Clinical trial NCT00247377: Laparoscopic Gastric Bypass vs LAP-BAND for Treatment of Morbid Obesity
Official title: A Prospective Randomized Trial of Laparoscopic Gastric Bypass vs Laparoscopic Adjustable Gastric Banding (LAP-BAND) for Treatment of Morbid Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Morbid Obesity
Keywords: Morbid Obesity
Laparoscopic Gastric Bypass
Laparoscopic Gastric Banding
Lead sponsor: University of California, Irvine
Sponsor class: OTHER
First posted: 2005-11-01
Enrollment: 197
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Excess Weight Loss From Pre-operation to 5 Years Post-operation
timeFrame: Baseline to 5 years
Secondary outcomes:
measure: Changes in Quality of Life- Physical Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation
timeFrame: Baseline to 12 months
measure: Cost of Procedure to the Medical Facility on Date of Procedure
timeFrame: date of surgery
measure: Changes in Quality of Life- Role- Physical Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation
timeFrame: Baseline to 12 months
measure: Changes in Quality of Life- Bodily Pain Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation
timeFrame: Baseline to 12 months
measure: Changes in Quality of Life: General Health Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation
timeFrame: Baseline to 12 months
measure: Changes in Quality of Life- Vitality Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation
timeFrame: Baseline to 12 months
measure: Changes in Quality of Life- Social Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation
timeFrame: Baseline to 12 months
measure: Changes in Quality of Life- Role- Emotional Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation
timeFrame: Baseline to 12 months
measure: Changes in Quality of Life- Mental Health Using SF-36 Questionnaire From Pre-operation to 12 Months Post-operation
timeFrame: Baseline to 12 months
Other outcomes:
Locations:
city: Orange
country: United States
facility: Univeristy of California, Irvine, Medical Center
state: California
Study officials:
affiliation: University of California, Irvine Medical Center, Orange, CA
name: Ninh T Nguyen, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nguyen NT, Slone JA, Nguyen XM, Hartman JS, Hoyt DB. A prospective randomized trial of laparoscopic gastric bypass versus laparoscopic adjustable gastric banding for the treatment of morbid obesity: outcomes, quality of life, and costs. Ann Surg. 2009 Oct;250(4):631-41. doi: 10.1097/SLA.0b013e3181b92480.