Condition of Patient 3 Years After FESS-operation
Conditions
Brief summary
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).
Interventions
None listed
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
19 Years to 74 Years
Healthy volunteers
No
Inclusion criteria
1. Patients that have undergone bilateral ESS for inflammatory sinonasal disease, without additional sino-nasal surgery after the ESS. 2. Age \> 18 and \< 75 years. 3. Written informed consent 4. Dutch, French or English speaking patients
Exclusion criteria
1. Unilateral ESS 2. Benign and malignant tumor disease 3. Patient with a psychiatric, addictive, or any disorder of which the investigators feel at the time of evaluation for participation in the study that this may compromise the ability to give truly informed consent for participation in this study or provide reliable information on the questionnaire 4. Lack of knowledge of Dutch, French or English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Control Status of Patients With Rhinosinusitis | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Control Nasal Endoscopy | 3 years after ESS | Evaluating of difference in control if nasal endoscopy is performed three years after ESS. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Countries
Belgium
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rhinosinusitis Patients patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010. | 389 |
| Total | 389 |
Baseline characteristics
| Characteristic | Rhinosinusitis Patients |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 389 Participants |
| Age, Continuous | 47.3 years STANDARD_DEVIATION 14.1 |
| Region of Enrollment Belgium | 389 participants |
| Sex: Female, Male Female | 183 Participants |
| Sex: Female, Male Male | 206 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 389 |
| serious Total, serious adverse events | 0 / 389 |
Outcome results
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.
Time frame: 3 years after FESS
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rhinosinusitis Patients and Status | Control Status of Patients With Rhinosinusitis | fully controlled three years after ESS | 19.5 percentage of participants |
| Rhinosinusitis Patients and Status | Control Status of Patients With Rhinosinusitis | partially controlled three years after ESS | 36.8 percentage of participants |
| Rhinosinusitis Patients and Status | Control Status of Patients With Rhinosinusitis | uncontrolled three years after ESS | 43.7 percentage of participants |
Secondary
Control Nasal Endoscopy
Evaluating of difference in control if nasal endoscopy is performed three years after ESS.
Time frame: 3 years after ESS
Population: fully controlled status with endoscopic evaluation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Rhinosinusitis Patients and Status | Control Nasal Endoscopy | fully controlled status with endoscopic evaluation | 8.6 percentage of participants |
| Rhinosinusitis Patients and Status | Control Nasal Endoscopy | partially controlled status with endoscopy | 24.7 percentage of participants |
| Rhinosinusitis Patients and Status | Control Nasal Endoscopy | uncontrolled status wih endoscopic evaluation | 66.7 percentage of participants |
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
Time frame: three years after ESS
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Rhinosinusitis Patients and Status | 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 score controlled group | 9.6 units on a scale | Standard Deviation 7.9 |
| Rhinosinusitis Patients and Status | 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 | SNOT 22 score controlled group | 10.2 units on a scale | Standard Deviation 9.7 |
| Rhinosinusitis Patients and Status | 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 | SF36 score controlled group | 82.1 units on a scale | Standard Deviation 14.3 |
| Rhinosinusitis Patients and Status | 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 score partially controlled group | 22.8 units on a scale | Standard Deviation 12 |
| Rhinosinusitis Patients and Status | 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 | SNOT22 score partially controlled group | 21.6 units on a scale | Standard Deviation 12.4 |
| Rhinosinusitis Patients and Status | 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 | SF36 score partially controlled group | 76.5 units on a scale | Standard Deviation 16.8 |
| Rhinosinusitis Patients and Status | 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 score uncontrolled group | 45.2 units on a scale | Standard Deviation 19 |
| Rhinosinusitis Patients and Status | 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 | SNOT22 score uncontrolled group | 43.4 units on a scale | Standard Deviation 19.9 |
| Rhinosinusitis Patients and Status | 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 | SF36 score uncontrolled group | 61.9 units on a scale | Standard Deviation 19.6 |