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BACKGROUND: The use of cerebral oximetry monitoring in the care of extremely preterm infants is increasing. However, evidence that its use improves clinical outcomes is lacking. METHODS: In this randomized, phase 3 trial conducted at 70 sites in 17 countries, we assigned extremely preterm infants (gestational age, <28 weeks), within 6 hours after birth, to receive treatment guided by cerebral oximetry monitoring for the first 72 hours after birth or to receive usual care. The primary outcome was a composite of death or severe brain injury on cerebral ultrasonography at 36 weeks' postmenstrual age. Serious adverse events that were assessed were death, severe brain injury, bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, and late-onset sepsis. RESULTS: A total of 1601 infants underwent randomization and 1579 (98.6%) were evaluated for the primary outcome. At 36 weeks' postmenstrual age, death or severe brain injury had occurred in 272 of 772 infants (35.2%) in the cerebral oximetry group, as compared with 274 of 807 infants (34.0%) in the usual-care group (relative risk with cerebral oximetry, 1.03; 95% confidence interval, 0.90 to 1.18; P = 0.64). The incidence of serious adverse events did not differ between the two groups. CONCLUSIONS: In extremely preterm infants, treatment guided by cerebral oximetry monitoring for the first 72 hours after birth was not associated with a lower incidence of death or severe brain injury at 36 weeks' postmenstrual age than usual care. (Funded by the Elsass Foundation and others; SafeBoosC-III ClinicalTrials.gov number, NCT03770741.).
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Recien Nacido Extremadamente Prematuro , Enfermedades del Prematuro , Oximetría , Humanos , Lactante , Recién Nacido , Lesiones Encefálicas/diagnóstico por imagen , Lesiones Encefálicas/etiología , Displasia Broncopulmonar/etiología , Circulación Cerebrovascular , Enfermedades del Prematuro/diagnóstico , Enfermedades del Prematuro/mortalidad , Enfermedades del Prematuro/terapia , Oximetría/métodos , Cerebro , Ultrasonografía , Retinopatía de la Prematuridad/etiología , Enterocolitis Necrotizante/etiología , Sepsis Neonatal/etiologíaRESUMEN
OBJECTIVE: Develop a pioneer surgical anonymization algorithm for reliable and accurate real-time removal of out-of-body images validated across various robotic platforms. BACKGROUND: The use of surgical video data has become a common practice in enhancing research and training. Video sharing requires complete anonymization, which, in the case of endoscopic surgery, entails the removal of all nonsurgical video frames where the endoscope can record the patient or operating room staff. To date, no openly available algorithmic solution for surgical anonymization offers reliable real-time anonymization for video streaming, which is also robotic-platform and procedure-independent. METHODS: A data set of 63 surgical videos of 6 procedures performed on four robotic systems was annotated for out-of-body sequences. The resulting 496.828 images were used to develop a deep learning algorithm that automatically detected out-of-body frames. Our solution was subsequently benchmarked against existing anonymization methods. In addition, we offer a postprocessing step to enhance the performance and test a low-cost setup for real-time anonymization during live surgery streaming. RESULTS: Framewise anonymization yielded a receiver operating characteristic area under the curve score of 99.46% on unseen procedures, increasing to 99.89% after postprocessing. Our Robotic Anonymization Network outperforms previous state-of-the-art algorithms, even on unseen procedural types, despite the fact that alternative solutions are explicitly trained using these procedures. CONCLUSIONS: Our deep learning model, Robotic Anonymization Network, offers reliable, accurate, and safe real-time anonymization during complex and lengthy surgical procedures regardless of the robotic platform. The model can be used in real time for surgical live streaming and is openly available.
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Algoritmos , Procedimientos Quirúrgicos Robotizados , Humanos , Anonimización de la Información , Grabación en Video , Aprendizaje ProfundoRESUMEN
OBJECTIVE: A multi-national high-volume center study was undertaken to evaluate outcomes after primary surgery (PS) or neoadjuvant treatment followed by surgery (NAT/S) in cT2 staged adenocarcinomas of the esophagus (EAC) and gastroesophageal junction (GEJ). BACKGROUND: Optimal treatment approach with either NAT/S or PS for clinically staged cT2cNany or cT2N0 EAC and GEJ remains unknown due to the lack of randomized controlled trials. METHODS: Retrospective analysis of prospectively maintained databases from ten centers was performed. Between 01/2012-08/2023 645 patients who fulfilled inclusion criteria of GEJ Siewert type I, II or EAC with cT2 status at diagnosis underwent PS or NAT/S with curative intent. Primary endpoint was overall survival (OS). RESULTS: In the cT2cNany cohort 192 patients (29.8%) underwent PS and 453 (70.2%) underwent NAT/S. In all cT2cN0 patients (n=333), NAT/s remained the more frequent treatment (56.2%). Patients undergoing PS were in both cT2 cohorts older (P<0.001) and had a higher ASA classification (P<0.05). R0 resection showed no differences between NAT/S and PS in both cT2 cohorts (P>0.4).Median OS was 51.0 months in the PS group (95% CI 31.6-70.4) versus 114.0 months (95% CI 53.9-174.1) in the NAT/S group (P=0.003) of cT2cNany patients. For cT2cN0 patients NAT/S was associated with longer OS (P=0.002) and disease-free survival (DFS) (P=0.001). After propensity score matching of cT2N0 patients, survival benefit for NAT/S remained (P=0.004). Histopathology showed that 38.1% of cT2cNany and 34.2% of cT2cN0 patients were understaged. CONCLUSIONS: Due to unreliable identification of cT2N0 disease, all patients should be offered a multimodal therapeutic approach.
