Minimally Invasive Control of Epistaxis (MICE)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Epistaxis |
Procedure: MICE Procedure: SPA ligation |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Minimally Invasive Control of Epistaxis: Efficacy and Economic Analysis |
- Change in hospital admission requirement between M.I.C.E. and Operative Sphenopalatine Ligation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
| Enrollment: | 3 |
| Study Start Date: | June 2008 |
| Study Completion Date: | June 2009 |
| Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
MICE
|
Procedure: MICE
MICE
|
|
Active Comparator: 2
SPA ligation
|
Procedure: SPA ligation
SPA ligation
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Joseph C. Dort MD, University of Calgary |
| ClinicalTrials.gov Identifier: | NCT00666471 History of Changes |
| Other Study ID Numbers: | UCENT0002 |
| Study First Received: | April 23, 2008 |
| Last Updated: | June 10, 2009 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by University of Calgary:
|
epistaxis Epistaxis refractory to emergency physician treatment |
Additional relevant MeSH terms:
|
Epistaxis Nose Diseases Respiratory Tract Diseases |
Otorhinolaryngologic Diseases Hemorrhage Pathologic Processes |
ClinicalTrials.gov processed this record on May 22, 2013