Point-of-Care Computed Tomography (CT) Chronic Rhinosinusitis Study

Study Overview
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Brief Summary
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The purpose of this research study is to determine whether or not computed tomography (CT) scans performed on patients with symptoms of chronic rhinosinusitis (CRS) but without any physical signs of the disease will (1) prove to be less expensive in the treatment and evaluation as compared to current practices, (2) avoid the use of unnecessary antibiotic prescriptions, and (3) provide a more efficient way to diagnose conditions in patients who have had CRS ruled out as a cause. The investigators hypothesize that current guidelines, when applied to subjects with symptoms of CRS in the absence of physical signs may be associated with (1) increased unnecessary prescription of antibiotics, (2) delay in further essential workup, and (3) increased overall health care costs.

Official Title
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Role of Point-of-Care CT Scanning in Patients Presenting With Symptoms of Chronic Rhinosinusitis

Conditions
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Chronic Rhinosinusitis

Intervention / Treatment
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* Procedure: Pre-treatment Sinus CT Scan
* Procedure: Post-treatment Sinus CT Scan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects actively meeting the symptomatic criteria for CRS as defined by the Taskforce on Rhinosinusitis but with physical and endoscopic examination that is within normal limits Exclusion Criteria: Subjects who are pregnant Subjects with a diagnosis of immune suppression or suspicion of malignancy that may be affecting the nose/paranasal sinuses Subjects who have had prior sinus surgery or who have been previously treated with a >3 week course of broad spectrum antibiotics for CRS

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT scan (sinus) pre-tx<br>Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit | Procedure: Pre-treatment Sinus CT Scan<br>* Pre-treatment Sinus CT Scan<br>|
| Other: CT scan (sinus) post-tx<br>Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines | Procedure: Post-treatment Sinus CT Scan<br>* Post-treatment Sinus CT Scan<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants in Compliance With Medical Recommendations | Number of participants in each group who complied with medical advice given at the initial appointment. | 8 weeks | 
| Number of Participants Having a CT Done | Total number of participants having a CT scan (sinus) done in each of the two groups over the study interval. | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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CRS, Chronic rhinosinusitis, Chronic sinusitis