Patients and study design
adenocarcinoma of the stomach, active primary tumor, obstruction or perforation, gastric cancer
ADENOCARCINOMA OF THE STOMACH, METASTASIS, PATHOLOGY, GASTRIC CANCER
This clinical trial was a single-arm prospective phase I/II study conducted at a single institution, performed by a single surgeon with vast experience in both laparoscopic and robotic gastrectomy. We enrolled 19 patients with gastric cancer scheduled for robotic distal gastrectomy from December 2021 to October 2022. The first patient was enrolled on 16/12/2021 (SP-01). The inclusion criteria were a biopsy-confirmed adenocarcinoma of the stomach scheduled to undergo radical gastrectomy, age between 20 and 80 years, American Society of Anesthesiologists (ASA) physical status classification system class I–III, and signed informed consent after a thorough explanation of the study. The exclusion criteria were patients with distant metastasis, candidate for endoscopic mucosal resection, complicated gastric cancer (obstruction or perforation), another active primary tumor, and vulnerable subject (illiterate or pregnant). Patient characteristics, surgical factors, and pathology results of enrolled patients were prospectively collected. Informed consent was obtained from all patients after providing sufficient information about gastrectomy using the da Vinci SP robotic system. This phase I/II single-arm study was approved by the Institutional Review Board of Severance Hospital, Yonsei University Health System (4-2021-0881) and was conducted in compliance with the ethical guidelines of the Helsinki Declaration of 1975. The study protocol was registered at clinicaltrials.gov (first posted date: 21/09/2021, NCT05051670). All methods were performed in accordance with the relevant guidelines and regulations.