Clinical trial NCT00871286: Point-of-Care Computed Tomography (CT) Chronic Rhinosinusitis Study
Official title: Role of Point-of-Care CT Scanning in Patients Presenting With Symptoms of Chronic Rhinosinusitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Rhinosinusitis
Keywords: Chronic rhinosinusitis
Chronic sinusitis
CRS
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2009-03-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants in Compliance With Medical Recommendations
timeFrame: 8 weeks
measure: Number of Participants Having a CT Done
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University/Northwestern Medical Faculty Foundation
state: Illinois
Study officials:
affiliation: Northwestern University, Northwestern Medical Faculty Foundation, Northwestern Memorial Hospital
name: Rakesh K Chandra, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stankiewicz JA, Chow JM. A diagnostic dilemma for chronic rhinosinusitis: definition accuracy and validity. Am J Rhinol. 2002 Jul-Aug;16(4):199-202.
citation: Stankiewicz JA, Chow JM. Cost analysis in the diagnosis of chronic rhinosinusitis. Am J Rhinol. 2003 May-Jun;17(3):139-42.
citation: Meltzer EO, Hamilos DL, Hadley JA, Lanza DC, Marple BF, Nicklas RA, Bachert C, Baraniuk J, Baroody FM, Benninger MS, Brook I, Chowdhury BA, Druce HM, Durham S, Ferguson B, Gwaltney JM Jr, Kaliner M, Kennedy DW, Lund V, Naclerio R, Pawankar R, Piccirillo JF, Rohane P, Simon R, Slavin RG, Togias A, Wald ER, Zinreich SJ; American Academy of Allergy, Asthma and Immunology; American Academy of Otolaryngic Allergy; American Academy of Otolaryngology-Head and Neck Surgery; American College of Allergy, Asthma and Immunology; American Rhinologic Society. Rhinosinusitis: Establishing definitions for clinical research and patient care. Otolaryngol Head Neck Surg. 2004 Dec;131(6 Suppl):S1-62. doi: 10.1016/j.otohns.2004.09.067.