Effectiveness of Budesonide Nasal Instillation in a Vertex-to-floor Position in Chronic Rhinosinusitis Patients Underwent Endoscopic Frontal Sinus Surgery: a Randomized, Controlled Trial.
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Total Sinonasal outcome test (SNOT) 20 score (validated Thai version)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic rhinosinusitis with frontal sinusitis patient
- •Post-frontal sinus surgery with frontal sinus opening>3mm
- •Satisfactory surgical technique: adequate sinus osteal drainage and mucosal sparing technique
排除标准
- •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
研究组 & 干预措施
Budesonide nasal instillation
budesonide(0.5mg/2ml) 1 respule plus normal saline solution 120ml instilled in vertex to floor position daily
干预措施: Budesonide nasal instillation (Drug)
Normal saline nasal instillation
Normal saline solution instilled in vertex to floor position daily
干预措施: Normal saline nasal instillation (Drug)
结局指标
主要结局
Total Sinonasal outcome test (SNOT) 20 score (validated Thai version)
时间窗: three months
次要结局
- Rhinological Sinonasal outcome test (SNOT) 20 score (validated Thai version)(three months)
- Video-recorded nasal endoscope scoring: Modified Lund-Mackay Endoscopy Score(MLMES)(three months)
研究者
Navarat Vatcharayothin
Principal Investigator
Khon Kaen University