Generic versus branded enoxaparin in the prevention of venous thromboembolism following major abdominal surgery: report of an exploratory clinical trial.

INTRODUCTION: Several generic low-molecular-weight heparins (LMWHs) have recently become available worldwide, including the United States. Companies have filed for regulatory approval of generic versions in many countries, based only on compound biochemical characteristics or its immunogenicity. METHODS: Prospective study to evaluate the comparative effect of 2 enoxaparins (Sanofi-Aventis branded enoxaparin [SAe] vs eurofarma-enoxaparin [Ee], a generic version) as prophylaxis for venous thromboembolism (VTE) following major abdominal surgery. A total of 200 patients were randomized in a 1:1 ratio either to receive 40 mg of SAe or Ee subcutaneously (sc) once daily (od) postoperatively for 7 to 10 days. Compressive ultrasound was performed on day 10 + 4. RESULTS: No statistically significant differences between the 2 groups were detected. In all, 2 SAe patients presented deep vein thrombosis ([DVT] 2.1%), none of the Ee group. No major bleeding events occurred. CONCLUSIONS: This exploratory trial suggests that the generic LMWH is probably as safe and as effective as the branded enoxaparin (Lovenox, Brazil) in the prophylaxis of VTE in this population.

Review: contaminants in heparin: review of the literature, molecular profiling, and clinical implications.

BACKGROUND: The contaminant isolated from contaminated heparin was oversulfated chondroitin sulfate (OSCS). Other possible contaminants should be evaluated. METHODS: Contaminants were isolated from recalled contaminated heparin and were compared to OSCS from animal sources and to heparin by-products synthetically persulfated. RESULTS: A great variability in molecular weight was observed in the isolated contaminants. Dermatan sulfate with high-molecular-weight in addition to OSCS was detected. Oversulfated chondroitin sulfate from different sources as well as heparin by-products produced activation of prekallikrein to kallikrein at variable rates as measured by the generation of kallikrein. All agents produced activation of the complement system. All compounds formed complexes with platelet factor 4 (PF4) and all produced (14)C serotonin release in the heparin-induced thrombocytopenia (HIT) analysis. The agents also exhibited variable anticoagulant responses that were mostly mediated via heparin cofactor II. CONCLUSION: These results suggest that heparin contaminants represent a heterogeneous group of oversulfated glycosaminoglycans (OSGAGs) which may mediate multiple pathophysiologic responses.

Latero-lateral femoro-femoral arteriovenous fistula: a new surgical approach for hemodialysis patients with no vascular access / Fístula artériovenosa fêmoro-femoral látero-lateral: uma nova abordagem para hemodiálise de pacientes sem opção de acesso vascular

Purpose: A new surgical approach for vascular access for hemodialysis using a latero-lateral arteriovenous fistula (AVF) in the thigh between the femoral artery (FA) and superficial femoral vein (SFV) transposed to the subcutaneous layer in patients with no other access options is described. Methods: Ten patients (mean age: 37,9 years) for whom all possible sites for execution of any other procedure had been exhausted, underwent latero-lateral AVF close to the adductor channel between the FA and the SFV. The FSV was released and sectioned 2 cm from its confluence with the deep femoral vein and transposed in the subcutaneous tissue with extensions using saphenous vein or prosthetic material (PTFE) when needed. Follow -up included patency, flow evaluation and complications. Results: Postoperative follow-up ranged from 3 to 96 months, with a mean of 38 months. The AVFs presented a flow of more than 350 ml/min and the AVFs remained patent for a mean period of 38 months. There were three failures of the procedures at 3, 5 and 7 months during postoperative follow-up due to graft infection and thrombosis (a case), anaphylactic shock and thrombosis (a case) and calf pain during dialysis (a case). Two patients developed slight inferior limb edema. Conclusion: The new surgical approach for access for hemodialysis represents a feasible procedure, with acceptable patency rates in exceptional cases where no other access option is available.

