European Surgical Outcomes Study (EuSOS)

This study has been completed.
Sponsor:
Collaborators:
European Society of Anaesthesiology
European Society of Intensive Care Medicine
Information provided by:
Queen Mary University of London
ClinicalTrials.gov Identifier:
NCT01203605
First received: September 15, 2010
Last updated: September 4, 2012
Last verified: June 2011
  Purpose

The European Surgical Outcomes Study (EuSOS) is a multi-centre, international cohort study of peri-operative care and clinical outcomes for patients undergoing non-cardiac surgery.

Participating centres throughout Europe will contribute routine clinical data describing all eligible patients who undergo surgery from 4th April 2011 to 11th April 2011. Patients will then be followed until hospital discharge (or for a maximum of 60 days) for duration of hospital stay and hospital mortality. Routine clinical data will also be collected for those patients admitted to critical care at any stage after surgery but during the same hospital admission. Specific objectives are to describe clinical outcomes and standards of peri-operative care for patients undergoing non-cardiac surgery in Europe.


Condition
Non-cardiac Surgery

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: European Surgical Outcomes Study: A Multi-centre, International Seven Day Evaluation of Patient Care and Clinical Outcomes for Patients Undergoing Non-cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Queen Mary University of London:

Primary Outcome Measures:
  • Mortality [ Time Frame: In-hospital (maximum 60 days) ] [ Designated as safety issue: No ]
    Mortality prior to actual hospital discharge regardless of location censored at 60 days.


Secondary Outcome Measures:
  • Duration of hospital stay [ Time Frame: Within single hospital admission ] [ Designated as safety issue: No ]
    Time in days from day of surgery to actual hospital discharge regardless of location

  • Planned admission to critical care [ Time Frame: Within same hospital admission ] [ Designated as safety issue: No ]
    Post-operative admission to critical care which was planned and agreed prior to surgery

  • Unplanned admission to critical care [ Time Frame: Within same hospital admission ] [ Designated as safety issue: No ]
    Unplanned post-operative admission to critical care at any stage in the same hospital admission

  • Duration of critical care stay [ Time Frame: Within same hospital admission ] [ Designated as safety issue: No ]
    Time in days from admission to critical care to actual discharge from critical care or death

  • 28 day mortality [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Mortality up to 28 days after primary surgical procedure


Enrollment: 46985
Study Start Date: April 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
In-patient adult non-cardiac surgery
Consecutive patients admitted to participating centres undergoing elective and non-elective non-cardiac surgery commencing during the seven day study period with a planned overnight stay. All eligible patients undergoing surgery within the seven day study period will be recruited wherever possible.

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

In-patient adult non-cardiac surgery

Criteria

Inclusion Criteria:

  • Consecutive patients admitted to participating centres undergoing elective and non-elective non-cardiac surgery commencing during the seven day cohort period with a planned overnight stay

Exclusion Criteria:

  • patients undergoing planned day-case surgery
  • cardiac surgery
  • neurosurgery
  • radiological procedures
  • obstetric procedures
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01203605

  Show 28 Study Locations
Sponsors and Collaborators
Queen Mary University of London
European Society of Anaesthesiology
European Society of Intensive Care Medicine
Investigators
Study Chair: Rupert Pearse, MBBS FRCA MD Queen Mary's University of London, UK
Principal Investigator: Andrew Rhodes, MBBS FRCA St Georges Hospital, London UK
Principal Investigator: Rui Moreno, MD Hospital de Santo António dos Capuchos, Lisboa, Portugal
Principal Investigator: Paolo Pelosi, MD University of Insubria, Varese, Italy.
Principal Investigator: Claudia Spies, MD Charité Universitätsmedizin, Berlin, Germany.
Principal Investigator: Jean-Louis Vincent, MD PhD Erasme Hospital, Free University of Brussels, Belgium.
Principal Investigator: Benoit Vallet, MD PhD Centre Hospitalier Universitaire de Lille, France.
Principal Investigator: Philip Metnitz, MD Medizinische Universität Wien, Austria.
Principal Investigator: Peter Bauer, PhD Medizinische Universität Wien, Austria.
Principal Investigator: Andreas Hoeft, MD PhD University Hospital Bonn, Germany
  More Information

Additional Information:
No publications provided

Responsible Party: Dr Rupert Pearse, Queen Mary's University of London
ClinicalTrials.gov Identifier: NCT01203605     History of Changes
Other Study ID Numbers: EuSOS 1.1
Study First Received: September 15, 2010
Last Updated: September 4, 2012
Health Authority: UK: Regulatory approval process differs in each nation. Sponsorship is not required in some nations or delegated to participating institutions in others.

Keywords provided by Queen Mary University of London:
Operative surgical procedures
mortality
adverse effects
Postoperative complications
Epidemiological Study

ClinicalTrials.gov processed this record on July 26, 2014