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

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

Study Overview

• Status: Completed
• Conditions: Lung Neoplasms

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Most series do not publish their early experience.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 Type: Observational
• Enrollment (Actual): 3076

Contacts and Locations

Study Locations

• Austria
  • Innsbruck, Austria
    • Department of Visceral, Transplant and Thoracic Surgery, Innsbruck University Hospital
• Denmark
  • Copenhagen, Denmark
    • Department of cardiothoracic surgery, Rigshospitalet
• France
  • Paris, France, F-75014
    • Thoracic Department, Institut Mutualiste Montsouris
• Germany
  • Koblenz, Germany
    • Katholisches Klinikum, Thoraxchirurgie
• Italy
  • Ancona, Italy, 60020
    • Division of Thoracic Surgery, Ospedali Riuniti Ancona
• Netherlands
  • Heerlen, Netherlands
    • Maatschap Heelkunde Zuid-Limburg
• Poland
  • Poznan, Poland
    • Karol Marcinkowski University of Med Sciences, Department of Thoracic Surgery
• Spain
  • Coruña, Spain
    • Department of Thoracic Surgery
• Switzerland
  • Zürich, Switzerland
    • Universitätsspital Zürich

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients intended to undergo a vats anatomical resection

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
No additional unplanned major surgery; uneventfull intra-operative and postoperative course
Additional unplanned major surgery; Additional per-operative or post-operative unplanned major surgery such as unforeseen pneumonectomy, bilobectomy, lobectomy or additional segmentectomy, repair of major vessels or bronchi, bronchopleural fistula, unplanned surgery to other organs, within 30 days after the primary surgery. These do not include: Conversions without additional unplanned major surgery or suddne blood loss less than 500cc; Conversions or additional resection for unforeseen oncologic reasons.; Plasty, repair or sleeve resection of vessels after deliberate resection or transection for oncologic reasons

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Gasthuisberg
• Investigators: Principal Investigator: Herbert Dacaluwé, MD, Universitaire Ziekenhuizen KU Leuven; Principal Investigator: Dominique Gossot, MD, Thoracic Department, Institut Mutualiste Montsouris, 42 Bd Jourdan, F-75014 Paris, France

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): October 1, 2015

Study Registration Dates

• First Submitted: January 7, 2014
• First Submitted That Met QC Criteria: January 8, 2014
• First Posted (Estimate): January 9, 2014

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Thoracic Surgery, Video-Assisted
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: MC_VATS complic