Aspirin plus calcium supplementation to prevent superimposed preeclampsia: a randomized trial

Preeclampsia is an important cause of maternal and perinatal morbidity and mortality. Previous studies have tested calcium supplementation and aspirin separately to reduce the incidence of preeclampsia but not the effects of combined supplementation. The objective of this study was to investigate the effectiveness of aspirin combined with calcium supplementation to prevent preeclampsia in women with chronic hypertension. A double-blind, placebo-controlled randomized clinical trial was carried out at the antenatal clinic of a large university hospital in São Paulo, SP, Brazil. A total of 49 women with chronic hypertension and abnormal uterine artery Doppler at 20-27 weeks gestation were randomly assigned to receive placebo (N = 26) or 100 mg aspirin plus 2 g calcium (N = 23) daily until delivery. The main outcome of this pilot study was development of superimposed preeclampsia. Secondary outcomes were fetal growth restriction and preterm birth. The rate of superimposed preeclampsia was 28.6% lower among women receiving aspirin plus calcium than in the placebo group (52.2 vs 73.1%, respectively, P=0.112). The rate of fetal growth restriction was reduced by 80.8% in the supplemented group (25 vs 4.8% in the placebo vs supplemented groups, respectively; P=0.073). The rate of preterm birth was 33.3% in both groups. The combined supplementation of aspirin and calcium starting at 20-27 weeks of gestation produced a nonsignificant decrease in the incidence of superimposed preeclampsia and fetal growth restriction in hypertensive women with abnormal uterine artery Doppler.

Does soy increase blood counts in myelodysplastic syndromes? / Será que a soja aumenta as contagens sanguíneas em síndrome mielodisplásica?

Myelodysplastic syndromes (MDS) are a group of clonal stem cell diseases characterized by ineffective hematopoiesis, bone marrow hyperproliferation, cytopenias in peripheral blood and risk of transformation into acute leukemia. We decided to investigate the effects of a soy concentrate on MDS patients based on the follow-up results of a 61 year-old Japanese female patient who was diagnosed with MDS and refractory cytopenia with multilineage dysplasia in 2003 (hemoglobin = 11g/dL; white blood cells count = 2,500/uL and platelets = 25,000/uL; marrow with mild dysplasia and normal karyotype; paroxysmal nocturnal hemoglobinuria was excluded). She started using soy as a dietary supplementation in May 2004 and presented a gradual increment in blood counts, achieving normalization approximately eight months afterwards. Among the soy components, the main compounds with anti-carcinogenic activity are the isoflavones (genistein and daidzein). Based on these lines of evidence, we proposed to administer daily a standard soy concentrate to 14 MDS out-patients for a minimum period of three months and maximum of 12 months, in an attempt to evaluate prospectively the possible increase in hemoglobin, neutrophils and platelet counts. A historical control group was used to compare results. The use of a soy concentrate in a standardized manner was associated with an increase in neutrophil and/or platelet counts in some cases, but spontaneous increments were also observed in historical controls. This preliminary study does not allow establishing a relation between soy supplementation and blood cell count increase.

As síndromes mielodisplásicas (SMD) são um grupo das doenças clonais de células-tronco caracterizado por hematopoese ineficaz, hiperproliferação de medula óssea, citopenias no sangue periférico e risco de transformação para leucemia aguda. Decidimos investigar os efeitos de um concentrado de soja em pacientes com SMD com base no fato de termos o seguimento de uma paciente japonesa, de 61 anos de idade, que foi diagnosticada em 2003 com SMD, citopenia refratária com displasia subtipo multilinhagens (hemoglobina = 11 g/dL; contagem de glóbulos brancos = 2.500/uL e plaquetas = 25.000/uL; medula com displasia leve e cariótipo normal; hemoglobinúria paroxística excluída), e que começou a usar a soja como suplemento alimentar em maio de 2004, apresentando gradual aumento da contagem das células sanguíneas, atingindo a normalização cerca de oito meses depois. Entre os componentes da soja, os principais compostos com propriedades anticarcinogênese são as isoflavonas (Ge nisteína e daidzeína). Com base nessas linhas de evidência, foi proposto oferecer diariamente um concentrado de soja padrão, por um período mínimo de três meses e máximo de doze meses, a 14 pacientes ambulatoriais, na tentativa de avaliar, prospectivamente, o possível aumento de hemoglobina, neutrófilos e plaquetas. Um grupo controle histórico foi utilizado para comparar os resultados. O uso de um concentrado de soja de forma padronizada foi associado ao aumento na contagem de neutrófilos e/ou de plaquetas em alguns casos, mas aumentos espontâneos também foram observados em controles históricos. Este estudo preliminar não permite estabelecer relação entre o uso de soja e o aumento na contagem sanguínea.

