Adenoidectomy, Allergic Rhinitis, Tonsillectomy
Conditions
Brief summary
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
DRUGDrug 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.
PROCEDUREAdenoidectomy
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 from center to periphery; the entire ablation takes approximately 10 min. Hemostasis is obtained with targeted cautery, the scope is withdrawn, and the operation is concluded. The technique produces minimal trauma, little bleeding, and rapid recovery. 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.
PROCEDUREAdenotonsillectomy
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 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.
Sponsors
Tongji Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
3 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
\- 3-12 years 1. Children with physician-diagnosed allergic rhinitis and typical symptoms (nasal obstruction, watery rhinorrhea, paroxysmal sneezing); 2. Co-existing adenoidal and tonsillar hypertrophy meeting surgical indications; 3. No systemic or topical corticosteroids, leukotriene antagonists, or antihistamines within the past 3 months.
Exclusion criteria
1. Prior adenoidectomy, tonsillectomy, or radio-frequency ablation; 2. Nasal polyps, cystic fibrosis, primary ciliary dyskinesia, fungal rhinosinusitis, systemic vasculitis/granulomatosis, tumor, or immunodeficiency; 3. Endoscopic nasal surgery within 6 months or severe asthma precluding surgery; 4. Upper respiratory infection within 4 weeks; 5. 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; 6. Currently enrolled or within 30 days of participation in another clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Symptom 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. | 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 | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Assesses systemic allergic status via blood samples. * For the Surgery Group: Venous blood samples are collected before surgery (baseline) and at 1, 3, 6 months after surgery. * For the Medication Group: bloods are collected before medication initiation (baseline) and at 1, 3, 6 months after medication initiation. * Serum IgE levels are detected. Results are reported as "IU/mL" (IgE). |
| 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. | Assesses the changes in the absolute number and relative proportion of inflammatory cells in the nasal cavity. Nasopharyngeal swabs are used to collect samples (sampling method: subjects sit, blow their noses, close their eyes to relax; professional doctors insert swabs to nasal cavity, rotate 5 times, stay for 10-15 seconds, and place swabs into 2mL RPMI medium containing 10% fetal bovine serum). Inflammatory cells are quantified by flow cytometry. |
| 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. | Rates nasal mucosal and structural changes via nasal endoscopy, with scored signs including mucosal edema, secretions, crusting, scarring, and nasal ventilation.The total score is the sum of individual sign scores; changes from baseline indicate nasal mucosal recovery and ventilation improvement. |
| 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. | Measures changes in inflammatory cytokine levels (e.g., IL-5, IL-13) in nasal secretions to evaluate local inflammatory responses. * For the Surgery Group: Nasal secretions are collected via nasal swabs before surgery (baseline) and at 1, 3, 6 months after surgery. * For the Medication Group: Nasal secretions are collected before medication initiation (baseline) and at 1, 3, 6 months after medication initiation. Cytokine levels are quantified by immunoassay (e.g., ELISA), reported as "pg/mL" to reflect the regulation of local nasal inflammation by intervention (surgery/medication). |
| Surgical Complications | Within 6 months after surgery. | Record Surgical Complications |
Countries
China
Contacts
CONTACTYin Yao
Outcome results
None listed