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

Completed

• Conditions: Condition of Patient 3 Years After FESS-operation

• Registration Number: NCT01777425
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Study First Submitted: 2013-01-23
• Study First Submitted QC: 2013-01-23
• Study First Posted: 2013-01-28
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Results First Submitted: 2013-08-14
• Results First Submitted QC: 2014-01-17
• Last Update Submitted: 2014-01-17
• Results First Posted: 2014-03-05
• Last Update Posted: 2014-03-05
• Status Verified: 2014-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 389

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Control Nasal Endoscopy	3 years after ESS	Evaluating of difference in control if nasal endoscopy is performed three years after ESS.

Trial Locations

Locations (2)

UZ Leuven; 🇧🇪 Leuven, Vlaams-Brabant, Belgium

UZ Leuven ORL; 🇧🇪 Leuven, Vlaams Brabant, Belgium