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Devices Gastroenterology

 News Release - February 26, 2007

Long-Term Safety Data Show the LAP-BAND(R) Adjustable Gastric Banding System Results in Fewer Complications Compared to Gastric Bypass

5-Year Comparative Data Published in Surgery for Obesity and Related Diseases

PORTLAND, Ore., Feb. 26 (HSMN NewsFeed) -- Researchers from Legacy Good Samaritan Obesity Institute announced today the results from a 5-year study of the safety of laparoscopic adjustable gastric banding (LAGB) compared to laparoscopic Roux-en Y gastric bypass (LRYGB), two bariatric surgical procedures performed in the United States for the treatment of morbid obesity. All patients undergoing LAGB received the LAP-BAND® System, which is the only FDA-approved adjustable implant device for individualized weight loss. The study, which was published in the recent issue of Surgery for Obesity and Related Diseases(1), found that the LAP-BAND® System results in significantly fewer complications, shorter operative times, and shorter hospital stays when compared with LRYGB.

"Given the lack of comparative data available from experienced institutions that frequently perform both laparoscopic adjustable gastric banding and laparoscopic Roux-en Y gastric bypass, we believe this study provides important insights for both bariatric surgeons and their patients on the safety of two of the most common surgical treatment options for obesity," explained Emma J. Patterson, M.D., F.R.C.S.C., F.A.C.S., Medical Director of the Legacy Good Samaritan Obesity Institute and lead investigator of the study. "Previously, making comparisons between these procedures has been challenging, as most reports of surgical outcomes have been from institutions which often favor one procedure over the other."

The Legacy Good Samaritan Obesity Institute study was based on a prospectively maintained database and included a total of 898 severely obese patients with either a Body Mass Index (BMI) of 40 or more or a lower BMI of 35 or more with at least one obesity-related co-morbidity, such as sleep apnea, diabetes, or hypertension. BMI is a weight-for-height measure; 18.5- 24.9 is considered "normal," 25-29.9 "overweight," and 30 and above as varying degrees of "obese." All procedures were performed at the Institute between October 2000 and October 2005. Of the 898 patients, 492 (55%) underwent LRYGB and 406 (45%) underwent laparoscopic adjustable gastric banding.

About the Study Findings and Adjustment of Patient Risk

While patients were generally able to choose the procedure they preferred, higher-risk patients were recommended for the LAP-BAND® System given its established lower risk of perioperative morbidity and mortality. As a result, LAP-BAND® System patients were significantly older, heavier, and had a significantly greater prevalence of sleep apnea compared to the patients in the LRYGB group. Additionally, there were more men in the LAP-BAND® System group than the LRYGB group.

However, even after adjusting for the differences in patient risks of the two groups before surgery, the researchers found that the LAP-BAND® System procedure was associated with half the rate of potentially life-threatening complications compared to LRYGB (p < 0.05). LAP-BAND® System patients also experienced about two-thirds the overall complication rate of LRYGB patients, or 24 percent vs. 32 percent (p<0.002), respectively. The LAP-BAND® System was also associated with approximately half the surgery time (68 vs. 134 minutes, p<0.001) and less than half the length of hospital stay (1.1 vs. 2.5 days, p<0.001) compared to LRYGB. Rates of re-operation were the same for both groups (17%) as well as rates of 90-day deaths (0.2%). Deaths were determined not to be related to either of the surgical procedures, with the exception of one death in the LRYGB group.

While comparison of weight loss was not the focus of this study, Dr. Patterson noted that both groups lost significant amounts of weight.

About Legacy Good Samaritan Obesity Institute

The Legacy Good Samaritan Obesity Institute is designed to help patients manage their weight and change their lives. A multi-specialty team which is comprised of surgeons, psychologists, dietitians, nurses, patient educators, support groups, insurance coordinators and exercise specialists, offer comprehensive care. The Institute recognizes the special needs of obese patients and features extra-wide doors and chairs and power-assisted tables. In addition, Legacy Good Samaritan Hospital has specialized equipment for severely overweight patients, such as beds, waiting room chairs, wheelchairs, recliners and stretchers.

The Legacy Good Samaritan Obesity Institute and Oregon Weight Loss Surgery, the physician practice that leads the Institute, are certified as an American Society for Bariatric Surgery (ASBS) Center of Excellence. This designation recognizes the program for its record of favorable outcomes in bariatric surgery.

(1) Jan JC, Hong D, Bardaro SJ, July LV, Patterson EJ. Comparative study between laparoscopic adjustable gastric banding and laparoscopic gastric bypass: single-institution, 5-year experience in bariatric surgery. Surgery for Obesity and Related Diseases 2007, 3(1): 42-50

Source: Legacy Good Samaritan Obesity Institute

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