Employing the Aviation Model to Reduce Errors in Robotic Gynecological Surgery: A Narrative Review.

The operating room is the environment where harm to the patient is most likely. Robotic surgery was listed as one of the top 10 health hazards as late as 2020. Taking inspiration from other fields of application, such as aeronautics, checklists have been increasingly implemented in medical practice over the years, becoming essential components of the operating theatre. In addition to checklists, simulation has taken on a fundamental importance in reducing errors. This paper aims to provide a narrative review to assess the importance of checklists and training in robotic surgery and how they improve the outcome. A comprehensive literature search from January 2000 to September 2023 was conducted. A total of 97 articles were included in the initial search. Eleven studies were deemed relevant and were considered eligible for full-text reading. Among these, ten studies focused on the analysis of training effectiveness. An article in our review assessed the benefits of introducing checklists in the operating room. Innovations created in aviation, such as checklists and simulation, have entered the medical field to prevent human error. Developing dedicated checklist and surgical teams, through theoretical and practical training, has become essential in modern medicine. Tools such as checklists, training, and simulation are among the best methods to reduce adverse medical events.

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.

The Importance of Fetoplacental Doppler Velocimetry for Fetal Surveillance During General Anesthesia for Non-obstetric Surgery.

Fetal heart rate monitoring during general anesthesia for non-obstetric surgery at viable gestational ages is recommended to evaluate fetal well-being during the intervention. Alteration induced by anesthetic drugs could mimic fetal acute hypoxia, leading to pointless Cesarean sections. We report a case of a pregnant woman in the third trimester undergoing neurosurgical surgery. The continuous heart rate registration showed a non-reassuring pattern, potentially inducing the multidisciplinary team to expedite the delivery. The seriate fetoplacental Doppler evaluations were reassuring about normal fetal conditions, suggesting that ultrasound surveillance could be more reliable than intraoperative heart rate monitoring.

Predictive factors of surgical complications after pelvic exenteration for gynecological malignancies: a large single-institution experience.

OBJECTIVE: To evaluate pre-operative predictors of early (<30 days) severe complications (grade Dindo 3+) in patients with gynecological malignancy submitted to pelvic exenteration (PE). METHODS: We retrospectively analyzed 129 patients submitted to surgery at Fondazione Policlinico Gemelli between 2010 and 2019. We included patients affected by primary or recurrent/persistent cervical, endometrial, or vulvar/vaginal cancers. Post-operative complications were graded according to the Dindo classification. Logistic regression was used to analyze potential predictors of complications. RESULTS: We performed 63 anterior PE, 10 posterior PE, and 56 total PE. The incidence of early severe post-operative complications was 27.9% (n=36), and the early mortality rate was 2.3% (n=3). More frequent complications were related to the urinary diversion and intestinal surgery. In univariable analysis, hemoglobin ≤10 g/dL (odds ratio [OR]=4.2; 95% confidence interval [CI]=1.65-10.7; p=0.003), low albumin levels (OR=3.9; 95% CI=1.27-12.11; p=0.025), diabetes (OR=4.15; 95% CI=1.22-14.1; p=0.022), 2+ comorbidities at presentation (OR=5.18; 95% CI=1.49-17.93; p=0.012) were predictors of early severe complications. In multivariable analysis, only low hemoglobin and comorbidities at presentation were independent predictors of complications. CONCLUSION: Pelvic exenteration is an aggressive surgery characterized by a high rate of post-operative complications. Pre-operative assessment of comorbidities and patient health status are crucial to better select the right candidate for this type of surgery.

Post Treatment Sexual Function and Quality of Life of Patients Affected by Cervical Cancer: A Systematic Review.

