The new surgical robot Hugo™ RAS for total hysterectomy: a pilot study.

Background: With the rising popularity of robotic surgery, Hugo™ RAS is one of the newest surgical robotic platforms. Investigating the reliability of this tool is the first step toward validating its use in clinical practice; and presently there arelimited data available regarding this. The literature is constantly enriched with initial experiences, however no study has demonstrated the safety of this platform yet. Objectives: This study aimed to investigate its reliability during total hysterectomy. Materials and Methods: A series of 20 consecutive patients scheduled for minimally invasive total hysterectomy with or without salpingo-oophorectomy for benign disease or prophylactic surgery were selected to undergo surgery with Hugo™ RAS. Data regarding any malfunction or breakdown of the robotic system as well as intra- and post-operative complications were prospectively recorded. Results: Fifteen of the twenty patients (75.0%) underwent surgery for benign uterine diseases, and five (25.0%) underwent prophylactic surgery. Among the entire series, an instrument fault occurred in one case (5.0%). The problem was solved in 4.8 minutes and without complications for the patient. The median total operative time was 127 min (range, 98-255 min). The median estimated blood loss was 50 mL (range:30-125 mL). No intraoperative complications were observed. One patient (5.0%) developed Clavien-Dindo grade 2 post-operative complication. Conclusions: In this pilot study, Hugo™ RAS showed high reliability, similar to other robotic devices. What is new?: Present findings suggest that Hugo™ RAS is a viable option for major surgical procedures and deserves further investigation in clinical practice.

The first European gynaecological procedure with the new surgical robot Hugo™ RAS. A total hysterectomy and salpingo-oophorectomy in a woman affected by BRCA-1 mutation.

Background: The benefits of minimally invasive surgery are well known in gynaecology. Robotic-assisted surgery has gained widespread acceptance within the surgical community and seems to be the most rapidly developing sector of minimally invasive surgery. Objectives: This video shows the salient steps of total hysterectomy with new robotic technology, Hugo™ RAS. The objectives were to introduce and demonstrate the feasibility, efficacy, and safety of this new advanced device. Materials and Methods: A sixty-two years-old woman affected by BRCA-1 mutation underwent the first European gynaecological surgical procedure using the new surgical robot Hugo™ RAS in the Division of Gynecologic Oncology, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy. Main Outcomes measures: Docking and operative times. Results: The docking time was 6 minutes and the total operative time was 58 minutes. There were no system errors and faults in the robotic arms. The surgeon found no friction or rasping in the arms. The estimated blood loss was 30 mL. No intraoperative complications were recorded. Conclusion: Gynaecological surgery with Hugo™ RAS seems feasible, safe and effective as shown by initial experiences in urological surgery. A larger case series would confirm the current experience and determine whether this technology could offer any additional benefit.

Sentinel lymph node detection in endometrial cancer with indocyanine green: laparoscopic versus robotic approach.

BACKGROUND: The aims of the present study were to assess bilateral sentinel lymph node (SLN) mapping with laparoscopic versus robotic approach, to assess variables affecting bilateral detection rates and to assess survival difference in patients with no/unilateral, compared to bilateral SLN detection. METHODS: This is a retrospective, single-centre, observational cohort study, including patients with endometrial cancer FIGO stage IA-IVB, treated with minimally invasive primary surgery and undergoing indocyanine green (ICG) injection to detect SLN, between January 2015 and December 2019. RESULTS: Of the 549 included patients, 286 (52.1%) and 263 (47.9%) underwent the laparoscopic and robotic approach respectively. 387 (70.5%) patients had bilateral SLN mapping, 102 (18.6%) and 60 (10.9%) had unilateral and no mapping, respectively. Patients who underwent the robotic approach were older (median 61 versus 64 years, p=0.046) and had a higher BMI (median 26.0 versus 34.8 kg/m2, p<0.001). No difference in any SLN mapping or in SLN bilateral detection was evident between the laparoscopic or robotic approach (p=0.892 and p=0.507 respectively). Patients with bilateral SLN detection in the entire cohort were younger (p<0.001) and had a better 3-year disease-free survival (DFS) compared to patients with no/unilateral SLN mapping (77.0% versus 66.3%, respectively, p=0.036). No 3-year overall survival (OS) difference was reported (p=0.491). CONCLUSION: SLN mapping and bilateral SLN detection with ICG in endometrial cancer was not different in the laparoscopic and robotic approach, even though patients undergoing the robotic approach were older and more obese. Bilateral SLN detection was associated with improved 3-year DFS, but not with 3-year OS, compared to no and unilateral SLN detection.

Diagnostic accuracy and economic impact of three work-up strategies identifying risk groups in endometrial cancer, fully incorporating sentinel lymph node algorithm.

