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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Allergic Rhinitis; Tonsillectomy; Adenoidectomy
• Intervention / Treatment: Drug: Drug therapy (NASONEX nasal spray); Procedure: Adenoidectomy; Procedure: Adenotonsillectomy

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yin Yao; Phone Number: +8615071077020; Email: Dr.yaoyin@hotmail.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology
      • Contact: Yin Yao; Phone Number: 86 15071077020; Email: Dr.yaoyin@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	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.
Experimental: Adenoidectomy and drug therapy	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 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.
Experimental: Adenotonsillectomy and drug therapy	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: 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 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.; 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).	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

Outcome Measure	Measure Description	Time Frame
Serum IgE Levels	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).	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.; 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).	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.

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): April 11, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: September 21, 2025
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Rhinitis, Allergic; Therapeutics; Surgical Procedures, Operative; Polycyclic Compounds; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Pregnadienediols; Otorhinolaryngologic Surgical Procedures; Mometasone Furoate; Drug Therapy; Adenoidectomy
• Other Study ID Numbers: TJ-IRB202508035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No