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OBJECTIVE: To define percentile charts for arterial oxygen saturation (SpO2), heart rate (HR), and cerebral oxygen saturation (crSO2) during the first 15 minutes after birth in neonates born very or extremely preterm and with favorable outcome. STUDY DESIGN: We conducted a secondary-outcome analysis of neonates born preterm included in the Cerebral regional tissue Oxygen Saturation to Guide Oxygen Delivery in preterm neonates during immediate transition after birth III (COSGOD III) trial with visible cerebral oximetry measurements and with favorable outcome, defined as survival without cerebral injuries until term age. We excluded infants with inflammatory morbidities within the first week after birth. SpO2 was obtained by pulse oximetry, and electrocardiogram or pulse oximetry were used for measurement of HR. crSO2 was assessed with near-infrared spectroscopy. Measurements were performed during the first 15 minutes after birth. Percentile charts (10th to 90th centile) were defined for each minute. RESULTS: A total of 207 neonates born preterm with a gestational age of 29.7 (23.9-31.9) weeks and a birth weight of 1200 (378-2320) g were eligible for analyses. The 10th percentile of SpO2 at minute 2, 5, 10, and 15 was 32%, 52%, 83%, and 85%, respectively. The 10th percentile of HR at minute 2, 5, 10, and 15 was 70, 109, 126, and 134 beats/min, respectively. The 10th percentile of crSO2 at minute 2, 5, 20, and 15 was 15%, 27%, 59%, and 63%, respectively. CONCLUSIONS: This study provides new centile charts for SpO2, HR, and crSO2 for neonates born extremely or very preterm with favorable outcome. Implementing these centiles in guiding interventions during the stabilization process after birth might help to more accurately target oxygenation during postnatal transition period.
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BACKGROUND: Robot-assisted procedures are increasingly common, and several systems are available for thoraco-abdominal surgery. Specific structured training is necessary, while access to these systems is still limited. This study aimed to assess surgeons' skill progress during consecutive training days of a curriculum with exposure to different robotic systems. METHODS: This prospective observational study enrolled 47 surgeons with anonymized analysis of SimNow™ simulator performance scores and dedicated questionnaires after written consent. The primary outcome was the overall score, based on economy of motion, time to complete the exercise, and penalty for errors. Course participants in 2022-2023 had chosen 2 full hands-on days on Da Vinci® consoles with either virtual reality (VR) simulation training using the SimNow (n = 21, 44.7%) or digestive surgery procedures with a live animal model (n = 26, 55.3%). In all participants, training on Da Vinci® systems included console functions and principles of docking, camera, and instrument use for console and procedural training. They additionally had access to introductory dry-lab and VR simulator exercises on the Versius, HugoTMRAS, and Dexter systems and to VR exercises on the ROBOTiS simulator. RESULTS: The participants (16F/31M, median age 40 years, range 29-58) from various surgical specialties (general/visceral/vascular) had no (n = 35, 74.5%) or little (n = 12, 25.5%) robotic experience including bedside assistance only and 20 (42.6%) had robotic simulator experience. The demographic variables fully completed by 44/47 participants (93.6%) and choice of module had no significant impact on the primary outcome. The considerable performance improvement from days 1 to 2 was exemplified by a significantly increased economy of motion and decreased amount of excessive force. CONCLUSION: Robotic surgical training is increasingly complex with several systems on the market. Within a dedicated robotic surgery curriculum and based on integrated performance metrics, a significant improvement of skill levels was observed in a relatively short period of time.
