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.

Surgical outcomes of diaphragmatic resection during cytoreductive surgery for advanced gynecological ovarian neoplasia: A randomized single center clinical trial - DRAGON.

INTRODUCTION: Ovarian cancer (OC) represent nearly 4% of gynecologic malignancies and it is often diagnosed at advanced stage. Diaphragmatic surgery, a fundamental step of advanced stage ovarian cancer (ASOC) debulking surgery, is associated with a high post-operative complication incidence, which is supposedly reduced with thoracostomy tube placement. We assessed the role of intra-operative thoracostomy tube placement, as a prevention measure for post-operative complications, after diaphragmatic resection. METHODS: This was a single center prospective randomized trial. Ovarian cancer patients, who underwent mono-lateral diaphragmatic resection, were randomized 1:1 into two arms. Arm A included patients receiving intra-operative thoracostomy tube placement (TP); Arm B patients did not receive thoracostomy tube placement (NTP). After surgery, all patients underwent seriate chest x-ray and ultrasound to record thoracic complications. Statistical analysis included uni- and multivariable logistic regression model (proportional odds model). RESULTS: Three hundred seventy-one patients were screened and 88 patients were enrolled: 44 in arm A and B, respectively. No statistically significant differences for intra-operative (p = 0.291) and any grade of post-operative complication (p = 0.072) were detected, while 6.8% of patients in arm A and 22.7% in arm B experienced severe respiratory symptoms (p = 0.035); 18.2% of patients in arm A had a moderate/large pleural effusion versus 65.9% in arm B (p < 0.0001). At multivariable analysis, results confirmed that the NTP-group had a higher risk to receive post-operative thoracostomy tube placement due to pleural effusion than the TP-group (odds ratio [95% Confidence Interval] = 14.5 [3.7-57.4]). CONCLUSIONS: Thoracostomy intra-operative tube placement after diaphragmatic resection is effective to prevent post-operative thoracic complications. The extension of resection does not influence outcomes and the risk of post-operative thoracentesis or TP remain elevated.

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.

Laparoscopic vs percutaneous hysterectomy in obese patients: a prospective evaluation.

BACKGROUND: Treatment of obese female patients represents a real challenge. Indeed, obesity among women has reached epidemic levels not only elevating the cardiovascular and endocrinological risks, but also increasing the incidence of various gynecological pathologies (e.g. endometrial cancer and hyperplasia, uterine fibroids, genital prolapse) which commonly require hysterectomy as a surgical solution. In the last decade, minimally invasive surgery has emerged as an approach reducing the invasiveness of the standard laparoscopic surgical procedures while maintaining efficacy and feasibility. As such, in this study we aimed to evaluate the feasibility of percutaneous hysterectomy (PSS-H) approach in obese patients by reporting the first prospective comparison between the PSS-H to laparoscopic hysterectomy (LPS-H). METHODS: In this multicentric comparative prospective study, 45 patients affected by benign and malignant gynecological conditions were considered eligible for minimally invasive surgery (MIS). Fifteen patients received PSS-H and 30 LPS-H. All patients enrolled received a total hysterectomy ± bilateral salpingo-oophorectomy, with or without lymph nodal staging. RESULTS: No statistically significant differences were noted in operative time and estimated blood loss between the two groups. Four patients in PSS-H group and 3 in LPS-H group received lymph node staging. A multifunctional energy device was used in all PSS-H and 73.3% of LPS-H procedures (p=0.038). There were no conversions to laparotomy in either group and similarly there were no conversions to conventional laparoscopy in the PSS-H group. In the LPS-H group, there was one (3.3%) case of major bleeding( ≥ 500 mls). We recorded one vaginal cuff bleeding in PSS-H, whereas for LPS-H we reported 4 (13.3%) 30-days complications (p=0.651). No differences in visual analogue scale (VAS) score were recorded. A significant disparity was noted in cosmetic outcome at discharge (p=0.001), but not after 30 days. CONCLUSION: We demonstrated for the first time, in a prospective comparison between PSS and LPS approaches, that PSS-H may represent a valid alternative to performing total hysterectomy in obese patients.

Robotic Single-Port Platform in General, Urologic, and Gynecologic Surgeries: A Systematic Review of the Literature and Meta-analysis.

