Short-term outcomes of KangDuo surgical robot- versus Da Vinci surgical robot-assisted radical resection of colorectal cancer: a prospective cohort study

摘要

BACKGROUND AND PURPOSE: The KangDuo Surgical Robot-01 (KD-SR-01) system is a recently introduced robot-assisted endoscopic surgical device originally designed in China. The purpose of this prospective cohort study was to ascertain whether the KD-SR-01 system was substantially equivalent to a comparable robotic device in terms of safety, efficacy and treatment costs during colorectal cancer resection, and evaluate the learning curve of KangDuo robotic surgery. METHOD: From October 2022 to May 2023, 50 patients (aged 18-80 years) with colorectal cancer were enrolled and randomly assigned to either the KangDuo group (KD-SR group; 26 patients) or the Da Vinci group (DV group; 24 patients). The primary endpoints were surgical success and conversion rates. In addition, cumulative summation (CUSUM) was used to plot the learning curve of KangDuo robot-assisted colorectal surgery and identify turning point (TP) case. RESULTS: The two cohorts both successfully completed the procedure without any conversion to open or laparoscopic surgery. Time to first flatus and incidence of perioperative adverse events were equivalent between the KD-SR and DV groups. Additionally, no disparities were observed in pathological outcomes. Duration of operation and console time of the KD-SR group were significantly longer than those of the DV group. However, DV group had higher total hospitalization costs. With CUSUM analysis, TP for docking time, console time and duration of operation of KD-SR group were seen at the 11th case. CONCLUSION: Considering the complexity of the procedure, KangDuo robot-assisted colorectal cancer surgery is safe and reproducible for the surgical management of colorectal cancer. In addition, 11 procedures seem to be the number required to reach the learning curve plateau in terms of operative time by the experienced surgeon. TRIAL REGISTRATION: The study was registered at www.chictr.org.cn (Registration number: ChiCTR2200063172, Data of Registration: 2022-09-01).