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

Chronic Rhinosinusitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00871286
• Other study ID #: STU 8997
• Secondary ID: STU 8997
• Status: Completed
• Phase: N/A
• First received: March 26, 2009
• Last updated: January 17, 2012
• Start date: March 2009
• Est. completion date: August 2010

Study information

• Verified date: January 2012
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Chronic Rhinosinusitis
• Sinusitis

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern University/Northwestern Medical Faculty Foundation	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. Review. — View 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. — View Citation

Stankiewicz JA, Chow JM. Cost analysis in the diagnosis of chronic rhinosinusitis. Am J Rhinol. 2003 May-Jun;17(3):139-42. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No

External Links

•   Reference