Laparoscopic Gastric Bypass vs LAP-BAND for Treatment of Morbid Obesity

RATIONALE:

• Morbid obesity and its health consequences is increasing in the United States
• Roux-en-Y GBP is an effective treatment for morbid obesity but can be associated with substantial morbidities
• LAP-BAND system can be an effective treatment for morbidly obese patients with potentially reduced morbidity compared to laparoscopic GBP

HYPOTHESIS:

• LAP-BAND can be performed safely and are associated with reduced postoperative pain, decrease in morbidity, decrease ICU and hospital stay, reduced costs, comparable improvement in quality-of-life, and acceptable long-term weight loss compared with laparoscopic GBP
• LAP-BAND is associated with a decrease in fluid requirement in the perioperative period, improved postoperative pulmonary function, and lower intraabdominal pressure compared to laparoscopic GBP
• LAP-BAND does not alter esophageal motility and is effective in improvement of gastroesophageal reflux disease (GERD) symptoms.

OBJECTIVES AND SPECIFIC AIMS:

• To determine the short-term outcome, quality-of-life, costs, and long-term weight loss after laparoscopic GBP compared with LAP-BAND.
• To compare physiologic changes such as perioperative fluid requirement, postoperative pulmonary function, and intraabdominal pressure after laparoscopic GBP and LAP-BAND.
• To evaluate the effect of LAP-BAND on esophageal motility and its effectiveness in controlling gastroesophageal reflux symptoms (GERD) for morbidly obese patients with GERD.

Please note: All physician, hospital, laboratory costs, the barium study tests, and the performance of the operation will be billed to the subject or their insurer as customary since these procedures are standard of care regardless of participation in the study. The research procedures such as the pulmonary function tests, intra-abdominal pressure, body fat composition tests, resting energy expenditure, exercise testing, strength testing, nutritional assessments, and esophageal function tests are considered research-related and will be paid for by the investigator.

Eligibility:

Inclusion criteria

• Male or female patients with BMI of 40-60 kg/m2 or 35 kg/m2 with comorbidities
• Good health status with acceptable operative risk (good cardiopulmonary function)
• Willingness to follow protocol requirements: Signing informed consent, follow-up, and completing protocol diagnostic tests

Exclusion criteria

• Prior upper abdominal surgery except cholecystectomy
• Large abdominal ventral hernia
• Patients with hiatal hernia
• Inadequate prior medical management
• Lack of patient's motivation and contribution to long-term success
• Unacceptable operative risk
• Minors and pregnant women are excluded as these patients do not qualify for the bariatric procedures. Minors are not psychologically fit to undergo such surgery and pregnant women are excluded because of safety for the fetus.