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

NCT07527260 | Not Yet Recruiting

• 1 other identifier: TJ-IRB202508035
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Adenoidectomy; Tonsillectomy; Allergic Rhinitis

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• Surgical Complications

  Within 6 months after surgery.

Study Arms (3)

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.

Drug: Drug therapy (NASONEX nasal spray)

Adenoidectomy and drug therapy

EXPERIMENTAL

Drug: Drug therapy (NASONEX nasal spray); Procedure: Adenoidectomy

Adenotonsillectomy and drug therapy

EXPERIMENTAL

Drug: Drug therapy (NASONEX nasal spray); Procedure: Adenotonsillectomy

Interventions

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.

Adenoidectomy and drug therapy; Adenotonsillectomy and drug therapy; Drug therapy

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.

Adenoidectomy and drug therapy

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.

Adenotonsillectomy and drug therapy

Eligibility Criteria

• Age: 3 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital of Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Drug Therapy; Mometasone Furoate; Adenoidectomy

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Otorhinolaryngologic Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

Yin Yao

CONTACT

+8615071077020; Dr.yaoyin@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Otolaryngology-Head & Neck Surgery Deputy Dean of Institute of Allergy and Clinical Immunology

Study Record Dates

• First Submitted: September 21, 2025
• First Posted: April 14, 2026
• Study Start: April 11, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

CN (1)