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内镜胃造口术与腹腔镜袖状胃切除术的对比:一项非劣效性倾向评分匹配的比较研究。

Endoscopic gastroplasty versus laparoscopic sleeve gastrectomy: a noninferiority propensity score-matched comparative study.

机构信息

Department of Surgery, New You Medical Center, Riyadh, Saudi Arabia.

Faculty of Medicine, King Abdulaziz University, Jeddah, Saudi Arabia.

出版信息

Gastrointest Endosc. 2022 Jul;96(1):44-50. doi: 10.1016/j.gie.2022.02.050. Epub 2022 Mar 3.

Abstract

BACKGROUND AND AIMS

Endoscopic bariatric therapies are less-invasive alternatives to bariatric surgery, and endoscopic gastroplasty (ESG) represents the latest evolution. This study aims to compare weight loss, safety, and comorbidity resolution of ESG compared with laparoscopic sleeve gastrectomy (LSG).

METHODS

This was a propensity score-matched study of patients who underwent ESG or LSG. Primary outcome was weight loss at 6, 12, 24, and 36 months. A noninferiority margin of 10% total weight loss (%TWL) was used. Secondary outcomes were safety and comorbidity resolution.

RESULTS

A 1:1 propensity score match yielded 3018 patient pairs. Average age and body mass index (BMI) were 34 ± 10 years and 33 ± 3 kg/m, respectively, and 89% were women. Mean percentage of excess weight loss at 1, 2, and 3 years after ESG was 77.1% ± 24.6%, 75.2% ± 47.9%, and 59.7% ± 57.1%, respectively. Mean percentage of excess weight loss at 1, 2, and 3 years after LSG was 95.1% ± 20.5%, 93.6% ± 31.3%, and 74.3% ± 35.2%, respectively. The mean difference in %TWL was 9.7% (95% confidence interval [CI], 6.9-11.8; P < .001), 6.0% (95% CI, -2.0 to 9.4; P < .001), and 4.8% (95% CI, -1.5 to 8.7; P < .001) at 1, 2, and 3 years, respectively. Noninferiority was demonstrated at all follow-up visits. Fourteen ESG patients developed adverse events (.5%) versus 10 LSG patients (.3%). Comorbidity remission rates after ESG versus LSG were 64% versus 82% for diabetes, 66% versus 64% for dyslipidemia, and 51% versus 46% for hypertension, respectively. Eighty ESG patients (2.7%) underwent revision to LSG for insufficient weight loss or weight regain, and 28 had resuturing after primary ESG (.9%).

CONCLUSIONS

ESG induces noninferior weight loss to LSG with similar comorbidity resolution and safety profiles.

摘要

背景与目的

内镜减重治疗是减重手术的一种微创替代方法,内镜胃成形术(ESG)代表了最新的发展。本研究旨在比较 ESG 与腹腔镜袖状胃切除术(LSG)的减重效果、安全性和合并症缓解情况。

方法

这是一项倾向评分匹配研究,纳入了接受 ESG 或 LSG 的患者。主要结局为 6、12、24 和 36 个月时的体重减轻。使用 10%总体重减轻(%TWL)的非劣效性边界。次要结局为安全性和合并症缓解情况。

结果

1:1 倾向评分匹配得到 3018 对患者。平均年龄和体重指数(BMI)分别为 34 ± 10 岁和 33 ± 3 kg/m²,89%为女性。ESG 治疗后 1、2 和 3 年时的平均超重体重减轻百分比分别为 77.1% ± 24.6%、75.2% ± 47.9%和 59.7% ± 57.1%。LSG 治疗后 1、2 和 3 年时的平均超重体重减轻百分比分别为 95.1% ± 20.5%、93.6% ± 31.3%和 74.3% ± 35.2%。%TWL 的平均差异为 9.7%(95%置信区间 [CI],6.9-11.8;P<0.001)、6.0%(95% CI,-2.0 至 9.4;P<0.001)和 4.8%(95% CI,-1.5 至 8.7;P<0.001),分别在 1、2 和 3 年时。在所有随访中均证明了非劣效性。14 名 ESG 患者(0.5%)出现不良事件,10 名 LSG 患者(0.3%)出现不良事件。ESG 与 LSG 相比,糖尿病的缓解率分别为 64%与 82%,血脂异常分别为 66%与 64%,高血压分别为 51%与 46%。80 名 ESG 患者(2.7%)因体重减轻不足或体重反弹而行 LSG 修正,28 名患者在初次 ESG 后行再缝合术(0.9%)。

结论

ESG 诱导的体重减轻与 LSG 相似,具有相似的合并症缓解和安全性。

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