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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Rakesh Chandra, Northwestern University
ClinicalTrials.gov Identifier:
NCT00871286
First received: March 26, 2009
Last updated: January 17, 2012
Last verified: January 2012

March 26, 2009
January 17, 2012
March 2009
August 2010   (final data collection date for primary outcome measure)
  • 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.
Whether or not point-of-care CT scans will prove cost effective, help avoid unnecessary antibiotic prescriptions, and be an efficient diagnostic workup in subjects with CRS [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00871286 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Point-of-Care Computed Tomography (CT) Chronic Rhinosinusitis Study
Role of Point-of-Care CT Scanning in Patients Presenting With Symptoms of Chronic Rhinosinusitis

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Chronic Rhinosinusitis
  • Procedure: Pre-treatment Sinus CT Scan
    Pre-treatment Sinus CT Scan
  • Procedure: Post-treatment Sinus CT Scan
    Post-treatment Sinus CT Scan
  • Experimental: CT scan (sinus) pre-tx
    Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit
    Intervention: Procedure: 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
    Intervention: Procedure: Post-treatment Sinus CT Scan

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00871286
STU 8997, STU 8997
No
Rakesh Chandra, Northwestern University
Northwestern University
Not Provided
Principal Investigator: Rakesh K Chandra, MD Northwestern University, Northwestern Medical Faculty Foundation, Northwestern Memorial Hospital
Northwestern University
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP