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

Primary Purpose

Chronic Rhinosinusitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Pre-treatment Sinus CT Scan
Post-treatment Sinus CT Scan
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Rhinosinusitis focused on measuring Chronic rhinosinusitis, Chronic sinusitis, CRS

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Northwestern University/Northwestern Medical Faculty Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

CT scan (sinus) pre-tx

CT scan (sinus) post-tx

Arm Description

Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit

Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines

Outcomes

Primary Outcome Measures

Number of Participants in Compliance With Medical Recommendations
Number of participants in each group who complied with medical advice given at the initial appointment.
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.

Secondary Outcome Measures

Full Information

First Posted
March 26, 2009
Last Updated
January 17, 2012
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT00871286
Brief Title
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

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Rhinosinusitis
Keywords
Chronic rhinosinusitis, Chronic sinusitis, CRS

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CT scan (sinus) pre-tx
Arm Type
Experimental
Arm Description
Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit
Arm Title
CT scan (sinus) post-tx
Arm Type
Other
Arm Description
Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines
Intervention Type
Procedure
Intervention Name(s)
Pre-treatment Sinus CT Scan
Intervention Description
Pre-treatment Sinus CT Scan
Intervention Type
Procedure
Intervention Name(s)
Post-treatment Sinus CT Scan
Intervention Description
Post-treatment Sinus CT Scan
Primary Outcome Measure Information:
Title
Number of Participants in Compliance With Medical Recommendations
Description
Number of participants in each group who complied with medical advice given at the initial appointment.
Time Frame
8 weeks
Title
Number of Participants Having a CT Done
Description
Total number of participants having a CT scan (sinus) done in each of the two groups over the study interval.
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rakesh K Chandra, MD
Organizational Affiliation
Northwestern University, Northwestern Medical Faculty Foundation, Northwestern Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northwestern University/Northwestern Medical Faculty Foundation
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
12222944
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.
Results Reference
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PubMed Identifier
12862401
Citation
Stankiewicz JA, Chow JM. Cost analysis in the diagnosis of chronic rhinosinusitis. Am J Rhinol. 2003 May-Jun;17(3):139-42.
Results Reference
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PubMed Identifier
15577816
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.
Results Reference
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Point-of-Care Computed Tomography (CT) Chronic Rhinosinusitis Study

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