Erschienen in:
24.07.2019 | Topic Paper
Safety of on- vs off-clamp robotic partial nephrectomy: per-protocol analysis from the data of the CLOCK randomized trial
verfasst von:
Alessandro Antonelli, Luca Cindolo, Marco Sandri, Riccardo Bertolo, Filippo Annino, Marco Carini, Antonio Celia, Carlo D’Orta, Bernardino De Concilio, Maria Furlan, Valentina Giommoni, Manuela Ingrosso, Andrea Mari, Gianluca Muto, Roberto Nucciotti, Angelo Porreca, Giulia Primiceri, Luigi Schips, Francesco Sessa, Claudio Simeone, Alessandro Veccia, Andrea Minervini, The AGILE Group (Italian Group for Advanced Laparo-Endoscopic Surgery)
Erschienen in:
World Journal of Urology
|
Ausgabe 5/2020
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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.