surgeons completed a training program for the Medtronic Hugo™ RAS system including simulator training, and dry‐run training at Orsi Academy in Ghent, Belgium, and the Copenhagen Academy for Medical Education and Simulation (CAMES), Rigshospitalet, Copenhagen University Hospital, Denmark. Eligible women requiring surgery for endometriosis, ≥18 years and able to provide informed consent were enrolled. The Department of Gynecology, Rigshospitalet, performs hysterectomies on malignant indication and resection of endometriosis. As integrated fluorescence cameras have not been developed for the Medtronic Hugo™ RAS system, patients undergoing robotic resection of endometriosis were chosen as the pilot population of the study. The patients were included for surgery on the same basis as any other patient at the outpatient clinic. The patients were booked for surgery with the Medtronic Hugo™ RAS system if they were deemed fit for robotic surgery and the surgical team was available. The first three cases were hand‐picked due to extra safety precautions in the start‐up period. The first three patients had minor areas of endometriosis located to the uterus and lower‐stage endometriosis and regular hysterectomies were performed on these patients. Subsequently, patients were included if bowel resection, disc resection or bladder resection was not planned. No other special precautions were taken. The patients had the option to decline undergoing surgery using the Medtronic Hugo™ RAS system and were instead scheduled for surgery using the Davinci® System. The surgical tower, the surgeon console and all four arms were used for all 12 cases. The most frequently used port positioning and the docking set‐ups used for surgery are shown in Figure  1 . The camera port was positioned above the umbilicus with a 12‐mm robotic port. Three 5‐mm ports used for the instruments and a 5‐mm assistant port were all placed according to Figure  1 . The surgeons used wristed instruments with seven degrees of freedom; Monopolar Curved Shears with a tip cover, Bipolar Maryland Forceps, Large Needle Drivers and Cadière Forceps as instruments for all cases (Figure  2 ). The bedside team consisted of the same three operating nurses present during all cases. An engineer and two OR nurses from Medtronic (Minneapolis, MN, USA) were present in the operating room to help guide and navigate the robotic system in case of technical issues. A slice of reality of the clinical setup with the surgeon at the console and a snapshot of the Medtronic Hugo™ RAS system with port placement and arm cart placement. Wristed instruments used for the 12 Hugo™ procedures. From the left: Monopolar Curved Shears with a tip cover, Bipolar Maryland Forceps, Large Needle Drivers and Cadière Forceps. All data was registered by an on‐site observer always present in the OR room. The observer registered predefined variables for the system's docking, console time and undocking. The on‐site observer noted all technical issues as they occurred on the Medtronic Hugo™ RAS system eg device failures, console errors and instrument malfunctions. The primary outcome was safe case completion of all surgical steps without major surgical complications (CD grade ≤2) or conversion of the procedure to open surgery or conventional laparoscopy. Secondary outcomes included docking time (after the port placement, where an OR nurse started moving the first arm until all arms were docked to the ports with instruments and camera attached to the ports, ready to use for surgery), console time (total time operating the robotic system at the console), undocking (from undocking of the first arm until removal of all surgical ports), reporting of technical challenges, in‐hospital complications, length of hospital stay and readmission within 30 days. All adverse events were collected from the medical record and graded using CD. 13

Video S1. Click here for additional data file.