The economic, patient related outcome, and effectiveness of balloon sinuplasty in the treatment of CRS patients with frontal and other sinus disease in the Canadian healthcare environment is not known at this time. This study will evaluate the impact of balloon sinuplasty and traditional FESS treatment on CRS patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
25
Catheter-based devices used to dilate blocked paranasal sinus ostia (openings).
Specialized probes are used to cannulate closed ostia (openings), and small forceps are used to resect periostial bone and tissue to enlarge the sinus ostia.
Hamilton General Hospital
Hamilton, Ontario, Canada
St. Joseph's Health Centre
London, Ontario, Canada
Ottawa Hospital - Civic Campus
Ottawa, Ontario, Canada
Trillium Health Centre
Toronto, Ontario, Canada
The direct and indirect costs of treatment of frontal and other sinus disease with Functional Endoscopic Sinus Surgery or balloon sinuplasty.
Time frame: 6 months
Health outcome of patients in the two treatment groups.
Health outcomes will be determined by the completion of the EQ-5D questionnaire in both treatment groups at various timepoint. The EQ-5D is a standardised measure of health status developed by the EuroQol Group in order to provide a simple, generic measure of health for clinical and economic appraisal. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys.
Time frame: 6 months
Effectiveness of the two treatment groups in relieving symptomology of CRS.
Effectiveness of the two treatment groups in relieving symptomology of CRS will be determined by the completion of the Sino-nasal Outcome Test - 20 (SNOT-20) questionnaire in both treatment groups at various timepoint. The SNOT-20 questionnaire is a validated instrument for the measurement of disease specific health status and quality of life in patients with chronic rhinosinusitis.
Time frame: 6 months
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Toronto East General
Toronto, Ontario, Canada
St. Michael's Hospital
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
St. Joseph's Health Centre
Toronto, Ontario, Canada