Plain English Summary
Background and study aims
The findings of a recent study have suggested that deaths after surgery may be more frequent than previously thought, suggesting some may be preventable. However, there are limited available data describing complications, and therefore why patients die, following surgery. The aim of this study is to confirm the incidence of 30-day in-hospital complications following elective in-patient surgery.
Who can participate?
Adult patients aged 18 years or older undergoing elective surgery and staying overnight in hospital during the study period.
What does the study involve?
Participants will not receive any additional treatments or medicines as part of this study. Patients will be followed up for information describing outcomes after surgery until they leave hospital.
What are the possible benefits and risks of participating?
There are no risks of taking part and no changes to your treatment.
Where is the study run from?
The study is taking place in hundreds of hospitals around the world.
When is the study starting and how long is it expected to run for?
The study will take place during the spring of 2014.
Who is funding the study?
The study is funded by the Nestle Health Science SA.
Who is the main contact?
Professor Rupert Pearse - Chief Investigator
Marta Januszewska - Study Coordinator
Trial website
Contact information
Type
Scientific
Primary contact
Prof Rupert Pearse
ORCID ID
Contact details
Adult Critical Care Unit
Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom
Type
Scientific
Additional contact
Mr Richard Haslop
ORCID ID
Contact details
Adult Critical Care Research Office
Room 14
Central Tower
Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
International observational 7-day cohort study of complications following elective surgery
Acronym
ISOS
Study hypothesis
To confirm the incidence of 30-day in-hospital complications following elective in-patient surgery.
On 21/07/2015 the overall trial end date was changed from 01/04/2016 to 09/07/2014.
Ethics approval
NRES Committee Yorkshire & The Humber - Humber Bridge, 20/11/2013, REC ref: 13/YH/0371
Study design
International multicentre observational 7-day cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Patient information can be found at http://www.isos.org.uk/isos.php?page=docs
Condition
Elective surgery
Intervention
This is an observational study. Patients will be followed up until hospital discharge or for a maximum of 30 days, whichever is shorter.
Intervention type
Procedure/Surgery
Phase
Not Applicable
Drug names
Primary outcome measure
To confirm the incidence of 30-day in-hospital complications following elective in-patient surgery.
Secondary outcome measures
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)
Overall trial start date
01/04/2014
Overall trial end date
09/07/2014
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
50000
Participant exclusion criteria
Patients undergoing emergency surgery, planned day-case surgery or radiological procedures
Recruitment start date
01/04/2014
Recruitment end date
09/07/2014
Locations
Countries of recruitment
Australia, Austria, Belgium, Brazil, Canada, China, Egypt, Germany, Greece, Hong Kong, India, Indonesia, Iraq, Italy, Malaysia, Mexico, New Zealand, Nigeria, Pakistan, Portugal, Romania, Russian Federation, Singapore, South Africa, Spain, Sweden, Switzerland, United Kingdom, United States of America
Trial participating centre
Royal London Hospital
London
E1 1BB
United Kingdom
Sponsor information
Organisation
Queen Mary University of London (UK)
Sponsor details
Joint Research & Development Office
5 Walden Street
London
E1 2EF
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Industry
Funder name
Nestlé Health Science SA.
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We are currently in the process of revising the main study paper and considering options for submission. There will be secondary papers; however, we are currently focussing on the primary paper. The protocol has been published open access on the trial website (isos.org.uk). We will disseminate the findings publicly following publication of the main paper.
The study sponsor, Queen Mary University of London, has and will act as custodian of the data. In line with the principles of data preservation and sharing, the steering committee will, after publication of the overall dataset, consider all reasonable requests to conduct secondary analyses. The primary consideration for such decisions will be the quality and validity of any proposed analysis.
Only summary data will be presented publicly and all national, institutional and patient level data will be strictly anonymised. Individual patient data provided by participating hospitals remain the property of the respective institution. The complete ISOS dataset, anonymised with respect to participating patients, hospitals and nations, will be made freely and publicly available two years following publication of the main scientific report.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2016 results in: https://www.ncbi.nlm.nih.gov/pubmed/27799174