RESUMEN
Introduction and objective: Magnetic-assisted robotic surgery (MARS) has been developed to maximize patient benefits of minimally invasive surgery while enhancing surgeon control and visualization. MARS platform (Levita Magnetics) comprises two robotic arms that provide control to an external magnetic controller and an off-the-shelf laparoscopic camera. Our aim was to evaluate the safety and efficacy of the MARS platform in laparoscopic renal and adrenal procedure for the first time. Methods: This is a prospective, single-arm, open-label study (Clinical Trials Identifier: NCT05353777) including patients with renal or adrenal pathology analysis, submitted to laparoscopic procedure between April and June 2022. Patients were followed up to 30 days postoperatively. Preoperative, intraoperative, and postoperative data were recorded. Polynomial regression was used to determine the learning curve for docking time. Results: Fifteen cases were performed using the MARS platform (three partial nephrectomies, five total nephrectomies for benign pathology analysis, four radical nephrectomies, and three adrenalectomies) corresponding to 10 women and 5 men (mean age, 55 years [18-77]; average body mass index, 29 cm/m2 [22-39]). No cases required conversion to open procedure and all patients were discharged on the first or second postoperative day. No complications or re-admissions were reported within the first 30 days. All oncologic cases had negative margins. Learning curve was achieved by the fourth case, diminishing docking time from 5.22 (2.6-11.5) to 2.68 minutes (2.1-3.8) (p = 0.002). The learning curve was fitted to a cubic regression (R2 = 0.714). Conclusion: This is the first clinical study demonstrating the safety and versatility of the MARS platform in urologic procedures. The robot was especially useful for tissue retraction, avoiding additional incisions and the need for a surgical assistant while increasing surgeon control and visualization. The learning curve was rapid, achieving a short docking time. MARS is a promising new technology that could be successfully evaluated in other surgeries.
Asunto(s)
Laparoscopía , Procedimientos Quirúrgicos Robotizados , Robótica , Urología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Laparoscopía/métodos , Fenómenos Magnéticos , Nefrectomía/métodos , Estudios Prospectivos , Procedimientos Quirúrgicos Robotizados/métodosRESUMEN
PURPOSE: To evaluate the safety and efficacy of the Optilume BPH Catheter System for the treatment of lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). METHODS: This open-label, single-arm study enrolled eighty subjects with LUTS secondary to BPH who were treated with the Optilume BPH Catheter System. Symptoms were recorded utilizing the International Prostate Symptom Score (IPSS) and Benign Prostatic Hyperplasia Impact Index (BPH-II). Functional improvement was measured utilizing peak urinary flow rate (Qmax) and post-void residual urine volume (PVR). Adverse events were systematically captured and reported at each follow-up visit. RESULTS: Subjects treated with the Optilume BPH Catheter System experienced a significant improvement in LUTS from baseline through 2 years of follow-up, as measured by IPSS (22.3 vs 8.2, p < 0.001) and BPH-II (6.9 vs 2.3, p < 0.001). Functional improvement was also significant, with Qmax improving from an average of 10.9 mL/s at baseline to 17.2 mL/s at the 2-year follow-up and PVR improving from 63.1 to 45.0 mL. Treatment-related adverse events were typically minor, with none occurring between 1- and 2-year post-treatment. CONCLUSIONS: The Optilume BPH Catheter System is a unique minimally invasive surgical therapy that combines mechanical and pharmaceutical aspects for the treatment of BPH. The functional and symptomatic improvements seen after treatment are significant and have been sustained through 2 years in this early feasibility study. REGISTRATION: NCT03423979, registered February 6, 2018.
Asunto(s)
Síntomas del Sistema Urinario Inferior , Hiperplasia Prostática , Masculino , Humanos , Hiperplasia Prostática/cirugía , Resultado del Tratamiento , Síntomas del Sistema Urinario Inferior/cirugíaRESUMEN
ABSTRACT Background: Many causes can lead to shoulder pain and subacromial impingement syndrome (SIS) is the most frequently recorded disorders. The aim of this study was to evaluate the clinical effects of diminutive incision acromioplasty assisted with arthroscopy for the treatment of Chinese patients with subacromial impingement syndrome. Subject and Methods: Twenty-two patients with 24-painful shoulders subacromial impingement syndrome were enrolled. All painful shoulders were in Grades II (8) and III (16) according to Neer's classification. Detailed physical examination was performed. Conventional radiography and subsequent magnetic resonance imaging (MRI) of the shoulder region of all patients were done. The University of California at Los Angeles Shoulder (UCLA) score system was used for all patients to evaluate their satisfaction after surgery. The preoperative recordings of the UCLA scores were collected and all enrolled cases including 24-painful shoulders were available for follow-up in 1, 3, 6, 12 months after surgery. Results: According to the UCLA scoring system, the symptom of all painful shoulders were improved after one year postoperatively. The average score before surgery from 15.4 points increased to 31.2 points postoperatively, showing a statistical difference (p < 0.05). Conclusions: A diminutive incision acromioplasty assisted with arthroscopy is a reliable approach to treat Chinese patients with subacromial impingement syndrome. All painful shoulders were obviously improved in one year after surgery.
