Laparoscopic Gastric Bypass vs LAP-BAND for Treatment of Morbid Obesity
Condition: Morbid Obesity
MeSH terms: Obesity; Obesity, Morbid
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Gastric bypass surgery; Lap-Band
Intervention type(s): Procedure; Procedure
Intervention description(s): in order to meet health requirements for patient, gastric bypass surgery was undergone; in order to meet health requirements for patient, gastric band surgery was undergone
Other intervention name(s): gastric bypass; bypass surgery; weight loss surgery; weight loss surgery; band
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Morbid Obesity; Laparoscopic Gastric Bypass; Laparoscopic Gastric Banding