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临床试验/NCT01899885
NCT01899885已完成不适用

Acute High-risk Abdominal Surgery Study - an Optimized Perioperative Course

Hvidovre University Hospital1 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2013年6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
1,200
试验地点
1
主要终点
mortality rate

研究概览

简要总结

The objective of this study is to implement an optimized perioperative course for patients undergoing acute high-risk abdominal surgery in order to improve the outcome.

The optimized perioperative course consists of a number of interventions carried out before, during and after surgery.

详细描述

Emergency surgery is associated with high mortality rates, post-operative complications and prolonged duration of hospital admission. The investigators will implement a multidisciplinary optimized perioperative course consisting of a number of interventions carried out before, during and after surgery.

Hypothesis

An optimized perioperative course will reduce the 30-day mortality in emergency abdominal surgery patients.

The investigators will do a post-hoc analysis of the data registered.

研究设计

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

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

  • •patients undergoing primary emergency laparotomy or laparoscopy
  • •patients undergoing reoperation after abdominal surgery.
  • •Age > 18 years

排除标准

  • •Appendectomy
  • •Emergency laparoscopic cholecystectomy
  • •Emergency diagnostic laparoscopy without intervention

研究组 & 干预措施

historic control group

No Intervention

Standard treatment in the historic control group

Intervention group

Active Comparator

AHA (Acute Highrisk Abdominalsurgery): Optimized Course:

Intervention before, during and after abdominal surgery.

Focus on fast track with multimodal standardized intervention:

  1. standardized preparing for surgery including high dose antibiotics and epidural analgesia etc. and transfer to intermediate care before surgery (the post-anaesthesia care unit)
  2. GDT-LiDCO fluid management pre-, per- and postoperative
  3. Postoperative triage to 24 hour intermediate care based on ASA score and Surgical Apgar Score
  4. Focus on early mobilization, fysiotherapy and optimal nutrition postoperatively

干预措施: AHA (Acute Highrisk Abdominalsurgery): Optimized Course (Procedure)

结局指标

主要结局

mortality rate

时间窗: Within 30 days of 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

Line Toft Tengberg

MD

Hvidovre University Hospital

研究点 (1)

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