ABSTRACT Antecedentes: Muchas causas pueden provocar dolor de hombro y síndrome de compresión subacromial (SIS) es el trastorno más frecuentemente registrado. El objetivo de este estudio fue evaluar la clínica. Efectos de la acromioplastia con incisión diminuta asistida con artroscopia para el tratamiento de Pacientes chinos con síndrome de pinzamiento subacromial. Sujeto y métodos: Se incluyeron veintidós pacientes con síndrome de afectación subacromial de 24-hombros dolorosos. Todos los hombros dolorosos estaban en Grados II (8) y III (16) de acuerdo con la clasificación de Neer. Se realizó examen físico detallado. Se realizaron radiografías convencionales y, posteriormente, imágenes de resonancia magnética (IRM) de la región del hombro de todos los pacientes. El sistema de puntuación de la Universidad de California en Los Angeles Shoulder (UCLA) se utilizó para que todos los pacientes evaluaran su satisfacción después de la cirugía. Los registros preoperatorios de las puntuaciones de UCLA se recopilaron y todos los casos incluidos, incluidos 24-hombros dolorosos, estaban disponibles para el seguimiento en 1, 3, 6 y 12 meses después de la cirugía. Resultados: De acuerdo con el sistema de puntuación de UCLA, el síntoma de todos los hombros dolorosos mejoró después de un año después de la operación. La puntuación promedio antes de la cirugía de 15.4 puntos aumentó a 31.2 puntos después de la operación, mostrando una diferencia estadística (p < 0.05) Conclusiones: Una acromioplastia de incisión diminuta asistida con artroscopia es un enfoque confiable para tratar a pacientes chinos con síndrome de pinzamiento subacromial. Todas las lesiones dolorosas se mejoraron obviamente en un año después de la cirugía.
Asunto(s)
Humanos , Masculino , Femenino , Adolescente , Adulto , Persona de Mediana Edad , Anciano , Adulto Joven , Artroscopía , Acromion/cirugía , Síndrome de Abducción Dolorosa del Hombro/cirugía , Periodo Posoperatorio , Hombro/cirugía , Acromion/diagnóstico por imagen , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Síndrome de Abducción Dolorosa del Hombro/diagnóstico por imagen , Dolor de Hombro/etiologíaRESUMEN
ABSTRACT Background : Laparoscopic manual suturing is probably the most difficult skill to be acquired in minimally invasive surgery. However, laparoscopic exercise endo-sutures can be learned with a simulator and are of great practical importance and clinical applicability, absorbing concepts that are immediately transferred to the operating room. Aim : To assess the progression of skills competence in endo-sutures through realistic simulation model of systematized education. Method : Evaluation of the progression of competence of students in three sequential stages of training in realistic simulation, pre-test (V.1), teaching concepts (V.2) and training station for absorption of video concepts in surgery - ergonomics, stereotaxia, ambidexterity, haptic touch, fucral effect, applied in the manufacture of points corresponding to a Nissen fundoplication, in endo-suture for realistic simulation. Results : All students who attended the course absorbed the video concepts in surgery; most participants showed steady and continued improvement and during the stages of training, obtained progression of appropriate skills, defining competence and validation of the teaching model to achieve proficiency. Conclusions : The teaching model was adequate, safe, revealed the profile of the student, the evolutionary powers of the endo-sutures performance and critical analysis of the training to achieve proficiency in bariatric procedures.
RESUMO Racional : A sutura manual laparoscópica é, provavelmente, a habilidade mais difícil de ser adquirida na cirurgia minimamente invasiva. No entanto, os exercícios laparoscópicos de endossuturas podem ser aprendidos com um simulador e se revestem de grande importância prática, haja vista que tem aplicabilidade clínica, sendo os conceitos absorvidos e transferidos imediatamente para a sala de operação. Objetivo : Avaliar a progressão decompetência de habilidades em endossuturas através de simulação realística em modelo de ensino metodizado. Método : Avaliação da progressão de competência dos alunos em três etapas sequenciais de treinamento em simulação realística, pré-teste (V.1), ensinamento dos conceitos (V.2) e estação de treinamento para absorção dos conceitos de videocirurgia - ergonomia, estereotaxia, ambidestria, hapticidade (movimento preciso de instrumentoscom as mão, sem o auxílio ou comando da visão), efeito fucral (movimento invertido de uma balança ou alavanca a partir de um ponto central), aplicados na confecção de pontos correspondentes à fundoplicatura de Nissen em endossutura por simulação realística. Resultados : Todos os alunos que participaram do curso absorveram os conceitos de videocirurgia; a maioria apresentou melhora constante e continuada, e no decorrer das etapas do treinamento,obtiveram progressão de habilidades adequadas, definindo competência e validação do modelo de ensino para atingir a proficiência. Conclusões : O modelo mostrou-se adequado, seguro, revelou o perfil do aluno, a competência evolutiva da performance em endossuturas e análise crítica da carga de treinamento para evoluir até atingir a proficiência nos procedimentos bariátricos.
