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11 results on '"Morelli, N"'

1. A - 30 Executive Function in Division-I Collegiate Athletes and Recreationally Active College Students

Author

Wilson J, Han Dy, Hoch Mc, and Morelli N

Subjects
medicine.medical_specialty, biology, Athletes, media_common.quotation_subject, General Medicine, Division (mathematics), biology.organism_classification, Psychiatry and Mental health, Clinical Psychology, Neuropsychology and Physiological Psychology, Physical therapy, medicine, Psychology, Function (engineering), media_common
Abstract

Objective High-level cognitive performance is important for navigating the complex environment of sport. The executive function domain may be of particular importance because it focuses on flexible thinking and self-control. It is unclear if high-level athletes exhibit similar executive function compared to recreational athletes. Therefore, the purpose of this study was to compare executive function between male and female Division-I collegiate athletes and recreationally active peers. Methods Thirty-seven Division-I athletes (16 females, 21 males) and 30 recreationally active college students (19 females, 11 males) participated. Participants completed the Flanker Inhibitory Control and Attention Test (FICA) and Dimensional Change Card Sort Test (DCCS) from the National Institute of Health Toolbox Cognitive Battery on a tablet to assess cognitive flexibility and attention and inhibitory control, respectively. Demographically-corrected T-scores were used for analysis. Two-way ANOVAs compared cognitive performance based on group and sex (p ≤ 0.05). Results There was a significant group-by-sex interaction for the FICA (p = 0.005). Female recreational athletes (50.68 ± 10.18) demonstrated higher FICA scores compared to female Division-I athletes (40.88 ± 7.35; p = 0.003, ES = 1.06). Male Division-I athletes (48.67 ± 10.39) also exhibited greater scores compared to female Division-I athletes (p = 0.015, ES = 0.83). There was no significant group-by-sex interaction (p = 0.84), group effect (p = 0.35), or sex effect (p = 0.43) for the DCCS. Conclusions Female Division-I athletes demonstrated poorer performance on the FICA compared to male Division-I athletes and recreational female athletes which may indicate a decreased ability to suppress motor responses caused by internal or external distractions. The significance of these findings for mitigating injury risk and improving athletic performance should be explored.

Published
2021

2. Incidence of neuroepithelial primary brain tumors among adult population of Emilia-Romagna Region, Italy

Author

Baldin, Elisa, Testoni, Stefania, de Pasqua, Silvia, Ferro, Salvatore, Albani, Fiorenzo, Baruzzi, Agostino, D’alessandro, Roberto, On behalf of PERNO study group, Null, Baruzzi, A., Albani, F., Calbucci, F., D’alessandro, R., Michelucci, R., Brandes, A., Eusebi, V., Ceruti, Stefano, Fainardi, Enrico, Tamarozzi, R., Emiliani, E., Cavallo, Michele Alessandro, Franceschi, E., Tosoni, A., Cavallo, M., Fiorica, F., Valentini, A., Depenni, R., Mucciarini, C., Crisi, G., Sasso, E., Biasini, C., Cavanna, L., Guidetti, D., Marcello, N., Pisanello, A., Cremonini, A. M., Guiducci, G., de Pasqua, S., Testoni, S., Agati, R., Ambrosetto, G., Bacci, A., Baldin, E., Baldrati, A., Barbieri, E., Bartolini, S., Bellavista, E., Bisulli, F., Bonora, E., Bunkheila, F., Carelli, V., Crisci, M., Dall’occa, P., Ferro, S., Franceschi, C., Frezza, G., Grasso, V., Leonardi, M., Mostacci, B., Palandri, G., Pasini, E., Pastore Trossello, M., Poggi, R., Riguzzi, P., Rinaldi, R., Rizzi, S., Romeo, G., Spagnolli, F., Tinuper, P., Trocino, C., Dall’agata, M., Faedi, M., Frattarelli, M., Gentili, G., Giovannini, A., Iorio, P., Pasquini, U., Galletti, G., Guidi, C., Neri, W., Patuelli, A., Strumia, S., Casmiro, M., Gamboni, A., Rasi, F., Cruciani, G., Cenni, P., Dazzi, C., Guidi, A. R., Zumaglini, F., Amadori, A., Pasini, G., Pasquinelli, M., Pasquini, E., Polselli, A., Ravasio, A., Viti, B., Sintini, M., Ariatti, A., Bertolini, F., Bigliardi, G., Carpeggiani, P., Cavalleri, F., Meletti, S., Nichelli, P., Pettorelli, E., Pinna, G., Zunarelli, E., Artioli, F., Bernardini, I., Costa, M., Greco, G., Guerzoni, R., Stucchi, C., Iaccarino, C., Ragazzi, M., Rizzi, R., Zuccoli, G., Api, P., Cartei, F., Fallica, Elisa, Granieri, Enrico Gavino Giuseppe, Latini, Francesco, Lelli, G., Monetti, C., Saletti, A., Schivalocchi, Roberta, Seraceni, S., Tola, Maria Rosaria, Urbini, B., Giorgi, C., Montanari, E., Cerasti, D., Crafa, P., Dascola, I., Florindo, I., Giombelli, E., Mazza, S., Ramponi, Vania, Servadei, F., Silini, E. M., Torelli, P., Immovilli, P., Morelli, N., Vanzo, C., Nobile, C., Baldin, Elisa, Testoni, Stefania, De Pasqua, Silvia, Ferro, Salvatore, Albani, Fiorenzo, Baruzzi, Agostino, D'Alessandro, Roberto, On behalf of PERNO study group, Baruzzi, A., Albani, F., Calbucci, F., D'Alessandro, R., Michelucci, R., Brandes, A., Eusebi, V., Ceruti, S., Fainardi, E., Tamarozzi, R., Emiliani, E., Cavallo, M., Franceschi, E., Tosoni, A., Fiorica, F., Valentini, A., Depenni, R., Mucciarini, C., Crisi, G., Sasso, E., Biasini, C., Cavanna, L., Guidetti, D., Marcello, N., Pisanello, A., Cremonini, A. M., Guiducci, G., de Pasqua, S., Testoni, S., Agati, R., Ambrosetto, G., Bacci, A., Baldin, E., Baldrati, A., Barbieri, E., Bartolini, S., Bellavista, E., Bisulli, F., Bonora, E., Bunkheila, F., Carelli, V., Crisci, M., Dall'Occa, P., Ferro, S., Franceschi, C., Frezza, G., Grasso, V., Leonardi, M., Mostacci, B., Palandri, G., Pasini, E., Pastore Trossello, M., Poggi, R., Riguzzi, P., Rinaldi, R., Rizzi, S., Romeo, G., Spagnolli, F., Tinuper, P., Trocino, C., Dall'Agata, M., Faedi, M., Frattarelli, M., Gentili, G., Giovannini, A., Iorio, P., Pasquini, U., Galletti, G., Guidi, C., Neri, W., Patuelli, A., Strumia, S., Casmiro, M., Gamboni, A., Rasi, F., Cruciani, G., Cenni, P., Dazzi, C., Guidi, A. R., Zumaglini, F., Amadori, A., Pasini, G., Pasquinelli, M., Pasquini, E., Polselli, A., Ravasio, A., Viti, B., Sintini, M., Ariatti, A., Bertolini, F., Bigliardi, G., Carpeggiani, P., Cavalleri, F., Meletti, S., Nichelli, P., Pettorelli, E., Pinna, G., Zunarelli, E., Artioli, F., Bernardini, I., Costa, M., Greco, G., Guerzoni, R., Stucchi, C., Iaccarino, C., Ragazzi, M., Rizzi, R., Zuccoli, G., Api, P., Cartei, F., Fallica, E., Granieri, E., Latini, F., Lelli, G., Monetti, C., Saletti, A., Schivalocchi, R., Seraceni, S., Tola, M. R., Urbini, B., Giorgi, C., Montanari, E., Cerasti, D., Crafa, P., Dascola, I., Florindo, I., Giombelli, E., Mazza, S., Ramponi, V., Servadei, F., Silini, E. M., Torelli, P., Immovilli, P., Morelli, N., Vanzo, C., and Nobile, C.

