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5. Results from a prospective observational study of men with premature ejaculation treated with dapoxetine or alternative care: The PAUSE study

Author

Mirone V, ARCANIOLO, Davide, Rivas D, Bull S, Aquilina JW, Verze P, PAUSE study team Berchart G, Hass M, Ludvik G, Aalto J, Hendolin N, Lukkarinen O, Multanen M, Nurmenniemi V, Piha J, Aheimer C, Alebrahim Dehkordy A, Andreessen R, Aust C, Baer P, Bath V, Baumgrass H, Beck C, Beecken WD, Behre H, Beitzinger M, Belusa A, Bermes UR, Berning T, Bieringer La Roche D, Blasko S, Boehmer S, Borchardt A, Boerner T, Brands F, Braun PM, Braun R, Breu D, Briken P, Brueske T, Bueker R, Buse A, Carius A, Christoph F, Cuno M, Dats E, Degen N, Denil J, Dietrichs K, Domnitz R, Dorn B, Dubiel J, Eckert R, Ehrenberg W, Eichler S, El Khadra S, Engl T, Esser O, Faragallah EA, Farahmandi R, Finke G, Fleig P, Fruehauf E, Gerhardt U, Girke CG, Glauche J, Gleissner J, Gnann R, Gralla O, Grandin A, Grewe W, Gronau E, Gruber S, Grunert S, Guelbeyaz M, Guelden H, Haendel D, Haefele J, Haghighat M, Hahne D, Haschemi Schirazi R, Hecker D, Herzig J, Hettmmer R, Hitschfeld K, Hofmann J, Hohmuth H, Hoelker D, Huebner A, Hudemann B, Hung Wehmann D, Huenninghaus K, Hueter K, Igde H, Jaeger T, Javadi P, John G, Ju M, Kaisser G, Kamann L, Kastein A, Kaup F, Kellner T, Kempe T, Kempter F, Kennerknecht M, Kirschner P, Koenig M, Konert J, Kowalik S, Krieger JU, Kruppa GL, Kube U, Kuehn F, Kuefer R, Kurt T, Kwela M, Laag R, Langen L, Lehmann J, Linder C, Loeber T, Lock UC, Loebenau M, Luberg Sievers G, Luebbe R, Lutz K, Maier S, Maletz C, Mertins B, Meschede E, Meschi MR, Miersch WD, Misera A, Muehlich S, Mueller HW, Mueller D, Muench HC, Nawka P, Othman K, Paiss T, Peter K, Peters T, Petras T, Petrischenko B, Pfund A, Plate H, Ploss HJ, Pohrt U, Pooyeh S, Potempa AJ, Pusinelli WD, Rausch U, Reinhardt F, Rengel U, Rietheimer W, Rinnab L, Rohrmann K, Romahn E, Romitan Baum R, Roessler T, Rudolph R, Rueffer J, Rug M, Rueth J, Ruettgers E, Santiago RB, Schaefer A, Schaefer T, Schaetzle P, Scheunpflug K, Schlicht J, Schmidt P, Schneider J, Schnitzler M, Schonfelder R, Schreier H, Schroeder A, Schulz FM, Schulze M, Schumann M, Seidler A, Seseke S, Siebel Eggeling G, Siebels M, Sinner B, Sippel F, Soballa M, Sommer F, Spielhaupter A, Steffen H, Steinacker M, Stiersdorfer A, Stoehr C, Sturm S, Surrey HW, Swoboda A, Szymula S, Telle J, Uththoff H, Vierneisel C, Vilmar W, Wagner M, Walhoefer F, Warnack W, Weiss J, Weizert P, Wicht A, Wieland J, Willgerodt J, Wilski B, Wilson E, Wipfler G, Wohn HG, Wolf J, Zoehrlaut B, Zuerner T, Angeletti G, Avolio A, Baldassarre R, Balercia G, Balloni F, Barba G, Bartoletti R, Basile Fasolo C, Bassi PF, Beatrici V, Bertozzi MA, Bocciardi AM, Bondavalli C, Bonini F, Bonsanto M, Branchi A, Briganti A, Calabrese M, Calafiore R, Calogero AE, Cantelmo P, Caraceni E, Carbone A, Cardella A, Carini M, Carmignani L, Carmignani G, Carrino M, Caviglia C, Cecchi M, Ceruti C, Chiovato L, Cicalese V, Colpi G, Corinti M, Cormio L, Cova G, Cozzupoli P, Ottavio G, Damiano R, De Ceglie G, De Grande G, De Lisa A, DE SIO, Marco, De Stefani S, Dehò F, Delsignore A, Di Filippo A, Di Lena S, Di Trapani D, Diambrini M, Drei GN, Fabbri A, Fasolis G, Ferone D, Ferrari G, Foresta C, Francavilla S, Gadda F, Galantini A, Galì A, Gentile V, Giammusso B, Giannubilo W, Granata A, Grasso M, Iafrate M, Ilacqua N, Isidori A, Italiano E, Jallous HA, Jannini E, La Pera G, Laganà F, Lauretti S, Leonardi R, Liguori G, Loiero G, Lombardi G, Lombardo F, Lusenti C, Maffucci A, Maggi M, Maio G, Mammana G, Manieri C, Marzotto Caotorta M, Mastroeni F, Mazzilli F, Mazzone L, Minervini M, Mirone VG, Montorsi F, Morelli G, Morrone G, Nicita G, Nicola M, Palmiotto F, Paradiso M, Paulis G, Pavone C, Pescatori ES, Petterle V, Piazza