Mendogni Paolo, Mazzucco Alessandra, Palleschi Alessandro, Rosso Lorenzo, Righi Ilaria, Carrinola Rosaria, Damarco Francesco, Privitera Emilia, Fumagalli Jacopo, Bonitta Gianluca, Nosotti Mario, Tosi Davide
Thoracic Surgery and Lung Transplant Unit, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Via Francesco Sforza 35, Milan, Italy.
Department of Anesthesia and Critical Care, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Milan, Italy.
Trials. 2021 Feb 25;22(1):163. doi: 10.1186/s13063-021-05115-w.
Video-assisted thoracoscopic surgery (VATS) lobectomy is currently the recommended approach for treating early-stage non-small cell lung cancer (NSCLC). Different VATS approaches have been proposed so far, and the actual advantages of one technique over the other are still under debate. The aim of our study is to compare postoperative pain and analgesic drug consumption in uniportal VATS and triportal VATS for pulmonary lobectomy in early-stage lung cancer patients.
This study is a single-center, prospective, two-arm, parallel-group, randomized controlled trial. It is designed to compare uniportal video-assisted thoracic surgery (u-VATS) and three-port video-assisted thoracic surgery (t-VATS) in terms of postoperative pain. The trial will enroll 120 patients with a 1:1 randomization. The primary outcome is the assessment of analgesic drug consumption. Secondary outcomes are postoperative pain measurement, evaluation of postoperative pulmonary function, and metabolic recovery after pulmonary lobectomy.
The choice of which VATS approach to adopt for treating patients undergoing pulmonary resection mostly depends on the surgeon's preferences; therefore, it is hard to prove whether one VATS technique is superior to the other. Moreover, postoperative analgesic protocols vary consistently among different centers. To date, only a few studies have evaluated the effects of the most popular VATS techniques. There is no evidence about the difference between multiport VATS and u-VATS in terms of postoperative pain. We hope that the results of our trial will provide valuable information on the outcomes of these different surgical approaches.
ClinicalTrials.gov NCT03240250 . Registered on 07 August 2017; retrospectively registered.
电视辅助胸腔镜手术（VATS）肺叶切除术是目前治疗早期非小细胞肺癌（NSCLC）的推荐方法。目前已提出了不同的VATS方法，而一种技术相对于另一种技术的实际优势仍存在争议。我们研究的目的是比较单孔VATS和三孔VATS用于早期肺癌患者肺叶切除术后的疼痛及镇痛药消耗量。
本研究是一项单中心、前瞻性、双臂、平行组、随机对照试验。旨在比较单孔电视辅助胸腔镜手术（u-VATS）和三孔电视辅助胸腔镜手术（t-VATS）术后疼痛情况。该试验将纳入120例患者，按1:1随机分组。主要结局是评估镇痛药消耗量。次要结局包括术后疼痛测量、术后肺功能评估以及肺叶切除术后的代谢恢复情况。
对于接受肺切除术的患者采用哪种VATS方法，很大程度上取决于外科医生的偏好；因此，很难证明一种VATS技术是否优于另一种。此外，不同中心的术后镇痛方案差异很大。迄今为止，只有少数研究评估了最常用的VATS技术的效果。尚无证据表明多端口VATS和u-VATS在术后疼痛方面存在差异。我们希望我们试验的结果将为这些不同手术方法带来的结局提供有价值的信息。
ClinicalTrials.gov NCT03240250。于2017年8月7日注册；回顾性注册。