Subjects
Registrie, Male, Pediatrics, Neurology, Survival, Epidemiology, medicine.medical_treatment, Primary brain tumors, 0302 clinical medicine, Neoplasms, 80 and over, Medicine, Oligodendroglial Tumor, Registries, Neuroradiology, Aged, 80 and over, education.field_of_study, Brain Neoplasms, Incidence (epidemiology), Incidence, General Medicine, Middle Aged, Neoplasms, Neuroepithelial, Glioblastoma, Incidence rate, Adult, Aged, Female, Humans, Italy, 2708, Neurology (clinical), Psychiatry and Mental Health, 030220 oncology & carcinogenesis, Neurosurgery, Human, medicine.medical_specialty, Population, Neuroepithelial, Dermatology, Primary brain tumor, NO, Brain Neoplasm, 03 medical and health sciences, education, business.industry, Radiation therapy, business, 030217 neurology & neurosurgery
Abstract

Incidence of neuroepithelial Primary Brain Tumors (nPBT) varies, ranging from 7.3 to 11.6 cases/100,000/year across Europe. We present incidence and survival of nPBT in the Emilia-Romagna region (ER), Italy. This study is the largest in Southern Europe. Specialists in neurosurgery, neurology, neuroradiology, oncology, radiotherapy, genetics, and pathology of ER notified all suspected nPBT adult cases residing in ER (4,337,966 inhabitants) observed during 2009. Furthermore, through ICD-9 discharge codes, we identified and reviewed all possible cases. Neuroepithelial PBT diagnosis was based on histological or radiological findings. We included 400 incident nPBT cases, of which 102 (25%) were retrospectively identified. These latter were significantly older. The standardized incidence was 10.5/100,000/year (95% CI 9.4–11.5), higher for men. It was 9.2/100,000/year (95% CI 8.3–10.2) for astrocytic tumors, 0.6/100,000/year (95% CI 0.4–0.9) for oligodendroglial tumors, and 7.1 (95% CI 6.3–8.0) for glioblastoma (GBM). Among GBM patients, median survival was 249 days if prospectively identified vs. 132 days when identified through ICD-9 codes (pÂ

Published
2017

3. Which elderly newly diagnosed glioblastoma patients can benefit from radiotherapy and temozolomide? A PERNO prospective study

