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Asimakopoulos A.D.,University of Rome Tor Vergata | Pereira Fraga C.T.,Institute Medicina Integral Prof Fernando Figueira | Annino F.,University of Modena and Reggio Emilia | Pasqualetti P.,Fatebenefratelli Association for the Research | And 2 more authors.
Journal of Sexual Medicine | Year: 2011

Introduction. Lack of randomized controlled trials (RCTs) that compare pure laparoscopic radical prostatectomy (LRP) with robot-assisted laparoscopic radical prostatectomy (RALRP) is an important gap of the literature related to the surgical treatment of the clinically localized prostate cancer (PCa). Aim. To provide the first prospective randomized comparison on the functional and oncological outcomes of LRP and RALRP for the treatment of the clinically localized PCa. Methods. Between 2007 and 2008, 128 consecutive male patients were randomized in two groups and treated by a single experienced surgeon with traditional LRP (Group I-64 patients) or RALRP (Group II-64 patients) in all cases with intent of bilateral intrafascial nerve sparing. Main Outcome Measures. Primary end point was to compare the 12 months erectile function (EF) outcomes. Complication rates, continence outcomes, and oncological results were also compared. The sample size of our study was able, with an adequate power (1-beta>0.90), to recognize as significant large differences (above 0.30) between incidence proportions of considered outcomes. Results. No statistically significant differences were observed for operating time, estimated blood loss, transfusion rate, complications, rates of positive surgical margins, rates of biochemical recurrence, continence, and time to continence. However, the 12-month evaluation of capability for intercourse (with or without phosphodiesterase type 5 inhibitors) showed a clear and significant advantage of RALRP (32% vs. 77%, P<0.0001). Time to capability for intercourse was significantly shorter for RALRP. Rates of return to baseline International Index of Erectile Function (IIEF-6) EF domain score questionnaires (questions 1-5 and 15) (25% vs. 58%) and to IIEF-6>17 (38% vs. 63%) were also significantly higher for RALRP (P=0.0002 and P=0.008, respectively). Conclusions. Our study offers the first high-level evidence that RALRP provides significantly better EF recovery than LRP without hindering the oncologic radicality of the procedure. Larger RCTs are needed to confirm if a new gold-standard treatment in the field of RP has risen. © 2011 International Society for Sexual Medicine. Source


Katz L.,Institute Medicina Integral Prof Fernando Figueira | Amorim M.,Federal University of Campina Grande | Souza J.P.,World Health Organization | Haddad S.M.,University of Campinas | Cecatti J.G.,University of Campinas
Reproductive Health | Year: 2013

Background: Hemolysis, elevated liver enzymes, and low platelets (HELLP) syndrome is one of the most severe forms of preeclampsia and aggravates both maternal and perinatal prognosis. The systematic review available in Cochrane Library compared corticosteroid (dexamethasone, betamethasone, or prednisolone) given during pregnancy, just after delivery or in the postnatal period, or both before and after birth, with placebo or no treatment. Those receiving steroids showed significantly greater improvement in platelet counts which was greater for those receiving dexamethasone than those receiving betamethasone. There was no clear evidence of any effect of corticosteroids on substantive clinical outcomes. These benefits appear to be greater in Class I HELLP syndrome. Objectives. To determine the effectiveness of dexamethasone for accelerating postpartum recovery in patients with Class I HELLP syndrome in a multicenter randomized controlled trial. Methods/Design. The study is a triple blind randomized controlled trial including women with class I HELLP syndrome, and exclusion criteria were dexamethasone use in the last 15 days before diagnosis of HELLP syndrome; chronic use of corticosteroids; chronic diseases that alter laboratory parameters of HELLP Syndrome, such as chronic liver disease or purpura, patients unable to consent (coma or critical clinical condition) and without accompanying persons that may consent to study participation. Eligible patients will be invited to participate and those who agree will be included in the study and receive placebo or dexamethasone according to a random list of numbers and subjects will receive the study medication every 12 hours for two days. During the study the women will be subject to strict control of blood pressure and urine output. Laboratory tests will be performed at regular intervals during treatment and 24 hours and 48 hours after its suspension. If worsening of clinical or laboratory variables is observed, a rescue scheme of dexamethasone will be administrated. This proposal has already obtained approval of the local Institutional Review Board of the coordinating center (IMIP, Recife, Brazil), all other participating centers and of the National Council for Ethics in Research (CONEP) of the Brazilian Ministry of Health. Trial Registration. Clinical Trials Register under the number NCT00711841. © 2013 Katz et al.; licensee BioMed Central Ltd. Source