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BACKGROUND: The ergonomic advantages and potential challenges that robotic surgery poses to the well-being of surgeons are mainly unexplored. The most recent surgical robot introduced on the European market is the Hugo™ RAS System by Medtronic. This study aims to evaluate the ergonomic benefits of the Hugo™ RAS System, which is available in our training laboratory, CeMIT (Center for Medical Innovation and Technology Cologne). METHODS AND PROCEDURES: Using the previously established Cologne Ergonomic Measurement Setup for Robotic Surgery (CEMRobSurg), we measured three parameters related to ergonomic posture from subjects with different levels of surgical expertise (laypeople, medical students, surgical residents, and expert robotic surgeons). The heart rate was measured continuously using a polar band. The noise level was measured while using the Hugo™ RAS System, and automated photographs using our locally developed methodology were captured of the participant every 2 s to assess body posture. The ergonomic measurements were conducted while the subject performed the same standardized robotic training exercises (Peg Board, Rope Walk, and Ring Walk). RESULTS: A total of 53 participants were enrolled in this study. The average noise level during all measurements was 54.87 dB. The highest stress level was measured in surgical residents with a sympathetic nervous system index (SNS index) of 1.15 (min - 1.43, max 3.56). The lowest stress level was measured in robotic experts with an SNS index of 0.23 (min - 0.18, max 0.91). We observed a risk-prone positioning of the neck and elbow in medical students (mean 39.6° and 129.48°, respectively). Robotic experts showed a risk positioning in the knee and hip region (mean 107.89° and 90.31°, respectively). CONCLUSION: This is the first study to analyze and objectify the ergonomic posture of medical students, surgical trainees, surgeons, and laypeople using the open console, modular Hugo™ RAS System. Our findings offer recommendations for operating surgeons and allow for a comparative analysis between the different robotic systems. Further evaluations in real-time operative scenarios will follow.
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BACKGROUND: Minimally invasive total gastrectomy (MITG) is a mainstay for curative treatment of patients with gastric cancer. To define and standardize optimal surgical techniques and further improve clinical outcomes through the enhanced MITG surgical quality, there must be consensus on the key technical steps of lymphadenectomy and anastomosis creation, which is currently lacking. This study aimed to determine an expert consensus from an international panel regarding the technical aspects of the performance of MITG for oncological indications using the Delphi method. METHODS: A 100-point scoping survey was created based on the deconstruction of MITG into its key technical steps through local and international expert opinion and literature evidence. An international expert panel comprising upper gastrointestinal and general surgeons participated in multiple rounds of a Delphi consensus. The panelists voted on the issues concerning importance, difficulty, or agreement using an online questionnaire. A priori consensus standard was set at > 80% for agreement to a statement. Internal consistency and reliability were evaluated using Cronbach's α. RESULTS: Thirty expert upper gastrointestinal and general surgeons participated in three online Delphi rounds, generating a final consensus of 41 statements regarding MITG for gastric cancer. The consensus was gained from 22, 12, and 7 questions from Delphi rounds 1, 2, and 3, which were rephrased into the 41 statetments respectively. For lymphadenectomy and aspects of anastomosis creation, Cronbach's α for round 1 was 0.896 and 0.886, and for round 2 was 0.848 and 0.779, regarding difficulty or importance. CONCLUSIONS: The Delphi consensus defined 41 steps as crucial for performing a high-quality MITG for oncological indications based on the standards of an international panel. The results of this consensus provide a platform for creating and validating surgical quality assessment tools designed to improve clinical outcomes and standardize surgical quality in MITG.
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Neoplasias Gástricas , Humanos , Técnica Delphi , Consenso , Neoplasias Gástricas/cirugía , Reproducibilidad de los Resultados , Escisión del Ganglio Linfático , Anastomosis Quirúrgica , GastrectomíaRESUMEN
PURPOSE: Patients with local recurrence of esophageal cancer have a highly decreased overall survival. There is currently no standardized treatment algorithm for this group. This retrospective cohort study aimed to evaluate the survival of patients with local recurrence, despite receiving individualized treatment options. METHODS: 241 of 1791 patients were diagnosed with a local recurrence following Ivor-Lewis esophagectomy at the University Hospital of Cologne. 59 patients, who were diagnosed only with a local recurrence of adeno- or squamous cell carcinoma and received their individualized therapy regimes at our high-volume center, were included. RESULTS: The study included 52 patients with adenocarcinoma and 7 with squamous cell carcinoma. Among these, 6 patients underwent resection, 19 received solely chemotherapy, 29 received chemoradiotherapy, and 5 were provided with best supportive care. Patients who underwent resection showed a better survival outcome compared to patients without resection (median OS: not reached vs. 15.1 months, p = 0.012). Best supportive care and palliative care were found to be independent risk factors for shorter overall survival compared to curative intended treatment options like local resection or chemoradiotherapy. CONCLUSION: In this study, different treatment strategies for patients with local recurrence of esophageal cancer were depicted. Resection as well as chemoradiotherapy could play a role in selected patients. Further prospective studies are needed to improve the selection of eligible patients.