Objetivo: Nova abordagem para acesso vascular para hemodiálise usando fistula artério-venosa (FAV) látero-lateral na coxa entre a artéria femoral (AF) e a veia femoral superficial (VFS) transposta no subcutâneo em pacientes sem opção de acesso. Métodos: Dez pacientes (idade média 37,9 anos), cuja possibilidade de acesso havia sido exaurido, foram submetidos a FAV látero-lateral na coxa entre a AF e a VFS.Esta veia foi liberada e seccionada 2 cm de sua confluência com a veia femoral profunda e transposta no plano superficial com extensão usando a veia safena ou material protético (PTFE) quando necessário.O seguimento incluíu a perviedade , fluxo e complicações. Resultados: O seguimento pós-operatório foi de 3 a 96 meses (média 38). A FAV apresentou fluxo mínimo de 350 ml/min e permaneceu pérvia no período médio de 38 meses. Houve 3 falências aos 3, 5, e 7 meses pós-operatórios por infecção de prótese e trombose da FAV (um caso), choque anafilático e trombose (um caso) e dor na panturrilha na hemodiálise (um caso). Dois pacientes desenvolveram discreto edema de membro inferior. Conclusão: A nova abordagem para acesso vascular para hemodiálise representa um procedimento factível, com aceitável perviedade em casos excepcionais onde nenhum outro acesso é disponível.

Latero-lateral femoro-femoral arteriovenous fistula: a new surgical approach for hemodialysis patients with no vascular access.

PURPOSE: A new surgical approach for vascular access for hemodialysis using a latero-lateral arteriovenous fistula (AVF) in the thigh between the femoral artery (FA) and superficial femoral vein (SFV) transposed to the subcutaneous layer in patients with no other access options is described. METHODS: Ten patients (mean age: 37,9 years) for whom all possible sites for execution of any other procedure had been exhausted, underwent latero-lateral AVF close to the adductor channel between the FA and the SFV. The FSV was released and sectioned 2 cm from its confluence with the deep femoral vein and transposed in the subcutaneous tissue with extensions using saphenous vein or prosthetic material (PTFE) when needed. Follow -up included patency, flow evaluation and complications. RESULTS: Postoperative follow-up ranged from 3 to 96 months, with a mean of 38 months. The AVFs presented a flow of more than 350 ml/min and the AVFs remained patent for a mean period of 38 months. There were three failures of the procedures at 3, 5 and 7 months during postoperative follow-up due to graft infection and thrombosis (a case), anaphylactic shock and thrombosis (a case) and calf pain during dialysis (a case). Two patients developed slight inferior limb edema. CONCLUSION: The new surgical approach for access for hemodialysis represents a feasible procedure, with acceptable patency rates in exceptional cases where no other access option is available.

An open label, non-randomized, prospective clinical trial evaluating the immunogenicity of branded enoxaparin versus biosimilars in healthy volunteers.

INTRODUCTION: Compositional variations among biosimilar enoxaparin could lead to a differential immunogenic response between these preparations. METHODS: Enoxaparin (Clexane, n = 110) and a biosimilar version (Cutenox, n = 110) were administered to healthy volunteers in Brazil, 40 mg subcutaneous (SQ), daily, for 10 days. Blood was collected at baseline, days 1 and 10, and analyzed for antiheparin/PF4 antibody (AHPF4 antibodies) titers and subtypes by enzyme-linked-immunosorbent serologic assay (ELISA). RESULTS: Low-molecular-weight heparin (LMWH) treatment resulted in AHPF4 antibodies generation, with differences on day 10 (P < .05). Antibody subtyping (immunoglobulin [Ig] G, IgA, IgM) demonstrated different profiles between LMWH with statistical significance for IgG (Clexane 10 = 0.21 ± 0.06, Cutenox 10 = 0.28 ± 0.10, P < .0001) and IgA (Clexane 10 = 0.15 ± 0.02, versus Cutenox 10 = 0.13 ± 0.02, P < .0001) on day 10, with a significant drug effect (P < .0001) and significant time by drug interaction (P = .0009). All antibody titers were stated in terms of optical density (OD) units. CONCLUSION: LMWHs immunogenic potential varies to generate AHPF4 antibodies and subtypes and cross-reactivity with preformed antibodies. Such parameters may be useful in defining the biosimilar LMWHs bioequivalence. Future studies evaluating the immunogenicity of biosimilar drugs are warranted.

