Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00247377
Status:
COMPLETED
Last Update Posted:
2023-04-24
First Post:
2005-10-31
Brief Title:
Laparoscopic Gastric Bypass vs LAP-BAND for Treatment of Morbid Obesity
Sponsor:
University of California Irvine
Organization:
University of California Irvine
Study Overview
Official Title:
A Prospective Randomized Trial of Laparoscopic Gastric Bypass vs Laparoscopic Adjustable Gastric Banding LAP-BAND for Treatment of Morbid Obesity
Status:
COMPLETED
Status Verified Date:
2023-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None