N, Pittaluga P, Piubello G, Polito M, Ponchietti R, Porena M, Rago R, Risi O, Roggia A, Salzano L, Sanseverino R, SASSO, Ferdinando Carlo, Savoca G, Scarano P, Schips L, Serao A, Sforza A, Sidari V, Silvani M, Sinisi A, Sorrentino F, Spera E, Strada G, Tenaglia R, Terrone C, Titta M, Tracia A, Turchi P, Ughi G, Vecchio D, Veneziano IA, Vicini P, Vita A, Vitti P, Volpi R, Zago T, Zenico T, Zito AR, Apolinario M, Carvalho AP, Corte Real J, Matos Cabeca J, Mendes Leal A, Monteiro Pereira N, Palma dos Reis J, Patricio A, Prisco R, Rocha Mendes J, Santos A, Vieira R, Abad Gairín C, Abascal García JM, Adot Zurbano JM, Álvarez de la Red PL, Al Wattar W, Antón Saiz C, Aranda Doncel N, Arrosagaray PM, Arteaga Serrano F, Barberán Soriano J, Bataller Perello V, Beltrán Persiva J, Benejam Gual J, Blanco Díez A, Blasco Casares FJ, Blasco Villalonga M, Blázquez Izquierdo J, Boladeras Sabater J, Borrás JJ, Bouchi Bakrim AR, Bucar Terrades S, Burgués Gasión JP, Busto Castañón L, Caballero JM, Cabello Santamaría F, Cabreja López E, Carrasco Aznar JC, Casasola Chamorro J, Castellanos González L, Cimadevila García A, Closas Capdevila M, Concepción Masip T, Conde C, Conde Santos G, Cortada i. Robert J, Cos Calvet JM, Crespi Martínez F, Cruz N, De la Rosa Khermann M, Delgado Martín JA, Devesa Mújica M, Doganis Peppas C, Domínguez Freire F, Donderis Guastavino C, Duarte Vázquez JJ, El Khoury Yacob R, Escobal Tamayo V, Farré Martí JM, Fernández Fernández A, Fernández Lozano A, Fernández Viñas JA, Fiter Gómez L, Fleitas Asencio E, Frago Valls SM, Galiana Álvarez A, García Bayo I, García Contreras J, García Cruz E, García de Jalón Martín A, García Giralda L, García Marco MA, García Navas R, García Reboll L, Garrido Insúa S, Giner Santamaría C, Gómez Berjón F, Gómez Gil E, Gómez Lanza E, Gómez Pérez L, Gómez Rodríguez A, González Sala JL, González Sala MJ, Gonzalvo Ybarra A, Guerrero Martínez V, Gutiérrez González MA, Gutierrez Mínguez E, Hidalgo Arroyo J, Hmeidan M, Idígora i. Planas X, Jara Rascón J, Jiménez Verdejo J, Lledó García E, Lliteras Arañi M, López Almansa M, López Palacios MÁ, López Tello J, Lorenzo Gómez MF, Luque Gálvez P, Luque López AJ, Mallafré Sala JM, Martí Cebrián JM, Martín Clos J, Martín Huescar A, Martín Morales A, Martín Rodríguez A, Martínez Rodríguez R, Martínez Salamanca JI, Mascarós Balaguer E, Mejide Manresa R, Molero Rodríguez F, Molina Carranza A, Moncada Iribarren I, Montagud Moncho JB, Montesino Semper M, Mosteiro Ponce JA, Mouaffak Tatari N, Navarro Gil JM, Novás Castro S, Ortiz del Corral ML, Ortiz Gamiz A, Osca García JM, Padilla León M, Palomino García A, Pascual Mateo C, Peinado Ibarra F, Pérez Mestre M, Portillo Martín JA, Poyato Galán JM, Prats de Puig J, Prieto Castro R, Puigvert Martínez A, Quintana de la Rosa JL, Ramada Benlloch FJ, Reyes Martínez F, Rigabert M, Ríos Espuny AF, Robles Iniesta A, Rodrigo Aliaga M, Rodríguez Alba JL, Rodríguez Bethencourt F, Rodríguez Jiménez FJ, Rodríguez Leal DA, Rodríguez Rubio F, Rodríguez Tolrá J, Rodríguez Vallejo JM, Romero Otero J, Roselló Barbará M, Rubio Briones J, Ruíz Moriana O, Sampol Company J, San Martín Blanco C, Sánchez Encinas M, Sánchez Sánchez F, Sancho Serrano C, Santandreu Puifros J, Santisteban González M, Santos Ascarza Tabares JL, Sanz Lahoz I, Sapiña Ortola F, Sarquella Geli J, Segarra Tomás J, Soler Fernández J, Tato Rodríguez J, Tesedo Cubedo J, Traid Sender V, Valbuena Álvarez R, Valverde Rubio JM, Varela Salgado M, Vargas Rugeles M, Vilches Cocovi E, Virto Bajo FJ, Andius P, Anker Hansen O, Arver S, Bosson P, Brattberg A, Grenabo L, Hanning J, Hassler L, Paradis AÅ, Wang E., Mirone, Vincenzo, Arcaniolo, Davide, David, Riva, Scott, Bull, Joseph W., Aquilina, Verze, Paolo, Mirone, V, Arcaniolo, D, Rivas, D, Bull, S, Aquilina, JW, Verze, P, Pavone, C, Aquilina, Jw, PAUSE study team