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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02031809

Enrollment

3076

Registered

2014-01-09

Start date

2014-01-31

Completion date

2015-10-31

Last updated

2019-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Neoplasms

Keywords

Thoracic Surgery, Video-Assisted

Brief 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 Most series do not publish their early experience.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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

Healthy volunteers

Inclusion criteria

* Patients that did undergo resection for oncologic reasons

Exclusion criteria

* Patients that did not undergo resection for oncologic reasons, such as pleural metastasis, irresectable disease.

Design outcomes

Primary

Measure	Time frame	Description
additional unplanned major surgery	during vats anatomical resection or at revision within 30 days	the percentage of major complications that resulted in additional unplanned major surgery during vats anatomical resection or at revision within 30 days.

Secondary

Measure	Time frame	Description
number of conversions to open surgery	during VATS procedure	The number of VATS procedures that need conversion to open surgery because of major complications or unplanned major surgery

Countries

Austria, Denmark, France, Germany, Italy, Netherlands, Poland, Spain, Switzerland

Outcome results