Randomized Prospective Clinical Study of Spatz3® Adjustable Intragastric Balloon Treatment with a Control Group: a Large-Scale Brazilian Experiment

Autor: Newton Teixeira dos Santos, Ricardo J. Fittipaldi-Fernandez, Cristina F. Diestel, Fernando Santos Silva Bastos, Marcelo Falcão de Santana, J. Lima, Idiberto José Zotarelli-Filho, Márcia Regina Simas Torres Klein
Rok vydání: 2020
Předmět:
Zdroj: Obesity surgery. 31(2)
ISSN: 1708-0428
Popis: To analyze the results regarding weight loss and complications related to the Spatz3® adjustable intragastric balloon (IGB) in Brazil. This randomized prospective study covered patients who had undergone treatment using a Spatz3® adjustable IGB between October 2016 and June 2018 at a private clinic in Rio de Janeiro, Brazil. The patients had a minimum body mass index (BMI) of 27 kg/m2. The study examined complications of Spatz3® treatment and BMI reduction, percentage of total weight loss (%TWL), and % of excess weight loss (%EWL). One hundred eighty patients underwent a Spatz3® balloon implant in the period. The patients were randomly divided into one group in which the Spatz balloon was kept at the same volume (600 mL) throughout treatment (Control Group), and another adjustment group with 250 mL greater volume. The complication rate was 16.14%. No death or major complication occurred during the study. Mean BMI decreased from 39.51 to 32.84 kg/m2 (p
Databáze: OpenAIRE