The new robotic system HUGO RAS for gynecologic surgery: First European experience from Gemelli Hospital.

OBJECTIVE: To evaluate the safety and feasibility of the new surgical robot HUGO robotic assisted surgery (RAS) in a series of gynecologic surgical procedures. METHODS: Between March and October 2022, 138 patients treated at Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy were enrolled in the study. All patients suitable for a minimally-invasive approach were prospectively included and divided into two groups: Group 1 (78 patients) made up of patients operated on for uterine and/or adnexal pathologies, and Group 2 (60 patients) made up of patients treated for pelvic organ prolapse. RESULTS: In Group 1, median docking time (DT) was 5 min and median console time (CT) was 90 min. In two patients (2.6%) redocking was necessary. In two patients (2.6%), the surgeon continued the surgery laparoscopically. Intraoperative complications occurred in two surgeries (2.6%). In Group 2, median DT was 4 min and median CT was 134.5 min. In three patients (5%), redocking was necessary. In all patients, the surgery was successfully completed robotically without intraoperative complications. CONCLUSIONS: The present study demonstrates that the new HUGO RAS system for gynecologic surgery is safe with good results in terms of surgical efficacy and perioperative outcomes. Further studies are needed to investigate its use in other technical and surgical aspects.

Robotic docking time with the Hugo™ RAS system in gynecologic surgery: a procedure independent learning curve using the cumulative summation analysis (CUSUM).

Robot-assisted surgery has been proven to offer improvements in term of surgical learning curve and feasibility of minimally invasive surgery, but has often been criticized for its longer operative times compared to conventional laparoscopy. Additional times can be split into time required for system set-up, robotic arms docking and calibration of robotic instruments; secondly, surgeon's learning curve. One of the newest systems recently launched on the market is the Hugo™ RAS (MEDTRONIC Inc, United States). As some of the earliest adopters of the Hugo™ RAS system technology, we present our data on robotic docking learning curve for the first 192 gynecologic robotic cases performed at our institution. Our data indicates that robotic set-up and docking with the new Hugo™ RAS robotic surgical system can be performed time-effectively and that the specific robotic docking learning curve is comparable to preexisting data for other platforms. This preliminary insights into this recently released system may be worthwhile for other centers which may soon adopt this new technology and may need some relevant information on topics such as OR times. Further studies are necessary to assess the different features of the Hugo™ RAS considering other technical and surgical aspects, to fully become familiar with this novel technology.

Major determinants of survival in recurrent endometrial cancer-the role of secondary cytoreductive surgery: a multicenter study.

OBJECTIVE: The main objective of the study was to assess the influence of different clinical and therapeutic variables on the oncological outcomes of patients with endometrial cancer relapse. In particular, we evaluated the impact of cytoreductive surgery with the achievement of complete gross resection. METHODS: This is a multicenter retrospective cohort study conducted in three centers in Italy and including all patients with first relapse of endometrial cancer from January 2010 to December 2021. RESULTS: Data from 331 women with recurrent endometrial cancer were analyzed. Secondary cytoreductive surgery was performed in 56.2% of cases (186 patients). Complete gross resection was achieved in 178 patients (95.7%). Complete gross resection conferred a statistically significant survival benefit both for post-relapse survival and post-relapse free survival (3 years post-relapse survival: 75.4% vs 56.4%, p<0.001; 3 years post-relapse free survival: 32.6% vs 26.5%, p=0.027). At multivariate Cox regression analysis, age ≥75 years, Eastern Cooperative Oncology Group Performance Status ≥2, the advanced-metastatic risk group, complete gross resection, and multiple site relapses were identified as independent significant predictors for post-relapse survival; regarding post-relapse free survival, only age ≥75, the high and advanced-metastatic risk groups, and complete gross resection confirmed their statistical significance. CONCLUSIONS: Secondary cytoreductive surgery with achievement of complete gross resection was confirmed to be an independent positive predictor for survival in patients with recurrent endometrial cancer and should be considered a valid primary treatment in the therapeutic decision-making process.

