Long-term Control in Rhinosinusitis After Functional Endoscopic Sinus Surgery (FESS)
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).
Condition of Patient 3 Years After FESS-operation
|Study Design:||Observational Model: Case Control
Time Perspective: Cross-Sectional
|Official Title:||Long-term Control in Rhinosinusitis After FESS: Cross-sectional Observational Study on Control in Rhinosinusitis at a Mean Interval of 3 Years After FESS|
- Control Status of Patients With Rhinosinusitis [ Time Frame: 3 years after FESS ] [ Designated as safety issue: No ]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.
- Control Nasal Endoscopy [ Time Frame: 3 years after ESS ] [ Designated as safety issue: No ]Evaluating of difference in control if nasal endoscopy is performed three years after ESS.
- 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 [ Time Frame: three years after ESS ] [ Designated as safety issue: No ]
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
|Study Start Date:||December 2012|
|Study Completion Date:||May 2013|
|Primary Completion Date:||May 2013 (Final data collection date for primary outcome measure)|
patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01777425
|UZ Leuven ORL|
|Leuven, Vlaams Brabant, Belgium, 3000|
|Leuven, Vlaams-Brabant, Belgium, 3000|
|Principal Investigator:||Peter Hellings, MD||UZ Leuven|