Evaluation of the one-step nucleic acid amplification method for rapid detection of lymph node metastases in endometrial cancer: prospective, multicenter, comparative study.

OBJECTIVE: To evaluate the diagnostic performance of the one-step nucleic acid amplification (OSNA) method for the detection of sentinel lymph node (SLN) metastases in women with apparent early-stage endometrial cancer compared with standard ultrastaging. METHODS: Prospective, multicentric, interventional study. Patients with apparent early-stage endometrial cancer who underwent primary surgical staging with SLN mapping were included. SLNs were serially sectioned with 2 mm slices perpendicular to the longest axis of the node: the odd slices were submitted to ultrastaging, whereas the even slices were submitted to the OSNA analysis. Diagnostic performance was calculated taking ultrastaging as referral standard. RESULTS: Three-hundred and sixteen patients with 668 SLNs were included. OSNA assay detected 22 (3.3%) positive SLNs, of which 17 (2.5%) were micrometastases and 5 (0.7%) macrometastases, whereas ultrastaging detected 24 (3.6%) positive SLNs, of which 15 (2.2%) were micrometastases and 9 (1.3%) macrometastases (p=0.48). Regarding negative SLNs, OSNA detected 646 (96.7%) negative nodes, including 8 (1.2%) isolated tumor cells, while ultrastaging detected 644 (96.4%) negative nodes with 26 (3.9%) isolated tumor cells. Specificity of OSNA was 98.4% (95% CI 97.5 to 99.4), accuracy was 96.7% (95% CI 95.4 to 98.1), sensitivity was 50% (95% CI 30.0 to 70.0), while negative predictive value was 98.1% (95% CI 97.1 to 99.2). Discordant results were found in 22 SLNs (3.3%) corresponding to 20 patients (6.3%). These were 10 (1.5%) false-positive SLNs (all micrometastases): one (0.1%) of these was a benign epithelial inclusion at ultrastaging. There were 12 (1.8%) false-negative SLNs of OSNA, of which 9 (1.3%) were micrometastases and 3 (0.5%) macrometastases. Overall, 17/668 (2.5%) benign epithelial inclusions were detected at ultrastaging. CONCLUSION: The OSNA method had high specificity and high accuracy in detecting SLN metastasis in apparent early-stage endometrial cancer. The advantage of the OSNA method could be represented as the possibility to analyze the entire lymph node thus eliminating sampling bias.

Laparoscopic sentinel node mapping with intracervical indocyanine green injection for endometrial cancer: the SENTIFAIL study - a multicentric analysis of predictors of failed mapping.

OBJECTIVES: Laparoscopy is commonly used for endometrial cancer treatment, and sentinel lymph node (SLN) mapping has become the standard procedure for nodal assessment. Despite the standardization of the technique, there is no definitive data regarding its failure rate. The objective of this study is to identify factors associated with unsuccessful SLN mapping in endometrial cancer patients undergoing laparoscopic SLN mapping after intracervical indocyanine green (ICG) injection. METHODS: We retrospectively evaluated a consecutive series of endometrial cancer patients who underwent laparoscopic SLN mapping with intracervical ICG injection, in four oncological referral centers from January 2016 to July 2019. Inclusion criteria were biopsy-proven endometrial cancer, total laparoscopic approach, and intracervical ICG injection. Exclusion criteria were evidence of lymph node involvement or extrauterine disease at pre-operative imaging, synchronous invasive cancer, the use of tracers different from ICG, and the use of neoadjuvant treatment. Bilateral and failed bilateral SLN mapping groups were compared for clinical and pathological features. In patients with an unsuccessful procedure, side-specific lymphadenectomy was performed. Logistic regression was used to identify predictors of failure. RESULTS: A total of 376 patients were included in the study. The overall bilateral and unilateral SLN detection rates were 96.3%, 76.3%, and 20.0% respectively. The failed bilateral mapping detection rate was 23.7%. The median number of sentinel nodes removed was 2.2 (range, 0-5). After multivariate analysis, lymph vascular space involvement [OR 2.4 (1.04-1.12), P=0.003], non-endometrioid histology [OR 3.0 (1.43-6.29), P=0.004], and intraoperative finding of enlarged lymph node [OR 2.3 (1.01-5.31), P=0.045] were identified as independent predictors of failure of SLN mapping. CONCLUSION: Lymph vascular space involvement, non-endometrioid histology, and intra-operative finding of enlarged lymph nodes were identified as independent risk factors for unsuccessful mapping in patients undergoing laparoscopic SLN mapping.

