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INTRODUCTION: Intragastric balloon (IGB) is a minimally invasive and reversible option for obesity treatment. There is a worldwide growing number of different IGB models. The efficacy and safety profile for each model must be demonstrated. We aim to evaluate IGB safety profile according to the experience of the Spanish Bariatric Endoscopy Group (GETTEMO). METHODS: A survey of 37 IGBs safety-related questions was sent to all GETTEMO members, to retrospectively collect a multicenter Spanish registry. Incidence, causes, and resolution of both major and minor complications and adverse events (AEs), including legal consequences, differentiated for each balloon model were evaluated. Secondary outcome was weight loss data to confirm efficacy. RESULTS: Twenty-one Spanish hospitals experienced in IGBs responded. The overall data encompassed 20,680 IGBs, including 12 different models. Mean %TBWL of 17.66 ± 2.5% was observed. Early removal rate due to intolerance was 3.62%. Mean major complications rate was 0.70% (> 1% in Spatz2, HB, and Spatz3 models), mainly complicated gastric ulcer. Minor AEs rate was 6.37%, mainly esophagitis. Nine cases (0.04%) required surgery. A single case of mortality (0.0048%) occurred. Seven lawsuits (0.0034%) were received, all with favorable resolution. CONCLUSIONS: In the Spanish experience accumulating 20,680 IGBs and including 12 different balloon models, a low incidence rate of major complications and minor AEs are observed (0.70% and 6.37%, respectively), mostly resolved with medical/endoscopic management. IGB shows good tolerance and efficacy profile. These safety data are within the accepted quality standards.

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Background: intragastric balloons (IGBs) are a minimally invasive, increasingly popular option for obesity treatment. However, there is only one worldwide guideline standardizing the technical aspects of the procedure (BIBC, SOARD 2018). Objectives: to construct a practical guideline for IGB usage by reproducing and expanding the BIBC survey among the Spanish Bariatric Endoscopy Group (GETTEMO). Methods: a 140-question survey was submitted to all GETTEMO members. Twenty-one Spanish experienced endoscopists in IGBs answered back. Eight topics on patient selection, indications/contraindications, technique, multidisciplinary follow-up, results, safety, and financial/legal aspects were discussed. Consensus was defined as consensus ≥ 70 %. Results: overall data included 20 680 IGBs including 12 different models. Mean age was 42.0 years-old, 79.9 % were women, and the mean preoperative body mass index (BMI) was 34.05 kg/m². Indication in BMI > 25 kg/m², 10 absolute contraindications, and nutritional and medication measures at follow-up were settled. A mean %TBWL (total body weight loss) of 17.66 % ± 2.5 % was observed. Early removal rate due to intolerance was 3.62 %. Adverse event rate was 0.70 % and 6.37 % for major and minor complications with consensual management. A single case of mortality occurred. IGBs were placed in private health, prior contract, and with full and single payment at the beginning. Seven lawsuits (0.034 %) were received, all ran through civil proceeding, and with favorable final resolution. Conclusions: this consensus based on more than 20 000 cases represents practical recommendations to perform IGB procedures. This experience shows that the device leads to satisfactory weight loss with a low rate of adverse events. Most results are reproducible compared to those obtained by the BIBC (AU)

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BACKGROUND: intragastric balloons (IGBs) are a minimally invasive, increasingly popular option for obesity treatment. However, there is only one worldwide guideline standardizing the technical aspects of the procedure (BIBC, SOARD 2018). OBJECTIVES: to construct a practical guideline for IGB usage by reproducing and expanding the BIBC survey among the Spanish Bariatric Endoscopy Group (GETTEMO). METHODS: a 140-question survey was submitted to all GETTEMO members. Twenty-one Spanish experienced endoscopists in IGBs answered back. Eight topics on patient selection, indications/contraindications, technique, multidisciplinary follow-up, results, safety, and financial/legal aspects were discussed. Consensus was defined as consensus ≥ 70 %. RESULTS: overall data included 20 680 IGBs including 12 different models. Mean age was 42.0 years-old, 79.9 % were women, and the mean preoperative body mass index (BMI) was 34.05 kg/m². Indication in BMI > 25 kg/m², 10 absolute contraindications, and nutritional and medication measures at follow-up were settled. A mean %TBWL (total body weight loss) of 17.66 % ± 2.5 % was observed. Early removal rate due to intolerance was 3.62 %. Adverse event rate was 0.70 % and 6.37 % for major and minor complications with consensual management. A single case of mortality occurred. IGBs were placed in private health, prior contract, and with full and single payment at the beginning. Seven lawsuits (0.034 %) were received, all ran through civil proceeding, and with favorable final resolution. CONCLUSIONS: this consensus based on more than 20 000 cases represents practical recommendations to perform IGB procedures. This experience shows that the device leads to satisfactory weight loss with a low rate of adverse events. Most results are reproducible compared to those obtained by the BIBC.

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Fundamentos: Analizar la relación entre las oscilaciones de peso y el IMC preoperatorio de 307 pacientes bariátricos. Conocer la causa fundamental del abandono de tratamientos dietéticos y la motivación principal para acudir a una Unidad de Cirugía Bariátrica (UCB). Métodos: Se recogieron prospectivamente en 307 casos las siguientes variables: edad, sexo, IMC máximo alcanzado, ratio 'oscilación máxima peso/peso máximo', motivo de la consulta y del fracaso de los tratamientos anteriores. Se estudió la relación entre el grado de obesidad y las variables mediante el test X2. Resultados: La 'oscilación máxima peso/peso máximo' no se asoció al grado de obesidad (correlación/Pearson -0,79). El 58,9% de los pacientes acudieron a una UCB motivados por el deseo de mejorar su calidad de vida, y un 26,1% para cambiar su imagen corporal. Los pacientes abandonaban las dietas por ser monótonas, poco realistas y por estancamiento en la pérdida de peso. Conclusiones: Los pacientes que acuden a una UCB presentan una mayor preocupación por la calidad de vida como motivo de consulta y refieren haber fracasado con las dietas como causa fundamental por la monotonía de éstas. Las oscilaciones de peso no se asocian al grado de obesidad (AU)

Background: To analyze the relationship between variations in weight and preoperative BMI of 307 bariatric patients. To know what is the principal cause of the abandonment of dietary treatments. To know what is the main motivation for attending a Bariatric Surgery Clinic (BSC). Methods: Age, sex, reached maximum BMI, ratio 'maximum weight fluctuations/maximum weight', reason for consultation and the failure of previous treatments. The following variables were collected retrospectively in 307 cases. We have studied the relationship between obesity and the variables by X2 test. Results: The 'maximum weight fluctuations/maximum weight' is not associated with the degree of obesity (Pearson correlation -0.79). 58.9% of patients come to a BSC motivated by a desire to improve their quality of life, and 26.1% do so to change their body image. Patients leave for being monotonous diets, unrealistic and stagnant in weight loss. Conclusions: Patients who come to a BSC have greater concern for quality of life as the reason for consultation and have failed with diets as a root cause for the monotony of these. Fluctuations in weight are not associated with the degree of obesity (AU)

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