Minimally Invasive Control of Epistaxis (MICE)

Study Overview
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Brief Summary
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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.

Official Title
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Minimally Invasive Control of Epistaxis: Efficacy and Economic Analysis

Conditions
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Epistaxis

Intervention / Treatment
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* Procedure: MICE
* Procedure: SPA ligation


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age ≥ 18 years old, Presenting to Rockyview General Hospital Emergency room No coagulopathy (must have INR reversed before inclusion) Available for follow-up at 1 week and 1 month in Calgary, Alberta Refractory or Recurrent Epistaxis defined as: Refractory = unable to control epistaxis with bilateral Merocel™ Nasal Tampons fully inserted into nasal cavity Recurrent = epistaxis after removal of Merocel™ Nasal Tampons following outpatient packing for 48 hours Exclusion Criteria: Uncorrectable coagulopathy Unable to comply with procedure Pregnancy Non-Calgary emergency room presentation Severe posterior epistaxis requiring intubation for airway protection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>MICE | Procedure: MICE<br>* MICE<br>|
| Active Comparator: 2<br>SPA ligation | Procedure: SPA ligation<br>* SPA ligation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in hospital admission requirement between M.I.C.E. and Operative Sphenopalatine Ligation |  | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epistaxis, Epistaxis refractory to emergency physician treatment