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

NCT ID: NCT01777425

Last Updated: 2014-03-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 389 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2013-05-31

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).

Conditions

Condition of Patient 3 Years After FESS-operation

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

rhinosinusitis patients

patients having undergone endoscopic sinus surgery (ESS) for bilateral inflammatory sinonasal disease from January 2008 until December 2010.

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 19 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Hellings, MD

Role: PRINCIPAL_INVESTIGATOR

UZ Leuven

Locations

UZ Leuven ORL

Leuven, Vlaams Brabant, Belgium

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Countries

Belgium

Other Identifiers

082012

Identifier Type: -

Identifier Source: org_study_id