Trials / Completed
CompletedNCT02031809
Multicentric Study VATS Major Introperative Complications
Analysis of the Most Common Major Intraoperative Complications During Video-assisted Thoracoscopic Surgery (VATS) Anatomical Resections - On Behalf of MITIG-ESTS
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 3,076 (actual)
- Sponsor
- University Hospital, Gasthuisberg · Academic / Other
- Sex
- All
- Age
- 18 Years – 90 Years
- Healthy volunteers
- Not accepted
Summary
This study investigates the most common major complications that result in unplanned additional surgery in patients undergoing vats anatomical resections. Several high-volume European centres participate. The purpose is to quantify these major complications, discuss the steps that can be taken to prevent these events, how they can be dealt with, be it by vats or conversion
Detailed description
Vats lobectomy is becoming the standard of care for early stage lung cancer. Several studies have shown feasibility and safety in dedicated centres. Compared to thoracotomy the procedure results in at least equal oncologic results and survival, perhaps better. Most series do not publish their early experience. They are retrospective and report on lobectomies and segmentectomies, excluding the live-saving pneumonectomies. They are potentially ignoring the intention-to-treat principle, excluding conversions. Based on scarce existing literature and conference worst-case presentations a pattern of the most common intraoperative major complications can be drawn In Europe, a large percentage of high-volume-centres have now successfully implemented a vats lobectomy program. In this era with low-volume-centres switching into vats anatomical resections, it is important to focus on potentially life-threatening complications. To be aware of potential hazards is the best way to avoid them.
Conditions
Timeline
- Start date
- 2014-01-01
- Primary completion
- 2015-09-01
- Completion
- 2015-10-01
- First posted
- 2014-01-09
- Last updated
- 2019-09-26
Locations
9 sites across 9 countries: Austria, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, Switzerland
Source: ClinicalTrials.gov record NCT02031809. Inclusion in this directory is not an endorsement.