Trial Outcomes & Findings for Long-term Control in Rhinosinusitis After Functional Endoscopic Sinus Surgery (FESS) (NCT NCT01777425)

Last Updated: 2014-03-05

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

389 participants

Primary outcome timeframe

3 years after FESS

Results posted on

2014-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	Rhinosinusitis Patients patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
Overall Study STARTED	389
Overall Study COMPLETED	389
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Long-term Control in Rhinosinusitis After Functional Endoscopic Sinus Surgery (FESS)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rhinosinusitis Patients n=389 Participants patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	389 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	47.3 years STANDARD_DEVIATION 14.1 • n=5 Participants
Sex: Female, Male Female	183 Participants n=5 Participants
Sex: Female, Male Male	206 Participants n=5 Participants
Region of Enrollment Belgium	389 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years after FESS

Outcome measures

Outcome measures
Measure	Rhinosinusitis Patients and Status n=389 Participants patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
Control Status of Patients With Rhinosinusitis partially controlled three years after ESS	36.8 percentage of participants
Control Status of Patients With Rhinosinusitis fully controlled three years after ESS	19.5 percentage of participants
Control Status of Patients With Rhinosinusitis uncontrolled three years after ESS	43.7 percentage of participants

SECONDARY outcome

Timeframe: 3 years after ESS

Population: fully controlled status with endoscopic evaluation

Evaluating of difference in control if nasal endoscopy is performed three years after ESS.

Outcome measures

Outcome measures
Measure	Rhinosinusitis Patients and Status n=81 Participants patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
Control Nasal Endoscopy fully controlled status with endoscopic evaluation	8.6 percentage of participants
Control Nasal Endoscopy partially controlled status with endoscopy	24.7 percentage of participants
Control Nasal Endoscopy uncontrolled status wih endoscopic evaluation	66.7 percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Rhinosinusitis Patients and Status n=389 Participants patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.
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
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
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
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
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
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
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 19.0
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
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

Adverse Events

Rhinosinusitis Patients

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Prof. Dr. P. Hellings

UZ Leuven

Phone: +3216332340

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place