Berchart, G, Hass, M, Ludvik, G, Aalto, J, Hendolin, N, Lukkarinen, O, Multanen, M, Nurmenniemi, V, Piha, J, Aheimer, C, Alebrahim Dehkordy, A, Andreessen, R, Aust, C, Baer, P, Bath, V, Baumgrass, H, Beck, C, Beecken, Wd, Behre, H, Beitzinger, M, Belusa, A, Bermes, Ur, Berning, T, Bieringer La Roche, D, Blasko, S, Boehmer, S, Borchardt, A, Boerner, T, Brands, F, Braun, Pm, Braun, R, Breu, D, Briken, P, Brueske, T, Bueker, R, Buse, A, Carius, A, Christoph, F, Cuno, M, Dats, E, Degen, N, Denil, J, Dietrichs, K, Domnitz, R, Dorn, B, Dubiel, J, Eckert, R, Ehrenberg, W, Eichler, S, El Khadra, S, Engl, T, Esser, O, Faragallah, Ea, Farahmandi, R, Finke, G, Fleig, P, Fruehauf, E, Gerhardt, U, Girke, Cg, Glauche, J, Gleissner, J, Gnann, R, Gralla, O, Grandin, A, Grewe, W, Gronau, E, Gruber, S, Grunert, S, Guelbeyaz, M, Guelden, H, Haendel, D, Haefele, J, Haghighat, M, Hahne, D, Haschemi Schirazi, R, Hecker, D, Herzig, J, Hettmmer, R, Hitschfeld, K, Hofmann, J, Hohmuth, H, Hoelker, D, Huebner, A, Hudemann, B, Hung Wehmann, D, Huenninghaus, K, Hueter, K, Igde, H, Jaeger, T, Javadi, P, John, G, Ju, M, Kaisser, G, Kamann, L, Kastein, A, Kaup, F, Kellner, T, Kempe, T, Kempter, F, Kennerknecht, M, Kirschner, P, Koenig, M, Konert, J, Kowalik, S, Krieger, Ju, Kruppa, Gl, Kube, U, Kuehn, F, Kuefer, R, Kurt, T, Kwela, M, Laag, R, Langen, L, Lehmann, J, Linder, C, Loeber, T, Lock, Uc, Loebenau, M, Luberg Sievers, G, Luebbe, R, Lutz, K, Maier, S, Maletz, C, Mertins, B, Meschede, E, Meschi, Mr, Miersch, Wd, Misera, A, Muehlich, S, Mueller, Hw, Mueller, D, Muench, Hc, Nawka, P, Othman, K, Paiss, T, Peter, K, Peters, T, Petras, T, Petrischenko, B, Pfund, A, Plate, H, Ploss, Hj, Pohrt, U, Pooyeh, S, Potempa, Aj, Pusinelli, Wd, Rausch, U, Reinhardt, F, Rengel, U, Rietheimer, W, Rinnab, L, Rohrmann, K, Romahn, E, Romitan Baum, R, Roessler, T, Rudolph, R, Rueffer, J, Rug, M, Rueth, J, Ruettgers, E, Santiago, Rb, Schaefer, A, Schaefer, T, Schaetzle, P, Scheunpflug, K, Schlicht, J, Schmidt, P, Schneider, J, Schnitzler, M, Schonfelder, R, Schreier, H, Schroeder, A, Schulz, Fm, Schulze, M, Schumann, M, Seidler, A, Seseke, S, Siebel Eggeling, G, Siebels, M, Sinner, B, Sippel, F, Soballa, M, Sommer, F, Spielhaupter, A, Steffen, H, Steinacker, M, Stiersdorfer, A, Stoehr, C, Sturm, S, Surrey, Hw, Swoboda, A, Szymula, S, Telle, J, Uththoff, H, Vierneisel, C, Vilmar, W, Wagner, M, Walhoefer, F, Warnack, W, Weiss, J, Weizert, P, Wicht, A, Wieland, J, Willgerodt, J, Wilski, B, Wilson, E, Wipfler, G, Wohn, Hg, Wolf, J, Zoehrlaut, B, Zuerner, T, Angeletti, G, Avolio, A, Baldassarre, R, Balercia, G, Balloni, F, Barba, G, Bartoletti, R, Basile Fasolo, C, Bassi, Pf, Beatrici, V, Bertozzi, Ma, Bocciardi, Am, Bondavalli, C, Bonini, F, Bonsanto, M, Branchi, A, Briganti, A, Calabrese, M, Calafiore, R, Calogero, Ae, Cantelmo, P, Caraceni, E, Carbone, A, Cardella, A, Carini, M, Carmignani, L, Carmignani, G, Carrino, M, Caviglia, C, Cecchi, M, Ceruti, C, Chiovato, L, Cicalese, V, Colpi, G, Corinti, M, Cormio, L, Cova, G, Cozzupoli, P, Ottavio, G, Damiano, R, De Ceglie, G, De Grande, G, De Lisa, A, DE SIO, Marco, De Stefani, S, Dehò, F, Delsignore, A, Di Filippo, A, Di Lena, S, Di Trapani, D, Diambrini, M, Drei, Gn, Fabbri, A, Fasolis, G, Ferone, D, Ferrari, G, Foresta, C, Francavilla, S, Gadda, F, Galantini, A, Galì, A, Gentile, V, Giammusso, B, Giannubilo, W, Granata, A, Grasso, M, Iafrate, M, Ilacqua, N, Isidori, A, Italiano, E, Jallous, Ha, Jannini, E, La Pera, G, Laganà, F, Lauretti, S, Leonardi, R, Liguori, G, Loiero, G, Lombardi, G, Lombardo, F, Lusenti, C, Maffucci, A, Maggi, M, Maio, G, Mammana, G, Manieri, C, Marzotto Caotorta, M, Mastroeni, F, Mazzilli, F, Mazzone, L, Minervini, M, Mirone, Vg, Montorsi, F, Morelli, G, Morrone, G, Nicita, G, Nicola, M, Palmiotto, F, Paradiso, M, Paulis, G, Pescatori, E, Petterle, V, Piazza, N, Pittaluga, P, Piubello, G, Polito, M, Ponchietti, R, Porena, M, Rago, R, Risi, O, Roggia, A, Salzano, L, Sanseverino, R, Sasso, Ferdinando