Evaluation of obstructive sleep apnea (OSA) management in obesity surgery.
- Registration Number
- NL-OMON21420
- Lead Sponsor
- Dr. E.J. Hazebroek, surgeonEHazebroek@rijnstate.nlDepartment of SurgeryRijnstate HospitalWagnerlaan 55, 6815 AD Arnhem, The NetherlandsT: +31 880055970 / F: +31880055580
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 1380
Inclusion Criteria
Scheduled for gastric bypass or sleeve gastrectomy
- BMI ≥ 35 kg/m2 (IFSO criteria for bariatric surgery)
Exclusion Criteria
- BMI < 35 kg/m2
- < 18 years or > 65 years
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Cost-effectiveness measured by:<br /><br>-Quality-adjusted-life-years (QALY¡¯s) calculated with the European Quality of Life-5 Dimensions (EQ-5D)<br /><br>-Productivity cost questionnaire (PCQ) <br /><br>-Use of health care resources.
- Secondary Outcome Measures
Name Time Method Pulmonary/cardiac/neurovascular complications <br /><br>Length of hospital stay <br /><br>Morbidity <br /><br>Mortality<br /><br>Generic quality of life: RAND-36 <br /><br>OSA-related quality of life: FOSQ-10 questionnaires <br /><br>CPAP compliance <br /><br>Resolution of OSA symptoms: Epworth Sleepiness Scale ¡°ESS¡± <br /><br>Weight loss <br /><br><br /><br>Postoperative hypoxemic episodes during the first night after bariatric surgery:<br /><br>- Mean SpO2 <br /><br>-Number of episodes SpO2 < 90%<br /><br>-Number of episodes SpO2 4% below baseline saturation<br /><br>-Duration of desaturations<br /><br>-Lowest SpO2