De Nunzio C.,University of Rome La Sapienza |
Franco G.,University of Rome La Sapienza |
Cindolo L.,Ospedale Padre Pio da Pietrelcina |
Autorino R.,2nd University of Naples |
And 8 more authors.
European Journal of Surgical Oncology | Year: 2014
Introduction To evaluate the applicability of a modified Clavien classification system (CCS) in grading postoperative complications of transurethral resection of bladder tumours (TURB). Materials and methods A series of patients undergoing monopolar TURB from April 2011 to March 2012 at five Italian centers were enrolled. All complications occurring within the first 30-day postoperative period were prospectively recorded and graded according to the CCS. Results Overall, 275 patients were included. Median age was 71 (63/78) years; median BMI was 28 (25.4/30.8) Kg/m2, median tumour size was 2 (1-3) cm; median number of tumour lesions was 1 (1-3). Median operative time was 30 (20/45) min. Fifty-seven complications were recorded in 43 patients. Overall postoperative morbidity rate was 16%. Most of the complications were not serious and classified as Clavien type I (42 cases; 74%) or II (8 cases, 14%). Higher grade complications were scarce: CCS IIIa in 1 case (2%) and CCS IIIb in six cases (10%). No TURB related death was reported. Six patients were re-operated due to significant bleeding or clot retention on postoperative days 2-7. On univariate (73.5 ± 38 versus 36.7 ± 21.6 min) and multivariate analysis longer operative time was an independent predictor of complications (OR: 1.06 per min, 95%CI 1.04-1.08, p = 0.001). Conclusions A modified CCS can be used as a standardized tool to objectively define the complications of TURB which confirms to be a safe procedure with a low surgical morbidity. This tool can be used to aid in patient counselling and to facilitate scientific assessment. © 2013 Elsevier Ltd. All rights reserved.
Morandi M.M.,Louisiana State University Health Sciences Center |
Rose K.M.,Louisiana State University Health Sciences Center |
Mangano S.S.,AOU Policlinico Vittorio Emanuele
Techniques in Orthopaedics | Year: 2014
Since the first description of modern intramedullary tibia nails by Kuntscher and through the subsequent introduction of the locked nails by Gross and colleagues, infrapatellar access routes have been utilized. The discussion on the correlation between different entry points and the incidence of anterior knee pain has been extensive. Furthermore, nailing of proximal tibia fracture can be complicated by malalignment, typically an apex anterior with valgus angulation, coupled with posterior displacement of the distal fragment. The insertion of an intramedullary nail in the tibia utilizing a lateral suprapatellar percutaneous entry point, with the knee in semiextension, appears to mitigate the establishment of malreduction. Because the suprapatellar route does not directly injure the tendon, it consequently appears to lead to reduced incidence of knee pain. Originally indicated for proximal tibia fractures, this modification of the classical tibial nailing has been proven effective in all tibial locations. It allows for fast setup of the operating room, without the need for cumbersome traction tables; it simplifies the treatment in polytrauma patients with injuries to the soft tissue surrounding the patellar tendon area and it reduces the manipulation of concomitant fractures, such as femur and pelvis. © 2014 by Lippincott Williams & Wilkins.
De Simone C.,Catholic University of the Sacred Heart |
Amerio P.,University of Chieti Pescara |
Amoruso G.,University of Catanzaro |
Bardazzi F.,University of Bologna |
And 12 more authors.
Expert Opinion on Biological Therapy | Year: 2013
Introduction: Immunogenicity of antitumor necrosis factor-alpha (TNFα) agents has been proven to play a significant role in the variability of clinical responses among patients with chronic inflammatory diseases. However, its clinical impact on the outcome of patients with psoriasis and psoriatic arthritis receiving anti-TNFα treatment is not yet fully clear. Despite the high rates of efficacy of anti-TNFα agents in psoriasis, a substantial proportion of patients remain who experience a primary or secondary failure or significant side effects, which are potentially ascribable to immunogenicity. Areas covered: Topics include immunologic response elicited by anti-TNFα agents, the impact of immunogenicity on treatment response to anti-TNFα and the role played by immunogenicity in the lack of efficacy of anti-TNFα agents (infliximab, adalimumab and etanercept) in psoriasis. Expert opinion: Based on data available in the literature and the clinical experience of the authors, this article suggests the optimal approach to drug monitoring and antidrug antibody assay and the most effective use of biologic immunotherapies in this setting. Immunogenicity should be taken into account in the adoption of therapeutic choices in psoriatic patients, such as anti-TNFα agent intensification, or switching to another anti-TNFα agent or a drug with a different mechanism of action. © 2013 Informa UK, Ltd.
