Feasibility, safety and efficacy of laparoscopic sleeve gastrectomy for obese patients with BMI over 32.0 kg/m2: A prospective, non-randomized, single center study
- Conditions
- Obesity
- Registration Number
- JPRN-UMIN000024732
- Lead Sponsor
- Hamamatsu University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 5
Not provided
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Post-operative complications Body weight, BMI, %EW