Robot-Assisted Radical Prostatectomy Using the KangDuo Surgical Robot-1500: A Prospective,Multicenter,Single-Arm Clinical Study

Abstract

Introduction:

The KangDuo Surgical Robot-1500 (KD-SR-1500) is a newly developed surgical robot. We aim to evaluate the feasibility and efficiency of the KD-SR-1500 system for robot-assisted radical prostatectomy (RARP).

Materials and Methods:

This prospective, multicenter, single-arm clinical study was conducted among 18–75-year-old patients with suspected T1-2N0M0 prostate cancer scheduled for RARP. The perioperative and follow-up data were prospectively recorded. Early oncologic outcomes were assessed according to surgical margin status and prostate-specific antigen (PSA) at 6 weeks after surgery. Continence was defined as no more than one pad daily. Ergonomics were assessed with the National Aeronautics and Space Administration task load index (NASA-TLX). Perioperative complications were recorded according to the Clavien–Dindo classification.

Results:

A total of 31 patients were involved in the trial. One patient with severe abdominal adhesion withdrew from the trial. All surgeries were performed successfully without any conversion or secondary surgery due to surgical complications. The median docking time and console time were 3.8 (3.3–5.2) and 104.6 (80.0–145.6) minutes, with a median estimated blood loss of 50 (20–100) mL. Positive surgical margin was observed in 6 (20%) patients. One (3.4%) patient experienced PSA persistence at 6 weeks after surgery. The urinary continence rate was 75.9% (22/29) at 4 weeks after catheter removal. There were no major complications (grade ≥ III) or equipment-related adverse events. The mean NASA-TLX score was 23.9 ± 11.7.

Conclusions:

The KD-SR-1500 is feasible and effective for the management of T1-T2 prostate cancer.