Effects of Adenoidectomy on Symptoms and IgE Levels in Children With AR

Официальное название

Effects of Adenoidectomy With or Without Tonsillectomy on Symptoms and Local IgE Levels in Children With Allergic Rhinitis

Обзор

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.

Вмешательства

• Препарат Drug therapy (NASONEX nasal spray)
  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.
• Процедура Adenoidectomy
  Low-temperature plasma adenoid ablation is a minimally invasive procedure performed under general anesthesia. After induction, the nose and face are disinfected and draped in the usual manner; a Davis mouth-gag is inserted and the soft palate is retracted with two fine suction catheters. The surgeon holds a disposable low-temperature plasma wand in the right hand and a 70° nasopharyngoscope in the left, then systematically ablates the hypertrophic adenoid tissue from inferior to superior and fro
• Процедура Adenotonsillectomy
  Low-temperature plasma adenoidectomy begins with general anesthesia for the patient. The surgeon holds a disposable low-temperature plasma electrode in the right hand and a 70° nasal endoscope in the left hand (inserted through the mouth), and gradually ablates the hypertrophic adenoidal tissue from bottom to top and from the center to the periphery. The entire procedure takes approximately 10 minutes. After ablation is completed, electrocoagulation is used for local hemostasis. Medical therapy

Первичные конечные точки

• Symptom scores [Срок оценки: 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.]
• Allergen-Specific IgE Levels in Nasal Cavity [Срок оценки: 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.]

Вторичные конечные точки (5)

• Serum IgE Levels [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Within 6 months after surgery.]

Критерии участия

Критерии включения

\- 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology — Ухань

Идентификаторы

NCT: NCT07527260 · TJ-IRB202508035

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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