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Randomized Study on Effects of Uniportal VATS Versus Triportal VATS

NCT03240250 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2021-02-09

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

    lead OTHER

Principal Investigators

  • Davide Tosi · Fondazione Ca' Granda IRCCS Policlinico Milan

Eligibility

Min Age
30 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-12
Primary Completion
2020-10-01
Completion
2020-10-01

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03240250 on ClinicalTrials.gov