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Humanos , Masculino , Femenino , Técnicas de Sutura/educación , Modelos Educacionales , Laparoscopía , Entrenamiento Simulado , Estudios Prospectivos , Competencia ClínicaRESUMEN
ABSTRACT Purpose: To report follow-up data for patients who underwent XEN45 gel stent implantation, a new method of minimally invasive glaucoma surgery. Methods: Fifteen eyes in fifteen patients who underwent XEN45 gel stent implantation surgery were investigated in the study. All patients were examined preoperatively and at the following postoperative time points: 1 day; 1 and 2 weeks; and 1, 2, 3, 6, and 12 months. Intraocular pressure (IOP) was measured via Goldmann applanation tonometry. Combined surgical procedures (XEN45 + phacoemulsification + intraocular lens) were performed in patients who that had cataracts in addition to glaucoma. Results: The mean IOP values were significantly lower than the preoperative values at all postoperative visits (p<0.001). In two patients, the IOP exceeded 20 mmHg 12 months after surgery. These IOP increases were controlled by medical therapy, and none of the patients needed another surgical procedure. Conclusion: XEN45 gel stent implantation is a minimally invasive glaucoma surgery that ensures the effective reduction of IOP. This new treatment modality also avoids the destructive complications encountered in other invasive surgical procedures. However, further studies with greater numbers of patients and longer follow-up periods are needed to clarify certain points.
RESUMO Objetivo: Relatar os dados de acompanhamento dos pacientes que apresentaram implante de endoprótese de gel XEN45, um novo método de cirurgia de glaucoma minimamente invasiva. Métodos: Foram investigados quinze olhos de quinze pacientes que tiveram cirurgia de implante de endoprótese de gel XEN45 no estudo. Todos os pacientes foram examinados no pré-operatório e nos seguintes pontos de tempo pós-operatório: 1 dia; 1 e 2 semanas; E 1, 2, 3, 6 e 12 meses. A pressão intraocular foi medida pela tonometria de aplanamento de Goldmann. Procedimentos cirúrgicos combinados (XEN 45 + facoemulsificação + lente intraocular) foram realizados nos casos que apresentavam catarata além do glaucoma. Resultados: Os valores médios de PIO foram significativamente menores em todas as visitas pós-operatórias quando comparados aos valores pré-operatórios (p<0,001). Em 2 casos, os valores da pressão intraocular foram superiores a 20 mmHg aos 12 meses pós-operatório. Estes aumentos da pressão intraocular foram controlados por terapia médica, e nenhum dos pacientes necessitou de outro procedimento cirúrgico. Conclusão: Implantação de endoprótese de gel XEN45 é uma cirurgia de glaucoma minimamente invasiva que garante a redução efetiva da pressão intraocular. Esta nova modalidade de tratamento também evita as complicações destrutivas encontradas em outros procedimentos cirúrgicos invasivos. No entanto, estudos adicionais com um maior número de pacientes e períodos de acompanhamento mais longos são necessários para esclarecer certos pontos.
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Humanos , Masculino , Femenino , Persona de Mediana Edad , Anciano , Stents , Glaucoma/cirugía , Implantación de Prótesis/métodos , Diseño de Prótesis , Agudeza Visual , Estudios Retrospectivos , Resultado del Tratamiento , Procedimientos Quirúrgicos Mínimamente InvasivosRESUMEN
O aprendizado através da simulaçao realística, apresenta relevância e importância cada vez maior no século da tecnologia e da informação, nas faculdades de medicina, no ensino e treinamento em extensão de educação continuada, além de pesquisa,para testar novas técnicas de uso potencial, contribuindo para a evolução da cirurgia. Objetivo- Validar o modelo teórico-prático de ensino em vídeo cirurgia, aplicado junto aos graduandos do Curso de Medicina da Universidade Estadual do Ceará, inserindo na plataforma curricular, por meio de um novo simulador real de cavidade abdominal, Endo Suture Trainning Box (ESTB), desenvolvido pelo autor, como instrumento de aprendizado, treinamento, progressão de habilidade psicomotoras em vídeo cirurgia, para consolidar a progressão e a manutenção da proficiência em video cirurgia...
The Surgical Skills Laboratory has increasing its relevance and importance in this century of technology and information, in medical schools, especially in the process of teaching and learning, and in training activities of continuing education programs, beyond research, testing new techniques and contributing to the evolution of surgery. Objective This study aims to validate the theoretical and practical teaching model, applied with the medical students, putting the EndoSuture TrainingBox (ESTB), developed by the author, into the subjects program, as a learning and training tool, which stimulates the development of psychomotor abilities in video surgery, to consolidate the progression skills until reachsatisfactory proficiency...