Prospective study of laparoscopic adjustable gastric banding with MIDBAND system for morbidly obese patients
- Conditions
- Patients for whom gastric banding was indicated will be included in the study. Exhaustive and consecutive inclusions of 20 patients will be carried out at Yotsuya Medical Cube with the MIDBAND implant.
- Registration Number
- JPRN-UMIN000005768
- Lead Sponsor
- Yotsuya Medical Cube
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 20
Not provided
(1) Cardiovascular event in the past 6 months. (2) Current evidence of congestive heart failure, angina pectoris, or symptomatic peripheral vascular disease. (3) Cardiac stress test indicating that surgery would not be safe. (4) Pulmonary embolus or thrombophlebitis in the past 6 months. (5) Cancer of any kind unless documented to be disease-free for 5 years. (6) Significant anemia (hemoglobin 1.0 g or more below normal range) or history of coagulopathy. (7) Serum creatinine 2.0 mg/dl or more. (8) History of stomach surgery, bile duct surgery, pancreatic surgery, splenectomy, or colon resection. (9) Gastric or duodenal ulcer in the past 6 months. (10) History of intra-abdominal sepsis. (11) Self-reported HIV-positive status, active tuberculosis, active malaria, chronic hepatitis B or C, cirrhosis, or inflammatory bowel disease. (12) Currently pregnant or nursing, or planning to become pregnant in the next 2 years. (13) History of alcohol or drug dependency in the past 5 years. (14) Active psychosocial or psychiatric problem that is likely to interfere with adherence to the protocol. (15) Presence of any chronic or debilitating disease that would make adherence to the protocol difficult. (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
- Secondary Outcome Measures
Name Time Method