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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01777425
First received: January 23, 2013
Last updated: January 17, 2014
Last verified: December 2014
  Purpose

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
Condition of Patient 3 Years After FESS-operation

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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



Enrollment: 389
Study Start Date: December 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
rhinosinusitis patients
patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.

  Eligibility

Ages Eligible for Study:   19 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

rhinosinusitis patients

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01777425

Locations
Belgium
UZ Leuven ORL
Leuven, Vlaams Brabant, Belgium, 3000
UZ Leuven
Leuven, Vlaams-Brabant, Belgium, 3000
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Peter Hellings, MD UZ Leuven
  More Information

No publications provided

Responsible Party: Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01777425     History of Changes
Other Study ID Numbers: 082012
Study First Received: January 23, 2013
Results First Received: August 14, 2013
Last Updated: January 17, 2014
Health Authority: Belgium: Ethics Committee

ClinicalTrials.gov processed this record on November 20, 2014