Multicentric Study VATS Major Introperative Complications

Lung Neoplasms Clinical Trial

Official title:

Analysis of the Most Common Major Intraoperative Complications During Video-assisted Thoracoscopic Surgery (VATS) Anatomical Resections - On Behalf of MITIG-ESTS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02031809
• Other study ID #: MC_VATS complic
• Status: Completed
• Start date: January 2014
• Est. completion date: October 2015

Study information

• Verified date: September 2019
• Source: University Hospital, Gasthuisberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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Most series do not publish their early experience.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3076
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Neoplasms

Locations

Country	Name	City	State
Austria	Department of Visceral, Transplant and Thoracic Surgery, Innsbruck University Hospital	Innsbruck
Denmark	Department of Cardiothoracic Surgery, Rigshospitalet	Copenhagen
France	Thoracic Department, Institut Mutualiste Montsouris	Paris
Germany	Katholisches Klinikum, Thoraxchirurgie	Koblenz
Italy	Division of Thoracic Surgery, Ospedali Riuniti Ancona	Ancona
Netherlands	Maatschap Heelkunde Zuid-Limburg	Heerlen
Poland	Karol Marcinkowski University of Med Sciences, Department of Thoracic Surgery	Poznan
Spain	Department of Thoracic Surgery	Coruña
Switzerland	UniversitätsSpital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gasthuisberg

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	additional unplanned major surgery	the percentage of major complications that resulted in additional unplanned major surgery during vats anatomical resection or at revision within 30 days.	during vats anatomical resection or at revision within 30 days
Secondary	number of conversions to open surgery	The number of VATS procedures that need conversion to open surgery because of major complications or unplanned major surgery	during VATS procedure