Safety of on- vs off-clamp robotic partial nephrectomy: per-protocol analysis from the data of the CLOCK randomized trial
| Autor: | Bernardino De Concilio, Luigi Schips, Andrea Minervini, R. Nucciotti, Manuela Ingrosso, Marco Carini, Gianluca Muto, Antonio Celia, Carlo D'Orta, Riccardo Bertolo, Alessandro Antonelli, Claudio Simeone, Luca Cindolo, Francesco Sessa, Giulia Primiceri, Alessandro Veccia, Marco Sandri, Angelo Porreca, Valentina Giommoni, Maria Furlan, Andrea Mari, Filippo Annino |
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| Rok vydání: | 2019 |
| Předmět: |
Nephrology
Male medicine.medical_specialty Multivariate analysis Robot Urology medicine.medical_treatment 030232 urology & nephrology Clamping Clampless Off-clamp On-clamp Partial nephrectomy Nephrectomy law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Robotic Surgical Procedures law Internal medicine medicine Humans Prospective Studies Aged Intention-to-treat analysis business.industry Acute kidney injury Middle Aged medicine.disease Constriction Kidney Neoplasms Clamp 030220 oncology & carcinogenesis Female Positive Surgical Margin business |
| Zdroj: | World journal of urology. 38(5) |
| ISSN: | 1433-8726 |
| Popis: | To compare the safety of on- vs off-clamp robotic partial nephrectomy (RAPN).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.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).The on-clamp and off-clamp approaches for RAPN showed a comparable safety profile. |
| Databáze: | OpenAIRE |
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