Comparabilità e valutazione dei servizi sanitari

  • Nerina Agabiti1

  1. Dipartimento di epidemiologia del servizio sanitario regionale, Lazio
Nera Agabiti -

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Ricerca bibliografica periodo 01 giugno 2012 – 15 agosto 2012

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Database: Pubmed/MEDline
Stringa: (((“Quality Indicators, Health Care"[Mesh] OR "Quality Assurance, Health Care"[Mesh] OR "Outcome Assessment (Health Care)" [Mesh:NoExp] OR Outcome* [tiab] OR “quality indicators” [tiab], OR appropriateness [tiab] OR indicator* [TIAB] OR procedure [TIAB] OR efficacy[tiab] OR effectiveness[tiab]) AND ("hospitals"[MeSH] OR hospital[tiab] OR mortality[tw] OR patient* [tiab]) AND (italy[mesh] OR ital* [tiab] OR ita [la] OR ital* [ad]) AND (“2012/06/01”[PDAT] : “2012/08/15”[PDAT])) NOT ((animals [mesh] NOT humans [mesh]) OR "Genetics"[Mesh] OR "Neurophysiology"[Mesh] "Drug Therapy"[Mesh] OR "Naturopathy"[Mesh] OR "drug therapy "[Subheading] OR Editorial[ptyp] OR "Case Reports "[Publication Type] OR Letter[ptyp] OR Clinical Trial, Phase I[ptyp] OR Clinical Trial, Phase II[ptyp]))

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1. Cirocchi R, Trastulli S, Boselli C, Montedori A, Cavaliere D, Parisi A, Noya G, Abraha I. Radiofrequency ablation in the treatment of liver metastases from colorectal cancer. Cochrane Database Syst Rev. 2012 Jun 13;6:CD006317.
Department of General Surgery, University of Perugia, Terni, Italy.

BACKGROUND: Colorectal cancer (CRC) is the most common malignant tumour and the third leading cause of cancer deaths in USA. For advanced CRC, the liver is the first site of metastatic disease; approximately 50 % of patients with CRC will develop liver metastases either synchronously or metachronously within 2 years after primary diagnosis. Hepatic resection (HR) is the only curative option, but only 15-20% of patients with liver metastases from CRC (CRLMs) are suitable for surgical standard treatment. In patients with unresectable CRLMs downsizing chemotherapy can improve resectability (16%). Modern systemic chemotherapy represents the only significant treatment for unresectable CRLMs. However several loco-regional treatments have been developed: hepatic arterial infusion (HAI), cryosurgical ablation (CSA), radiofrequency ablation (RFA), microwave ablation and selective internal radion treatment (SIRT). During the past decade RFA has superseded other ablative therapies, due to its low morbidity, mortality, safety and patient acceptability.
OBJECTIVES: The objective of this study was to systematically review the role of radiofrequency ablation (RFA) in the treatment of CRLMs.
SEARCH METHODS: We performed electronic searches in the following databases:CENTRAL, MEDLINE and EMBASE. Current trials were identified through the Internet using the site (to January 2, 2012) and ASCO Proceedings. The reference lists of identified trials were reviewed for additional studies.
SELECTION CRITERIA: Randomized clinical trials (RCTs), quasi-randomised or controlled clinical trials (CCTs) comparing RFA to any other therapy for CRLMs were included. Observational study designs including comparative cohort studies comparing RFA to another intervention, single arm cohort studies or case control studies have been included if they have: prospectively collected data, ten or more patients; and have a mean or median follow-up time of 24 months. Patients with CRLMs who have no contraindications for RFA. Patients with unresectable extra-hepatic disease were also included.Trials have been considered regardless of language of origin.
DATA COLLECTION AND ANALYSIS: A total of 1144 records were identified through the above electronic searching. We included 18 studies: 10 observational studies, 7 Clinical Controlled Trials (CCTs) and an additional 1 Randomized Clinical Trial (RCT) (abstract) identified by hand searching in the 2010 ASCO Annual Meeting. The most appropriate way of summarizing time-to-event data is to use methods of survival analysis and express the intervention effect as a hazard ratio. In the included studies these outcome are mostly reported as dichotomous data so we should have asked authors research data for each participant and perform Individual Patient Data (IPD) meta-analysis. Given the study design and low quality of included studies we decided to give up and not to summarize these data.
MAIN RESULTS: Seventeen studies were not randomised and this increases the potential for selection bias. In addition, there was imbalance in the baseline characteristics of the participants included in all studies. All studies were classified as having a elevate risk of bias. The assessment of methodological quality of all non-randomized studies included in meta-analysis performed by the STROBE checklist has allowed us to identify several methodological limits in most of the analysed studies. At present, the information from the single RCT included (Ruers 2010) comes from an abstract of 2010 ASCO Annual Meeting where the allocation concealment was not reported; however in original protocol allocation concealment was adequately reported (EORTC 40004 protocol). The heterogeneity regarding interventions, comparisons and outcomes rendered the data not suitable.
AUTHORS' CONCLUSIONS: This systematic review gathers information from several controlled clinical trials and observational studies which are vulnerable to different types of bias. The imbalance between characteristics of patients in the allocated groups appears to be the main concern. Only one randomised clinical trial (published as an abstract), comparing 60 patients receiving RFA plus CT versus 59 patients receiving CT alone, was identified. This study showed that PFS was significantly higher in the group that received RFA. However, it was not able to provide information on overall survival. In conclusion, evidence from the included studies are insufficient to recommend RFA for a radical oncological treatment of CRLMs.