Intermittent versus continuous androgen suppression for prostatic cancer.

BACKGROUND: After lung cancer, prostate cancer is the most common cause of death among males. The aim of treatment is to prevent disease-related morbidity and mortality while minimizing intervention-related adverse events. Androgen suppression therapy (AST) to reduce circulating serum testosterone and disease progression is considered a mainstay of treatment for men with advanced prostate cancer. It has been increasingly utilized for early stage disease despite a lack of evidence of effectiveness. OBJECTIVES: Evaluate the effectiveness and safety of intermittent androgen suppression (IAS) compared to continuous androgen suppression for treating prostatic cancer. SEARCH STRATEGY: The following databases were searched to identify randomised or quasi-randomised, controlled trials comparing intermittent and continuous androgen suppression in the treatment of any stage of prostate cancer: the Cochrane Central Register of Controlled Trials; EMBASE and LILACS. SELECTION CRITERIA: Studies were included if they were randomised or quasi-randomized, and compare the effects of IAS versus CAS. DATA COLLECTION AND ANALYSIS: Two reviewers selected relevant trials, assessed methodological quality and extracted data. MAIN RESULTS: Five randomized studies involving 1382 patients were included in this review. All the included studies involved advanced (T3 or T4) prostate cancer, had relatively small populations, and were of short duration. Few events were reported and did not assess disease-specific survival or metastatic disease. Only one study (N = 77) evaluated biochemical outcomes. A subgroup analysis found no significant differences in biochemical progression (defined by the authors as PSA >/= 10 ng/mL) between IAS and CAS for Gleason scores 4 - 6, 7, and 8 - 10. For patients with a Gleason score > 6, reduction in biochemical progression favoured the IAS group (RR 0.10, 95% CI 0.01 to 0.67, P = 0.02). Studies primarily reported on adverse events. One trial (N = 43) found no difference in adverse effects (gastrointestinal, gynecomastia and asthenia) between IAS ( two events) and CAS (five events), with the exception of impotence, which was significantly lower in the IAS group (RR 0.72, 95% CI 0.56 to 0.92, P = 0.008). AUTHORS' CONCLUSIONS: Data from RCTs comparing IAS to CAS are limited by small sample size and short duration. There are no data for the relative effectiveness of IAS versus CAS for overall survival, prostate cancer-specific survival, or disease progression. Limited information suggests IAS may have slightly reduced adverse events. Overall, IAS was also as effective as CAS for potency, but was superior during the interval of cycles (96%).

Incentive spirometry for preventing pulmonary complications after coronary artery bypass graft.

BACKGROUND: Following coronary artery bypass graft (CABG), the main causes of postoperative morbidity and mortality are postoperative pulmonary complications, respiratory dysfunction and arterial hypoxemia. Incentive spirometry is a treatment technique that uses a mechanical device (an incentive spirometer) to reduce such pulmonary complications during postoperative care. OBJECTIVES: To assess the effects of incentive spirometry for preventing postoperative pulmonary complications in adults undergoing CABG. SEARCH STRATEGY: We searched CENTRAL on The Cochrane Library (Issue 2, 2004), MEDLINE (1966 to December 2004), EMBASE (1980 to December 2004), LILACS (1982 to December 2004), the Physiotherapy Evidence Database (PEDro) (1980 to December 2004), Allied & Complementary Medicine (AMED) (1985 to December 2004), CINAHL (1982 to December 2004), and the Database of Abstracts of Reviews of Effects (DARE) (1994 to December 2004). References were checked and authors contacted. No language restrictions were applied. SELECTION CRITERIA: Randomized controlled trials comparing incentive spirometry with any type of prophylactic physiotherapy for prevention of postoperative pulmonary complications in adults undergoing CABG. DATA COLLECTION AND ANALYSIS: Two reviewers independently evaluated the quality of trials using the guidelines of the Cochrane Reviewers' Handbook and extracted data from included trials. MAIN RESULTS: Four trials with 443 participants contributed to this review. There was no significant difference in pulmonary complications (atelectasis and pneumonia) between treatment with incentive spirometry and treatment with positive pressure breathing techniques (continuous positive airway pressure (CPAP), bilevel positive airway pressure (BiPAP) and intermittent positive pressure breathing (IPPB)) or preoperative patient education. Patients treated with incentive spirometry had worse pulmonary function and arterial oxygenation compared with positive pressure breathing (CPAP, BiPAP, IPPB). AUTHORS' CONCLUSIONS: Individual small trials suggest that there is no evidence of benefit from incentive spirometry in reducing pulmonary complications and in decreasing the negative effects on pulmonary function in patients undergoing CABG. In view of the modest number of patients studied, methodological shortcomings and poor reporting of the included trials, these results should be interpreted cautiously. An appropriately powered trial of high methodological rigour is needed to determine those patients who may derive benefit from incentive spirometry following CABG.

