Interim results at 48 weeks of LAP-BAND AP experience (APEX) study: prospective, multicenter, open-label longitudinal patient observational study
| Autor: | Michael G. Oefelein, Robert Cywes, Jaime Ponce, Helmuth Billy, Ted Okerson, Sunil Bhoyrul |
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| Rok vydání: | 2012 |
| Předmět: |
Adult
Male medicine.medical_specialty Malabsorption Adolescent Gastroplasty Body Mass Index Young Adult Weight loss Interim Weight Loss medicine Humans Prospective Studies Adjustable gastric band Adverse effect Aged business.industry Equipment Design Middle Aged medicine.disease Obesity Morbid Surgery Treatment Outcome Female Laparoscopy Observational study medicine.symptom business Laparoscopic adjustable gastric banding Body mass index |
| Zdroj: | Surgery for Obesity and Related Diseases. 8:741-746 |
| ISSN: | 1550-7289 |
| DOI: | 10.1016/j.soard.2011.09.006 |
| Popis: | Background The development of laparoscopic adjustable gastric banding marked a breakthrough in minimally invasive bariatric surgery. The unique features of gastric banding, including device adjustability, lack of malabsorption, and easy reversibility, have contributed to its widespread use. Since Food and Drug Administration approval of the first laparoscopic adjustable gastric band, the device design has undergone engineering improvements. The LAP-BAND AP (LBAP) system received Food and Drug Administration approval in 2006. Little is known about the safety and efficacy of this new system. Our objective was to prospectively assess the efficacy and safety of the LBAP system in real-world clinical settings at 50 clinical centers throughout the United States. Methods In an open-label 5-year evaluation, 508 severely or morbidly obese patients from 50 centers in the United States underwent surgery using the LBAP system. The present interim report describes the results from 323 patients after ≥48 weeks of follow-up. Results By week 48, the patients had experienced a mean percentage of excess weight loss of 46% and a mean ± standard deviation reduction in the body mass index of 8.4 ± 3.69 kg/m 2 . Sixteen patients (3.1%) experienced a severe device- or procedure-related adverse event. There were no deaths. Conclusion These 48-week interim data demonstrate that the LBAP system offers a safe and effective therapy to reduce weight in severely obese patients. |
| Databáze: | OpenAIRE |
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