Introduction: The aim of this study is to analyze the available scientific evidence regarding the quality of life (QoL) and sexual function (SF) in patients affected by cervical cancer (CC) after surgical and adjuvant treatments. Materials and Methods: Preliminary research was conducted via electronic database (MEDLINE, PubMed and Cochrane Library) with the use of a combination of the following keywords: SF, QoL, and CC. The principal findings considered in the present review were the study design, the number of patients included in each study, the information about the malignancy (histology and stage of disease), the questionnaires administered, and the principal findings concerning SF and QoL. Results: All studies were published between 2003-2022. The studies selected consisted of one randomized control study, seven observational studies (three prospective series), and nine case control studies. The scores used were focused on SF, QOL, fatigue, and psychological aspects. All studies reported a decreased SF and QOL. The most developed questionnaires were the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), the Female Sexual Function Index (FSFI), the Hospital Anxiety and Depression scale (HADS), and the Female Sexual Distress Scale (FSDS). Discussion: All studies reported a decreased SF and QOL. In addition to the perception of body image, several factors coexist in influencing the outcomes such as the physical, hormonal, psychological. Conclusions: Sexual dysfunction after CC treatment has a multifactorial aetiology which negatively affects the quality of life. For these reasons, it is important to follow and support patients with a multidisciplinary team (doctors, nurses, psychologists, dieticians) before and after therapy. This type of tailored therapeutic approach should become a standard. Women should be informed about possible vaginal changes and menopausal symptoms after surgery and on the positive effects of psychological therapy.

Minimally invasive versus open pelvic exenteration in gynecological malignancies: a propensity-matched survival analysis.

OBJECTIVE: The primary endpoint of this study was to compare the disease-free survival of patients undergoing open versus minimally invasive pelvic exenteration. The secondary endpoints were cancer-specific survival and peri-operative morbidity. METHODS: A multi-center, retrospective, observational cohort study was undertaken. Patients undergoing curative and palliative anterior or total pelvic exenteration for gynecological cancer by a minimally invasive approach and an open approach between June 2010 and May 2021 were included. Patients with distant metastases were excluded. A 1:2 propensity match analysis between patients undergoing minimally invasive and open pelvic exenteration was performed to equalized baseline characteristics. RESULTS: After propensity match analysis a total of 117 patients were included, 78 (66.7%) and 39 (33.3%) in the open and minimally invasive group, respectively. No significant difference in intra-operative (23.4% vs 10.3%, p=0.13) and major post-operative complications (24.4% vs 17.9%, p=0.49) was evident between the open and minimally invasive approach. Patients undergoing open pelvic exenteration received higher rates of intra-operative transfusions (41.0% vs 17.9%, p=0.013). Median disease-free survival was 17.0 months for both the open and minimally invasive groups (p=0.63). Median cancer-specific survival was 30.0 months and 26.0 months in the open and minimally invasive groups, respectively (p=0.80). Positivity of surgical margins at final histology was the only significant factor influencing the risk of recurrence (hazard ratio (HR) 2.38, 95% CI 1.31 to 4.31) (p=0.004), while tumor diameter ≥50 mm at the time of pelvic exenteration was the only significant factor influencing the risk of death (HR 1.83, 95% CI 1.08 to 3.11) (p=0.025). CONCLUSION: In this retrospective study no survival difference was evident when minimally invasive pelvic exenteration was compared with open pelvic exenteration in patients with gynecological cancer. There was no difference in peri-operative complications, but a higher intra-operative transfusion rate was seen in the open group.

Lung-protective ventilation during Trendelenburg pneumoperitoneum surgery: A randomized clinical trial.

