Chronic Frontal Rhinosinusitis Clinical Trial
Official title:
Effectiveness of Budesonide Nasal Instillation in a Vertex-to-floor Position in Chronic Rhinosinusitis Patients Underwent Endoscopic Frontal Sinus Surgery: a Randomized, Controlled Trial.
Verified date | August 2016 |
Source | Khon Kaen University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Thailand: Thai Clinical Trial Registry |
Study type | Interventional |
o Chronic rhinosinusitis is one of the most common health issue affected American population. Surgery plays an important role in the patients who failed the medical treatment. The most difficult location to be operated endoscopically is the frontal sinus. Frontal sinus is also found to be one of the most common sinus for residual and recurrence after the operation. Intranasal steroid seems to be one of the most beneficent post-sinus surgery cares. The topical therapy can be delivered by many approaches. According to the standard clinical practice guideline and recommendations, intranasal corticosteroid spray is suggested. The technique proved to have greater distribution than standard intranasal spray is instillation of steroid nose drops. The head position for instillation of steroid nose drops proven to have a greater access to olfactory cleft and frontal area is Vertex-to-floor position.
Status | Active, not recruiting |
Enrollment | 60 |
Est. completion date | August 2017 |
Est. primary completion date | August 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years and older |
Eligibility |
Inclusion Criteria: - Chronic rhinosinusitis with frontal sinusitis patient - Age =12 - Post-frontal sinus surgery with frontal sinus opening>3mm - Satisfactory surgical technique: adequate sinus osteal drainage and mucosal sparing technique Exclusion Criteria: - Isolated frontal sinus surgery - History of previous head and neck radiation - Previous nasal or sinus operation - Clinically significant deviated nasal septum - History of paranasal sinus tumor - Known immunocompromised Host - History of budesonide allergy - Cannot provide full flexion of the neck (cannot perform vertex-to-floor position) - Post-randomization exclusion: Pathologic invasive fungal infection |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Thailand | King Chulalongkorn Memorial Hospital | Bangkok | |
Thailand | Srinagarind Hospital | Khon Kaen |
Lead Sponsor | Collaborator |
---|---|
Khon Kaen University |
Thailand,
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Sinonasal outcome test (SNOT) 20 score (validated Thai version) | three months | Yes | |
Secondary | Video-recorded nasal endoscope scoring: Modified Lund-Mackay Endoscopy Score(MLMES) | three months | Yes | |
Secondary | Rhinological Sinonasal outcome test (SNOT) 20 score (validated Thai version) | three months | Yes |