Comparison of short-term outcomes and quality of life in totally laparoscopic distal gastrectomy and totally robotic distal gastrectomy for clinical stage I–III gastric cancer: study protocol for a multi-institutional randomised clinical trial

INTRODUCTION: Laparoscopic distal gastrectomy (LDG) is regarded as a standard treatment for patients with clinical stage I–III gastric cancer. With the popularisation of the Da Vinci robotic system in the 21st century, robotic distal gastrectomy has been increasingly applied, and its potential advantages over LDG have been proved by several studies. Intraperitoneal anastomosis is a hot topic in research as it highlights the superiority of minimally invasive surgery and is safe and feasible. We intend to conduct this randomised clinical trial to focus on short-term outcomes and quality of life (QOL) in totally laparoscopic distal gastrectomy (TLDG) and totally robotic distal gastrectomy (TRDG) for patients with clinical stage I–III gastric cancer. METHODS AND ANALYSIS: This study is a prospective, multi-institutional, open-label randomised clinical trial that will recruit 722 patients with a 1:1 ratio (361 patients in the TLDG group and 361 patients in the TRDG group) from eight large-scale gastrointestinal medical centres in China. The primary endpoint is 30-day postoperative morbidity. The secondary endpoints include QOL, 30-day severe postoperative morbidity and mortality, anastomotic-related complication rate, conversion to open surgery rate, intraoperative and postoperative indicators, operative and total costs during hospitalisation, 1-year overall survival and disease-free survival. QOL is determined by the The European Organization for Reasearch and Treatment of Cancer Quality of Life Questionnare-Core 30 and Stomach22 (EORTC QLQ-C30 and STO22) questionnaires which are completed before surgery and 1, 3, 6 months, and 1 year after surgery. χ(2) test will be used for the primary endpoint, while analysis of covariance will be used to compare the overall changes of QOL between the two groups. ETHICS AND DISSEMINATION: This trial was approved by the Ethics Committee of the Chinese PLA General Hospital. The trial’s results will be disseminated via peer-reviewed scientific journals and conference presentations. TRIAL REGISTRATION NUMBER: ChiCTR2000032670.