Multicentric Study VATS Major Introperative Complications

NCT02031809 | Completed

• 1 other identifier: MC_VATS complic
• Study Type: observational
• Target: 3,076
• Locations: 9 countries
• Sites: 9

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

Conditions

Lung Neoplasms

Keywords

Thoracic Surgery, Video-Assisted

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• number of conversions to open surgery

  during VATS procedure

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients intended to undergo a vats anatomical resection

You may qualify if:

• Patients that did undergo resection for oncologic reasons

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Gasthuisberg: lead

Study Sites (9)

Department of Visceral, Transplant and Thoracic Surgery, Innsbruck University Hospital

Innsbruck, Austria

Location

Department of Cardiothoracic Surgery, Rigshospitalet

Copenhagen, Denmark

Location

Thoracic Department, Institut Mutualiste Montsouris

Paris, F-75014, France

Location

Katholisches Klinikum, Thoraxchirurgie

Koblenz, Germany

Location

Division of Thoracic Surgery, Ospedali Riuniti Ancona

Ancona, 60020, Italy

Location

Maatschap Heelkunde Zuid-Limburg

Heerlen, Netherlands

Location

Karol Marcinkowski University of Med Sciences, Department of Thoracic Surgery

Poznan, Poland

Location

Department of Thoracic Surgery

A Coruña, Spain

Location

UniversitätsSpital Zürich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Herbert Dacaluwé, MD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

• Dominique Gossot, MD

  Thoracic Department, Institut Mutualiste Montsouris, 42 Bd Jourdan, F-75014 Paris, France

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Datamanager Thoracic Surgery

Study Record Dates

• First Submitted: January 7, 2014
• First Posted: January 9, 2014
• Study Start: January 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: October 1, 2015
• Last Updated: September 26, 2019

Record last verified: 2019-09

Locations

DK (1); DE (1); PL (1); AU (1); FR (1); IT (1); ES (1); NL (1); CH (1)