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Enhanced Recovery After Surgery (ERAS) on Laparoscopy-assisted Distal Gastrectomy

2017年1月9日 更新者:Guoxin Li、Nanfang Hospital of Southern Medical University

Effect of Enhanced Recovery After Surgery (ERAS) on Laparoscopy-assisted Distal Subtotal Gastrectomy: A Single Arm Trial

This study evaluates the safety and effectiveness of enhanced recovery after surgery(ERAS) on laparoscopic distal gastrectomy for gastric cancer.All of participants received an ERAS program.

研究概览

地位

未知

条件

干预/治疗

详细说明

Preoperative education about ERAS program is administered in the ward after admission by a specific team. Breathing training and atomizing during the time of preoperative preparation is performed during hospitalization (5-7 days). Patients are allowed to eat a normal diet and intake of 1000 ml 10% carbohydrate drink 10 hours before surgery and oral 500ml 10% carbohydrate drink 2 hours before the induction of anesthesia. Mechanical bowel preparation is not recommended as routine procedure.

The intravenous fluid therapy is restricted. Urinary catheters are routinely placed after anesthesia. In principle, drainage and nasogastric tube are not placed (except the concerns of surgical safety). Surgical site infiltration is implemented.All patients undergo laparoscopic distal gastrectomy.

Urinary catheters are routinely removed within 24 hours after operation. An optimal management of acute postoperative pain is multimodal analgesia consists of surgical site infiltration, a nonsteroidal anti-inflammatory drug for postoperative three days (POD) and epidural analgesia. Adjunctive analgesia with acetaminophen is used after the resumption of oral intake until adequate pain relief. Patients were encouraged to move from POD 1. The patients are encouraged to a full fluid diet on POD 2. Adhere to the premise of eating little and often daily increase, then to semi-fluids to soft diet. A normal diet is often started on POD 4. Abdominal drains are routinely removed within 72 hours after operation.

研究类型

介入性

注册 (预期的)

98

阶段

  • 阶段2

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Guangdong
      • Guangzhou、Guangdong、中国、510-515
        • 招聘中
        • Nanfang Hospital, Southern Medical University
        • 接触:

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 75年 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age from over 18 to under 75 years
  • Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy
  • cT1-4a, N0-3, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual Seventh Edition
  • Expected curative resection through distal subtotal gastrectomy with D2 lymphadenectomy
  • no severe organ dysfunction
  • Performance status of 0 or 1 on ECOG (Eastern Cooperative Oncology Group) scale
  • ASA (American Society of Anesthesiology) score class I or II
  • Written informed consent

Exclusion Criteria:

  • Women during pregnancy or breast-feeding
  • Severe mental disorder
  • History of previous upper abdominal surgery (except laparoscopic cholecystectomy)
  • History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
  • Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
  • History of other malignant disease within past five years
  • History of previous neoadjuvant chemotherapy or radiotherapy
  • History of unstable angina or myocardial infarction within past six months
  • History of cerebrovascular accident within past six months
  • History of continuous systematic administration of corticosteroids within one month
  • Requirement of simultaneous surgery for other disease
  • Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  • FEV1<50% of predicted values

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的:ERAS
Preoperative education,breathing training and atomizing during the time of preoperative preparation.Shorten fasting time and carbohydrate load.The intravenous fluid therapy is restricted.Drainage and nasogastric tube are not placed (except the concerns of surgical safety).All patients undergo laparoscopic distal gastrectomy.An optimal management of acute postoperative pain is multimodal analgesia consists of surgical site infiltration, a nonsteroidal anti-inflammatory drug for postoperative three days (POD) and epidural analgesia.Early oral take and move.
Undergo an ERAS program

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Postoperative hospital stays
大体时间:1 month
Days from surgery to discharge
1 month
Rehabilitative rate
大体时间:4 days
Postoperative 4 days
4 days

次要结果测量

结果测量
措施说明
大体时间
Medical cost
大体时间:1 month
From surgery to discharge
1 month
Postoperative pain score
大体时间:4 days
Postoperative 4 days
4 days
Postoperative recovery index
大体时间:1 month
1 month
Postoperative inflammatory immune response
大体时间:4 days
Postoperative 4 days
4 days
Morbidity rates
大体时间:30 days
30 days
Mortality rates
大体时间:30 days
30 days

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Guoxin Li, MD.,Ph.D、Southern Medical University, Guangzhou,China
  • 首席研究员:Kexuan Liu, MD.,Ph.D、Southern Medical University, Guangzhou,China
  • 研究主任:Hao Liu, MD.,Ph.D、Southern Medical University, Guangzhou,China
  • 研究主任:Li Zhen, MD.,Ph.D、Southern Medical University, Guangzhou,China
  • 研究主任:Xiaomin Hou, MD.,Ph.D、Southern Medical University, Guangzhou,China
  • 研究主任:Jiang Yu, MD.,Ph.D、Southern Medical University, Guangzhou,China
  • 研究主任:Yu Zhu, MD.、MD.,Ph.D

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年11月1日

初级完成 (预期的)

2018年6月1日

研究完成 (预期的)

2018年7月1日

研究注册日期

首次提交

2016年11月24日

首先提交符合 QC 标准的

2017年1月9日

首次发布 (估计)

2017年1月10日

研究记录更新

最后更新发布 (估计)

2017年1月10日

上次提交的符合 QC 标准的更新

2017年1月9日

最后验证

2017年1月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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