International Surgical Outcomes Study (ISOS)
| ISRCTN | ISRCTN51817007 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51817007 |
| Secondary identifying numbers | N/A |
- Submission date
- 11/12/2013
- Registration date
- 03/01/2014
- Last edited
- 29/06/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
Adult Critical Care Unit
Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom
Scientific
Adult Critical Care Research Office
Room 14
Central Tower
Royal London Hospital
Whitechapel
London
E1 1BB
United Kingdom
Study information
| Study design | International multicentre observational 7-day cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Patient information can be found at http://www.isos.org.uk/isos.php?page=docs |
| Scientific title | International observational 7-day cohort study of complications following elective surgery |
| Study acronym | ISOS |
| Study objectives | 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(s) | NRES Committee Yorkshire & The Humber - Humber Bridge, 20/11/2013, REC ref: 13/YH/0371 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/04/2014 |
| Completion date | 09/07/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50000 |
| Key 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. |
| Key exclusion criteria | Patients undergoing emergency surgery, planned day-case surgery or radiological procedures |
| Date of first enrolment | 01/04/2014 |
| Date of final enrolment | 09/07/2014 |
Locations
Countries of recruitment
- Australia
- Austria
- Belgium
- Brazil
- Canada
- China
- Egypt
- England
- 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
Study participating centre
E1 1BB
United Kingdom
Sponsor information
University/education
Joint Research & Development Office
5 Walden Street
London
E1 2EF
England
United Kingdom
| Website | http://www.bartshealth.nhs.uk/research |
|---|---|
"ROR" |
https://ror.org/026zzn846 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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. |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 31/10/2016 | Yes | No | |
| Results article | India results | 01/05/2021 | 29/06/2021 | Yes | No |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
29/06/2021: Publication reference added.
11/12/2017: Publication reference added.
