Impact of Sinus Surgery on Individuals With Cystic Fibrosis

Study Overview
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Brief Summary
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This study will be a prospective, observational study of patients who undergo endoscopic sinus surgery for cystic fibrosis-related chronic rhinosinusitis (CRS). Individuals who do not undergo surgery but are treated medically for CRS will also be enrolled to serve as a control group. Outcomes analyzed will include pulmonary, quality of life, and others.

Official Title
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The Impact of Sinus Surgery in the Era of Highly Effective Modulatory Therapy

Conditions
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Chronic Rhinosinusitis (Diagnosis), Cystic Fibrosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects between the ages of 18 years old (inclusive) and 99 years old (inclusive, subjects over the age of 89 will be recorded to be 89 years old). Diagnosed with cystic fibrosis as established by genetic testing combined with clinical assessment and/or sweat chloride Diagnosed with chronic rhinosinusitis by multidisciplinary sinusitis guidelines chronic rhinosinusitis symptoms persisting beyond initial medical treatment Counseled for endoscopic sinus surgery and ongoing medical therapy with each patient electing their preferred treatment Exclusion Criteria: Underwent endoscopic sinus surgery in past 12 months Will obtain follow up care at non-participating institutions Unable to complete follow-up surveys

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical group<br>Individuals with cystic fibrosis and chronic rhinosinusitis who undergo endoscopic sinus surgery | |
| Medical group<br>Individuals with cystic fibrosis and chronic rhinosinusitis who do not undergo endoscopic sinus surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pulmonary function | Pulmonary function will be measured using spirometry - the percent of predicted forced expiratory volume in the first second (ppFEV1) | baseline, 3, 6, 9, 12 months | 
| Change in days of inpatient hospitalization | Days of inpatient hospitalization will be assessed | baseline, 3, 6, 9, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life | Quality of life will be assessed using the 22-question SinoNasal Outcome test (range 0-110, with higher scores signifying worse quality of life) | baseline, 3, 6, 9, 12 months | 
| Change in quality of life | Quality of life will be assessed using the Cystic Fibrosis Questionnaire-Revised instrument (range 0-100, with higher scores signifying worse quality of life) | baseline, 3, 6, 9, 12 months | 
| Change in olfaction | Olfaction will be assessed using the Smell Identification Test (score range: 0-40, with higher scores demonstrated better olfactory ability) | baseline, 3, 6, 9, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic Rhinosinusitis, Cystic Fibrosis, Endoscopic Sinus Surgery