The Procedureless Elipse Gastric Balloon Program: Multicenter Experience in 1770 Consecutive Patients (vol 17, pg 851, 2020)

被引:5
作者
Ienca, R. [1 ]
Al Jarallah, Mohammed [2 ]
Caballero, Adelardo [3 ]
Giardiello, Cristiano [4 ]
Rosa, Michele [5 ]
Kolmer, Sebastien [6 ]
Sebbag, Hugues [7 ]
Hansoulle, Julie [8 ]
Quartararo, Giovanni [9 ]
Zouaghi, Sophie Al Samman [10 ]
Juneja, Girish [11 ]
Murcia, Sebastien [12 ]
Turro, Roman [13 ]
Pagan, Alberto [14 ]
Badiuddin, Faruq [15 ]
Dargent, Jerome [16 ]
Urbain, Pierre [17 ]
Paveliu, Stefan [18 ]
di Cola, Rita Schiano [4 ]
Selvaggio, Corrado [5 ]
Al Kuwari, Mohammed [19 ]
机构
[1] Nuova Villa Claudia Clin, Weight Management Ctr, Rome, Italy
[2] Jarallah German Clin, Gen Surg Dept, Kuwait, Kuwait
[3] Inst Obesidad, Bariatr Ctr, Madrid, Spain
[4] Pineta Grande Hosp, Emergency & Metab Surg Dept, Caserta, Italy
[5] Micros Clin, Nutr Ctr, Modica, Italy
[6] Le Reseau Pondera, Digest Surg Dept, Mulhouse, France
[7] Polyclin Parc Rambot, Digest Surg Dept, Aix En Provence, France
[8] Claris Clin, Nutr Ctr, Brussels, Belgium
[9] Villa Donatello, Gen & Bariatr Surg Unit, Florence, Italy
[10] Infirm Protestante, Digest & Bariatr Surg Dept, Caluire Et Cuire, France
[11] Cocoona Ctr, Bariatr & Weight Loss Ctr, Dubai, U Arab Emirates
[12] Nouvelle Clin Bordeaux Tondu, Bariatr Surg Dept, Floirac, France
[13] Ctr Med Teknon, Digest Endoscopy Dept, Barcelona, Spain
[14] Ctr Integral Nutr Baleares Cinib, Nutr Ctr, Palma De Mallorca, Spain
[15] BR Med Suites, Gen & Obes Surg Dept, Dubai, U Arab Emirates
[16] Polyclin Lyon Nord, Bariatr Surg Dept, Rillieux La Pape, France
[17] Polyclin St Privat, Gen Surg Dept, Boujan Sur Libron, France
[18] Ctr Med Matisse, Gen & Obes Surg Dept, Nice, France
[19] Masters Med Clin, Bariatr Surg Dept, Doha, Qatar
关键词
Allurion balloon; Elipse balloon; Intragastric balloon; Multicenter study; Non-endoscopic balloon; Obesity; Overweight; Procedureless; Swallowable balloon; Weight loss;
D O I
10.1007/s11695-020-04640-y
中图分类号
R61 [外科手术学];
学科分类号
摘要
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. © 2020, Springer Science+Business Media, LLC, part of Springer Nature.
引用
收藏
页码:3363 / 3364
页数:2
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[1]  
Ienca R, 2020, OBES SURG, V30, P3354, DOI 10.1007/s11695-020-04539-8