Original ArticleIntragastric balloon for treatment-resistant obesity: safety, tolerance, and efficacy of 1-year balloon treatment followed by a 1-year balloon-free follow-up
Section snippets
Patients and methods
The study protocol was approved by the ethical committee of our hospital. Written informed consent was obtained from each participating patient.
Results
Fifty-six patients were screened for inclusion in the study. Of these, 13 were ineligible for the following reasons: a large hiatal hernia (4), a peptic ulcer (1), treatment with anticoagulant medication (2), prior bariatric surgery (1), intra-abdominal adhesions (1), BMI less than 32 kg/m2 (2), and no prior weight-reduction program (2). Thus, 43 patients (7 men, 36 women; mean age 41.4 years, range 22-64 years) entered the study. Mean weight and BMI were 125.2 kg (range 93.2-187.7), and 43.3
Discussion
The complex design of the present study ensued from problems encountered with prior versions of intragastric balloons. The FDA acted as an adviser and had a major influence on the design of the study protocol.4 To maximize safety and to prevent unduly long exposure of nonresponding patients to a potentially hazardous treatment, balloons had to be removed every 3 months, and strict weight-loss goals were defined as a requirement for continuation of treatment. Although the protocol was approved
Acknowledgments
The authors are greatly indebted to H. Reitsma, MD, PhD, Department of Clinical Epidemiology and Biostatistics, for statistical help and to BioEnterics Corp. (Carpinteria, Calif.) for providing the balloons and the sham placement assemblies.
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See CME Section; p. 128.