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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

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Tian, Yulong ; Cao, Shougen ; Li, Leping ; He, Qingsi ; Xia, Lijian ; Jiang, Lixin ; Ding, Yinlu ; Wang, Xinjian ; Wang, Hao ; Mao, Weizheng ; Hui, Xizeng ; Shi, Yiran ; Zhang, Huanhu ; Chu, Xianqun ; Kehlet, Henrik ; Zhou, Yanbing. / 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. In: Trials. 2020 ; Vol. 21, No. 1. pp. 369.

Bibtex

@article{9463cf895ade463c96be02075cee6b57,
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",
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.",
author = "Yulong Tian and Shougen Cao and Leping Li and Qingsi He and Lijian Xia and Lixin Jiang and Yinlu Ding and Xinjian Wang and Hao Wang and Weizheng Mao and Xizeng Hui and Yiran Shi and Huanhu Zhang and Xianqun Chu and Henrik Kehlet and Yanbing Zhou",
year = "2020",
month = "5",
day = "1",
doi = "10.1186/s13063-020-04272-8",
language = "English",
volume = "21",
pages = "369",
journal = "Trials",
issn = "1745-6215",
publisher = "BioMed Central Ltd",
number = "1",

}

RIS

TY - JOUR

T1 - 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

T2 - study protocol for a randomized controlled trial

AU - Tian, Yulong

AU - Cao, Shougen

AU - Li, Leping

AU - He, Qingsi

AU - Xia, Lijian

AU - Jiang, Lixin

AU - Ding, Yinlu

AU - Wang, Xinjian

AU - Wang, Hao

AU - Mao, Weizheng

AU - Hui, Xizeng

AU - Shi, Yiran

AU - Zhang, Huanhu

AU - Chu, Xianqun

AU - Kehlet, Henrik

AU - Zhou, Yanbing

PY - 2020/5/1

Y1 - 2020/5/1

N2 - 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.

AB - 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.

U2 - 10.1186/s13063-020-04272-8

DO - 10.1186/s13063-020-04272-8

M3 - Journal article

VL - 21

SP - 369

JO - Trials

JF - Trials

SN - 1745-6215

IS - 1

ER -

ID: 59817519