Innovation and Minimal Invasive Surgery Unit, Hospital Virgen del Rocio, Avda Manuel Siurot, S/N, 41010, Sevilla, Spain.
Department of Medicine - University of Padova, Center for the Study and the Integrated Management of Obesity, Clinica Medica 3 - Padova University Hospital, Via Giustiniani 2, 35128, Padova, Italy.
Obes Surg. 2018 Jun;28(6):1766-1774. doi: 10.1007/s11695-017-3093-8.
Weight regain following bariatric surgery is not uncommon. Safe, effective weight loss treatment up to 1 year has been reported with the closed-loop gastric electrical stimulation (CLGES) system. Continuous recording of eating and activity behavior by onboard sensors is one of the novel features of this closed-loop electrical stimulation therapy, and may provide improved long-term weight maintenance by enhancing aftercare.
Four centers participating in a 12-month prospective multicenter randomized study monitored all implanted participants (n = 47) up to 24 months after laparoscopic implantation of a CLGES system. Weight loss, safety, quality of life (QOL), and cardiac risk factors were analyzed.
Weight regain was limited in the 35 (74%) participants remaining enrolled at 24 months. Mean percent total body weight loss (%TBWL) changed by only 1.5% between 12 and 24 months, reported at 14.8% (95% CI 12.3 to 17.3) and 13.3% (95% CI 10.7 to 15.8), respectively. The only serious device-/procedure-related adverse events were two elective system replacements due to lead failure in the first 12 months, while improvements in QOL and cardiovascular risk factors were stable thru 24 months.
During the 24 month follow-up, CLGES was shown to limit weight regain with strong safety outcomes, including no serious adverse events in the second year. We hypothesize that CLGES and objective sensor-based behavior data combined to produce behavior change. The study supports CLGES as a safe obesity treatment with potential for long-term health benefits.
ClinicalTrials.gov identifier: NCT01448785.
减重手术后体重反弹并不少见。据报道，闭环胃电刺激（CLGES）系统可实现长达 1 年的安全、有效的减肥治疗。通过内置传感器对进食和活动行为进行连续记录是这种闭环电刺激疗法的一个新颖特征，通过增强后续护理，可能会更好地维持长期体重。
四个参与为期 12 个月的前瞻性多中心随机研究的中心监测了所有植入参与者（n=47），直至腹腔镜植入 CLGES 系统后 24 个月。分析体重减轻、安全性、生活质量（QOL）和心脏危险因素。
在 24 个月时仍有 35 名（74%）参与者继续入组，体重反弹受到限制。12 至 24 个月之间，总体重减轻的平均百分比（%TBWL）仅变化 1.5%，分别报告为 14.8%（95%CI 12.3 至 17.3）和 13.3%（95%CI 10.7 至 15.8）。唯一与设备/程序相关的严重不良事件是前 12 个月内因导联故障而进行的两次选择性系统更换，而 QOL 和心血管危险因素的改善在 24 个月时保持稳定。
在 24 个月的随访期间，CLGES 被证明可以限制体重反弹，安全性结果良好，第二年没有严重不良事件。我们假设 CLGES 和基于客观传感器的行为数据相结合可产生行为改变。该研究支持 CLGES 作为一种安全的肥胖治疗方法，具有长期健康获益的潜力。
ClinicalTrials.gov 标识符：NCT01448785。
