PD12-05 PER-PROTOCOL ANALYSIS FROM THE CLOCK II RANDOMIZED CLINICAL TRIAL COMPARING OFF-CLAMP VERSUS ON-CLAMP PURE LAPAROSCOPIC PARTIAL NEPHRECTOMY

Abstract

You have accessJournal of UrologyKidney Cancer: Localized: Surgical Therapy I (PD12)1 Sep 2021PD12-05 PER-PROTOCOL ANALYSIS FROM THE CLOCK II RANDOMIZED CLINICAL TRIAL COMPARING OFF-CLAMP VERSUS ON-CLAMP PURE LAPAROSCOPIC PARTIAL NEPHRECTOMY Riccardo Bertolo, Pierluigi Bove, Marco Sandri, Chiara Cipriani, Luca Cindolo, Costantino Leonardo, Paolo Parma, Mario Falsaperla, Domenico Veneziano, Antonio Celia, Andrea Minervini, and Alessandro Antonelli Riccardo BertoloRiccardo Bertolo More articles by this author , Pierluigi BovePierluigi Bove More articles by this author , Marco SandriMarco Sandri More articles by this author , Chiara CiprianiChiara Cipriani More articles by this author , Luca CindoloLuca Cindolo More articles by this author , Costantino LeonardoCostantino Leonardo More articles by this author , Paolo ParmaPaolo Parma More articles by this author , Mario FalsaperlaMario Falsaperla More articles by this author , Domenico VenezianoDomenico Veneziano More articles by this author , Antonio CeliaAntonio Celia More articles by this author , Andrea MinerviniAndrea Minervini More articles by this author , and Alessandro AntonelliAlessandro Antonelli More articles by this author View All Author Informationhttps://doi.org/10.1097/JU.0000000000001987.05AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVE: Comprehensive systematic literature reviews including pure laparoscopic partial nephrectomy (LPN) showed no impact on either surgical or oncological outcomes by the off-clamp technique. This finding is debatable and based on the pooled analysis of mostly small sample size studies, affected by several bias. We aimed to report a comparative analysis of perioperative outcomes of on-clamp vs off-clamp LPN in the setting of a randomized controlled trial. METHODS: 217 patients with RENAL masses ≤10 were randomized to on-clamp (106) vs off-clamp (111) LPN (The CLOCK II trial - ClinicalTrials.gov NCT 02287987). Data were collected at 5 participating institutions. One experienced surgeon per institution performed all the surgeries. Baseline and perioperative outcomes were collected and analyzed. The per-protocol analysis (patients who actually received an on-clamp or an off-clamp approach) is herein reported. RESULTS: After randomization, treatment groups were comparable at baseline in age, body mass index, comorbidities, clinical tumor size, RENAL score, serum creatinine, hemoglobin. A total of 189 patients actually underwent surgery as assigned (82 vs 107 on-clamp vs off-clamp, respectively). Tumors treated by an on-clamp approach were significantly bigger (4.0, IQR 3.0-5.0, vs 3.0, IQR 2.2-4.0 cm) but no difference was found in the baseline RENAL score. Regarding the perioperative outcomes, significant differences were found in the resection technique, the renorrhaphy technique, the use of hemostatic agents, the complications’ and transfusions’ rates, the operative time and the hospital stay, favoring the off-clamp approach. Groups were comparable in the blood loss. No significant differences were found in the positive surgical margins rate. CONCLUSIONS: When analyzing the patients who actually received an on-clamp or an off-clamp approach in the setting of a randomized trial, off-clamp LPN resulted in at least non inferior perioperative outcomes. Source of Funding: None © 2021 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 206Issue Supplement 3September 2021Page: e204-e204 Advertisement Copyright & Permissions© 2021 by American Urological Association Education and Research, Inc.MetricsAuthor Information Riccardo Bertolo More articles by this author Pierluigi Bove More articles by this author Marco Sandri More articles by this author Chiara Cipriani More articles by this author Luca Cindolo More articles by this author Costantino Leonardo More articles by this author Paolo Parma More articles by this author Mario Falsaperla More articles by this author Domenico Veneziano More articles by this author Antonio Celia More articles by this author Andrea Minervini More articles by this author Alessandro Antonelli More articles by this author Expand All Advertisement Loading ...