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一项验证机器人辅助胸外科手术与电视辅助胸腔镜手术治疗肺癌术后疼痛非劣效性的多中心前瞻性研究:日本机器人辅助胸外科手术兴趣小组 01 期(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).

机构信息

Department of Thoracic and Cardiovascular Surgery, Mie University, Tsu, Japan; Clinical Research Support Center, Mie University Hospital, Tsu, Japan.

Clinical Research Support Center, Mie University Hospital, Tsu, Japan.

出版信息

Lung Cancer. 2024 Oct;196:107961. doi: 10.1016/j.lungcan.2024.107961. Epub 2024 Sep 21.

Abstract

OBJECTIVES

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.

METHODS

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.

RESULTS

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.

CONCLUSION

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.

摘要

目的

我们旨在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,并阐明肺癌患者端口数量或位置与术后疼痛之间的关系。

方法

纳入接受 RATS 或 VATS 解剖性肺切除术且在 7 天内拔除胸腔引流管的患者。主要终点是术后第 30 天(POD30)数字评分量表(NRS)评分≤3 的患者比例。目标样本量为 400 例患者。

结果

纳入了来自 12 家机构的 405 例患者(RATS 组 n=196,VATS 组 n=209)。VATS 组中有 99 例患者接受了单端口手术。RATS 组与 VATS 组之间在插入端口的平均数量(5.0 个比 2.2 个)、受伤的肋间部位数量(2.9 个比 1.9 个)、最大伤口大小(3.4cm 比 3.7cm)、手术时间(202min 比 165min)和硬膜外麻醉或连续神经阻滞的使用(45%比 31%)方面存在显著差异。在 RATS 组和 VATS 组中,POD30 时 NRS≤3 的比例分别为 82.0%和 94.7%(95%CI:-19.0 至-6.6%),这不能证明非劣效性。然而,在多变量分析中,RATS 方法并不能证明是一个显著的风险因素。

结论

在日本微创胸腔镜手术的现状下,RATS 比 VATS 涉及更多的端口、更长的手术时间和更高的局部麻醉频率,并且在术后疼痛方面可能更差。

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