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

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.

Conditions

• Morbid Obesity

Interventions

PROCEDURE

Gastric bypass surgery

in order to meet health requirements for patient, gastric bypass surgery was undergone

PROCEDURE

Lap-Band

in order to meet health requirements for patient, gastric band surgery was undergone

Sponsors & Collaborators

• University of California, Irvine

  lead OTHER

Principal Investigators

• Ninh T Nguyen, MD · University of California, Irvine Medical Center, Orange, CA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2002-10-31

Primary Completion

2009-12-31

Completion

2009-12-31

Countries

• United States

Study Locations