Effects of Adenoidectomy With or Without Tonsillectomy on Symptoms and Local IgE Levels in Children With Allergic Rhinitis
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Symptom scores
研究概览
简要总结
This study aims to evaluate the effects of conservative management versus surgical intervention (adenoidectomy alone or adenotonsillectomy) on symptoms and local IgE levels in children with allergic rhinitis (AR) accompanied with adenotonsillar hypertrophy. The primary objectives include the impact of conservative management and surgical interventions on AR symptoms and local IgE levels. The second outcomes include serum IgE levels, inflammatory cell profiles within the nasal mucosa, and postoperative complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- 3-12 years
- •Children with physician-diagnosed allergic rhinitis and typical symptoms (nasal obstruction, watery rhinorrhea, paroxysmal sneezing);
- •Co-existing adenoidal and tonsillar hypertrophy meeting surgical indications;
- •No systemic or topical corticosteroids, leukotriene antagonists, or antihistamines within the past 3 months.
排除标准
- •Prior adenoidectomy, tonsillectomy, or radio-frequency ablation;
- •Nasal polyps, cystic fibrosis, primary ciliary dyskinesia, fungal rhinosinusitis, systemic vasculitis/granulomatosis, tumor, or immunodeficiency;
- •Endoscopic nasal surgery within 6 months or severe asthma precluding surgery;
- •Upper respiratory infection within 4 weeks;
- •Serious metabolic, cardiovascular, immune, neurologic, hematologic, gastrointestinal, cerebrovascular, or respiratory disease, or any condition judged by the investigator to interfere with outcome assessment or participant safety;
- •Currently enrolled or within 30 days of participation in another clinical trial.
研究组 & 干预措施
Drug therapy
Medical therapy with daily administration of NASONEX nasal spray (50 µg per nostril, once every morning). Treatment was maintained for four weeks, with scheduled follow-up visits to evaluate efficacy and monitor adverse reactions.
干预措施: Drug therapy (NASONEX nasal spray) (Drug)
Adenoidectomy and drug therapy
干预措施: Drug therapy (NASONEX nasal spray) (Drug)
Adenoidectomy and drug therapy
干预措施: Adenoidectomy (Procedure)
Adenotonsillectomy and drug therapy
干预措施: Adenotonsillectomy (Procedure)
Adenotonsillectomy and drug therapy
干预措施: Drug therapy (NASONEX nasal spray) (Drug)
结局指标
主要结局
Symptom scores
时间窗: Surgery Group: at baseline (Pre-surgery) and at 1, 3, and 6 months post-surgery; Medication Group: at baseline (Pre-treatment ) and at 1, 3, and 6 months post-treatment initiation.
Record self-assessed AR symptom scores including nasal congestion, runny nose, nasal itching, sneezing, itching and burning eyes, tearing and watering eyes, and eye redness. Each symptom was scored from 0 to 3 (0, no symptom; 1, mild symptom; 2, moderate symptom; and 3, severe symptom)
Allergen-Specific IgE Levels in Nasal Cavity
时间窗: Surgery Group: at baseline (Pre-surgery) and at 1, 3, and 6 months post-surgery; Medication Group: at baseline (Pre-treatment ) and at 1, 3, and 6 months post-treatment initiation.
Measures the change in allergen-specific IgE (sIgE) levels in nasal cavity to evaluate the regulation of local allergic responses. * For the Surgery Group: Samples (nasal mucosa samples via endoscopic biopsy, nasopharyngeal swab samples) are collected before surgery (baseline) and at 1, 3, 6 months after surgery. * For the Medication Group: Samples are collected before medication initiation (baseline) and at 1, 3, 6 months after medication initiation. sIgE levels are detected using immunoassay techniques (e.g., ELISA). Results are reported as standardized concentration units (e.g., kU/L).
次要结局
- Serum IgE Levels(Surgery Group: at baseline (Pre-surgery) and at 1, 3, and 6 months post-surgery; Medication Group: at baseline (Pre-treatment ) and at 1, 3, and 6 months post-treatment initiation.)
- Numbers and Proportions of Inflammatory cells in Nasal Cavity(Surgery Group: at baseline (Pre-surgery) and at 1, 3, and 6 months post-surgery; Medication Group: at baseline (Pre-treatment ) and at 1, 3, and 6 months post-treatment initiation.)
- Nasal Endoscopy Scores(Surgery Group: at baseline (Pre-surgery) and at 1, 3, and 6 months post-surgery; Medication Group: at baseline (Pre-treatment ) and at 1, 3, and 6 months post-treatment initiation.)
- Inflammatory Cytokine Levels in Nasal Secretions(Surgery Group: at baseline (Pre-surgery) and at 1, 3, and 6 months post-surgery; Medication Group: at baseline (Pre-treatment ) and at 1, 3, and 6 months post-treatment initiation.)
- Surgical Complications(Within 6 months after surgery.)
研究者
Yin Yao
Professor of Otolaryngology-Head & Neck Surgery Deputy Dean of Institute of Allergy and Clinical Immunology
Tongji Hospital