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.

Intra-operative assessment of sentinel lymph node status by one-step nucleic acid amplification assay (OSNA) in early endometrial cancer: a prospective study.

BACKGROUND: Sentinel node mapping has been proposed to reduce surgical side effects, maintaining the accuracy in nodal status assessment for endometrial cancer. OBJECTIVE: To investigate the role of one-step nucleic acid amplification assay (OSNA) analysis, in the intra-operative tailoring of full nodal dissection, and to analyze the correlation between the type of sentinel node metastasis and the risk of non-sentinel node metastasis. METHODS: Surgical and pathological data were collected from 141 consecutive, clinical stage I patients with endometrial cancer undergoing surgical staging. Patients were excluded if they had previous pelvic or abdominal radiotherapy, chemotherapy, abdominal cancer, pelvic or abdominal lymphadenectomy, or contraindications to indocyanine green. All sentinel nodes were analyzed by OSNA, and full lymphadenectomy was performed in positive cases. Statistical analysis was performed using Χ2 and Fisher's exact test to determine whether any of these characteristics could accurately predict the non-sentinel nodes status in positive sentinel node patients. RESULTS: A total of 141 patients were included in the analysis. Bilateral sentinel nodes were identified in 104 (73.8%) patients, with a median number of 2 (range 2-6) sentinel nodes per patient. In the remaining 37 patients (26.2%), a unilateral sentinel node was obtained, with a median of 1 (range 1-3) sentinel node per patient. Thirty-three (12.0%) positive nodes were found in 24 (17.0%) patients: micro-metastases and macro-metastases were detected in 22 and 2 patients, respectively. At final pathology, all patients with positive non-sentinel nodes had macro-metastases in the sentinel node, whereas in micro-metastatic sentinel nodes no other positive nodes were found at full lymphadenectomy (p<0.001). CONCLUSIONS: Our results showed a correlation between the type of metastasis in the sentinel lymph node (SLN) and the incidence of positive non-SLNs. These data suggest a potential role of OSNA analysis in the surgical tailoring of patients with early endometrial cancer, with the goal of definitive risk stratification and a better individualization of adjuvant therapy.

Tumor Size, an Additional Risk Factor of Local Recurrence in Low-Risk Endometrial Cancer: A Large Multicentric Retrospective Study.

OBJECTIVE: The identification of patients with endometrial cancer (EC) at higher risk for relapse is critical to individualize and better tailor postoperative treatment. No evidence is available regarding the possible association between tumor size (TS) and the risk of local recurrence. The purpose of this study was to analyze the correlation between TS and risk/type of recurrence in EC patients, stratified according to the new European Society of Medical Oncology-European Society of Gynecological Oncology-European Society for Radiotherapy and Oncology classification. METHODS: Data of patients with histologically proven EC who received primary surgical treatment between November 1999 and June 2015 were retrospectively retrieved from 5 institutions. Optimal TS cutoff was calculated using a receiver operating characteristic curve. Site of recurrence as a function of TS and groups of risk were analyzed. Local recurrence-free survival, recurrence-free survival, and overall survival were calculated using the Kaplan-Meier method. RESULTS: Data of 1166 patients were analyzed. Among them, 514 (44.1%) had low-risk EC, 174 (14.9%) had intermediate risk EC, 173 (14.8%) had high-intermediate risk EC, and 305 (26.2%) had high-risk EC. A total of 134 (11.5%) women had recurrence: 47 (4%) of them had local relapse, 30 (2.6%) had locoregional relapse, and 57 (4.9%) had distant relapse. Tumor size 25 mm or greater emerged as the threshold for the prediction of a higher rate of local recurrence (P < 0.0001, hazard ratio = 18.2, P = 0.005) and a lower local recurrence-free survival and recurrence-free survival (P < 0.0001) only in patients with low-risk EC. There was no statistically significant correlation between TS and recurrence in the other risk groups. CONCLUSIONS: In this very large series, tumor size emerges as an independent prognostic factor of local recurrence in women with low-risk EC and could be a valuable additional criterion to personalize the treatment approach to these patients.

