Long-term Control in Rhinosinusitis After Functional Endoscopic Sinus Surgery (FESS)
|ClinicalTrials.gov Identifier: NCT01777425|
Recruitment Status : Completed
First Posted : January 28, 2013
Results First Posted : March 5, 2014
Last Update Posted : March 5, 2014
|Condition or disease|
|Condition of Patient 3 Years After FESS-operation|
|Study Type :||Observational|
|Actual Enrollment :||389 participants|
|Observational Model:||Case Control|
|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|
|Study Start Date :||December 2012|
|Primary Completion Date :||May 2013|
|Study Completion Date :||May 2013|
patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
- Control Status of Patients With Rhinosinusitis [ Time Frame: 3 years after FESS ]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 ]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 ]
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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777425
|UZ Leuven ORL|
|Leuven, Vlaams Brabant, Belgium, 3000|
|Leuven, Vlaams-Brabant, Belgium, 3000|
|Principal Investigator:||Peter Hellings, MD||UZ Leuven|