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
| Autor: | Davide Tosi, Mario Nosotti, Paolo Mendogni, Jacopo Fumagalli, Emilia Privitera, Alessandro Palleschi, Alessandra Mazzucco, Lorenzo Rosso, Ilaria Righi, Rosaria Carrinola, Gianluca Bonitta, F. Damarco |
|---|---|
| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
medicine.medical_specialty
Lung Neoplasms Randomization Analgesic Medicine (miscellaneous) VATS 030204 cardiovascular system & hematology Single Center Pulmonary function testing law.invention Postoperative pain Pulmonary lobectomy Study Protocol 03 medical and health sciences 0302 clinical medicine Randomized controlled trial law Carcinoma Non-Small-Cell Lung parasitic diseases Humans Medicine Pharmacology (medical) Prospective Studies Stage (cooking) Pneumonectomy Lung cancer Randomized Controlled Trials as Topic Uniportal lcsh:R5-920 Thoracic Surgery Video-Assisted business.industry nutritional and metabolic diseases medicine.disease Surgery Thoracic surgery 030228 respiratory system Cardiothoracic surgery business lcsh:Medicine (General) human activities tissues |
| Zdroj: | Trials, Vol 22, Iss 1, Pp 1-8 (2021) Trials |
| ISSN: | 1745-6215 |
| Popis: | Background 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. Methods 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. Discussion 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. Trial registration ClinicalTrials.gov NCT03240250. Registered on 07 August 2017; retrospectively registered. |
| Databáze: | OpenAIRE |
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