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机器人胃癌根治术与开腹胃癌根治术治疗胃癌的短期手术效果比较:一项随机试验。

Short-Term Surgical Outcomes of Robotic Gastrectomy Compared to Open Gastrectomy for Patients with Gastric Cancer: a Randomized Trial.

机构信息

Department of Gastroenterology, Instituto do Cancer do Estado de São Paulo, Hospital das Clinicas, Faculdade de Medicina, Universidade de São Paulo (ICESP- HCFMUSP), Av. Dr. Arnaldo, 251. 4th floor. Cerqueira Cesar, São Paulo, SP, 01246-000, Brazil.

出版信息

J Gastrointest Surg. 2022 Dec;26(12):2477-2485. doi: 10.1007/s11605-022-05448-0. Epub 2022 Sep 20.

Abstract

BACKGROUND

Robotic gastrectomy (RG) has been shown to be a safe and feasible method in gastric cancer (GC) treatment. However, most studies are in Eastern cohorts and there is great interest in knowing whether the method can be used routinely, especially in the West.

OBJECTIVES

The aim of this study was to compare the short-term surgical outcomes of D2-gastrectomy by RG versus open gastrectomy (OG).

METHODS

Single-institution, open-label, non-inferiority, randomized clinical trial performed between 2015 and 2020. GC patients were randomized (1:1 allocation) to surgical treatment by RG or OG. Da Vinci Si platform was used.

INCLUSION CRITERIA

gastric adenocarcinoma, stage cT2-4 cN0-1, potentially curative surgery, age 18-80 years, and ECOG performance status 0-1.

EXCLUSION CRITERIA

emergency surgery and previous gastric or major abdominal surgery. Primary endpoint was short-term surgical outcomes. The study is registered at clinicaltrials.gov (NCT02292914).

RESULTS

Of 65 randomized patients, 5 were excluded (3 palliatives, 1 obstruction and emergency surgery, and 1 for material shortage). Consequently, 31 and 29 patients were included for final analysis in the OG and RG groups, respectively. No differences were observed between groups regarding age, sex, BMI, comorbidities, ASA, and frequency of total gastrectomy. RG had similar mean number of harvested lymph nodes (p = 0.805), longer surgical time (p < 0.001), and less bleeding (p < 0.001) compared to OG. Postoperative complications, length of hospital stay, and readmissions in 30 days were equivalent between OG and RG.

CONCLUSIONS

RG reduces operative bleeding by more than 50%. The short-term outcomes were non-inferior to OG, although surgical time was longer in RG.

摘要

背景

机器人胃切除术(RG)已被证明是治疗胃癌(GC)的一种安全且可行的方法。然而,大多数研究都来自东方人群,人们非常关注这种方法是否可以常规应用,尤其是在西方。

目的

本研究旨在比较 RG 与开腹胃切除术(OG)行 D2 胃切除术的短期手术结果。

方法

这是一项于 2015 年至 2020 年进行的单中心、开放标签、非劣效性、随机临床试验。GC 患者按 1:1 分配接受 RG 或 OG 手术治疗。使用达芬奇 Si 平台。

纳入标准

胃腺癌,cT2-4 cN0-1 期,潜在可治愈性手术,年龄 18-80 岁,ECOG 表现状态 0-1。

排除标准

急症手术和既往胃或主要腹部手术。主要终点是短期手术结果。本研究在 clinicaltrials.gov 注册(NCT02292914)。

结果

在 65 名随机患者中,有 5 名被排除(3 名姑息治疗,1 名梗阻和急症手术,1 名因材料短缺)。因此,OG 和 RG 组分别有 31 名和 29 名患者最终纳入分析。两组患者的年龄、性别、BMI、合并症、ASA 和全胃切除术的频率无差异。与 OG 相比,RG 的平均淋巴结清扫数量相似(p=0.805),手术时间更长(p<0.001),出血量更少(p<0.001)。OG 和 RG 术后并发症、住院时间和 30 天内再入院率相当。

结论

RG 可减少 50%以上的手术出血。尽管 RG 的手术时间较长,但短期结果与 OG 相当。

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