BACKGROUND: Robotic platforms have recently acquired progressive importance in different surgical fields, such as urology, gynecology, and general surgery. Through the years, new surgical robots have become available as single-port robotic platform. The study is aimed to value the single-port robotic platform characteristics in different surgical specialties. METHODS: The terms "LESS" OR "single port" OR "single site" AND "robot" OR "robotic" were systematically used to search the PubMed and Scopus databases. A total of 57 studies were considered eligible for the present review. The articles included were divided according to the surgical field in which the study was conducted: General surgery (29 articles), Gynecology (18 articles), Urology (10 articles). RESULTS: Most part of the articles showed the feasibility of robotic single-port surgical procedures and described advantages in terms of cosmetic, hospital stay, and in some series even cost reduction. A meta-analysis was conducted, showing a significant increment of complications using RSP if compared with SLPS and a trend (P = 0.008) when RSP was compared with LESS. The comparison of different techniques in terms of conversion to laparotomy did not show any significant difference. CONCLUSION: Robotic single port potentially furnishes an important surgical and post-operatory improvement; however, some limits still prolong the surgical time and complication rate.

Total laparoscopic hysterectomy for enlarged uteri: factors associated with the rate of conversion to open surgery.

A hysterectomy for enlarged uteri is considered a challenge for gynaecologic surgeons, due to the limit of exposure to surgical spaces. Our objective is to investigate the different variables that may have an impact on the risk of conversion to open surgery. This is a retrospective cohort study consisting of 133 women who were submitted to surgery for uterine fibroids and who underwent total hysterectomy by laparoscopic approach attempt. The median uterus weight was 622 grams (range 301-3882) and the median maximum diameter of the bigger fibroid was 74 mm (range 33-148). We registered 13 (9.8%) cases of conversion to laparotomy. Minor and major post-operative complications were recorded in 4 (3%) and in 4 (3%) cases, respectively. After multivariable analysis, the surgeon's experience (OR: 0.24; 95% CI: 0.06-0.94, p = .027) and a maximum diameter of the biggest fibroid ≥10 cm (4.7; 1.39-15.87; p = .046), but not the uterus weight were associated with the risk of conversion to open surgery. IMPACT STATEMENT What is already known on this subject? Laparoscopic procedures for enlarged uteri are well described in literature; however, the only parameters that have been studied for the success of a laparoscopic procedure have been the uterus weight and the surgeon's experience. What do the results of this study add? This study aimed to value all the possible variables related to the successful of laparoscopic procedures; in fact, we investigated not only the uterine weight, but in our multivariate analysis, the position of the fibroids, the trocar's setting, etc. were analysed. What are the implications of these findings for clinical practice and/or further research? This study reported novel data about the feasibility of laparoscopic hysterectomy for enlarged uteri. In opposition to the literature, the uterine weight is not a predictive value for laparotomic conversion. Moreover, we discussed the possible reasons of our novel findings. It opens new perspective to create a predictive value of laparoscopic feasibility for the different types of enlarged uteri.

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 INTERNATIONAL MISSION study: minimally invasive surgery in ovarian neoplasms after neoadjuvant chemotherapy.

OBJECTIVES: The aim of this retrospective multicenter study was to investigate the extent, feasibility, and outcomes of minimally invasive surgery at the time of interval debulking surgery in different gynecological cancer centers. METHODS/MATERIALS: In December 2016, 20 gynecological cancer centers were contacted by e-mail, to participate in the INTERNATIONAL MISSION study. Seven centers confirmed and five were included, with a total of 127 patients diagnosed with advanced epithelial ovarian cancer after neoadjuvant chemotherapy and minimally invasive interval surgery. Only women with a minimum follow-up time of 6 months from interval surgery or any cancer-related event before 6 months were included in the survival analysis. Baseline characteristics, chemotherapy, and operative data were evaluated. Survival analysis was evaluated using the Kaplan-Meier method. RESULTS : All patients had optimal cytoreduction at the time of interval surgery: among them, 122 (96.1%) patients had no residual tumor. Median operative time was 225 min (range 60 - 600) and median estimated blood loss was 100 mL (range 70 - 1320). Median time to discharge was 2 days (1-33) and estimated median time to start chemotherapy was 20 days (range 15 - 60). Six (4.7%) patients experienced intraoperative complications, with one patient experiencing two serious complications (bowel and bladder injury at the same time). There were six (4.7%) patients with postoperative short-term complications: among them, three patients had severe complications. The conversion rate to laparotomy was 3.9 %. Median follow-up time was 37 months (range 7 - 86): 74 of 127 patients recurred (58.3%) and 31 (24.4%) patients died from disease. Median progression-free survival was 23 months and survival at 5 years was 52 % (95% CI: 35 to 67). CONCLUSIONS: Minimally invasive surgery may be considered for the management of patients with advanced ovarian cancer who have undergone neoadjuvant chemotherapy, when surgery is limited to low-complexity standard cytoreductive procedures.

