E66.82 M62.59
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: - 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
Exclusion criteria
Exclusion criteria: - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Preoperative primary endpoint: Does the preoperative body composition influence the postoperative change in body composition? Postoperative primary endpoint: 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
| Measure | Time frame |
|---|---|
| Preoperative secondary endpoints: Does the preoperative body composition have influence on intra- and postoperative complications as well as the duration of the hospital stay? Postoperative secondary endpoints: 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). | — |
Countries
Germany
Contacts
Adipositas Klinik, Schön Klinik Hamburg Eilbek