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Hereditary breast and ovarian cancer syndrome is an autosomal dominant cancer susceptibility syndrome mainly due to variants in BRCA1 or BRCA2 genes. Patients presenting with BRCA1 or BRCA2 gene mutations have a lifetime risk of developing breast or ovarian cancer (80% and 40%, respectively). Genetic testing to explore the predisposition to develop cancer represents a pivotal factor in such cases, and this review wants to explore the main implications in terms of medicolegal liability and insurance issues. Medicolegal issues related to these diagnostic processes include: (a) failure to recommend the test; (b) failure to properly interpret the test; (c) failure to correctly translate results into clinical practice; (d) lack of informed consent; and (e) failure to refer patients to specialized genetic counseling. Such errors may lead to compensation since the legal burden inherent in the efficacy of prophylactic interventions is a proof that requires the so-called 'preponderance of the evidence'. Concerning insurance issues, the carriers of such alleles without cancer are healthy because the genetic predisposition is not a disease per se but represents a (relevant) health risk. However, disclosure of these conditions can be impelled by insurers. It can lead to so-called 'genetic discrimination' because insurance companies might use genetic information to limit insurance options or increase their costs. Many private and public healthcare funders do not cover risk reducing surgeries, even when recommended as part of a risk reduction management plan for BRCA gene mutation carriers. Here, positions on these matters from different high income countries are discussed, stressing the importance of a common supranational or international regulatory framework to reach a trade-off between the economic interests of insurers and the rights of carriers not to disclose extremely sensitive information.
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Pruebas Genéticas , Humanos , Pruebas Genéticas/legislación & jurisprudencia , Pruebas Genéticas/economía , Femenino , Países Desarrollados , Predisposición Genética a la Enfermedad , Genes BRCA2 , Genes BRCA1 , Neoplasias de la Mama/genética , Neoplasias de la Mama/diagnóstico , Neoplasias Ováricas/genética , Neoplasias Ováricas/diagnóstico , Proteína BRCA2/genética , Asesoramiento Genético/legislación & jurisprudencia , Proteína BRCA1/genética , Seguro de Salud/legislación & jurisprudenciaRESUMEN
OBJECTIVE: Retrospective series have shown secondary cytoreductive surgery improves oncological outcomes in recurrent low-grade serous ovarian cancer. We aim to compare surgical procedures and complications between patients with low-grade and high-grade recurrent serous ovarian cancer. METHODS: This retrospective single-institution study includes patients with recurrent low-grade and high-grade serous ovarian cancer undergoing surgery between January 2012 to December 2021. Patients were propensity matched 1:3 for residual tumor at first surgery, presence of ascites and performance status. Complexity of surgery and postoperative complications were analyzed. RESULTS: A total of 116 patients undergoing secondary cytoreductive surgery were included with 29 patients (25%) having low-grade ovarian cancer. The median age of the patients was 54 years (range: 19-85) and 57 years (range: 29-78) in low-grade and high-grade ovarian cancer, respectively (p=0.13). Stages III/IV at diagnosis were more frequent in patients with high-grade ovarian cancers (p<0.001). Peritoneal involvement was higher in low-grade compared with high-grade ovarian cancer as shown by the higher rate of diaphragmatic (41.4% vs 21.8%, p=0.05), abdominal wall (41.4% vs 18.4%, p=0.02) and pelvic (51.7% vs 21.8%, p=0.01) peritonectomy. Multiple bowel resections were higher in low-grade ovarian cancer (24.1% vs 8.0%, p=0.04), while high-grade ovarian cancer had a higher rate of nodal recurrences (73.2%% vs 37.9%, p=0.03). Overall, surgical complexity was higher in low-grade ovarian cancer (58.6% vs 36.8%; p=0.05), with higher median estimated blood loss (400 vs 200 mL; p=0.01) compared with high-grade. Complete cytoreduction was achieved in 26 patients (89.7%) with low-grade and 84 (96.6%) with high-grade (p=0.16) ovarian cancer, with no significant differences in postoperative complications. CONCLUSIONS: Secondary cytoreductive surgery in low-grade serous ovarian cancer patients was associated with higher complexity, multiple bowel resections, and higher median estimated blood loss than in high-grade serous ovarian cancer. The comparable rate of postoperative complications suggests that secondary cytoreductive surgery in this group of patients is feasible in expert centers.
