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

Purpose

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.

Condition	Intervention
Chronic Rhinosinusitis	Procedure: Pre-treatment Sinus CT Scan Procedure: Post-treatment Sinus CT Scan

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	Role of Point-of-Care CT Scanning in Patients Presenting With Symptoms of Chronic Rhinosinusitis

Resource links provided by NLM:

MedlinePlus related topics: CT Scans Nuclear Scans Sinusitis

U.S. FDA Resources

Further study details as provided by Northwestern University:

Primary Outcome Measures:

Number of Participants in Compliance With Medical Recommendations [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Number of participants in each group who complied with medical advice given at the initial appointment.
Number of Participants Having a CT Done [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Total number of participants having a CT scan (sinus) done in each of the two groups over the study interval.

Enrollment:	40
Study Start Date:	March 2009
Study Completion Date:	August 2010
Primary Completion Date:	August 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: CT scan (sinus) pre-tx Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit	Procedure: Pre-treatment Sinus CT Scan Pre-treatment Sinus CT Scan
CT scan (sinus) post-tx 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 Post-treatment Sinus CT Scan

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00871286

Locations

United States, Illinois
Northwestern University/Northwestern Medical Faculty Foundation
Chicago, Illinois, United States, 60611

Sponsors and Collaborators

Northwestern University

Investigators

Principal Investigator:

Rakesh K Chandra, MD

Northwestern University, Northwestern Medical Faculty Foundation, Northwestern Memorial Hospital

More Information

Additional Information:

Principal Investigators Site This link exits the ClinicalTrials.gov site

Reference

Publications:

Stankiewicz JA, Chow JM. A diagnostic dilemma for chronic rhinosinusitis: definition accuracy and validity. Am J Rhinol. 2002 Jul-Aug;16(4):199-202.

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

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. No abstract available.

Responsible Party:	Rakesh Chandra, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier:	NCT00871286 History of Changes
Other Study ID Numbers:	STU 8997, STU 8997
Study First Received:	March 26, 2009
Results First Received:	August 29, 2011
Last Updated:	January 17, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Northwestern University:

Chronic rhinosinusitis
Chronic sinusitis
CRS

Additional relevant MeSH terms:

Sinusitis
Paranasal Sinus Diseases
Nose Diseases

Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013