跳至主要内容
临床试验/NCT00498290
NCT00498290Unknown不适用

The Protocol of Enhanced Recovery After Surgery in Colorectal Surgery

Fudan University1 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2006年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
500
试验地点
1
主要终点
safety of the ERAS protocol and whether it can decrease surgical stress, increase functional recovery and reduce complication rate in colorectal surgery

研究概览

简要总结

The purpose of this study is to determine whether ERAS is safe and can decrease surgical stress, increase functional recovery and reduce complication rate in colorectal surgery.

详细描述

The key factors that keep a patient in hospital after uncomplicated major colorectal surgery include the need for parenteral analgesia(persistent pain), intravenous fluids (persistent gut dysfunction), and bed rest (persistent lack of mobility). These factors often overlap and interact to delay return of function. Obviously, postoperative complications will also prolong the time until recovery and ultimately length of stay. A clinical pathway, called Enhanced Recovery After Surgery(ERAS), to accelerate recovery after colonic resection based on a multimodal programme with optimal pain relief, stress reduction with regional anaesthesia, early enteral nutrition and early mobilisation has demonstrated improvements in physical performance, pulmonary function, body composition and a marked reduction of length of stay.

Comparison(s): A total of 500 cases colorectal surgery were randomized to receive ERAS protocol or the traditional protocol, such as mechanical bowl preparation, intravenous fluids until bowl movement recovery and bed rest.

研究设计

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

入排标准

年龄范围
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Colorectal surgery patients
  • Age 20~80
  • Without comorbidities which will influence prognosis, such as paralysis, spine cataface, or cardiac infarction

排除标准

  • Emergency
  • Combined other organ resection
  • Age > 80
  • Comorbidities which will influence prognosis, such as paralysis, spine cataface, or cardiac infarction

结局指标

主要结局

safety of the ERAS protocol and whether it can decrease surgical stress, increase functional recovery and reduce complication rate in colorectal surgery

时间窗: perioperation and until 30 days after surgery

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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