背景:需要简单的手术方法,以最大程度地减少吻合并发症,同时改善代谢/减肥手术(MBS)结局。
方法:这项前瞻性单中心研究评估了可行性,安全,以及新型线性磁吻合系统(LMAS[3cm])在进行左右十二指肠回肠造口术(MagDI)二分置以修改临床上次优的原发性袖状胃切除术(SG)中的功效。重度肥胖伴/不伴2型糖尿病(T2D)的患者体重减轻欠佳,重新获得,和/或在SG接受MagDI修订后T2D复发。远端和近端磁铁通过内窥镜输送到回肠和十二指肠,并通过腹腔镜辅助对齐。逐渐的磁体融合形成DI双分区。
方法:技术可行性,1年时的安全性(Clavien-Dindo[CD]严重不良事件分类)。次要终点:MBS重量和T2D减少。
结果:2022年7月29日至2023年3月28日,24名患者(95.8%为女性,平均年龄44.9±1.5岁,体重指数[BMI]39.4±1.3kg/m2)接受MagDI。通过正确的磁铁放置达到可行性(平均手术时间63.5±3.3分钟),创造了专利吻合,100.0%的患者肛门和磁铁通道。有4例CD-III轻度或中度严重不良事件,0.0%与LMAS或MagDI相关:0.0%吻合口漏,阻塞,出血,感染,再干预,或死亡。平均BMI降低2.1kg/m2(p<0.05);总体重减轻5.3%,过量体重减轻16.4%;T2D患者改善。
结论:使用新型3-cmLMAS修改临床次优SG的单吻合术MagDI程序在技术上很简单,没有发生重大并发症,减轻体重恢复,并恢复了有临床意义的体重减轻。
结果:
■NCT05322122。
BACKGROUND: Uncomplicated surgical approaches that minimize anastomotic complications while improving revisional metabolic/bariatric surgical (MBS) outcomes are needed.
METHODS: This prospective single-center study assessed the feasibility, safety, and efficacy of the novel linear magnetic anastomosis system (LMAS [3 cm]) in performing a side-to-side duodeno-ileostomy (MagDI) bipartition to revise clinically suboptimal primary sleeve gastrectomy (SG). Patients with severe obesity with/without type 2 diabetes (T2D) with suboptimal weight loss, regain, and/or T2D recurrence post SG underwent revisional MagDI. A distal and proximal magnet were delivered endoscopically to the ileum and duodenum and aligned via laparoscopic assistance. Gradual magnet fusion formed a DI bipartition.
METHODS: technical feasibility, safety (Clavien-Dindo [CD] severe adverse event classification) at 1 year. Secondary endpoints: MBS weight and T2D reduction.
RESULTS: July 29, 2022-March 28, 2023, 24 patients (95.8% female, mean age 44.9 ± 1.5 years, and body mass index [BMI] 39.4 ± 1.3 kg/m2) underwent MagDI. Feasibility was attained via correct magnet placement (mean operative time 63.5 ± 3.3 min), patent anastomoses created, and magnet passage per anus in 100.0% of patients. There were 4 CD-III mild or moderate severe AEs, 0.0% associated with the LMAS or MagDI: 0.0% anastomotic leakage, obstruction, bleeding, infection, reintervention, or death. Mean BMI reduction was 2.1 kg/m2 (p < 0.05); total weight loss 5.3%, excess weight loss 16.4%; and the patient with T2D improved.
CONCLUSIONS: The single-anastomosis MagDI procedure using the novel 3-cm LMAS to revise clinically suboptimal SG was technically straightforward, incurred no major complications, mitigated weight regain, and renewed clinically meaningful weight loss.
RESULTS: UNASSIGNED: NCT05322122.