Prospective clinical investigation of the effects of bariatric surgery on nocturnal hypoxaemic burden in patients with severe obesity
- Conditions
- E66.02G47.9Sleep disorder, unspecified
- Registration Number
- DRKS00026004
- Lead Sponsor
- Klinikum Saarbrücken
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Indication for bariatric surgery according to the S3 guideline: Surgery of obesity and metabolic diseases
The patient is fully informed and agrees to participate in the study
The surgical indication has been secured by a multidisciplinary team consisting of a nutritionist, surgeon, psychosomatic specialist / psychologist and, if necessary a general doctor.
Consent to participate in the study has not been given or will be revoked.
Bariatric surgery is not performed.
Previously known severe chronic respiratory failure requiring oxygen therapy
General inoperability
Contraindication to bariatric surgery according to the S3 guideline: Surgery for obesity and metabolic diseases:
- Unstable psychopathological conditions, untreated bulimia nervosa, active substance dependence
- Consuming underlying diseases, malignant neoplasms, untreated endocrine causes, chronic diseases worsened by a postoperative catabolic metabolism
- Present or planned pregnancy
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method octurnal hypoxaemic burden preoperativly and six month postoperatively
- Secondary Outcome Measures
Name Time Method Weight loss<br>Apnea / Hypopnea Index (AHI)<br>Static and dynamic lung volumes (vital capacity, inspiratory capacity,<br>expiratory reserve volume, forced one-second capacity (FEV1))<br>Systolic and diastolic cardiac function (morphology, global longitudinal<br>Strain)<br>Parameters of the acid-base balance (blood pH, carbon dioxide partial pressure,<br>Standard bicarbonate and base excess)<br>Characterization of daytime sleepiness