Author

Franceschi, Enrico, Depenni, R., Paccapelo, Alexandro, Ermani, Mario, Faedi, M., Sturiale, Carmelo, Michiara, Maria, Servadei, F., Pavesi, Giacomo, Urbini, B., Pisanello, A., Crisi, G., Cavallo, Michele A., Dazzi, C., Biasini, C., Bertolini, F., Mucciarini, C., Pasini, G., Baruzzi, Agostino, Brandes, Alba A, Albani, F., Calbucci, F., D’Alessandro, R., Michelucci, R., de Pasqua, S., Testoni, S., Brandes, A., Franceschi, E., Tosoni, A., Eusebi, V., Ceruti, S., Fainardi, E., Tamarozzi, R., Emiliani, E., Cavallo, M., Fiorica, F., Sasso, E., Cavanna, L., Guidetti, D., Marcello, N., Cremonini, A. M., Guiducci, G., Agati, R., Ambrosetto, G., Bacci, A., Baldin, E., Baldrati, A., Barbieri, E., Bartolini, S., Bellavista, E., Bisulli, F., Bonora, E., Bunkheila, F., Carelli, V., Crisci, M., Dall’Occa, P., de Biase, D., Ferro, S., Franceschi, C., Frezza, G., Grasso, V., Leonardi, M., Marucci, G., Morandi, L., Mostacci, B., Palandri, G., Pasini, E., Pastore Trossello, M., Pession, A., Poggi, R., Riguzzi, P., Rinaldi, R., Rizzi, S., Romeo, G., Spagnolli, F., Tinuper, P., Trocino, C., Dall’Agata, M., Frattarelli, M., Gentili, G., Giovannini, A., Iorio, P., Pasquini, U., Galletti, G., Guidi, C., Neri, W., Patuelli, A., Strumia, S., Casmiro, M., Gamboni, A., Rasi, F., Cruciani, G., Cenni, P., Guidi, A. R., Zumaglini, F., Amadori, A., Pasquinelli, M., Pasquini, E., Polselli, A., Ravasio, A., Viti, B., Sintini, M., Ariatti, A., Bigliardi, G., Carpeggiani, P., Cavalleri, F., Meletti, Stefano, Nichelli, Paolo Frigio, Pettorelli, E., Pinna, G., Zunarelli, E., Artioli, F., Bernardini, I., Costa, M., Greco, G., Guerzoni, R., Stucchi, C., Iaccarino, C., Ragazzi, M., Rizzi, R., Zuccoli, G., Api, P., Cartei, F., Colella, M., Fallica, E., Farneti, M., Frassoldati, A., Granieri, E., Latini, F., Monetti, C., Saletti, A., Schivalocchi, R., Sarubbo, S., Seraceni, S., Tola, M. R., Zini, G., Giorgi, C., Montanari, E., Cerasti, D., Crafa, P., Dascola, I., Florindo, I., Giombelli, E., Mazza, S., Ramponi, V., Silini, E. M., Torelli, P., Immovilli, P., Morelli, N., Vanzo, C., Nobile, C., Franceschi, E., Depenni, R., Paccapelo, Alexandro, Ermani, Mario, Faedi, M., Sturiale, Carmelo, Michiara, Maria, Servadei, F., Pavesi, Giacomo, Urbini, B., Pisanello, A., Crisi, G., Cavallo, Michele A., Dazzi, C., Biasini, C., Bertolini, F., Mucciarini, C., Pasini, G., Baruzzi, Agostino, Brandes, Alba A., Albani, F., Calbucci, F., D’Alessandro, R., Michelucci, R., de Pasqua, S., Testoni, S., Brandes, A., Tosoni, A., Eusebi, V., Ceruti, S., Fainardi, E., Tamarozzi, R., Emiliani, E., Cavallo, M., Fiorica, F., Sasso, E., Cavanna, L., Guidetti, D., Marcello, N., Cremonini, A.M., Guiducci, G., Agati, R., Ambrosetto, G., Bacci, A., Baldin, E., Baldrati, A., Barbieri, E., Bartolini, S., Bellavista, E., Bisulli, F., Bonora, E., Bunkheila, F., Carelli, V., Crisci, M., Dall’Occa, P., de Biase, D., Ferro, S., Franceschi, C., Frezza, G., Grasso, V., Leonardi, M., Marucci, G., Morandi, L., Mostacci, B., Palandri, G., Pasini, E., Pastore Trossello, M., Pession, A., Poggi, R., Riguzzi, P., Rinaldi, R., Rizzi, S., Romeo, G., Spagnolli, F., Tinuper, P., Trocino, C., Dall’Agata, M., Frattarelli, M., Gentili, G., Giovannini, A., Iorio, P., Pasquini, U., Galletti, G., Guidi, C., Neri, W., Patuelli, A., Strumia, S., Casmiro, M., Gamboni, A., Rasi, F., Cruciani, G., Cenni, P., Guidi, A.R., Zumaglini, F., Amadori, A., Pasquinelli, M., Pasquini, E., Polselli, A., Ravasio, A., Viti, B., Sintini, M., Ariatti, A., Bigliardi, G., Carpeggiani, P., Cavalleri, F., Meletti, S., Nichelli, P., Pettorelli, E., Pinna, G., Zunarelli, E., Artioli, F., Bernardini, I., Costa, M., Greco, G., Guerzoni, R., Stucchi, C., Iaccarino, C., Ragazzi, M., Rizzi, R., Zuccoli, G., Api, P., Cartei, F., Colella, M., Fallica, E., Farneti, M., Frassoldati, A., Granieri, E., Latini, F., Monetti, C., Saletti, A., Schivalocchi, R., Sarubbo, S., Seraceni, S., Tola, M.R., Zini, G., Giorgi, C., Montanari, E., Cerasti, D., Crafa, P., Dascola, I., Florindo, I., Giombelli, E., Mazza, S., Ramponi, V., Silini, E.M., Torelli, P., Immovilli, P., Morelli, N., Vanzo, C., and Nobile, C.

Subjects
Oncology, medicine.medical_specialty, Cancer Research, medicine.medical_treatment, Dacarbazine, Population, Context (language use), NO, 03 medical and health sciences, 0302 clinical medicine, Elderly, Internal medicine, medicine, Temozolomide, Humans, MGMT methylation, Prospective Studies, Prospective cohort study, education, Promoter Regions, Genetic, Antineoplastic Agents, Alkylating, DNA Modification Methylases, Survival analysis, Aged, Aged, 80 and over, education.field_of_study, Radiotherapy, business.industry, Brain Neoplasms, Tumor Suppressor Proteins, Glioblastoma, Neurology (clinical), Neurology, DNA Methylation, Survival Analysis, Surgery, Radiation therapy, DNA Repair Enzymes, 030220 oncology & carcinogenesis, Concomitant, business, 030217 neurology & neurosurgery, medicine.drug
Abstract

The role of temozolomide concurrent with and adjuvant to radiotherapy (RT/TMZ) in elderly patients with glioblastoma (GBM) remains unclear. We evaluated the outcome of patients >70 years in the context of the Project of Emilia-Romagna Region in Neuro-Oncology (PERNO), the first Italian prospective observational population-based study in neuro-oncology. For this analysis the criteria for selecting patients enrolled in the PERNO study were: age >70 years; PS 0–3; histologically confirmed GBM; postoperative radiotherapy (RT) after surgery with or without concomitant temozolomide (TMZ) or postsurgical TMZ alone. Between January 2009 and December 2010, 76 GBM elderly patients were identified in the prospective PERNO study. Twenty-three patients did not receive any treatment after surgery, and 53 patients received postsurgical treatments (25 patients received RT alone and 28 patients RT/TMZ). Median survival was 11.1 months (95 % CI 8.8–13.5), adding temozolomide concomitant and adjuvant to radiotherapy it was 11.6 months (95 % CI 8.6–14.6), and 9.3 months (95 % CI 8.1–10.6) in patients treated with RT alone (P = 0.164). However, patients with MGMT methylated treated with RT/TMZ obtained a better survival (17.2 months, 95 % CI 11.5–22.9) (P = 0.042). No difference in terms of survival were observed if patients with MGMT unmethylated tumor received RT alone, or RT/TMZ or, in MGMT methylated tumor, if patients received radiotherapy alone. In elderly patients RT/TMZ represent a widely used approach but it is effective with methylated MGMT tumors only.

