Canadian Health Economics, Outcome, and Effectiveness Comparison of Treatment in Patients With Chronic Rhinosinusitis

Study Overview
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Brief Summary
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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.

Official Title
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Canadian Health Economics, Health Outcome, and Effectiveness Comparison of Treatment of the Frontal Sinus Ostium and Recess and Other Sinuses With Functional Endoscopic Sinus Surgery (FESS) or Balloon Sinuplasty in Patients With Chronic Sinusitis (CRS)

Conditions
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Chronic Rhinosinusitis

Intervention / Treatment
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* Device: Relieva Balloon Sinuplasty™ System
* Procedure: Functional Endoscopic Sinus Surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented diagnosis of unilateral or bilateral Chronic Rhinosinusitis based on the European Position Paper on Rhinosinusitis and Nasal Polyps (2) with at least frontal and maxillary sinus involvement Documented failed medical treatment of CRS Eighteen (18) to sixty-five (65) years of age Employed in full time position or equivalent Planned FESS for treatment of CRS Must have an American Society of Anesthesiologists physical status of P3 classification or less Able to provide informed consent by signing the informed consent document at the screening visit prior to any study activities Able to read and understand English Exclusion Criteria: Previous sinonasal surgery Pregnant Cystic Fibrosis Diagnosed immotile cilia syndrome Samter's Triad Diagnosed immunodeficiency syndrome Diagnosed fungal sinusitis Concurrent septoplasty or turbinate surgery Diagnosed recurrent acute sinusitis Current smoker Presence of grade 2 or greater nasal polyps Sinonasal tumors or obstructive lesions History of substance or alcohol abuse within the past 12 months Investigator's opinion that the subject should not be in the study such as any conditions that could compromise the wellbeing of the patient or integrity of the study or prevent the patient from meeting or performing study requirements Participation in a research study 30 days prior to surgery

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Balloon Sinuplasty™ System<br> | Device: Relieva Balloon Sinuplasty™ System<br>* Catheter-based devices used to dilate blocked paranasal sinus ostia (openings).<br>|
| Active Comparator: Functional Endoscopic Sinus Surgery<br> | Procedure: Functional Endoscopic Sinus Surgery<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The direct and indirect costs of treatment of frontal and other sinus disease with Functional Endoscopic Sinus Surgery or balloon sinuplasty. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sinusitis, chronic, Functional endoscopic sinus surgery, balloon sinuplasty