Aesthetic Medical Center, Clinica Bruselas, 28028, Madrid, Spain.
Bariatric and Metabolic Surgery Unit, Clinica Las Condes, 7591046, Santiago, Chile.
Obes Surg. 2024 Oct;34(10):3762-3770. doi: 10.1007/s11695-024-07458-0. Epub 2024 Aug 28.
Medical devices benefit patients living with overweight or obesity, but studies in the adolescent population are lacking. The goal of this study was to collect information on the performance and safety of a swallowable intragastric balloon program (SGBP) in adolescent patients.
Data were collected retrospectively on patients aged 15 to 17 years with body mass index (BMI) ≥ 27 kg/m who received the swallowable intragastric balloon (SGB) and associated lifestyle and nutritional change program. Patients had not responded to previous dietary and behavioral modification weight loss treatments and elected to undergo SGBP. The SGB was swallowed and filled with 550 mL of distilled water in an outpatient setting, and a multidisciplinary team delivered a lifestyle/nutritional change program. Mean % total body weight loss (%TBWL) was calculated for each patient compared with baseline.
A total of 91 patients, 69 (75.8%) female and 22 (24.2%) male, underwent SGBP and completed follow-up through SGB passage at 4 months. Baseline mean ± SD age, weight, and BMI were 16.4 ± 0.77, 99.70 ± 21.33 kg, and 35.60 ± 5.59 kg/m, respectively. After 4 months, mean weight and BMI were 86.37 ± 18.83 kg and 30.86 ± 5.16 kg/m respectively; %TBWL was 13.05 ± 7.64 (1-sided t-test, p < 0.0001). Most (80, 87.9%) reported no adverse events; 11/91 (12.1%) experienced an adverse event. Of these, 9/91 (9.9%) experienced nausea and/or vomiting; 1/91 (1.1%) reported abdominal pain only; 1/91 (1.1%) reported flatulence only. There were no serious adverse events or premature device removals.
The SGBP provides safe and effective short-term weight loss in adolescents living with overweight and obesity.
医疗器械有益于超重或肥胖患者,但青少年人群的相关研究较少。本研究的目的是收集关于可吞咽胃内球囊计划(SGBP)在青少年患者中的性能和安全性的信息。
回顾性收集了 91 名年龄在 15 至 17 岁,BMI≥27kg/m²的患者数据,这些患者接受了可吞咽胃内球囊(SGB)和相关生活方式及营养改变计划。这些患者之前的饮食和行为改变减肥治疗没有效果,选择接受 SGBP。SGB 在门诊环境下被吞咽并用 550ml 蒸馏水填充,一个多学科团队提供生活方式/营养改变计划。与基线相比,计算每位患者的平均总体重减轻百分比(%TBWL)。
共有 91 名患者(69 名女性,22 名男性)接受了 SGBP 并完成了 4 个月的 SGB 随访。基线时的平均年龄±标准差、体重和 BMI 分别为 16.4±0.77 岁、99.70±21.33kg 和 35.60±5.59kg/m²。4 个月后,平均体重和 BMI 分别为 86.37±18.83kg 和 30.86±5.16kg/m²;%TBWL 为 13.05±7.64(单侧 t 检验,p<0.0001)。大多数(80 例,87.9%)报告无不良事件;91 例中有 11 例(12.1%)发生不良事件。其中,91 例中有 9 例(9.9%)出现恶心和/或呕吐;91 例中有 1 例(1.1%)仅报告腹痛;91 例中有 1 例(1.1%)仅报告腹胀。无严重不良事件或过早取出装置。
SGBP 为超重和肥胖的青少年提供了安全有效的短期减肥效果。