Published
2016

4. Balancing donor and recipient risk factors in liver transplantation: the value of D-MELD with particular reference to HCV recipients

Author

Avolio, A, Cillo, U, Salizzoni, M, DE CARLIS, LUCIANO GREGORIO, Colledan, M, Gerunda, G, Mazzaferro, V, Tisone, G, Romagnoli, R, Caccamo, L, Rossi, M, Vitale, A, Cucchetti, A, Lupo, L, Gruttadauria, S, Nicolotti, N, Burra, P, Gasbarrini, A, Agnes, S, Lirosi, M, Miele, L, Pompili, M, Siciliano, M, Perilli, V, Gaspari, R, Castagneto, M, Lupo, F, Tandoi, F, De Carlis, L, Mangoni, I, Belli, L, Pinna, A, Cescon, M, Gridelli, B, Li Petri, S, Volpes, R, Pinelli, D, Fagiuoli, S, Montalti, R, Regalia, E, Rossi, G, Antonelli, B, Berloco, P, Lai, Q, Risaliti, A, Nicolini, D, Valente, U, Gelli, M, Morelli, N, Zamboni, F, Tondolo, V, Ettorre, G, Vennarecci, G, Bresadola, F, Baccarani, U, Toniutto, P, Manzia, T, Anselmo, A, Angelico, M, Calise, F, Scuderi, V, Romano, M, Rendina, M, Barone, M, Cuomo, O, Perrella, A, Santaniello, W, Donataccio, M, Dalle Ore, G, De Ville De Goyet, J, Monti, L, De Waure, C., Avolio A.W., Cillo U., Salizzoni M., De Carlis L., Colledan M., Gerunda G.E., Mazzaferro V., Tisone G., Romagnoli R., Caccamo L., Rossi M., Vitale A., Cucchetti A., Lupo L., Gruttadauria S., Nicolotti N., Burra P., Gasbarrini A., Agnes S., Lirosi M.C., Miele L., Pompili M., Siciliano M., Perilli V., Gaspari R., Castagneto M., Tandoi F., Mangoni I., Belli L., Pinna A.D., Cescon M., Gridelli B., Li Petri S., Volpes R., Pinelli D., Fagiuoli S., Montalti R., Regalia E., Rossi G., Antonelli B., Berloco P., Lai Q., Risaliti A., Nicolini D., Valente U., Gelli M., Morelli N., Zamboni F., Tondolo V., Brotzu G., Ettorre G.M., Vennarecci G., Bresadola F., Baccarani U., Toniutto P.L., Manzia T., Anselmo A., Angelico M., Calise F., Scuderi V., Romano M., Rendina M., Barone M., Cuomo O., Perrella A., Santaniello W., Donataccio M., Dalle Ore G., de Ville de J., Monti L., Avolio, A W, Cillo, U, Salizzoni, M, De Carlis, L, Colledan, M, Gerunda, G E, Mazzaferro, Mariapia, Tisone, G, Romagnoli, R, Caccamo, L, Rossi, M, Vitale, A, Cucchetti, A, Lupo, L, Gruttadauria, S, Nicolotti, N, Burra, P, Gasbarrini, A, Agnes, S, Montalti, Roberto, Avolio, A, DE CARLIS, L, Gerunda, G, Mazzaferro, V, Lirosi, M, Miele, L, Pompili, M, Siciliano, M, Perilli, V, Gaspari, R, Castagneto, M, Lupo, F, Tandoi, F, Mangoni, I, Belli, L, Pinna, A, Cescon, M, Gridelli, B, Li Petri, S, Volpes, R, Pinelli, D, Fagiuoli, S, Montalti, R, Regalia, E, Rossi, G, Antonelli, B, Berloco, P, Lai, Q, Risaliti, A, Nicolini, D, Valente, U, Gelli, M, Morelli, N, Zamboni, F, Tondolo, V, Ettorre, G, Vennarecci, G, Bresadola, F, Baccarani, U, Toniutto, P, Manzia, T, Anselmo, A, Angelico, M, Calise, F, Scuderi, V, Romano, M, Rendina, M, Barone, M, Cuomo, O, Perrella, A, Santaniello, W, Donataccio, M, Dalle Ore, G, De Ville De Goyet, J, Monti, L, and De Waure, C

Subjects
Graft Rejection, Male, medicine.medical_treatment, Settore MED/18 - CHIRURGIA GENERALE, Hepacivirus, Liver transplantation, Gastroenterology, Liver disease, Postoperative Complications, Retrospective Studie, UNSUSTAINABLE MATCH, Models, Risk Factors, Immunology and Allergy, Health Status Indicators, Age Factor, PROGNOSTIC INDICES, Pharmacology (medical), Health Status Indicator, D-MELD, Liver Transplantation, liver transplantation, Hazard ratio, Graft Survival, donor-recipient match, outcome, prognosis, risk factors, Age Factors, Trapianto epatico, Hepatitis C, Hepatitis B, Statistical, Middle Aged, Prognosis, Tissue Donors, Survival Rate, Italy, HCV, Female, Human, Adult, medicine.medical_specialty, Prognosi, Donor Selection, End Stage Liver Disease, Young Adult, Internal medicine, medicine, Humans, fattori di rischio, Aged, Retrospective Studies, Transplantation, Hepaciviru, Models, Statistical, business.industry, Donor selection, Risk Factor, Settore MED/09 - MEDICINA INTERNA, Odds ratio, medicine.disease, Settore MED/18, Surgery, body regions, Postoperative Complication, business
Abstract

Donor-recipient match is a matter of debate in liver transplantation. D-MELD (donor age × recipient biochemical model for end-stage liver disease [MELD]) and other factors were analyzed on a national Italian database recording 5946 liver transplants. Primary endpoint was to determine factors predictive of 3-year patient survival. D-MELD cutoff predictive of 5-year patient survival 1628). At 3 years, the odds ratio (OR) for death was 2.03 (95% confidence interval [CI], 1.44-2.85) in D-MELD class C versus B. The OR was 0.40 (95% CI, 0.24-0.66) in class A versus class B. Other predictors were hepatitis C virus (HCV; OR = 1.42; 95% CI, 1.11-1.81), hepatitis B virus (HBV; OR = 0.69; 95% CI, 0.51-0.93), retransplant (OR = 1.82; 95% CI, 1.16-2.87) and low-volume center (OR = 1.48; 95% CI, 1.11-1.99). Cox regressions up to 90 months confirmed results. The hazard ratio was 1.97 (95% CI, 1.59-2.43) for D-MELD class C versus class B and 0.42 (95% CI, 0.29-0.60) for D-MELD class A versus class B. Recipient age, HCV, HBV and retransplant were also significant. The 5yrsPS

