Effects of perioperative enhanced recovery after surgery pathway management versus traditional management on the clinical outcomes of laparoscopic-assisted radical resection of distal gastric cancer: study protocol for a randomized controlled trial

Abstract Background: The incidence of gastric cancer in East Asia is much higher than the international average. Therefore, improving the prognosis of patients and establishing effective clinical pathways are important topics for the prevention and treatment of gastric cancer. At present, the enhanced recovery after surgery (ERAS) pathway is widely used in the field of gastric surgery. Many randomized controlled trial (RCT) studies have proven that the ERAS regimen can improve the short-term clinical outcomes of gastric cancer patients. However, a prospective study on the effect of the ERAS pathway on the prognosis of gastric cancer patients has not yet been reported. This trial aims to confirm whether the ERAS pathway can improve the disease-free survival (DFS) and overall survival (OS) of patients undergoing laparoscopic-assisted radical resection for distal gastric cancer. Methods/design: This study is a prospective, multicentre, randomized controlled trial. This experiment will include randomly divided groups, the experimental group and the control group, according to a 1:1 ratio. The perioperative period of the experimental group will be managed according to the ERAS pathway, and that of the control group will be managed according to the traditional management mode. An estimated 400 patients will be enrolled. The main endpoint for comparison is the 3-year OS and DFS between the two groups. Discussion: The results of this RCT should clarify whether the ERAS pathway is superior to traditional treatment on inflammatory indexes, short-term clinical outcome and survival for laparoscopic-assisted radical resection of distal gastric cancer. It is hoped that our data will provide evidence that the ERAS pathway improves survival in patients with gastric cancer.