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

Study Overview
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Brief Summary
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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
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RATIONALE: Morbid obesity and its health consequences is increasing in the United States Roux-en-Y GBP is an effective treatment for morbid obesity but can be associated with substantial morbidities LAP-BAND system can be an effective treatment for morbidly obese patients with potentially reduced morbidity compared to laparoscopic GBP HYPOTHESIS: 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 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 LAP-BAND does not alter esophageal motility and is effective in improvement of gastroesophageal reflux disease (GERD) symptoms. OBJECTIVES AND SPECIFIC AIMS: To determine the short-term outcome, quality-of-life, costs, and long-term weight loss after laparoscopic GBP compared with LAP-BAND. To compare physiologic changes such as perioperative fluid requirement, postoperative pulmonary function, and intraabdominal pressure after laparoscopic GBP and LAP-BAND. 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.

Official Title
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A Prospective Randomized Trial of Laparoscopic Gastric Bypass vs Laparoscopic Adjustable Gastric Banding (LAP-BAND) for Treatment of Morbid Obesity

Conditions
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Morbid Obesity

Intervention / Treatment
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* Procedure: Gastric bypass surgery
* Procedure: Lap-Band


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Laparoscopic Gastric Bypass<br>Subject undergoes Laparoscopic Gastric Bypass | Procedure: Gastric bypass surgery<br>* in order to meet health requirements for patient, gastric bypass surgery was undergone<br>* Other names: weight loss surgery;|
| Active Comparator: LAP-BAND<br>Subject undergoes LAP-BAND procedure | Procedure: Lap-Band<br>* in order to meet health requirements for patient, gastric band surgery was undergone<br>* Other names: band;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Excess Weight Loss From Pre-operation to 5 Years Post-operation | weight loss as measured by change in percent of excess body weight | Baseline to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Quality of Life- Physical Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation | change in quality of life survey response where 0 is non-functioning and 100 is fully functioning | Baseline to 12 months | 
| Cost of Procedure to the Medical Facility on Date of Procedure | operative and post-operative direct costs including hospital service costs per patient. costs reflect the average cost per patient in each of the two groups (band vs. bypass) at a single time point: date of surgery. | date of surgery | 
| Changes in Quality of Life- Role- Physical Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation | change in quality of life survey response for physical aspects of life using the SF-36 questionnaire where 0 corresponds to no Role-Physical and 100 corresponds to full Role-Physical | Baseline to 12 months | 
| Changes in Quality of Life- Bodily Pain Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation | change in quality of life survey response for bodily pain using the SF-36 questionnaire where 0 corresponds to no bodily pain and 100 corresponds to complete bodily pain | Baseline to 12 months | 
| Changes in Quality of Life: General Health Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation | change in quality of life survey response for general health using the SF-36 questionnaire where 0 corresponds to no general health satisfaction and 100 corresponds to complete health satisfaction | Baseline to 12 months | 
| Changes in Quality of Life- Vitality Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation | change in quality of life survey response for vitality as measured using the SF-36 questionnaire with worst score being 0 and best score being 100 on a 1-100 point scale. | Baseline to 12 months | 
| Changes in Quality of Life- Social Functioning Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation | change in quality of life survey response for social functioning as measured using the SF-36 questionnaire where 0 corresponds to no social functioning and 100 corresponds to full social functioning | Baseline to 12 months | 
| Changes in Quality of Life- Role- Emotional Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation | change in quality of life survey response for the emotional role using the SF-36 questionnaire where 0 corresponds to no emotional role and 100 corresponds to full emotional role | Baseline to 12 months | 
| Changes in Quality of Life- Mental Health Using SF-36 Questionnaire From Pre-operation to 12 Months Post-operation | change in quality of life survey response for mental health using the SF-36 questionnaire where 0 corresponds to no mental health well-being and 100 corresponds to complete mental health well-being | Baseline to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Morbid Obesity, Laparoscopic Gastric Bypass, Laparoscopic Gastric Banding