Drainage or nondrainage in elective colorectal anastomosis: a systematic review and meta-analysis.

BACKGROUND: There is little agreement on prophylactic use of drains in anastomoses in elective colorectal surgery despite many randomized clinical trials. Once anastomotic leakage occurs it is generally agreed that drains should be used for therapeutic purposes. However, on prophylactic use no such agreement exists. AIM: To compare the safety and effectiveness of routine drainage and nondrainage regimes after elective colorectal surgery. The primary outcome was clinical anastomotic leakage. METHODS: A systematic search was undertaken to identify randomized clinical trials. Of the 1140 patients who were enrolled (six randomized controlled trials), 573 were allocated for drainage and 567 for no drainage. Outcome measures were: (i) mortality: 3% (18 of 573 patients) compared with 4% (25 of 567 patients); (ii) clinical anastomotic dehiscence: 2% (11 of 522 patients) compared with 1% (7 of 519 patients); (iii) radiological anastomotic dehiscence: 3% (16 of 522 patients) compared with 4% (19 of 519 patients); (iv) wound infection: 5% (29 of 573 patients) compared with 5% (28 of 567 patients); (v) reintervention: 6% (34 of 542 patients) compared with 5% (28 of 539 patients); (vi) extra-abdominal complications: 7% (34 of 522 patients) compared with 6% (32 of 519 patients). None of these differences in outcome was significant. CONCLUSION: There is insufficient evidence showing that routine drainage after colorectal anastomoses prevents anastomotic and other complications.

Mechanical bowel preparation for elective colorectal surgery.

BACKGROUND: For over a century the presence of bowel content during surgery has been linked to anastomotic leakage. Mechanical bowel preparation has been considered an efficient agent against leakage and infectious complications. This dogma is not based on solid evidence, but on observational data and expert's opinions. OBJECTIVES: To determine the effectiveness and safety of prophylactic mechanical bowel preparation for morbidity and mortality rates in elective colorectal surgery. SEARCH STRATEGY: We searched MEDLINE, EMBASE, LILACS, and the Cochrane Central Register of Controlled Trials. We also searched relevant medical journals, and conference proceedings from major gastroenterological congresses and contacted experts in the field. We used the search strategy described by the Colorectal Cancer Review Group, without limitations for date of publication and language. I SELECTION CRITERIA: Randomised, clinical trials that compared any strategy in mechanical bowel preparation with no mechanical bowel preparation. DATA COLLECTION AND ANALYSIS: Data were independently extracted by the reviewers and cross-checked. The same reviewers assessed the methodological quality of each trial. Details of the randomisation (generation and concealment), blinding, whether an intention-to-treat analysis was done, and the number of patients lost to follow-up was recorded. For analysis the Peto odds ratio (OR) was used as defaults. MAIN RESULTS: Of the 1592 patients (9 trials), 789 were allocated to mechanical bowel preparation (Group A) and 803 to no preparation (Group B) before elective colorectal surgery. For anastomotic leakage (main outcome) the results were: - Low anterior resection: 9.8% (11 of 112 patients in Group A) compared with 7.5% (9 of 119 patients in Group B); Peto OR 1.45, 95% confidence interval (CI): 0.57 to 3.67 (non-significant); - Colonic surgery: 2.9% (Group A) compared with 1.6% (Group B) ; Peto OR 1.80, 95% CI: 0.68 to 4.75 (non-significant); Overall anastomotic leakage: 6.2% (Group A) compared with 3.2% (Group B); Peto OR 2.03, 95% CI: 1.276 to 3.26 (p=0.003). For the secondary outcome of wound infection the result was: 7.4% (Group A) compared with 5.4% (Group B); Peto OR 1.46, 95% CI: 0.97 - to 2.18 (p=0.07); Sensitivity analyses excluding studies with dubious randomisation, studies published as abstracts only, and studies involving children did not change the overall conclusions AUTHORS' CONCLUSIONS: There is no convincing evidence that mechanical bowel preparation is associated with reduced rates of anastomotic leakage after elective colorectal surgery. On the contrary, there is evidence that this intervention may be associated with an increased rate of anastomotic leakage and wound complications. It is not possible to be conclusion on the latter issue because of the clinical heterogeneity of trial inclusion criteria, methodological inadequacies in trial (in particular, poor reporting of concealment and allocation), potential performance biases, and failure of intention-to-treat analyses. Nevertheless, the dogma that mechanical bowel preparation is necessary before elective colorectal surgery should be reconsidered.

Prophylactic anastomotic drainage for colorectal surgery.

