跳至主要内容
临床试验/NCT01766765
NCT01766765Unknown4 期

Fast-track Surgery Recovery Program With Early Jejunostomy Nutrition Protocol Minimizes Time to Adjuvant Chemotherapy in Patients Undergoing Laparoscopic Gastrectomy for Gastric Cancer

Jinling Hospital, China1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2013年4月1日最近更新:
适应症

试验速览

阶段
4 期
发起方
入组人数
100
试验地点
1
主要终点
The time to the first adjuvant chemotherapy

研究概览

简要总结

Adjuvant chemotherapy (AC) for gastric cancer is known to improve prognosis, and longer time to AC is associated with worse survival. However, most clinical trials mandate that AC is still to commence within 6 to 8 weeks after surgery consideration for malnutrition, postoperative complications and intolerance of AC. Placement of jejunostomy nutrition tube for enteral nutrition is a common component of these procedures, as a result of superior postoperative organ function, decreased infection rates, and a greater likelihood to complete AC with enteral nutritional support.

Fast-track surgery (FTS) recovery program focuses on enhancing recovery and reducing morbidity. Introduction of FTS concepts are safe, feasible, and can achieve shorter hospital stays and reduced costs. Early postoperative enteral nutrition combined with FTS results in reductions in total complications compared with traditional postoperative feeding practices and does not negatively affect outcomes. However, the benefit of jejunostomy nutrition tube routine placement and combination with FTS is still being debated. Besides, there remains some controversy over the optimal combination of nutrients and duration and timing and routes of feed administration.

The aim of this study was to determine whether FTS with early jejunostomy nutrition (EJN) following laparoscopic gastrectomy for gastric cancer improved postoperative recovery and minimizes time to AC when compared with FTS with early oral nutrition (EON).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary gastric cancer
  • R0 resection

排除标准

  • Metastatic tumor
  • Locally unresectable tumor
  • Previous gastric/enteral resection
  • Age under 18 years or over 70 years
  • Preoperative complete parenteral or enteral nutrition
  • Neo-adjuvant chemotherapy
  • Severe malnutrition
  • Lack of the patient's consent for the trial participation, jejunostomy tube insertion or epidural analgesia

结局指标

主要结局

The time to the first adjuvant chemotherapy

时间窗: 30 days after operation

次要结局

  • Overall morbidity rate of jejunostomy nutrition(60 days after operation)
  • Overall morbidity rate of early oral nutrition(60 days after operation)
  • Postoperative mortality rate(60 days after operation)
  • Time to tolerate EJN/EON(30 days after operation)
  • Time to full oral nutrition(30 days after operation)
  • Body composition(10 days after operation)
  • Energy metabolism(10 days after operation)
  • Postoperative hospital stay length(60 days after operation)
  • Rehospitalization rate(30 days after discharge)

研究者

发起方
Jinling Hospital, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Qi Mao

Senior Resident

Jinling Hospital, China

研究点 (1)

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