Breugom A.J.,Leiden University |
Swets M.,Leiden University |
Bosset J.-F.,Besancon University Hospital njoz |
Collette L.,European Organisation for Research |
And 9 more authors.
The Lancet Oncology | Year: 2015
Background: The role of adjuvant chemotherapy for patients with rectal cancer after preoperative (chemo)radiotherapy and surgery is uncertain. We did a meta-analysis of individual patient data to compare adjuvant chemotherapy with observation for patients with rectal cancer. Methods: We searched PubMed, Medline, Embase, Web of Science, the Cochrane Library, CENTRAL, and conference abstracts to identify European randomised, controlled, phase 3 trials comparing observation with adjuvant chemotherapy after preoperative (chemo)radiotherapy and surgery for patients with non-metastatic rectal cancer. The primary endpoint of interest was overall survival. Findings: We analysed data from four eligible trials, including data from 1196 patients with (y)pTNM stage II or III disease, who had an R0 resection, had a low anterior resection or an abdominoperineal resection, and had a tumour located within 15 cm of the anal verge. We found no significant differences in overall survival between patients who received adjuvant chemotherapy and those who underwent observation (hazard ratio [HR] 0.97, 95% CI 0.81-1.17; p=0.775); there were no significant differences in overall survival in subgroup analyses. Overall, adjuvant chemotherapy did not significantly improve disease-free survival (HR 0.91, 95% CI 0.77-1.07; p=0.230) or distant recurrences (0.94, 0.78-1.14; p=0.523) compared with observation. However, in subgroup analyses, patients with a tumour 10-15 cm from the anal verge had improved disease-free survival (0.59, 0.40-0.85; p=0.005, pinteraction=0.107) and fewer distant recurrences (0.61, 0.40-0.94; p=0.025, pinteraction=0.126) when treated with adjuvant chemotherapy compared with patients undergoing observation. Interpretation: Overall, adjuvant fluorouracil-based chemotherapy did not improve overall survival, disease-free survival, or distant recurrences. However, adjuvant chemotherapy might benefit patients with a tumour 10-15 cm from the anal verge in terms of disease-free survival and distant recurrence. Further studies of preoperative and postoperative treatment for this subgroup of patients are warranted. Funding: None. © 2015 Elsevier Ltd.
Landoni G.,Vita-Salute San Raffaele University |
Biondi-Zoccai G.,University of Turin |
Greco M.,Vita-Salute San Raffaele University |
Greco T.,Vita-Salute San Raffaele University |
And 4 more authors.
Critical Care Medicine | Year: 2012
Objective: Catecholaminergic inotropes have a place in the management of low output syndrome and decompensated heart failure but their effect on mortality is debated. Levosimendan is a calcium sensitizer that enhances myocardial contractility without increasing myocardial oxygen use. A meta-analysis was conducted to determine the impact of levosimendan on mortality and hospital stay. Data Sources: BioMedCentral, PubMed, Embase, and the Cochrane Central Register of clinical trials were searched for pertinent studies. International experts and the manufacturer were contacted. Study Selection: Articles were assessed by four trained investigators, with divergences resolved by consensus. Inclusion criteria were random allocation to treatment and comparison of levosimendan vs. control. There were no restrictions on dose or time of levosimendan administration or on language. Exclusion criteria were: duplicate publications, nonadult studies, oral administration of levosimendan, and no data on main outcomes. Data Extraction: Study end points, main outcomes, study design, population, clinical setting, levosimendan dosage, and treatment duration were extracted. Data Synthesis: Data from 5,480 patients in 45 randomized clinical trials were analyzed. The overall mortality rate was 17.4% (507 of 2,915) among levosimendan-treated patients and 23.3% (598 of 2,565) in the control group (risk ratio 0.80 [0.72; 0.89], p for effect <.001, number needed to treat = 17 with 45 studies included). Reduction in mortality was confirmed in studies with placebo (risk ratio 0.82 [0.69; 0.97], p = .02) or dobutamine (risk ratio 0.68 [0.52-0.88]; p = .003) as comparator and in studies performed in cardiac surgery (risk ratio 0.52 [0.35; 0.76] p = .001) or cardiology (risk ratio 0.75 [0.63; 0.91], p = .003) settings. Length of hospital stay was reduced in the levosimendan group (weighted mean difference = -1.31 [-1.95; -0.31], p for effect = .007, with 17 studies included). A trend toward a higher percentage of patients experiencing hypotension was noted in levosimendan vs. control (risk ratio 1.39 [0.97-1.94], p = .053). Conclusions: Levosimendan might reduce mortality in cardiac surgery and cardiology settings of adult patients. Copyright © 2012 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins.