The impact on survival of two different staging strategies in apparent early stage endometrial cancer comparing sentinel lymph nodes mapping algorithm and selective lymphadenectomy: An Italian retrospective analysis of two reference centers.

OBJECTIVE: The role of lymphadenectomy in endometrial cancer is still uncertain. We aimed to evaluate the survival outcomes of two different strategies in apparent uterine confined disease by comparing sentinel lymph node (SLN) mapping and selective lymphadenectomy (LD). METHODS: We retrospectively reviewed women with preoperative stage I endometrial cancer underwent surgical staging with either SLN mapping, or LD in two Italian centers. RESULTS: Eight hundred and two women underwent surgical staging for preoperative stage I endometrial cancer were revised (145 Monza; 657 Rome). All patients underwent peritoneal washing, simple hysterectomy with bilateral salpingo-oophorectomy and nodal staging including SLN mapping, or LD. Overall 8229 lymph nodes were removed (1595 in Monza, 6634 in Rome). Pelvic lymphadenectomy was performed in 33.1% and 52.4% in Monza and Rome, respectively (p<0.001). Patients with positive pelvic LN were 16.7% and 7.3%, in SLN and LD groups, respectively (p=0.002). Disease-free survival (DFS) curves did not showed a statistically significant difference between centers and strategies adopted (SLN mapping, LD, SLN+LD) with a HR of 0.87 (95% CI 0.63-2.16; p=0.475). CONCLUSIONS: Survival outcomes were similar for both strategies. The SLN strategy allowed to identify a higher rate of stage IIIC1 disease even with a lower median number of lymph node removed in SLN group. Applying a SLN algorithm does not impair the prognosis of endometrial cancer patients. The clinical impact and management of low volume metastasis in high-risk patients should be further clarify.

Minimally Invasive Approach in Type II Endometrial Cancer: Is It Wise and Safe?

STUDY OBJECTIVE: To compare perioperative and survival outcomes in patients with type II endometrial cancer surgically staged by a minimally invasive surgery (MIS) approach and those surgically staged by laparotomy. DESIGN: Retrospective cohort study (Canadian Task Force classification II-2). SETTING: Catholic University of the Sacred Heart of Rome, University of Insubria, Varese and "Regina Elena" National Cancer Institute of Rome. PATIENTS: A total of 283 patients with type II endometrial cancer in clinical International Federation of Gynecology and Obstetrics stage I-II and pathological stage III with apparent early-stage disease detected on preoperative instrumental examination. INTERVENTIONS: Baseline features and perioperative data were evaluated in 142 patients who underwent hysterectomy via open surgery (laparotomy [LPT] group) and 141 patients who did so via a minimally invasive approach (MIS group). MEASUREMENTS AND MAIN RESULTS: The 2 groups were comparable in terms of baseline features and perioperative data except for operative time, which was longer in the LPT group (p < .001) and hospital stay, which was shorter in the MIS group. There were no between-group differences in pathological features, except for myometrial invasion and the rate of positive pelvic lymph nodes. Therefore, we obtained a higher number of early stages in the MIS group (p < .001). In the overall population, significant differences were observed in the recurrence rate, number, and site of relapses, with a higher recurrence rate and number in the LPT group (p < .001). Progression-free and overall survival were not significantly different in the 2 groups. CONCLUSION: Women with type II endometrial cancer submitted to MIS for hysterectomy experienced fewer complications and similar survival outcomes compared with those who underwent open surgery. When managed by an expert surgeon, a high-risk histological subtype should not be considered a contraindication for MIS. Further prospectively randomized studies are needed to definitively evaluate the safety and feasibility of MIS in early-stage type II endometrial cancer.

Laparoscopic vs. open treatment of endometrial cancer in the elderly and very elderly: An age-stratified multicenter study on 1606 women.