Hysteroscopic endometrial tumor localization and sentinel lymph node mapping. An upgrade of the hysteroscopic role in endometrial cancer patients.

INTRODUCTION: Given the growing interest in sentinel node mapping (SLN) biopsy in Endometrial Cancer (EC) patients, many efforts have been made to maximize the SLN bilateral detection rate. However, at present, no previous research assessed the potential correlation between primary EC location in the uterine cavity and SLN mapping. In this context, this study aims to investigate the possible role of intrauterine EC hysteroscopic localization in predicting SLN nodal placement. MATERIALS AND METHODS: EC patients surgically treated from January 2017 to December 2021 were retrospectively analyzed. All patients underwent hysterectomy, bilateral salpingo-oophorectomy, and SLN mapping. During hysteroscopy, the location of the neoplastic lesion was described as follows: uterine fundus (comprising the most cranial portion of the uterine cavity up to the tubal ostium including the cornual areas), corpus uteri (from the tubal ostium to the inner uterine orifice), and diffuse (when the tumor invades more than 50% of the uterine cavity). RESULTS: Three hundred ninety patients met the inclusion criteria. The tumor pattern diffused to the whole uterine cavity was statistically associated with SLN uptake on common iliac lymph nodes (OR 2.4, 95%CI 1-5.8, p = 0.05). Patients'age is an independent factor associated with SLN failure (OR: 0.95, 95%CI 0.93-0.98, p < 0.001). CONCLUSIONS: The study showed a statistically significant association between EC hysteroscopically spread throughout the whole uterine cavity and SLN uptake at the common iliac lymph nodes. Furthermore, patient age negatively affected the SLN detection rate.

Use of Laparoscopic and Laparotomic J-Plasma Handpiece in Gynecological Malignancies: Results From A Pilot Study in A Tertiary Care Center.

Introduction: The J-Plasma has recently been introduced into the surgical community with different intrinsic characteristics aimed to further reduce the thermal effect and enhance precision when compared to standard radiofrequency. This study aimed to investigate the role of this new technology in different conditions of gynecological carcinomatosis characterized by the indication for regional peritonectomy and/or ablation, either in laparotomy (LPT) or in laparoscopy (LPS), in the context of a modern personalized approach to the surgical management of gynecological malignancies. Material and Methods: From January 2019 to April 2019, 12 patients were selected for this prospective pilot study at the Division of Gynecologic Oncology, Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome. In this single surgeon experience, the inclusion criteria were: histologically proven advanced ovarian/endometrial cancer, primary or interval debulking surgery, and intraoperative indication for regional peritonectomy. Six patients were treated by LPS (Group 1) and 6 by LPT (Group 2). Results: In Group 1 the indication for debulking surgery was in 4 cases an interval debulking surgery and 2 advanced endometrial cancer. All patients in Group 2 underwent primary debulking surgery for advanced ovarian cancer. The whole cohort achieved a complete tumor excision after surgery. The median OT and median EBL were 195 min and 100 ml in Group 1, and 420 min and 500 ml in Group 2. The median hospital stay was 4 days in Group 1 and 13 days in Group 2, respectively. No intra and postoperative complications were registered within 60 days after surgery. Conclusions: J-Plasma allows to approach delicate maneuvers on viscera, mesentery, and blood vessels with a high degree of safety and precision thanks to its limited vertical and lateral thermal spread, favoring the surgeon to push ever higher the cytoreduction/morbidity tradeoff. The use of J-Plasma in cytoreductive surgery could also increase the range of possible minimally invasive procedures, narrowing the technical distance with the open technique and thus contributing to designing a personalized surgical strategy for each patient in different scenarios of peritoneal carcinomatosis.

Introducing the New Surgical Robot HUGO™ RAS: System Description and Docking Settings for Gynecological Surgery.