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Carcinoma de Células Escamosas , Neoplasias Esofágicas , Esofagectomía , Hospitales de Alto Volumen , Recurrencia Local de Neoplasia , Humanos , Neoplasias Esofágicas/terapia , Neoplasias Esofágicas/mortalidad , Neoplasias Esofágicas/patología , Neoplasias Esofágicas/cirugía , Esofagectomía/métodos , Masculino , Femenino , Estudios Retrospectivos , Persona de Mediana Edad , Anciano , Hospitales de Alto Volumen/estadística & datos numéricos , Carcinoma de Células Escamosas/cirugía , Carcinoma de Células Escamosas/terapia , Carcinoma de Células Escamosas/mortalidad , Carcinoma de Células Escamosas/patología , Adenocarcinoma/terapia , Adenocarcinoma/cirugía , Adenocarcinoma/mortalidad , Adenocarcinoma/patología , Quimioradioterapia/métodos , Resultado del Tratamiento , AdultoRESUMEN
AIM: The aim of this study was to evaluate the clinical relevance, diagnostic procedures and treatment strategies for metabolic bone disease in preterm infants across Europe. METHODS: An e-survey was distributed by email to 545 neonatal units in 38 European countries between July and October 2021. The protocol was based on the Checklist for Reporting Results of Internet E-Surveys. RESULTS: In total, 76 neonatal units (14%) from 22 European countries (58%) completed the e-survey. In the 12 months prior to the survey, 29% of 76 units reported at least one symptomatic case of fracture associated with metabolic bone disease of prematurity, and 18% of 76 units reported at least one case of craniofacial deformity. Most centres followed local guidelines for diagnosis (77% of 73 units) and treatment (63% of 72 units). Alkaline phosphatase was the blood marker most used for treatment indication (81% of 72 units), and phosphate supplementation was the treatment most used (82% of 71 units). CONCLUSION: Metabolic bone disease of prematurity remains clinically relevant. Wide variations in diagnostic procedures and management strategies were observed in European neonatal units. Evidence-based consensus guidelines appear urgently needed to reduce the number of symptomatic cases.
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Enfermedades Óseas Metabólicas , Enfermedades del Prematuro , Recien Nacido Prematuro , Humanos , Recién Nacido , Europa (Continente) , Enfermedades Óseas Metabólicas/diagnóstico , Enfermedades Óseas Metabólicas/terapia , Enfermedades del Prematuro/diagnóstico , Enfermedades del Prematuro/terapiaRESUMEN
Previous studies have shown that surgical residents can safely perform a variation of complex abdominal surgeries when provided with adequate training, proper case selection, and appropriate supervision. Their outcomes are equivalent when compared to experienced board-certified surgeons. Our previously published training curriculum for robotic assisted minimally invasive esophagectomy already demonstrated a possible reduction in time to reach proficiency. However, esophagectomy is a technically challenging procedure and comes with high morbidity rates of up to 60%, making it difficult to provide opportunities to train surgical residents. We aimed to investigate if a surgical resident could safely perform complex esophageal surgery when a structured modular teaching curriculum is applied. A structured teaching program based on our previously published modular step-up approach was applied by two experienced board-certified esophageal surgeons. Our IRB-approved (Institutional Review Board) database was searched to identify all Ivor-Lewis esophagectomies performed by the selected surgical resident from August 2019 to July 2021. The cumulative sum method was used to analyze the learning curve of the surgical resident. Outcomes of patients operated by the resident were then compared to our overall cohort of open, hybrid, and robotic Ivor-Lewis esophagectomies from May 2016 to May 2020. The total cohort included 567 patients, of which 65 were operated by the surgical resident and 502 patients were operated by experienced esophageal cancer surgeons as the control group. For baseline characteristics, a significant difference for BMI (Body mass index) was observed, which was lower in the resident's group (25.5 kg/m2 vs. 26.8 kg/m2 (P = 0.046). A significant difference of American Society of Anesthesiologists- and Eastern Cooperative Oncology Group-scores was seen, and a subgroup analysis including all patients with American Society of Anesthesiologists I and Eastern Cooperative Oncology Group 0 was performed revealing no significant differences. Postoperative complications did not differ between groups. The anastomotic leak rate was 13.8% in the resident's cohort and 12% in the control cohort (P = 0.660). Major complications (Clavien-Dindo ≥ IIIb) occurred in 16.9% of patients in both groups. Oncological outcome, defined by harvested lymph nodes (35 vs. 32.33, P = 0.096), proportion of lymph node compliant performed operations (86.2% vs. 88.4%, P = 0.590), and R0-resection rate (96.9% vs. 96%, P = 0.766), was not compromised when esophagectomies were performed by the resident. The resident completed the learning curves after 39 cases for the total operating time, 38 cases for the thoracic operating time, 26 cases for the number of harvested lymph nodes, 29 cases for anastomotic leak rate, and finally 58 cases for the comprehensive complication index. For postoperative complications, no significant difference was seen between patients operated in the resident group versus the control group, with a third of patients being discharged with a textbook outcome in both cohorts. Furthermore, no difference in oncological quality of the resection was found, emphasizing safety and feasibility of our training program. A structured modular step-up for training a surgical resident to perform complex esophageal cancer surgery can successfully maintain patient safety and outcomes.