The user's perspective is essential to improve health policies aimed at guaranteeing the constitutional principles of universality and integrality. This descriptive cross-sectional study aimed to evaluate access to urgency and emergency departments of the regional hospitals in Pernambuco state, Brazil, based on user's itinerary and on the barriers to health care. A stratified random sample was selected to carry out 853 semi-structured interviews with users of seven hospitals distributed in the regions of zona da mata, agreste and sertão. Among respondents, 74.9% live in the municipality where the hospital is located, and 66.9% declared themselves registered in Family Health Team. Most of them had the hospital as first care unit (77.1%), highlighting the confidence in the service as main reason for selecting the emergency care. Regarding itinerary, respondents (99.5%) sought predominantly just one health unit and underwent medical consultation (75.4%). However, 42.8% still were transferred and of these, most (78.9%) were taken to the hospital being evaluated. Among those who required previous health care, the absence of professionals (65.5%) was the main reason for the lack of care, highlighting the deficiency in problem solving and distance between home and hospital, as important obstacles. The results reveal a scene in which the hospital is the center of health care, indicating the need for strengthening the network of comprehensive health care with a view to reducing social differences in the regional context. Source


Analyze the factors infl uencing avoidable infant mortality from the perspective of the protagonists involved. Qualitative study with a critical-constructivist approach, examining children's access to health care and avoiding preventable infant mortality through health care campaigns and services in Health District I of Recife, Northeastern Brazil, between February 2007 and February 2008. The theoretical sample was designed in two stages: I) institutions providing health services to children; II) interviewees: managers (11); professionals from the Family Health Strategy and Programme of Community Health Workers (48); and from outpatient clinics (12); mothers (20), with sample size defi ned by "saturation of the speeches". Data was collected using individual semistructured interviews and case studies of avoidable infant death. Thematic content analysis was used, generating mixed categories (emerging and scripted). There were perceived to be confl icting positions between different stakeholder groups refl ecting their role in the care network. All institutional participants related infant deaths to the absence/poor dissemination of child health policies and inter-sectoral actions; professionals and mothers highlighted diffi culties in accessing health care due to insuffi cient global resources, especially the lack of doctors in Family Health Strategy, shifting health care to nurses. Lack of doctors, acute diseases rejection, and dehumanized and/or poor technical quality care were the main factors which the mothers related to deaths. Family Health Strategy participants from the Programme of Community Health Workers and mothers identifi ed the condition of social exclusion and maternal neglect with deaths, but the case study of death revealed the association with lower quality of care offered. Numerous barriers to access indicate insuffi cient the Brazilian Unifi ed Health System implementation and lack of resolution of the main access route, the Family Health Strategy. The results indicate the need for improvement of structural and organizational factors of supply, with emphasis on mechanisms to stimulate the recruitment of doctors for the Family Health Strategy professional training of all staff consistent with the model of care to comply with health care policies for children and avoiding preventable infant mortality. Source


Ventura C.M.,Institute Medicina Integral Prof Fernando Figueira
Revista brasileira de enfermagem | Year: 2012

This was a prospective, observational study conducted in a neonatal intensive care unit to determine the incidence of adverse events. A specific trigger tool instrument was used, based on the one from Vermont-Oxford Network. A total of 218 neonates were followed and AEs were detected in 183 (84%) of them, with a rate of 2,6 AE/patient. Thermoregulation disorders (29%), disorders of glycemic control (17,1%) and nosocomial infections (13,5%) were the most frequent. Some AE were associated with birth weight (p<0.05). The accidental extubations and nosocomial infections were associated with hospital days. The incidence of AEs is high, especially among neonates with very low birth weight. Best practices regarding preventive strategies are necessary to improve quality of health care for these infants. Source

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