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临床试验/NCT00666471
NCT00666471终止2 期

Minimally Invasive Control of Epistaxis: Efficacy and Economic Analysis

University of Calgary1 个研究点 分布在 1 个国家目标入组 3 人开始时间: 2008年6月最近更新:
适应症

试验速览

阶段
2 期
状态
终止
入组人数
3
试验地点
1
主要终点
Change in hospital admission requirement between M.I.C.E. and Operative Sphenopalatine Ligation

研究概览

简要总结

Epistaxis is a common disorder with 60% of the population suffering from one episode and 10% of these cases requiring medical attention. Between March 2006 and March 2007, in Calgary, Alberta, there were 1500 presentations of epistaxis to adult emergency rooms with 7% of these (105 patients) requiring packing with admission. Common methods to control epistaxis include, nasal packing (88%), operative arterial ligation (10%), and arterial embolization (2%). A cost analysis demonstrated that nasal packing had a lower cost compared to embolization and arterial ligation, and all modalities had similar lengths of stay (Goddard, Otolaryng Head Neck Surg. 2006). Arterial ligation is the current recommended therapy for recurrent or refractory epistaxis, with a success rate of 98%. With the advancement of endoscopic techniques, emergency room Minimally Invasive Control of Epistaxis (M.I.C.E.) allows for selective packing and cauterization, which provides the patient with retained function of their nasal cavity and prevents a hospital admission, resulting in significant cost savings.

Hypothesis:

Does the M.I.C.E. procedure provide significant cost savings compared to operative sphenopalatine artery ligation? Null hypothesis is that there is no difference in hospital admission rates between M.I.C.E. and operative sphenopalatine artery ligation.

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

  • 未提供

排除标准

  • Uncorrectable coagulopathy
  • Unable to comply with procedure
  • Pregnancy
  • Non-Calgary emergency room presentation
  • Severe posterior epistaxis requiring intubation for airway protection

结局指标

主要结局

Change in hospital admission requirement between M.I.C.E. and Operative Sphenopalatine Ligation

时间窗: 30 days

次要结局

未报告次要终点

研究者

申办方类型
Other

研究点 (1)

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相似试验

Minimally Invasive Control of Epistaxis (MICE) | 临床试验