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Competencia Clínica , Neoplasias Esofágicas , Esofagectomía , Internado y Residencia , Procedimientos Quirúrgicos Robotizados , Humanos , Internado y Residencia/métodos , Neoplasias Esofágicas/cirugía , Esofagectomía/educación , Esofagectomía/métodos , Esofagectomía/efectos adversos , Femenino , Masculino , Persona de Mediana Edad , Anciano , Procedimientos Quirúrgicos Robotizados/educación , Procedimientos Quirúrgicos Robotizados/efectos adversos , Curva de Aprendizaje , Tutoría/métodos , Curriculum , Hospitales de Alto Volumen , Estudios RetrospectivosRESUMEN
In pediatrics chronic respiratory insufficiency is increasingly treated on an outpatient basis with home mechanical ventilation. Nursing and medical teams with different structures take care of the often complex ill children in the outpatient setting. Structured treatment processes, especially emergency plans for the management of respiratory emergencies of home mechanical ventilated children are lacking. This article is a proposal for emergency management of respiratory infections, emergencies of non-invasively ventilated and invasively ventilated, tracheotomized children. In addition to resuscitation measures according to ERC/AHA, the focus is primarily on secretion management, as well as on the handling of ventilators and devices.
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Servicios Médicos de Urgencia , Servicios de Atención de Salud a Domicilio , Insuficiencia Respiratoria , Humanos , Niño , Respiración Artificial , Urgencias Médicas , Insuficiencia Respiratoria/etiología , Insuficiencia Respiratoria/terapiaRESUMEN
When working with, and learning about, the thermal balance of a chemical reaction, we need to consider two overlapping but conceptually distinct aspects: one relates to the process of reallocating entropy between reactants and products (because of different specific entropies of the new substances compared to those of the old), and the other to dissipative processes. Together, they determine how much entropy is exchanged between the chemicals and their environment (i.e., in heating and cooling). By making explicit use of (a) the two conjugate pairs chemical amount (i.e., amount of substance) and chemical potential, and entropy and temperature, respectively, (b) the laws of balance of amount of substance on the one hand and entropy on the other, and (c) a generalized approach to the energy principle, it is possible to create both imaginative and formal conceptual tools for modeling thermal balances associated with chemical transformations in general and exothermic and endothermic reactions in particular. In this paper, we outline the concepts and relations needed for a direct approach to chemical and thermal dynamics, create a model of exothermic and endothermic reactions, including numerical examples, and discuss how to relate the direct entropic approach to traditional models of these phenomena.
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OBJECTIVE: The aim of this study was to explore oncologic outcomes of transhiatal gastrectomy (THG) or transthoracic esophagectomy (TTE) for neoadjuvantly treated gastroesophageal junction (GEJ) Siewert type II adenocarcinomas, a multinational, high-volume center cohort analysis was undertaken. BACKGROUND: Neoadjuvant radiochemotherapy or perioperative chemotherapy (CTx) followed by surgery is the standard therapy for locally advanced GEJ. However, the optimal surgical approach for type II GEJ tumors remains unclear, as the decision is mainly based on individual experience and assessment of operative risk. METHODS: A retrospective analysis of 5 prospectively maintained databases was conducted. Between 2012 and 2021, 800 patients fulfilled inclusion criteria for type II GEJ tumors and neoadjuvant radiochemotherapy or CTx. The primary endpoint was median overall survival (mOS). Propensity score matching was performed to minimize selection bias. RESULTS: Patients undergoing THG (n=163, 20.4%) had higher American Society of Anesthesiologists (ASA) classification and cT stage ( P <0.001) than patients undergoing TTE (n=637, 79.6%). Neoadjuvant therapy was different as the THG group were mainly undergoing CTx (87.1%, P <0.001). The TTE group showed higher tumor regression ( P =0.009), lower ypT/ypM categories (both P <0.001), higher nodal yield ( P =0.009) and higher R0 resection rate ( P =0.001). The mOS after TTE was longer (78.0 vs 40.0 months, P =0.013). After propensity score matching a higher R0 resection rate ( P =0.004) and mOS benefit after TTE remained ( P =0.04). Subgroup analyses of patients without distant metastasis ( P =0.037) and patients only after neoadjuvant chemotherapy ( P =0.021) confirmed the survival benefit of TTE. TTE was an independent predictor of longer survival. CONCLUSION: Awaiting results of the randomized CARDIA trial, TTE should in high-volume centers be considered the preferred approach due to favorable oncologic outcomes.
