The magic sextet of clinical research

This article approaches sonic general guidelines for evaluating clinical research (design, execution and reporting), including the initial research idea (or question to be answered), hypothesis and objective which should be aligned with the primary variable to be investigated and the conclusions reached on the basis of the results of the study. One cannot forget that the study title should reflect the idea and relative objective of the study and the conclusion, emphasizing the Magic Sextet of Research.Univ Fed Sao Paulo, Sao Paulo, BrazilUniv Estadual Ciencias Saude Alagoas UNCISAL, Maceio, AL, BrazilUCB, Med Acad, Berkeley, CA USAUniv Fed Sao Paulo, Sao Paulo, BrazilWeb of Scienc

Neovascularization after surgical exposure of rat external jugular vein endothelium

PURPOSE: To investigate the neovascularization after exposure of the external jugular venous endothelium in an experimental model. METHODS: The sample was composed of 60 male rats of Wistar OUT B breed provided by animal colony of the Medicine College of Juazeiro do Norte, weighing 250 to 350g, aged 90-120 days. Randomized study in OUT B Wistar rats, open, with 60 days duration. The animals were distributed into three groups of 20 specimens and were subjected to the following: Group 1: neck incision with dissection, ligation and section of the external jugular vein. Group 2: neck incision with dissection and ligation of the external jugular vein. Group 3: cervicotomy without dissection of the external jugular vein without ligation or section. The animals were sacrificed, half of them in 30 days and the other half within 60 days. The material in block harvested from the operated site were sectioned and stained for immunohistochemistry with CD34 marker. RESULTS: Neovascularization occurred with level of significance when compared group 1 to group 3 at 30 days (p=0.0076) and the same occurred at 60 days (p=0.0001) (Newman-Keuls test). CONCLUSION: The group with exposure of the venous endothelium showed a significant increase of neovascularization when compared with other groups.São Paulo Federal University Postgraduate Program in Interdisciplinary Surgical ScienceUniversity of Health Sciences of Alagoas Department of SurgeryUNIFESP Paulista School of Medicine Department of SurgerySão Paulo Federal University Postgraduate Program in Interdisciplinary Surgical ScienceUNIFESP, Paulista School of Medicine Department of SurgerySciEL

Assessment of calf muscle pump in patients with primary varicose veins of the lower limbs by air plethysmography

OBJECTIVE: This article aims at assessing the influence of calf muscle vein reflux (suraland genicular veins) on calf muscle pump function in patients with primary varicose veins of the lower limbs. METHODS: Cross-sectional and prospective study assessing 120 patients divided into two groups (60 subjects each) by physical examination, duplex scan and air plethysmography. The first group showed calf muscle venous reflux, whereas the second group presented absence of reflux. Both groups were examined by air plethysmography to verify calf pump function through measurement of ejection fraction, residual volume fraction, ejected volume and venous filling index in both limbs. RESULTS: In the group of patients with reflux, ejection fraction indexes lower than 60% (p < 0.001) were found in 82.3% (left leg) and 74.6% (right leg) of cases. Levels of residual volume fraction greater than 60% were identified in 62.5% (left leg, p= 0.015) and in 86.7% (right leg, p = 0.014) of assessed cases. There was no statistically significant variation concerning the venous filling index between groups with or without reflux, with p= 0.140 in both legs. Of all patients, 63.6% had calf vein reflux (left leg) and 61.8% (right leg) had ejection volume greater than 150 mL (p = 0.001). CONCLUSIONS: The calf pump function decreased in both lower limbs, due to presence of calf muscle vein reflux (genicular and sural veins).OBJETIVO:Avaliar a influência do refluxo das veias musculares da panturrilha (surais e geniculares) na função da bomba muscular da panturrilha em pacientes com varizes primárias nos membros inferiores. MÉTODOS: Estudo transversal prospectivo, no qual os pacientes foram avaliados por meio de exame físico, mapeamento dúplexe pletismografia a ar. Foram selecionados 120 pacientes divididos em dois grupos (60 indivíduos em cada). O primeiro grupo apresentava refluxo das veias musculares da panturrilha e o segundo grupo apresentava ausência de refluxo. Cada grupo foi analisado com pletismografia a ar para estudo da função da bomba da panturrilha. As variáveis estudadas foram fração de ejeção, fração do volume residual, volume ejetado e índice de enchimento venoso para membro inferior direito e esquerdo. RESULTADOS: No grupo com refluxo, índices de fração de ejeção abaixo de 60% (com p < 0,001) foram encontrados em 82,3% (em perna esquerda) e em 74,6% (em perna direita) dos casos. Índices de fração do volume residual acima de 60% foram identificados em 62,5% (em perna esquerda, p = 0,015) e em 86,7% (em perna direita, p = 0,014) dos casos avaliados. Não houve variação estatisticamente significativa para o índice de enchimento venoso entre os grupos com e sem refluxo, com p = 0,140 e p = 0,140 para pernas esquerda e direita, respectivamente. Foram encontrados 63,6% dos pacientes com refluxo das veias da panturrilha (em perna esquerda), e 61,8% (em perna direita) com volume ejetado acima de 150 mL (p = 0,001). CONCLUSÕES: Houve alteração da bomba muscular da panturrilha, levando a uma diminuição de sua função, em ambos os membros inferiores por conseqüência da presença do refluxo das veias musculares da panturrilha (geniculares e surais).Universidade Federal de Campina Grande Universidade Federal de Campina GrandeUniversidade Estadual de Ciências da Saúde de Alagoas Escola de Ciências Médicas de Alagoas Departamento de Medicina SocialUniversidade Federal de São Paulo (UNIFESP)UNIFESPSciEL