2. De Berardis G, Lucisano G, D'Ettorre A, Pellegrini F, Lepore V, Tognoni G, Nicolucci A. Association of aspirin use with major bleeding in patients with and without diabetes. JAMA. 2012 Jun 6;307(21):2286-94.
Department of Clinical Pharmacology and Epidemiology, Consorzio Mario Negri Sud, S. Maria Imbaro, Italy. Comment in JAMA. 2012 Jun 6;307(21):2318-20.

CONTEXT: The benefit of aspirin for the primary prevention of cardiovascular events is relatively small for individuals with and without diabetes. This benefit could easily be offset by the risk of hemorrhage.
OBJECTIVE: To determine the incidence of major gastrointestinal and intracranial bleeding episodes in individuals with and without diabetes taking aspirin.
DESIGN, SETTING, AND PARTICIPANTS: A population-based cohort study, using administrative data from 4.1 million citizens in 12 local health authorities in Puglia, Italy. Individuals with new prescriptions for low-dose aspirin (≤300 mg) were identified during the index period from January 1, 2003, to December 31, 2008, and were propensity-matched on a 1-to-1 basis with individuals who did not take aspirin during this period.
MAIN OUTCOME MEASURES: Hospitalizations for major gastrointestinal bleeding or cerebral hemorrhage occurring after the initiation of antiplatelet therapy.
RESULTS: There were 186,425 individuals being treated with low-dose aspirin and 186,425 matched controls without aspirin use. During a median follow-up of 5.7 years, the overall incidence rate of hemorrhagic events was 5.58 (95% CI, 5.39-5.77) per 1000 person-years for aspirin users and 3.60 (95% CI, 3.48-3.72) per 1000 person-years for those without aspirin use (incidence rate ratio [IRR], 1.55; 95% CI, 1.48-1.63). The use of aspirin was associated with a greater risk of major bleeding in most of the subgroups investigated but not in individuals with diabetes (IRR, 1.09; 95% CI, 0.97-1.22). Irrespective of aspirin use, diabetes was independently associated with an increased risk of major bleeding episodes (IRR, 1.36; 95% CI, 1.28-1.44).
CONCLUSIONS: In a population-based cohort, aspirin use was significantly associated with an increased risk of major gastrointestinal or cerebral bleeding episodes. Patients with diabetes had a high rate of bleeding that was not independently associated with aspirin use.

Breve commento a cura di Nerina Agabiti
Il lavoro pubblicato su JAMA 2012 da De Berardis et al è un originale contributo sul tema dei benefici delll’uso a basse dosi di aspirina per la prevenzione degli eventi cardiovascolari. In particolare il problema è aperto per la popolazione con diabete. Si tratta di uno studio di coorte di popolazione basato sui dati dei sistemi informativi della regione Puglia che ha coinvolto circa 190.000 individui. Sono stati arrruolati sulla base dell’archivio della farmaceutica territoriale i “nuovi utilizzatori” di aspirina nel periodo 2003-2008 e sono stati seguiti in per un tempo medio di 5,7 anni. Gli esiti in studio sono stati eventi emorragici maggiori che hanno richiesto ospedalizzazione.
E’ stata osservata una importante differenza tra i tassi di incidenza degli eventi avversi emorraggici tra gli utilizzatori di aspirina a basse dosi (< 300 mg /die))(tasso di incidenza 5,58 x 1000 vs. 3,60 nei non-utilizzatori (RR=1,55; IC95% 1,48-1,63). L’effetto è evidente nella stessa direzione e intensità in diverse sottopopolazioni individuate sulla base dello uso concomitante di altri farmaci e della presenza o meno di patologie concomitanti. Per quanto riguarda il diabete, invece, non si osservano differenze negli esiti tra utilizzatori e non utilizzatori di aspirina. Il diabete stesso è fattore di rischio per eventi di tipo emorraggico. Il lavoro è molto apprezzabile come una delle poche esperienze in Italia di studi di coorte basate sui dati dei sistemi informativi sanitari per analizzare comparativamente l’occorrenza di eventi avversi di farmaci. Dà anche un pregievole contributo in tema di strategie di disegno e di analisi in tema della valutazione comparativa di esito.