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Adenocarcinoma , Neoplasias Esofágicas , Neoplasias Gástricas , Humanos , Estudios Retrospectivos , Estudios de Cohortes , Unión Esofagogástrica/cirugía , Unión Esofagogástrica/patología , Adenocarcinoma/cirugía , Adenocarcinoma/tratamiento farmacológico , Neoplasias Esofágicas/cirugía , Esofagectomía/métodos , Gastrectomía/métodos , Neoplasias Gástricas/cirugía , Terapia NeoadyuvanteRESUMEN
BACKGROUND: The question of the ideal neoadjuvant therapy for locally advanced esophagogastric adenocarcinoma has not been answered to date. Multimodal treatment has become a standard treatment for these adenocarcinomas. Currently, perioperative chemotherapy (FLOT) or neoadjuvant chemoradiation (CROSS) is recommended. METHODS: A monocentric retrospective analysis compared long-term survival after CROSS versus FLOT. The study enrolled patients with adenocarcinoma of the esophagus (EAC) or the esophagogastric junction type I or II undergoing oncologic Ivor-Lewis esophagectomy between January 2012 and December 2019. The primary objective was to determine the long-term outcome in terms of overall survival. The secondary objectives were to determine differences regarding the histopathologic categories after neoadjuvant treatment and the histomorphologic regression. RESULTS: The findings showed no survival advantage for one or the other treatment in this highly standardized cohort. All the patients underwent open (CROSS: 9.4% vs. FLOT: 22%), hybrid (CROSS: 82% vs. FLOT: 72%), or minimally invasive (CROSS: 8.9% vs. FLOT: 5.6%) thoracoabdominal esophagectomy. The median post-surgical follow-up period was 57.6 months (95% confidence interval [CI] 23.2-109.7 months), and the median survival was longer for the CROSS patients (54 months) than for the FLOT patients (37.2 months) (p = 0.053). The overall 5-years survival was 47% for the entire cohort (48% for the CROSS and 43% for the FLOT patients). The CROSS patients showed a better pathologic response and fewer advanced tumor stages. CONCLUSION: The improved pathologic response after CROSS cannot be translated into longer overall survival. To date, the choice of which neoadjuvant treatment to use can be made only on the basis of clinical parameters and the patient's performance status.
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Adenocarcinoma , Neoplasias Esofágicas , Neoplasias Gástricas , Humanos , Terapia Neoadyuvante , Esofagectomía , Resultado del Tratamiento , Estudios Retrospectivos , Neoplasias Esofágicas/patología , Unión Esofagogástrica/patología , Adenocarcinoma/patología , Protocolos de Quimioterapia Combinada Antineoplásica/uso terapéutico , Neoplasias Gástricas/patologíaRESUMEN
BACKGROUND: Oesophagectomy is an operation with a high risk of postoperative complications. The aim of this single-centre retrospective study was to apply machine-learning methods to predict complications (Clavien-Dindo grade IIIa or higher) and specific adverse events. METHODS: Patients with resectable adenocarcinoma or squamous cell carcinoma of the oesophagus and gastro-oesophageal junction who underwent Ivor Lewis oesophagectomy between 2016 and 2021 were included. The tested algorithms were logistic regression after recursive feature elimination, random forest, k-nearest neighbour, support vector machine, and neural network. The algorithms were also compared with a current risk score (the Cologne risk score). RESULTS: 457 patients had Clavien-Dindo grade IIIa or higher complications (52.9 per cent) versus 407 patients with Clavien-Dindo grade 0, I, or II complications (47.1 per cent). After 3-fold imputation and 3-fold cross-validation, the overall accuracies were: logistic regression after recursive feature elimination, 0.528; random forest, 0.535; k-nearest neighbour, 0.491; support vector machine, 0.511; neural network, 0.688; and Cologne risk score, 0.510. For medical complications, the results were: logistic regression after recursive feature elimination, 0.688; random forest, 0.664; k-nearest neighbour, 0.673; support vector machine, 0.681; neural network, 0.692; and Cologne risk score, 0.650. For surgical complications, the results were: logistic regression after recursive feature elimination, 0.621; random forest, 0.617; k-nearest neighbour, 0.620; support vector machine, 0.634; neural network, 0.667; and Cologne risk score, 0.624. The calculated area under the curve of the neural network was 0.672 for Clavien-Dindo grade IIIa or higher, 0.695 for medical complications, and 0.653 for surgical complications. CONCLUSION: The neural network scored the highest accuracies compared with all of the other models for the prediction of postoperative complications after oesophagectomy.
The human gullet or stomach can develop tumours. Surgery can help to cure patients with these tumours. But the operation is risky because sometimes adverse events can happen afterwards. So far, there is no reliable prediction model. It may help to predict the risk of adverse events accurately. For example, patients with a high risk could be observed more thoroughly. Patients with a low risk may not need unnecessary procedures. The information of all patients with an operation at a specialized hospital was collected. Machine learning is a complex mathematical method and was used in this study. It is able to analyse big data sets of information. One machine-learning method called neural network was best in predicting adverse events. Right now, the performance may not be strong enough to fully rely on the prediction. However, refinement of the prediction and more data could improve the neural network in the future.