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Cistadenocarcinoma Seroso , Procedimientos Quirúrgicos de Citorreducción , Neoplasias Ováricas , Humanos , Femenino , Persona de Mediana Edad , Procedimientos Quirúrgicos de Citorreducción/métodos , Neoplasias Ováricas/cirugía , Neoplasias Ováricas/patología , Estudios Retrospectivos , Adulto , Anciano , Cistadenocarcinoma Seroso/cirugía , Cistadenocarcinoma Seroso/patología , Anciano de 80 o más Años , Recurrencia Local de Neoplasia/cirugía , Recurrencia Local de Neoplasia/patología , Clasificación del Tumor , Adulto Joven , Complicaciones Posoperatorias/epidemiologíaRESUMEN
INTRODUCTION: Vaginal approaches have become routine in the field of gynecologic surgery, whereas in general surgery vaginal wall transection is an infrequent practice typically reserved for extensive tumor resections. Approximately two decades ago, natural orifice transluminal endoscopic surgery (NOTES) revolutionized conventional boundaries by accessing the peritoneal cavity transorally, transrectally, or transvaginally, enabling general surgery without visible scars. Although transvaginal approaches have been successfully used for various abdominal procedures by general surgeons, a gap remains in comprehensive training to fully exploit the potential of this route. MATERIAL AND METHODS: PubMed, Google Scholar, and Scopus databases were searched to retrieve relevant articles illustrating how general surgeons can adeptly manage vaginal approaches. RESULTS: The article presents a practical framework for general surgeons to execute a complete vaginal approach, addressing the management of vaginal specimen extraction and vaginal cuff closure, even in the absence of an experienced gynecologist. CONCLUSION: The evolution of abdominal surgery is moving towards less invasive techniques, emphasizing the importance of understanding the nuances and challenges associated with the vaginal route. This approach is linked to minimal oncological, sexual, and infective complications, and to the absence of pregnancy-related complications. Such knowledge becomes increasingly crucial, particularly with the renewed demand for transvaginal access in robot-assisted NOTES procedures.
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OBJECTIVE: To evaluate a relation between BRCA1/2 status and the Chemotherapy Response Score in patients with epithelial ovarian cancer undergoing neoadjuvant chemotherapy and interval debulking surgery. METHODS: Data were retrospectively collected on patients with unresectable disease undergoing three or four cycles of neoadjuvant chemotherapy and interval debulking surgery at the Gynecologic Oncology Unit of the Catholic University of the Sacred Heart from January 2016 to December 2020. All patients were assessed for BRCA1/2 somatic mutation at diagnosis. The omental specimens obtained at the interval surgery were evaluated according to Bohm's Chemotherapy Response Score System. RESULTS: A total of 172 patients were included in the analysis, 69 (40%) patients were BRCA1/2 mutation carriers and 103 (60%) patients were wild type. In the wild-type group (BRCAwt), 73 (70.9%) patients had a Chemotherapy Response Score of 1 or 2 and 30 (29.1%) patients had a score of 3. In the BRCA1/2 carriers group (BRCAmut), 39 (56.5%) patients had a score of 1 or 2 and 30 (43.5%) patients had a score of 3. Among the BRCAwt group, those with a Chemotherapy Response Score of 3 had a prolonged median progression-free survival (22 vs 15 months, p=0.003). Among the BRCAmut carriers group, no differences were found (30 vs 27 months, p=0.55). No difference in overall survival was observed in either the BRCAmut carriers population (p=0.23) or the BRCAwt population (60 vs 44 months, p=0.06). CONCLUSIONS: Patients with BRCA1/2mut seem to achieve a score of 1, 2 or 3 with the same frequency. In contrast, patients with BRCAwt seem to have a score of 1 or 2 more frequently than a score of 3. In patients with BRCA1/2mut, this score may not be an indicator of chemosensitivity.
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Neoplasias Ováricas , Carcinoma Epitelial de Ovario/tratamiento farmacológico , Carcinoma Epitelial de Ovario/genética , Procedimientos Quirúrgicos de Citorreducción , Femenino , Humanos , Terapia Neoadyuvante , Neoplasias Ováricas/tratamiento farmacológico , Neoplasias Ováricas/genética , Estudios RetrospectivosRESUMEN
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.