BACKGROUND: There is little agreement on prophylactic use of drains in anastomoses in elective colorectal surgery despite many randomized clinical trials. Results of these trials are contradictory, quality and statistical power of these individual studies have been questioned. Once anastomotic leakage has occurred it is generally agreed that drains should be used for therapeutic purposes. However, on prophylactic use no such agreement exists. OBJECTIVES: Comparison of safety and effectiveness of routine drainage and non-drainage regimes after colorectal surgery. The following hypothesis was tested: The use of prophylactic anastomotic drainage after elective colorectal surgery does not prevent development of complications. SEARCH STRATEGY: The studies were identified from CINAHL, EMBASE, LILACS, MEDLINE, Controlled Clinical Trials Database, Trials Register of the Cochrane Colorectal Cancer Group, reference lists. SELECTION CRITERIA: Randomized controlled trials comparing drainage with non-drainage regimes after anastomoses in elective colorectal surgery were reviewed. Outcome measures were: 1. mortality; 2. clinical anastomotic dehiscence; 3. radiological anastomotic dehiscence; 4. wound infection; 5. reoperation; 6. extra-abdominal complications. DATA COLLECTION AND ANALYSIS: Data were independently extracted and cross-checked by the two reviewers. The methodological quality of each trial was assessed. Details of the randomization (generation and concealment), blinding, and the number of patients lost to follow-up were recorded. The RCTs were stratified based on experimental group, according to clinical homogeneity (external validity). MAIN RESULTS: Of the 1140 patients enrolled (6 RCTs), 573 were allocated for drainage and 567 for no drainage. The patients assigned to the drainage group compared with the ones assigned to non-drainage group showed: a) Mortality: 3% (18 of 573 patients) compared with 4% (25 of 567 patients); b) Clinical anastomotic dehiscence: 2% (11 of 522 patients) compared with 1% (7 of 519 patients); c) Radiological anastomotic dehiscence: 3% (16 of 522 patients) compared with 4% (19 of 519 patients); d) Wound infection: 5% (29 of 573 patients) compared with 5% (28 of 567 patients); e) Reintervention: 6% (34 of 542 patients) compared with 5% (28 of 539 patients); f) Extra abdominal complications: 7% (34 of 522 patients) compared with 6% (32 of 519 patients). REVIEWERS' CONCLUSIONS: There is insufficient evidence showing that routine drainage after colorectal anastomoses prevents anastomotic and other complications.

Diet plus insulin compared to diet alone in the treatment of gestational diabetes mellitus: a systematic review

Fetuses of mothers with gestational diabetes mellitus are at increased risk to develop perinatal complications mainly due to macrosomia. However, in view of the marked heterogeneity of this disease, it seems difficult to set guidelines for diagnosis and treatment. This complicates the choice of assigning patients either to diet or to insulin therapy. Also of concern is how much benefit could be expected from insulin therapy in preventing fetal complications in these patients. In a systematic review of the literature assessing the efficacy of insulin in preventing macrosomia in fetuses of mothers with gestational diabetes, we found six randomized controlled trials comparing diet alone to diet plus insulin. The studies included a total of 1281 patients (644 in the diet plus insulin group and 637 in the diet group), with marked differences among trials concerning diagnostic criteria, randomization process and treatment goals. Meta-analysis of the data resulted in a risk difference of -0.098 (95 percentCI: -0.168 to -0.028), and a number-necessary-to-treat of 11 (95 percentCI: 6 to 36), which means that it is necessary to treat 11 patients with insulin to prevent one case of macrosomia. This indicates a potential benefit of insulin, but not significantly enough to set treatment guidelines. Because of the heterogeneous evidence available in the literature about this matter, we conclude that larger trials addressing the efficacy of these two therapeutic modalities in preventing macrosomia are warranted

Mechanical bowel preparation for elective colorectal surgery.