3. Vikatmaa P, Mitchell D, Jensen LP, Beiles B, Björck M, Halbakken E, Lees T, Menyhei G, Palombo D, Troëng T, Wigger P, Venermo M. Variation in clinical practice in carotid surgery in nine countries 2005-2010. Lessons from VASCUNET and recommendations for the future of national clinical audit. Eur J Vasc Endovasc Surg. 2012 Jul;44(1):11-7. Epub 2012 May 24
Department of Vascular Surgery, Helsinki University Central Hospital, Helsinki, Finland. Comment in Eur J Vasc Endovasc Surg. 2012 Jul;44(1):18-9.

OBJECTIVES: The aim of the study was to analyse variation in carotid surgical practice, results and effectiveness in nine countries.
PATIENTS AND METHODS: A total of 48,185 carotid endarterectomies (CEAs) and 4602 carotid artery stenting (CAS) procedures were included in the comparison. A theoretical effectiveness of CEA provision for each country was estimated.
RESULTS: 92.6% of the CEAs were performed according to the inclusion criteria based on the current European recommendations and had a theoretical benefit for the patient. The indication for surgery was symptomatic stenosis in 60.1% and this proportion varied between 31.4% in Italy and 100% in Denmark. The overall combined stroke and death rate in symptomatic patients was 2.3%. This varied between rates of 0.9% in Italy and 3.8% in Norway. The overall combined stroke and death rate in asymptomatic patients was 0.9%. It was lowest in Italy at 0.5%, and highest in Sweden at 2.7%. We estimated that the stroke prevention rate per 1000 CEAs varied from 72.9 in Italy to 130.8 in Denmark.
CONCLUSIONS: There is significant variation in clinical practice across the participating countries. The theoretical stroke prevention potential of CEA seems to vary between participating countries due to differences in the inclusion criteria.

Breve commento a cura di Nerina Agabiti
L’obiettivo del lavoro di Vikatmaa et al è di analizzare la variabilità della chirurgia sulla carotide in nove Paesi europei tra cui l’Italia. Vengono riportati i risultati dello studio VASCUNET. Sono state analizzati oltre 48.000 interventi di endoarterectomia carotidea e circa 4.600 interventi di stent carotideo. E’ stata anche eseguita un'analisi di efficacia “teorica” all’interno di ciascun paese con il calcolo del “tasso di prevenzione di ictus cerebrale”. E’ stato osservato che nel 92,6% dei casi l’intervento di endoarterectomia è stato eseguito in linea con le raccomandazioni europee per quanto riguarda la scelta della popolazione. La stenosi carotidea sintomatica è risultata presente in circa il 60% dei casi, con una grande variabilità tra Paesi (31,4% in Italia, 100% in Danimarca). L’occorrenza di ictus/morte overall nei pazienti sintomatici è stata del 2,3%, con un'ampia variabilità tra Paesi (0,9% in Italia, 3,8% in Norvegia). L’occorrenza di ictus/morte nei pazienti asintomatici overall è stata dello 0,9% (0,5% in Italia, 2,7% in Svezia). Il tasso x 1.000 di eventi di ictus prevenibili è stimato pari a 72,9% in Italia vs. 103,8% in Danimarca. Lo studio è interessante perché permette di valutare la variabilità nell’uso delle procedure chirurgiche sulla carotidea livello europeo. La differenza nell’efficacia “teorica” sembra essere maggiormente dovuta alle differenze nei criteri di inclusione dei pazienti. Studi comparativi tra Paesi, come il presente lavoro, supportano l’evidenza sul reale impatto nella pratica clinica di interventi o procedure, ne permettono il monitoraggio anche nel tempo dell’aderenza alle Linee Guida e degli esiti, e stimolano al miglioramento della qualità dell’assistenza.

4. Fagotti A, Gagliardi ML, Fanfani F, Salerno MG, Ercoli A, D'Asta M, Tortorella L, Turco LC, Escobar P, Scambia G. Perioperative outcomes of total laparoendoscopic single-site hysterectomy versus total robotic hysterectomy in endometrial cancer patients: a multicentre study. Gynecol Oncol. 2012 Jun;125(3):552-5. Epub 2012 Mar 3.
Department of Obstetrics and Gynecology, Division of Gynecologic Oncology, Catholic University of the Sacred Heart, Rome, Italy.