Published
2011

5. A prospective policy development to increase split-liver transplantation for 2 adult recipients: results of a 12-year multicenter collaborative study

Author

Aseni, P, De Feo, T, Valente, U, Colledan, M, Cillo, U, Rossi, G, Mazzaferro, V, Donataccio, M, De Fazio, N, Andorno, E, Burra, P, Giacomoni, A, Slim, A, Sposito, C, De Gasperi, A, Antonelli, B, Zanus, G, Pinelli, D, Zambelli, M, Morelli, N, Valente, R, Grosso, G, Mantovani, M, Piccolo, G., DE CARLIS, LUCIANO GREGORIO, Aseni, P, De Feo, T, DE CARLIS, L, Valente, U, Colledan, M, Cillo, U, Rossi, G, Mazzaferro, V, Donataccio, M, De Fazio, N, Andorno, E, Burra, P, Giacomoni, A, Slim, A, Sposito, C, De Gasperi, A, Antonelli, B, Zanus, G, Pinelli, D, Zambelli, M, Morelli, N, Valente, R, Grosso, G, Mantovani, M, and Piccolo, G

Subjects
Adult, Male, medicine.medical_specialty, Policy development, Adolescent, segmental liver transplantation, medicine.medical_treatment, Transplants, Transplant, Liver transplantation, surgical technique, Young Adult, Postoperative Complications, Retrospective Studie, Surgical complication, medicine, Humans, Prospective Studies, Young adult, Intensive care medicine, Prospective cohort study, Policy Making, Retrospective Studies, business.industry, Graft Survival, Retrospective cohort study, Middle Aged, liver transplantation, split-liver transplantation, surgical complications, Liver Transplantation, Algorithm, Transplantation, Prospective Studie, Multicenter study, Split liver transplantation, Surgery, Female, Postoperative Complication, business, Algorithms, Human
Abstract

OBJECTIVE: To analyze in a multicenter study the potential benefit of a new prospective policy development to increase split-liver procedures for 2 adult recipients. BACKGROUND: Split-liver transplantation is an important means of overcoming organ shortages. Division of the donor liver for 1 adult and 1 pediatric recipient has reduced the mortality of children waiting for liver transplantation but the benefits or disadvantages to survival when the liver is divided for 2 adults (adult-to-adult split-liver transplant, AASLT) compared with recipients of a whole graft have not been fully investigated. METHODS: We developed a computerized algorithm in selected donors for 2 adult recipients and applied it prospectively over a 12-year period among 7 collaborative centers. Patient and graft outcomes of this cohort receiving AASLT either as full right grafts or full left grafts were analyzed and retrospectively compared with a matched cohort of adults who received a conventional whole-liver transplant (WLT). Univariate and multivariate analysis was done for selected clinical variables in the AASLT group to assess the impact on the patient outcome. RESULTS: Sixty-four patients who received the AASLT had a high postoperative complication rate (64.1% grade III and IV) and a lower 5-year survival rate than recipients of a WLT (63.3% and 83.1%) CONCLUSIONS: AASLT should be considered a surgical option for selected smaller-sized adults only in experimental clinical studies in experienced centers. Copyright © 2013 by Lippincott Williams & Wilkins.

Published
2013

6. Erratum to: Survival prediction in high-grade gliomas using CT perfusion imaging

Author

Yeung, Tp, Wang, Y, He, W, Urbini, B, Gafà, R, Ulazzi, L, Yartsev, S, Bauman, G, Lee TY, Fainardi, E, Project of Emilia-Romagna Region on Neuro-Oncology (PERNO) Study Group Participants :Agati, R., Ambrosetto, G., Bacci, A., Baldin, E., Baldrati, A., Barbieri, E., Bartolini, S., Bellavista, E., Bisulli, F., Bonora, E., Bunkheila, F., Carelli, V., Crisci, M., Dall’Occa, P., de Biase, D., Ferro, S., Franceschi, C., Frezza, G., Grasso, V., Leonardi, M., Marucci, G., Morandi, L., Mostacci, B., Palandri, G., Pasini, E., Pastore Trossello, M., Pession, A., Poggi, R., Riguzzi, P., Rinaldi, R., Rizzi, S., Romeo, G., Spagnolli, F., Tinuper, P., (Bologna), Trocino C., Dall’Agata, M., Frattarelli, M., Gentili, G., Giovannini, A., Iorio, P., Pasquini, U., Galletti, G., Guidi, C., Neri, W., Patuelli, A., (Forlı`-Cesena), Strumia S., Faedi, M., (IRCCS Istituto Scientifico Romagnolo per lo Studio, e la Cura dei Tumori), Casmiro, M., Gamboni, A., Rasi, F. (Faenza R. A. )., (Lugo, Cruciani G., RA), Cenni, P., Dazzi, C., Guidi, A. R., (Ravenna), Zumaglini F., Amadori, A., Pasini, G., Pasquinelli, M., Pasquini, E., Polselli, A., Ravasio, A., (Rimini), Viti B., (Cattolica, Sintini M., RN), Ariatti, A., Bertolini, F., Bigliardi, G., Carpeggiani, P., Cavalleri, F., Meletti, S., Nichelli, P., Pettorelli, E., Pinna, G., (Modena), Zunarelli E., Artioli, F., Bernardini, I., Costa, M., Greco, G., Guerzoni, R., Stucchi, C. (Carpi M. O. )., Iaccarino, C, Ragazzi, M., Rizzi, R., (Istituto di Ricovero e Cura a Carattere Scientifico, Zuccoli G., Reggio, Emilia), Api, P., Cartei, F., Colella, M., Fallica, E., Farneti, M., Frassoldati, A., Granieri, E., Latini, F., Monetti, C., Saletti, A., Schivalocchi, R., Sarubbo, S., Seraceni, S., Tola, M. R., Urbini, B., (Ferrara), Zini G., Giorgi, C., Montanari, E. (Fidenza P. R. )., Cerasti, D., Crafa, P., Dascola, I., Florindo, I., Giombelli, E., Mazza, S., Ramponi, V., Servadei, F., Silini, Em., (Parma), Torelli P., Immovilli, P., Morelli, N., (Piacenza), Vanzo C., and Nobile, C. (Padova).

