VATS Versus Open Pulmonary Lobectomy in the Limelight of OEP (NCT02910453) | Clinical Trial Compass
CompletedNot Applicable
VATS Versus Open Pulmonary Lobectomy in the Limelight of OEP
Italy78 participantsStarted 2015-01
Plain-language summary
The standard operative approach to pulmonary lesions has been via postero-lateral thoracotomy and direct vision. This technique has some advantages but its morbidity is significant. Some surgeons advocate a resection by video-assisted thoracic surgery (VATS) to reduce the impact on chest wall and the impairment on respiratory mechanic. However, an evidence for superiority of the approach minimally invasive is lacking, particularly for the difficult assessment of the change in pulmonary function. The aim of this study is to compare VATS- over open lobectomy regarding the differences of chest wall kinematic, analyzed by optoelectronic plethysmography (OEP).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Lesion not in close relation to the hilar structures (bronchus, vessels) based on CT
* Non-Small Cell Lung Cancer clinically staged T1-2, N0 or N1, M0
* Subject must be able to tolerate general anesthesia and have cardiopulmonary reserve to tolerate a lobectomy
Exclusion Criteria:
* Previous thoracic surgery on same side
* Planned segment resection or pneumonectomy
* Any type of chronic pain, requiring daily use of analgesics
* Body Mass Index (BMI) ≥ 35
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Modification of respiratory kinematic
Timeframe: T0: preoperatively (2 weeks before surgery); T1: 1 week after surgery; T2: 2 months after surgery
Trial details
NCT IDNCT02910453
SponsorFondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico