SUMMARY OBJECTIVE: The aim of this study was to identify predictive factors for complications after percutaneous nephrolithotomy. METHODS: We prospectively analyzed patients who underwent percutaneous nephrolithotomy from June 2011 to October 2018. The association of preoperative and intraoperative factors with the presence of complications was assessed using univariate and multivariate analyses. The significance level was set at p<0.05. RESULTS: A total of 1,066 surgeries were evaluated, and the overall complication rate was 14.9%. In all, 105 (9.8%) surgeries were performed in the prone position, and 961 (90.2%) were performed in the supine position. Univariate analysis demonstrated that surgical position, upper pole puncture, surgical time, number of tracts, and Guys Stone Score were associated with complications. In multivariate analyses, prone position (odds ratio [OR] 2.10; p=0.003), surgical time ≥90 min (OR 1.76; p=0.014), upper pole puncture (OR 2.48; p<0.001), and Guys Stone Score 3 or 4 (OR 1.90; p=0.033) were independent predictive factors for complications after percutaneous nephrolithotomy. CONCLUSION: Performing percutaneous nephrolithotomy in the supine position, in under 90 min, and avoiding upper pole punctures may reduce complications during the treatment of large kidney stones.

ABSTRACT Background: Endoscopic combined intrarenal surgery (ECIRS) has been used to treat complex kidney stones (1). The combined use of ultrasound (US) has the potential to improve safety and reduce radiation exposure, however, it is still underutilized (2). Objectives: Our objective is to describe, in a step-by-step manner, the ultrasound-guided ECIRS (USG ECIRS) technique, in order to facilitate learning by urologists. Materials and Methods: We describe the 10 standardized steps that we recommend to achieve a good outcome, based on our previous experience on a high-volume kidney stone center. We recorded a case of a 37-year-old female patient with complex bilateral kidney stones that underwent a left simultaneous combined retrograde and antegrade approach. The 10 described steps are: 1 - case evaluation with CT scan (3); 2 - preoperative care with antibiotics and tranexamic acid; 3 - warm-up and training with phantoms; 4 - patient positioning in Barts flank free position; 5 - retrograde nephroscopy with flexible ureteroscope; 6 - US and endoscopic guided puncture; 7 - tract dilation under endoscopic view; 8 - stone fragmentation; 9 - status free checking and 10, kidney drainage. Images were captured by external and internal cameras, promoting a complete understanding of the procedure. The patient has signed a written informed consent form. Results: Puncture was achieved under US guidance with one attempt. Another puncture was necessary in the lower pole, parallel to the initial puncture, due to a large fragment. Surgical time was 140 min. Stone-free status was verified by retrograde and antegrade view. Kidney drainage was done with ureteral stent on string, removed after 7 days. Hb drop was 1.1 Hb/dL. The first postoperative day CT scan showed no residual stones and no complications. The patient was discharged after the CT and urethral catheter removal. Conclusion: The USG ECIRS seems to be a very efficient and reproducible technique for the treatment of complex kidney stones. Its use should be widespread.

SUMMARY OBJECTIVE: The aim of this study was to evaluate the predictive factors for success following percutaneous nephrolithotomy in the supine position. METHODS: Patients who underwent percutaneous nephrolithotomy in the supine position from June 2011 to October 2018 were evaluated. Age, sex, body mass index, the American Society of Anesthesiologists physical status classification, hemoglobin level, number of previous surgeries, stone size, and the Guy’s Stone Score were analyzed. Success was considered if no fragments were observed on the computed tomography scan on the first postoperative day. Univariate and multivariate analyses were performed to determine significant parameters. RESULTS: We evaluated 961 patients; of them, 483 (50.2%) underwent previous stone-related surgery, and 499 (51.9%) had Guy’s Stone Score 3 or 4. The overall success rate in a single procedure was 40.7%, and complication rate was 13.7%. The univariate analysis showed that the maximum diameter of the stone (25.10±10 mm; p<0.001), previous percutaneous nephrolithotomy (OR 0.52; p<0.001), number of previous percutaneous nephrolithotomy (OR 0.15; p<0.001), the Guy’s Stone Score (OR 0.28; p<0.001), and the number of tracts (OR 0.32; p<0.001) were significant. In the multivariate analysis, the number of previous percutaneous nephrolithotomy (OR 0.54; p<0.001) and the Guy’s Stone Score (OR 0.25; p<0.001) were statically significant. CONCLUSIONS: Guy’s Stone Score and the number of previous percutaneous nephrolithotomy are predictors of success with the supine position. Complex cases and with previous percutaneous interventions may require technical improvements to achieve higher stone-free rates.

