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Published in: Trials 1/2020

Open Access 01-12-2020 | Gastrectomy | Study protocol

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

Authors: 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

Published in: Trials | Issue 1/2020

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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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Metadata
Title
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
Authors
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
Publication date
01-12-2020
Publisher
BioMed Central
Published in
Trials / Issue 1/2020
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-020-04272-8

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