Carlo, Savoca, G, Scarano, P, Schips, L, Serao, A, Sforza, A, Sidari, V, Silvani, M, Sinisi, A, Sorrentino, F, Spera, E, Strada, G, Tenaglia, R, Terrone, C, Titta, M, Tracia, A, Turchi, P, Ughi, G, Vecchio, D, Veneziano, Ia, Vicini, P, Vita, A, Vitti, P, Volpi, R, Zago, T, Zenico, T, Zito, Ar, Apolinario, M, Carvalho, Ap, Corte Real, J, Matos Cabeca, J, Mendes Leal, A, Monteiro Pereira, N, Palma dos Reis, J, Patricio, A, Prisco, R, Rocha Mendes, J, Santos, A, Vieira, R, Abad Gairín, C, Abascal García, Jm, Adot Zurbano, Jm, Álvarez de la Red, Pl, Al Wattar, W, Antón Saiz, C, Aranda Doncel, N, Arrosagaray, Pm, Arteaga Serrano, F, Barberán Soriano, J, Bataller Perello, V, Beltrán Persiva, J, Benejam Gual, J, Blanco Díez, A, Blasco Casares, Fj, Blasco Villalonga, M, Blázquez Izquierdo, J, Boladeras Sabater, J, Borrás, Jj, Bouchi Bakrim, Ar, Bucar Terrades, S, Burgués Gasión, Jp, Busto Castañón, L, Caballero, Jm, Cabello Santamaría, F, Cabreja López, E, Carrasco Aznar, Jc, Casasola Chamorro, J, Castellanos González, L, Cimadevila García, A, Closas Capdevila, M, Concepción Masip, T, Conde, C, Conde Santos, G, Cortada i., Robert J, Cos Calvet, Jm, Crespi Martínez, F, Cruz, N, De la Rosa Khermann, M, Delgado Martín, Ja, Devesa Mújica, M, Doganis Peppas, C, Domínguez Freire, F, Donderis Guastavino, C, Duarte Vázquez, Jj, El Khoury Yacob, R, Escobal Tamayo, V, Farré Martí, Jm, Fernández Fernández, A, Fernández Lozano, A, Fernández Viñas, Ja, Fiter Gómez, L, Fleitas Asencio, E, Frago Valls, Sm, Galiana Álvarez, A, García Bayo, I, García Contreras, J, García Cruz, E, García de Jalón Martín, A, García Giralda, L, García Marco, Ma, García Navas, R, García Reboll, L, Garrido Insúa, S, Giner Santamaría, C, Gómez Berjón, F, Gómez Gil, E, Gómez Lanza, E, Gómez Pérez, L, Gómez Rodríguez, A, González Sala, Jl, González Sala, Mj, Gonzalvo Ybarra, A, Guerrero Martínez, V, Gutiérrez González, Ma, Gutierrez Mínguez, E, Hidalgo Arroyo, J, Hmeidan, M, Idígora i., Planas X, Jara Rascón, J, Jiménez Verdejo, J, Lledó García, E, Lliteras Arañi, M, López Almansa, M, López Palacios, Má, López Tello, J, Lorenzo Gómez, Mf, Luque Gálvez, P, Luque López, Aj, Mallafré Sala, Jm, Martí Cebrián, Jm, Martín Clos, J, Martín Huescar, A, Martín Morales, A, Martín Rodríguez, A, Martínez Rodríguez, R, Martínez Salamanca, Ji, Mascarós Balaguer, E, Mejide Manresa, R, Molero Rodríguez, F, Molina Carranza, A, Moncada Iribarren, I, Montagud Moncho, Jb, Montesino Semper, M, Mosteiro Ponce, Ja, Mouaffak Tatari, N, Navarro Gil, Jm, Novás Castro, S, Ortiz del Corral, Ml, Ortiz Gamiz, A, Osca García, Jm, Padilla León, M, Palomino García, A, Pascual Mateo, C, Peinado Ibarra, F, Pérez Mestre, M, Portillo Martín, Ja, Poyato Galán, Jm, Prats de Puig, J, Prieto Castro, R, Puigvert Martínez, A, Quintana de la Rosa, Jl, Ramada Benlloch, Fj, Reyes Martínez, F, Rigabert, M, Ríos Espuny, Af, Robles Iniesta, A, Rodrigo Aliaga, M, Rodríguez Alba, Jl, Rodríguez Bethencourt, F, Rodríguez Jiménez, Fj, Rodríguez Leal, Da, Rodríguez Rubio, F, Rodríguez Tolrá, J, Rodríguez Vallejo, Jm, Romero Otero, J, Roselló Barbará, M, Rubio Briones, J, Ruíz Moriana, O, Sampol Company, J, San Martín Blanco, C, Sánchez Encinas, M, Sánchez Sánchez, F, Sancho Serrano, C, Santandreu Puifros, J, Santisteban González, M, Santos Ascarza Tabares, Jl, Sanz Lahoz, I, Sapiña Ortola, F, Sarquella Geli, J, Segarra Tomás, J, Soler Fernández, J, Tato Rodríguez, J, Tesedo Cubedo, J, Traid Sender, V, Valbuena Álvarez, R, Valverde Rubio, Jm, Varela Salgado, M, Vargas Rugeles, M, Vilches Cocovi, E, Virto Bajo, Fj, Andius, P, Anker Hansen, O, Arver, S, Bosson, P, Brattberg, A, Grenabo, L, Hanning, J, Hassler, L, Paradis, Aå, and Wang, E.