This study provides a detailed description of the new HUGO™ RAS System and suggests docking settings for gynecological surgery. The system is composed of an "open" surgical console with an HD-3D passive display, a system tower, and four arm carts. Each arm has an extremely wide range of adaptability resulting from the numerous joints. The human cadaver labs were performed at the ORSI Academy between August and December 2021. All procedures were performed by two surgical teams, each composed of a high-volume surgeon experienced in robotic surgery, gynecologic oncology, and pelvic sidewall surgery, and one bedside assistant. Three main gynecological surgical scenarios were identified: standard pelvic surgery, pelvic sidewall surgery, and para-aortic/upper abdominal surgery. Concerning the port placement, the chosen options were called "straight" and "bridge"; instead, the so-called "compact" and "butterfly" configurations were identified for the arm cart positioning. Four cadavers were used to perform total hysterectomy, radical hysterectomy, pelvic exenteration, pelvic and para-aortic lymphadenectomy, and omentectomy. We performed several tests, identifying the best system configurations to draw the proper efficiency from the flexibility of the system in all gynecological surgical scenarios. The straight port placement seems to be adequate for standard pelvic surgery. The bridge trocar position is best to reach the deeper and lateral anatomical regions of the female pelvis. The compact and butterfly arm cart allocations are adequate for both straight and bridge port placement. When deep pelvic surgery was performed, the bedside assistant became more proficient by working with a standard laparoscopic instrument from an ancillary port placed in the left iliac fossa. The arm carts needed to be moved in an open manner, like for the proposed butterfly configuration. On the contrary, the compact disposition left enough space to assist from Palmer's point port. Several basic and advanced gynecological surgical procedures were performed and completed successfully without encountering any technical or surgical issue, the results obtained were judged sufficient to proceed with the clinical experience in daily practice. The HUGO™ RAS system is flexible and highly performative in various surgical scenarios.

Isolated humeral metastasis in cervical cancer: A case report and review of the literature.

There are a few reported cases of isolated localized metastasis to bone arising from cancer of uterine cervix in the literature. This is a case of uterine cervix cancer with isolated metastasis to the humerus. A 57-year-old female with a diagnosis of FIGO Stage IIB invasive squamous cell carcinoma of uterine cervix underwent neoadjuvant chemoradiation therapy (CRT) and radical surgery with complete pathological response. Nine months after the surgery, a total body positron emission tomography/computed tomography (PET/CT) scan documented a lesion localized in the proximal part of the right humerus, whereas no evidence of skeletal metastasis found elsewhere. The biopsy from the bone lesion showed a metastatic squamous cell carcinoma of the uterine cervix. A surgical excision of the humeral lesion plus chemotherapy and zoledronic acid was performed. After 9 months, the patient experienced liver metastases and died 2 months later. Bone metastasis is not so infrequent in patients with locally advanced cervical cancer. Total body PET/CT scan should be included in staging work up, and an appropriate treatment should have the primary objective of quality of life preservation.

Needleoscopic-assisted risk-reducing bilateral salpingo-oophorectomy in BRCA1/2 mutation carriers: Peri-operative outcomes and psychological impact.