OBJECTIVE: To compare the peri-operative outcomes between total laparo-endoscopic single-site (LESS) and robotic approaches for the staging and treatment of early stage endometrial cancer patients.
METHODS: A multicentre retrospective study involving three Italian gynaecological groups and one American centre. The peri-operative outcomes of LESS and robotic approach were compared in similar groups of patients, with regard to surgical outcomes and intra- and post-operative parameters and complications.
RESULTS: During the study period, 75 patients submitted to a total LESS hysterectomy and 75 patients received a total robotic hysterectomy. The median operative time - 122 versus 175 min (p=0.0001) - and the estimated blood loss - 50 versus 80 mL (p=0.03) - were slightly more favourable in the LESS group. The intra-operative complications were equally distributed (p=0.99); in the robotic group there were 4 (5.3%) post-operative grade IIIb complications versus 1 (1.3%) in the LESS group (p=0.172).
CONCLUSIONS: The LESS and robotic approaches both appear reasonable and each may have benefits and limitations depending upon the patient population. Further studies are needed to validate these preliminary conclusions.

5. Cucchetti A, Cescon M, Ercolani G, Bigonzi E, Torzilli G, Pinna AD. A Comprehensive Meta-regression Analysis on Outcome of Anatomic Resection Versus Nonanatomic Resection for Hepatocellular Carcinoma. Ann Surg Oncol. 2012 Jun 22. [Epub ahead of print]
Liver and Multiorgan Transplant Unit, Alma Mater Studiorum, University of Bologna, Bologna, Italy,

BACKGROUND: It remains unclear whether hepatectomy for hepatocellular carcinoma should be performed as an anatomic resection (AR) or a nonanatomic resection (NAR). Because no randomized controlled trials are currently available on this topic, a meta-regression analysis was performed on available observational studies to control for confounding variables.
METHODS: A systematic review of studies published from 1990 to 2011 in the PubMed and Embase databases was performed. Patient and disease-free survival (DFS), postoperative mortality, and morbidity were considered as outcomes. Results are expressed as relative risk (RR) or weighted mean differences with 95 % of confidence interval.
RESULTS: Eighteen observational studies involving 9,036 patients were analyzed: 4,012 were in the AR group and 5,024 in the NAR group. Meta-analysis suggested that AR provided better 5-year patient survival (RR 1.14; P = 0.001) and DFS than NAR (RR 1.38; P = 0.001). However, patients in the NAR group were characterized by a higher prevalence of cirrhosis (RR 1.27; P = 0.010), more advanced hepatic dysfunction (RR 0.90 for Child-Pugh class A; P = 0.001) and smaller tumor size (weighted mean difference 0.36 cm; P < 0.001) compared with patients in the AR group. Meta-regression analysis showed that the different proportion of cirrhosis in the NAR group significantly affected both 5-year patient survival (RR 1.28; P = 0.016) and DFS (RR 1.74; P = 0.022). Tumor size only slightly affected DFS (RR 1.72; P = 0.076). Postoperative mortality and morbidity were unaffected (P > 0.05 in all cases).
CONCLUSIONS: Patient survival and DFS after AR seem to be superior to NAR because the worse liver function reserve in the NAR group significantly affects prognosis.

6. Santini D, Tampellini M, Vincenzi B, Ibrahim T, Ortega C, Virzi V, Silvestris N, Berardi R, Masini C, Calipari N, Ottaviani D, Catalano V, Badalamenti G, Giannicola R, Fabbri F, Venditti O, Fratto ME, Mazzara C, Latiano TP, Bertolini F, Petrelli F, Ottone A, Caroti C, Salvatore L, Falcone A, Giordani P, Addeo R, Aglietta M, Cascinu S, Barni S, Maiello E, Tonini G. Natural history of bone metastasis in colorectal cancer: final results of a large Italian bone metastases study. Ann Oncol. 2012 Aug;23(8):2072-7. Epub 2012 Jan 4.
Department of Medical Oncology, University Campus Bio-Medico, Rome.

Background Data are limited regarding bone metastases from colorectal cancer (CRC). The objective of this study was to survey the natural history of bone metastasis in CRC.
Patients and methods This retrospective, multicenter, observational study of 264 patients with CRC involving bone examined cancer treatments, bone metastases characteristics, skeletal-related event (SRE) type and frequency, zoledronic acid therapy, and disease outcomes.
Results Most patients with bone metastases had pathologic T3/4 disease at CRC diagnosis. The spine was the most common site involved (65%), followed by hip/pelvis (34%), long bones (26%), and other sites (17%). Median time from CRC diagnosis to bone metastases was 11.00 months; median time to first SRE thereafter was 2.00 months. Radiation and pathologic fractures affected 45% and 10% of patients, respectively; 32% of patients had no reported SREs. Patients survived for a median of 7.00 months after bone metastases diagnosis; SREs did not significantly affect survival. Subgroup analyses revealed that zoledronic acid significantly prolonged median time to first SRE (2.00 months versus 1.00 month, respectively, P = 0.009) and produced a trend toward improved overall survival versus no zoledronic acid.
Conclusion This study illustrates the burden of bone metastases from CRC and supports the use of zoledronic acid in this setting.

