Uniportal and three-portal video-assisted thoracic surgery pulmonary lobectomy for early-stage lung cancer (UNIT trial): study protocol of a single-center randomized trial

Trials

Jacopo Fumagalli¹  Emilia Privitera²  Alessandra Mazzucco²  Francesco Damarco²  Gianluca Bonitta²  Paolo Mendogni²  Ilaria Righi²  Davide Tosi²  Alessandro Palleschi²  Lorenzo Rosso²  Rosaria Carrinola²  Mario Nosotti³ 

[1] Department of Anesthesia and Critical Care, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, Milan, Italy;Thoracic Surgery and Lung Transplant Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, University of Milan, Via Francesco Sforza 35, Milan, Italy;Thoracic Surgery and Lung Transplant Unit, Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico, University of Milan, Via Francesco Sforza 35, Milan, Italy;Department of Pathophysiology and Transplantation, Università degli Studi di Milano, Milan, Italy;

关键词: Lung cancer;    Postoperative pain;    Pulmonary lobectomy;    Uniportal;    Thoracic surgery;    VATS;   

DOI  :  10.1186/s13063-021-05115-w

来源: Springer

【 摘 要 】

BackgroundVideo-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.MethodsThis 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.DiscussionThe 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.Trial registrationClinicalTrials.gov NCT03240250. Registered on 07 August 2017; retrospectively registered.

【 授权许可】

CC BY