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

NCT ID: NCT00871286

Last Updated: 2012-01-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2010-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Chronic Rhinosinusitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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CT scan (sinus) pre-tx

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

Group Type EXPERIMENTAL

Pre-treatment Sinus CT Scan

Intervention Type 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

Group Type OTHER

Post-treatment Sinus CT Scan

Intervention Type PROCEDURE

Post-treatment Sinus CT Scan

Interventions

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Pre-treatment Sinus CT Scan

Pre-treatment Sinus CT Scan

Intervention Type PROCEDURE

Post-treatment Sinus CT Scan

Post-treatment Sinus CT Scan

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Rakesh Chandra

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rakesh K Chandra, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University, Northwestern Medical Faculty Foundation, Northwestern Memorial Hospital

Locations

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Northwestern University/Northwestern Medical Faculty Foundation

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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

Reference Type BACKGROUND
PMID: 12222944 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 12862401 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15577816 (View on PubMed)

Other Identifiers

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STU 8997

Identifier Type: -

Identifier Source: secondary_id

STU 8997

Identifier Type: -

Identifier Source: org_study_id

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