Minimally Invasive Control of Epistaxis (MICE)

Phase 2

Terminated

• Conditions: Epistaxis
• Interventions: Procedure: MICE; Procedure: SPA ligation

• Registration Number: NCT00666471
• Lead Sponsor: University of Calgary

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-04-23
• Study First Submitted QC: 2008-04-24
• Study First Posted: 2008-04-25
• Study Start: 2008-06
• Status Verified: 2009-06
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Last Update Submitted: 2009-06-10
• Last Update Posted: 2009-06-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Not provided

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	MICE	MICE
2	SPA ligation	SPA ligation

Primary Outcome Measures

Name	Time	Method
Change in hospital admission requirement between M.I.C.E. and Operative Sphenopalatine Ligation	30 days

Trial Locations

Locations (1)

Rockyview General Hospital / University of Calgary; 🇨🇦 Calgary, Alberta, Canada