Obesity
Conditions
Interventions
Laparoscopic sleeve gastrectomy
Sponsors
Hamamatsu University School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age 18 to 65 years 2) Written informed consent is obtained 3) Under the active care of a doctor for at least the 6 months prior to enrollment 4) BMI over 32.0 kg/m2 5) Obese patient with DM or more than one obesity-related metabolic disease
Exclusion criteria
Exclusion criteria: 1) Cardiovascular event in the past 6 months or unstable ungina 2) Pulmonary embolus or thrombophlebitis in the past 6 months 3) Cancer of any kind unless documented to be disease-free for 5 years 4) Significant anemia or coagulopathy 5) Renal dysfunction: serum creatinine 2.0 mg/dl and over 6) Hepatic dysfunction: serum total bilirubin greater than 1.5 times the upper limit of normal, or alkaline phosphatase or ALT greater than twice the upper limit of normal. Chronic hepatitis B or C, cirrhosis 7) History of stomach surgery, bile duct surgery, pancreatic surgery, splenectomy, or colon resection. 8) Gastric or duodenal ulcer in the past 6 months 9) History of intra-abdominal sepsis 10) Currently pregnant or nursing 11) Receiving steroids 12) Receiving immune suppressor 13) Patients with pulmonary disease and require continuous oxygen therapy 14) History of alcohol or drug dependency in the past 5 years 15) Patients with psychiatric or mental disorders 16) Exclusions may also be made at the discretion of the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The improvement rate of obesity-related metabolic disease at 1 year after surgery: glycosylated hemoglobin (HbA1c) < 7.0%, LDL cholesterol < 100 mg/dl and systolic blood pressure < 130 mmHg. | — |
Secondary
| Measure | Time frame |
|---|---|
| Post-operative complications Body weight, BMI, %EWL | — |
Countries
Japan
Contacts
Public ContactYoshihiro Hiramatsu
Hamamatsu University School of Medicine Bariatric and metabolic surgery
Outcome results
None listed