Falcone M.,University of Rome La Sapienza |
Blasi F.,University of Milan |
Menichetti F.,Azienda Ospedaliera Universitaria Pisana |
Pea F.,Instituto Of Farmacologia Clinica E Tossicologia |
Violi F.,University of Rome La Sapienza
Internal and Emergency Medicine | Year: 2012
Despite advances in diagnosis, antimicrobial therapy and supportive care modalities, community-acquired pneumonia (CAP) remains an important cause of morbidity and mortality, especially in patients who require hospitalization. Elderly patients with poor functional status are characterized by a higher risk of developing severe CAP, due to the frequent presence of underlying respiratory and cardiac diseases, alteration of mental status, and immunosuppression. In recent years, changes in the healthcare system have shifted a considerable part of older patient care from hospitals to the community, and the traditional distinction between community- and hospital-acquired infections has become less clear. Pneumonia occurring among outpatients in contact with the healthcare system has been termed healthcare-associated pneumonia. Older frail patients have a high frequency of aspiration pneumonia and pneumonia due to gram-negative bacilli and other multidrug resistant pathogens. The contemporary presence of renal impairment usually requires specific dose adjustment of antibiotic therapy, which may be toxic in this specific patient population. This review produces a summary of therapeutic recommendations on the basis of the most updated clinical and pharmacological data. © 2012 SIMI.
Nannipieri M.,University of Pisa |
Baldi S.,University of Pisa |
Mari A.,National Research Council Italy |
Colligiani D.,University of Pisa |
And 8 more authors.
Journal of Clinical Endocrinology and Metabolism | Year: 2013
Context: In obese patients with type 2 diabetes (T2DM), Roux-en-Y-gastric-bypass (RYGB) and sleeve gastrectomy (SLG) improve glycemic control. Objective: The objective of this study was to investigate the mechanisms of surgery-induced T2DM improvement and role of gastrointestinal hormones. Patients, Setting, and Intervention: In 35 patients with T2DM, we performed a mixed-meal test before and 15 days and 1 year after surgery (23 RYGB and 12 SLG). Main Outcome Measures: Insulin sensitivity, β-cell function, and amylin, ghrelin, PYY, pancreatic polypeptide (PP), glucagon, and glucagon-like peptide-1 (GLP-1) responses to the meal were measured. Results: T2DM remission occurred in 13 patients undergoing RYGB and in 7 patients undergoing SLG. Similarly in the RYGB and SLG groups, β-cell glucose sensitivity improved both early and long term (P < .005), whereas insulin sensitivity improved long term only (P < .006), in proportion to body mass index changes (P < .001). Early after RYGB, glucagon and GLP-1 responses to the meal increased, whereas the PP response decreased. At 1 year, PYY was increased, and PP, amylin, ghrelin, and GLP-1 were reduced. After SLG, hormonal responses were similar to those with RYGB except that PP was increased, whereas amylin was unchanged. In remitters, fasting GLP-1 was higher (P = .04), but its meal response was flat compared with that of nonremitters; postsurgery, however, the GLP-1 response was higher. Other hormone responses were similar between the 2 groups. In logistic regression, presurgery β-cell glucose sensitivity (positive, P < .0001) and mealstimulated GLP-1 response (negative, P = .004) were the only predictors of remission. Conclusions: RYGB and SLG have a similar impact on diabetes remission, of which baseline β-cell glucose sensitivity and a restored GLP-1 response are the chief determinants. Other hormonal responses are the consequences of the altered gastrointestinal anatomy. Copyright © 2013 by The Endocrine Society.
Benedetto N.,Azienda Ospedaliera Universitaria Pisana |
Vannozzi R.,Azienda Ospedaliera Universitaria Pisana
British Journal of Neurosurgery | Year: 2012
Major intracranial arteries can be injured during tumor removal. Surgeons routinely manage this event by using either microvascular direct repair, by-pass of the wounded segment or the placement of a sutureless device. These procedures, however, are not always possible due to artery brittleness, deep operating field, vascular configuration, or restricted viewing field. In this particular case, we illustrate an example of innovative use of gelatinthrombin matrix sealant used to repair a hidden tear of pericallosalcallosomarginal bifurcation. A 49-year-old man underwent resection of a recurrent left frontal glioma. During an attempt to remove a firmly attached portion of the tumor, a tear occured in the pericallosalcallosomarginal bifurcation. The wall defect was repaired with a temporary vascular clip placed on the pericallosal artery and gelatinthrombin matrix sealant sprayed over the tear. An intraoperative indocyanine videoangiography showed patency of both the pericallosal and callosomarginal arteries. Gelatinthrombin matrix sealant is useful to control bleeding from an artery when the viewing field is restricted. In some cases, however, blood outflow must first be reduced in order to allow clot formation. © 2012 The Neurosurgical Foundation.
