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Randomized Prospective Clinical Study On The Spatz3® Adjustable Intragastric Balloon Treatment With a Control Group: A Large Brazilian Experience
  • Dr. Idiberto Jose Zotarelli Filho, MSc, Ph.D
Dr. Idiberto Jose Zotarelli Filho, MSc, Ph.D
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AIM: To analyze the results regarding weight loss and complications with Spatz3® adjustable intragastric balloon (IGB) in Brazil. METHODS: In this randomized prospective study were included patients that were submitted to Spatz3® adjustable IGB treatment between October 2016 to June 2018 in a private clinic in Rio de Janeiro/Brazil. The patients presented a minimum body mass index (BMI) of 27kg/m². Were analyzed the complications of Spatz3® treatment and BMI reduction, percentage of total weight loss (%TWL) and % of excess weight loss (%EWL). RESULTS: 180 patients underwent implant Spatz3® balloon in the period. The patients were randomly separated in one group the Spatz balloon kept the same volume (600 mL) during all the treatment (Control Group), and adjustment group with 250 mL more. The complications were 16.14%. No death or major complications happened in the study. The BMI decreased from 39.51 to 32.84 kg/m² (p<0.0001), body weight decreased from 111.87 to 90.28 kg (p<0.0001) and excess weight diminished from 41.55 to 22.99kg (p<0.0001). The adjustment resulted in a further mean weight loss of 4,35kg (-8 to 17.6kg) and the moment of the procedure was 7.12±1.63 months. The upward adjustment group doesn´t have a higher %TWL, %EWL or a higher BMI reduction when compared to the control group (p=0.4413, p=0,9245, p=0.2729, respectively).CONCLUSION: This study shows that Spatz3® IGB treatment is an effective procedure for weight reduction, without mortality but with higher morbidity rates when compared to tradition IGBs. The upward adjustment efficacy still needs to be confirmed.