Study objective To assess the effects of a protective ventilation strategy during Trendelenburg pneumoperitoneum surgery on postoperative oxygenation. DESIGNS: Parallel-group, randomized trial. SETTING: Operating room of a university hospital, Italy. PATIENTS: Morbidly obese patients undergoing Trendelenburg pneumoperitoneum gynaecological surgery. INTERVENTIONS: Participants were randomized to standard (SV: tidal volume = 10 ml/kg of predicted body weight, PEEP = 5 cmH2O) or protective (PV: tidal volume = 6 ml/kg of predicted body weight, PEEP = 10 cmH2O, recruitment maneuvers) ventilation during anesthesia. MEASUREMENTS: Primary outcome was PaO2/FiO2 one hour after extubation. Secondary outcomes included day-1 PaO2/FiO2, day-2 respiratory function and intraoperative respiratory/lung mechanics, assessed through esophageal manometry, end-expiratory lung volume (EELV) measurement and pressure-volume curves. MAIN RESULTS: Sixty patients were analyzed (31 in SV group, 29 in PV group). Median [IqR] tidal volume was 350 ml [300-360] in PV group and 525 [500-575] in SV group. Median PaO2/FiO2 one hour after extubation was 280 mmHg [246-364] in PV group vs. 298 [250-343] in SV group (p = 0.64). Day-1 PaO2/FiO2, day-2 forced vital capacity, FEV-1 and Tiffenau Index were not different between groups (all p > 0.10). Intraoperatively, 59% of patients showed complete airway closure during pneumoperitoneum, without difference between groups: median airway opening pressure was 17 cmH2O. In PV group, airway and transpulmonary driving pressure were lower (12 ± 5 cmH2O vs. 17 ± 7, p < 0.001; 9 ± 4 vs. 13 ± 7, p < 0.001), PaCO2 and respiratory rate were higher (48 ± 8 mmHg vs. 42 ± 12, p < 0.001; 23 ± 5 breaths/min vs. 16 ± 4, p < 0.001). Intraoperative EELV was similar between PV and SV group (1193 ± 258 ml vs. 1207 ± 368, p = 0.80); ratio of tidal volume to EELV was lower in PV group (0.45 ± 0.12 vs. 0.32 ± 0.09, p < 0.001). CONCLUSIONS: In obese patients undergoing Trendelenburg pneumoperitoneum surgery, PV did not improve postoperative oxygenation nor day-2 respiratory function. PV was associated with intraoperative respiratory mechanics indicating less injurious ventilation. The high prevalence of complete airway closure may have affected study results. TRIAL REGISTRATION: Prospectively registered on http://clinicaltrials.govNCT03157479 on May 17th, 2017.

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.

Different Surgical Approaches for Early-Stage Ovarian Cancer Staging. A Large Monocentric Experience.

Introduction: Ovarian cancer is the third most frequent gynecological cancer. In early stage ovarian cancer (ESOC) comprehensive surgical staging is recommended. Surgical staging is traditionally approached by laparotomy, although minimally invasive surgery can be a valid alternative in selected patients. This study aims to analyze the surgical and oncological outcomes of three different surgical approaches in a large series of patients. Methods: We retrospectively included all histologically proven ESOC cases treated between January 2014 and December 2017. ESOC was defined as stage IA to IIB according to the 2018 FIGO staging system. Subjects were divided into groups 1, 2, and 3, based on the surgical approach (open abdominal, laparoscopic, or robotic, respectively). Results: Within patients enrolled during the study period, 455 met the inclusion criteria. No difference in intraoperative complications was recorded in the three groups (p = 0.709). Conversely, a significant difference occurred in postoperative complications (16.2 vs. 3.8 vs. 11.1%, in groups 1, 2, and 3 respectively, p = 0.004). No difference was found in overall survival (OS) (32 vs. 31 vs. 25 months, p = 0.481) and disease-free survival (DFS) (26 vs. 29 vs. 24 months, p = 0.178) in groups 1, 2, and 3, respectively. At univariate analysis FIGO stage I (p = 0.004) showed a lower recurrence rate compared to FIGO stage II. Conclusion: No significant difference was found in OS and DFS among the three groups (open, laparoscopic, and robotic). The minimally invasive approach showed lower rate of complications than the laparotomic approach.

A Laparoscopic Adjusted Model Able to Predict the Risk of Intraoperative Capsule Rupture in Early-stage Ovarian Cancer: Laparoscopic Ovarian Cancer Spillage Score (LOChneSS Study).

