Trials (May 2020)

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

  • Yulong Tian,
  • Shougen Cao,
  • Leping Li,
  • Qingsi He,
  • Lijian Xia,
  • Lixin Jiang,
  • Yinlu Ding,
  • Xinjian Wang,
  • Hao Wang,
  • Weizheng Mao,
  • Xizeng Hui,
  • Yiran Shi,
  • Huanhu Zhang,
  • Xianqun Chu,
  • Henrik Kehlet,
  • Yanbing Zhou

DOI
https://doi.org/10.1186/s13063-020-04272-8
Journal volume & issue
Vol. 21, no. 1
pp. 1 – 10

Abstract

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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 patients with gastric cancer. However, a prospective study on the effect of the ERAS pathway on the prognosis of patients with gastric cancer has not yet been reported. This trial aims to confirm whether the ERAS pathway can improve the disease-free survival and overall survival of patients undergoing laparoscopic-assisted radical resection for distal gastric cancer. Methods/design This study is a prospective, multicentre RCT. This experiment will consist of two groups – an experimental group and a control group – randomly divided in 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 overall survival and disease-free survival 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. Trial registration Chinese Clinical Trial Registry, CHiCTR1900022438 . Registered on 11 April 2019.

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