Robot-assisted Radical Prostatectomy with the KangDuo Surgical System Versus the da Vinci Si System: A Prospective, Double-center, Randomized Controlled Trial
Abstract
BACKGROUND
The KangDuo Surgical Robot (KD-SR) is a newly developed surgical robot.
OBJECTIVE
To compare the safety and efficacy of robot-assisted radical prostatectomy (RARP) using the KD-SR with those of the da Vinci Si Surgical System (DV-SS-Si).
DESIGN, SETTING, AND PARTICIPANTS
A prospective double-center noninferiority randomized controlled trial was conducted among 18-75-yr-old patients with suspected T1-2N0M0 prostate cancer (PCa) scheduled for RARP.
INTERVENTION
RARP with the KD-SR (KD-RARP) versus RARP with the DV-SS-Si (DV-RARP).
OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS
The primary outcome was surgical success, defined as follows: surgery can be performed according to the established protocol, without switching to other surgical modalities, and without secondary surgery due to surgical complications after surgery. The secondary outcome was short-term functional and oncological outcomes. The noninferiority threshold was set at 10%.
RESULTS AND LIMITATIONS
Eighty patients were enrolled, while the full analysis set finally included 79 patients (40 with KD-RARP and 39 with DV-RARP). The success rate was 100% in both groups. We could not find differences in urinary continence rate at 1, 2, 3, and 4 wk after catheter removal between the groups (p > 0.05). The rate of Clavien-Dindo grade II adverse events was 20% in the KD-RARP group and 17.9% in the DV-RARP group (p = 0.82), and no grade ≥III adverse events occurred. The median operation time was significantly…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 79 participants or records.
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