Vascular flow of the gastric fundus after arterial devascularization: an experimental study.

BACKGROUND: The main complication of transhiatal subtotal esophagectomy with esophagogastric reconstruction is anastomotic leak, which is responsible for a large number of postoperative deaths. It is believed that this complication is due to gastric fundus ischemia caused by the sectioning of the short gastric, left gastric, and left gastro-omental arteries. The literature, however, presents controversies. An experimental study was performed with the aim of evaluating the vascularization of the gastric fundus following sectioning of these arteries. MATERIALS AND METHODS: Forty mongrel dogs were distributed into 2 groups: a control group consisting of 15 dogs subjected to surgical simulation and an experimental group consisting of 25 dogs that underwent sectioning of these arteries. Fluorescein testing, gastric mummification, and morphometric image analysis were performed on both groups. RESULTS: In comparison with the control group, fluorescein testing on the experimental group demonstrated time-delayed fluorescence in the gastric fundus and partial coloring, (P < 0.001). Image analysis on the mummified gastric samples demonstrated significant reduction in blood vessels in the gastric fundus of the experimental group (P < 0.001). CONCLUSIONS: We conclude that sectioning of the short gastric, left gastric, and left gastro-omental arteries causes reduction in blood circulation and in the quantity of blood vessels on the anterior side of the gastric fundus of dogs.

A cost analysis of the treatment of patients with post-thrombotic syndrome in Brazil.

INTRODUCTION: Post-thrombotic syndrome (PTS) occurs in 15-50% of patients with deep vein thrombosis (DVT), and is associated with substantial medical costs. This prospective observational study investigated the costs associated with the treatment of PTS in Brazil. MATERIALS AND METHODS: A total of 157 patients diagnosed with PTS and with a history of DVT were recruited from nine centers in Brazil. The costs of investigations and treatment for PTS over a 1-year follow-up period were analyzed. Ninety patients were available for this analysis. RESULTS: Of the 90 patients, 17 had mild-to-moderate PTS, and 73 had severe PTS. The patients with severe PTS tended to undergo more investigations and hospitalizations for PTS than those with mild-to-moderate PTS, although the differences between the two groups did not reach statistical significance. The mean annual cost of treating PTS in Brazilian Reais was 1214 R dollars (426 US dollars) for mild-to-moderate PTS and 3386 R dollars (1188 US dollars) for severe PTS. The difference was mainly due to significantly higher hospitalization costs in patients with severe PTS (704 R dollars/247 US dollars vs. 0 R dollars; p=0.044). CONCLUSION: These results suggest that PTS imposes substantial demands on health care resources in Brazil. The implementation of effective thromboprophylactic strategies could significantly reduce the incidence of DVT, and hence of PTS, potentially resulting in significant cost savings.

Colecistectomia videolaparoscópica ambulatorial: estudo de 60 casos / Laparoscopic cholecystectomy in an ambulatory care setting: study of 60 cases