Laparoscopic, minilaparoscopic, single-port and percutaneous hysterectomy: Comparison of perioperative outcomes of minimally invasive approaches in gynecologic surgery.

OBJECTIVES: During the last decade endoscopic surgical procedures have been constantly evolving. The latest innovation in ultra-minimally invasive surgery (MIS) is the percutaneous technology (Percuvance™ Percutaneous Surgical System (PSS), Teleflex Inc., USA). We compared surgical outcome of hysterectomy, in a retrospective cohort study using the most recent MIS techniques as single-site (LESS) surgery, 3mm laparoscopy (MiniLPS) and percutaneous system (PSS) with standard laparoscopy (LPS). STUDY DESIGN: This is a matched retrospective cohort study. Endometrial Hyperplasia/Early stage endometrial cancer or benign pathology were the indication for surgery. Data of laparoscopic hysterectomies performed between May 2013 and April 2016 using PSS, LPS, MiniLPS, and LESS were collected and compared. RESULTS: The characteristics of each group were similar. The median Operative time (OT) was significantly longer in LESS compared to all other groups (120min [range 55-165] in LESS, 91min [range 60-180] in MiniLPS, 70min [range 55-230] in LPS and 65 [range 40-180] in PSS; p=0.0001). No significant differences among the 4 groups were observed in terms of estimated blood loss, conversion to laparoscopy or laparotomy, and intra e post-operative complications. Statistically significant differences were recorded in median VAS 24h (2 [range 0-3] in PSS, 2 [range 0-3] in MiniLPS, 3 [range 2-5] in LESS and 2 [range 1-5] in LPS; p=0.0001). The average time of discharge was (1day [range 1-3] in PSS, 1day [range 1-2] in MiniLPS, 1days [range 1-2] in LESS and 1day [range 1-3] in LPS; p=0.99). CONCLUSIONS: Data show that the effort to minimize the impact of surgical invasiveness can be feasible and could improve the advantages, not only in terms of aesthetic outcomes, even if the differences among the endoscopic approaches have not a relevant clinical impact. The technology innovations like PSS maintain the same triangulation between instruments as standard LPS with an evident decrease of the invasiveness thanks to reduced instruments size, even if the lack of suitability of bipolar energy, that require a multifunction instrument, remain a limit of these instruments.

Out-of-the-box pelvic surgery including iliopsoas resection for recurrent gynecological malignancies: Does that make sense? A single-institution case-series.

OBJECTIVE: To report morbidity and oncological outcomes in a consecutive series of lateral isolated recurrent gynecological cancer involving the pelvic side wall (PSW) including the iliopsoas muscle. MATERIAL AND METHODS: We retrospectively evaluated a consecutive series between 6/2013 and 12/2015 of lateral isolated recurrent gynecological malignancies treated with a lateral endopelvic resection (LEPR). LEPR was defined as an en-bloc lateral resection of a pelvic tumor with sidewall muscle, and/or bone, and/or major nerve, and/or major vascular structure. Post-surgical complications, quality of life (QoL) and survivals were computed. RESULTS: Seventy-four women with pelvic isolated relapse were admitted for surgery during the study period. Among them, 8 cases (10.8%) showed lateral isolated relapse involving the iliopsoas muscle and were treated with LEPR. R0 resection was achieved in 6/8 patients (75.0%), while the pathologic margins were microscopically and macroscopically positive in 1 patient (12.5%), respectively. There were no perioperative mortalities. Major postoperative complications occurred in 3 patients (37.5%) through peripheral neuropathies, thrombosis of the vascular graft and compartment syndrome of the leg. Median follow-up time was 21 months (range, 12-28). The 2-year overall survival (OS) was 88% improving up to 100% if R0 resection was achieved. In patients with positive pathologic margins (n = 2), the 2-year OS was 50%. All women showed an improved QoL after surgery. CONCLUSION: LEPR with iliopsoas resection can be safely performed in selected cases with lateral isolated gynecological relapse involving the PSW and was associated with improved QoL and prolonged survival when an R0 resection was achieved.

Minimally invasive versus standard laparotomic interval debulking surgery in ovarian neoplasm: A single-institution retrospective case-control study.