Subjects
Cancer Research, medicine.medical_specialty, Neuroradiology unit, Neurology, Oncology, business.industry, General surgery, Medicine, Neurology (clinical), business
Abstract

Baruzzi A. (Chair), Albani F., Calbucci F., D’Alessandro R., Michelucci R. (IRCCS Institute of Neurological Sciences, Bologna, Italy), Brandes A. (Department of Medical Oncology, Bellaria-Maggiore Hospitals, Bologna, Italy), Eusebi V. (Department of Hematology and Oncological Sciences ‘‘L. & A. Seragnoli’’, Section of Anatomic Pathology at Bellaria Hospital, Bologna, Italy), Ceruti S., Fainardi E., Tamarozzi R. (Neuroradiology Unit, Department of Neurosciences and Rehabilitation, S. Anna Hospital, Ferrara, Italy), Emiliani E. (Istituto Oncologico Romagnolo, Department of Medical Oncology, Santa Maria delle Croci Hospital, Ravenna, Italy), Cavallo M. (Division of Neurosurgery, Department of Neurosciences and Rehabilitation, S. Anna Hospital, Ferrara, Italy).

Published
2015

7. Pattern of care and effectiveness of treatment for glioblastoma patients in the real world: Results from a prospective population-based registry. Could survival differ in a high-volume center?

Author

Alba A. Brandes, Enrico Franceschi, Mario Ermani, Alicia Tosoni, Fiorenzo Albani, Roberta Depenni, Marina Faedi, Anna Pisanello, Girolamo Crisi, Benedetta Urbini, Claudio Dazzi, Luigi Cavanna, Claudia Mucciarini, Giuseppe Pasini, Stefania Bartolini, Gianluca Marucci, Luca Morandi, Elena Zunarelli, Serenella Cerasoli, Giorgio Gardini, Giovanni Lanza, Enrico Maria Silini, Silvio Cavuto, Agostino Baruzzi, A. Baruzzi, F. Albani, F. Calbucci, R. D'Alessandro, R. Michelucci, A. Brandes, V. Eusebi, S. Ceruti, E. Fainardi, R. Tamarozzi, E. Emiliani, M. Cavallo, E. Franceschi, A. Tosoni, F. Fiorica, A. Valentini, R. Depenni, C. Mucciarini, G. Crisi, E. Sasso, C. Biasini, L. Cavanna, D. Guidetti, N. Marcello, A. Pisanello, A.M. Cremonini, G. Guiducci, S. de Pasqua, S. Testoni, R. Agati, G. Ambrosetto, A. Bacci, E. Baldin, A. Baldrati, E. Barbieri, S. Bartolini, E. Bellavista, F. Bisulli, E. Bonora, F. Bunkheila, V. Carelli, M. Crisci, P. Dall'Occa, D. de Biase, S. Ferro, C. Franceschi, G. Frezza, V. Grasso, M. Leonardi, G. Marucci, V. Mazzocchi, L. Morandi, B. Mostacci, G. Palandri, E. Pasini, M. Pastore Trossello, A. Pession, M. Ragazzi, P. Riguzzi, R. Rinaldi, S. Rizzi, G. Romeo, F. Spagnolli, P. Tinuper, C. Trocino, S. Cerasoli, M. Dall'Agata, M. Faedi, M. Frattarelli, G. Gentili, A. Giovannini, P. Iorio, U. Pasquini, G. Galletti, C. Guidi, W. Neri, A. Patuelli, S. Strumia, M. Casmiro, A. Gamboni, F. Rasi, G. Cruciani, P. Cenni, C. Dazzi, AR. Guidi, F. Zumaglini, A. Amadori, G. Pasini, M. Pasquinelli, E. Pasquini, A. Polselli, A. Ravasio, B. Viti, M. Sintini, A. Ariatti, F. Bertolini, G. Bigliardi, P. Carpeggiani, F. Cavalleri, S. Meletti, P. Nichelli, E. Pettorelli, G. Pinna, E. Zunarelli, F. Artioli, I. Bernardini, M. Costa, G. Greco, R. Guerzoni, C. Stucchi, C. Iaccarino, R. Rizzi, G. Zuccoli, P. Api, F. Cartei, E. Fallica, E. Granieri, F. Latini, G. Lelli, C. Monetti, V. Ramponi, A. Saletti, R. Schivalocchi, S. Seraceni, M.R. Tola, B. Urbini, C. Giorgi, E. Montanari, D. Cerasti, P. Crafa, I. Dascola, I. Florindo, S. Mazza, F. Servadei, EM. Silini, P. Torelli, P. Immovilli, N. Morelli, C. Vanzo, Brandes, Alba A, Franceschi, Enrico, Ermani, Mario, Tosoni, Alicia, Albani, Fiorenzo, Depenni, Roberta, Faedi, Marina, Pisanello, Anna, Crisi, Girolamo, Urbini, Benedetta, Dazzi, Claudio, Cavanna, Luigi, Mucciarini, Claudia, Pasini, Giuseppe, Bartolini, Stefania, Marucci, Gianluca, Morandi, Luca, Zunarelli, Elena, Cerasoli, Serenella, Gardini, Giorgio, Lanza, Giovanni, Silini, Enrico Maria, Cavuto, Silvio, Baruzzi, Agostino, Calbucci, F, D'Alessandro, R, Michelucci, R, Eusebi, V, Ceruti, S, Fainardi, E, Tamarozzi, R, Emiliani, E, Cavallo, M, Fiorica, F, Valentini, A, Depenni, R, Mucciarini, C, Crisi, G, Sasso, E, Biasini, C, Cavanna, L, Guidetti, D, Marcello, N, Pisanello, A, Cremonini, A M, Guiducci, G, de Pasqua, S, Testoni, S, Agati, R, Ambrosetto, G, Bacci, A, Baldin, E, Baldrati, A, Barbieri, E, Bartolini, S, Bellavista, E, Bisulli, F, Bonora, E, Bunkheila, F, Carelli, V, Crisci, M, Dall'Occa, P, de Biase, D, Ferro, S, Franceschi, C, Frezza, G, Grasso, V, Leonardi, M, Marucci, G, Mazzocchi, V, Morandi, L, Mostacci, B, Palandri, G, Pasini, E, Pastore Trossello, M, Pession, A, Ragazzi, M, Riguzzi, P, Rinaldi, R, Rizzi, S, Romeo, G, Spagnolli, F, Tinuper, P, Trocino, C, Cerasoli, S, Dall'Agata, M, Faedi, M, Frattarelli, M, Gentili, G, Giovannini, A, Iorio, P, Pasquini, U, Galletti, G, Guidi, C, Neri, W, Patuelli, A, Strumia, S, Casmiro, M, Gamboni, A, Rasi, F, Cruciani, G, Cenni, P, Dazzi, C, Guidi, Ar, Zumaglini, F, Amadori, A, Pasini, G, Pasquinelli, M, Pasquini, E, Polselli, A, Ravasio, A, Viti, B, Sintini, M, Ariatti, A, Bertolini, F, Bigliardi, G, Carpeggiani, P, Cavalleri, F, Meletti, S, Nichelli, P, Pettorelli, E, Pinna, G, Zunarelli, E, Artioli, F, Bernardini, I, Costa, M, Greco, G, Guerzoni, R, Stucchi, C, Iaccarino, C, Rizzi, R, Zuccoli, G, Api, P, Cartei, F, Fallica, E, Granieri, E, Latini, F, Lelli, G, Monetti, C, Ramponi, V, Saletti, A, Schivalocchi, R, Seraceni, S, Tola, M R, Urbini, B, Giorgi, C, Montanari, E, Cerasti, D, Crafa, P, Dascola, I, Florindo, I, Mazza, S, Servadei, F, Silini, Em, Torelli, P, Immovilli, P, Morelli, N, and Vanzo, C