OBJECTIVE: To investigate the role of needleoscopic-assisted laparoscopy in terms of surgical impact and psychological outcomes in RR-BSO for BRCA1/2 patients. STUDY DESIGN: Prospective monocentric trial conducted at the Division of Gynecologic Oncology, "Fondazione Policlinico Universitario A. Gemelli" IRCSS in Rome. Between March 2016 and March 2018, 26 consecutive patients were prospectively enrolled in the study and underwent RR-BSO. Peri-operative surgical variables were collected. The psychological interview was performed at the discharge and during the first post-operative follow-up visit (between 30 and 60 days after surgery). RESULTS: We reported a median OT of 18.5 min (range, 15-37), a median EBL of 0 mL (0-20), and no conversion to laparoscopy or laparotomy. The median VAS score was "at rest" of 2, 3, and 1; while under "Valsalva maneuver" was 4, 3, 2, respectively at 2, 4, and 24 h. 77% (20/26) of the whole population had a previous diagnosis of breast cancer. All patients expressed great cosmetic satisfaction both at discharge and after 30/60 days, with an 84.6% of score 5 and a 15.4% of score 4. The highest number of "score 5", concerning the cosmetic outcomes, were clustered in the subgroup of breast cancer survivors with a 95% of score 5 versus 50% of score 5 in patients with no previous breast cancer (p = 0.0073). Similarly, the maximal psychological advantage of the ultra-MIS approach was revealed in the breast cancer survivors (70% of score 5 versus 16% of score 5, p = 0.02). CONCLUSIONS: The use of 2.4 mm instruments raises the possibility of decreasing post-operative incisional pain, reducing hospitalization, and ensuring better cosmetic and psychological outcomes without increasing complications. The full psychosomatic benefit of ultra-MIS within BRCA mutation carriers is revealed in breast cancer survivors, probably due to the comparison with the mutilating and invasive previous breast surgery.

Impact of Obesity on Sentinel Lymph Node Mapping in Patients with apparent Early-Stage Endometrial Cancer: The ObeLyX study.

OBJECTIVE: Conflicting data exists on the impact of Body Mass Index (BMI) on sentinel lymph-node (SLN) detection. The primary study endpoint was to investigate the impact of obesity on overall detection rate, bilateral mapping, and mapping failure rate of SLN. In addition, we evaluated possible differences in terms of surgical management and "empty-packet dissection" rate among obese and non-obese patients. METHODS: Multicenter, propensity-matched, retrospective study. Patients with apparent early-stage endometrial cancer were included. Study population was divided into women with BMI

Sentinel Lymph Node in Aged Endometrial Cancer Patients "The SAGE Study": A Multicenter Experience.

OBJECTIVE: The incidence of endometrial cancer is increasing in elderly people. Considering that aging progressively affects lymphatic draining function, we aimed to define its impact on IGC uptake during SLN mapping. METHODS: A multicenter retrospective cohort of endometrial cancer patients with apparently early-stage endometrial cancer undergoing complete surgical staging with SLN dissection was identified in four referral cancer centers from May 2015 to March 2021. Patients were classified in Group 1 (<65 years old) and Group 2 (≥65 years old). The primary endpoint was the assessment of the overall, bilateral, and unsuccessful SLN mapping in the two groups. Secondary outcomes were the evaluation of SLN anatomical distribution and the identification of predictors for mapping failure applying a logistic regression. RESULTS: A total of 844 patients were enrolled in the study (499 in Group 1 and 395 in Group 2). The overall detection rate, the successful bilateral mapping, and the mapping failure rate of the SLN were 93.8% vs. 87.6% (p = 0.002), 77.1% vs. 66.8% (p = 0.001), and 22.9% vs. 33.2% (p = 0.001), respectively, in Group 1 vs. Group 2. The advanced age affects the anatomical distribution of the SLN leading to a stepwise reduction of "unexpected" mapping sites (left hemipelvis: p < 0.001; right hemipelvis: p = 0.058). At multivariate analysis age ≥ 65 (OR: 1.495, 95% CI: 1.095-2.042, p = 0.011), BMI (OR: 1.023, 95% CI: 1.000-1.046, p = 0.047), non-endometrioid histotype (OR: 1.619, 95% CI: 1.067-2.458, p = 0.024), and LVSI (OR: 1.407, 95% CI: 1.010-1.961, p = 0.044) represent independent predictors of unsuccessful mapping. Applying binomial logistic regression analysis, there was a 1.280-fold increase in the risk of failed mapping for every 10-year-old increase in age (OR: 1.280, 95% CI: 1.108-1.479, p = 0.001). A higher rate of surgical under-staging (0.9% vs. 3.3%, p = 0.012) and adjuvant undertreatment (p = 0.018) was reported in Group 2. CONCLUSIONS: Old age represents a risk factor for SLN mapping failure both intrinsically and in relation to the greater incidence of other independent risk factors such as LVSI, non-endometrioid histotype, and BMI. Surgeons should target the usual uptake along UPP during the SLN dissection in this subgroup of patients to minimize mapping failure and the consequent risk of surgical under-staging and adjuvant undertreatment.

