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内镜下袖状胃成形术后体重减轻与缝合方式无关:一项随机对照试验的结果

Weight loss after endoscopic sleeve gastroplasty is independent of suture pattern: results from a randomized controlled trial.

作者信息

Gkolfakis Paraskevas, Van Ouytsel Pauline, Mourabit Youssef, Fernandez Michael, Yared Rawad, Deviere Jacques, Huberty Vincent

机构信息

Department of Gastroenterology, Erasme Hospital, Université Libre de Bruxelles, Brussels, Belgium.

出版信息

Endosc Int Open. 2022 Sep 14;10(9):E1245-E1253. doi: 10.1055/a-1880-7580. eCollection 2022 Sep.

Abstract

This was a single-blind, single-center, prospective randomized controlled trial aimed at comparing the efficacy of three different suture patterns for endoscopic sleeve gastroplasty using Endomina (E-ESG). The suture patterns aimed to modify gastric accommodation by increasing the fundus distention ability (Group A), to reduce gastric volume (Group B) or to interrupt gastric emptying (Group C). Patients were randomized 1:1:1 and underwent clinical follow-up, gastric emptying scintigraphy, and satiety tests at baseline and 6 and 12 months post-procedure. The primary outcome was total body weight loss (TBWL) and excess weight loss (EWL) at 12 months post-procedure. Secondary outcomes included the impact of the suture patterns on gastric emptying and satiety. Overall, 48 patients (40 [83.3 %] female, aged 41.9 ± 9.5 years, body mass indexI 33.8 ± 2.7 kg/m ) were randomized (16 in each group). In the entire cohort, mean (95 % confidence interval [CI]) TBWL and EWL at the end of the follow-up were 10.11 % (7.1-13.12) and 42.56 (28.23-56.9), respectively. There was no difference among the three study groups in terms of TBWL (95 %CI) (9.13 % [2.16-16.11] vs. 11.29 % [5.79-16.80] vs. 9.96 % [4.58-15.35];  = 0.589) and EWL (95 %CI) (34.54 % [6.09-62.99] vs. 44.75 % [23.63-65.88] vs. 46.94 % [16.72-77.15];  = 0.888) at 12 months post-procedure. The three groups did not differ in terms of mean gastric emptying time or in terms of satiety tests at the end of the follow-up. No serious adverse events occurred. Three different suture patterns during E-ESG demonstrated comparable efficacy in terms of weight loss, with an overall EWL of > 25 % and TBWL of > 10 % at 12 months.

摘要

这是一项单盲、单中心、前瞻性随机对照试验,旨在比较使用Endomina(E-ESG)进行内镜袖状胃成形术时三种不同缝合方式的疗效。这些缝合方式旨在通过提高胃底扩张能力来改变胃的容纳功能(A组)、减少胃容量(B组)或中断胃排空(C组)。患者按1:1:1随机分组,并在基线时以及术后6个月和12个月接受临床随访、胃排空闪烁扫描和饱腹感测试。主要结局是术后12个月时的总体体重减轻(TBWL)和超重减轻(EWL)。次要结局包括缝合方式对胃排空和饱腹感的影响。总体而言,48例患者(40例[83.3%]为女性,年龄41.9±9.5岁,体重指数33.8±2.7kg/m²)被随机分组(每组16例)。在整个队列中,随访结束时的平均(95%置信区间[CI])TBWL和EWL分别为10.11%(7.1-13.12)和42.56(28.23-56.9)。在术后12个月时,三组在TBWL(95%CI)(9.13%[2.16-16.11] vs. 11.29%[5.79-16.80] vs. 9.96%[4.58-15.35];P=0.589)和EWL(95%CI)(34.54%[6.09-62.99] vs. 44.75%[23.63-65.88] vs. 46.94%[16.72-77.15];P=0.888)方面没有差异。三组在随访结束时的平均胃排空时间或饱腹感测试方面也没有差异。未发生严重不良事件。E-ESG期间的三种不同缝合方式在体重减轻方面显示出相当的疗效,术后12个月时总体EWL>25%,TBWL >l0%。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4b8a/9473843/036474a2e8b5/10-1055-a-1880-7580-i2656ei1.jpg

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