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Esofagectomía , Aprendizaje Automático , Humanos , Estudios Retrospectivos , Redes Neurales de la Computación , Complicaciones PosoperatoriasRESUMEN
OBJECTIVE OF THE STUDY: The most common functional complication after Ivor-Lewis esophagectomy is the delayed emptying of the gastric conduit (DGCE) for which several diagnostic tools are available, e.g. chest X-ray, upper esophagogastroduodenoscopy (EGD) and water-soluble contrast radiogram. However, none of these diagnostic tools evaluate the pylorus itself. Our study demonstrates the successful measurement of pyloric distensibility in patients with DGCE after esophagectomy and in those without it. METHODS AND PROCEDURES: Between May 2021 and October 2021, we performed a retrospective single-centre study of all patients who had an oncological Ivor-Lewis esophagectomy and underwent our post-surgery follow-up programme with surveillance endoscopies and computed tomography scans. EndoFlip™ was used to perform measurements of the pylorus under endoscopic control, and distensibility was measured at 40 ml, 45 ml and 50 ml balloon filling. RESULTS: We included 70 patients, and EndoFlip™ measurement was feasible in all patients. Successful application of EndoFlip™ was achieved in all interventions (n = 70, 100%). 51 patients showed a normal postoperative course, whereas 19 patients suffered from DGCE. Distensibility proved to be smaller in patients with symptoms of DGCE compared to asymptomatic patients. For 40 ml, 45 ml and 50 ml, the mean distensibility was 6.4 vs 10.1, 5.7 vs 7.9 and 4.5 vs 6.3 mm2/mmHg. The differences were significant for all three balloon fillings. No severe EndoFlip™ treatment-related adverse events occurred. CONCLUSION: Measurement with EndoFlip™ is a safe and technically feasible endoscopic option for measuring the distensibility of the pylorus. Our study shows that the distensibility in asymptomatic patients after esophagectomy is significantly higher than that in patients suffering from DGCE. However, more studies need to be conducted to demonstrate the general use of EndoFlip™ measurement of the pylorus after esophagectomy.
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Neoplasias Esofágicas , Gastroparesia , Humanos , Píloro/diagnóstico por imagen , Píloro/cirugía , Esofagectomía/efectos adversos , Esofagectomía/métodos , Gastroparesia/cirugía , Estudios Retrospectivos , Neoplasias Esofágicas/diagnóstico por imagen , Neoplasias Esofágicas/cirugía , Neoplasias Esofágicas/complicaciones , Complicaciones Posoperatorias/diagnóstico por imagen , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/epidemiologíaRESUMEN
OBJECTIVE OF THE STUDY: In esophageal surgery, anastomotic leak (AL) remains one of the most severe and critical adverse events after oncological esophagectomy. Endoscopic vacuum therapy (EVT) can be used to treat AL; however, in the current literature, treatment outcomes and reports on how to use this novel technique are scarce. The aim of this study was to evaluate the outcomes of patients with an AL after IL RAMIE and to determine whether using EVT as an treatment option is safe and feasible. MATERIAL AND METHODS: This study includes all patients who developed an Esophagectomy Complications Consensus Group (ECCG) type II AL after IL RAMIE at our center between April 2017 and December 2021. The analysis focuses on time to EVT, duration of EVT, and follow up treatments for these patients. RESULTS: A total of 157 patients underwent an IL RAMIE at our hospital. 21 patients of these (13.4%) developed an ECCG type II AL. One patient died of unrelated Covid-19 pneumonia and was excluded from the study cohort. The mean duration of EVT was 12 days (range 4-28 days), with a mean of two sponge changes (range 0-5 changes). AL was diagnosed at a mean of 8 days post-surgery (range 2-16 days). Closure of the AL with EVT was successful in 15 out of 20 patients (75%). Placement of a SEMS (Self-expandlable metallic stent) after EVT was performed in four patients due to persisting AL. Overall success rate of anastomotic sealing independently of the treatment modality was achieved in 19 out of 20 Patients (95%). No severe EVT-related adverse events occurred. CONCLUSION: This study shows that EVT can be a safe and effective endoscopic treatment option for ECCG type II AL.
Asunto(s)
Boehmeria , COVID-19 , Terapia de Presión Negativa para Heridas , Procedimientos Quirúrgicos Robotizados , Humanos , Esofagectomía/efectos adversos , Procedimientos Quirúrgicos Robotizados/efectos adversos , Terapia de Presión Negativa para Heridas/métodos , Fuga Anastomótica/etiología , Fuga Anastomótica/cirugía , Resultado del Tratamiento , Estudios RetrospectivosRESUMEN
BACKGROUND: Surgical video recording provides the opportunity to acquire intraoperative data that can subsequently be used for a variety of quality improvement, research, and educational applications. Various recording devices are available for standard operating room camera systems. Some allow for collateral data acquisition including activities of the OR staff, kinematic measurements (motion of surgical instruments), and recording of the endoscopic video streams. Additional analysis through computer vision (CV), which allows software to understand and perform predictive tasks on images, can allow for automatic phase segmentation, instrument tracking, and derivative performance-geared metrics. With this survey, we summarize available surgical video acquisition technologies and associated performance analysis platforms. METHODS: In an effort promoted by the SAGES Artificial Intelligence Task Force, we surveyed the available video recording technology companies. Of thirteen companies approached, nine were interviewed, each over an hour-long video conference. A standard set of 17 questions was administered. Questions spanned from data acquisition capacity, quality, and synchronization of video with other data, availability of analytic tools, privacy, and access. RESULTS: Most platforms (89%) store video in full-HD (1080p) resolution at a frame rate of 30 fps. Most (67%) of available platforms store data in a Cloud-based databank as opposed to institutional hard drives. CV powered analysis is featured in some platforms: phase segmentation in 44% platforms, out of body blurring or tool tracking in 33%, and suture time in 11%. Kinematic data are provided by 22% and perfusion imaging in one device. CONCLUSION: Video acquisition platforms on the market allow for in depth performance analysis through manual and automated review. Most of these devices will be integrated in upcoming robotic surgical platforms. Platform analytic supplementation, including CV, may allow for more refined performance analysis to surgeons and trainees. Most current AI features are related to phase segmentation, instrument tracking, and video blurring.
