NCT03240250

Randomized Study on Effects of Uniportal VATS Versus Triportal VATS

Randomized Study on Effects of Uniportal VATS Versus Triportal VATS for the Treatment of Stage I-II NSCLC

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 120 (actual)
• Sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Academic / Other
• Sex: All
• Age: 30 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

For the treatment of stage I-II NSCLC, two mini-invasive techniques are mostly utilized: uni-portal and three-portal VATS. In the uniportal approach, the injury on a single intercostal space could determine a lower level of pain than the three-portal approach, allowing a better postoperative course. Few studies in Literature compare these techniques, and most of them are retrospective. The main purpose of this randomized study is to compare uni-portal VATS with three-portal VATS, in terms of postoperative pain. Secondary objectives of the study are valutations of: * respiratory and functional capacity between the two groups * operative time * number of resected lymphnodes * intra and postoperative complications, such as conversions to open surgery, amount of bleeding, prolonged air leaks, surgical site infections, pulmonary complications.

Detailed description

Randomized cohort clinical trial, prospectic, monocentric. Procedure of randomization: the day before the operation, with the "Random Allocation Rule" technique Arm 1: pulmonary lobectomy and lymphoadenectomy with uni-portal VATS approach Arm 2: pulmonary lobectomy and lymphoadenectomy with three-portal VATS approach Misurations Total analgesic consumption, normalized to morphine milligrams, recorded in the 7 days following the operation. The choice of cumulative analgesic consumption as parameter of primary outcome is because pain valuation with VAS is significantly affected by individual variability. Secondary outcomes: measure of postoperative pain with NRS at 2,6,12,24 hours and at 2,3,4,5,30 days from sugery. A pain score will be assigned to each patient after the total amount of NRS. Respiratory function will be valuated with spirometry after 7 and 30 days from surgery, and compared with pre-operative tests. All intraoperative parameters will be compared between the two groups: operative time (skin to skin), proportion of conversions to open surgery, number of resected lymphnodes, amount of bleeding. Postoperative complications will be analyzed: rate of prolonged air leaks, surgical site infections, cardiac rythhm disfunctions, pulmonary complications, post-thoracotomy syndrome, as well as lenght of stay at the hospital.

Conditions

• Lung Cancer

Interventions

Type	Name	Description
PROCEDURE	VATS uni-portal lobectomy and lymphoadenectomy	VATS uni-portal lobectomy and lymphoadenectomy
PROCEDURE	VATS three-portal lobectomy and lymphoadenectomy	VATS three-portal lobectomy and lymphoadenectomy, Copenhagen approach

Timeline

• Start date: 2017-03-12
• Primary completion: 2020-10-01
• Completion: 2020-10-01
• First posted: 2017-08-07
• Last updated: 2021-02-09

Locations

1 site across 1 country: Italy