Full Text View  
  Tabular View  
  Contacts and Locations  
  No Study Results Posted  
  Related Studies  
Laparoscopic Gastric Bypass vs LAP-BAND for Treatment of Morbid Obesity
This study is ongoing, but not recruiting participants.
Sponsored by: University of California, Irvine
Information provided by: University of California, Irvine
ClinicalTrials.gov Identifier: NCT00247377
  Purpose

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.


Condition
Morbid Obesity

MedlinePlus related topics: Obesity Weight Control
U.S. FDA Resources
Study Type: Observational
Study Design: Cohort, Prospective
Official Title: A Prospective Randomized Trial of Laparoscopic Gastric Bypass vs Laparoscopic Adjustable Gastric Banding (LAP-BAND) for Treatment of Morbid Obesity

Further study details as provided by University of California, Irvine:

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 250
Study Start Date: October 2002
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Laparoscopic Gastric Bypass
2
LAP-BAND

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

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00247377

Locations
United States, California
Univeristy of California, Irvine, Medical Center
Orange, California, United States, 92868
Sponsors and Collaborators
University of California, Irvine
Investigators
Principal Investigator: Ninh T Nguyen, MD University of California, Irvine Medical Center, Orange, CA
  More Information

Responsible Party: Chief, Division of Gastrointestinal Surgery University of California, Irvine Medical Center ( Ninh T. Nguyen, MD )
Study ID Numbers: HS-2002-2394
Study First Received: October 31, 2005
Last Updated: March 12, 2008
ClinicalTrials.gov Identifier: NCT00247377  
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Irvine:
Morbid Obesity, Laparoscopic Gastric Bypass, Laparoscopic Gastric Banding

Study placed in the following topic categories:
Body Weight
Signs and Symptoms
Obesity
Nutrition Disorders
 Overweight
Overnutrition
Obesity, Morbid

ClinicalTrials.gov processed this record on January 16, 2009



U.S. National Library of Medicine,  Contact Help Desk
U.S. National Institutes of Health,  U.S. Department of Health & Human Services,
USA.gov,  Copyright,  Privacy,  Accessibility,  Freedom of Information Act

U.S. National Institutes of Health U.S. National Library of Medicine U.S. Department of Health & Human Services