Alessandro Antonelli1, Luca Cindolo2, Marco Sandri3, Riccardo Bertolo4, Filippo Annino5, Marco Carini6, Antonio Celia7, Carlo D'Orta2, Bernardino De Concilio7, Maria Furlan8, Valentina Giommoni5, Manuela Ingrosso2, Andrea Mari6, Gianluca Muto6, Roberto Nucciotti9, Angelo Porreca10, Giulia Primiceri2, Luigi Schips2, Francesco Sessa6, Claudio Simeone8, Alessandro Veccia8, Andrea Minervini6. 1. Urology Unit, ASST Spedali Civili Hospital and Department of Medical and Surgical Specialties, Radiological Science, and Public Health, University of Brescia, Brescia, Italy. alessandro_antonelli@me.com. 2. Urology Unit, D'Annunzio Hospital, University of Chieti, Chieti, Italy. 3. Data Methods and Systems Statistical Laboratory, University of Brescia, Brescia, Italy. 4. Urology Unit, San Carlo di Nancy Hospital, Rome, Italy. 5. Urology Unit, San Donato Hospital, Arezzo, Italy. 6. Urology Unit, Careggi Hospital, University of Florence, Florence, Italy. 7. Urology Unit, San Bassiano Hospital, Bassano Del Grappa, Italy. 8. Urology Unit, ASST Spedali Civili Hospital and Department of Medical and Surgical Specialties, Radiological Science, and Public Health, University of Brescia, Brescia, Italy. 9. Urology Unit, Misericordia Hospital, Grosseto, Italy. 10. Urology Unit, Policlinico of Abano, Abano Terme, Italy.
Abstract
PURPOSE: To compare the safety of on- vs off-clamp robotic partial nephrectomy (RAPN). METHODS:302 patients with RENAL masses ≤ 10 were randomized to undergo on-clamp (150) vs off-clamp (152) RAPN (CLOCK trial-ClinicalTrials.gov NCT02287987) at seven institutions by one experienced surgeon per institution. Intra-operative data, complications, and positive surgical margins were compared. RESULTS: Due to a relevant rate of shift from the assigned treatment, the per-protocol analysis only was considered and the data from 129 on-clamp vs 91 off-clamp RAPNs analyzed. Tumor size (off-clamp vs on-clamp, 2.2 vs 3.0 cm, p < 0.001) and RENAL score (5 vs 6, p < 0.001) significantly differed. At univariate analysis, no differences were found regarding intra-operative estimated blood loss (off- vs on-clamp, 100 vs 100 ml, p = 0.7), post-operative complications rate (19% vs 26%, p = 0.2), post-operative anemia (Hb decrease >; 2.5 g/dl 26% vs 27%, p = 0.9; transfusion rate 3.4% vs 6.3%, p = 0.5; re-intervention due to bleeding 1.1% vs 4%, p = 0.4), acute kidney injury (4% vs 6%, p = 0.8), and positive surgical margins (3.5% vs 8.2%, p = 0.1). At multivariate analysis accounting for tumor diameter and complexity, considering the on-clamp group as the reference category, a significant difference was noted in the off-clamp group exclusively for blood loss (OR 0.3, 95% CI 0.09-0.52, p = 0.008). CONCLUSIONS: The on-clamp and off-clamp approaches for RAPN showed a comparable safety profile.
RCT Entities:
PURPOSE: To compare the safety of on- vs off-clamp robotic partial nephrectomy (RAPN). METHODS: 302 patients with RENAL masses ≤ 10 were randomized to undergo on-clamp (150) vs off-clamp (152) RAPN (CLOCK trial-ClinicalTrials.gov NCT02287987) at seven institutions by one experienced surgeon per institution. Intra-operative data, complications, and positive surgical margins were compared. RESULTS: Due to a relevant rate of shift from the assigned treatment, the per-protocol analysis only was considered and the data from 129 on-clamp vs 91 off-clamp RAPNs analyzed. Tumor size (off-clamp vs on-clamp, 2.2 vs 3.0 cm, p < 0.001) and RENAL score (5 vs 6, p < 0.001) significantly differed. At univariate analysis, no differences were found regarding intra-operative estimated blood loss (off- vs on-clamp, 100 vs 100 ml, p = 0.7), post-operative complications rate (19% vs 26%, p = 0.2), post-operative anemia (Hb decrease > 2.5 g/dl 26% vs 27%, p = 0.9; transfusion rate 3.4% vs 6.3%, p = 0.5; re-intervention due to bleeding 1.1% vs 4%, p = 0.4), acute kidney injury (4% vs 6%, p = 0.8), and positive surgical margins (3.5% vs 8.2%, p = 0.1). At multivariate analysis accounting for tumor diameter and complexity, considering the on-clamp group as the reference category, a significant difference was noted in the off-clamp group exclusively for blood loss (OR 0.3, 95% CI 0.09-0.52, p = 0.008). CONCLUSIONS: The on-clamp and off-clamp approaches for RAPN showed a comparable safety profile.
Authors: Clément Michiels; Zine-Eddine Khene; Thomas Prudhomme; Astrid Boulenger de Hauteclocque; François H Cornelis; Mélanie Percot; Hélène Simeon; Laure Dupitout; Henri Bensadoun; Grégoire Capon; Eric Alezra; Vincent Estrade; Franck Bladou; Grégoire Robert; Jean-Marie Ferriere; Nicolas Grenier; Nicolas Doumerc; Karim Bensalah; Jean-Christophe Bernhard Journal: World J Urol Date: 2021-04-02 Impact factor: 4.226