MP74-09 A PROSPECTIVE, RANDOMIZED, PHASE 3 TRIAL ASSESSING THE IMPACT OF EARLY DORSAL VENOUS COMPLEX LIGATION ON URINARY CONTINENCE RECOVERY AFTER ROBOT-ASSISTED RADICAL PROSTATECTOMY. RESULTS OF AN INTERIM ANALYSIS ON EARLY POST-OPERATIVE OUTCOMES

You have accessJournal of UrologyProstate Cancer: Localized: Surgical Therapy IV (MP74)1 Apr 2020MP74-09 A PROSPECTIVE, RANDOMIZED, PHASE 3 TRIAL ASSESSING THE IMPACT OF EARLY DORSAL VENOUS COMPLEX LIGATION ON URINARY CONTINENCE RECOVERY AFTER ROBOT-ASSISTED RADICAL PROSTATECTOMY. RESULTS OF AN INTERIM ANALYSIS ON EARLY POST-OPERATIVE OUTCOMES Francesco Montorsi, Carlo Bravi*, Giuseppe Fallara, Luigi Nocera, Lucia D'Ambrosio, Andrea Gallina, Simone Scuderi, Alberto Martini, Elio Mazzone, Giuseppe Rosiello, Francesco Barletta, Daniele Robesti, Donato Cannoletta, Elio Zito, Vito Cucchiara, Armando Stabile, Pierre I. Karakiewicz, Aldo Rizzo, Emanuele Zaffuto, Francesco Pellegrino, Matteo Menean, Riccardo Leni, Nicola Longo, Vincenzo Mirone, Giorgio Gandaglia, Nicola Fossati, and Alberto Briganti Francesco MontorsiFrancesco Montorsi More articles by this author , Carlo Bravi*Carlo Bravi* More articles by this author , Giuseppe FallaraGiuseppe Fallara More articles by this author , Luigi NoceraLuigi Nocera More articles by this author , Lucia D'AmbrosioLucia D'Ambrosio More articles by this author , Andrea GallinaAndrea Gallina More articles by this author , Simone ScuderiSimone Scuderi More articles by this author , Alberto MartiniAlberto Martini More articles by this author , Elio MazzoneElio Mazzone More articles by this author , Giuseppe RosielloGiuseppe Rosiello More articles by this author , Francesco BarlettaFrancesco Barletta More articles by this author , Daniele RobestiDaniele Robesti More articles by this author , Donato CannolettaDonato Cannoletta More articles by this author , Elio ZitoElio Zito More articles by this author , Vito CucchiaraVito Cucchiara More articles by this author , Armando StabileArmando Stabile More articles by this author , Pierre I. KarakiewiczPierre I. Karakiewicz More articles by this author , Aldo RizzoAldo Rizzo More articles by this author , Emanuele ZaffutoEmanuele Zaffuto More articles by this author , Francesco PellegrinoFrancesco Pellegrino More articles by this author , Matteo MeneanMatteo Menean More articles by this author , Riccardo LeniRiccardo Leni More articles by this author , Nicola LongoNicola Longo More articles by this author , Vincenzo MironeVincenzo Mirone More articles by this author , Giorgio GandagliaGiorgio Gandaglia More articles by this author , Nicola FossatiNicola Fossati More articles by this author , and Alberto BrigantiAlberto Briganti More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000000960.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The ligation of the dorsal venous complex (DVC) is a key step during robot-assisted radical prostatectomy (RARP) and it may affect urinary continence (UC) recovery. We hypothesized that the early ligation of the DVC before lateral dissection and nerve sparing approach during RARP might allow for a better preservation of the urethral sphincter and thus for improved UC over the traditional technique. METHODS: In this registered randomized controlled trial (NCT03368378), candidates to RARP have been randomly assigned to the experimental group (early DVC ligation, before the bladder neck incision and nerve sparing lateral dissection, right after the incision of the endopelvic fascia) and to the control group (standard technique, the DVC ligated after the bladder neck incision and the development of the postero-lateral aspect of the prostate). Primary endpoint was UC recovery at 1 and 4 months from surgery. According to power analyses, a total of 312 patients were recruited as of September 2017 to achieve a statistically significant difference of 15% between the two groups. Continence recovery was defined as the use of 0-1 pads. Secondary outcomes were positive surgical margins (PSM) rate, erectile function recovery (assessed by the International Index of Erectile Function, IIEF-6), and 30-day complications according to the Clavien-Dindo classification. We here report final results at one month after surgery. RESULTS: Preoperative PSA, biopsy grade and clinical stage did not differ between the two groups (all p≥0.1). One month after surgery, 23% vs 28% of patients were continent in the experimental vs control group, respectively (p=0.4). The proportion of men who had PSM at final pathology did not differ between the groups (22% vs 23%; p=0.9). One month after surgery, there was no significant difference in median postoperative IIEF-6 between patients receiving early DVC ligation vs. those in the control group (p=0.4). Overall, the rate of Clavien-Dindo ≥3 complications was slightly lower in the experimental vs control group (5% vs 7%, p=0.8). CONCLUSIONS: Our results suggest that early DVC ligation does not increase the rate of early UC at 1 month after surgery. Awaiting final analyses including all men with 4-month assessment available, we did not find any impact of early DVC ligation on early erectile function recovery, PSM rate or 30-day complication rates. Source of Funding: none © 2020 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 203Issue Supplement 4April 2020Page: e1135-e1135 Advertisement Copyright & Permissions© 2020 by American Urological Association Education and Research, Inc.MetricsAuthor Information Francesco Montorsi More articles by this author Carlo Bravi* More articles by this author Giuseppe Fallara More articles by this author Luigi Nocera More articles by this author Lucia D'Ambrosio More articles by this author Andrea Gallina More articles by this author Simone Scuderi More articles by this author Alberto Martini More articles by this author Elio Mazzone More articles by this author Giuseppe Rosiello More articles by this author Francesco Barletta More articles by this author Daniele Robesti More articles by this author Donato Cannoletta More articles by this author Elio Zito More articles by this author Vito Cucchiara More articles by this author Armando Stabile More articles by this author Pierre I. Karakiewicz More articles by this author Aldo Rizzo More articles by this author Emanuele Zaffuto More articles by this author Francesco Pellegrino More articles by this author Matteo Menean More articles by this author Riccardo Leni More articles by this author Nicola Longo More articles by this author Vincenzo Mirone More articles by this author Giorgio Gandaglia More articles by this author Nicola Fossati More articles by this author Alberto Briganti More articles by this author Expand All Advertisement PDF downloadLoading ...