一项前瞻性多机构研究,旨在验证机器人辅助胸腔镜手术与电视辅助胸腔镜肺癌手术相比术后疼痛的非劣效性:日本 RATS 兴趣组 01 (J-RATSIG 01)。
A prospective multi-institutional study to verify the non-inferiority of postoperative pain in robot-assisted thoracic surgery in comparison with video-assisted thoracoscopic surgery for lung cancer: The Japanese RATS interest group 01 (J-RATSIG 01).
发表日期:2024 Oct
作者:
Koji Kawaguchi, Toru Ogura, Shinji Kaneda, Takuya Watanabe, Junichi Soh, Kumiko Hashimoto, Noriaki Sakakura, Mikio Okazaki, Shoichi Mori, Masaki Hashimoto, Koichi Fukumoto, Masahiro Miyajima, Shuhei Yoshida, Satoru Moriyama, Satoshi Tamaru, Motoshi Takao
来源:
LUNG CANCER
摘要:
我们试图比较机器人辅助胸腔镜手术(RATS)和电视辅助胸腔镜手术(VATS)术后疼痛的最新数据,并阐明肺癌患者手术端口的数量或位置与术后疼痛之间的关系。纳入通过 RATS 或 VATS 进行解剖性肺切除术并在 7 天内拔除胸管的患者。主要终点是术后第 30 天 (POD30) 数字评定量表 (NRS) 评分≤ 3 的患者百分比。目标样本量为 400 名患者。包括在 12 个机构管理的 405 名患者(RATS,n = 196;VATS,n = 209)。 VATS 组中的 99 名患者接受了单孔手术。 RATS 组和 VATS 组之间在平均插入端口数量(5.0 vs. 2.2)、受伤肋间部位数量(2.9 vs. 1.9)、最大伤口尺寸(3.4 vs. 3.7 cm)、手术时间(3.4 vs. 3.7 cm)方面观察到显着差异。 202 与 165 分钟),并使用硬膜外麻醉或连续神经阻滞(45 与 31%)。在RATS组和VATS组中,POD30时NRS≤3的比率分别为82.0%和94.7%(95%CI:-19.0至-6.6%),不能证明非劣效性。然而,在多变量分析中,RATS方式并未被证明是显着的危险因素。在日本微创胸外科现状中,RATS涉及的端口数量较多、手术时间较长、局麻频率较高。与 VATS 相比,在术后疼痛方面可能较差。版权所有 © 2024 作者。由 Elsevier B.V. 出版。保留所有权利。
We sought to compare the latest data on postoperative pain between robot-assisted thoracic surgery (RATS) and video-assisted thoracoscopic surgery (VATS), and to clarify the relationship between the number or placement of ports and postoperative pain in patients with lung cancer.Patients who underwent anatomical lung resection by RATS or VATS and whose chest tube was removed within 7 days were enrolled. The primary endpoint was the percentage of patients with a numeric rating scale (NRS) score ≤ 3 on postoperative day 30 (POD30). The target sample size was 400 patients.Four hundred five patients (RATS, n = 196; VATS, n = 209) managed at 12 institutions were included. Ninety-nine patients in the VATS group underwent a uniport procedure. Significant differences were observed between the RATS and VATS groups in the mean number of inserted ports (5.0 vs. 2.2), number of injured intercostal sites (2.9 vs. 1.9), largest wound size (3.4 vs. 3.7 cm), operation time (202 vs. 165 min), and use of epidural anesthesia or continuous nerve block (45 vs. 31 %). In the RATS and VATS groups, the rates of NRS≤3 on POD30 were 82.0 % and 94.7 % (95 %CI: -19.0 to -6.6 %), respectively, which could not prove noninferiority. However, in a multivariable analysis, the RATS approach was not proven to be a significant risk factor.In the current status of minimally invasive thoracic surgery in Japan, RATS involves a greater number of ports, longer operation time, and higher frequency of local anesthesia than VATS and may be inferior in terms of postoperative pain.Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.