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

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Northwestern University

Status

Completed

Conditions

Chronic Rhinosinusitis

Treatments

Procedure: Post-treatment Sinus CT Scan
Procedure: Pre-treatment Sinus CT Scan

Study type

Interventional

Funder types

Other

Identifiers

NCT00871286
STU 8997

Details and patient eligibility

About

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.

Enrollment

40 patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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