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Effects of combined surgery on obstructive sleep apnea in obese patients: an open-label randomized controlled clinical trial

Effect of laparoscopic sleeve gastrectomy (LSG) plus uvulopalatopharyngoplasty and adenoidectomy/tonsillectomy on severe obstructive sleep Apnea & Hyponea Syndromes in moderate-to-severe obese patients: an open-label randomized controlled clinical trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IIR-16009718
Enrollment
Unknown
Registered
2016-11-03
Start date
2017-01-02
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

Obstructive Sleep Apnea Hyponea Syndromes

Interventions

A:laparoscopic sleeve gastrectomy
B:LSG + uvulopalatopharyngoplasty and adenoidectomy/tonsillectomy

Sponsors

9th People's Hospital affiliated to Shanghai Jiao Tong University, School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Chinese Han population aged 16 to 65 years; 2. BMI more than 32.5Kg/? with AHI more than =30/hour; 3. First diagnosed with PSG without any corresponding treatment; 4. adenoid tonsil hypertrophy (Friedman stage II-III).

Exclusion criteria

Exclusion criteria: 1. Drug abuse, alcohol addiction and mental diseases; 2. dysgnosia; 3. over-high expectation; 4. risk-averse patient; 5. poor tolerance to surgery; 6. patient suffering from gastroesophageal reflux and hiatal hernia; 7. central or mixed sleep apnea diagnosed by PSG; 8. PO2<60mmHg when the patient is awake; 9. suffering from maligent tumor, neural system injury and respiratory insufficiency; 10. hypothyroidism; 11. other special issue decided by specialist.

Design outcomes

Primary

MeasureTime frame
Apnea–hypopnea index (AHI);

Secondary

MeasureTime frame
The average blood oxygen saturation at night;BMI;Decrease in excessive body weight;The lowest oxygen saturation;

Countries

China

Contacts

Public ContactBing WANG

9th People's Hospital affiliated to Shanghai Jiao Tong University School of Medicine

wingping01@126.com+86 13482154296

Outcome results

None listed

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