Subjects
Oncology, medicine.medical_specialty, medicine.medical_treatment, Population, Medicine (miscellaneous), temozolomide, NO, surgery, center volume, glioblastoma, radiotherapy, Internal medicine, Glioma, medicine, education, Prospective cohort study, education.field_of_study, Temozolomide, Neurologic Oncology, business.industry, Incidence (epidemiology), Articles, medicine.disease, nervous system diseases, Clinical trial, Radiation therapy, business, medicine.drug
Abstract

Background As yet, no population-based prospective studies have been conducted to investigate the incidence and clinical outcome of glioblastoma (GBM) or the diffusion and impact of the current standard therapeutic approach in newly diagnosed patients younger than aged 70 years. Methods Data on all new cases of primary brain tumors observed from January 1, 2009, to December 31, 2010, in adults residing within the Emilia-Romagna region were recorded in a prospective registry in the Project of Emilia Romagna on Neuro-Oncology (PERNO). Based on the data from this registry, a prospective evaluation was made of the treatment efficacy and outcome in GBM patients. Results Two hundred sixty-seven GBM patients (median age, 64 y; range, 29–84 y) were enrolled. The median overall survival (OS) was 10.7 months (95% CI, 9.2–12.4). The 139 patients ≤aged 70 years who were given standard temozolomide treatment concomitant with and adjuvant to radiotherapy had a median OS of 16.4 months (95% CI, 14.0–18.5). With multivariate analysis, OS correlated significantly with KPS (HR = 0.458; 95% CI, 0.248–0.847; P = .0127), MGMT methylation status (HR = 0.612; 95% CI, 0.388–0.966; P = .0350), and treatment received in a high versus low-volume center (HR = 0.56; 95% CI, 0.328–0.986; P = .0446). Conclusions The median OS following standard temozolomide treatment concurrent with and adjuvant to radiotherapy given to (72.8% of) patients aged ≤70 years is consistent with findings reported from randomized phase III trials. The volume and expertise of the treatment center should be further investigated as a prognostic factor.

Published
2014

8. One liver for two adults: in situ split liver transplantation for two adult recipients

Author

A Giannelli, A Genzone, B. Gridelli, G Bottino, Giorgio Rossi, Umberto Valente, Nicola Morelli, F Ravazzoni, G Ardizzone, Enzo Andorno, Michele Colledan, R Mondello, Andorno, E, Genzone, A, Morelli, N, Mondello, R, Colledan, M, Gridelli, B, Ravazzoni, F, Giannelli, A, Rossi, G, Ardizzone, G, Bottino, G, and Valente, U

Subjects
Adult, medicine.medical_specialty, Adolescent, Split Liver Transplantation, Treatment outcome, MEDLINE, living donor, surgical technique, outcomes research, Text mining, SLT, Medicine, Hepatectomy, Humans, human, Hepatic lobe, Child, conference paper, clinical article, Transplantation, recipient, business.industry, organ size, Length of Stay, Middle Aged, human tissue, Surgery, Liver Transplantation, Treatment Outcome, priority journal, Liver, Split liver transplantation, Tissue and Organ Harvesting, business
Published
2001

9. Chlamydia pneumoniae DNA detection in peripheral blood mononuclear cells is predictive of vascular infection

Author

Monia Betti, Yamume Tshomba, Gloria Esposito, Marinella Alessi, Roberto Cosentini, Germano Melissano, Francesco Blasi, Jens Boman, Luigi Allegra, Paolo Tarsia, Nicoletta Morelli, Roberto Chiesa, Blasi, F, Boman, J, Esposito, G, Melissano, Germano, Chiesa, Roberto, Cosentini, R, Tarsia, P, Tshomba, Yamume, Betti, M, Alessi, M, Morelli, N, and Allegra, L.

Subjects
DNA, Bacterial, Male, Pathology, medicine.medical_specialty, Mycoplasma pneumoniae, Aortic Diseases, medicine.disease_cause, Peripheral blood mononuclear cell, Polymerase Chain Reaction, law.invention, Serology, Aneurysm, law, Predictive Value of Tests, medicine, Immunology and Allergy, Humans, Chlamydiaceae, Aorta, Abdominal, Polymerase chain reaction, Aged, Aged, 80 and over, biology, Helicobacter pylori, Chlamydia Infections, Chlamydophila pneumoniae, Middle Aged, medicine.disease, biology.organism_classification, Abdominal aortic aneurysm, respiratory tract diseases, Infectious Diseases, cardiovascular system, Leukocytes, Mononuclear, Female, Aortic Aneurysm, Abdominal
Abstract

