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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00871286
Recruitment Status : Completed
First Posted : March 30, 2009
Results First Posted : January 18, 2012
Last Update Posted : January 18, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Role of Point-of-Care CT Scanning in Patients Presenting With Symptoms of Chronic Rhinosinusitis
Study Start Date : March 2009
Primary Completion Date : August 2010
Study Completion Date : August 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Number of Participants in Compliance With Medical Recommendations [ Time Frame: 8 weeks ]
    Number of participants in each group who complied with medical advice given at the initial appointment.

  2. Number of Participants Having a CT Done [ Time Frame: 8 weeks ]
    Total number of participants having a CT scan (sinus) done in each of the two groups over the study interval.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications:
Responsible Party: Rakesh Chandra, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT00871286     History of Changes
Other Study ID Numbers: STU 8997
First Posted: March 30, 2009    Key Record Dates
Results First Posted: January 18, 2012
Last Update Posted: January 18, 2012
Last Verified: January 2012

Keywords provided by Rakesh Chandra, 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