BACKGROUND: For more than a century the presence of bowel content during surgery has been related to anastomotic leakage. Mechanical bowel preparation has been considered an efficient agent against leakage and infections complications. This dogma is not based on solid evidence, but more on observational data and expert's opinions. OBJECTIVES: To determine the security and effectiveness of prophylactic mechanical bowel preparation for morbidity and mortality rates in colorectal surgery. The following hypothesis was tested: "The use of mechanical bowel preparation before elective colorectal surgery reduces the incidence of postoperative complications". SEARCH STRATEGY: All publications describing mechanical bowel preparation before elective colorectal surgery was sought through computerized searches of EMBASE, LILACS, MEDLINE, and Cochrane Library; by hand-searching in relevant medical journals, from major gastroenterological congresses, without limitation for date and language, using the search strategy described by the Colorectal Cancer Review Group. In addition, randomised clinical trials will be searched through personal communication with colleagues and from conference proceedings STUDIES: All randomised, clinical trials, that were performed in order to answer the hypothesis. PARTICIPANTS: Patients submitted elective colorectal surgery. INTERVENTIONS: Any strategy in mechanical bowel preparation compared with no mechanical bowel preparation. PRIMARY OUTCOME MEASURES: 1. Anastomosis leakage- stratified for rectum and colon 2. Overall anastomotic leakage SECONDARY OUTCOME MEASURES: 3. Mortality 4. Peritonitis 5. Re operation 6. Wound Infection 7 Infectious extra-abdominal complication 8. Non-infection extra-abdominal 9. Overall surgical site infections DATA COLLECTION AND ANALYSIS: Data was independently extracted by two reviewers and cross-checked. The methodological quality of each trial was assessed by the same two reviewers. Details of the randomisation (generation and concealment), blinding, whether an intention-to-treat analysis was done, and the number of patients lost to follow-up was recorded. The results of each RCT was summarised in 2 x 2 tables for each outcome. For analysis the Peto-Odds ratio was used as defaults (no statistical heterogeneity was observed) MAIN RESULTS: Of the 1159 patients with anastomosis (6 RCTs), 576 were allocated for mechanical bowel preparation (groups 1) and 583 for no preparation (groups 2) before elective colorectal surgery. Of 1204 patients totally enrolled 595 were in groups 1 and 609 in groups 2. PRIMARY OUTCOMES: 1) Anastomotic leakage - stratified:A) Low anterior resection: 12.5% (6 of 48 patients in 1) compared with 12% (6 of 50 patients in 2); Peto OR 1.17, 95% CI: 0.35 - 3.96 (non-significant) B) Colonic surgery: 1.16% (2 of 172 patients in 1) compared with 0.6% (1 of 166 patients in 2); Peto OR 1.75, 95% CI: 0.18 - 17.02 2) Overall anastomotic leakage: 5.5% (32 of 576 patients in 1) compared with 2.9% (17 of 583 patients in 2); Peto OR 1.94, 95% CI: 1.09 - 3.43 (P=0.02) SECONDARY OUTCOMES: 3) Mortality: 0.6% (2 of 329 patients in 1) compared with 0% (0 of 326 patients in 2); Peto OR 7.95, 95% CI: 0.49 - 128.34 (non-significant) 4) Peritonitis: 5.1% ( 13 of 254 patients in 1) compared with 2.8% (7 of 252 patients in 2); Peto OR 1.90, 95% CI: 0.78 -4.64) (non significant) 5) Reoperation: 3.3% ( 11 of 329 patients) compared with 2.5% (8 of 326 patients); Peto OR 1.40, 95% CI: 0.56 - 3.49) (non-significant) 6) Wound infection: 7.4% (44 of 595 patients in 1) compared with 5.7% (35 of 609 patients in 2); Peto OR 1.34, 95% CI: 0.85 - 2.13 (non-significant) 7) Infectious extra-abdominal complication: 8.3% ( 14 of 168 patients in 1) compared with 9.4% (15 of 159 patients in 2); Peto OR, 95%: 0.87 (0.41 - 1.87) 8) Non-infection extra-abdominal complication: 8.0% ( 20 of 250 patients in 1) compared with 7.0% (17 of 246 patients in 2); Peto OR 1.19, 95% CI: 0.61 - 2.32 (non-significant) - 9) Surgical site infection: 9.8% (31 of 325 patients in 1) compared with 8.3% (27 of 322 patients in 2); Peto OR 1.20, 95% CI: 0.70 - 2.05 (non-significant) - REVIEWER'S CONCLUSIONS: The results failed to support the hypothesis that bowel preparation reduces anastomotic leak rates and other complications. There was no a priori hypothesis that bowel preparation may increase anastomotic leak rates, so this was not stated. Thus, the routine use of mechanical bowel preparation in patients undergoing elective colorectal surgery is questioned.

Stapled versus handsewn methods for colorectal anastomosis surgery.