Asunto(s)
Inteligencia Artificial , Procedimientos Quirúrgicos Robotizados , Humanos , Endoscopía , Programas Informáticos , Privacidad , Grabación en VideoRESUMEN
BACKGROUND: Robotic-assisted minimally invasive esophagectomy (RAMIE) was first introduced in 2003 and has since then shown to significantly improve the postoperative course. Previous studies have shown that a structured training pathway based on proficiency-based progression using individual skill levels as measures of reach of competence can enhance surgical performance. The aim of this study was to evaluate and help understand our pathway to reach surgical expert levels using a proficiency-based approach introducing RAMIE at our German high-volume center. METHODS: All patients undergoing RAMIE performed by two experienced surgeons for esophageal cancer since the introduction of the robotic technique in 2017 was included in this analysis. Intraoperative outcomes and postoperative outcomes were included in the analysis. The cumulative sum method was used to analyze how many cases are needed to reach expert levels for different performance characteristics and skill sets during robotic-assisted minimally invasive esophagectomy. RESULTS: From 06/2017 to 03/2022, a total of 154 patients underwent RAMIE at our facility and were included in the analysis. An advancement in performance level was observed for total operating time after 70 cases and for thoracic operative time after 79 cases. Lymph node yield showed an increase up until case 60 in the CUSUM analysis. Length of hospital stay stabilized after case 55. The CCI score inflection point was at case 55 in both CUSUM and regression analyses. Anastomotic leak rate stabilized at case 38 and showed another inflection point after case 83. CONCLUSION: Our data and analysis showed the progression from proficient to expert performance levels during the implementation of RAMIE at a European high-volume center. Further analysis of surgeons, especially with a different training status has yet to reveal if the caseloads found in this study are universally applicable. However, skill acquisition and respective measures of such are diverse and as a great range of number of cases was observed, we believe that the learning curve and ascent in performance levels cannot be defined by one parameter alone.
Asunto(s)
Boehmeria , Neoplasias Esofágicas , Procedimientos Quirúrgicos Robotizados , Humanos , Esofagectomía/métodos , Procedimientos Quirúrgicos Robotizados/métodos , Neoplasias Esofágicas/cirugía , Neoplasias Esofágicas/patología , Ganglios Linfáticos/patología , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Resultado del Tratamiento , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/patología , Estudios RetrospectivosRESUMEN
BACKGROUND: Currently, little is known regarding the optimal technique for the abdominal phase of RAMIE. The aim of this study was to investigate the outcome of robot-assisted minimally invasive esophagectomy (RAMIE) in both the abdominal and thoracic phase (full RAMIE) compared to laparoscopy during the abdominal phase (hybrid laparoscopic RAMIE). METHODS: This retrospective propensity-score matched analysis of the International Upper Gastrointestinal International Robotic Association (UGIRA) database included 807 RAMIE procedures with intrathoracic anastomosis between 2017 and 2021 from 23 centers. RESULTS: After propensity-score matching, 296 hybrid laparoscopic RAMIE patients were compared to 296 full RAMIE patients. Both groups were equal regarding intraoperative blood loss (median 200 ml versus 197 ml, p = 0.6967), operational time (mean 430.3 min versus 417.7 min, p = 0.1032), conversion rate during abdominal phase (2.4% versus 1.7%, p = 0.560), radical resection (R0) rate (95.6% versus 96.3%, p = 0.8526) and total lymph node yield (mean 30.4 versus 29.5, p = 0.3834). The hybrid laparoscopic RAMIE group showed higher rates of anastomotic leakage (28.0% versus 16.6%, p = 0.001) and Clavien Dindo grade 3a or higher (45.3% versus 26.0%, p < 0.001). The length of stay on intensive care unit (median 3 days versus 2 days, p = 0.0005) and in-hospital (median 15 days versus 12 days, p < 0.0001) were longer for the hybrid laparoscopic RAMIE group. CONCLUSIONS: Hybrid laparoscopic RAMIE and full RAMIE were oncologically equivalent with a potential decrease of postoperative complications and shorter (intensive care) stay after full RAMIE.