Feasibility of robotic-assisted surgery in advanced rectal cancer: a multicentre prospective phase II study (VITRUVIANO trial).

IF 3.5 3区医学 Q1 SURGERY

BJS Open Pub Date : 2024-05-08 DOI:10.1093/bjsopen/zrae048

Atsushi Hamabe, Ichiro Takemasa, Masanori Kotake, Daisuke Nakano, Suguru Hasegawa, Akio Shiomi, Masakatsu Numata, Kazuhiro Sakamoto, Kei Kimura, Tsunekazu Hanai, Takeshi Naitoh, Yosuke Fukunaga, Yusuke Kinugasa, Jun Watanabe, Junichiro Kawamura, Mayumi Ozawa, Koji Okabayashi, Shuichiro Matoba, Yoshinao Takano, Mamoru Uemura, Yukihide Kanemitsu, Yoshiharu Sakai, Masahiko Watanabe

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引用次数: 0

Abstract

Background: The potential benefits of robotic-assisted compared with laparoscopic surgery for locally advanced cancer have not been sufficiently proven by prospective studies. One factor is speculated to be the lack of strict surgeon criteria. The aim of this study was to assess outcomes for robotic surgery in patients with locally advanced rectal cancer with strict surgeon experience criteria.

Methods: A criterion was set requiring surgeons to have performed more than 40 robotically assisted operations for rectal cancer. Between March 2020 and May 2022, patients with rectal cancer (distance from the anal verge of 12 cm or less, cT2-T4a, cN0-N3, cM0, or cT1-T4a, cN1-N3, cM0) were registered. The primary endpoint was the rate positive circumferential resection margin (CRM) from the pathological specimen. Secondary endpoints were surgical outcomes, pathological results, postoperative complications, and longterm outcomes.

Results: Of the 321 registered patients, 303 were analysed, excluding 18 that were ineligible. At diagnosis: stage I (n = 68), stage II (n = 84) and stage III (n = 151). Neoadjuvant therapy was used in 56 patients. There were no conversions to open surgery. The median console time to rectal resection was 170 min, and the median blood loss was 5 ml. Fourteen patients had a positive CRM (4.6%). Grade III-IV postoperative complications were observed in 13 patients (4.3%).

Conclusion: Robotic-assisted surgery is feasible for locally advanced rectal cancer when strict surgeon criteria are used.

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机器人辅助手术治疗晚期直肠癌的可行性：多中心前瞻性 II 期研究（VITRUVIANO 试验）。

背景：与腹腔镜手术相比，机器人辅助手术治疗局部晚期癌症的潜在优势尚未得到前瞻性研究的充分证实。据推测，其中一个因素是缺乏严格的外科医生标准。本研究的目的是在严格的外科医生经验标准下评估局部晚期直肠癌患者的机器人手术效果：方法：设定的标准是外科医生必须实施过 40 例以上的直肠癌机器人辅助手术。在 2020 年 3 月至 2022 年 5 月期间，登记了直肠癌患者（距离肛门边缘 12 厘米或以下、cT2-T4a、cN0-N3、cM0 或 cT1-T4a、cN1-N3、cM0）。主要终点是病理标本的周缘切除边缘（CRM）阳性率。次要终点是手术结果、病理结果、术后并发症和长期疗效：在 321 名登记患者中，除去 18 名不符合条件的患者，共对 303 名患者进行了分析。诊断时：I期（68人）、II期（84人）和III期（151人）。56名患者接受了新辅助治疗。没有患者转为开放手术。直肠切除术的中位控制时间为170分钟，中位失血量为5毫升。14名患者的CRM呈阳性（4.6%）。13名患者（4.3%）出现了III-IV级术后并发症：结论：如果严格遵守外科医生的标准，机器人辅助手术对局部晚期直肠癌是可行的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

BJS Open SURGERY-

CiteScore

6.00

自引率

3.20%

发文量

144