QOL Outcomes in CRS With Polyps

Study Overview
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Brief Summary
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Chronic rhinosinusits (CRS) is common disease with reports of prevalence ranging from 4-16% in the western population. The main outcome measure for chronic disease treatment, such as CRS, is quality of life. Several large multi-institutional studies have shown that improvement in disease specific Quality of life was greater in patients who had surgery for their CRS with polyps. The timing of surgery in these patients has not been well studied but it is generally agreed upon that surgical candidates much had failed medical management. The definition of medical management varies greatly but usually includes some form of nasal or oral steroids and a prolonged ( >10 days) course of antibiotics. Another known way to improve QOL is through education and individualized optimization. This has been utilized successfully in other fields with good success and improved QOL. Similar studies looking at combining non-surgical optimization and education have not been performed in CRS. This study aims to address this potential area for improvement in patient quality of life outcomes. Investigators plan to assess the potential role for pre-operative non-surgical medical and educational optimization in CRS standard of care treatment.

Official Title
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Comparison of Outcomes After Peri-operative Optimization and Standard Surgical Treatment or Standard of Care Surgical Treatment in Patients Who Have Chronic Rhinosinusitis With Polyposis.

Conditions
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Chronic Rhinosinusitis, Polyps

Intervention / Treatment
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* Other: Medical optimization and education
* Procedure: Standard of Care sinus surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults with Rhinosinusitis with polyps who have had appropriate treatment qualifying them for surgery and are good surgical candidates Exclusion Criteria: Cystic fibrosis, Cilia disorders, other specialized forms of sinus disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Medical Optimization<br>Medical treatment and education x 4 months, re- eval at 4 months and possible cross-over to surgery | Other: Medical optimization and education<br>* Medical treatment and education about the sinusitis disease process prior to surgery as compared to baseline surgical and treatment counseling<br>Procedure: Standard of Care sinus surgery<br> <br> |
| Active Comparator: Surgical treatment<br>Surgical treatment up front | Procedure: Standard of Care sinus surgery<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SNOT-22 |  | 4 months |