7. Adibi M, Youssef R, Shariat SF, Lotan Y, Wood CG, Sagalowsky AI, Zigeuner R, Montorsi F, Bolenz C, Margulis V. Oncological outcomes after radical nephroureterectomy for upper tract urothelial carcinoma: Comparison over the three decades. Int J Urol. 2012 Aug 12. doi: 10.1111/j.1442-2042.2012.03110.x. [Epub ahead of print]
Department of Urology, UT Southwestern Medical Center, Dallas The University of Texas MD Anderson Cancer Center, Houston, Texas Department of Urology, Cornell University, New York City, New York, USA Medical University of Graz, Graz, Austria Department of Urology, Vita-Salute University, Milan, Italy Mannheim Medical Center, University of Heidelberg, Mannheim, Germany.

Abstract To evaluate temporal trends in clinicopathological features and Objective: oncological outcomes after radical nephroureterectomy for upper tract urothelial Utilizing a multi-institutional database of patients treated carcinoma. Methods: with radical nephroureterectomy between 1983 and 2007, we compared clinicopathological features and survival outcomes over the past three decades using the following cohorts: group 1 comprised of patients treated before the 655), and group 3 from 2000 to = 106), group 2 from 1990 to1999 (n = 1990s (n 701). Survival rates were compared using Kaplan-Meier survival = 2007 (n The study included 1462 patients, 992 men and 470 women, with analysis. Results: months) after radical nephroureterectomy. months median follow up (range 1-250 36 Tumors were organ confined (≤T2/N0) in 88% and high-grade in 64%. Neoadjuvant and adjuvant systemic chemotherapy was administered in 47 (3.2%) and 171 (11.7%) patients, respectively. There was a significant increase in the use of laparoscopic radical nephroureterectomy, endoscopic management of urothelial carcinoma and utilization of perioperative chemotherapy between decades 1 to 3. There were no significant differences in pathological stage distribution. The 2%, ± 2% and 71 ± 5%, 68.5 ± overall 5-year disease-free survival rates were 66 2% ± 2%, and 75 ± 5%, 72 ± and the 5-year cancer-specific survival rates were 75 for groups 1, 2 and 3, respectively, with no significant statistical differences  between the three decades (P> Outcomes after radical 0.05). Conclusion:  nephroureterectomy have not changed significantly over the past three decades, despite staging and surgical refinements. Utilization of perioperative systemic chemotherapy in urothelial carcinoma management remains low. Further improvements in outcomes of urothelial carcinoma patients necessitate rigorous investigation of multimodal treatment approaches.

8. Zullo A, Hassan C, Ridola L, De Francesco V, Vaira D. Standard triple and sequential therapies for Helicobacter pylori eradication: An update. Eur J Intern Med. 2012 Aug 6. [Epub ahead of print]
Gastroenterology and Digestive Endoscopy, 'Nuovo Regina Margherita' Hospital, Rome, Italy.

Abstract H. pylori infection remains a worldwide spread disease with a definite morbidity and mortality. Unfortunately, no current therapy regimen is able to cure the infection in all treated patients. The efficacy of the widely recommended triple therapies is decreasing, and a novel 10-day sequential therapy has been proposed. Data of 3 previous meta-analyses showed a significantly higher eradication rate following the sequential as compared to the 7-10 days triple therapies. The sequential therapy achieved significantly better results than triple therapies in children, elderly patients, non-ulcer dyspepsia patients, and in those infected with resistant strains towards either clarithromycin or metronidazole. We identified further 10 randomized trials. By pooling data, H. pylori infection was cured in 2,454 (86%; 95% CI: 84.7-87.3) out of 2,853 patients with the sequential therapy and in 2,320 (75.3%; 95% CI: 73.8-76.9) out of 3,079 patients treated with standard triple therapies (p<0.001), corresponding to a number to treat (NNT) of 9. The comparison between the 10-day sequential regimen and 14-day triple therapies deserves further investigations.

9. Pengo V, Crippa L, Falanga A, Finazzi G, Marongiu F, Moia M, Palareti G, Poli D, Testa S, Tiraferri E, Tosetto A, Tripodi A, Siragusa S, Manotti C. Phase III studies on novel oral anticoagulants for stroke prevention in atrial fibrillation -a look beyond the excellent results. J Thromb Haemost. 2012 Jul 24. doi: 10.1111/j.1538-7836.2012.04866.x. [Epub ahead of print]
Clinical Cardiology, Thrombosis Centre, University of Padua, Padua, Italy Thrombosis Research Unit, IRCCS H S.Raffaele, Milan, Italy Division of Immunohematology and Transfusion Medicine, Ospedali Riuniti, Bergamo, Italy Division of Hematology, Ospedali Riuniti, Bergamo, Italy Department of Medical Sciences, University Hospital, Cagliari, Italy Angelo Bianchi Bonomi Hemophilia and Thrombosis Center, IRCCS Cà Granda Maggiore Hospital Foundation and Università degli Studi di Milano, Milan, Italy Department of Angiology and Blood Coagulation ″Marino Golinelli″, University Hospital, Bologna, Italy Department of Heart and Vessels, Thrombosis Center, Careggi University Hospital, Florence, Italy Thrombosis Centre, District Hospital, Cremona, Italy Haemostasis and Thrombosis Centre, City Hospital, Rimini, Italy Department of Hematology, San Bortolo Hospital, Vicenza, Italy Department of Internal and Specialized Medicine, University Hospital, Palermo, Italy Anticoagulation Service, Fidenza, Italy, all members of the steering committee of Italian Federation of Thrombosis Centers (FCSA).

