Bariatric surgery in patients with progressive organ failure and patients with terminal organ failure who are expecting are already have received a solid organ transplantatio
Phase 4
Recruiting
- Conditions
- E66N19K72I50J96T86E14E78I10Obesity
- Registration Number
- DRKS00025465
- Lead Sponsor
- niversitätsklinikum Heidelberg, Abteilung für Allgemein-, Viszeral-, und Transplantationschirurgie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 110
Inclusion Criteria
Age 18-80 years
-BMI 35-60 kg/m²
-End stage organ disease awaiting transplantation
•GFR <15ml/min
•Liver cirrhosis Child A
•LVEF < 30%
•Written informed consent
Exclusion Criteria
Cirrhosis Child B & C, Portal hypertension, Esophageal/gastric varices, Portal venous gradient > 20 mmHg (with or without transjugular intrahepatic portosystemic (Stent-) Shunt (TIPPS)), Hepatic encephalopathy, Severe coagulopathy INR >2,5, EF <15% without LVAD, = ASA IV
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Transplantation success (12 months after transplantation), Function of transplanted organ (12 months after transplantation)<br>
- Secondary Outcome Measures
Name Time Method Remission of obesity-related co-morbidities (12 months after bariatric surgery):<br>-Type 2 Diabetes Mellitus type 2<br>-Arterial hypertension<br>-Obstructive sleep apnea, obesity hypoventilation syndrome<br>-Kidney failure<br>Rate of malnutrition (12 months after bariatric surgery)<br>Weight loss (12 months after bariatric surgery)