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临床试验/NCT01610726
NCT01610726已完成不适用

Economic and Clinical Evaluation of Enhanced Recovery in Colorectal Surgery

Haukeland University Hospital2 个研究点 分布在 1 个国家目标入组 484 人开始时间: 2012年2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
发起方
入组人数
484
试验地点
2
主要终点
Length of stay

研究概览

简要总结

The purpose of this study is to evaluate the health cost and clinical outcome by introducing enhanced recovery (ERAS) compared to conventional recovery in colorectal surgery.

详细描述

Aim of the sudy:

  1. Clinical evaluation: To investigate if patients treated with enhanced recovery have a shorter hospital stay and less morbidity than the patients treated conventionally. Other clinical questions witch might be answered in this study are clinical surgical stress response (insulin resistent), amount of analgetics used and time to normal activity.
  2. Evaluation of quality of life: Instruments used in this sudy to evaluate quality of life are 15 D and qualitative interview.
  3. Economic evaluation: Cost-utility analysis of the clinical studies
  4. Compare patients who received a fast track program with dedicated fast track- and stoma nurse specialist and special focus on counselling and stoma education, compared with patients receiving existing current practice of stoma-education in a traditional care pathway, could reduce the length of hospital stay, readmission and stoma related complications
  5. Further we will tray to generate additional insights into the impact of counselling when groups of patients are otherwise equal in terms of fast-track criteria. We are therefore continuing the enrolling of our colorectal patients in which both study arms contain the same ERAS items; the arms will only differ in terms of perioperative information and guidance as well as follow-up by dedicated nurses.

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

入选标准

  • Planed elective colorectal surgery, written consent and age above 18 years

排除标准

  • Patients below 18 years, pregnancy, surgical emergency and no informed consent

研究组 & 干预措施

enhanced recovery

Active Comparator

干预措施: Enhanced versus conventional recovery in colorectal surgery (Procedure)

conventional recovery

No Intervention

结局指标

主要结局

Length of stay

时间窗: 30 days

次要结局

  • Morbidity(30 days)

研究者

发起方
Haukeland University Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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