Abstract In this overview we address the three phase III studies that compared new oral anticoagulants (dabigatran, rivaroxaban, apixaban) with warfarin in the setting of stroke prevention in atrial fibrillation. Strengths and weaknesses of the studies were examined in detail through indirect comparison. We analyse and comment the inclusion and exclusion criteria, the characteristics of randomized patients, the primary efficacy and safety end points and side effects. All new oral anticoagulants resulted to be non-inferior to vitamin K antagonists in reducing stroke or systemic embolism in patients with atrial fibrillation. Dabigatran 150 mg and Apixaban were superior to vitamin K antagonists. Importantly, new oral anticoagulants significantly reduced hemorrhagic stroke in all three studies . Major differences among new oral anticoagulants include the way they are eliminated and side effects. Both dabigatran and apixaban were tested in low-moderate risk patients (mean CHADS2 - Congestive heart failure, Hypertension, Age, Diabetes, Stroke - score = 2.1-2.2) while rivaroxaban was tested in high risk patients (mean CHADS2 - Congestive heart failure, Hypertension, Age, Diabetes, Stroke - score = 3.48) and at variance with dabigatran and apixaban was administered once daily. Apixaban significantly reduced mortality from any cause. The choice of a new oral anticoagulant should take into account these and other differences between the new drugs. © 2012 International Society on Thrombosis and Haemostasis.

10. Marano A, Hyung WJ. Robotic gastrectomy: the current state of the art. J Gastric Cancer. 2012 Jun;12(2):63-72. Epub 2012 Jun 27.
Division of Surgical Oncology, Department of Surgery, San Giovanni Battista Hospital, University of Turin, Turin, Italy.

Abstract Since the first laparoscopic gastrectomy for cancer was reported in 1994, minimally invasive surgery is enjoying its wide acceptance. Numerous procedures of this approach have developed, and many patients have benefited from its effectiveness, which has been recently demonstrated for early gastric cancer. However, since laparoscopic surgery is not exempt from some limitations, the robotic surgery system was introduced as a solution by the late 1990's. Many experienced surgeons have embraced this new emerging method that provides undoubted technical and minimally invasive advantages. To date, several studies have concentrated to this new system, and have compared it with open and laparoscopic approach. Most of them have reported satisfactory results concerning the post-operative short-term outcomes, but almost all believe that the role of robotic gastrectomy is still out of focus, especially because long-term outcomes that can prove robotic oncologic equivalency are lacking, and operative costs and time are higher in comparison to the open and laparoscopic ones. This article is a review about the current status of robotic surgery for the treatment of gastric cancer, especially, focusing on the technical aspects, comparisons to other approaches and future prospects.

11. Ficarra V, Novara G, Rosen RC, Artibani W, Carroll PR, Costello A, Menon M, Montorsi F, Patel VR, Stolzenburg JU, Van der Poel H, Wilson TG, Zattoni F, Mottrie A. Systematic Review and Meta-analysis of Studies Reporting Urinary Continence Recovery After Robot-assisted Radical Prostatectomy. Eur Urol. 2012 Sep;62(3):405-17. Epub 2012 Jun 1.
University of Padua, Padua, Italy; O.L.V. Clinic, Aalst, Belgium.