BACKGROUND: Randomized controlled trials comparing stapled with handsewn colorectal anastomosis have not shown either technique to be superior, perhaps because individual studies lacked statistical power. A systematic review, with pooled analysis of results, might provide a more definitive answer. OBJECTIVES: To compare the safety and effectiveness of stapled and handsewn colorectal anastomosis. The following primary hypothesis was tested: the stapled technique is more effective because it decreases the level of complications. SEARCH STRATEGY: The RCT register of the Cochrane Review Group was searched for any trial or reference to a relevant trial (published, in-press, or in progress). All publications were sought through computerised searches of EMBASE, LILACS, MEDLINE, the Cochrane Controlled Clinical Trials Database, and through letters to industrial companies and authors. There were no limits upon language, date, or other criteria. STUDIES: All randomized clinical trials (RCTs) in which stapled and handsewn colorectal anastomosis were compared. PARTICIPANTS: Adult patients submitted electively to colorectal anastomosis. INTERVENTIONS: Endoluminal circular stapler and handsewn colorectal anastomosis. OUTCOMES: a) Mortality b) Overall Anastomotic Dehiscence c) Clinical Anastomotic Dehiscence d) Radiological Anastomotic Dehiscence e) Stricture f) Anastomotic Haemorrhage g) Reoperation h) Wound Infection i) Anastomosis Duration j) Hospital Stay. DATA COLLECTION AND ANALYSIS: Data were independently extracted by the two reviewers (SASL, DM) and cross-checked. The methodological quality of each trial was assessed by the same two reviewers. Details of the randomization (generation and concealment), blinding, whether an intention-to-treat analysis was done, and the number of patients lost to follow-up were recorded. The results of each RCT were summarised on an intention-to-treat basis in 2 x 2 tables for each outcome. External validity was defined by characteristics of the participants, the interventions and the outcomes. The RCTs were stratified according to the level of colorectal anastomosis. The Risk Difference method (random effects model) and NNT for dichotomous outcomes measures and weighted mean difference for continuous outcomes measures, with the corresponding 95% confidence interval, were presented in this review. Statistical heterogeneity was evaluated by using funnel plot and chi-square testing. MAIN RESULTS: Of the 1233 patients enrolled ( in 9 trials), 622 were treated with stapled, and 611 with manual, suture. The following main results were obtained: a) Mortality: result based on 901 patients; Risk Difference - 0.6% Confidence Interval -2.8% to +1.6%. b) Overall Dehiscence: result based on 1233 patients; Risk Difference 0.2%, 95% Confidence Interval -5.0% to +5.3%. c) Clinical Anastomotic Dehiscence : result based on 1233 patients; Risk Difference -1.4%, 95% Confidence Interval -5.2 to +2.3%. d) Radiological Anastomotic Dehiscence : result based on 825 patients; Risk Difference 1.2%, 95% Confidence Interval -4.8% to +7.3%. e) Stricture: result based on 1042 patients; Risk Difference 4.6%, 95% Confidence Interval 1.2% to 8.1%. Number needed to treat 17, 95% confidence interval 12 to 31. f) Anastomotic Hemorrhage: result based on 662 patients; Risk Difference 2.7%, 95% Confidence Interval - 0.1% to +5.5%. g) Reoperation: result based on 544 patients; Risk Difference 3.9%, 95% Confidence Interval 0.3% to 7.4%. h) Wound Infection: result based on 567 patients; Risk Difference 1.0%, 95% Confidence Interval -2.2% to +4.3%. i) Anastomosis duration: result based on one study (159 patients); Weighted Mean Difference -7.6 minutes, 95% Confidence Interval -12.9 to -2.2 minutes. j) Hospital Stay: result based on one study (159 patients), Weighted Mean Difference 2.0 days, 95% Confidence Interval -3.27 to +7.2 days. REVIEWER'S CONCLUSIONS: The evidence found was insufficient to demonstrate any superiority of stapled over handsewn techniques in colorectal anastomosis, regardless of the level of anastomosis.

[Applicability of the Torrington and Henderson scale]. / Aplicabilidade da escala de Torrington e Henderson.

PURPOSE: To validate the Torrington & Henderson preoperative risk assessment program in the population of surgical patients in an university hospital (Hospital São Paulo, UNIFESP, São Paulo, Brasil). MATERIAL AND METHODS: We evaluated 1162 patients who underwent to major thoracic, upper and under abdominal surgery using the Torrington & Henderson program. The patients were classified in low (785), moderate (317) and high risk (60). All patients were accompanied daily during the postoperative period by the same medical team which assessed the preoperative period, until discharged or died. RESULTS: The postoperative pulmonary complications were present in 6.1%, 23.3% and 35.0% in the low, moderate and high risk respectively. The relative risk to develop postoperative pulmonary complications was 3.8 higher in the patients with moderate risk and 5.7 higher in the patients with high risk. The mortality rate due to pulmonary complications was 1.7%, 6.3% and 11.7% respectively in the patients with low, moderate and high risk. The relative risk to the death was 3.7 higher in the patients with moderate risk and 6.9 in the high risk. CONCLUSION: We concluded that the Torrington & Henderson preoperative risk assessment program can identify in our population patients who will develop postoperative pulmonary complications.