Subjects
Adult, Complementary Therapies, Male, medicine.medical_specialty, Benzylamines, Adolescent, Nausea, Urology, Naphthalenes, Dapoxetine Safety Cardiovascular events Syncope, Syncope, Cardiovascular events, Young Adult, Internal medicine, Premature ejaculation, medicine, 80 and over, Dapoxetine, Safety, Aged, Aged, 80 and over, Humans, Middle Aged, Premature Ejaculation, Prospective Studies, Serotonin Uptake Inhibitors, Adverse effect, Prospective cohort study, Sertraline, business.industry, Settore MED/24 - UROLOGIA, Incidence (epidemiology), syncope, Anesthesia, Observational study, medicine.symptom, business, Selective Serotonin Reuptake Inhibitors, medicine.drug, Cardiovascular events, Dapoxetine, Safety, Syncope
Abstract

Background Dapoxetine hydrochloride is a selective serotonin reuptake inhibitor and the first drug approved for the on-demand treatment of premature ejaculation (PE). Its safety was established in a thorough clinical development program. Objective To characterize the safety profile of dapoxetine in PE treatment and to report the incidence, severity, and type of adverse events. Design, setting, and participants We conducted a 12-wk, open-label, observational study with a 4-wk, postobservational contact. A total of 10 028 patients were enrolled, with 6712 patients (67.6%) treated with dapoxetine 30–60mg (group A)and 3316 (32.4%) treated with alternative care/nondapoxetine (group B). Interventions Treatment with dapoxetine or alternative care/nondapoxetine. Outcome measurements and statistical analysis Treatment-emergent adverse events (TEAEs) and concomitant therapy use during the 12-wk observational and the postobservational period were reported. Results and limitations The mean age for all patients was 40.5 yr. In group A, 93.0% of the patients were initially prescribed dapoxetine 30mg. Treatment options for group B patients included clomipramine, paroxetine, fluoxetine, sertraline, topical drugs, condoms, and behavioral counseling. Both treatment regimens were well tolerated. TEAEs were reported by 12.0% and 8.9% of group A and group B, respectively, with the highest incidence observed in patients aged >65 yr for group A (21.4%) and 30–39 yr (9.8%) for group B. The most commonly reported TEAEs were nausea, headache, and vertigo, with a higher incidence in group A (3.1%, 2.6%, and 1.0%, respectively) than in group B (oral drugs: 2.3%, 1.3%, and 0.9%, respectively). There were no cases of syncope in group A and one case in group B. A major limitation is that this was a nonrandomized, open-label, short-term study lacking efficacy data. Conclusions The results of this postmarketing observational study demonstrated that dapoxetine for treatment of PE has a good safety profile and low prevalence of TEAEs. Syncope and major cardiovascular adverse events were not reported. The high level of adherence by healthcare providers to the contraindications, special warnings, and precautions for dapoxetine minimizes the risk for its use in routine clinical practice. The current risk minimization measures for its identified and potential risks are effective.

