PD61-09 FINAL RESULTS OF A PROSPECTIVE, RANDOMIZED CONTROLLED TRIAL ASSESSING THE IMPACT OF EARLY DORSAL VENOUS COMPLEX (eDVC) LIGATION ON URINARY CONTINENCE RECOVERY AFTER ROBOT-ASSISTED RADICAL PROSTATECTOMY

Abstract

You have accessJournal of UrologyProstate Cancer: Localized: Surgical Therapy V (PD61)1 Sep 2021PD61-09 FINAL RESULTS OF A PROSPECTIVE, RANDOMIZED CONTROLLED TRIAL ASSESSING THE IMPACT OF EARLY DORSAL VENOUS COMPLEX (eDVC) LIGATION ON URINARY CONTINENCE RECOVERY AFTER ROBOT-ASSISTED RADICAL PROSTATECTOMY Francesco Montorsi, Giuseppe Cirulli, Gabriele Sorce, Andrea Gallina, Marco Moschini, Giorgio Gandaglia, Francesco Pellegrino, Luigi Nocera, Nicola Fossati, Armando Stabile, Simone Scuderi, Francesco Barletta, Elio Mazzone, Andrea Salonia, Carlo Andrea Bravi, Giuseppe Rosiello, and Alberto Briganti Francesco MontorsiFrancesco Montorsi More articles by this author , Giuseppe CirulliGiuseppe Cirulli More articles by this author , Gabriele SorceGabriele Sorce More articles by this author , Andrea GallinaAndrea Gallina More articles by this author , Marco MoschiniMarco Moschini More articles by this author , Giorgio GandagliaGiorgio Gandaglia More articles by this author , Francesco PellegrinoFrancesco Pellegrino More articles by this author , Luigi NoceraLuigi Nocera More articles by this author , Nicola FossatiNicola Fossati More articles by this author , Armando StabileArmando Stabile More articles by this author , Simone ScuderiSimone Scuderi More articles by this author , Francesco BarlettaFrancesco Barletta More articles by this author , Elio MazzoneElio Mazzone More articles by this author , Andrea SaloniaAndrea Salonia More articles by this author , Carlo Andrea BraviCarlo Andrea Bravi More articles by this author , Giuseppe RosielloGiuseppe Rosiello More articles by this author , and Alberto BrigantiAlberto Briganti More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000002098.09AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: The ligation of the dorsal venous complex (DVC) and the approach to the prostatic apex represent crucial steps of robot-assisted radical prostatectomy (RARP) which may affect urinary continence (UC) recovery. We hypothesized that the early ligation of the DVC during RARP might allow for a better preservation of urethral sphincter and thus improved continence recovery over the traditional technique. METHODS: In this randomized controlled trial (RCT - NCT03368378) a total of 312 consecutive prostate cancer (PCa) patients were randomly assigned to the experimental group (early DVC ligation, before the bladder neck incision and nerve-sparing lateral dissection) vs. control group (standard DVC ligation after the bladder neck). The minimum number of subjects for an 80% study power has been calculated considering an alfa-error of 5% and a UC recovery of 26% at 4 weeks obtained with the standard treatment. The hypothesis was that the early DVC ligation could improve UC recovery by 15% at 4-month after RARP. Primary endpoint was continence recovery at 1 and 4 months from surgery. UC was defined as 0/1 protective pad over 24-hour. Secondary outcomes were positive surgical margins (PSM), erectile function (IIEF-6), and 30-day complications (Clavien-Dindo classification). RESULTS: The per-protocol analyses included 276 patients. At 1 and 4 months after surgery, the percentage of patients who recovered continence in the experimental vs. control group was 23% vs. 28% and 71% vs. 64%, respectively (both p ≥0.2). Similar results were found at 1-year follow-up (90% vs. 91%; p=0.6). The percentage of PSM at final pathology did not differ between the groups (22% vs 24%; p=0.7). This finding was not affected by pathologic stage (PSM rate in organ-confined for experimental vs. control group: 12% vs. 18%; non-organ confined: 29% vs. 27%; both p ≥0.4). One year after surgery, there was no significant difference in median postoperative IIEF-6 between patients receiving early DVC ligation and the control group (p=0.07). The rate of Clavien-Dindo ≥2 complications during hospital stay did not differ between the experimental vs. control group (12% vs 11%, p=0.7). CONCLUSIONS: Although an early DVC ligation during RARP is safe and not associated with an increased risk of PSM or complications, our RCT demonstrated that this approach did not improve UC recovery at 4-months. These results were maintained at 1-year follow-up. Thus, early DVC has no impact on either functional or oncological outcomes. Source of Funding: None © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e1069-e1070 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Francesco Montorsi More articles by this author Giuseppe Cirulli More articles by this author Gabriele Sorce More articles by this author Andrea Gallina More articles by this author Marco Moschini More articles by this author Giorgio Gandaglia More articles by this author Francesco Pellegrino More articles by this author Luigi Nocera More articles by this author Nicola Fossati More articles by this author Armando Stabile More articles by this author Simone Scuderi More articles by this author Francesco Barletta More articles by this author Elio Mazzone More articles by this author Andrea Salonia More articles by this author Carlo Andrea Bravi More articles by this author Giuseppe Rosiello More articles by this author Alberto Briganti More articles by this author Expand All Advertisement Loading ...