Not yet recruiting NCT07527260
Effects of Adenoidectomy on Symptoms and IgE Levels in Children With AR
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Drug therapy (NASONEX nasal spray), Adenoidectomy, Adenotonsillectomy.
- Who it may be relevant to
- Registry conditions: Adenoidectomy, Tonsillectomy, Allergic Rhinitis. Basic parameters: 3 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Adenoidectomy With or Without Tonsillectomy on Symptoms and Local IgE Levels in Children With Allergic Rhinitis
Overview
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.
Interventions
- Drug 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. - Procedure 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 - Procedure 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
Primary outcome measures
- Symptom scores [Time frame: 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 [Time frame: 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.]
Secondary outcome measures (5)
- Serum IgE Levels [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Within 6 months after surgery.]
Eligibility criteria
Inclusion criteria
\- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology — Wuhan
Identifiers
NCT: NCT07527260 · TJ-IRB202508035