CONTEXT: Robot-assisted radical prostatectomy (RARP) was proposed to improve functional outcomes in comparison with retropubic radical prostatectomy (RRP) or laparoscopic radical prostatectomy (LRP). In the initial RARP series, 12-mo urinary continence recovery rates ranged from 84% to 97%. However, the few available studies comparing RARP with RRP or LRP published before 2008 did not permit any definitive conclusions about the superiority of any one of these techniques in terms of urinary continence recovery.
OBJECTIVE: The aims of this systematic review were (1) to evaluate the prevalence and risk factors for urinary incontinence after RARP, (2) to identify surgical techniques able to improve urinary continence recovery after RARP, and (3) to perform a cumulative analysis of all available studies comparing RARP versus RRP or LRP in terms of the urinary continence recovery rate.
EVIDENCE ACQUISITION: A literature search was performed in August 2011 using the Medline, Embase, and Web of Science databases. The Medline search included only a free-text protocol using the term radical prostatectomy across the title and abstract fields of the records. The following limits were used: humans; gender (male); and publication date from January 1, 2008. Searches of the Embase and Web of Science databases used the same free-text protocol, keywords, and search period. Only comparative studies or clinical series including >100 cases reporting urinary continence outcomes were included in this review. Cumulative analysis was conducted using the Review Manager v.4.2 software designed for composing Cochrane Reviews (Cochrane Collaboration, Oxford, UK).
EVIDENCE SYNTHESIS: We analyzed 51 articles reporting urinary continence rates after RARP: 17 case series, 17 studies comparing different techniques in the context of RARP, 9 studies comparing RARP with RRP, and 8 studies comparing RARP with LRP. The 12-mo urinary incontinence rates ranged from 4% to 31%, with a mean value of 16% using a no pad definition. Considering a no pad or safety pad definition, the incidence ranged from 8% to 11%, with a mean value of 9%. Age, body mass index, comorbidity index, lower urinary tract symptoms, and prostate volume were the most relevant preoperative predictors of urinary incontinence after RARP. Only a few comparative studies evaluated the impact of different surgical techniques on urinary continence recovery after RARP. Posterior musculofascial reconstruction with or without anterior reconstruction was associated with a small advantage in urinary continence recovery 1 mo after RARP. Only complete reconstruction was associated with a significant advantage in urinary continence 3 mo after RARP (odds ratio [OR]: 0.76; p=0.04). Cumulative analyses showed a better 12-mo urinary continence recovery after RARP in comparison with RRP (OR: 1.53; p=0.03) or LRP (OR: 2.39; p=0.006).
CONCLUSIONS: The prevalence of urinary incontinence after RARP is influenced by preoperative patient characteristics, surgeon experience, surgical technique, and methods used to collect and report data. Posterior musculofascial reconstruction seems to offer a slight advantage in terms of 1-mo urinary continence recovery. Update of a previous systematic review of literature shows, for the first time, a statistically significant advantage in favor of RARP in comparison with both RRP and LRP in terms of 12-mo urinary continence recovery.

12. Bracale U, Melillo P, Pignata G, Di Salvo E, Rovani M, Merola G, Pecchia L. Which is the best laparoscopic approach for inguinal hernia repair: TEP or TAPP? A systematic review of the literature with a network meta-analysis. Surg Endosc. 2012 Jun 16. [Epub ahead of print]
General and Mini-Invasive Surgical Unit, San Camillo Hospital, Trento, Italy,

BACKGROUND: Totally extraperitoneal (TEP) repair and transabdominal preperitoneal (TAPP) repair are the most used laparoscopic techniques for inguinal hernia treatment. However, many studies have shown that laparoscopic hernia repair compared with open hernia repair (OHR) may offer less pain and shorter convalescence. Few studies compared the clinical efficacy between TEP and TAPP technique. The purpose of this study is to provide a comparison between TEP and TAPP for inguinal hernia repair to show the best approach.
METHODS: We performed an indirect comparison between TEP and TAPP techniques by considering only randomized, controlled trials comparing TEP with OHR and TAPP with OHR in a network meta-analysis. We considered the following outcomes: operative time, postoperative complications, hospital stay, postoperative pain, time to return to work, and recurrences.
RESULTS: The two techniques improved some short outcomes (such as time to return to work) with respect to OHR. In the network meta-analysis, TEP and TAPP were equivalent for operative time, postoperative complications, postoperative pain, time to return to work, and recurrences, whereas TAPP was associated with a slightly longer hospital stay compared with TEP.
CONCLUSIONS: TEP and TAPP improved clinical outcomes compared with OHR, but the network meta-analysis showed that TEP and TAPP efficacy is equivalent. TAPP was associated with a slightly longer hospital stay compared with TEP.

13. Lees T, Troëng T, Thomson IA, Menyhei G, Simo G, Beiles B, Jensen LP, Palombo D, Venermo M, Mitchell D, Halbakken E, Wigger P, Heller G, Björck M. International Variations in Infrainguinal Bypass Surgery - A VASCUNET Report. Eur J Vasc Endovasc Surg. 2012 Aug;44(2):185-92. Epub 2012 May 31.
Northern Vascular Centre, Newcastle Upon Tyne Hospitals NHS Trust, UK.

