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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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12 July 2021 |
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Main ID: |
ISRCTN51817007 |
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Date of registration:
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03/01/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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International Surgical Outcomes Study (ISOS)
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Scientific title:
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International observational 7-day cohort study of complications following elective surgery |
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Date of first enrolment:
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01/04/2014 |
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Target sample size:
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50000 |
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Recruitment status: |
Completed |
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URL:
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https://www.isrctn.com/ISRCTN51817007 |
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Study type:
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Observational |
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Study design:
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International multicentre observational 7-day cohort study (Treatment)
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Phase:
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Not Applicable
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Countries of recruitment
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Australia
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Austria
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Belgium
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Brazil
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Canada
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China
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Egypt
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Germany
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Greece
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Hong Kong
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India
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Indonesia
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Iraq
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Italy
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Malaysia
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Mexico
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New Zealand
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Nigeria
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Pakistan
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Portugal
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Romania
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Russian Federation
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Singapore
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South Africa
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Spain
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Sweden
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Switzerland
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United Kingdom
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United States of America
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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Rupert
Pearse |
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Address:
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Adult Critical Care Unit
Royal London Hospital
Whitechapel
E1 1BB
London
United Kingdom |
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Telephone:
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: All adult patients (aged 18 years or older) undergoing elective surgery in a participating hospital during the seven-day cohort period with a planned overnight stay.
Exclusion criteria: Patients undergoing emergency surgery, planned day-case surgery or radiological procedures
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Elective surgery
Surgery
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Intervention(s)
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This is an observational study. Patients will be followed up until hospital discharge or for a maximum of 30 days, whichever is shorter.
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Primary Outcome(s)
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To confirm the incidence of 30-day in-hospital complications following elective in-patient surgery.
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Secondary Outcome(s)
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1. In-hospital all-cause mortality (censored at 30 days following surgery)
2. Admission to critical care (within 30 days following surgery)
3. Duration of hospital stay (duration of primary hospital stay after surgery)
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Source(s) of Monetary Support
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Nestlé Health Science SA.
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Ethics review
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Status:
Approval date:
Contact:
NRES Committee Yorkshire & The Humber - Humber Bridge, 20/11/2013, REC ref: 13/YH/0371
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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09/07/2014 |
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URL:
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