N/A
N=197
Laparoscopic Gastric Bypass vs LAP-BAND for Treatment of Morbid Obesity
Morbid Obesity
Bottom Line
View on ClinicalTrials.gov: NCT00247377 ↗Enrolled (actual)
197
Serious AEs
24.4%
Results posted
Apr 2010
Primary outcome: Primary: Excess Weight Loss From Pre-operation to 5 Years Post-operation — 68.4; 45.4 percent change
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Gastric bypass surgery (Procedure); Lap-Band (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Irvine
- Primary completion
- Dec 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Excess Weight Loss From Pre-operation to 5 Years Post-operation |
68.4; 45.4 | — |
| SECONDARY Changes in Quality of Life- Physical Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation |
86.8; 93.1 | — |
| SECONDARY Cost of Procedure to the Medical Facility on Date of Procedure |
12310; 10767 | — |
| SECONDARY Changes in Quality of Life- Role- Physical Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation |
88.2; 100.0 | — |
| SECONDARY Changes in Quality of Life- Bodily Pain Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation |
81.1; 84.5 | — |
| SECONDARY Changes in Quality of Life: General Health Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation |
82.7; 85.3 | — |
| SECONDARY Changes in Quality of Life- Vitality Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation |
73.2; 71.3 | — |
| SECONDARY Changes in Quality of Life- Social Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation |
92.8; 81.3 | — |
| SECONDARY Changes in Quality of Life- Role- Emotional Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation |
82.5; 100 | — |
| SECONDARY Changes in Quality of Life- Mental Health Using SF-36 Questionnaire From Pre-operation to 12 Months Post-operation |
83.6; 86 | — |
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.
Eligibility Criteria
Eligibility:
Inclusion Criteria
- Male or female patients with BMI of 40-60 kg/m2 or 35 kg/m2 with comorbidities
- Good health status with acceptable operative risk (good cardiopulmonary function)
- Willingness to follow protocol requirements: Signing informed consent, follow-up, and completing protocol diagnostic tests
Exclusion Criteria
- Prior upper abdominal surgery except cholecystectomy
- Large abdominal ventral hernia
- Patients with hiatal hernia
- Inadequate prior medical management
- Lack of patient's motivation and contribution to long-term success
- Unacceptable operative risk
- 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.
Data sourced from ClinicalTrials.gov (NCT00247377). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.