Laparoscopic vs. robotic-assisted laparoscopy in endometrial cancer staging: large retrospective single-institution study.

OBJECTIVE: The aim of this study is to analyze and draw the potential differences between the robotic-assisted surgery (RS) and the laparoscopy (LPS) in endometrial cancer staging. METHODS: In this single-institution retrospective study we enrolled 1,221 consecutive clinical stage I-III endometrial cancer patients undergone minimally invasive surgical staging. We compared patients treated by LPS and by RS, on the basis of perioperative and oncological outcomes (disease-free survival [DFS] and overall survival [OS]). A sub-analysis of the high-risk endometrial cancer population was performed in the 2 cohorts. RESULTS: The 2 cohorts (766 treated by LPS and 455 by RS) were homogeneous in terms of perioperative and pathological data. We recorded differences in number of relapse/progression (11.7% in LPS vs. 7% in RS, p=0.008) and in number of deaths (9.8% in LPS vs. 4.8% in RS, p=0.002). Whereas, univariate and multivariate analyses according to DFS and OS confirmed that the surgical approach did not influence the DFS or the OS. In the multivariable analysis the association of the age and grading was significant for DFS and OS. In the sub-analysis of the 426 high risk EC patients (280 in LPS and 146 in RS) the univariate and the multivariate confirmed the influence of the age in DFS and OS, independently of the minimally invasive approach. CONCLUSIONS: In our large retrospective analysis, we confirmed that the RS and LPS have similar efficacy and safety for endometrial cancer staging also for the high-risk endometrial cancer patients.

Substantial lymph-vascular space invasion (LVSI) as predictor of distant relapse and poor prognosis in low-risk early-stage endometrial cancer.

OBJECTIVE: The aim of this study is to analyze the prognostic role of lymph-vascular space invasion (LVSI), evaluated in a semi-quantitative fashion on prognosis of early stage, low risk endometrial cancer (EC). METHODS: We enrolled patients who underwent surgery for endometrial cancer between 2003 and 2018 in two referral cancer center. All patients had endometrioid EC, G1-G2, with myometrial invasion <50%, and no lymph-node involvement. LVSI was analyzed in a semi-quantitative way, according to a 3-tiered scoring system in absent, focal and substantial. RESULTS: Among 524 patients, any positive LVSI was found in 57 patients (10.9%) with focal LVSI (n=35, 6.7%) and substantial LVSI (n=22, 4.2%). Substantial LVSI was associated to higher rate of G2 (p<0.001), myometrial infiltration (p=0.002) and greater tumor dimensions (p=0.014). Patients with substantial LVSI were more likely to receive adjuvant treatment (6.6% vs. 52.6%, p<0.001). The 5-year OS was 99.5% in patients with absent LVSI and 70.6% in those with substantial LVSI (p<0.001). The 5-year disease free survival (DFS) was 93.6% in patients with absent LVSI and 56.5% in those with substantial LVSI (p<0.001). The rate of distant failures increased from 1.8% for absent LVSI to 22.7% for substantial LVSI (p=0.002). In univariate analysis substantial LVSI was the strongest predictor of poor overall survival (hazard ratio [HR]=11.9, p=0.001). Multivariate analysis showed that substantial LVSI was an independent predictive factor of both recurrence (HR=5.88, p=0.001) and distant failure (HR=10.6, p=0.006). CONCLUSIONS: Substantial LVSI represents the strongest independent risk factor for decreased survival and distant relapse, indicating a role for potential hematogenous dissemination.

Standard ultra-staging compared to one-step nucleic acid amplification for the detection of sentinel lymph node metastasis in endometrial cancer patients: a retrospective cohort comparison.

