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A prospective clinical study on the evaluation of the efficacy of subtotal tonsillectomy in obese children with obstructive sleep apnea syndrome

A prospective clinical study on the evaluation of the efficacy of subtotal tonsillectomy in obese children with obstructive sleep apnea syndrome

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100043190
Enrollment
Unknown
Registered
2021-02-08
Start date
2021-02-10
Completion date
Unknown
Last updated
2021-05-24

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

Conditions

Obstructive sleep apnea

Interventions

Adenotonsillectomy:Adenotonsillectomy
Adenotonsillotomy:Adenotonsillotomy

Sponsors

The Ninth People's Hospital Affiliated to Medical College of Shanghai Jiaotong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Children aged 2-12 years; 2. Subjects with AHI > 5; 3. Children with body mass index (BMI) > 95% (BMI Z score > 1.65); 4. Subjects with OSA characteristic symptoms such as sleep snoring, suffocation and mouth opening breathing; 5. Subjects with adenoid hypertrophy (nostril > 2 / 3 after adenoid obstruction under nasal endoscope, or adenoid / nasopharyngeal cavity (A / N) > 2 / 3 in lateral nasopharyngeal film); 6. Subjects with grade III-IV tonsil enlargement; 7. Subjects with no obvious effect or recurrence after conservative treatment for more than 2 months; 8. Subjects without surgical contraindications.

Exclusion criteria

Exclusion criteria: 1. Subjects with central sleep apnea; 2. Subjects with chromosomal abnormalities; 3. Subjects with hemorrhagic diseases; 4. Subjects with a history of tonsillectomy and / or adenoidectomy; 5. Subjects with cardiopulmonary disease who could not tolerate surgery; 6. Subjects who cannot be followed up regularly as required.

Design outcomes

Primary

MeasureTime frame
OSA-18;

Secondary

MeasureTime frame
Lymphocyte subset ratio;AHI;wonWong-baker faces pain scale;

Countries

China

Contacts

Public ContactZhang Zhihua

Department of Otolaryngology Head and neck surgery, the Ninth People's Hospital Affiliated to Medical College of Shanghai Jiaotong University

zhihua.zhang2015@aliyun.com+86 13917426208

Outcome results

None listed

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