OBJECTIVE: To further investigate the role of MIS comparing patients submitted to MI-IDS with a balanced population treated by standard laparotomy. METHODS: The investigational arm (Cases) includes 30 AEOC patients treated with MI-IDS. The Control arm included a consecutive series of 65 AEOC patients submitted to laparotomic IDS. Inclusion criteria were: age>18years, histologically proven EOC, clinical complete/partial response after NACT, and ECOG PS <2. Preoperative clinical data, perioperative and oncological outcomes were analyzed. General Well-Being Schedule (GWBS) was administered to evaluate quality of life before and after surgery. RESULTS: Both groups were well-balanced. A higher percentage of women among Cases received bevacizumab-containing NACT compared with Controls. No statistical differences were registered in terms of surgical procedures and residual tumor. A significantly longer median OT in Cases was counterbalanced by more favorable EBL and median length of stay and TTC. No statistically significant differences were registered in terms of postoperative complications. Cases showed a 6months longer PFS compared to Controls. However, in multivariate analysis only the administration of Bevacizumab and a shorter TTC were independently associated with a longer PFS. Regarding QoL, no statistically significant differences were registered in Cases between pre- and postoperative GWBS score. Differently from Controls where this difference was statistically significant and a more intense distress were recorded. CONCLUSIONS: Minimally invasive approach could represent an advantageous alternative surgical way to perform interval debulking surgery in this specific subset of patients, with no impact on PFS. Based on these findings a randomized clinical trial is now under evaluation in our Institution.

A laparoscopic risk-adjusted model to predict major complications after primary debulking surgery in ovarian cancer: A single-institution assessment.

OBJECTIVE: To develop and validate a simple adjusted laparoscopic score to predict major postoperative complications after primary debulking surgery (PDS) in advanced epithelial ovarian cancer (AEOC). METHODS: From January 2006 to June 2015, preoperative, intraoperative, and post-operative outcome data from patients undergoing staging laparoscopy (S-LPS) before receiving PDS (n=555) were prospectively collected in an electronic database and retrospectively analyzed. Major complications were defined as levels 3 to 5 of MSKCC classification. On the basis of a multivariate regression model, the score was developed using a random two-thirds of the population (n=370) and was validated on the remaining one-third patients (n=185). RESULTS: Major complication rate was 18.3% (102/555). Significant predictors included in the scoring system were: poor performance status, presence of ascites (>500cm(3)), CA125 serum level (>1000U/ml), and high laparoscopic tumor load (predictive index value, PIV ≥8). The mean risk of developing major postoperative complications was 3.7% in patients with score 0 to 2, 13.2% in patients with score 3 to 5, 37.1% in patients with score 6 to 8. In the validation population, the predicted risk of major complications was 17.8% (33/185) versus a 16.7% (31/185) observed risk (C-statistic index=0.790). CONCLUSION: This new score may accurately predict a patient's postoperative outcome. Early identification of high-risk patients could help the surgeon to adopt tailored strategies on individual basis.

Introduction of staging laparoscopy in the management of advanced epithelial ovarian, tubal and peritoneal cancer: impact on prognosis in a single institution experience.

OBJECTIVE: To evaluate the prognostic impact of routinely use of staging laparoscopy (S-LPS) in patients with primary advanced epithelial ovarian cancer (AEOC). METHODS: All women were submitted to S-LPS before receiving primary debulking surgery (PDS) or neoadjuvant treatment (NACT). The surgical and survival outcome were evaluated by univariate and multivariate analysis. RESULTS: Among 300 consecutive patients submitted to S-LPS no complications related to the surgical procedure were registered. The laparoscopic evaluation showed that almost half of the patients (46.3%) had a high tumor load. One-hundred forty-eight (49.3%) women were considered suitable for PDS and the remaining 152 (50.7%) were submitted to NACT. The percentages of complete (residual tumor, RT=0) and optimal (RT<1cm) cytoreduction of PDS and interval debulking surgery (IDS) were 62.1% and 57.5%, 22.5% and 27.7%, respectively, p=0.07. The post-operative complications of NACT/IDS group were lower than PDS group (p=0.01). The median progression free survival in women with RT=0 at PDS was 25 months (95% CI, 15.1-34.8), which was statistically significant longer than in all other patients, irrespective of the type of treatment they received (p=0.0001). At multivariate analysis, residual disease (p=0.011) and performance status (p=0.016) maintained an independent association with the PFS. CONCLUSIONS: Including S-LPS in a tertiary referral center for the management AEOC does not appear to have a negative impact in terms of survival and it may be helpful to individualize the treatment avoiding unnecessary laparotomies and surgical complications.