STUDY OBJECTIVE: To identify preoperative/intraoperative patient and tumor characteristics associated with an increased risk of tumor spillage during minimally invasive surgery (MIS) for early-stage ovarian cancer (OC). The secondary end point was to develop a score system able to estimate the risk of tumor rupture during MIS. DESIGN: Retrospective observational study. SETTING: Patients with International Federation of Gynecology and Obstetrics stage I OC. PATIENTS: Patients aged ≥18 years old, with International Federation of Gynecology and Obstetrics stage IA to IC1 OC of any histology. INTERVENTIONS: Preoperative and intraoperative characteristics of patients treated with MIS for early-stage OC at Policlinico Universitario Agostino Gemelli, IRCCS in Rome, Italy, from January 1, 2001, to December 31, 2017, were collected. MEASUREMENTS AND MAIN RESULTS: A total of 151 patients were included. Previous pelvic surgery was more represented in patients with nonruptured tumors (46.0% vs 63.4%; p = .042). In addition, a larger tumor diameter (p <.001), a higher body mass index (p = .032), ultrasound characteristics (p = .029), and adhesions to large bowel (14% vs 2.0%; p = .003), uterus (44% vs 6.9%; p <.001), contralateral ovary (8.0% vs 0%; p = .004), ovarian fossa (64% vs 14.9%; p <.001), and pouch of Douglas peritoneum (32% vs 4.0%; p <.001) increased rupture rate. At multivariate analysis, a larger tumor diameter (p <.001) and adhesions to ovarian fossa peritoneum (p = .007) were independently associated with intraoperative cancer spillage and included in the score calculation. A disease-free survival (DFS) difference between the rupture group and the no-rupture group was detected (5-year DFS, 74.9% vs 94.4%; p = .011), with superimposable overall survival (5-year overall survival, 91.2% vs 97.9%; p = .089). CONCLUSION: Some preoperative/intraoperative characteristics increase the risk of tumor rupture during MIS for early-stage OC. A laparoscopic predictive model of capsule disruption could be considered to intraoperatively tailor surgical approach to prevent tumor spillage and avoid affecting patient's DFS.

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.

Nomogram to predict feasibility of minimally invasive interval debulking surgery in advanced ovarian cancer.

OBJECTIVE: Currently, there is no clear guidance defining the ideal candidate for minimally invasive interval debulking surgery. This study aimed to identify predictive factors for a minimally invasive approach in patients with advanced ovarian cancer who are candidates for interval debulking surgery after neoadjuvant chemotherapy. METHODS: This was a single institution retrospective study conducted between January 2014 and June 2020 Perioperative variables were used to predict the likelihood of minimally invasive interval debulking surgery using multivariable models. A nomogram was developed, and internal validation was performed using the bootstrapping correction technique. This nomogram was built to visualize the effect of perioperative variables on the estimated probability of minimally invasive interval debulking surgery in patients with a clinical response after neoadjuvant chemotherapy. We used the four significant perioperative variables according to logistic regression. RESULTS: A total of 108 (28.4%) and 272 (71.6%) patients underwent interval debulking surgery by a minimally invasive or open approach, respectively. Absence of omental cake (odds ratio (OR) 9.15, 95% confidence interval (CI) 4.26 to 19.64, p<0.001), high volume surgeon (OR 5.43, 95% CI 2.75 to 10.71, p<0.001), less than two peritoneal sites involved (OR 2.94, 95% CI 1.34 to 6.43, p=0.007), and CA125 normalization (OR 1.79, 95% CI 1.05 to 3.36, p=0.049) correlated with the feasibility of minimally invasive interval debulking surgery at multivariate analysis. The calibration plot demonstrated good agreement between the predicted and actual probability of minimally invasive interval debulking surgery (p=0.93, Hosmer-Lemeshow test). CONCLUSIONS: Our nomogram may serve as a useful tool to choose the surgical approach in patients with advanced ovarian cancer undergoing interval debulking surgery.

Indocyanine Green to Assess Vascularity of Ileal Conduit Anastomosis During Pelvic Exenteration for Recurrent/Persistent Gynecological Cancer: A Pilot Study.