Aplicabilidade da escala de Torrington e Henderson / Applicability of the Torrington and Henderson scale

OBJETIVO: Validar a escala de Torrington e Henderson na estratificação do risco cirúrgico da nossa população, fornecendo a quantificação do mesmo. Tipo de estudo: coorte prospectivo longitudinal. Duração do estudo: 30 meses. MÉTODOS: Foram avaliados 1162 pacientes no pré-operatório de cirurgia geral eletiva no Ambulatório de Risco Cirúrgico da Disciplina de Pneumologia da EPM/Unifesp. De acordo com a escala de Torrington e Henderson os pacientes foram classificados no período pré-operatório em portadores de baixo (n=785), moderado (n=317) e alto risco (n=60) para a ocorrência de complicações pulmonares e óbito, no período pós-operatório. No pós-operatório realizou-se avaliação clínica diária dos mesmos até alta hospitalar ou óbito verificando-se a ocorrência das seguintes complicações pulmonares neste período: infecção respiratória aguda (pneumonia ou traqueobronquite),atelectasia, insuficiência respiratória aguda, entubação orotraqueal ou ventilação mecânica por mais de 48 horas e broncoespasmo. RESULTADOS: Complicações pulmonares no pós-operatório ocorreram em 6,1 por cento dos pacientes de baixo risco, 23,3 por cento nos de moderado e 35 por cento nos de alto risco (p < 0,05). O risco relativo de ocorrer complicações pulmonares foi de 3,8 vezes para os pacientes de moderado risco e de 5,7 vezes para os de alto risco em relação aos de baixo risco. A incidência de óbito de causa pulmonar no pós-operatório foi, respectivamente, de 1,7 por cento , 6,3 e 11,7 por cento entre os pacientes de baixo, moderado e de alto risco (p < 0,001). O risco relativo de óbito pulmonar foi de 3,7 vezes para os pacientes de moderado risco e de 6,9 vezes para aqueles de alto risco em relação aos de baixo risco. CONCLUSÃO: A escala de Torrington e Henderson é útil na estratificação do risco cirúrgico nesta população estudada.

[Biliary microcrystals in idiopathic acute pancreatitis: clue for occult underlying biliary etiology]. / Microcristais biliares na pancreatite aguda idiopática: indício para etiologia biliar oculta subjacente.

The main causes of pancreatic inflammation worldwide are biliary lithiasis and alcoholism. However, 10 to 30% of patients have been considered to have "idiopathic" acute pancreatitis. Recently, some studies showed that a significant rate of the so called idiopathic pancreatitis are caused by microlithiasis and/or biliary sludge, identified by the presence of cholesterol monohidrate and/or calcium bilirubinate microcrystals in the biliary sediment. In the present study, the analysis of microcrystals from bile obtained during endoscopic retrograde cholangiopancreatography was done in patients with pancreatitis (idiopathic, biliary or alcoholic--20 in each group). Patients with idiopathic pancreatitis and microcrystals in the bile underwent cholecystectomy whenever possible. Those who refused or were inapt to surgery underwent endoscopic sphincterotomy or received continuous therapy with ursodeoxycholic acid. Patients with idiopathic pancreatitis without biliary crystals did not receive any specific treatment. The prevalence of biliary microcrystals in patients with idiopathic pancreatitis (75%) and biliary pancreatitis (90%) was significantly higher than in those with alcoholic pancreatitis (15%). In the identification of the etiology of biliary pancreatitis, the presence of microcrystals had a sensitivity of 90%, specificity of 85%, positive predictive value of 85.7%, negative predictive value of 89.4% and accuracy of 87.5%. In the patients with recurrent idiopathic pancreatitis, with biliary crystals, there was an statistically significant reduction in the number of pancreatitis episodes after specific treatment. In the follow-up of this group during 23.3 +/- 4.8 months, recurrence of pancreatitis occurred only in patients with "persistent biliary factor" (choledocholithiasis and/or persistence of cholesterol monohidrate). All patients with idiopathic pancreatitis who underwent cholecystectomy had chronic cholecystitis. Moreover, cholelithiasis was present in one case. In the ultrassonographic follow-up of the patients with idiopathic acute pancreatitis with microcrystals in the bile, cholelithiasis was detected in one case. In the subgroup of five patients with idiopathic pancreatitis without biliary microcrystals recurrence occurred in one case. Ultrassonographic study during follow-up did not reveal biliary stones in any of these patients. We concluded that the detection of biliary microcrystals in "idiopathic" pancreatitis suggested an underlying biliary etiology, even if occult. What's more, early specific therapeutic procedure (cholecystectomy, endoscopic sphincterotomy or ursodeoxycholic acid) in patients with recurrent idiopathic pancreatitis with microcrystals in the bile reduced significantly the recurrence during the follow-up. Finally, acute pancreatitis (specially recurrent) should not be called idiopathic before the microscopic analysis of the bile, aiming to detect or exclude the presence of microcrystals.

