Condition category
Surgery
Date applied
11/12/2013
Date assigned
03/01/2014
Last edited
21/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://www.isos.org.uk

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 measures

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

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

http://www.bartshealth.nhs.uk/research

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes