This study is to evaluate the safety and efficacy of Gastric Banding for patients with body mass index (BMI) between 30-40 kg/m2 with medical conditions related to obesity.
TITLE OF STUDY:A prospective study to evaluate the safety and efficacy of LAP-BAND® Adjustable Gastric Band (LAGB®) operations for patients with BMI between 30-40 kg/m2 with co-morbidities CLINICAL PHASE: Phase III new indication for use of the device not yet approved by FDA STUDY OBJECTIVES * To determine the safety and efficacy of the LAP-BAND® Adjustable Gastric Band (LAGB®) for patients with BMI between 30-40 kg/m2 with co-morbidities * To determine long-term effects on patients' co-morbidities STUDY VARIABLES: Morbidity \& mortality, percent of excess weight loss, nutritional status, improvement of pre-operative co-morbidities, weight loss maintained, and quality of life evaluation DESIGN: Prospective single center study
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Bariatric surgery for patient whose BMI is between 30 and 40 kg/m\^2
To Determine Percent of Excess Weight Loss (%EWL) After Laparoscopic Adjustable Gastric Banding Surgery
Change in weight from baseline at 5 years by calculating the percentage of the weight loss from the total excess weight.
Time frame: 5 years
Level of LDL (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery
Change in level of LDL from baseline at 5 years
Time frame: 5 years
Level of Triglycerides (Bad Cholesterol) After Laparoscopic Adjustable Gastric Band Surgery
Change in level of Triglycerides from baseline at 5 years
Time frame: 5 years
Level of HbA1c (Blood Test for Diabetes) After Laparoscopic Adjustable Gastric Band Surgery
Change in level of HbA1c from baseline at 5 years
Time frame: 5 years
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