INTRODUCTION: Pelvic exenteration performed for recurrent/persistent gynecological malignancies has been associated with urological short- and long-term morbidity due to altered vascularization of tissues for previous radiotherapy. The aims of the present study were to describe the use of intravenous indocyanine green (ICG) to assess vascularity of urinary diversion (UD) after pelvic exenteration for gynecologic cancers, to evaluate the feasibility and safety of this technique, and to assess the postoperative complications. METHODS: Prospective, observational, single-center, pilot study including consecutive patients undergoing anterior or total pelvic exenteration due to persistent/recurrent gynecologic cancers between August 2020 and March 2021 at Fondazione Policlinico Gemelli IRCCS, Rome, Italy. All patients underwent intravenous injection of 3-6 ml of ICG (1.25 mg/ml) once the UD was completed. A near-infrared camera was used to evaluate ICG perfusion of anastomoses (ileum-ileum, right and left ureter with small bowel, and colostomy or colorectal sides of anastomosis) a few seconds after ICG injection. RESULTS: Fifteen patients were included in the study. No patient reported adverse reactions to ICG injection. Only 3/15 patients (20.0%) had an optimal ICG perfusion in all anastomoses. The remaining 12 (80.0%) patients had at least one ICG deficit; the most common ICG deficit was on the left ureter: 3 (20.0%) vs. 1 (6.7%) patient had no ICG perfusion on the left vs. right ureter, respectively (p = 0.598). 8/15 (53.3%) and 6/15 (40.0%) patients experienced grade ≥3 30-day early and late postoperative complications, respectively. Of these, two patients had early and one had late postoperative complications directly related to poor perfusion of anastomosis (UD leak, ileum-ileum leak, and benign ureteric stricture); all these cases had a suboptimal intraoperative ICG perfusion. CONCLUSION: The use of ICG to intraoperatively assess the anastomosis perfusion at time of pelvic exenteration for gynecologic malignancy is a feasible and safe technique. The different vascularization of anastomotic stumps may be related to anatomical sites and to previous radiation treatment. This approach could be in support of selecting patients at higher risk of complications who may need personalized follow-up.

Near-Infrared Imaging With Indocyanine Green for the Treatment of Endometriosis: Results From the Gre-Endo Trial.

INTRODUCTION: A current challenge for endometriosis surgery is to correctly identify the localizations of disease, especially when small or hidden (occult endometriosis), and to exactly define their real extension. The use of near-infrared radiation imaging (NIR) after injection of indocyanine green (ICG) represents one of the most encouraging method. The aim of this study is to assess the diagnostic value of NIR-ICG imaging in the surgical treatment of endometriosis compared with the standard of treatment. MATERIAL AND METHODS: The Gre-Endo trial is a prospective, single-arm study (NCT03332004). After exploring the operatory field using the white light (WL) mode, patients were injected with ICG and then observed in NIR mode. All suspected areas were classified and chronicled according to lesions visualized only in WL, NIR-ICG, or in the combination of both. Lesion not visualized in WL was considered as suspect occult lesion (s-OcL). In addition, a random control biopsy from an apparent negative peritoneum visualized in WL and NIR-ICG imaging was taken for all patients (control cases). All lesions removed were considered "suspect endometriosis" until pathology. RESULTS: Fifty-one patients were enrolled between January 2016 and October 2019. A total of 240 suspected lesions have been identified with both methods (WL + NIR-ICG). Two hundred and seven (86.2%) lesions out of the overall 240 were visualized with WL imaging, and 200 were confirmed to be pathologic (true positive for WL). The remaining 33/240 (13.75%) (false negative for WL) lesions were identified only with NIR-ICG imaging and collected as s-OcL. All 33 s-OcLs removed were confirmed to be pathologic (c-OcL = 100%). NIR-ICG vision showed PPV of 98.5%, NPV of 87.1%, Se of 87%, and Sp of 98.5%, confirming that this kind of imaging is an excellent diagnostic and screening test (p = 0.001 and p = 0.835, according to McNemar's and Cohen's kappa tests, respectively). CONCLUSIONS: The use of NIR-ICG vision alone and combined with WL showed good results in intraoperative detection rate and fluorescence-guided surgery of endometriosis. Furthermore, NIR-ICG allowed surgeons to remove occult lesions that otherwise would remain, leading to possible greater postoperative pain and a higher risk of persistence and relapse.

Surgical Treatment of "Large Uterine Masses" in Pregnancy: A Single-Center Experience.

