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临床试验/NCT01653496
NCT01653496已完成2 期

Phase II Study Evaluating the Compliance to the Enhanced Recovery After Surgery (ERAS) Program in Patients Undergoing Gastrectomy for Gastric Carcinoma

Chonnam National University Hospital2 个研究点 分布在 1 个国家目标入组 168 人开始时间: 2012年7月最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
168
试验地点
2
主要终点
Overall compliance to the ERAS program

研究概览

简要总结

The purpose of this study is to prospectively evaluate the overall compliance to the enhanced recovery after surgery (ERAS) program in patients undergoing gastric cancer surgery.

详细描述

The feasibility and effectiveness of ERAS program for various major surgical procedures have been well studies in the literature. However, ERAS program has not been widely accepted for patients undergoing gastric cancer surgery because of the paucity of evidence about its feasibility and efficacy. In this study, we developed ERAS program for gastric cancer surgery, based on the systemic review about perioperative cares. The main elements of ERAS program includes: 1preoperative patient education, 2)no preoperative bowel preparation, 3) provision of normal diet until the night before surgery, 4)carbohydrate rich drink 2 hrs before surgery, 5)epidural anesthesia for pain control, 6) local wound anesthetic infiltration for pain control, 7)no routine abdominal drain, 8)no naso-gastric tube insertion, 9)intraoperative antibiotics, 10)thromboprophylaxis using intermittent pneumatic compression device, 11)intraoperative normothermia using warm air blanket, 12)low oxygen supply during immediate postoperative period, 13)restrictive postoperative fluid administration, 14)early postoperative oral diet, 15)early active ambulation, 16)early removal of the urinary catheter, 17)patient education before discharge, and 18)hospital discharge based on discharge criteria.

The aim of study is to evaluate the compliance to these main elements of ERAS program in patients undergoing gastric cancer surgery.

Previously reported data about ERAS program for colon surgery reported overall compliance as about 65%. Considering that this is a single center study, we expected overall compliance rate of 70%. Therefore, the sample size of 173 patients was calculated based on this expected compliance rate, with permitted error of 95% confidence interval of 14%.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
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

  • Patients who are to undergo gastric cancer surgery
  • ASA score < 3
  • ECOG performance status 0-1
  • Adequate hepatic, renal, and hematologic function
  • Written informed consent

排除标准

  • Previous abdominal operation history
  • Concommitant other organ malignant disease
  • Preoperative chemotherapy or radiation therapy
  • Concommitant other organ resection during surgery
  • Emergency operation due to bleeding or perforation
  • Active underlying medical illness
  • Pregnancy

结局指标

主要结局

Overall compliance to the ERAS program

时间窗: 90 days

Patient's compliance to the 18 main elements of ERAS program

次要结局

  • Morbidity(90 days)
  • Mortality(90 days)
  • Hospital stay(90 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Young Kyu Park

Professor, Department of Gastroenterologic Surgery

Chonnam National University Hospital

研究点 (2)

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Compliance to ERAS After Gastric Surgery | 临床试验