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

Abstract 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-centre, prospective, two-arm, parallel-group, randomized controlled trial. It is designed to compare uniportal video-assisted thoracic surgery (u-VATS) and three-ports video-assisted thoracic surgery (t-VATS) in terms of post-operative pain. The trial will enrol 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 centres. To date, only a few studies have evaluated the effects of the most popular VATS techniques. There is no evidence about difference between multi-ports 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 08/07/2017; retrospectively registered; https://clinicaltrials.gov/ct2/show/NCT03240250?term=NCT03240250&draw=2&rank=1