Uterine myomas or uterine fibroids are the most common benign uterine masses affecting women. The management of large myoma during pregnancy is challenging, and surgical treatment is a possible option. We report nine cases of pregnant women affected by uterine masses larger than 10 cm, who underwent surgical treatment during the second trimester of pregnancy. In all cases, the masses were preconceptionally unknown and diagnosed during the first trimester. In eight cases, no maternal and fetal complications arose during or after surgical treatment and delivery occurred at full term of pregnancy. In one case, spontaneous abortion was recorded. In all cases, histologic diagnosis demonstrated the benign nature. Women affected by large uterine masses diagnosed for the first time in pregnancy could be taken into consideration for surgical treatment in a referral center during the second trimester.

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.

A Multicentric Randomized Trial to Evaluate the ROle of Uterine MANipulator on Laparoscopic/Robotic HYsterectomy for the Treatment of Early-Stage Endometrial Cancer: The ROMANHY Trial.

OBJECTIVE: This prospective randomized trial aimed to assess the impact of the uterine manipulator in terms of lymph vascular space invasion (LVSI) in patients undergoing minimally invasive staging for early-stage endometrial cancer. METHODS: In this multicentric randomized trial, enrolled patients were randomly allocated in two groups according to the no use (arm A) or the use (arm B) of the uterine manipulator. Inclusion criteria were G1-G2 early-stage endometrial cancer at preoperative evaluation. The variables collected included baseline demographic characteristics, perioperative data, final pathology report, adjuvant treatment, and follow-up. RESULTS: In the study, 154 patients (76 in arm A and 78 in arm B) were finally included. No significant differences were recorded regarding the baseline characteristics. A statistically significant difference was found in operative time for the laparoscopic staging (p=0.005), while no differences were reported for the robotic procedures (p=0.419). The estimated blood loss was significantly lower in arm A (p=0.030). No statistically significant differences were recorded between the two study groups in terms of peritoneal cytology, LVSI (p=0.501), and pattern of LVSI (p=0.790). No differences were detected in terms of overall survival and disease-free survival (p=0.996 and p=0.480, respectively). Similarly, no differences were recorded in the number of recurrences, 6 (7.9%) in arm A and 4 (5.2%) in arm B (p=0.486). The use of the uterine manipulator had no impact on DFS both at univariable and multivariable analyses. CONCLUSIONS: The intrauterine manipulator does not affect the LVSI in early-stage endometrial cancer patients undergoing laparoscopic/robotic staging. CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov, identifier (NCT: 02762214).

Subcutaneous Vulvar Flap Viability Evaluation With Near-Infrared Probe and Indocyanine Green for Vulvar Cancer Reconstructive Surgery: A Feasible Technique.

Introduction: Vulvar cancer is a rare condition affecting older women and accounts for 3-5% of all gynecological cancers. Primary surgical treatment involves the removal of a large amount of tissue for which reconstructive surgery is often necessary with a high rate of postoperative complications. Despite several techniques for the evaluation of vulvar flap viability have been proposed, many methods cannot be performed during surgery and require expensive devices often missing in a gynecological clinic. This study aims to verify the feasibility and the safety of the vulvar flap viability evaluation through a near-infrared endoscopic probe and Indocyanine green (ICG) tracer in a small group of patients and to evaluate long-term vulvar flap outcomes. Methods: Patients with primary vulvar cancer who required surgical treatment and subsequent vulvar flap reconstructive surgery were prospectively included in the study. A 25 mg ICG vial diluted in 20 ml of saline solution was intravenously infused before closing the skin edges of the flaps. All patients were given 0.2 mg/kg body weight of intravenous ICG. After 10-15 min, a near-infrared endoscopic probe was used to evaluate the vulvar flap viability. Results: Of the 18 patients who underwent radical vulvectomy for vulvar cancer during the study period, 15 were included in the analysis. All packaged surgical flaps showed tracer uptake on the surgical margin. No intro-operative complications were recorded neither surgery-related nor to dye infusion. No surgical infection, dehiscence, or necrosis was recorded. Conclusions: Vulvar flap viability assessment using Indocyanine green and a laparoscopic infrared probe is a feasible method. All cases included in the analysis showed a dye uptake on the surgical edge of the flap. Further, prospective studies are needed to confirm the method in clinical practice and to evaluate its superiority over simple subjective clinical evaluation.