Intragastric balloon as an adjunct to lifestyle intervention: a randomized controlled trial
| Autor: | M Fusco, J Robinson, George Woodman, Vafa Shayani, Helmuth Billy, Daniel J. Pambianco, Anita P. Courcoulas, B. K. Abu Dayyeh, L Eaton, Christopher J. Gostout |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Adult
Male medicine.medical_specialty Time Factors Nausea Vomiting Endocrinology Diabetes and Metabolism Treatment outcome Medicine (miscellaneous) 030209 endocrinology & metabolism Balloon law.invention Body Mass Index 03 medical and health sciences 0302 clinical medicine Postoperative Complications Randomized controlled trial Device removal Double-Blind Method law Lifestyle intervention Gastroscopy Weight Loss medicine Humans Prospective Studies Device Removal Gastric Balloon Nutrition and Dietetics business.industry Adjunct United States Abdominal Pain Obesity Morbid Treatment Outcome Multicenter study Physical therapy 030211 gastroenterology & hepatology Female medicine.symptom business Risk Reduction Behavior Follow-Up Studies |
| Zdroj: | International journal of obesity (2005). 41(3) |
| ISSN: | 1476-5497 |
| Popis: | This trial evaluated the safety and effectiveness of the Orbera Intragastric Balloon as an adjunct to lifestyle intervention.In this multicenter, randomized, open-label clinical trial, 255 adults with a body mass index of 30-40 kg mAt 6 months, weight loss was -3.3% of total body weight (-3.2 kg) in the lifestyle arm vs -10.2% (-9.9 kg) in the balloon plus lifestyle arm (P0.001); at 9 months (3 months postballoon removal), weight loss was -3.4% (-3.2 kg) vs -9.1% (-8.8 kg, P⩽0.001); and at 12 months, -3.1% (-2.9 kg) vs -7.6% (-7.4 kg, P⩽0.001). For the primary end points, at 9 months, mean percent loss of weight in excess of ideal body weight (s.d.) at 9 months was 26.5% (20.7) (P=0.32) and 9.7% (15.1) in the balloon and control groups, respectively. Also, 45.6% (36.7, 54.8) of the subjects randomized to the balloon achieved at least 15% loss of weight in excess of ideal body weight greater than the control group (P0.001). The majority of balloon subjects experienced adverse events; 86.9% nausea, 75.6% vomiting, 57.5% abdominal pain and 18.8% had their device removed before 6 months because of an adverse event or subject request. Five subjects (3.1%) in the balloon group had a gastric abnormality at the time of device removal, and no ulcers were found.Intragastric balloon achieved greater short-term weight loss at 3 and 6 months postballoon removal than lifestyle intervention alone. Adverse gastrointestinal events were common. |
| Databáze: | OpenAIRE |
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