BACKGROUND: According to the European Society for Medical Oncology/ European Society of Gynaecological Oncology/European Society for Radiotherapy and Oncology (ESMO/ESGO/ESTRO) Consensus Conference, the role of preoperative risk groups (RGs) in endometrial cancer (EC) is to direct surgical nodal staging. We compared diagnostic accuracy and economic impact of three work-up strategies to identify RGs. METHODS: A retrospective multicentre study including patients with early-stage EC. The three different work-up strategies were as follows:-Mondovì Hospital: transvaginal ultrasonography, pelvic magnetic resonance imaging (MRI); frozen section examination of the uterus in case of imaging discordance. High-risk patients underwent abdominal computed tomography.-Gemelli Hospital: transvaginal ultrasonography, MRI, One-Step Nucleic Acid Amplification (OSNA) of sentinel lymph node (SLN); frozen section examination of the uterus in case of imaging discordance.-Negrar Hospital: positron emission tomography (PET), frozen section examination of the uterus and of SLN. For statistical purposes patients were assigned, preoperatively and postoperatively, to two groups: group A (high-risk) and group B (not high-risk). RESULTS: Three hundred eighty-five patients were included (93 Mondovì, 215 Gemelli, 77 Negrar). Endometrial biopsy errors led to 47.3% misclassifications. Test accuracy of Mondovì, Gemelli and Negrar strategies was 0.83 (95%CI 0.734-0.901), 0.95 (95%CI 0.909-0.975) and 0.94 (95%CI 0.866-0.985), respectively. Preoperative work-up mean cost per patient in group A was €514.5 at Mondovì, €868.5 at Gemelli, and €1212.8 at Negrar hospital (p-value < 0.001), while in group B was €378.8 at Mondovì, €941.2 at Gemelli, and €1848.4 at Negrar hospital (p-value < 0.001). CONCLUSIONS: In our study, work-up strategies with more relevant economic impact showed a better diagnostic accuracy. Upcoming guidelines should specify recommendations about the gold standard work-up strategy, including the role of SLN.

Technological innovation and personalized surgical treatment for early-stage endometrial cancer patients: A prospective multicenter Italian experience to evaluate the novel percutaneous approach.

OBJECTIVE: To investigate the safety, feasibility and oncological adequacy of the Percutaneous Surgical System - PSS in a consecutive series of low-risk endometrial cancer staging. STUDY DESIGN: From May 2015 to April 2017, we prospectively performed 30 consecutive percutaneous staging for low/intermediate risk endometrial cancer (FIGO stage IA G1-G2, IB G1-G2, IA G3). All patients were divided in two different groups on the basis of surgical procedure received: Group A included patients submitted to radical Class A hysterectomy and bilateral salpingo-oophorectomy; Group B concerned patients that received a lymph nodal assessment also. RESULTS: The time needed to install percutaneous instruments and suprapubic trocar was 4 min. (range 2-10). The recorded median operative time (OT) was 80 min. (range 65-120) for Gr.A and 143 min. (range 107-190) for Gr.B, in which the median time of lymph nodal assessment was 55 min. (range 20-76). The median time for hysterectomy was 60 min. (range 40-110) in all cases. Lymph nodal assessment was performed in 14 (46.6%) cases: 7 sentinel node mapping, 7 pelvic lymphadenectomy. No intraoperative complications or LPS/LPT conversions were recorded. Median discharge time was 2 days (range 1-4), 5 patients were discharged in 3rd post-op day, and only 1 patient was discharged in 4th day for fever. All patients conveyed high satisfaction with the cosmetic results. A progressive overall reduction of pain perception was observed at 24 h after surgery. Median follow-up was of 14 months (range 12-36), no recurrences have been detected. CONCLUSIONS: PSS seems to be a feasible approach for endometrial cancer staging. Larger experiences and prospective comparative studies are important to assess our assumptions and further investigate the real benefits of percutaneous surgical system.

The Senhance™ surgical robotic system ("Senhance") for total hysterectomy in obese patients: a pilot study.

This pilot study was aimed to value the feasibility and safety of Senhance Robotic Platform for hysterectomy in obese patients. Ten obese patients (30 < BMI < 40) underwent elective Senhance total extrafascial hysterectomy with bilateral salpingo-oophorectomy at the Division of Gynecologic Oncology of "Policlinico A. Gemelli" Foundation, Rome, Italy. Perioperative and postoperative outcomes data were recorded. The median age was 60 years (range 51-75) and the median BMI was 33.3 kg/m2 (range 30.4-38.3). The median uterine weight was 112.5 g (range 77-225). Indication to total hysterectomy was early-stage (FIGO Stage IA) endometrial cancer in 100% of patients. The median operative time (OT) was 110 min (70-200). The median docking time was 10.5 min (5-25). The median estimated blood loss was 100 mL (50-200). No conversions to laparotomy were recorded. No intra- and 30-day postoperative complications were registered. The median ileus was 17 h (12-36) and the median time to discharge was 2 days (1-4). The median VAS scores registered at 2, 4, 12, and 24 h were, respectively, 2 (1-3), 2 (1-3), 4 (1-8), and 3 (1-5). Our study results suggest that Senhance platform could be safe for hysterectomy even in obese patients. More clinical data are needed to determine whether this approach would offer any additional benefits in a new middle line between standard laparoscopy and robotics.

