Clinical trial NCT02031809: Multicentric Study VATS Major Introperative Complications
Official title: Analysis of the Most Common Major Intraoperative Complications During Video-assisted Thoracoscopic Surgery (VATS) Anatomical Resections - On Behalf of MITIG-ESTS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Neoplasms
Keywords: Thoracic Surgery, Video-Assisted
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2014-01-09
Enrollment: 3076
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients intended to undergo a vats anatomical resection

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Most series do not publish their early experience.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.

Eligibility criteria: 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.

Primary outcomes:
measure: additional unplanned major surgery
timeFrame: during vats anatomical resection or at revision within 30 days
Secondary outcomes:
measure: number of conversions to open surgery
timeFrame: during VATS procedure
Other outcomes:
Locations:
city: Innsbruck
country: Austria
facility: Department of Visceral, Transplant and Thoracic Surgery, Innsbruck University Hospital
city: Copenhagen
country: Denmark
facility: Department of Cardiothoracic Surgery, Rigshospitalet
city: Paris
country: France
facility: Thoracic Department, Institut Mutualiste Montsouris
city: Koblenz
country: Germany
facility: Katholisches Klinikum, Thoraxchirurgie
city: Ancona
country: Italy
facility: Division of Thoracic Surgery, Ospedali Riuniti Ancona
city: Heerlen
country: Netherlands
facility: Maatschap Heelkunde Zuid-Limburg
city: Poznan
country: Poland
facility: Karol Marcinkowski University of Med Sciences, Department of Thoracic Surgery
city: Coruña
country: Spain
facility: Department of Thoracic Surgery
city: Zürich
country: Switzerland
facility: UniversitätsSpital Zürich
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Herbert Dacaluwé, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Thoracic Department, Institut Mutualiste Montsouris, 42 Bd Jourdan, F-75014 Paris, France
name: Dominique Gossot, MD
role: PRINCIPAL_INVESTIGATOR
References: