CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 197 enrolled
Drug / intervention
Gastric bypass surgery +1 moreprocedure
Likely dose
Not stated in record
Key inclusion· 3
  • BMI 40-60 kg/m² or ≥35 kg/m² with comorbidities
  • Good cardiopulmonary function and acceptable operative risk
  • Willing and able to comply with follow-up and protocol requirements
Key exclusion· 7
  • Prior upper abdominal surgery (except cholecystectomy)
  • Large abdominal ventral hernia
  • Hiatal hernia
  • Inadequate prior medical optimization

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00247377
NCT00247377N/ACompleted

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

University of California, Irvine·interventional·Posted Nov 1, 2005·Updated Apr 24, 2023

In Brief

A clinical study evaluating Gastric bypass surgery and Lap-Band for Morbid Obesity. Completed, enrolled 197 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMorbid Obesity
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 1, 2005
Enrollment StartOct 1, 2002
Primary CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 7.2 yearsPosted 20.7 years ago

Interventions

Gastric bypass surgeryprocedure

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

Lap-Bandprocedure

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