Evaluation of venous reflux by color duplex scanning in patients with varicose veins of the lower limbs: correlation with clinical severity by CEAP classification

Background: Skin changes observed in chronic venous insufficiency have venous reflux as the most common etiology. Some authors have reported that reflux in the superficial venous system accounts for 40-60% of leg ulcers in patients with primary varicose veins. Objective: To evaluate the correlation between superficial venous reflux and clinical status (CEAP classification - clinical, etiology, anatomy and pathophysiology) in patients with primary varicose veins of the lower limbs using duplex scanning. Method: A cross-sectional and descriptive study was performed in patients with primary varicose veins. Primary variables were venous reflux and clinical status. Clinical status was characterized by groups A, B, and C, represented by CEAP clinical categories. Types of venous reflux in the great and small saphenous veins were used as complementary data, according to Engelhorn’s classification (2004). Hypotheses of interrelationship between incidence and types of reflux were statistically analyzed using Fisher’s exact and chi-square tests. Significance was set at 0.05%. Results: Of 242 lower limbs, 15 were excluded, so that the final sample was comprised of 227 lower limbs. Ninety-nine (83.9%) patients were female. Mean age was 50 years and median was 49 years. Reflux was absent in 93 limbs (41%), and 134 (59%) showed isolated and/or associated reflux. Isolated reflux in perforating veins (p = 0.0008) or in association with great saphenous vein reflux (p < 0.0001) was significantly related to clinical status severity. Conclusion: Duplex scan showed correlation between presence of superficial venous reflux and clinical status severity in patients with primary varicose veins of the lower limbs.Contexto: As alterações de pele manifestadas na insuficiência venosa crônica têm como etiologia mais comum o refluxo venoso. Alguns autores relatam que o refluxo venoso superficial é responsável por 40-60% das úlceras de perna nos portadores de varizes primárias. Objetivo: Correlação do refluxo venoso superficial ao mapeamento dúplex com o quadro clínico (classificação CEAP - clínica, epidemiológica, anatômica e fisiopatológica) nos portadores de varizes primárias de membros inferiores. Método: Estudo transversal e descritivo, desenvolvido em portadores de varizes primárias. As variáveis primárias foram: refluxo venoso e quadro clínico. O quadro clínico foi caracterizado por grupos: A, B e C, representados pelas categorias clínicas da CEAP. Dados complementares foram: tipos de refluxo em veias safenas magnas e parvas, conforme classificação de Engelhorn (2004). Testaram-se as hipóteses de inter-relações entre presença de refluxo e quadro clínico, utilizando-se os testes exato de Fisher e qui-quadrado no nível de 5% de probabilidade. Resultados: Das 242 extremidades inferiores examinadas, 15 foram excluídas, totalizando 227 na amostra final. Noventa e nove (83,9%) pacientes eram do sexo feminino. A média de idade foi de 50 anos, com mediana igual a 49 anos. Noventa e três extremidades (41%) não apresentavam refluxo, e 134 (59%) o apresentavam isolado e/ou associado. O refluxo isolado em veias perfurantes (p = 0,0008) e destas em associação com o refluxo em veias safenas magnas (p < 0,0001) estão significativamente relacionados à gravidade do quadro clínico. Conclusão: Há correlação entre a presença do refluxo venoso superficial ao mapeamento dúplex e a gravidade do quadro clínico nos portadores de varizes primárias de membros inferiores.Hospital das Clínicas Dr. José Augusto Leite , SBACV e Associação Médica BrasileiraUniversidade Federal de São Paulo (UNIFESP) Escola Paulista de MedicinaUniversidade Estadual de Ciências da Saúde de Alagoas Governador Lamenha Filho Escola de Ciências Médicas de Alagoas Departamento de CirurgiaUNCISAL Departamento de Medicina SociaUNIFESP, EPMSciEL

