Multicentric Study VATS Major Introperative Complications

Completed

• Conditions: Lung Neoplasms

• Registration Number: NCT02031809
• Lead Sponsor: University Hospital, Gasthuisberg

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Most series do not publish their early experience.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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-07
• Study First Submitted QC: 2014-01-08
• Study First Posted: 2014-01-09
• Primary Completion: 2015-09
• Study Completion: 2015-10
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-24
• Last Update Posted: 2019-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3076

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (9)

Department of Visceral, Transplant and Thoracic Surgery, Innsbruck University Hospital; 🇦🇹 Innsbruck, Austria

Karol Marcinkowski University of Med Sciences, Department of Thoracic Surgery; 🇵🇱 Poznan, Poland

Thoracic Department, Institut Mutualiste Montsouris; 🇫🇷 Paris, France

Katholisches Klinikum, Thoraxchirurgie; 🇩🇪 Koblenz, Germany

Maatschap Heelkunde Zuid-Limburg; 🇳🇱 Heerlen, Netherlands

UniversitätsSpital Zürich; 🇨🇭 Zürich, Switzerland

Department of Cardiothoracic Surgery, Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Division of Thoracic Surgery, Ospedali Riuniti Ancona; 🇮🇹 Ancona, Italy

Department of Thoracic Surgery; 🇪🇸 Coruña, Spain