Prospective assessment of the risk of postoperative pulmonary complications in patients submitted to upper abdominal surgery.

OBJECTIVE: To investigate associations between preoperative variables and postoperative pulmonary complications (PPC) in elective upper abdominal surgery. DESIGN: Prospective clinical trial. SETTING: A tertiary university hospital. PATIENTS: 408 patients were prospectively analyzed during the preoperative period and followed up postoperatively for pulmonary complications. MEASUREMENTS: Patient characteristics, with clinical and physical evaluation, related diseases, smoking habits, and duration of surgery. Preoperative pulmonary function tests (PFT) were performed on 247 patients. RESULTS: The postoperative pulmonary complication rate was 14 percent. The significant predictors in univariate analyses of postoperative pulmonary complications were: age >50, smoking habits, presence of chronic pulmonary disease or respiratory symptoms at the time of evaluation, duration of surgery >210 minutes and comorbidity (p <0.04). In a logistic regression analysis, the statistically significant predictors were: presence of chronic pulmonary disease, surgery lasting >210 and comorbidity (p <0.009). CONCLUSIONS: There were three major clinical risk factors for pulmonary complications following upper abdominal surgery: chronic pulmonary disease, comorbidity, and surgery lasting more than 210 minutes. Those patients with three risk factors were three times more likely to develop a PPC compared to patients without any of these risk factors (p <0.001). PFT is indicated when there are uncertainties regarding the patient's pulmonary status.

Langerhans cell histiocytosis.

The authors present a rare case of Langerhans cell histiocytosis in a 31 year old female patient with vulvar, peri-anal and oral lesions, diabetes insipidus, pulmonary skin and bone infiltrations. Skin biopsy immunohistochemistry presented positive S100 protein and vimentin, but the diagnosis was done with the demonstration of Birbeck granules with electronic microscopy. The treatment was based on systematical chemotherapy although vulvar lesion has a bad response to chemotherapy.

[Smoking and inflammatory bowel disease: an epidemiological case-control study]. / Tabagismo e doença inflamatória intestinal: estudo epidemiológico caso-controle.

Smoking is one of the most consistent epidemiological features related to occurrence and evolution of inflammatory bowel disease. Ulcerative colitis is accepted as a non or ex-smokers disease suggesting a protective role of tobacco against its development. In contrast there are more Crohn's disease cases between smokers. Sixty eight patients with inflammatory disease (36 ulcerative colitis; 32 Crohn's disease) and 136 patients with gastrointestinal functional disorders were matched for sex, age, scholarity and professional and religious patterns. They are divided in smokers, ex- and non-smokers. The inflammatory bowel disease patients were asked about the relationship between smoking and onset of the disease, and exposure, as passive smokers, during childhood. Smoking habit protected against ulcerative colitis (OR:0.30, IC:95%), but not against Crohn's disease (OR:0.81, P > 0.5). There was no increased risk for development of Crohn's disease between smokers; 72.7% of ex-smokers acquired ulcerative colitis and 44.4% Crohn's disease after tobacco habit has stopped. Exposure to environmental tobacco smoking during childhood did not increased the risk for ulcerative colitis (OR:0.93, P < 0.1) neither for Crohn's disease (OR:0.44, P < 0.2). Our results are similar to those of the literature related to protection of ulcerative colitis by smoking habit. Further experimental and clinic studies are in need to clarify the possible pharmacological and therapeutic action of tobacco products in this inflammatory disease.

Progesterone increases glomerular filtration rate, urinary kallikrein excretion and uric acid clearance in normal women.

In pregnancy there is a rise in glomerular filtration rate (GFR), plasma aldosterone levels, uric acid clearance and urinary kallikrein excretion. In toxemia all the above parameters tend to decrease. Progesterone has a diuretic effect which is usually related to aldosterone antagonism. We administered progesterone to normal women and observed that GFR, uric acid clearance and kallikrein excretion increased significantly, GFR from 103.0 +/- 13.7 ml/min to 118.0 +/- 18.0 ml/min (P less than 0.01), uric acid clearance from 9.0 +/- 3.6 ml/min to 14.3 +/- 4.0 ml/min (P less than 0.01), and urinary kallikrein excretion from 165 +/- 156 mU to 432 +/- 220 mU (P less than 0.01). Natriuresis and potassium excretion also increased from 15.9 +/- 6.4 mEq to 33.4 +/- 10.9 mEq (P less than 0.01) and from 7.6 +/- 2.7 mEq to 14.0 +/- 5.4 mEq, (P less than 0.01), respectively, suggesting that in this situation aldosterone antagonism is not relevant to explain the diuretic effects of progesterone.