Resumo Este estudo trata do recrutamento de sujeitos de pesquisa em ensaios clínicos multicêntricos internacionais financiados pela indústria executados em uma universidade pública brasileira entre janeiro de 2010 e dezembro de 2016. Analisou-se um conjunto de 63 contratos de ensaios clínicos, documentos administrativos e regulatórios. Os resultados demonstraram a participação de 75 países, dos quais 16% são latino-americanos. Foram obtidos dados sobre o recrutamento de sujeitos de pesquisa em âmbito local (356 sujeitos), nacional (3.774 sujeitos) e internacional (82.696 sujeitos), além de informações sobre o número de centros participantes no Brasil e o custo de cada ensaio. A maioria dos ensaios era de fase III (77,78% dos casos) e previa um recrutamento total nacional entre 18 e 80 sujeitos de pesquisa por ensaio (entre 4,42% e 11,46% do recrutamento internacional). Identificou-se forte correlação negativa entre os dados sobre contratos, orçamento e recrutamento e a cotação média anual do dólar. A totalidade dos ensaios adotou método competitivo de recrutamento associado ao pagamento por sujeito incluído na pesquisa. Isso é preocupante e demonstra uma contradição entre essa prática e as recomendações das diretrizes éticas nacionais. A ausência da informação sobre o número de sujeitos a serem recrutados no país revela, em 19% dos casos, um erro recorrente no processo regulatório. Conclui-se que a disponibilidade de informações detalhadas sobre o recrutamento nas pesquisas envolvendo seres humanos é importante para o correto dimensionamento e organização dos esforços de proteção dos sujeitos de pesquisa, e que atualmente essa premissa não está sendo cumprida de modo adequado.

Abstract This study concerns the recruitment of research subjects in industry-sponsored multicentric international clinical trials carried out at a Brazilian public university between January 2010 and December 2016. A set of 63 clinical trial agreements, administrative and regulatory documents was analyzed. The results showed that 75 countries were involved in these international trials, of which 16% were Latin American. Data about the recruitment of research subjects at the local (356 subjects), national (3774 subjects) and international (82,696 subjects) levels were obtained, as well as information on the number of Brazilian research centers involved and the costs of each trial. Phase III trials were the most frequent (77.78% of the cases) and they estimated a total national enrollment between 18 and 80 research subjects per trial (which means between 4.42% and 11.46% of international recruitment). A negative correlation was found between agreements, research resources, recruitment data, and yearly average dollar exchange rate. All the trials adopted competitive recruitment method associated with payment for subject included in the research. This is worrying and shows contradiction between this practice and the recommended national ethical guidelines. The lack of data on recruitment at the national level reveals, in 19% of the cases, a frequent regulatory process failure. It is concluded that the availability of detailed data on recruitment for researches involving human beings is important for the accurate sizing and organization of the efforts to protect research subjects, and that currently this premise is not being appropriately followed.

Resumo Este estudo trata do recrutamento de sujeitos de pesquisa em ensaios clínicos multicêntricos internacionais financiados pela indústria executados em uma universidade pública brasileira entre janeiro de 2010 e dezembro de 2016. Analisou-se um conjunto de 63 contratos de ensaios clínicos, documentos administrativos e regulatórios. Os resultados demonstraram a participação de 75 países, dos quais 16% são latino-americanos. Foram obtidos dados sobre o recrutamento de sujeitos de pesquisa em âmbito local (356 sujeitos), nacional (3.774 sujeitos) e internacional (82.696 sujeitos), além de informações sobre o número de centros participantes no Brasil e o custo de cada ensaio. A maioria dos ensaios era de fase III (77,78% dos casos) e previa um recrutamento total nacional entre 18 e 80 sujeitos de pesquisa por ensaio (entre 4,42% e 11,46% do recrutamento internacional). Identificou-se forte correlação negativa entre os dados sobre contratos, orçamento e recrutamento e a cotação média anual do dólar. A totalidade dos ensaios adotou método competitivo de recrutamento associado ao pagamento por sujeito incluído na pesquisa. Isso é preocupante e demonstra uma contradição entre essa prática e as recomendações das diretrizes éticas nacionais. A ausência da informação sobre o número de sujeitos a serem recrutados no país revela, em 19% dos casos, um erro recorrente no processo regulatório. Conclui-se que a disponibilidade de informações detalhadas sobre o recrutamento nas pesquisas envolvendo seres humanos é importante para o correto dimensionamento e organização dos esforços de proteção dos sujeitos de pesquisa, e que atualmente essa premissa não está sendo cumprida de modo adequado.

