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前瞻性多中心腹腔镜袖状胃切除术标准治疗研究。

A Prospective Multicenter Standard of Care Study of Outpatient Laparoscopic Sleeve Gastrectomy.

机构信息

Bariatric Medicine Institute, 1046 E 100 S, Salt Lake City, UT, USA.

Stony Brook University Hospital, 23 South Howell Ave, Centereach, NY, USA.

出版信息

Obes Surg. 2024 Apr;34(4):1122-1130. doi: 10.1007/s11695-024-07094-8. Epub 2024 Feb 17.

Abstract

UNLABELLED

A global shift is occurring as hospital procedures move to ambulatory surgical settings. Surgeons have performed outpatient sleeve gastrectomy (SG) in bariatric surgery since 2010. However, prospective trials are needed to ensure its safety before widespread adoption.

PURPOSE

The study aimed to present a comprehensive report on the prospective data collection of 30-day outcomes of outpatient primary laparoscopic SG (LSG). This trial seeks to assess whether outpatient LSG is non-inferior to hospital-based surgery in selected patients who meet the outpatient surgery criteria set by the American Society for Metabolic and Bariatric Surgery.

MATERIALS AND METHODS

This study is funded by the Society of American Gastrointestinal and Endoscopic Surgeons and has been approved by the Advarra Institutional Review Board (Pro00055990). Cognizant of the necessity for a prospective approach, data collection commenced after patients underwent primary LSG procedures, spanning from August 2021 to September 2022, at six medical centers across the USA. Data centralization was facilitated through ArborMetrix. Each center has its own enhanced recovery protocols, and no attempt was made to standardize the protocols.

RESULTS

The analysis included 365 patients with a mean preoperative BMI of 43.7 ± 5.7 kg/m. Rates for 30-day complications, reoperations, readmissions, emergency department visits, and urgent care visits were low: 1.6%, .5%, .2%, .2%, and 0%, respectively. Two patients (0.5%) experienced grade IIIb complications. There were no mortalities or leaks reported.

CONCLUSION

The prospective cohort study suggests that same-day discharge following LSG seems safe in highly selected patients at experienced US centers.

摘要

未加标签

随着医院手术向门诊手术环境转移,全球正在发生转变。自 2010 年以来,外科医生已经在减重手术中开展了门诊袖状胃切除术(SG)。然而,在广泛采用之前,需要进行前瞻性试验以确保其安全性。

目的

本研究旨在全面报告前瞻性收集的 30 天门诊腹腔镜 SG(LSG)初级结果的数据集。该试验旨在评估在符合美国代谢和减重外科学会设定的门诊手术标准的选定患者中,门诊 LSG 是否不劣于医院手术。

材料和方法

这项研究由美国胃肠内镜外科医师学会资助,已获得 Advarra 机构审查委员会(Pro00055990)的批准。考虑到需要前瞻性方法,在 2021 年 8 月至 2022 年 9 月期间,在美国六个医疗中心对接受原发性 LSG 手术的患者进行数据收集后,本研究开始进行。通过 ArborMetrix 实现了数据集中化。每个中心都有自己的强化康复方案,并未尝试对方案进行标准化。

结果

分析包括 365 名术前 BMI 平均值为 43.7±5.7kg/m²的患者。30 天并发症、再次手术、再入院、急诊就诊和紧急护理就诊的发生率较低,分别为 1.6%、0.5%、0.2%、0.2%和 0%。两名患者(0.5%)发生 IIIb 级并发症。无死亡或漏诊报告。

结论

这项前瞻性队列研究表明,在经验丰富的美国中心,高度选择的患者在 LSG 后当天出院似乎是安全的。

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