Radical hysterectomy after chemoradiation in FIGO stage III cervical cancer patients versus chemoradiation and brachytherapy: Complications and 3-years survival.

BACKGROUND: To compare patterns and rates of early and late complications, and survival outcome in FIGO stage III cervical cancer patients underwent to radical hysterectomy after chemo-radiation (CT-RT) vs. chemo-radiation alone. METHODS: Between May 1996 and April 2013 150 FIGO stage III cervical cancer patients were treated. We divide patients according to type of treatment: 77 were submitted to standard treatment (Group A), and 73 to completion hysterectomy after chemo-radiation (Group B). RESULTS: The baseline characteristics of the 2 groups were superimposable. We observed lower intra-operative and treatment-related early urinary and gastro-intestinal complications in Group B with respect to Group A (p < 0.001). Vascular complications were registered only in Group B (p < 0.001). We found a significantly higher rate of local recurrences in the Group A than in the Group B (p < 0.002). We registered 29 deaths in the Group A and 22 in the Group B (p = 0.021). The 3-years disease-free survival rate in the Group A and in the Group B was 62.9% and 68.3%, respectively (p = 0.686), and the 3-years overall survival rate in the Group A and in the Group B was 63.2% and 67.7%, respectively (p = 0.675). CONCLUSIONS: This study confirms that radical hysterectomy after CT-RT is an effective therapeutic approach for advanced cervical cancer. Further prospective and randomized studies should be performed in order to solve the question about the standard approach, and how the different pattern of complication could impact on the quality of life.

Pre-hysterectomy cone biopsy is able to predict response in locally advanced cervical cancer patients submitted to neo-adjuvant chemoradiation.

BACKGROUND: To evaluate the feasibility and the predictive value of cone biopsy before performing radical hysterectomy in locally advanced cervical cancer patients showing complete clinical response to neo-adjuvant chemoradiation. METHODS: Between March 2010 to March 2012 74 consecutive FIGO stage IIA2-IIB patients were submitted to neo-adjuvant chemoradiation. All complete clinical responder patients were enrolled in this pilot trial. RESULTS: Fifty-seven out of 74 patients (77%) showed complete clinical response and were enrolled in the study. Forty-two out of 57 patients (74%) underwent successful pre-completion surgery cone biopsy with a median cone's tissue diameter of 24 mm (range 18-35). In 33 out of 42 patients (58%) a complete pathological response was found. In the remaining 5 (9%) and 4 (7%) a microscopic partial and partial response was found, respectively. All 33 cases (58%) with negative cone showed complete pathological response in the radical hysterectomy specimens. Patients with microscopic residual tumor foci in the cone showed negative residual cervical and paracervical tissue at definitive diagnosis, whereas in patients with partial response macroscopic residual disease in the surgical specimens was found. The negative predictive value of cone biopsy, MRI and PET/CT in the prediction of pathological status of the cervical and paracervical tissue was 100%, 79% and 79%, respectively (Table 2). CONCLUSIONS: In this study we observed that, in locally advanced cervical patients showing complete clinical response to neo-adjuvant chemoradiation, the cone biopsy feasibility was almost 75%, and that there is a complete pathological correspondence between cone and definitive pathology.

Elderly and very elderly advanced ovarian cancer patients: does the age influence the surgical management?

BACKGROUND: To examine the surgical treatment and clinical outcome of elderly and very elderly advanced epithelial ovarian cancer patients. METHODS: We retrospectively analyzed FIGO stage IIIC-IV ovarian cancer patients, divided in elderly (Group A, >65 and <75 years) and very elderly patients (Group B, ≥ 75 years) treated by primary debulking surgery (PDS) or by interval debulking surgery (IDS) at the Catholic University at Rome and Campobasso, Italy. RESULTS: 164 patients were included: 123 (Group A) and 41 (Group B). Complete cytoreduction was achieved in 60 patients (60.6%) in Group A and in 20 patients (62.5%) in Group B (p = 0.75). In the remaining cases, optimal cytoreduction was performed (39 cases (39.4%) in Group A and 12 (37.5%) in Group B; p = 0.75). In Group A complete/optimal debulking was achieved in 53 patients (53.5%) at PDS and in 46 patients (46.5%) at IDS (p = 0.55). In the Group B a higher rate of patients was debulked at IDS with respect to PDS (10 (31.3%) vs. 22 patients (68.7%); p = 0.02). In Group A patients debulked at PDS showed better DFS (p = 0.007) and OS (p = 0.003) with respect to patients submitted to successful IDS, whereas in group B we did not observed any survival difference according to time of cytoreduction. CONCLUSIONS: Our data suggest that elderly and very elderly patients may tolerate radical and ultra-radical surgery. These patients should be managed in a gynecologic oncology unit, with prudent but complete approach.