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

IntroductionLaparoscopic 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 analysisThis 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. χ2 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 disseminationThis 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 numberChiCTR2000032670.

Application of double layered end-to-end anastomosis with continuous manual suture for completing digestive tract reconstruction in totally laparoscopic distal gastrectomy

Background We retrospectively reviewed and consecutively collected the clinical data of distal gastric cancer patients who received surgical treatment, and we discuss the safety and feasibility of double layered end-to-end anastomosis with continuous manual suture to complete digestive tract reconstruction in totally laparoscopic distal gastrectomy. Methods We reviewed the clinical data of 41 patients with distal gastric cancer from the gastroenterology department of the Second Affiliated Hospital of Dalian Medical University, from September 2018 to August 2019, who underwent totally laparoscopic distal gastrectomy. During the operation, the method of double layered end-to-end anastomosis with continuous manual suture was used for Billroth type I anastomosis to complete digestive tract reconstruction. All patients have been given a follow-up visit and gastroscopy three months after the operation. The peri-operative clinical information and postoperative follow-up information were collected for analysis, and the clinical application value was evaluated. Results General information: male(n = 27), female(n = 14), age = 65.02(SD 9.94) years, and BMI = 23.52(SD 2.56) kg/m2, Tumor location: antrum(32,78.0%), angle (6,14.6%), and body (3,7.3%). Clinical stage: I (27, 65.9%), II (7, 17.1%), and III (7, 17.1%). Operative information: operation time = 154.51(SD 33.37) min, anastomosis time = 26.88(SD 5.11) min; intraoperative bleeding = 66.34(SD 48.81) ml; first postoperative ambulation Median = 1(IQR 0) d, first postoperative flatus Median = 3(IQR 2) d, first postoperative diet Median = 3(IQR 1) d, postoperative hospital stay Median = 7(IQR 2) d, and total hospitalization cost = 10,935.00(SD 2205.72)USD. Differentiation degree: high and high-moderate (3,7.32%), moderate and poor-moderate (24, 58.54%), poor differentiation (14, 34.15%), dissected lymph nodes Median = 31(IQR 17), and positive lymph nodes Median = 0(IQR 1). Pathological stage: IA (20, 48.78%), IB (3, 7.32%), IIA (4, 9.76%), IIB (5, 12.20%), IIIA (1, 2.44%), IIIB (3, 7.32%), and IIIC (5, 12.20%). Complications (n = 4): lung infection (1, 2.44%), anastomotic leakage (1, 2.44%), and gastroparesis (2, 4.88%). Conclusion It is safe and feasible in clinical treatment to apply the method of double layered end-to-end anastomosis with continuous manual suture to complete digestive tract reconstruction in totally laparoscopic distal gastrectomy.