Published
2014

6. Late abstracts 186–187

Author

Jaehne, J., Meyer, H. -J., Wittekind, Ch., Maschek, H., Pichlmayr, R., Jacobi, G., Weiermann, G., Vitzthum, H. Gräfin, Schwabe, D., Manegold, Ch., Krempien, B., Kaufmann, M., Bailly, M., Doré, J. -F., Fodstad, Ø., Kjønniksen, I., Brøgger, A., Flørenes, V. A., Pihl, A., Aamdal, S., Nesland, J. M., Geldof, A. A., Rao, B. R., De Giovanni, C., Lollini, P. -L., Del Re, B., Scotlandi, K., Nicoletti, G., Nanni, P., Van Muijen, G. N. P., Van Der Wiel-Miezenbeek, J. M., Cornelissen, L. M. H. A., Jansen, C. F. J., Ruiter, D. J., Kieler, J., Oda, Y., Tokuriki, Y., Tenang, E. M., Lamb, J. F., Galante, E., Zanoni, F., Galluzzi, D., Cerrotta, A., Martelli, G., Guzzon, A., Reduzzi, D., Barberá-Guillem, E., Barceló, J. R., Urcelay, B., Alonso-Varona, A. I., Vidal-Vanaclocha, F., Bassukas, I. D., Maurer-Schultze, B., Storeng, R., Manzotti, C., Pratesi, G., Schachert, G., Fidler, I. J., Grimstad, I. A., Rutt, G. Th., Riesinger, P., Frank, J., Neumann, G., Wissler, J. H., Bastert, G., Liebrich, W., Lehner, B., Gonzer, S., Schlag, P., Vehmeyer, K., Hajto, T., Gabius, H. -J., Funke, I., Schlimok, G., Bock, B., Dreps, A., Schweiberer, B., Riethmüller, G., Nicolai, U., Vykoupil, K. -F., Wolf, M., Havemann, K., Georgii, A., Bertrand, S., N'Guyen, M. -J., Siracky, J., Kysela, B., Siracka, E., Pflüger, E., Schirrmacher, V., Boyano, M. D., Hanania, N., Poupon, M. F., Sherbet, G. V., Lakshmi, M. S., Van Roy, F., Vleminckx, K., Fiers, W., Dragonetti, C., De Bruyne, G., Messiaen, L., Mareel, M., Kuhn, S., Choritz, H., Schmid, U., Bihl, H., Griesbach, A., Matzku, S., Eccles, S. A., Purvies, H. P., Miller, F. R., McEachern, D., Ponton, A., Waghorne, C., Coulombe, B., Kerbel, R. S., Breitman, M., Skup, D., Gingras, M. C., Jarolim, L., Wright, J. A., Greenberg, A. H., N'Guyen, M. J., Allavena, G., Melchiori, A., Aresu, O., Percario, M., Parodi, S., Schmidt, J., Kars, P., Chader, G., Albini, A., Zöller, M., Lissitzky, J. C., Bouzon, M., Martin, P. M., Grossi, I. M., Taylor, J. D., Honn, K. V., Koch, B., Baum, W., Giedl, J., Gabius, H. J., Kalden, J. R., Hakim, A. A., LadÁnyi, A., Timár, J., Moczar, E., Lapis, K., Müller, K., Wolf, M. F., Benz, B., Schumacher, K., Kemmner, W., Morgenthaler, J., Brossmer, R., Hagmar, B., Burns, G., Erkell§, L. J., Ryd, W., Paku, S., Rot, A., Hilario, E., Unda, F., Simón, J., Aliño, S. F., Sargent, N. S. E., Burger, M. M., Altevogt, P., Kowitz, A., Chopra, H., Bandlow, G., Nagel, G. A., Lotan, R., Carralero, D., Lotan, D., Raz, A., Skubitz, A. P. N., Koliakos, G. G., Furcht, L. T., Charonis, A. S., Hamann, A., Jablonski-Westrich, D., Jonas, P., Harder, R., Butcher, E. C., Thiele, H. G., Breillout, F., Antoine, E., Lascaux, V., Boxberger, H. -J., Paweletz, N., Bracke, M., Vyncke, B., Opdenakker, G., Castronovo, V., Foidart, J. -M., Camacho, M., Fras, A. Fabra, Llorens, A., Rutllant, M. L., Erkell, L. J., Brunner, G., Heredia, A., Imhoff, J. M., Burtin, P., Nakajima, M., Lunec, J., Parker, C., Fennelly, J. A., Smith, K., Roossien, F. F., La Rivière, G., Roos, E., Erdel, M., Trefz, G., Spiess, E., Ebert, W., Verhaegen, S., Remels, L., Verschueren, H., Dekegel, D., De Baetselier, P., Van Hecke, D., Hannecart-Pokorni, E., Falkvoll, K. H., Alonso, A., Baroja, A., Sebbag, U., Barbera-Guillem, E., Behrens, J., Mareel, M. M., Birchmeier, W., Waterhouse, P., Khokha, R., Chambers, A., Yagel, S., Lala, P. K., Denhardt, D. T., Hennes, R., Frantzen, F., Keller, R., Schwartz-Albiez, R., Fondaneche, M. C., Mignatti, P., Tsuboi, R., Robbins, E., Rifkin, D. B., Overall, C. M., Sacchi, A., Falcioni, R., Piaggio, G., Rizzo, M. G., Perrotti, N., Kennel, S. J., Girschick, H., Müller-Hermelink, H. K., Vollmers, H. P., Wenzel, A., Liu, S., Günthert, U., Wesch, V., Giles, M., Ponta, H., Herrlich, P., Stade, B., Hupke, U., Holzmann, B., Johnson, J. P., Sauer, A., Roller, E., Klumpp, B., Güttler, N., Lison, A., Walk, A., Redini, F., Moczar, M., Leoni, F., Da Dalt, M. G., Ménard, S., Canevari, S., Miotti, S., Tagliabue, E., Colnaghi, M. I., Ostmeier, H., Suter, L., Possati, L., Rosciani, C., Recanatini, E., Beatrici, V., Diambrini, M., Polito, M., Rothbächer, U., Eisenbach, L., Plaksin, D., Gelber, C., Kushtai, G., Gubbay, J., Feldman, M., Benke, R., Benedetto, A., Elia, G., Sala, A., Belardelli, F., Lehmann, J. M., Ladanyi, A., Hanisch, F. -G., Sölter, J., Jansen, V., Böhmer, G., Peter-Katalinic, J., Uhlenbruck, G., O'Connor, R., Müller, J., Kirchner, T., Bover, B., Tucker, G., Valles, A. M., Gavrilovic, J., Thiery, J. P., Kaufmann, A. M., Volm, M., Edel, G., Zühlsdorf, M., Voss, H., Wörmann, B., Hiddemann, W., De Neve, W., Van Den Berge, D., Van Loon, R., Storme, G., Zacharski, L. R., Wojtukiewicz, M. Z., Memoli, V., Kisiel, W., Kudryk, B. J., Stump, D., Piñol, G., Gonzalez-Garrigues, M., Fabra, A., Marti, F., Rueda, F., Lichtner, R. B., Khazaie, K., Timar, J., Greenzhevskaya, S. N., Shmalko, Yu. P., Hill, S. E., Rees, R. C., MacNeil, S., Millon, R., Muller, D., Eber, M., Abecassis, J., Betzler, M., Bahtsky, K. P., Umansky, V. Yu., Krivorotov, A. A., Balitskaya, E. K., Pridatko, O. E., Smelkova, M. I., Smirnov, I. M., Korczak, B., Fisher, C., Thody, A. J., Young, S. D., Hill, R. P., Frixen, U., Gopas, J., Segal, S., Hammerling, G., Bar-Eli, M., Rager-Zisman, B., Har-Vardi, I., Alon, Y., Hämmerling, G. J., Perez, M., Algarra, I., Collado, Ma. D., Peran, E., Caballero, A., Garrido, F., Turner, G. A., Blackmore, M., Stern, P. L., Thompson, S., Levin, I., Kuperman, O., Eyal, A., Kaneti, J., Notter, M., Knuth, A., Martin, M., Chauffert, B., Caignard, A., Hammann, A., Martin, F., Dearden, M. T., Pelletier, H., Dransfield, I., Jacob, G., Rogers, K., Pérez-Yarza, G., Cañavate, M. L., Lucas, R., Bouwens, L., Mantovani, G., Serri, F. G., Macciò, A., Zucca, M. V., Del Giacco, G. S., Pérez, M., Kärre, K., Apt, D., Traversari, C., Sensi, M., Carbone, G., Parmiani, G., Hainaut, P., Weynants, P., Degiovanni, G., Boon, T., Marquardt, P., Stulle, K., Wölfel, T., Herin, M., Van den Eynde, B., Klehmann, E., Büschenfelde, K. -H. Meyer zum, Samija, M., Gerenčer, M., Eljuga, D., Bašić, I., Heacock, C. S., Blake, A. M., D'Aleo, C. J., Alvarez, V. L., Gresser, I., Maury, C., Moss, J., Woodrow, D., von Ardenne, M., Krüger, W., Möller, P., Schachert, H. K., Itaya, T., Frost, P., Rodolfo, M., Salvi, C., Bassi, C., Huland, E., Huland, H., Sersa, G., Willingham, V., Hunter, N., Milas, L., Schild, H., von Hoegen, P., Mentges, B., Bätz, W., Suzuki, N., Mizukoshi, T., Sava, G., Ceschia, V., Zabucchi, G., Farkas-Himsley, H., Schaal, O., Klenner, T., Keppler, B., Alvarez-Diaz, A., Bizzari, J. P., Barbera-Guillem, F., Osterloh, B., Bartkowski, R., LÖhrke, H., Schwahn, E., Schafmayer, A., Goerttler, K., Cillo, C., Ling, V., Giavazzi, R., Vecchi, A., Luini, W., Garofalo, A., Iwakawa, M., Arundel, C., Tofilon, P., Giraldi, T., Perissin, L., Zorzet, S., Piccini, P., Pacor, S., Rapozzi, V., Fink, U., Zeuner, H., Dancygier, H., Classen, M., Lersch, C., Reuter, M., Hammer, C., Brendel, W., Mathé, G., Bourut, C., Chenu, E., Kidani, Y., Mauvernay, Y., Schally, A. V., Reizenstein, P., Gastiaburu, J., Comaru-Schally, A. M., Cupissol, D., Jasmin, C., Missot, J. L., Wingen, F., Schmähl, D., Pauwels-Vergely, C., Poupon, M. -F., Gasic, T. B., Ewaskiewicz, J. I., Gasic, G. J., Pápay, J., Mauvernay, R., Schally, A., Keiling, R., Hagipantelli, R., Busuttil, M., VoVan, M. L., Misset, J. L., Lévi, F., Musset, M., Ribaud, P., Hilgard, P., Reissmann, T., Stekar, J., Voegeli, R., Den Otter, W., Maas, H. A., Dullens, H. F. J., Merriman, R. L., Tanzer, L. R., Shackelford, K. A., Bemis, K. G., Campbell, J. B., and Matsumoto, K.

