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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Drug therapy | Active Comparator | 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. |
|
| Adenoidectomy and drug therapy | Experimental |
| |
| Adenotonsillectomy and drug therapy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug therapy (NASONEX nasal spray) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom scores | 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) | 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 | Measures the change in allergen-specific IgE (sIgE) levels in nasal cavity to evaluate the regulation of local allergic responses.
sIgE levels are detected using immunoassay techniques (e.g., ELISA). Results are reported as standardized concentration units (e.g., kU/L). | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum IgE Levels | Assesses systemic allergic status via blood samples.
|
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Inclusion Criteria:
- 3-12 years
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yin Yao | Contact | +8615071077020 | Dr.yaoyin@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology | Wuhan | Hubei | 430030 | China |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D000068656 | Mometasone Furoate |
| D000233 | Adenoidectomy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| Adenoidectomy | Procedure | 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. |
|
| Adenotonsillectomy | Procedure | 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. |
|
| 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 | 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. | 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 | 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. | 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 | Measures changes in inflammatory cytokine levels (e.g., IL-5, IL-13) in nasal secretions to evaluate local inflammatory responses.
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). | 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 | Record Surgical Complications | Within 6 months after surgery. |
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013517 | Otorhinolaryngologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |