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State-of-the-art documents like ARIA and european position paper on rhinosinusitis (EPOS) provide clinicians with evidence-based treatment algorithms for allergic rhinitis (AR) and chronic rhinosinusitis (CRS) respectively (1)(2) . The currently available medications can alleviate symptoms associated with AR and RS, and most patients with RS benefit from endoscopic sinus surgery (ESS). In real life, a significant percentage of patients with AR and CRS continue to experience bothersome symptoms despite adequate treatment. This group with so-called severe chronic upper airway disease (SCUAD) represents a therapeutic challenge (3).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| rhinosinusitis patients | patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010. |
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| Measure | Description | Time Frame |
|---|---|---|
| Control Status of Patients With Rhinosinusitis | 1. Percentage of patients with rhinosinusitis that are fully controlled, partly controlled and uncontrolled according to the new european position paper on rhinosinusitis (EPOS) definitions at a mean interval of 3 years after endoscopic sinus surgery. | 3 years after FESS |
| Measure | Description | Time Frame |
|---|---|---|
| Control Nasal Endoscopy | Evaluating of difference in control if nasal endoscopy is performed three years after ESS. | 3 years after ESS |
| Measure | Description | Time Frame |
|---|---|---|
| Visual Analogue Scale (VAS), Sinonasal Outcome Test (SNOT22) and Short Form (36) Health Survey (SF36) Score Three Years After ESS in Controlled, Partially Controlled and Uncontrolled Group | VAS scores: a measurement of patient's subjective evaluation by indicating a position on a line between two endpoints. Patients will score eight individual symptoms on a scale from 0 until 10, being 0 no trouble and 10 maximum trouble. Finally a mean symptom score will be calculated per symptom. The SNOT-22 questionnaire is a validated 22 item questionnaire. patients indicate how much they are affected in eight different areas and identify the 5 most important items. The SNOT-22 total score can range from 0 to 110, with higher scores representing worse quality of life. Perceived health status can be evaluated by the 36-item short-form (SF-36). It consists of 36 items covering eight domains. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability |
Inclusion Criteria:
Exclusion Criteria:
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rhinosinusitis patients
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| Name | Affiliation | Role |
|---|---|---|
| Peter Hellings, MD | UZ Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Leuven ORL | Leuven | Vlaams Brabant | 3000 | Belgium | ||
| UZ Leuven |
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| ID | Title | Description |
|---|---|---|
| FG000 | Rhinosinusitis Patients | patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Rhinosinusitis Patients | patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010. |
| 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 | Control Status of Patients With Rhinosinusitis | 1. Percentage of patients with rhinosinusitis that are fully controlled, partly controlled and uncontrolled according to the new european position paper on rhinosinusitis (EPOS) definitions at a mean interval of 3 years after endoscopic sinus surgery. | Posted | Number | percentage of participants | 3 years after FESS |
|
|
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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 | Rhinosinusitis Patients | patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010. |
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patients had to fill in the questionnaire at home, with no help of an expert
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. P. Hellings | UZ Leuven | +3216332340 | peter.hellings@uzleuven.be |
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| three years after ESS |
| Leuven |
| Vlaams-Brabant |
| 3000 |
| Belgium |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| Secondary | Control Nasal Endoscopy | Evaluating of difference in control if nasal endoscopy is performed three years after ESS. | fully controlled status with endoscopic evaluation | Posted | Number | percentage of participants | 3 years after ESS |
|
|
|
| Other Pre-specified | Visual Analogue Scale (VAS), Sinonasal Outcome Test (SNOT22) and Short Form (36) Health Survey (SF36) Score Three Years After ESS in Controlled, Partially Controlled and Uncontrolled Group | VAS scores: a measurement of patient's subjective evaluation by indicating a position on a line between two endpoints. Patients will score eight individual symptoms on a scale from 0 until 10, being 0 no trouble and 10 maximum trouble. Finally a mean symptom score will be calculated per symptom. The SNOT-22 questionnaire is a validated 22 item questionnaire. patients indicate how much they are affected in eight different areas and identify the 5 most important items. The SNOT-22 total score can range from 0 to 110, with higher scores representing worse quality of life. Perceived health status can be evaluated by the 36-item short-form (SF-36). It consists of 36 items covering eight domains. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability | Posted | Mean | Standard Deviation | units on a scale | three years after ESS |
|
|
|
| 0 |
| 389 |
| 0 |
| 389 |
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| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| VAS score partially controlled group |
|
| SNOT22 score partially controlled group |
|
| SF36 score partially controlled group |
|
| VAS score uncontrolled group |
|
| SNOT22 score uncontrolled group |
|
| SF36 score uncontrolled group |
|