Published
1988
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10. The Role of Intraoperative Ultrasonography Associated with Clampless Technique in Three-Dimensional Retroperitoneoscopic Laparoscopic Enucleation of Completely Endophytic Renal Tumors.

Author

Giulioni C, Scarcella S, Di Biase M, Marconi A, Sortino G, Diambrini M, Giannubilo W, Castellani D, and Ferrara V

Subjects
Humans, Nephrectomy methods, Retrospective Studies, Treatment Outcome, Ultrasonography, Kidney Neoplasms diagnostic imaging, Kidney Neoplasms pathology, Kidney Neoplasms surgery, Laparoscopy methods
Abstract

Objectives: To evaluate perioperative and functional outcomes of clampless laparoscopic tumor enucleation for completely endophytic renal tumors with the guide of intraoperative ultrasonography. Methods: We analyzed patients with clinically completely endophytic tumors, renal tumors, who underwent clampless three-dimensional (3D) retroperitoneoscopic laparoscopic tumor enucleation between January 2012 and January 2021. Patients with exophytic tumors were excluded. Intraoperative ultrasonography was used to map out the mass in all surgeries. Results: Overall, 57 patients underwent clampless 3D retroperitoneoscopic laparoscopic tumor enucleation. Mean surgical time was 131 minutes, and mean estimated blood loss was 202 mL. Mean hospital stay was 4.7 days. Major and minor postoperative complications occurred, respectively, in 3 and 10 cases. Only a patient had a positive surgical margin. One-year renal function did not differ from baseline. Conclusion: Our study showed that clampless laparoscopic enucleation guided by laparoscopic ultrasonography ensured satisfactory outcomes for completely intrarenal tumors, with excellent renal function preservation 1 year after surgery.

