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

Not Applicable

Completed

• Conditions: Chronic Rhinosinusitis
• Interventions: Procedure: Pre-treatment Sinus CT Scan; Procedure: Post-treatment Sinus CT Scan

• Registration Number: NCT00871286
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-26
• Study First Submitted QC: 2009-03-27
• Study First Posted: 2009-03-30
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Results First Submitted: 2011-08-29
• Status Verified: 2012-01
• Results First Submitted QC: 2012-01-17
• Last Update Submitted: 2012-01-17
• Results First Posted: 2012-01-18
• Last Update Posted: 2012-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT scan (sinus) pre-tx	Pre-treatment Sinus CT Scan	Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit
CT scan (sinus) post-tx	Post-treatment Sinus CT Scan	Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines

Primary Outcome Measures

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

Trial Locations

Locations (1)

Northwestern University/Northwestern Medical Faculty Foundation; 🇺🇸 Chicago, Illinois, United States