Anatomical study of valves in the gastrocnemius trunk in human cadavers

BACKGROUND: Valves are characteristic structures of veins and are important to guide blood flow. Their presence in the superficial venous system of lower limbs has been well studied. However, there is a lack of published literature on deep veins, such as the gastrocnemius vein. OBJECTIVE: To carry out an anatomical study of the veins in the main gastrocnemius trunk in adult human cadavers. METHODS: The main gastrocnemius trunks of 80 gastrocnemius muscle heads of 20 adult cadavers were dissected. The cadavers were males, aged between 40 and 68 years, and fixed in 10% formaldehyde solution. Trunks and net types were classified according to Aragão et al.'s proposal. The valves were studied as to quantity, distribution, location and type with regard to trunk, leg, muscle head and type of gastrocnemius net. RESULTS: Of 80 gastrocnemius muscle heads, there were 95 main gastrocnemius trunks, and 17 were duplicated. There were 65 valves in 60 gastrocnemius trunks, all of them bicuspid: 35 in type I net, 23 in type II and seven in type III net. Valves were located in the proximal third of the main gastrocnemius trunk in 74% of cases. CONCLUSION: Valves were found in all net types that had main gastrocnemius trunk. These valves were bicuspid and predominantly located in the proximal third of main gastrocnemius trunks.CONTEXTO: As válvulas são estruturas características das veias, importantes na orientação do fluxo sangüíneo. Sua presença no sistema venoso superficial dos membros inferiores tem sido bastante estudada. No entanto, nas veias profundas, como a veia gastrocnêmia, a literatura é escassa. OBJETIVO: Realizar um estudo anatômico das válvulas do tronco gastrocnêmio principal em cadáveres humanos adultos. MÉTODOS: Foram dissecados os troncos gastrocnêmios principais de 80 cabeças de músculos gastrocnêmios de 20 cadáveres adultos do sexo masculino, com idade entre 40 e 68 anos, após fixados e mantidos em solução de formol a 10%. Os troncos e tipos de redes foram classificados de acordo com o proposto por Aragão et al. As válvulas foram estudadas quanto ao número, distribuição, localização e tipo com relação ao tronco, perna, cabeça do músculo e tipo de rede gastrocnêmia. RESULTADO: Em 80 cabeças de músculos gastrocnêmios, foram encontrados 95 troncos gastrocnêmios principais, sendo que 17 deles eram duplicados. Foram encontradas 65 válvulas em 60 troncos gastrocnêmios principais, todas elas do tipo bicúspide, sendo 35 na rede tipo I, 23 na do tipo II e sete na rede tipo III. Em 74% dos casos, as válvulas estavam localizadas no terço proximal do tronco gastrocnêmio principal. CONCLUSÃO: As válvulas foram encontradas em todos os tipos de redes que possuíam tronco gastrocnêmio principal, eram todas do tipo bicúspide e se localizaram predominantemente no terço proximal dos troncos gastrocnêmios principais.Universidade Federal de SergipeUniversidade TiradentesUniversidade Federal de São Paulo (UNIFESP)UNIT Instituto de Tecnologia e Pesquisa Laboratório de Morfologia e Biologia EstruturalUNIFESP Departamento de CirurgiaUniversidade Estadual de Ciências da Saúde de AlagoasUNIFESP, Depto. de CirurgiaSciEL

Financial implementation and the impact of vascular surgery task force, after the creation of the Strategic Actions and Compensation Fund (FAEC)

