Affordable Access

Publisher Website

Safety and effectiveness of Realizeadjustable gastric band: 3-year prospective study in the United States

Authors
Journal
Surgery for Obesity and Related Diseases
1550-7289
Publisher
Elsevier
Publication Date
Volume
5
Issue
5
Identifiers
DOI: 10.1016/j.soard.2008.12.007
Keywords
  • Morbid Obesity
  • Bariatric Surgery
  • Gastric Band
  • Swedish Adjustable Gastric Band
  • Sagb
  • Body Mass Index
  • Weight Loss
  • Realize
  • Realizeadjustable Gastric Band
  • Laparoscopic Adjustable Gastric Band
  • Lagb
Disciplines
  • Biology
  • Medicine

Abstract

Abstract Background The effectiveness and safety of bariatric surgery using laparoscopic adjustable gastric bands have been demonstrated in numerous published studies. We present the results of the first U.S. multicenter trial of the R ealize adjustable gastric band, a laparoscopic adjustable gastric band previously available only outside the United States as the Swedish adjustable gastric band. Methods A total of 405 morbidly obese patients were screened at 12 different centers from May to November 2003 to participate in a prospective, single-arm study of the safety and effectiveness of the laparoscopically implanted R ealize band. Changes in excess body weight, the parameters of diabetes and dyslipidemia, and the incidence of complications were assessed at 3 years of follow-up. Results Of the 405 patients, 276 (78.3% women and 61.2% white) qualified for the study. The average age was 38.6 ± 9.4 years (range 18–61), and the preoperative body mass index was 44.5 ± 4.7 kg/m 2. The mean hospital stay was 1.2 ± 1.3 days. At 3 years, the average excess weight loss was 41.1% ± 25.1% or a decrease in the body mass index of 8.2 kg/m 2 (18.6%) ( P < .001). In diabetic patients with a baseline elevated hemoglobin A 1c level, the level decreased by 1% ( P < .001). The total cholesterol, low-density lipoprotein cholesterol, and triglycerides decreased by 9%, 16%, and 50%, respectively ( P < .001), and the high-density lipoprotein cholesterol increased by 25% ( P < .001) in patients with abnormal baseline values. One patient required conversion to an open surgical technique. No 30-day mortality occurred. The complication frequencies were generally low and included esophageal dysmotility in 0.4%, late balloon failure in 0.4%, band erosion in 0.4%, slippage in 3.3%, esophageal dilation in 3.3%, pouch dilation in 3.6%, catheter kinking in 1.1%, port displacement in 2.5%, and port disconnection in 4.3%. Reoperations were required in 15.2% of the patients and involved 2 band replacements, 9 band revisions, 5 port replacements, 22 port revisions, and 4 explants. Conclusion The results of our study have shown that the R ealize adjustable gastric band is safe and effective in a diverse U.S. population of morbidly obese patients. Significant weight loss was achieved throughout the 3 years of follow-up, with corresponding improvements in the indicators of diabetes and dyslipidemia.

There are no comments yet on this publication. Be the first to share your thoughts.

Statistics

Seen <100 times
0 Comments

More articles like this

Design and demography of the United States Swedish...

on Surgery for Obesity and Relate... Jan 01, 2008

The Safety and Effectiveness of the Retrievable Op...

on Journal of Vascular and Interv... Jan 01, 2010

Safety and Effectiveness of LAP-BAND AP System: Re...

on Journal of the American Colleg...

International multicenter study of safety and effe...

on Surgery for Obesity and Relate... Jan 01, 2009
More articles like this..