Stummer W.,Universitatsklinikum Munster |
Rodrigues F.,Medac GmbH |
Schucht P.,Freiburgstr. |
Preuss M.,University of Leipzig |
And 18 more authors.
Acta Neurochirurgica | Year: 2014
Background: Five-aminolevulinic acid (Gliolan, medac, Wedel, Germany, 5-ALA) is approved for fluorescence-guided resections of adult malignant gliomas. Case reports indicate that 5-ALA can be used for children, yet no prospective study has been conducted as of yet. As a basis for a study, we conducted a survey among certified European Gliolan users to collect data on their experiences with children.Methods: Information on patient characteristics, MRI characteristics of tumors, histology, fluorescence qualities, and outcomes were requested. Surgeons were further asked to indicate whether fluorescence was “useful”, i.e., leading to changes in surgical strategy or identification of residual tumor. Recursive partitioning analysis (RPA) was used for defining cohorts with high or low likelihoods for useful fluorescence.Results: Data on 78 patients <18 years of age were submitted by 20 centers. Fluorescence was found useful in 12 of 14 glioblastomas (85 %), four of five anaplastic astrocytomas (60 %), and eight of ten ependymomas grades II and III (80 %). Fluorescence was found inconsistently useful in PNETs (three of seven; 43 %), gangliogliomas (two of five; 40 %), medulloblastomas (two of eight, 25 %) and pilocytic astrocytomas (two of 13; 15 %). RPA of pre-operative factors showed tumors with supratentorial location, strong contrast enhancement and first operation to have a likelihood of useful fluorescence of 64.3 %, as opposed to infratentorial tumors with first surgery (23.1 %).Conclusions: Our survey demonstrates 5-ALA as being used in pediatric brain tumors. 5-ALA may be especially useful for contrast-enhancing supratentorial tumors. These data indicate controlled studies to be necessary and also provide a basis for planning such a study. © 2014, The Author(s).
Navarria A.,University of Catania |
Drago V.,University of Piemonte Orientale |
Gozzo L.,University of Catania |
Longo L.,AOU Policlinico Vittorio Emanuele |
And 3 more authors.
Value in Health | Year: 2015
Background Drug costs have risen rapidly in the last decade, driving third-party payers to adopt performance-based agreements that provide either a discount before payment or an ex post reimbursement on the basis of treatments' effectiveness and/or safety issues. Objectives This article analyses the strategies currently approved in Italy and proposes a novel model called "success fee" to improve payment-by-result schemes and to guarantee patients rapid access to novel therapies. Methods A review of the existing risk-sharing schemes in Italy has been performed, and data provided by the Italian National report (2012) on drug use have been analyzed to assess the impact on drug expenditure deriving from the application of "traditional" performance-based strategies since their introduction in 2006. Results Such schemes have poorly contributed to the fulfillment of the purpose in Italy, producing a trifling refund, compared with relevant drugs costs for the National Health System: €121 million out of a total of €3696 million paid. The novel risk-sharing agreement called "success fee" has been adopted for a new high-cost therapy approved for idiopathic pulmonary fibrosis, pirfenidone, and consists of an ex post payment made by the National Health System to the manufacturer for those patients who received a real benefit from treatment. Conclusions "Success fee" represents an effective strategy to promote value-based pricing, making available to patients a rapid access to innovative and expensive therapies, with an affordable impact on drug expenditure and, simultaneously, ensuring third-party payers to share with manufacturers the risk deriving from uncertain safety and effectiveness. © 2015 Published by Elsevier Inc.