Abstract This study concerns the recruitment of research subjects in industry-sponsored multicentric international clinical trials carried out at a Brazilian public university between January 2010 and December 2016. A set of 63 clinical trial agreements, administrative and regulatory documents was analyzed. The results showed that 75 countries were involved in these international trials, of which 16% were Latin American. Data about the recruitment of research subjects at the local (356 subjects), national (3774 subjects) and international (82,696 subjects) levels were obtained, as well as information on the number of Brazilian research centers involved and the costs of each trial. Phase III trials were the most frequent (77.78% of the cases) and they estimated a total national enrollment between 18 and 80 research subjects per trial (which means between 4.42% and 11.46% of international recruitment). A negative correlation was found between agreements, research resources, recruitment data, and yearly average dollar exchange rate. All the trials adopted competitive recruitment method associated with payment for subject included in the research. This is worrying and shows contradiction between this practice and the recommended national ethical guidelines. The lack of data on recruitment at the national level reveals, in 19% of the cases, a frequent regulatory process failure. It is concluded that the availability of detailed data on recruitment for researches involving human beings is important for the accurate sizing and organization of the efforts to protect research subjects, and that currently this premise is not being appropriately followed.

A estrutura formada pelos conselhos de saúde representa um exemplo de como a democracia participativa é fundamental na legitimação das decisões sobre a gestão da saúde pública. A atuação desses conselhos avança para além da deliberação técnica e jurídica, alcançando a dimensão dos conflitos morais, onde elas são reorientadas à luz de uma ordem de deliberações que pode ser denominada moral. O estudo da Teoria das Ordens de Comte-Sponville pode auxiliar na compreensão da ordem moral no papel desempenhado pelos conselhos de saúde, bem como permite avaliar os desafios que se colocam para a manutenção e para a eficácia dessa estrutura na concretização das políticas de saúde no Brasil. O autor faz referência às ordens tecnocientífica e jurídico-política e destaca a necessidade de limitar estas ordens por meio da moralidade. A partir desse modelo teórico e da contribuição de autores nacionais, o presente artigo tenta compreender a estrutura adotada pelos conselhos de saúde e a ordem específica de manifestação do controle social.

The structure formed by the Health Councils represents an example of the importance of participatory democracy for the legitimation of the decisions on public health management. The existence of social control mechanisms of Brazilian public policies is also indispensable to the analysis of the subject matter in light of bioethics. Accordingly, the study of Comte-Sponville's ideas can aid the understanding of the role played by the Health Councils. The author refers to the techno-scientific and juridical-political orders, and he highlights the need to limit those orders through morality. Based on this theoretical model, the article attempts to comprehend the structure adopted by the Health Councils and the specific order of manifestation of social control. Finally, it emphasizes the importance of the consolidation of participatory forums and their capacity for aiding the democratization of the Brazilian institutions, as well as the need of increasing the social movements' participation, indicating that mobilization cannot be limited to the formal spaces of social control.

A estrutura formada pelos conselhos de saúde representa um exemplo de como a democracia participativa é fundamental na legitimação das decisões sobre a gestão da saúde pública. A atuação desses conselhos avança para além da deliberação técnica e jurídica, alcançando a dimensão dos conflitos morais, onde elas são reorientadas à luz de uma ordem de deliberações que pode ser denominada moral. O estudo da Teoria das Ordens de Comte-Sponville pode auxiliar na compreensão da ordem moral no papel desempenhado pelos conselhos de saúde, bem como permite avaliar os desafios que se colocam para a manutenção e para a eficácia dessa estrutura na concretização das políticas de saúde no Brasil. O autor faz referência às ordens tecnocientífica e jurídico-política e destaca a necessidade de limitar estas ordens por meio da moralidade. A partir desse modelo teórico e da contribuição de autores nacionais, o presente artigo tenta compreender a estrutura adotada pelos conselhos de saúde e a ordem específica de manifestação do controle social.

The structure formed by the Health Councils represents an example of the importance of participatory democracy for the legitimation of the decisions on public health management. The existence of social control mechanisms of Brazilian public policies is also indispensable to the analysis of the subject matter in light of bioethics. Accordingly, the study of Comte-Sponville's ideas can aid the understanding of the role played by the Health Councils. The author refers to the techno-scientific and juridical-political orders, and he highlights the need to limit those orders through morality. Based on this theoretical model, the article attempts to comprehend the structure adopted by the Health Councils and the specific order of manifestation of social control. Finally, it emphasizes the importance of the consolidation of participatory forums and their capacity for aiding the democratization of the Brazilian institutions, as well as the need of increasing the social movements' participation, indicating that mobilization cannot be limited to the formal spaces of social control.