Comparison of short-term outcomes and quality of life in fully laparoscopic distal gastrectomy and fully robotic distal gastrectomy for clinical stage I-III gastric cancer: study protocol for a multi-institutional randomized clinical trial
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BMJ Open. 2021 May 25; 11 (5): e043535. doi: 10.1136 / bmjopen-2020-043535.
INTRODUCTION: Laparoscopic Distal Gastrectomy (LDG) is considered standard treatment for patients with clinical stage I-III gastric cancer. With the popularization of Da vinci robotic system in the 21st century, robotic distal gastrectomy has been increasingly applied, and its potential advantages over LDG have been proven by several studies. Intraperitoneal anastomosis is a hot topic in research because it demonstrates the superiority of minimally invasive surgery and is safe and feasible. We intend to conduct this randomized clinical trial to focus on the short-term outcomes and quality of life (QOL) in fully laparoscopic distal gastrectomy (TLDG) and fully robotic distal gastrectomy (TRDG) for patients with gastric cancer of clinical stage I-III.
METHODS AND ANALYSIS: This study is a prospective, multi-institutional, randomized open-label clinical trial that will enroll 722 patients with a 1: 1 ratio (361 patients in the TLDG group and 361 patients in the TRDG group) from eight major gastro-medical centers. large-scale intestinal tract in China. The primary endpoint is postoperative morbidity at 30 days. Secondary endpoints include quality of life, severe postoperative morbidity and mortality at 30 days, rate of complications related to anastomosis, rate of conversion to open surgery, intraoperative and postoperative indicators, operative and total costs during l hospitalization, 1-year overall survival and recurrence-free survival. Quality of life is determined by the questionnaires of the European Organization for Research and Treatment of Cancer Quality of Life Questionnare-Core 30 and Stomach22 (EORTC QLQ-C30 and STO22) which are completed before surgery and 1, 3, 6 months and 1 year after surgery. χ2 test will be used for the primary endpoint, while analysis of covariance will be used to compare overall changes in quality of life between the two groups.
ETHICS AND DISSEMINATION: This trial has been approved by the ethics committee of the Chinese General Hospital of the PLA. The results of the trial will be disseminated through peer-reviewed scientific journals and presentations at conferences.
TRIAL REGISTRATION NUMBER: ChiCTR2000032670.