Os autores apresentam sua experiência com 60 pacientes operados de colecistectomia videolaparoscópica em regime ambulatorial, no Hospital de Ensino da Faculdade de Medicina do ABC. Cinqüenta e um pacientes (85%) eram do sexo feminino e 9 (15%) do masculino, a idade variou de 21 a 60 anos, com média de 40,5 anos. Foram submetidos ao procedimento pacientescom diagnóstico de colecistite crônica calculosa, que obedeciam os seguintes critérios: inexistência de colecistite aguda, idade máxima de 60 anos, ausência de coledocolitíase, avaliação clínica pré-operatória ASA I ou II, aprovação do paciente quanto ao método e período de internação empregados e presença de acompanhante. O posicionamento da equipe e a técnica utilizada foi aquela preconizada pela escola americana. O tempo cirúrgico variou de 40 minutos a 2 horas e meia, com média de 1 hora e 35 minutos. A colangiografia intra-operatória foi realizada em 44 pacientes (73%), demonstrando coledocolitíase em dois casos (3%), que necessitou conversão para cirurgia aberta. As complicações mais freqüentes no período pós-operatório imediato foram náuseas e vômitos em cinco casos (8%), seguidas de dor abdominal intensa em dois casos (3%). Foram tratados com anti–eméticos e analgésicos e tiveram a alta hospitalar adiada para o dia seguinte à cirurgia. Cinqüenta e um pacientes (85%) tiveram condições de alta no mesmo dia da cirurgia. O período de permanência hospitalar foi entre 9 e 12 horas. O retorno ambulatorial era programado para o sétimo e trigésimo dia pós-operatório, não-havendo necessidade de reinternação em nenhum caso.

Adenocarcinoma de apêndice: relato de dois casos / Appendicecal carcinoma: report of two cases

The authors report two cases of patients with appendix adenocarcinoma, manifested as a syndrome of abdominal tumor of unknown origin. It was not possible to perform etiological diagnosis in the preoperative period for any of them. Literature data show that large locoregional tumor is a manifestation of appendix adenocarcinoma, although acute appendicites is the most frequent clinical manifestation. Preoperative diagnosis is rare and usually performed during laparotomy or through histopathological examination of the specimen. In large tumors, total mass resection including hemicolectomy should be carried out whenever possible. Whenever diagnosis of appendix adenocarcinoma is performed by the histopathological examination of the acute appendicites specimen, re-intervention is indicated for a right hemicolectomy.

Preparo intra-operatório do cólon / Intraoperative bowel preparation

OBJETIVO: Apresentar nossa experiência com o preparo intra-operatório do cólon no tratamento de pacientes com obstrução neoplásica do cólon esquerdo. MÉTODO: Vinte e três pacientes com obstrução neoplásica do cólon esquerdo foram operados no Hospital de Ensino da Faculdade de Medicina do ABC e no Hospital São Bernardo no período de 1992 a 1999. O preparo intra-operatório do cólon e a anastomose intestinal primária foram realizados em todos os pacientes e os resultados analisados. RESULTADOS: Em todos os pacientes o preparo de cólon foi adequado e a anastomose intestinal primária foi realizada em condições satisfatórias. Um paciente (4,3%) apresentou fístula bloqueada e outro (4,3%) broncopneumonia, complicações estas não relacionadas com o método de preparo intestinal; ambos evoluíram bem com tratamento clínico. Os demais não apresentaram complicações e permaneceram internados em média sete dias. CONCLUSÕES: O preparo intra-operatório do cólon é um método simples, seguro e permite a reconstrução imediata do trânsito intestinal em situações adversas.

BACKGROUND: In this study we present our experience with intraoperative colon preparation when treating patients bearing left colon neoplasic obstruction. METHOD: Twenty-three patients with left colon neoplasic obstruction were operated in the School Hospital of the ABC Medical College and Hospital São Bernardo from 1992 to 1999. The intraoperative bowel preparation and the primary bowel anastomosis was performed in all patients. RESULTS: In all patients the bowel preparation was adequate and the primary bowel anastomosis was performed in satisfactory conditions. One of the patients (4,3%) presented a bloked leak and another (4,3%) had bronchial pneumonia. Both responded well to clinical treatment and it was considered that these complications were not related to the bowel preparation procedures. None of the other patients presented complications, with a mean hospital stay of 7 days. CONCLUSIONS: The authors concluded that intraoperative bowel preparation is simple, safe and allows immediate reconstruction of the intestinal transit.

