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临床试验/NCT03566056
NCT03566056已完成不适用

Early Recovery Outcomes After Standardized Fast-track Whipples Procedure

Eske Kvanner Aasvang1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年1月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Hypotension, defined as mean arterial bloodpressure <65 mmHg, measured by invasive arterial blood-pressure, the first morning after surgery at 06.00 (AM)

研究概览

简要总结

Today the Whipple procedure is the preferred operation for malignancy in the pancreas. In abdominal surgery this procedure is known for its high surgical stress-response in the patient, which has been attempted to be resolved with the introduction of preoperative high-dose steroids and goal-directed fluid therapy (GDT). Despite this effort, complications still occur regularly (30%) in the first weeks after the operation here at Rigshospitalet. Therefore there is still a challenge in the patients who have undergone the Whipple procedure in the acute postoperative phase. This shows in for example at Rigshospitalet, where 50% of the patients continue to be in the need of vasoactive medication the morning after the operation.

Nevertheless, no studies have in detail described the acute (<24h) postoperative phase. There is also an importance in the fact that there is often no description or control over other important factors, for example medicine with influence on the circulatory system, fluid treatment and response to this etc..

The purpose of this study is to investigate what issues or complications, in particular those of circulatory matter that occurs in this particular group of patients 24 hours after the operation. Furthermore there is lacking a description of which cause-response- link there can be between early and later (30 days) complications, as well as when each of these complications occur. Therefore, there will also be collected data on complications within the first 30 days after the operation for the purpose of a later secondary publication with the same authors.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

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

  • the patient has undergone the Whipple procedure
  • The patient is over 18 years ol
  • The patient has signed a consent statement from the postoperative therapy ward

排除标准

  • The patient did not receive 125 mg of methylprednisolone prior to the operation
  • The patient did only undergo pancreatectomy
  • The patient wasn't given epidural anesthesia
  • the patient was given anesthesia through a mask

结局指标

主要结局

Hypotension, defined as mean arterial bloodpressure <65 mmHg, measured by invasive arterial blood-pressure, the first morning after surgery at 06.00 (AM)

时间窗: 6 am on the day after surgery

Number of patients with the need for nor-adrenalin infusion to maintain mean arterial blood-pressure \>65 mmHg, the first morning after surgery

次要结局

未报告次要终点

研究者

发起方
Eske Kvanner Aasvang
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Eske Kvanner Aasvang

Principle investigator, Associate professor

Rigshospitalet, Denmark

研究点 (1)

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