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Procedimientos Quirúrgicos Ginecológicos , Procedimientos Quirúrgicos Robotizados , Humanos , Femenino , Procedimientos Quirúrgicos Robotizados/métodos , Procedimientos Quirúrgicos Robotizados/instrumentación , Persona de Mediana Edad , Procedimientos Quirúrgicos Ginecológicos/métodos , Procedimientos Quirúrgicos Ginecológicos/instrumentación , Adulto , Anciano , Estudios Prospectivos , Tempo Operativo , Laparoscopía/métodos , Laparoscopía/instrumentación , Estudios de Factibilidad , Prolapso de Órgano Pélvico/cirugía , Italia , Complicaciones Intraoperatorias/epidemiología , Anciano de 80 o más AñosRESUMEN
INTRODUCTION: Microvascular invasion (MVI) is the main risk factor for overall mortality and recurrence after surgery for hepatocellular carcinoma (HCC).The aim was to train machine-learning models to predict MVI on preoperative CT scan. METHODS: 3-phases CT scans were retrospectively collected among 4 Italian centers. DICOM files were manually segmented to detect the liver and the tumor(s). Radiomics features were extracted from the tumoral, peritumoral and healthy liver areas in each phase. Principal component analysis (PCA) was performed to reduce the dimensions of the dataset. Data were divided between training (70%) and test (30%) sets. Random-Forest (RF), fully connected MLP Artificial neural network (neuralnet) and extreme gradient boosting (XGB) models were fitted to predict MVI. Prediction accuracy was estimated in the test set. RESULTS: Between 2008 and 2022, 218 preoperative CT scans were collected. At the histological specimen, 72(33.02%) patients had MVI. First and second order radiomics features were extracted, obtaining 672 variables. PCA selected 58 dimensions explaining >95% of the variance.In the test set, the XGB model obtained Accuracy = 68.7% (Sens: 38.1%, Spec: 83.7%, PPV: 53.3% and NPV: 73.4%). The neuralnet showed an Accuracy = 50% (Sens: 52.3%, Spec: 48.8%, PPV: 33.3%, NPV: 67.7%). RF was the best performer (Acc = 96.8%, 95%CI: 0.91-0.99, Sens: 95.2%, Spec: 97.6%, PPV: 95.2% and NPV: 97.6%). CONCLUSION: Our model allowed a high prediction accuracy of the presence of MVI at the time of HCC diagnosis. This could lead to change the treatment allocation, the surgical extension and the follow-up strategy for those patients.
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INTRODUCTION: Although the management of gynecological cancers recurrences may be challenging, due to the heterogeneity of recurrent disease, the aim of this work is to present a descriptive analysis of gynecological malignancies recurrences in our institution treated by robotic approach. MATERIALS AND METHODS: We performed a retrospective review and analysis of data of patients who underwent robotic surgery for recurrent gynecological malignancies at Catholic University of the Sacred Hearth, Rome, from January 2013 to January 2024. RESULTS: A total of 54 patients underwent successful robotic cytoreductive surgery. The median age was 63 years; the median BMI was 33 kg/m2 and most of the patients (59 %) were obese. In 12 cases (22 %) the relapse presented was the second or third relapse. The most frequent patterns of recurrence were represented by lymph nodes (41 %), followed by peritoneal (26 %), pelvic (22 %) and parenchymal (11 %). In all patients complete cytoreduction was achieved. In 29 patients (54 %) the surgical field was previous treated. The median operative time and estimated blood loss were, respectively, 270 min and 100 ml. There were 2 intraoperative complications, managed endoscopically; 10 early postoperative complications, and 3 late postoperative complications. The 2-year progression-free-survival and overall survival were, respectively, 39.8 % and 72.3 %. CONCLUSION: Robotic approach in the treatment of recurrent gynecological cancers should be considered in selected patients with oligometastatic disease, in high-volume centers with expert surgeons, particularly in obese patients.
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Ovarian cancer (OC) represents one of the most lethal cancers in women. The aim of surgical treatment is complete cytoreduction in advanced stages and a surgical staging in early stages. Although the guidelines still suggest laparotomy as the standard approach, in recent years minimally invasive surgery (MIS) has become increasingly popular in the treatment of OC, especially in early stages, because the 5-year relative survival exceeds 90% and the patients' quality of life cannot be overshadowed. However, MIS has been demonstrated to have a role even in advanced stages, in the prediction of optimal cytoreduction, identification patients who may benefit from neoadjuvant chemotherapy, and, more recently, in the interval debulking surgery, as in selected cases of secondary cytoreduction for recurrent ovarian cancer. The aim of this review is to describe the MIS (especially robotic surgery), with its advantages and pitfalls, in the treatment of OC.
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Neoplasias Ováricas , Procedimientos Quirúrgicos Robotizados , Humanos , Femenino , Calidad de Vida , Recurrencia Local de Neoplasia/cirugía , Recurrencia Local de Neoplasia/tratamiento farmacológico , Neoplasias Ováricas/patología , Carcinoma Epitelial de Ovario/cirugía , Terapia Neoadyuvante , Quimioterapia Adyuvante , Procedimientos Quirúrgicos de Citorreducción , Estadificación de NeoplasiasRESUMEN
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.
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Laparoscopía , Procedimientos Quirúrgicos Robotizados , Robótica , Humanos , Femenino , Procedimientos Quirúrgicos Robotizados/métodos , Curva de Aprendizaje , Procedimientos Quirúrgicos Ginecológicos/métodos , Laparoscopía/métodos , Tempo OperativoRESUMEN
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.