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Long-term Control in Rhinosinusitis After ESS

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: May 21, 2013
Last verified: May 2013
History of Changes
  Purpose

State-of-the-art documents like ARIA and EP3OS 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 ESS: Cross-sectional Observational Study on Control in Rhinosinusitis at a Mean Interval of 3 Years After ESS

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Control status of patients with rhinosinusitis + symptoms analysis [ 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 EPOS definitions at a mean interval of 3 years after endoscopic sinus surgery.
    2. Correlation between the new definition of control and the SNOT-22 questionnaire and VAS scores for total and individual sino-nasal symptoms


Secondary Outcome Measures:
  • factor analysis and clinical examination [ Time Frame: 3 years after FESS ] [ Designated as safety issue: No ]
    Subgroup analysis with delineation of different factors associated with the degree of control in rhinosinusitis: age, gender, allergy, smoking, occupation, anatomic factors, asthma, COPD, aspirin intolerance, current medication use, CF, PCD, known immune deficiency.

  • degree of control of symptoms [ Time Frame: 3 years after ESS ] [ Designated as safety issue: No ]
    Doctors' evaluation of the reason for degree of control of symptoms: disease-related (SCUAD), diagnosis-related, treatment-related, or patient related reasons for lack of control.

  • 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.


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.
control patients
control group of 200 patients attending the general ENT Outpatient clinic

  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
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
Last Updated: May 21, 2013
Health Authority: Belgium: Ethics Committee

ClinicalTrials.gov processed this record on June 18, 2013