Objective To investigate in depth the effect of increasing age on the peri-operative outcomes of laparoscopic treatment for endometrial cancer, compared to open surgery, with stratification of patients according to the different definitions of elderly age used in the literature. METHODS: Data of consecutive patients who underwent surgery for endometrial cancer staging at six centers were reviewed and analyzed according to surgical approach (laparoscopic or open), different definitions of elderly and very elderly age (≥65years, ≥75years, ≥80years), and class of age (<65; ≥65-<75; ≥75-80; ≥80years). Multivariable analysis to correct for possible confounders and propensity-score matching to minimize selection bias were used. RESULTS: A total of 1606 patients were included: 938 and 668 patients received laparoscopic and open surgery, respectively. With increasing age, fewer patients received laparoscopy (P<0.001 with ANOVA). The percentage of patients who received lymphadenectomy declined significantly in both groups for age ≥80years. Blood transfusions, incidence and severity of post-operative complications, and hospital stay were significantly lower among patients who had laparoscopy both in younger (<65years) and elderly (whether defined as ≥65 or ≥75years) patients, with no effect of age on any of the characteristics analyzed ( ANOVA: P>0.05). The same tendency was observed among very-elderly patients (≥80years). Multivariable and propensity score-matched analysis confirmed these findings. CONCLUSIONS: Laparoscopy for staging endometrial cancer retains its advantages over open surgery even in elderly and very-elderly patients. Our data strongly suggest that minimally-invasive surgery is advantageous even among subjects ≥80years.

The new robotic TELELAP ALF-X in gynecological surgery: single-center experience.

BACKGROUND: To evaluate the safety and feasibility of the new robotic TELELAP ALF-X platform in a heterogeneous series of gynecological procedures. METHODS: Between September 2013 and May 2014, 146 patients were enrolled in this Phase II study trial. Patients with presumed benign or borderline adnexal disease, and benign and early stage malignant uterine disease were prospectively included. RESULTS: Median age was 52 years (range 19-79 years), and median BMI was 23.7 (range 17.3-34.0 kg/m(2)). Sixty-two patients (32.5%) underwent mono/bilateral salpingo-oophorectomy or cyst removal (Group A), four patients (2.7%) myomectomy (Group B), 46 patients (31.5%) total hysterectomy (Group C), and 34 (23.3%) endometrial cancer staging (Group D). Median docking time was 7 min (range 3-36). Median OT was 35 min (range 17-145) in the Group A, 40 min (range 10-50) in the Group B, 133 min (range 58-320) in the Group C, and 160 min (range 69-290) in the Group D. Reduction in OT over the study period for hysterectomy (p < 0.001) and adnexal surgery (p < 0.002) was observed. We registered two laparoscopic conversion (3.2%) in the Group A and two (4.3 %) in the Group C. In the Group D, we showed one (2.9%) laparoscopic and two (5.8%) laparotomic conversions. One patient (2.17%) in the Group C was readmitted in the early postoperative period for severe vaginal bleeding. CONCLUSIONS: We report the first series of a novel robotic approach for the treatment of various gynecological conditions. When performed by experienced minimally invasive surgeons, TELELAP ALF-X is feasible and safe. Further studies are mandatory to define the benefits, advantages, and costs of this new robotic approach with respect to others minimally invasive approaches.

How Technology Can Impact Surgeon Performance: A Randomized Trial Comparing 3-Dimensional versus 2-Dimensional Laparoscopy in Gynecology Oncology.

This randomized clinical trial (Canadian Task Force classification I) aimed to compare 2-dimension (2-D) versus 3-dimensional (3-D) laparoscopic hysterectomy and pelvic lymphadenectomy in endometrial and cervical cancer patients. Between December 2014 and March 2015, 90 patients were enrolled: 29 (32.2%) with early or locally advanced cervical cancer after neoadjuvant treatment and 61 (67.8%) with early-stage endometrial cancer. Patients were randomly assigned to undergo 2-D (Group A, n = 48 [53.3%]) or 3-D (Group B, n = 42 [46.7%)]) laparoscopy. Baseline characteristics were superimposable in the 2 groups. Median operative time was similar in the 2 groups. Median estimated blood loss during lymphadenectomy was significantly lower in Group B than in Group A (38 mL [range, 0-450] vs 65 mL [range, 0-200]; p = .033). In cervical cancer patients operative time of pelvic lymphadenectomy performed by "novice" surgeons (those with <10 procedures performed) was statistically significantly lower in Group B (p = .047). No differences in perioperative outcomes and postoperative complications were observed between the 2 groups. The 2-D and 3-D systems can be used safely in laparoscopic hysterectomy. However, the 3-D system could provide key benefits to intraoperative techniques and postoperative outcomes in reducing operative time for "expert" surgeons and in enhancing surgical precision for "novice" surgeons.

