advanced obesity
Conditions
Interventions
None listed
Sponsors
Wakayama Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients 20 to 65 years 2. Patients with primary obesity 3. (a) or (b) (a) BMI over 35 kg/m2 (b) Patients whose BMI are over 32 kg/m2 and with DM or more than one obesity-related metabolic disease 4. Patients under the active care of a doctor for at least the 6 months prior to enrollment 5. Patients judged as appropriate by obesity care team 6. ECOG Performance Status(PS) 0-1 7. Main organs function is maintained Platelet 100,000/mm3 and over, Serum creatinine 2.0mg/dl or under, AST 200 IU/L or under, ALT 200 IU/L or under, Total bilirubin 2.0 mg/dL or under, Hemoglobin 8.0 g/dL and over 8. Written informed consent is obtained
Exclusion criteria
Exclusion criteria: 1. History of bariatric surgery 2. Currently pregnant or nursing 3. Receiving steroids or immune suppressor 4. Uncontrollable infection 5. Patients who need treatment of Ischemic heart disease 6. Liver cirrhosis of active hepatitis 7. Patients with respiratory disease and require oxygen therapy 8. Patients with renal dysfunction and require dialysis 9. Active cancer of any kind 10. Patients who have history of upper abdominal surgery and cannot accept laparoscopic surgery 11. Cases in which surgeon cannot perform safety operation 12. Patients uncooperative to treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| percent total weight loss(%TWL) occurrence rate of adverse event percent excess weight loss(%EVL) improvement ratio of Obesity related complications Health related QOL | — |
Secondary
| Measure | Time frame |
|---|---|
| Various hormones Various cytokines | — |
Countries
Japan
Contacts
Public ContactNaoki Fukuda
Wakayama Medical University Second Department of Surgery
Outcome results
None listed