OBJECTIVES: To compare practice in lower limb bypass surgery in nine countries.
DESIGN: A prospective study amalgamating and analysing data from national and regional vascular registries.
METHODS: A table of data fields and definitions was agreed by all member countries of the Vascunet Collaboration. Data from January 2005 to December 2009 was submitted to a central database.
RESULTS: 32,084 cases of infrainguinal bypass (IIB) in nine countries were analysed. Procedures per 100,000 population varied between 2.3 in the UK and 24.6 in Finland. The proportion of women varied from 25% to 43.5%. The median age for all countries was 70 for men and 76 for women. Hungary treated the youngest patients. IIB was performed for claudication for between 15.7% and 40.8% of all procedures. Vein grafts were used in patients operated on for claudication (52.9%), for rest pain (66.7%) and tissue loss (74.1%). Italy had the highest use of synthetic grafts. Among claudicants 45% of bypasses were performed to the below knee popliteal artery or more distally. Graft patency at 30 days varied between 86% and 99%.
CONCLUSIONS: Significant variations in practice between countries were demonstrated. These results should be interpreted alongside the known limitations of such registry data with respect to quality and completeness of the data. Variation in data completeness and data validation between countries needs to be improved for useful international comparison of outcomes.

14. Colli A, Conte D, Valle SD, Sciola V, Fraquelli M. Meta-analysis: nonsteroidal anti-inflammatory drugs in biliary colic. Aliment Pharmacol Ther. 2012 Jun;35(12):1370-8. doi: 10.1111/j.1365-2036.2012.05115.x. Epub 2012 Apr 29.
Department of Internal Medicine, Ospedale "A. Manzoni", Lecco, Italy.

BACKGROUND: Biliary colic is a common manifestation of cholelithiasis, developing in about one-third of patients. Even if nonsteroid anti-inflammatory drugs (NSAIDs) have widely been used to relieve biliary pain, there is a lack of systematic review of treatments on this issue. AIM: To assess the potential benefits in terms of both pain control and reduction of complications, and the potential harms of NSAIDs in patients with biliary colic.
METHODS: Data from randomised clinical trials (RCTs) comparing NSAIDs with no treatment, placebo or other drugs in patients with biliary colic, were collected from Medline and Embase. The outcome measures were expressed as odds ratio and relative risk and then pooled using fixed or random-effect models.
RESULTS: Eleven RCTs involving 1076 subjects (268 men, 808 women; 18-86 years), including 442 controls were analysed. In comparison with placebo, NSAIDs led to a significantly higher proportion of patients with complete pain relief (RR 3.77, 95%CI 1.65-8.61; I(2) : 73%) and a significantly lower rate of complications (RR 0.53, 95% CI 0.31-0.89; I(2) : 35%). In comparison with other drugs, NSAIDs were more efficacious in controlling pain than spasmolytics (RR 1.47, 95% CI 1.03-2.10; I(2) : 55%); there was no difference between NSAIDs and opioids (RR 1.05, 95% CI 0.82-1.33; I(2) : 74%).
CONCLUSIONS: In patients with biliary colic NSAIDs are the first-choice treatments as they control pain with the same efficacy of opioids and significantly reduce the proportion of patients with severe complications. However, the lack of high-quality RCTs and the presence of consistent heterogeneity among studies may partially flaw these results.

15. Trastulli S, Cirocchi R, Listorti C, Cavaliere D, Avenia N, Gullà N, Giustozzi G, Sciannameo F, Noya G, Boselli C. Laparoscopic vs open resection for rectal cancer: a meta-analysis of randomized clinical trials. Colorectal Dis. 2012 Jun;14(6):e277-96. doi: 10.1111/j.1463-1318.2012.02985.x.
Department of General Surgery, S Maria Hospital, University of Perugia, Terni, Italy.

AIM: Laparoscopic and open rectal resection for cancer were compared by analysing a total of 26 end points which included intraoperative and postoperative recovery, short-term morbidity and mortality, late morbidity and long-term oncological outcomes.
METHOD: We searched for published randomized clinical trials, presenting a comparison between laparoscopic and open rectal resection for cancer using the following electronic databases: PubMed, OVID, Medline, Cochrane Database of Systematic Reviews, EBM Reviews, CINAHL and EMBASE.
RESULTS: Nine randomized clinical trials (RCTs) were included in the meta-analysis incorporating a total of 1544 patients, having laparoscopic (N = 841) and open rectal resection (N = 703) for cancer. Laparoscopic surgery for rectal cancer was associated with a statistically significant reduction in intraoperative blood loss and in the number of blood transfusions, earlier resuming solid diet, return of bowel function and a shorter duration of hospital stay. We also found a significant advantage for laparoscopy in the reduction of post-operative abdominal bleeding, late intestinal adhesion obstruction and late morbidity. No differences were found in terms of intra-operative and late oncological outcomes.
CONCLUSION: The meta-analysis indicates that laparoscopy benefits patients with shorter hospital stay, earlier return of bowel function, reduced blood loss and number of blood transfusions and lower rates of abdominal postoperative bleeding, late intestinal adhesion obstruction and other late morbidities.

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