跳至主要内容
临床试验/NCT07008313
NCT07008313已完成不适用

Enhanced Recovery After Surgery Promotes the Rehabilitation of Patients With Acute Gastrointestinal Perforation, a Randomized Controlled Study

Hebei Medical University1 个研究点 分布在 1 个国家目标入组 362 人开始时间: 2018年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
362
试验地点
1
主要终点
change of the c-reactive protein in plasma

研究概览

简要总结

The enhanced recovery after surgery(ERAS) has been gradually extended from its initial colorectal surgery to almost all surgical fields. However, there are few reports about the application value of ERAS in emergency surgery. The goal of this clinical trial is to evaluate the value of ERAS in the perioperative period of acute gastrointestinal perforation. All the patients will be treated by emergency operation. The changes of CRP, PA, PCT in Plasma 1 hour before operation and 1,3,7 days after operation, the operation time, the amount of bleeding during operation, the recovery time of intestinal function and the time of the first meal after operation,the incidence of postoperative complications, the degree of postoperative pain, the time of first out-of-bed activity, fatigue and mental status, quality of life, the length and the cost of hospital stay will be monitored and recorded.

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
Single (Participant)

入排标准

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

入选标准

  • •Age≥14years old and ≤80 years old
  • •The initial diagnosis is acute gastrointestinal perforation

排除标准

  • •Patients with unconsciousness,or patients with past psychiatric history
  • •Patients with shock and/or severe organ failure
  • •Patients who are pregnant
  • •Patients with severe spinal deformity who are unable to receive epidural anesthesia

研究组 & 干预措施

the enhanced recovery after surgery (ERAS) group

Experimental

Patients were rehabilitated using the ERAS concept.

干预措施: The enhanced recovery after surgery (Behavioral)

the conventional surgical treatment (CST) group

Placebo Comparator

Traditional treatment methods.

干预措施: Traditional treatment methods. (Behavioral)

结局指标

主要结局

change of the c-reactive protein in plasma

时间窗: 1, 3, and 7 days after surgery

change of the prealbumin in plasma

时间窗: 1, 3, and 7 days after surgery

change of the procalcitonin in plasma

时间窗: 1, 3, and 7 days after surgery

次要结局

未报告次要终点

研究者

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

Chunjie Liu

Professor

Hebei Medical University

研究点 (1)

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