Total Laparoscopic (S-LPS) versus TELELAP ALF-X Robotic-Assisted Hysterectomy: A Case-Control Study.

STUDY OBJECTIVE: To compare the feasibility and safety of the TELELAP ALF-X system and standard laparoscopy for total hysterectomy to treat patients with benign and early malignant gynecologic disease. DESIGN: Single-institution retrospective case-control study (Canadian Task Force classification II-2). SETTING: Catholic University of the Sacred Heart, Rome, Italy. PATIENTS: Between October 2013 and May 2015, 203 women underwent TELELAP-ALF X (group 1) or standard laparoscopic (group 2) total hysterectomy and were enrolled. INTERVENTIONS: Total standard laparoscopy vs TELELAP ALF-X robot-assisted hysterectomy for benign and early malignant gynecologic disease. MEASUREMENTS AND MAIN RESULTS: In group 1, the median age was 55 years (range, 40-79 years), median body mass index (BMI) was 25 kg/m(2) (range, 17-38 kg/m(2)), and 51 patients (58%) had undergone previous abdominal surgery. In the control group, the median age was 55 years (range, 34-90 years), median BMI was 25 kg/m(2) (range, 17-41 kg/m(2)), and 31 patients (27%) had previous abdominal surgery. The median operative time was 147 minutes (range, 58-320 minutes) in group 1 and 80 minutes (range, 22-300 minutes) in group 2 (p = .055). The median estimated blood loss was 57 mL (range, 0-600 mL) in group 1 and 99 mL (range, 0-400 mL) in group 2, with no significant differences between the 2 groups (p = .963). Procedures were successfully performed without conversion in 94.3% of cases in the group 1 and in all cases in group 2. Early postoperative pain was significantly lower in group 2. CONCLUSION: TELELAP ALF-X hysterectomy in patients with benign and early malignant gynecologic disease is feasible and safe, and can be considered a valid option for these patients.

Positron emission tomography-laparoscopy based method in the prediction of complete cytoreduction in platinum-sensitive recurrent ovarian cancer.

BACKGROUND: This study was designed to evaluate the positron emission tomography-laparoscopy-based method in the prediction of complete/optimal cytoreduction in platinum sensitive recurrent epithelial ovarian cancer patients. METHODS: We analysed 223 consecutive recurrent epithelial ovarian cancer patients. Inclusion criteria were absence of extra-abdominal disease and Eastern Cooperative Oncology Group Performance Status ≤2. Complete and optimal secondary cytoreduction are defined as macroscopic absence or less than 1 cm of residual tumor at the end of surgery. RESULTS: Laparoscopy was feasible in 210 of 223 patients (94.2 %). Laparoscopy stated 127 (60.5 %) possible cytoreductions and 83 (39.5 %) systemic chemotherapies. In the same population, AGO score evaluation avowed 150 possible cytoreduction (71.5 %) and 60 unresectable women (28.5 %). Overall, 115 of 210 patients (54.7 %) underwent successful secondary cytoreduction: complete and optimal cytoreduction was obtained in 103 (89.5 %) and 12 (10.5 %) patients, respectively. Laparoscopy obtained a positive predictive value of 91.3 %. Laparoscopy recovered to secondary cytoreduction 13 of 60 patients (21.7 %) deemed as not resectable according to AGO score. Forty-eight of 150 AGO score positive patients (32 %) were judged nonresectable by laparoscopy. CONCLUSIONS: This study confirmed that laparoscopy could be effective for the selection of platinum-sensitive recurrent epithelial ovarian cancer patients suitable for complete cytoreduction.

