Robotic-assisted radical colorectal cancer surgery with the KangDuo surgical robotic system vs. the da Vinci Xi surgical system in elderly patients: A multicenter randomized controlled trial

Abstract

To the Editor: Recently, a novel robotic surgical platform, the KangDuo surgical robot (KD-SR), has emerged in China. As depicted in Supplementary Figure 1, https://links.lww.com/CM9/C379, the KD-SR-01 system integrates an open vision system, which not only enables a natural posture for surgeons and mitigates potential neck strain, but also enhances effective communication between the primary surgeon and their assistant. Previous studies have demonstrated encouraging outcomes of this novel robotic surgical system in certain instances.[1] By the end of 2019, China’s elderly population aged ≥60 years had surged to a staggering 253 million individuals, constituting an impressive 18.1% of the total populace.[2] Elderly colorectal cancer (CRC) patients are featured by lower health performance status, more cautious perioperative risk evaluation, worse surgical tolerance, and more postoperative complications. Hence, the outcomes of the KD-SR system for elderly patients is a pivotal inquiry in its clinical advancement for treating CRC. Regarding robotic surgical platforms, the da Vinci robot’s dominance in global surgical robotics stems from its proven track record in delivering improved patient outcomes along with increased surgeon efficiency.[3] Furthermore, the da Vinci robot provides a standardized platform for robotic-assisted surgeries. Thus, we aimed to assess the outcomes of the KD-SR-01 in elderly CRC patients by comparing it with the da Vinci Robotic System through a multicenter randomized controlled trial. This multicenter prospective randomized controlled trial was conducted from July 2022 to May 2023 at Peking University First Hospital (Center I), the Second Affiliated Hospital of Harbin Medical University (Center II), and the First Affiliated Hospital of Chongqing Medical University (Center III). The original protocol was registered at www.chictr.org.cn (ChiCTR2200063172). The study was approved by Ethics Committee of Drug Clinical Trials, Chinese Academy of Medical Sciences and Peking Union Hospital (No. KS2022261). Written informed consent was obtained from all patients after providing a comprehensive explanation regarding the study’s objectives. Inclusion criteria included: (1) confirmation of colorectal adenocarcinoma through pathological biopsy; (2) age 60 years or older; (3) absence of extensive infiltration and metastasis as observed on imaging; (4) American Society of Anesthesiologists Physical Status Classification System grade I–II classification; and (5) voluntary participation in this trial with informed consent provided. Exclusion criteria included: (1) patients with familial adenomatous polyposis or cancerous lesions resulting from ulcerative colitis; (2) individuals unable to tolerate anesthesia and luminal surgery procedures; (3) body mass index (BMI) >30 kg/m2; (4) presence of intestinal obstruction, hemorrhage, or perforation necessitating emergency surgery; and (5) participants concurrently involved in other investigational drug or device clinical trials that were not yet completed. Withdrawal criteria included: (1) the subject’s withdrawal of informed consent; (2) the investigator’s determination that the subject was no longer suitable for continuation within the clinical trial; (3) death of the subject; (4) loss to follow-up; and (5) sponsor’s request for termination of the trial. All surgeries were performed by expert surgeons from three large tertiary centers with experience of >100 standard robotic surgical procedures (Prof. Yi Xiao in Center I, Prof. Guiyu Wang in Center II, and Prof. Zhengqiang Wei in Center III). More detailed surgical procedures are given in Supplementary Method and Supplementary Figure 2A–I, https://links.lww.com/CM9/C379. In this study, the primary outcomes were surgical success and conversion rates. The secondary outcomes were time to first flatus, National Aeronautics and Space Administration task load index (NASA-TLX) score, and operational experience score. The NASA-TLX