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World J Urol. 2019 Jul 24. doi: 10.1007/s00345-019-02879-4. [Epub ahead of print]

Safety of on- vs off-clamp robotic partial nephrectomy: per-protocol analysis from the data of the CLOCK randomized trial.

Author information

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.

KEYWORDS:

Clamping; Clampless; Off-clamp; On-clamp; Partial nephrectomy; Robot

PMID:
31342246
DOI:
10.1007/s00345-019-02879-4

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