The Procedureless Elipse Gastric Balloon Program: Multicenter Experience in 1770 Consecutive Patients
| Autor: | Rita Schiano di Cola, Pierre Urbain, Mohammed Al Kuwari, Jerome Dargent, Sébastien Murcia, Michele Rosa, Alberto Pagan, Faruq Badiuddin, Roman Turro, Roberta Ienca, Stefan Paveliu, Adelardo Caballero, Corrado Selvaggio, Girish Juneja, Giovanni Quartararo, Mohammed Al Jarallah, Julie Hansoulle, Sébastien Kolmer, Hugues Sebbag, Sophie Al Samman Zouaghi, Cristiano Giardiello |
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| Jazyk: | angličtina |
| Rok vydání: | 2020 |
| Předmět: |
Laparoscopic surgery
medicine.medical_specialty Weight loss Intragastric balloon Endocrinology Diabetes and Metabolism medicine.medical_treatment Original Contributions Perforation (oil well) Population Swallowable balloon Balloon Non-endoscopic balloon medicine Obesity education education.field_of_study Nutrition and Dietetics Elipse balloon business.industry Gastric outlet obstruction Overweight medicine.disease Multicenter study Stylet Surgery Procedureless medicine.symptom business Esophagitis Allurion balloon |
| Zdroj: | Obesity Surgery |
| ISSN: | 1708-0428 0960-8923 |
| Popis: | Purpose The Elipse balloon is a novel, non-endoscopic option for weight loss. It is swallowed and filled with fluid. After 4 months, the balloon self-empties and is excreted naturally. Aim of the study was to evaluate safety and efficacy of Elipse balloon in a large, multicenter, population. Materials and Methods Data from 1770 consecutive Elipse balloon patients was analyzed. Data included weight loss, metabolic parameters, ease of placement, device performance, and complications. Results Baseline patient characteristics were mean age 38.8 ± 12, mean weight 94.6 ± 18.9 kg, and mean BMI 34.4 ± 5.3 kg/m2. Triglycerides were 145.1 ± 62.8 mg/dL, LDL cholesterol was 133.1 ± 48.1 mg/dL, and HbA1c was 5.1 ± 1.1%. Four-month results were WL 13.5 ± 5.8 kg, %EWL 67.0 ± 64.1, BMI reduction 4.9 ± 2.0, and %TBWL 14.2 ± 5.0. All metabolic parameters improved. 99.9% of patients were able to swallow the device with 35.9% requiring stylet assistance. Eleven (0.6%) empty balloons were vomited after residence. Fifty-two (2.9%) patients had intolerance requiring balloon removal. Eleven (0.6%) balloons deflated early. There were three small bowel obstructions requiring laparoscopic surgery. All three occurred in 2016 from an earlier design of the balloon. Four (0.02%) spontaneous hyperinflations occurred. There was one (0.06%) case each of esophagitis, pancreatitis, gastric dilation, gastric outlet obstruction, delayed intestinal balloon transit, and gastric perforation (repaired laparoscopically). Conclusion The Elipse™ Balloon demonstrated an excellent safety profile. The balloon also exhibited remarkable efficacy with 14.2% TBWL and improvement across all metabolic parameters. |
| Databáze: | OpenAIRE |
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