INTRODUCTION: The objective of this study was to compared standard ultra-staging (SU) with one-step nucleic acid amplification (OSNA) for the detection of sentinel lymph node (SLN) metastasis in women with apparent uterine-confined endometrial cancer. METHODS: All women underwent SLN identification with complete surgical staging. All SLNs were cut perpendicular to the long axis and two adjacent 5 µm sections were cut at each of two levels 50 µm apart. At each level, one slide was stained with hematoxylin and eosin and the other with immunohistochemistry using the AE1/AE3 anti-cytokeratin antibody, as well as one negative control slide for a total of five slides per block. For OSNA analysis, the 2 mm sections of the lymph nodes were homogenized to form a lysate. The lysate was then centrifuged and inserted into the RD 100i instrument where the isothermal amplification of CK19 mRNA was executed. RESULTS: Of the 396 patients included in the retrospective analysis, 214 were in the SU group, and 182 in the OSNA group. Overall 869 SLNs were identified (490 SU, 379 OSNA). Sixty patients exhibited SLN metastasis (34 SU, 26 OSNA). Macrometastasis, micrometastases, and isolated tumor cells (ITC) were 5.1%, 4.1%, and 0.2%, respectively, in the US group, and 2.4%, 6.3%, and 0.1%, respectively, in the OSNA group (p=0.022). CONCLUSIONS: The OSNA assay detected a higher rate of micrometastasis and a lower rate of macrometastasis and ITC when compared with SU. The clinical and prognostic impact of ITC is debatable and controversial. Further studies are needed to clarify the respective roles of the OSNA and SU methods, and the possible role of ITC in the prognosis of patients with apparent early-stage endometrial cancer.

Inguino-abdominal combined approach for laterally extended pelvic resection: a step by step procedure.

This video article demonstrates an inguino-abdominal combined approach for laterally extended pelvic resection, a major surgical procedure for locally advanced primary or recurrent gynecological cancer infiltrating the pelvic sidewall, for which palliative therapy is the only alternative.1 After local institutional review board approval (protocol No CICOG 02/03/62), we made a step by step surgical video of an inguino-abdominal combined approach for laterally extended pelvic resection , defined as an en bloc resection of a pelvic tumor with pelvic sidewall structures, including the iliopsoas and/or obturator internus muscles.2 3 The patient, a 48-year-old woman, diagnosed with single pelvic platinum resistant recurrence after five lines of chemotherapy for serous ovarian cancer G3, International Federation of Gynecology and Obstetrics (FIGO) stage IIIC, BRCA wild type. The preoperative positron emission tomography/computed tomography scan detected uptake on the right side at the level of the external iliac region and obturator fossa: the tumor surrounded the right external iliac vessels by more than 50% of their circumferences, with possible involvement of the vascular wall and venous vascular compression (Tinelli's score=4).4 The tumor extended towards the obturator fossa, with possible involvement of the inguinal canal. Due to an uncertain pathological response, the size of the recurrence, and its close contiguity with the ureter and bowel, we decided to avoid radiation therapy as it could result in a ureteral or intestinal fistula. We performed a laterally extended pelvic resection, as shown step by step in the video.The procedure was conducted until complete removal of recurrence (R0). Estimated blood loss was 1000 mL and total operative time was 240 min. The patient was discharged after 15 days; we reported a urinary infection, a likely postoperative complication. The pathology report described a lymphnodal relapse of ovarian cancer (diameter=6 cm) with infiltration of surrounding tissue and in the sano margins. Six months after surgery, the patient is alive without evidence of relapse.The borders of pelvic surgical anatomy are continually extending, requiring surgeons to use a personalized approach and to continually update their anatomic knowledge. In this context, laterally extended pelvic resection could be a feasible surgical procedure, representing a salvage treatment in recurrent or persistent primary gynecological malignancies infiltrating the pelvic sidewall, when other approaches have failed. However, additional clinical trials are needed to confirm these results.3.