European Surgical Outcomes Study

NCT01203605 | Completed

• 1 other identifier: EuSOS 1.1
• Study Type: observational
• Target: 46,985
• Locations: 25 countries
• Sites: 25

Brief Summary

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.

Conditions

Non-cardiac Surgery

Keywords

Operative surgical procedures; mortality; adverse effects; Postoperative complications; Epidemiological Study

Outcome Measures

Primary Outcomes (1)

• Mortality

  Mortality prior to actual hospital discharge regardless of location censored at 60 days.

  In-hospital (maximum 60 days)

Secondary Outcomes (5)

• Duration of hospital stay

  Within single hospital admission

• Planned admission to critical care

  Within same hospital admission

• Unplanned admission to critical care

  Within same hospital admission

• Duration of critical care stay

  Within same hospital admission

• 28 day mortality

  28 days

Study Arms (1)

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.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

In-patient adult non-cardiac surgery

You may qualify if:

• 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

You may not qualify if:

• patients undergoing planned day-case surgery
• cardiac surgery
• neurosurgery
• radiological procedures
• obstetric procedures

Sponsors & Collaborators

• Queen Mary University of London: lead
• European Society of Anaesthesiology: collaborator
• European Society of Intensive Care Medicine: collaborator

Study Sites (28)

National co-ordinator

Ghent, Belgium

Location

National co-ordinator

Zagreb, Croatia

Location

National co-ordinator

Nicosia, Cyprus

Location

National co-ordinator

Brno, Czechia

Location

National co-ordinator

Odense, Denmark

Location

National co-ordinator

Tallinn, Estonia

Location

National co-ordinator

Helsinki, Finland

Location

National co-ordinator

Nîmes, France

Location

National co-ordinator

Berlin, Germany

Location

National co-ordinator

Athens, Greece

Location

National co-ordinator

Pécs, Hungary

Location

National co-ordinator

Reykjavik, Iceland

Location

National co-ordinator

Mullingar, Ireland

Location

National co-ordinator

Udine, Italy

Location

National co-ordinator

Riga, Latvia

Location

National co-ordinator

Vilnius, Lithuania

Location

National co-ordinator

Leeuwarden, Netherlands

Location

National co-ordinator

Bergen, Norway

Location

National co-ordinator

Poznan, Poland

Location

National co-ordinator

Lisbon, Portugal

Location

National co-ordinator

Iași, Romania

Location

National co-ordinator

Belgrade, Serbia

Location

National co-ordinator

Košice, Slovakia

Location

National co-ordinator

Ljubljana, Slovenia

Location

National co-ordinator

Valladolid, Spain

Location

National co-ordinator

Malmo, Sweden

Location

National co-ordinator

Geneva, Switzerland

Location

National co-ordinator

London, United Kingdom

Location

Related Publications (4)

• Ahmad T, Beilstein CM, Aldecoa C, Moreno RP, Molnar Z, Novak-Jankovic V, Hofer CK, Sander M, Rhodes A, Pearse RM. Variation in haemodynamic monitoring for major surgery in European nations: secondary analysis of the EuSOS dataset. Perioper Med (Lond). 2015 Sep 23;4:8. doi: 10.1186/s13741-015-0018-8. eCollection 2015.

  PMID: 26405521 DERIVED

• van Zaane B, van Klei WA, Buhre WF, Bauer P, Boerma EC, Hoeft A, Metnitz P, Moreno RP, Pearse R, Pelosi P, Sander M, Vallet B, Pettila V, Vincent JL, Rhodes A; European Surgical Outcomes Study (EuSOS) group for the Trials groups of the European Society of Intensive Care Medicine and the European Society of Anaesthesiology. Nonelective surgery at night and in-hospital mortality: Prospective observational data from the European Surgical Outcomes Study. Eur J Anaesthesiol. 2015 Jul;32(7):477-85. doi: 10.1097/EJA.0000000000000256.

  PMID: 26001104 DERIVED

• Jammer I, Ahmad T, Aldecoa C, Koulenti D, Goranovic T, Grigoras I, Mazul-Sunko B, Matos R, Moreno R, Sigurdsson GH, Toft P, Walder B, Rhodes A, Pearse RM; European Surgical Outcomes Study (EuSOS) group. Point prevalence of surgical checklist use in Europe: relationship with hospital mortality. Br J Anaesth. 2015 May;114(5):801-7. doi: 10.1093/bja/aeu460. Epub 2015 Jan 13.

  PMID: 25586728 DERIVED

• Baron DM, Hochrieser H, Posch M, Metnitz B, Rhodes A, Moreno RP, Pearse RM, Metnitz P; European Surgical Outcomes Study (EuSOS) group for Trials Groups of European Society of Intensive Care Medicine; European Society of Anaesthesiology. Preoperative anaemia is associated with poor clinical outcome in non-cardiac surgery patients. Br J Anaesth. 2014 Sep;113(3):416-23. doi: 10.1093/bja/aeu098. Epub 2014 May 14.

  PMID: 24829444 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Rupert Pearse, MBBS FRCA MD

  Queen Mary's University of London, UK

  STUDY CHAIR

• 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

  Charite University, 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 16, 2010
• Study Start: April 1, 2011
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: September 5, 2012

Record last verified: 2011-06

Locations

CY (1); FI (1); CZ (1); DK (1); IE (1); LI (1); RO (1); SE (1); SL (1); ES (1); LA (1); NO (1); CR (1); GR (1); PL (1); DE (1); IC (1); PT (1); FR (1); CH (1); GB (1); BE (1); NL (1); IT (1); HU (1)