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临床试验/NCT02728973
NCT02728973Unknown不适用

Effects of Enhanced Recovery After Surgery (ERAS) Protocol on the Incidence of Postoperative Complications Following Intestinal Surgery

First Affiliated Hospital of Chongqing Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年2月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
200
试验地点
1
主要终点
The difference in postoperative morbidity rate

研究概览

简要总结

Enhanced recovery after surgery (ERAS) was first proposed by Kehlet in Copenhagen Denmark, this is a new concept for the integration of the latest study of the surgical, anesthesia, and nursing. The purpose of optimization measures, reduce patient trauma stress, promote early rehabilitation of patients. The investigators plan to compare the feasibility, clinical effectiveness, and cost savings of an ERAS program with traditional treatment program at a major teaching hospital in China.The investigators will apply ERAS plan or traditional treatment regimens in the treatment of 100 cases of colorectal cancer patients, respectively. And data Compare the two programs about the incidence of postoperative complications, postoperative hospital stay, cost of hospitalization, and readmission rate will be collected.

详细描述

Major colorectal surgery usually requires a hospital stay of more than 12 days. Inadequate pain management, intestinal dysfunction and immobilisation are the main factors associated with delay in recovery. This study aims to assess the short and medium term results achieved by an enhanced recovery program based on previously published protocols. This prospective study will be performed at a major hospital in China, involved 200 patients. All patients underwent elective colorectal resection for cancer are divided into enhanced recovery program group or conventional treatment group. The main elements of this program were: preoperative advice, no colon preparation, provision of carbohydrate-rich drinks one day prior and on the morning of surgery, goal directed fluid administration, body temperature control during surgery, avoiding drainages and nasogastric tubes, early mobilization, and the taking of oral fluids in the early postoperative period. Perioperative morbidity and mortality data will be collected and the length of hospital stay and protocol compliance recorded.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

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

入选标准

  • •Elective laparotomy or laparoscopic intestinal surgery.
  • •Age ≥ 18 years old.
  • •ASA grade II - IV.
  • •General anesthesia.

排除标准

  • •Patients with cognitive dysfunction and uncooperative subjects.
  • •Failure to obtain informed consent

结局指标

主要结局

The difference in postoperative morbidity rate

时间窗: within postoperative 30 days

次要结局

  • mortality(within postoperative 30 days)
  • length of hospital stay(within postoperative 30 days)

研究者

发起方
First Affiliated Hospital of Chongqing Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Min Su

Professor

First Affiliated Hospital of Chongqing Medical University

研究点 (1)

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