TELELAP ALF-X Robotic-assisted Laparoscopic Hysterectomy: Feasibility and Perioperative Outcomes.

STUDY OBJECTIVE: To show the safety, feasibility, and perioperative outcomes of total TELELAP ALF-X hysterectomy (SOFAR S.p.A., ALF-X Surgical Robotics Department, Trezzano Rosa, Milan, Italy). DESIGN: Phase II study (Canadian Task Force II-2). SETTING: Catholic University of the Sacred Heart, Rome, Italy. PATIENTS: From October 2013 to May 2014, 80 women underwent total TELELAP ALF-X hysterectomy. The study population was divided into 2 groups according to surgical procedures: total hysterectomy ± bilateral salpingo-oophorectomy (group 1) and endometrial cancer patients staged with pelvic lymphadenectomy (group 2). INTERVENTIONS: Total TELELAP ALF-X hysterectomy ± bilateral salpingo-oophorectomy with or without pelvic lymphadenectomy. MEASUREMENTS AND MAIN RESULTS: The median age was 51 years (range, 48-79), and the median body mass index was 24 kg/m(2) (range, 17.3-34.2). Forty-five patients (56.2%) had previous surgery. The median operative time was 140 minutes (range, 58-320) in group 1 and 197 minutes (range, 129-290) in group 2 (p < .001). The median docking time was 8 minutes (range, 3-25). During the study period, a significant trend in operative time reduction was observed. Procedures were successfully performed without conversion in 93.7% of cases. We observed 2 (2.5%) intraoperative complications, 3 (3.7%) conversions to standard laparoscopy, and 2 (2.5%) to laparotomy. The median time to discharge was 2 days (range, 1-5). One patient (1.2%) was readmitted in the early postoperative period. CONCLUSION: As new technology evolves, critical appraisal of patient-related outcomes, use, cost, and access to minimally invasive hysterectomy must remain a priority. Despite the relative small number of our series, we showed the feasibility and safety of total TELELAP ALF-X hysterectomy for benign and malignant disease.

Telelap Alf-X-Assisted Laparoscopy for Ovarian Cyst Enucleation: Report of the First 10 Cases.

This prospective single-institutional clinical trial sought to assess the safety and feasibility of laparoscopic benign ovarian cyst enucleation with a novel robotic-assisted laparoscopic system. Here we report a series of 10 patients treated using the Telelap ALF-X system in the first clinical application on patients at the Division of Gynecologic Oncology, Catholic University of the Sacred Heart of Rome. The primary inclusion criterion was the presence of monolateral ovarian cyst without a preoperative assessment suspicious for malignancy. Intraoperative data, including docking time, operative time, estimated blood loss, intraoperative and perioperative complications, and conversion to either standard laparoscopy or laparotomy, were collected. The cysts were removed with an ovary-sparing technique with respect to conservative surgical principles. The median operative time was 46.3 minutes, and patients without postoperative complications were discharged at 1 or 2 days after the procedure. Telelap ALF-X laparoscopic enucleation of benign ovarian cysts with an ovary-sparing technique is feasible, safe, and effective; however, more clinical data are needed to determine whether this approach can offer any other benefits over other minimally invasive surgical techniques.

Laparoendoscopic single-site hysterectomy: is it safe and feasible?

PURPOSE OF REVIEW: The goal was to evaluate the safety, feasibility, and reproducibility of total and radical single-site hysterectomy. RECENT FINDINGS: Minimally invasive surgery represents the gold standard for benign and malignant gynecological disease. Laparoendoscopic single-site surgery has emerged as a new technical concept to decrease parietal trauma and improve body image. Laparoendoscopic single-site surgery is not a new essay, but recent developments in surgical technology have resulted in an exponential enlargement of indications. Recently published data showed feasibility, safety, and reproducibility of single-port hysterectomy for benign and malignant gynecological diseases. SUMMARY: Laparoendoscopic single-site surgery represents a new challenge in minimally invasive surgery and appears to be feasible and safe to perform in a variety of gynecologic diseases. The aim of this review is to critically analyze the recent literature about single-site hysterectomy.