Colecistectomia videolaparoscópica ambulatorial / Laparoscopic cholecystectomy in an ambulatory care setting

OBJETIVO: Os autores apresentam sua experiência com 50 pacientes operados de colecistectomia videolaparoscópica em regime ambulatorial, no Hospital de Ensino da Faculdade de Medicina do ABC. MÉTODO: Quarenta e dois pacientes (84 por cento) eram do sexo feminino e oito (16 por cento) do masculino, a idade variou de 23 a 60 anos, com média de 41,5 anos. Foram submetidos ao procedimento pacientes com diagnóstico de colecistite crônica calculosa, que obedeciam aos seguintes critérios: inexistência de colecistite aguda, idade máxima de 60 anos, ausência de suspeita de coledocolitíase, avaliação clínica pré-operatória ASA I ou II, aprovação do paciente quanto ao método e período de internação empregados e presença de acompanhante. O posicionamento da equipe e a técnica utilizada foram os preconizados pela escola americana. RESULTADOS: O tempo cirúrgico variou de 50 minutos a 2 horas, com média de 1 hora e 25 minutos. A colangiografia intra-operatória foi realizada em 35 pacientes (70 por cento), demonstrando coledocolitíase em um caso (2 por cento), que necessitou conversão para cirurgia aberta. As complicações mais freqüentes no período pós-operatório imediato foram náuseas e vômitos em três casos (6 por cento), seguidas de dor abdominal intensa em dois casos (4 por cento). Foram tratados com antieméticos e analgésicos e tiveram a alta hospitalar adiada para o dia seguinte à operação. Quarenta e quatro pacientes (88 por cento) tiveram condições de alta no mesmo dia. O período de permanência hospitalar foi entre nove e 12 horas. O retorno ambulatorial era programado para o sétimo e trigésimo dias pós-operatório, não havendo necessidade de reinternação em nenhum caso. CONCLUSÕES: A colecistectomia videolaparoscópica ambulatorial é um procedimento seguro.

BACKGROUND: The authors present their experience with 50 patients undergoing videolaparoscopic cholecystectomy in an ambulatory care setting at University Hospital, ABC Medical School. METHODS:Forty-two patients (84 percent) were female and 8 (16 percent) male, age ranged from 23 and 60 years, mean age 41,5 years. Patients with diagnosis of calculous chronic cholecystitis were selected under the following criteria: no accute cholecystitis, maximum age of 60 years, no suspicion of choledocolithiasis, preoperative clinical evaluation ASA I or II, patient consent for the procedure and hospitalization period and presence of a companion. The team position and operative technique were the same as the american school. RESULTS: Surgical time ranged from 50 minutes to 2 hours, mean time of 1 hour and 25 minutes. Intraoperative cholangiography was carried out in 35 patients (70 percent), showing choledocolithiasis in one case (2 percent), requiring a shift toward an open surgery. The most frequent complications in the early postoperative period were nausea and vomit in 3 cases (6 percent), followed by intense abdominal pain in 2 cases (4 percent). These patients were treated with antiemetic drugs and analgesics and were discharged one day after the surgery. Forty-four patients (88 percent) were discharged after a mean hospitalization period of 12 hours. Follow-up visits were scheduled for postoperative day 7 and 13 and none of patients required readmission. CONCLUSIONS: Ambulatory videolaparoscopic cholecystectomy is a security surgery.

Procedimentos cirúrgicos em pacientes proctológicos selecionados, sob anestesia local: estudo de 150 casos / Surgical procedures in proctological selected patients, with local anesthesia: study of 150 cases

Experience in the treatment of 150 patients with anorectal disorders and disorders of the sacrococcygeal region who were operated on with local anesthesia at the University Hospital, ABC Medical School, Sao Bernardo do Campo, SP, Brazil, from March 1995 to March 1998. The anesthesia technique, the operations carried out and the tolerance to the procedure are reported. Intraoperative morbidity was 10.6 per cent (16 patients), and postoperative morbidity was 6 per cent (nine patients). The age of patients was between 15 and 92 years old, with mean age 42 years old; 58 per cent of patients were male and 42 per cent female. Surgical mean time was 45 minutes and the patients remained in the hospital for a mean time of 8 hours. All of patients was instructed about the anesthesia technique, their advantages and disadvantages, and only with their permit the surgery was programmed. Hospitalization was required in five patients (3.3 per cent). The anesthesia technique employed was the same for all patients. Upon survey, 96.7 per cent of the patients stated they did not feel pain during the surgery and that they would go through the procedure again. The authors conclude the surgical treatment of anorectal disorders and disorders of the sacrococcygeal region with local anesthesia is viable and safe, and in addition, is well accepted by the patients