Published
2022
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11. Clampless Laparoscopic Tumor Enucleation for Exophytic Masses Greater Than 4 cm: Is Renorrhaphy Necessary?

Author

Giulioni C, Di Biase M, Marconi A, Sortino G, Diambrini M, Iacovelli V, Giannubilo W, and Ferrara V

Subjects
Humans, Nephrectomy, Retrospective Studies, Treatment Outcome, Urologic Surgical Procedures, Carcinoma, Renal Cell surgery, Kidney Neoplasms pathology, Kidney Neoplasms surgery, Laparoscopy
Abstract

Objective: To demonstrate the safety of clampless 3D laparoscopic tumor enucleation (cLTE) for exophytic T1b kidney masses, avoiding suture to achieve hemostasis. Methods: Between January 2010 and January 2021, 241 consecutive patients with an exophytic renal tumor underwent sutureless cLTE. Patients with predominantly endophytic growth or tumors 4 mm closer to the collecting system less were excluded. In all cases, an attempt was made to accomplish surgery without suturing kidney parenchyma. Data were obtained from a retrospective review of history and physical examinations, operative and pathology reports, anesthesia records during the hospital stay, and follow-up visits. Results: Among 241 patients who underwent cLTE, 148 had cT1a and 93 had cT1b renal tumor. The median tumor size was 32 mm, and the median R.E.N.A.L. (radius exophytic/endophytic nearness anterior/posterior location) score was 6. Renorrhaphy was necessary in 5 cases. The median operative time (OT) was 100 minutes, and the estimated blood loss (EBL) was 150 mL. The median 24-hour decrease in hemoglobin was 1.8 g/dL. The median length of stay was 4 days. Nineteen patients had postoperative complications: 3 cases had Clavien-Dindo (CD) 3a or more, 6 had CD2, and 10 had CD1. Comparing the T1a and T1b groups, except for the median OT and the EBL, no significant differences were observed in all the other variables analyzed. In both groups, renal function was preserved after 1 year from surgery. Conclusion: Our experience showed that sutureless cLTE is safe and feasible for T1b tumors leading to radical oncological outcomes and preserving renal function.

Published
2022
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12. Laparoscopic single port radical prostatectomy in the 2020: Why not? Our experience.

Author

Sortino G, Giannubilo W, Di Biase M, Marconi A, Diambrini M, and Ferrara V

Subjects
Aged, Humans, Male, Middle Aged, Prostatectomy, Retrospective Studies, Treatment Outcome, Laparoscopy, Prostatic Neoplasms surgery
Abstract

Objectives: To analyze the feasibility, safety and advantages of Laparo-Endoscopic Single-site Surgery radical prostatectomy (LESS-RP) based on our personal experience., Patients and Methods: Details of 520 patients were retrospectively analyzed, from 2009 to 2019. Extraperitoneal approach, with only two accesses (2.5 cm and 5 mm respectively) was used to perform radical prostatectomy. Perioperative characteristics and postoperative oncologic and functional outcomes are reported., Results: The mean age was 66.6 ± 5.6 years. Mean PSA level was 9 ± 3.5 ng/ml. According to D'Amico classification, the percentage of patients with low-, intermediate-, and high-risk disease cases were 116 (22.4%), 275 (52.8%), and 129 (24.8%) respectively. Mean operative time was 156 ± 43 min. Mean estimated blood loss was 214 ± 93 ml. Positive surgical margins (PSMs) were detected in 110 (21.2%) patients. PSM rates in pT2 and pT3 stages were 20.1% and 22.9%, respectively. The overall complication rate was 9.2%, based on the modified Clavien classification. The 12 months continence and potency rates were 90.9% and 49.1%, respectively. The biochemical recurrence rate was 6.8%, at the median follow-up time of 26.7 months (IQR 12-32)., Conclusions: Our analyses show that LESS-RP is a safe procedure, if performed by surgeons with adequate experience and skills. Unlike the classic laparoscopic prostatectomy, this technique allows better aesthetic and psychological results, reduced postoperative pain, and a faster return to normal daily activity with the same functional and oncological results.

Published
2021
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13. Laparoscopic radical nephrectomy with inferior vena cava thrombectomy: A combined retroperitoneal and transperitoneal approach.

Author

Giannubilo W, Sortino G, Diambrini M, Di Biase M, Marconi A, and Ferrara V

Subjects
Carcinoma, Renal Cell secondary, Humans, Kidney Neoplasms pathology, Male, Middle Aged, Peritoneum, Retroperitoneal Space, Carcinoma, Renal Cell surgery, Kidney Neoplasms surgery, Laparoscopy, Neoplastic Cells, Circulating, Nephrectomy methods, Thrombectomy, Vena Cava, Inferior, Venous Thrombosis surgery
Abstract

Renal cell carcinoma with inferior cava thrombus indicates biologically aggressive cancer, so the complete surgical resection remains standard of care with best long-term outcomes. Laparoscopic radical nephrectomy with vena cava thrombectomy represents nowadays a mini-invasive surgical alternative to the classic open nephrectomy. We present the case of a patient with incidental diagnosis of a right renal mass with level II inferior cava thrombus completely managed with both retroperitoneal and transperitoneal approaches. The use of a double access was planned to ensure a safe and complete vascular control. In our opinion, optimal patient selection, extensive laparoscopic experience, and knowledge of both transperitoneal and retroperitoneal approaches are critical elements for the safe application of this technique, although this procedure remains challenging and technically demanding.

Published
2020
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