RESUMO
BACKGROUND: The combination of radiotherapy plus long-term medical suppression of androgens (> or = 2 years) improves overall survival in patients with locally advanced prostate cancer. We compared the use of radiotherapy plus short-term androgen suppression with the use of radiotherapy plus long-term androgen suppression in the treatment of locally advanced prostate cancer. METHODS: We randomly assigned patients with locally advanced prostate cancer who had received external-beam radiotherapy plus 6 months of androgen suppression to two groups, one to receive no further treatment (short-term suppression) and the other to receive 2.5 years of further treatment with a luteinizing hormone-releasing hormone agonist (long-term suppression). An outcome of noninferiority of short-term androgen suppression as compared with long-term suppression required a hazard ratio of more than 1.35 for overall survival, with a one-sided alpha level of 0.05. An interim analysis showed futility, and the results are presented with an adjusted one-sided alpha level of 0.0429. RESULTS: A total of 1113 men were registered, of whom 970 were randomly assigned, 483 to short-term suppression and 487 to long-term suppression. After a median follow-up of 6.4 years, 132 patients in the short-term group and 98 in the long-term group had died; the number of deaths due to prostate cancer was 47 in the short-term group and 29 in the long-term group. The 5-year overall mortality for short-term and long-term suppression was 19.0% and 15.2%, respectively; the observed hazard ratio was 1.42 (upper 95.71% confidence limit, 1.79; P=0.65 for noninferiority). Adverse events in both groups included fatigue, diminished sexual function, and hot flushes. CONCLUSIONS: The combination of radiotherapy plus 6 months of androgen suppression provides inferior survival as compared with radiotherapy plus 3 years of androgen suppression in the treatment of locally advanced prostate cancer. (ClinicalTrials.gov number, NCT00003026.)
Assuntos
Antagonistas de Androgênios/administração & dosagem , Hormônio Liberador de Gonadotropina/análogos & derivados , Neoplasias da Próstata/tratamento farmacológico , Adulto , Idoso , Idoso de 80 Anos ou mais , Antagonistas de Androgênios/efeitos adversos , Anilidas/efeitos adversos , Anilidas/uso terapêutico , Terapia Combinada , Intervalo Livre de Doença , Esquema de Medicação , Flutamida/efeitos adversos , Flutamida/uso terapêutico , Seguimentos , Cardiopatias/mortalidade , Humanos , Masculino , Pessoa de Meia-Idade , Nitrilas/efeitos adversos , Nitrilas/uso terapêutico , Modelos de Riscos Proporcionais , Neoplasias da Próstata/mortalidade , Neoplasias da Próstata/radioterapia , Qualidade de Vida , Radioterapia Conformacional/efeitos adversos , Compostos de Tosil/efeitos adversos , Compostos de Tosil/uso terapêutico , Falha de TratamentoRESUMO
The expansion of laparoscopy and endoscopic surgery has promoted a change in surgical skills acquisition. This review aims to identify problems that modulate surgical skills acquisition and the role of simulation in the current training programs. Social, medical, and working time constraints, together with patient safety issues, lead to a decreased availability of operating room (OR) training opportunities. Systematic reviews show that there is a positive "model to model" transfer of skills more evident for virtual reality (VR) simulation, although transfer from video tower exists for naïve trainees, both of which supplement standard laparoscopic training. VR to OR positive transfer is proven for laparoscopic cholecystectomy and colonoscopy/sigmoidoscopy, although not for all parameters analyzed. A mixed model integrating both types of trainers into surgical curricula may strengthen their respective possibilities. To what extent simulation will be included in the surgical training programs depends on development of objective and finer assessment tools and proficiency-based criteria.
Assuntos
Competência Clínica , Ensino/métodos , Procedimentos Cirúrgicos Urológicos/educação , Simulação por Computador , Endoscopia/educação , Humanos , Laparoscopia , Modelos Anatômicos , Modelos Animais , Análise e Desempenho de Tarefas , Procedimentos Cirúrgicos Urológicos/métodos , Urologia/educaçãoRESUMO
Open pyeloplasty is traditionally the recommended treatment for ureteropelvic junction obstruction. In the past decades, several less invasive procedures emerged with the advantages of lower morbidity and better patient tolerance. In 1993, an electrosurgical cutting balloon device called the Acucise (Applied Medical Resources Corp., Laguna Hills, CA) was introduced. It was presented as a straightforward, safe procedure that can be performed in a complete retrograde fashion under fluoroscopic guidance. Despite these advantages; however, it is not yet a generally excepted procedure. This is mainly due to the fact that specific patient selection is needed, and success rates are comparable with other already established endoscopic procedures. Considering the large variety of minimally invasive procedures available, treatment of choice must be based on several factors such as success rate, morbidity, cost, and surgeon's experience. Acucise is considered a good alternative for the treatment of ureteropelvic junction obstruction in selected patients. However, the efficacy is significantly lower than the reference standard.
Assuntos
Cateterismo/instrumentação , Pelve Renal/cirurgia , Nefrostomia Percutânea/instrumentação , Obstrução Ureteral/cirurgia , Adulto , Cateterismo/métodos , Criança , Desenho de Equipamento , Segurança de Equipamentos , Feminino , Fluoroscopia , Seguimentos , Humanos , Pelve Renal/fisiopatologia , Tempo de Internação , Masculino , Procedimentos Cirúrgicos Minimamente Invasivos/instrumentação , Dor Pós-Operatória/fisiopatologia , Seleção de Pacientes , Medição de Risco , Resultado do Tratamento , Obstrução Ureteral/diagnóstico , Ureteroscopia/métodosRESUMO
PURPOSE OF REVIEW: Training in laparoscopy has become an important issue in the current surgical scenario. In this overview we aim to update the current knowledge in the field of laparoscopic urological training and to highlight the potential dangers of using simulation for accreditation and selection purposes at this stage. RECENT FINDINGS: Physical simulators are widely available and seem to be equally efficient as virtual reality simulators. Transfer of training has been proven to be beneficial in randomized controlled trials for virtual reality and cholecystectomy. A model for the vesico-urethral suture has been described and integrated in a skills laboratory program. The program has construct validity and can discriminate at least between beginners and advanced laparoscopists. Efforts have still to be made in defining appropriate tools to assess competence and evidence for reliability, and validity must be obtained before including simulators in accreditation programs. SUMMARY: In spite of the abundant literature there is still little evidence about the learning mechanism involved in acquiring laparoscopic skills. Physical and virtual reality simulators have been proven to be efficient in improving dexterity and some evidence exists of a positive transfer from virtual reality to the operating room in cholecystectomy. Very few models, however, have been described for reconstructive urology, and effective transfer to the operating room has not yet been proven, although validation work is in progress in the field of urology.