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| ID | Type | Description | Link |
|---|---|---|---|
| STU 8997 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CT scan (sinus) pre-tx | Experimental | Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit |
|
| CT scan (sinus) post-tx | Other | Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pre-treatment Sinus CT Scan | Procedure | Pre-treatment Sinus CT Scan |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants in Compliance With Medical Recommendations | Number of participants in each group who complied with medical advice given at the initial appointment. | 8 weeks |
| 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. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rakesh K Chandra, MD | Northwestern University, Northwestern Medical Faculty Foundation, Northwestern Memorial Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University/Northwestern Medical Faculty Foundation | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12222944 | Background | Stankiewicz JA, Chow JM. A diagnostic dilemma for chronic rhinosinusitis: definition accuracy and validity. Am J Rhinol. 2002 Jul-Aug;16(4):199-202. | |
| 12862401 | Background | Stankiewicz JA, Chow JM. Cost analysis in the diagnosis of chronic rhinosinusitis. Am J Rhinol. 2003 May-Jun;17(3):139-42. |
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| ID | Title | Description |
|---|---|---|
| FG000 | CT Scan (Sinus) Pre-tx | Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event. |
| FG001 | 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. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | CT Scan (Sinus) Pre-tx | Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event. |
| BG001 | CT Scan (Sinus) Post-tx |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants in Compliance With Medical Recommendations | Number of participants in each group who complied with medical advice given at the initial appointment. | Posted | Aug 2011 | Number | participants | 8 weeks |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CT Scan (Sinus) Pre-tx | Sinus CT scan performed at initial otolaryngology (ear, nose, and throat)visit. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Rakesh Chandra | Northwestern | 312-695-8182 | rchandra@nmff.org |
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| Post-treatment Sinus CT Scan |
| Procedure |
Post-treatment Sinus CT Scan |
|
| 15577816 | Background | 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. |
Sinus CT scan performed after 3-4 weeks of antibiotic treatment and any other indicated medical treatment(s), per insurance company guidelines. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Primary | 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. | Per protocol; this was a nonpowered convenience sample | Posted | Number | participants | 8 weeks |
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| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. This study was riskless, and was meant to study the timing of a test (CT) so there were no patients subjected to risk of an adverse event. | 0 | 0 | 0 | 0 |
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