Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
University of Calgary |
---|---|
Information provided by: | University of Calgary |
ClinicalTrials.gov Identifier: | NCT00666471 |
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 II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Minimally Invasive Control of Epistaxis: Efficacy and Economic Analysis |
Estimated Enrollment: | 36 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | December 2011 |
Estimated Primary Completion Date: | June 2011 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
MICE
|
Procedure: MICE
MICE
|
2: Active Comparator
SPA ligation
|
Procedure: SPA ligation
SPA ligation
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion criteria:
Refractory or Recurrent Epistaxis defined as:
Exclusion Criteria:
Contact: Joseph Dort, MD | 403-220-4307 | jdort@ucalgary.ca |
Contact: Bradford Mechor, MD | 403-944-3628 | bmechor@mac.com |
Canada, Alberta | |
Rockyview General Hospital / University of Calgary | |
Calgary, Alberta, Canada |
Responsible Party: | University of Calgary ( Joseph C. Dort MD ) |
Study ID Numbers: | UCENT0002 |
Study First Received: | April 23, 2008 |
Last Updated: | April 24, 2008 |
ClinicalTrials.gov Identifier: | NCT00666471 |
Health Authority: | Canada: Ethics Review Committee |
epistaxis Epistaxis refractory to emergency physician treatment |
Otorhinolaryngologic Diseases Respiratory Tract Diseases Epistaxis Emergencies Hemorrhage |
Pathologic Processes Nose Diseases |