Laparoscopic Gastric Bypass vs LAP-BAND for Treatment of Morbid Obesity
Laparoscopic Gastric Bypass vs LAP-BAND for Treatment of Morbid Obesity
PURPOSE Obesity is a growing problem in the United States. Severe obesity, known as "morbid
 obesity", is defined as being 100 pounds in excess of ideal body weight. Nonsurgical
 treatments for morbid obesity include exercise, dietary restriction, behavior modification,
 and pharmacological intervention. However, it is estimated that most patients undergoing
 nonsurgical treatments for weight reduction will regain their weight within 2 to 4 years
 after treatment. According to the NIH consensus conference in 1991, surgery remains the only
 effective sustained weight loss treatment for morbid obesity. The Roux-en-Y gastric bypass
 (GBP) is currently considered the gold standard bariatric surgical operation. Mean weight
 loss following GBP is approximately 65% of the excess body weight during the first 12 to 18
 months postoperatively. Long-term weight loss is in the range of 55-70% of excess body weight
 loss.

 Recently, the laparoscopic approach to GBP was reported. Wittgrove and colleagues reported
 their results of 75 patients who underwent laparoscopic GBP and demonstrated significant
 short-term advantages with comparable weight loss and reversal of comorbidities compared to
 the open approach. However, GBP might it be done laparoscopic or open approach can
 potentially be associated with significant morbidity and mortality such as anastomotic leak,
 pulmonary embolism, bowel obstruction, and postoperative stricture.

 The FDA recently approved the laparoscopic adjustable banding system (LAP-BAND) for use in
 the United States in June 2001. The LAP-BAND system is a device designed to induce weight
 loss in severely obese patients. It is surgically placed around the proximal stomach to
 create a small proximal stomach pouch and restricted opening, or stoma, through which passage
 of food will be slowed. An inflatable portion along the inner aspect of the band is connected
 to an access port, placed intramuscularly. This enabled stoma adjustments to be made without
 the need for further surgery. The advantages of the LAP-BAND system included no cutting or
 opening of the stomach wall, ability to adjust the stoma and a technically easier operation
 to perform than laparoscopic GBP. We wanted to evaluate if the LAP-BAND procedure is as
 effective as the laparoscopic GBP procedure for treatment of morbid obesity.
RATIONALE:

 1. Morbid obesity and its health consequences is increasing in the United States

 2. Roux-en-Y GBP is an effective treatment for morbid obesity but can be associated with
 substantial morbidities

 3. LAP-BAND system can be an effective treatment for morbidly obese patients with
 potentially reduced morbidity compared to laparoscopic GBP

 HYPOTHESIS:

 1. 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

 2. 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

 3. LAP-BAND does not alter esophageal motility and is effective in improvement of
 gastroesophageal reflux disease (GERD) symptoms.

 OBJECTIVES AND SPECIFIC AIMS:

 1. To determine the short-term outcome, quality-of-life, costs, and long-term weight loss
 after laparoscopic GBP compared with LAP-BAND.

 2. To compare physiologic changes such as perioperative fluid requirement, postoperative
 pulmonary function, and intraabdominal pressure after laparoscopic GBP and LAP-BAND.

 3. 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:

 1. Male or female patients with BMI of 40-60 kg/m2 or 35 kg/m2 with comorbidities

 2. Good health status with acceptable operative risk (good cardiopulmonary function)

 3. Willingness to follow protocol requirements: Signing informed consent, follow-up, and
 completing protocol diagnostic tests

 Exclusion Criteria:

 1. Prior upper abdominal surgery except cholecystectomy

 2. Large abdominal ventral hernia

 3. Patients with hiatal hernia

 4. Inadequate prior medical management

 5. Lack of patient's motivation and contribution to long-term success

 6. Unacceptable operative risk

 7. 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.