Centre for Advancement of Surgical Education and Simulation (CASES), Royal Alexandra Hospital, 502 Community Services Centre10240 Kingsway Avenue, Edmonton, AB, T5H 3V9, Canada.
Department of Surgery, University of Alberta, Dvorkin Lounge Mailroom 2G2 Walter C. Mackenzie Health Sciences Centre, 8440 - 112 Street NW, Edmonton, AB, T6G 2B7, Canada.
Obes Surg. 2022 May;32(5):1649-1657. doi: 10.1007/s11695-022-06005-z. Epub 2022 Mar 15.
The use of intragastric balloons (IGBs) for the treatment of obesity was approved by the US Food and Drug Administration in 2015. This study aims to characterize preoperative factors and outcomes of patients undergoing IGB therapy compared to bariatric surgery (non-IGB) and evaluate 5-year trends in IGB use.
A retrospective cohort study was performed by extracting data from the MBSAQIP registry between 2015 and 2019. All non-IGB and IGB procedures were included while revisional and emergency surgeries were excluded. Multivariable logistic regression analysis was used to determine independent predictors of patient selection for IGB therapy.
Of 652,927 patients identified, only 2910 (0.4%) underwent IGB therapy. Patients who underwent IGB therapy were older (46.7 ± 11.4 years vs 44.4 ± 12.0 years; p < 0.0001), had lower BMI at baseline (37.0 ± 6.2 kg/m vs 45.3 ± 7.8 kg/m; p < 0.0001), and were overall healthier with fewer comorbidities and better functional status. The rate of early nonoperative reintervention was higher in the IGB cohort (7.7% vs 1.1%; p < 0.0001). Age was the only significant predictor of selection for IGB therapy (OR 1.32; 95% CI 1.24-1.37; p < 0.0001). The number of IGB procedures reported between 2016 and 2019 declined significantly (953 (0.62%) vs 418 (0.25%); p < 0.0001).
Appropriate indications for IGBs appear to be increasingly limited. The ongoing role of IGBs in the treatment of obesity is unclear given the safety and efficacy of modern bariatric surgery and new pharmacological agents for weight loss.
2015 年,美国食品和药物管理局批准了胃内球囊(IGB)用于肥胖症的治疗。本研究旨在对接受 IGB 治疗的患者与接受减肥手术(非 IGB)的患者进行术前因素和结果的比较,并评估 5 年来 IGB 使用的趋势。
通过从 2015 年至 2019 年的 MBSAQIP 注册中心提取数据,进行了回顾性队列研究。纳入了所有非 IGB 和 IGB 手术,但排除了修订和急诊手术。采用多变量逻辑回归分析确定患者选择 IGB 治疗的独立预测因素。
在确定的 652927 名患者中,仅有 2910 名(0.4%)接受了 IGB 治疗。接受 IGB 治疗的患者年龄更大(46.7±11.4 岁 vs 44.4±12.0 岁;p<0.0001),基线 BMI 较低(37.0±6.2 kg/m vs 45.3±7.8 kg/m;p<0.0001),且合并症和功能状态总体较好。IGB 组的早期非手术再干预率较高(7.7% vs 1.1%;p<0.0001)。年龄是唯一显著预测 IGB 治疗选择的因素(OR 1.32;95%CI 1.24-1.37;p<0.0001)。2016 年至 2019 年报告的 IGB 手术数量显著下降(953(0.62%) vs 418(0.25%);p<0.0001)。
IGB 的适当适应证似乎越来越有限。鉴于现代减肥手术和新的减肥药物的安全性和有效性,IGB 在肥胖症治疗中的作用尚不清楚。