Abdominal aortic aneurysm tissue and peripheral blood mononuclear cells (PBMC) of 41 consecutive subjects undergoing abdominal aortic aneurysm surgery were analyzed by polymerase chain reaction (PCR) for the presence of Chlamydia pneumoniae, Mycoplasma pneumoniae, and Helicobacter pylori DNA. Twenty patients (49%) were positive for C, pneumoniae DNA-16 (39%) in both PBMC and aneurysm tissue, 3 (7.3%) in PBMC only, and 1 (2.4%) in the artery specimen only. Previous exposure to C. pneumoniae was confirmed in 19 (95%) of the 20 PCR positive subjects by C, pneumoniae-specific serology, using the microimmunofluorescence test. None was positive for H. pylori or M pneumoniae DNA, either in the PBMC or in the artery specimens. In conclusion, carriage of C. pneumoniae DNA is common both in PBMC and in abdominal aortic tissue from patients undergoing abdominal aneurysm surgery. Blood PCR may be a useful tool for identifying subjects carrying C. pneumoniae in the vascular wall. Abdominal aortic aneurysm tissue and peripheral blood mononuclear cells (PBMC) of 41 consecutive subjects undergoing abdominal aortic aneurysm surgery were analyzed by polymerase chain reaction (PCR) for the presence of Chlamydia pneumoniae, Mycoplasma pneumoniae, and Helicobacter pylori DNA. Twenty patients (49%) were positive for C. pneumoniae DNA-16 (39%) in both PBMC and aneurysm tissue, 3 (7.3%) in PBMC only, and 1 (2.4%) in the artery specimen only. Previous exposure to C. pneumoniae was confirmed in 19 (95%) of the 20 PCR positive subjects by C. pneumoniae-specific serology, using the microimmunofluorescence test. None was positive for H. pylori or M. pneumoniae DNA, either in the PBMC or in the artery specimens. In conclusion, carriage of C. pneumoniae DNA is common both in PBMC and in abdominal aortic tissue from patients undergoing abdominal aneurysm surgery. Blood PCR may be a useful tool for identifying subjects carrying C. pneumoniae in the vascular wall.

Published
1999

10. In situ liver splitting of cadaveric donors: Four cases of Italian experience

Author

Enzo Andorno, R Mondello, G Paraluppi, R Valente, Umberto Valente, Nicola Morelli, A. Antonucci, Dardano G, B. Gridelli, G Ardizzone, Alessandro Lucianetti, M Vertocchi, Michele Colledan, F. Ermili, Andorno, E, Antonucci, A, Valente, R, Vertocchi, M, Dardano, G, Morelli, N, Ermili, F, Mondello, R, Paraluppi, G, Ardizzone, G, Colledan, M, Gridelli, B, Lucianetti, A, and Valente, U

Subjects
In situ, medicine.medical_specialty, Time Factors, surgical technique, newborn, italy, Cadaver, Hepatectomy, Humans, Medicine, cadaver donor, human, Child, Intraoperative Complications, hepatorenal syndrome, conference paper, Transplantation, clinical article, liver transplantation, business.industry, adult, Middle Aged, bleeding, Kidney Transplantation, Tissue Donors, Surgery, artery thrombosi, Survival Rate, priority journal, adolescent, budd chiari syndrome, business, Cadaveric spasm
Published
1998

11. Laparoscopic bridging vs. anatomic open reconstruction for midline abdominal hernia mesh repair [LABOR]: single-blinded, multicenter, randomized, controlled trial on long-term functional results

Author

Fabrizio Lazzara, Denise Palombo, Umberto Bracale, Maria Santina Bruno, Stefano Pezzato, Tommaso Testa, Mikaela Imperatore, Cesare Stabilini, Gian Marco Rosa, Nicola Morelli, Serena Perotti, Marco Casaccia, Carolina Righetti, Marco Frascio, Rosario Fornaro, Giusto Pignata, Alessio Signori, Paolo Pelosi, Ezio Gianetta, Stabilini, C, Bracale, Umberto, Pignata, G, Frascio, M, Casaccia, M, Pelosi, P, Signori, A, Testa, T, Rosa, Gm, Morelli, N, Fornaro, R, Palombo, D, Perotti, S, Bruno, M, Imperatore, M, Righetti, C, Pezzato, S, Lazzara, F, and Gianetta, E.

Subjects
medicine.medical_specialty, Midline, Bridging (networking), Hernia, Time Factors, Incisional, Abdominal Hernia, Randomized, Medicine (miscellaneous), law.invention, Abdominal wall, Study Protocol, Postoperative Complications, Randomized controlled trial, Clinical Protocols, law, Recurrence, Functional results, Medicine, Humans, Single-Blind Method, Pharmacology (medical), Prospective Studies, Laparoscopy, Incisional, Midline, Hernia, Laparoscopy, Mesh, Functional results, Rives, Randomized, Herniorrhaphy, Mesh, Mesh repair, medicine.diagnostic_test, business.industry, Rives, Equipment Design, Middle Aged, Surgical Mesh, medicine.disease, Surgery, Hernia, Abdominal, Surgical mesh, medicine.anatomical_structure, Treatment Outcome, Italy, Research Design, Quality of Life, business
Abstract

BACKGROUND: Re-approximation of the rectal muscles along the midline is recommended by some groups as a rule for incisional and ventral hernia repairs. The introduction of laparoscopic repair has generated a debate because it is not aimed at restoring abdominal wall integrity but instead aims just to bridge the defect. Whether restoration of the abdominal integrity has a real impact on patient mobility is questionable, and the available literature provides no definitive answer. The present study aims to compare the functional results of laparoscopic bridging with those of re-approximation of the rectal muscle in the midline as a mesh repair for ventral and incisional abdominal defect through an "open" access. We hypothesized that, for the type of defect suitable for a laparoscopic bridging, the effect of an anatomical reconstruction is near negligible, thus not a fixed rule. METHODS AND DESIGN: The LABOR trial is a multicenter, prospective, two-arm, single-blinded, randomized trial. Patients of more than 60 years of age with a defect of less than 10 cm at its greatest diameter will be randomly submitted to open Rives or laparoscopic defect repair. All the participating patients will have a preoperative evaluation of their abdominal wall strength and mobility along with volumetry, respiratory function test, intraabdominal pressure and quality of life assessment.The primary outcome will be the difference in abdominal wall strength as measured by a double leg-lowering test performed at 12 months postoperatively. The secondary outcomes will be the rate of recurrence and changes in baseline abdominal mobility, respiratory function tests, intraabdominal pressure, CT volumetry and quality of life at 6 and 12 months postoperatively. DISCUSSION: The study will help to define the most suitable treatment for small-medium incisional and primary hernias in patients older than 60 years. Given a similar mid-term recurrence rate in both groups, if the trial shows no differences among treatments (acceptance of the null-hypothesis), then the choice of whether to submit a patient to one intervention will be made on the basis of cost and the surgeon's experience. TRIAL REGISTRATION: Current Controlled Trials ISRCTN93729016.

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