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A prospective comparative study on the effects of adenotonsillectomy or drug therapy of adenoid hypertrophy on maxillofacial growth and development and sleep respiration

A prospective comparative study on the effects of adenotonsillectomy or drug therapy of adenoid hypertrophy on maxillofacial growth and development and sleep respiration

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000031949
Enrollment
Unknown
Registered
2020-04-15
Start date
2020-04-27
Completion date
Unknown
Last updated
2020-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

hypertrophic adenoids and/or tonsils on children

Interventions

Group 1:Adenotonsillectomy
Group 2:drug therapy group

Sponsors

The Second Hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Ages 4.0 to 14 years at time of screening; 2. Parents report of history of more than 12 weeks; 3. Diagnosed with hypertrophic adenoids defined as: adenoids blocking posterior nostril over 50% based on nasal endoscopy; 4. Not were treated with leukotriene receptor antagonists or nasal corticosteroid sprays before screening.

Exclusion criteria

Exclusion criteria: 1. Have had adenoid surgery before; 2. Craniofacial anomalies, including cleft palate, immunodeficiency disease, hematological disease, cardiovascular disease and central nervous system disease; 3. Other diseases requiring or likely to require other antibiotics and other drugs that may affect the curative effect; 4. Attention deficit hyperactivity disorder (ADHD) patients requiring medication; 5. Deviated nasal septum; 6. Allergic to experimental drugs.

Design outcomes

Primary

MeasureTime frame
Adenoid and tonsil size;skeletal and dental indicators;Polysomnography (PSG);Quality-of-Life (QOL) tool OSA-18;

Countries

China

Contacts

Public ContactShan Lihua

The Second Hospital of Hebei Medical University

selindashan@163.com+86 15803210595

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026