Tricobezoar gástrico / Gastric trichobezoar

Os autores relatam o caso de paciente feminina, 18 anos, que procurou assistência médica com história de tricofagia e sinais e sintomas da síndrome de obstruçäo antropilórica. O exame físico revelou tumor de grandes dimensöes em epigástrico; a endoscopia digestiva alta evidenciou tricobezoar gigante. Na impossibilidade de retirada por via endoscópica, a paciente foi submetida laparotomia para retirada do tricobezoar que ocupava toda cavidade gástrica, através de gastronomia ampla. Evoluiu bem no período pós-operatório e recebeu alta no 5. dia de pós-operatório. Na avaliaçäo ambulatorial realizada no 9. mês após cirurgia a paciente mantinha-se assintomática. O tricobezoar gástrico é uma concreçäo de cabelos ou pêlos achados na cavidade gástrica, observado mais frequentemente em pacientes jovens com distúrbios psicológicos. Trata-se de afecçäo incomum e causa rara de obstruçäo do trato gastrointestinal alto. Tardiamente causa sintomas gástricos, manifestando-se quando o tricobezoar atinge grandes proporçöes...

Colecistectomia Videolaparoscopica: estudo de 130 casos / Laparoscopic Cholecystectomy: study of 130 cases

Os autores apresentam sua experiência com 130 casos submetidos à colecistectomia videolaparoscópica realizadas no hospital de Ensino da FMABC. Foram operados pacientes com diagnóstico de colecistite crônica calculosa. O posicionamento da equipe e a técnica utilizada foram aquelas preconizadas pela escola americana. Complicaçöes ocorreram em 20(15,38) casos, mas apenas 2(1,53), com peritonite biliar, foram graves e puderam ser atribuídas ao método. Em 14(10,76) pacientes foi necessário a conversäo para uma laparotomia convencional. A colangiografia intra-operatória foi realizada em 77(59,23) pacientes e em um caso foi diagnosticado coledocolitíase. Cento e nove(83,84)pacientes receberam alta hospitalar em 24 horas. Os autores concluem que a colecistectomia videolaparoscópica é um método eficaz no tratamento da colelitíase, porém exige um rigoroso treinamento para minimizar complicaçöes durante a curva de aprendizado

Hérnia intercostal abdominal / Abdominal intercostal hernia

Two cases of abdominal intercostal hernia are presented. One of them contained the colonic hepatic flexure and was caused by a thoraco-abdominal trauma ten months before the patient was referred to us. The second patient noticed the hernia few days after the trauma and the hernial sac content was a loop of small bowel. The clinical presentation of abdominal intercostal hernia is of an uncomplicated hernia, easily diagnosed on clinical examination. Further respiratory and digestive investigations are however essential to determine the content of the hernia sac. Treatment consisted of surgical repair. In one case we prefered the transperitoneal approach with the use of a Marlex mesh to repair the diaphragmatic defect. After one year of the operation the patient had no signs of recurrence. On the other patient we used the same approach and the defect was closed after the approximation of the 10§ and the 11§ ribs with pericostal suture. Nineth days after the operation the patient had no evidence of recurrence

Pseudocisto esplênico pós-traumático / A traumatic splenic pseudocyst

A case of an unusual evolution for splenic trauma is reported. Following a blunt abdominal trauma a 48 year-old female patient developped a voluminous tumor on the upper left abdominal quadrant. The diagnosis of subcapsular splenic ruptures and the formation of a traumatic splenic pseudocyst was made clinically and by abdominal computadorized tomography and splenic cintilography with Tc99. Due to the great volume of the pseudocyst, with very few viable splenic tissue, a splenectomy was performed