Importance Robotic gastrectomy (RG) for gastric cancer may be associated with decreased incidence of intra-abdominal infectious complications, including pancreatic fistula, leakage, and abscess. Prospective randomized clinical trials comparing laparoscopic gastrectomy (LG) and RG are thus required.

Objective To compare the short-term surgical outcomes of RG with those of LG for patients with gastric cancer.

Design, Setting, and Participants In this phase 3, prospective superiority randomized clinical trial of RG vs LG regarding reduction of complications, 241 patients with resectable gastric cancer (clinical stages I-III) were enrolled between April 1, 2018, and October 31, 2020.

Interventions LG vs RG.

Main Outcomes and Measures The primary end point was the incidence of postoperative intra-abdominal infectious complications. Secondary end points were incidence of any complications, surgical results, postoperative courses, and oncologic outcomes. The modified intention-to-treat population excluded patients who had been randomized and met the postrandomization exclusion criteria. There was also a per-protocol population for analysis of postoperative complications.

Results This study enrolled 241 patients, with 236 patients in the modified intention-to-treat population (150 men [63.6%]; mean [SD] age, 70.8 [10.7] years). There was no significant difference in the incidence of intra-abdominal infectious complications (per-protocol population: 10 of 117 [8.5%] in the LG group vs 7 of 113 [6.2%] in the RG group). Of 241 patients, 122 were randomly assigned to the LG group, and 119 patients were randomly assigned to the RG group. Two of the 122 patients (1.6%) in the LG group converted from LG to open surgery, and 4 of 119 patients (3.4%) in the RG group converted from RG to open or laparoscopic surgery, with no significant difference. Finally, 117 patients in the LG group completed the procedure, and 113 in the RG group completed the procedure; these populations were defined as the per-protocol population. The overall incidence of postoperative complications of grade II or higher was significantly higher in the LG group (23 [19.7%]) than in the RG group (10 [8.8%]) (P = .02). Even in analysis limited to grade IIIa or higher, the complication rate was still significantly higher in the LG group (19 [16.2%]) than in the RG group (6 [5.3%]) (P = .01).

Conclusions and Relevance This study found no reduction of intra-abdominal infectious complications with RG compared with LG for gastric cancer.

Trial Registration umin.ac.jp/ctr Identifier: UMIN000031536

重要性 胃癌机器人胃切除术 (RG) 可能与降低腹内感染并发症的发生率有关，包括胰瘘、渗漏和脓肿。因此，需要比较腹腔镜胃切除术 (LG) 和 RG 的前瞻性随机临床试验。

目的 比较RG与LG对胃癌患者的近期手术效果。

设计、设置和参与者 在这个 3 期，RG 与 LG 关于减少并发症的前瞻性随机临床试验中，241 名可切除胃癌（临床 I-III 期）患者在 2018 年 4 月 1 日至 10 月 31 日期间入组， 2020 年。

干预 LG 与 RG。

主要结果和措施 主要终点是术后腹腔感染并发症的发生率。次要终点是任何并发症的发生率、手术结果、术后疗程和肿瘤学结果。修改后的意向治疗人群排除了已随机化并符合随机化后排除标准的患者。还有一个符合方案的人群用于分析术后并发症。

结果 该研究招募了 241 名患者，其中 236 名患者属于改良意向治疗人群（150 名男性 [63.6%]；平均 [SD] 年龄，70.8 [10.7] 岁）。腹腔感染并发症的发生率没有显着差异（符合方案人群：LG 组 117 人中有 10 人 [8.5%]，而 RG 组 113 人中有 7 人 [6.2%]）。在 241 名患者中，122 名患者被随机分配到 LG 组，119 名患者被随机分配到 RG 组。LG组122例患者中2例（1.6%）LG转开腹手术，RG组119例患者中4例（3.4%）RG转开腹或腹腔镜手术，差异无统计学意义。最终，LG组117人完成手术，RG组113人完成手术；这些人群被定义为符合方案的人群。P  = .02)。即使在仅限于 IIIa 级或更高级别的分析中，LG 组 (19 [16.2%]) 的并发症发生率仍显着高于 RG 组 (6 [5.3%]) ( P  = .01)。

结论和相关性 本研究发现，与 LG 相比，RG 对胃癌的腹内感染并发症没有减少。

试用注册 umin.ac.jp/ctr 标识符：UMIN000031536