Clinical trial NCT02862509: Effectiveness of Budesonide Nasal Instillation in a Vertex-to-floor Position
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chronic Frontal Rhinosinusitis
Vertex to Floor Position
Keywords: Post-frontal sinus operation chronic rhinosinusitis patients
Budesonide nasal instillation
Vertex to floor position
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 60
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Total Sinonasal outcome test (SNOT) 20 score (validated Thai version)
timeFrame: three months
Secondary outcomes:
measure: Video-recorded nasal endoscope scoring: Modified Lund-Mackay Endoscopy Score(MLMES)
timeFrame: three months
measure: Rhinological Sinonasal outcome test (SNOT) 20 score (validated Thai version)
timeFrame: three months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: King Chulalongkorn Memorial Hospital
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital
Study officials:
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