BACKGROUND: In spite of the fact that the number of surgeries presented by the elective surgery task force did not entirely reflect the reality, it is possible to declare that the financial implementation of the Brazilian Ministry of Health has been significative, as well as the increasing number of varicose vein surgeries, especially after the creation of the Strategic Actions and Compensation Fund (FAEC). OBJECTIVE: To evaluate the application of financial investment in the Ministry of Health campaign for varicose vein surgery. METHODS: A transversal study of retrospective nature has been conducted, using information available at the Data Processing Department of the National Healthcare System database (DATASUS). All the authorization of hospital internment from the inferior member varicose vein surgeries, financed by the Brazilian Ministry of Health from January 1998 to December 2004, have been included in the research. RESULTS: In 1998, before the implementation of the elective surgery task force, 23,531 varicose vein surgeries have been performed, and R$5,819,033.27 invested. After the creation of the FAEC, 457,026 inferior member varicose vein surgeries have been performed from 1999 to 2004, and R$ 187,760,196.81 were invested with an average of R$31,293,336.13 per year. CONCLUSION: Thus, it is possible to conclude that the bigger investment from the Brazilian Ministry of Health, represented by the implementation of the elective surgery task forces by the FAEC, has been responsible for increasing the number of varicose vein surgeries all around Brazil.CONTEXTO: Apesar de reconhecer que o número apresentado pelo mutirão de cirurgias eletivas não refletisse inteiramente a realidade, foi significativa a implementação financeira do Ministério da Saúde do Brasil, bem como o aumento de cirurgias de varizes, após criação do Fundo de Ações Estratégias e Compensação (FAEC). OBJETIVO: Avaliar os resultados da aplicação do investimento financeiro do Ministério da Saúde no mutirão de cirurgias de varizes. MÉTODOS:Foi realizado um estudo transversal de natureza retrospectiva, utilizando informações do banco de dados do Departamento de Informática do Sistema Único de Saúde. Foram incluídas na pesquisa todas autorizações de internação hospitalar das cirurgias de varizes de membros inferiores pagas pelo Ministério da Saúde do Brasil, no período de janeiro de 1998 a dezembro de 2004. RESULTADOS: Em 1998, antes da implementação do mutirão de cirurgias eletivas foram realizadas 23.531 cirurgias de varizes e investidos R$ 5.819.033,27. Após a criação do FAEC, foram realizadas 457.026 cirurgias de varizes de membros inferiores, no período de 1999 a 2004, e foram investidos R$187.760.196,81 com média de R$ 31.293.336,13 por ano. CONCLUSÃO: O investimento feito pelo Ministério da Saúde durante o programa de mutirões de cirurgias eletivas pelo FAEC, proporcionou aumento significativo do número de cirurgias de varizes em todo Brasil.Sociedade Brasileira de Angiologia e de Cirurgia VascularUniversidade Federal de São Paulo (UNIFESP) Departamento de Cirurgia VascularUniversidade de São Paulo Faculdade de Medicina Departamento de CirurgiaUNCISALUniversidade Tiradentes Faculdade de MedicinaUNIFESP, Depto. de Cirurgia VascularSciEL

Evaluation of the venous reflux of the great saphenous vein by duplex scan after surgical treatment of the saphenofemoral junction insufficiency