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.

Minilaparoscopic versus single-port total hysterectomy: a randomized trial.

STUDY OBJECTIVE: To compare perioperative outcomes and postoperative pain of minilaparoscopic (M-LPS) and laparoendoscopic single-site total hysterectomy (LESS). DESIGN: Prospectively randomized study (Canadian Task Force classification II-2). SETTING: Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Catholic University of the Sacred Heart, Rome. PATIENTS: A total of 86 patients underwent total hysterectomy. Seventy-one met the inclusion criteria and were included in this study. Three of them refused randomization, 34 were randomly assigned to undergo to single-port hysterectomy and 34 to undergo to minilaparoscopy. INTERVENTIONS: The operative technique is the same in the 2 groups with the exception of videolaparoscopy, port type, and some specific instruments. All surgical procedures were performed with an intrauterine manipulator. Single-port hysterectomy was performed through a multichannel single trocar inserted in the umbilicus. Minilaparoscopic hysterectomy was performed through one optical transumbilical 5-mm trocar and three 3-mm suprapubic ancillary ports. MEASUREMENTS AND MAIN RESULTS: Sixty-eight patients met the inclusion criteria and were enrolled in the study. The baseline characteristics of the 2 groups were comparable. Median operative time was longer in LESS with respect to M-LPS (120 minutes vs 90 minutes; p = .038). There were no differences between the 2 groups for median estimated blood loss, ileus, and postoperative stay. Additional 5-mm port insertion was needed in 1 case (2.9%) in the M-LPS group and in 2 cases (5.9%) in the LESS group, respectively (p = .311). No patient had development of intraoperative or early postoperative complications. Patients in the M-LPS group experienced a minor pain at each evaluation, compared with patients who underwent LESS. The rescue analgesic requirement was similar in the 2 groups. CONCLUSIONS: Laparoscopic hysterectomy can be safely performed by M-LPS and LESS. M-LPS is associated with significantly lower operative time and less postoperative pain than LESS. Advantages of M-LPS hysterectomy than LESS have no noteworthy impact on the patients' early postoperative management. The decision on the best access to the hysterectomy might take into account the surgeon's skill and feeling with the different possible approaches.

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.

One biopsy, two tumors: A case report of collision tumor consisting in breast and endometrioid carcinoma detected on bioptic sample of peritoneal carcinomatosis.

Collision tumors are rare and very few cases were described in which collision was revealed in a metastatic lesion. Herein we report a case of woman with a peritoneal carcinomatosis underwent to bioptic procedure in correspondence of a nodule of Douglas peritoneum with clinical suspect of ovarian/uterine origin. Histologic examination revealed two different colliding epithelial neoplasms: an endometrioid carcinoma and a ductal breast carcinoma, the latter not suspected at the time of biopsy. Morphology and immunohistochemistry, in particular GATA3 and PAX8, defined clearly the two different colliding carcinomas.

Laparoscopic, minilaparoscopic and single-port hysterectomy: perioperative outcomes.

OBJECTIVE: This study was designed to compare perioperative outcomes and postoperative pain of standard laparoscopic (S-LPS), minilaparoscopic (M-LPS), and laparoendoscopic single-site (LESS) hysterectomy. METHODS: A single-institutional, matched, retrospective, cohort study was performed. Between May 2010 and March 2011, 85 consecutive women were submitted to a total laparoscopic hysterectomy by S-LPS, M-LPS, and single-port LESS. Perioperative outcomes of these three techniques were analyzed and compared. RESULTS: Demographics and baseline characteristics of each group were absolutely comparable. The median operative time was longer [105 (range, 75-125) min] in the LESS group compared with the M-LPS group [90 (range, 60-120) min; p < 0.011] and S-LPS [80 (range, 50-110) min; p < 0.001]. No statistically significant differences have been reported for estimated blood loss or intra- and early postoperative complications. Postoperative pain control was better for LESS and M-LPS than S-LPS. CONCLUSIONS: M-LPS and LESS hysterectomy can be performed safely, and both seem to be associated with a halving of early postoperative pain with a lower request of analgesics.