Influence of body composition on perioperative outcome and effects of regular visualization of medical body composition after Mini Gastric Bypass/One Anastomosis Gastric Bypass (MGB/OAGB)
- Conditions
- E66.82M62.59
- Registration Number
- DRKS00015488
- Lead Sponsor
- Adipositas Klinik Schön Klinik Hamburg Eilbek
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 60
Existence of a cost assumption statement of the responsible payers for the planned intervention or fulfillment of the criteria of the S3 Guideline Surgery of Obesity and metabolic disorders
- Body mass index (BMI) preoperatively 40 to 60 kg / m²
- Mini Gastric Bypass / One-Anastomosis Gastric Bypass (MGB / OAGB) as a scheduled Operation
- Presence of signed patient information and consent
- Prior Bariatric surgery
- Weight loss> 10% in the previous 3 months
- no present consent
- pregnancy
- known heart failure NYHA II or higher
- GFR <60 ml / min or known renal insufficiency KDIGO G3 or major change in diuretic therapy in the past 6 months
- Paralyzes, e.g. as a result of a stroke
- Amputations
- electric implants e.g. Pacemaker or ICD (implanted cardio defibrillator)
- insulin pumps
- persons dependent on the sponsor or the study Center
- alcohol addiction
- active prostheses
- electronic life support systems, e.g. Artificial heart, artificial lung
- mobile, electrical, medical devices, e.g. ECG, infusion pumps
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Preoperative primary endpoint:<br>Does the preoperative body composition influence the postoperative change in body composition?<br><br>Postoperative primary endpoint:<br>Does the regular measurement of the body composition pre- and postoperatively with visualization and quantification of the changes have influence the change of the body?
- Secondary Outcome Measures
Name Time Method Preoperative secondary endpoints:<br>Does the preoperative body composition have influence on intra- and postoperative complications as well as the duration of the hospital stay?<br><br>Postoperative secondary endpoints:<br>The regular measurement of body composition pre- and postoperatively with visualization and quantification of the changes influences other parameters such as the initial extent of weight reduction, quality of life, psychological well-being, comorbidities, laboratory values, etc. (see secondary endpoints).