OBJECTIVE: To evaluate the occurrence of reflux from the great saphenous vein by color Doppler ultrasonography in subjects undergoing treatment of insufficiency of the saphenofemoral junction by simple ligation or ligation with section of the saphenous arch. METHODS: We performed 60 operations (in 45 subjects) of varicose insufficiency of the saphenofemoral junction (SFJ), belonging to the CEAP clinical classification of 2-5, who were randomly divided into two groups. A group called C, with ligature and section of the saphenous arch, and a group called L, with simple ligation of the saphenous vein and no sectioning of its arch. We then investigated the occurrence of reflux from the great saphenous vein in groups C and L through postoperative color Doppler ultrasonography at intervals of six months to one year. RESULTS: Of the 60 members submitted to the approach of the saphenous arch, 57 were evaluated by postoperative doppler ultrasound, since two subjects (three limbs) did not return and were excluded from the study. The mean age was 54 years, with 93% females and predominance of CEAP classification 2 in 60.5%. Of the 57 operations for the treatment of reflux of the saphenous arch, 43.9% had reflux postoperatively,14.1% in group C and 29.8% in group L (p < 0,05). The relative risk of reflux of the saphenous arch in group L was 2.03 times higher compared with group C. CONCLUSION: the section of the arch of the great saphenous vein causes less postoperative reflux than simple ligation in treatment of insufficiency of the great saphenous vein.OBJETIVO: avaliar a ocorrência do refluxo da safena magna através da ultrassonografia com Doppler colorido em sujeitos submetidos ao tratamento da insuficiência da junção safeno-femoral por ligadura simples ou por ligadura com secção da crossa. MÉTODOS: foram realizadas 60 operações (45 sujeitos) de varizes com insuficiência da junção safeno-femoral (JSF), pertencentes à classificação clínica do CEAP 2 a 5, que foram distribuídos aleatoriamente em dois grupos. Um grupo denominado C, com ligadura e secção da crossa, e um grupo denominado L, com ligadura simples sem secção da crossa da veia safena magna. Foi então pesquisada a ocorrência do refluxo da safena magna nos grupos C e L através da ultrassonografia doppler colorida após o tratamento cirúrgico com intervalos de seis meses a um ano. RESULTADOS: dos 60 membros submetidos à abordagem da crossa da safena magna, 57 foram avaliados pela ultrassonografia doppler pós-operatório, pois dois sujeitos (três membros) não retornaram e foram excluídos do estudo. A média de idade foi 54 anos, 93% do sexo feminino e predominância da classificação (CEAP) C2 de 60,5%. Das 57 operações para o tratamento do refluxo da crossa da safena, 43,9% apresentaram refluxo no pós-operatório, sendo 14,1% do grupo C e 29,8% no grupo L (p<0,05). O risco relativo de apresentar refluxo da crossa da safena no grupo L foi 2,03 vezes maior em comparação com o grupo C. CONCLUSÃO: a secção da crossa da safena magna apresenta menos refluxo pós-operatório do que a ligadura simples no tratamento da insuficiência da crossa da veia safena magna.Universidade Potiguar Disciplina de Cardio-Renal-VascularUniversidade Estadual de Ciências da Saúde de Alagoas Departamento de Medicina SocialUniversidade Estadual de Santa Cruz Departamento de Saúde Disciplina de AngiologiaUniversidade Federal de São Paulo (UNIFESP) Departamento de Cirurgia Disciplina de Cirurgia VascularUniversidade Estadual de Ciências da Saúde de Alagoas Clinica CirúrgicaUNIFESP, Depto. de Cirurgia Disciplina de Cirurgia VascularSciEL

Alprostadil attenuates inflammatory aspects and leucocytes adhesion on renal ischemia and reperfusion injury in rats

PURPOSE:To evaluate the effects of alprostadil in an experimental model of ischemia and reperfusion injury (IRI) in rat renal tissue.METHODS: Adult male Wistar rats were randomized into three groups Vehicle-treated group(Veh), Alprostadil-treated(Al), and sham(Sh) group. Veh and Al groups had suprarenal aorta occluded for 30 minutes and reperfused for 60 minutes. Saline or 20 µg/kg of Alprostadil was intravenously infused immediately before declamping. Sh group animals underwent similar procedure without aortic occlusion. Left nephrectomy and blood sampling were performed after 60 minutes of reperfusion. Renal ICAM-1 expression and histological analysis were performed to estimate inflammatory response and tissue disarrangement. Serum biochemical markers for IRI were also measured. Kruskal-Wallis test was used to assess differences between the groups.RESULTS: There was lower expression of ICAM-1 in groups Veh and Sh. On histologically evaluation, inflammation and necrosis in the Veh group was significantly higher (grades III/IV) than Al group (Veh>Al=Sh; p = 0.025), as well as CPK levels (Veh>Al=Sh; p = 0.03).CONCLUSION: Alprostadil attenuates the immunohistochemical and histological repercussions in the renal tissue of rats submitted to a post-ischemic reperfusion with supra-renal aortic clamping.Federal University of São Paulo Department of SurgeryFederal University do Vale do São Francisco Faculty of NursingUniversity of São Paulo Faculty of Medicine Department of SurgeryUniversity of Health Sciences of Alagoas Faculty of MedicineUniversidade Federal de São Paulo (UNIFESP) Department of Surgery Faculty of MedicineUNIFESP, Department of SurgeryUNIFESP, Department of Surgery Faculty of MedicineSciEL