Clinical Trials Directory

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 Most series do not publish their early experience.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.