Background: We present our results from the "B" trial (the 2nd U.S. FDA-approved clinical trial) with the laparoscopic adjustable gastric band (LAGB) or Lap-Band System, regarding weight loss, complications, and effect on co-morbidities with up to 3-year follow-up.
Methods: Between March 1999 and June 2001, 63 morbidly obese patients underwent LAGB following accepted ASBS/SAGES guidelines and protocol requirements. All bands were placed via the classic high peri-gastric dissection above the lesser sac, corresponding to the equator of the calibration-tube balloon. Frequent follow-up by a multidisciplinary program was maintained.
Results: All procedures were performed laparoscopically with no conversion to laparotomy. Operative time decreased from a mean of 197 minutes for the first 10 patients to 120 minutes for the last group. Average hospital stay was 1.4 days. Perioperative complications included 1 intraoperative gastric perforation, which was closed and did not prevent band placement, and 5 port problems. Gastric slippage occurred in 9 patients (14.2%), 3 of whom were revised to a gastric bypass and 6 who had the band removed. Three additional bands were removed due to infection (1), band erosion (1) and a cluster of gastric symptoms (1). Percent excess weight loss averaged 27.2 at 6 months (range 1-68), 38.3 at 1 year (range 10-77), 46.6 at 2 years (range 16-89), and 53.6 at 3 years (range 21-94). Before surgery, 46 of 63 patients (73%) suffered from a serious comorbidity. Following LAGB, all categories showed marked improvement.
Conclusions: In this study up to 3 years, LAGB provided a safe and sustainable weight loss. Significant resolution of serious co-morbidities was common. A U.S. bariatric practice achieved results comparable to those in the international literature. The primary requisites to achieve optimal results include careful patient selection, the refined surgical technique, and a comprehensive long-term patient management program.