Rizzo S.,Azienda Ospedaliera Universitaria Pisana |
Genovesi-Ebert F.,Azienda Ospedaliera Universitaria Pisana |
Belting C.,Azienda Ospedaliera Universitaria Pisana
Retina | Year: 2011
AIM:: To compare a standard 25-gauge vitrectomy system with a new ultrahigh-speed (UHS) 25-gauge system with duty cycle control for pars plana vitrectomy. METHODS:: In this prospective, controlled clinical trial, 120 patients (divided into 2 groups of 60 patients) underwent a 3-port pars plana vitrectomy for the treatment of epiretinal membranes, macular holes, retinal detachment, and complications of diabetic retinopathy. Evaluations were performed preoperatively, intraoperatively, on the first 3 postoperative days, and at 1 week, 1 month, and 3 months. Main outcome measures were vitrectomy time, induction of posterior vitreous detachment, and intra- and postoperative complications. Vitrectomy time included retinal manipulation, but did not include wound opening and closure. RESULTS:: The duration of surgery was significantly different between the groups. Patients in the new UHS 25-gauge group had a significantly shorter duration of vitrectomy time (P < 0.0001). Mean overall vitrectomy time was 1,583.7 ± 875.4 seconds (26 minutes) in the standard 25-gauge group and 1,106.3 ± 575.9 seconds (18 minutes) in the UHS 25-gauge group. Twenty-nine patients (48.3%) in the standard group and 27 patients (45.0%) in the UHS group experienced induction of posterior vitreous detachment. Thirteen patients (21.7%) in the standard 25-gauge group and 1 patient (1.7%) in the new UHS group had intraoperative iatrogenic retinal breaks. CONCLUSION:: The new-generation UHS 25-gauge system may provide a new paradigm of high-flow, smaller-diameter instrumentation, thus increasing the efficiency of the small-gauge technique and the safety of the surgery. © The Ophthalmic Communications Society, Inc.
Malacarne P.,Azienda Ospedaliera Universitaria Pisana |
Corini M.,Azienda Ospedaliera Universitaria Pisana |
Petri D.,Azienda Ospedaliera Universitaria Pisana
American Journal of Infection Control | Year: 2011
A frequent objection to the unrestricted visiting policy in intensive care units (ICUs) is the risk of acquired infections. In a mixed 8-bed ICU, an adopted shift from a restricted to a partially unrestricted visiting policy did not result in an increase in ICU-acquired infections. © 2011 by the Association for Professionals in Infection Control and Epidemiology, Inc. Published by Elsevier Inc. All rights reserved.
Benedetto N.,Azienda Ospedaliera Universitaria Pisana |
Aquila F.,Azienda Ospedaliera Universitaria Pisana |
Vannozzi R.,Azienda Ospedaliera Universitaria Pisana
British Journal of Neurosurgery | Year: 2013
Haemangioblastomas are hypervascularized tumours. Their surgical management requires a complete resectioning and a prompt handling of the vascular inlets and outlets. The use of intraoperative indocyanine green video angiography (ICG-VAG) depicts the precise vascular pattern for the surgeon. Its use is safe and easy, and the procedure can be repeated during the operation. Here we present a case of spinal haemangioblastoma treated with the aid of intraoperative ICG-VAG and the Flow 800 software. The use of the Flow 800 allowed the surgeon to detect, at a glance, minimal changes in the vascular supply during the dissection. The colour-coded images generated by the Flow 800 increase the ICG-CAG sensitivity, improving the capability to detect changes in vascular patterns. © 2013 The Neurosurgical Foundation.
Boggi U.,Azienda Ospedaliera Universitaria Pisana |
Amorese G.,Azienda Ospedaliera Universitaria Pisana |
Marchetti P.,Azienda Ospedaliera Universitaria Pisana
Current Opinion in Organ Transplantation | Year: 2010
Purpose of review: Pancreas transplantation reproducibly induces insulin independence in β-cell penic diabetic patients. The difference between full insulin independence, partial graft function, and graft loss, mostly results from technical failure, graft rejection, and patient death with function graft. The purpose of this review is to examine recent surgical advances and discuss their contribution to improved graft function. Recent findings: Few actual surgical innovations were described in the period reviewed.Duodenoduodenostomy is an interesting option for drainage of digestive secretions, when the pancreas is placed behind the right colon and is oriented cephalad. The main advantage of this technique is easy endoscopic assessment of donor duodenum but, when allograft pancreatectomy is necessary, repair of native duodenum may be troublesome.Selective revascularization of the gastroduodenal artery, at the back-table, possibly improves blood supply to the head of the pancreas graft and duodenal segment. There is no proof that this additional maneuver is always beneficial, although it can be graft saving in case of poor segmental graft perfusion. Summary: Transplant surgeons should be familiar with all techniques for pancreas transplantation. Long-term graft function is possible only after technically successful pancreas transplantation. There is clearly a need for more objective assessment and standardization of surgical techniques for pancreas transplantation. © 2010 Wolters Kluwer Health | Lippincott Williams & Wilkins.
Menichetti F.,Azienda Ospedaliera Universitaria Pisana
Internal and Emergency Medicine | Year: 2010
Cancer patients are at risk of infectious complications due to neutropenia following chemotherapy or early post-HSCT (Hemato Stem Cell Transplantation). The first episode of fever during recent onset neutropenia is caused mostly by bacteria, while subsequent episodes are mainly fungal in nature. Proper management of infectious complications in neutropenic cancer patients requires classification into the appropriate risk category and knowledge of the local epidemiology of infections, of the causative organisms and their resistance phenotype. © 2010 SIMI.