Long-term survival after surgery. Version 1.5 (12 Aug 2019)
Research type
Research Study
Full title
International Surgical Outcomes Study: Long-term survival
IRAS ID
241147
Contact name
Alexander J Fowler
Contact email
Sponsor organisation
Barts Health NHS Trust
Clinicaltrials.gov Identifier
9264QM, Prior R&D reference; 13/YH/0371, Prior ethical review reference
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
Over 230 million patients undergo surgery worldwide each year with an associated mortality of between 1 and 4%. Data from the USA suggest that complications after surgery are associated with a significantly increased risk of poor long-term outcomes, but this finding has not been confirmed in the NHS population.
Our understanding of outcomes after surgery at an international level is incomplete and the need remains for data describing the long-term outcomes after surgery, including the risk of death and need to be re-admitted to hospital. The International Surgical Outcomes Study (ISOS) was an international seven-day cohort study of adults undergoing in-patient elective surgery that provides detailed data describing post-operative complications and associated mortality. Part of the planned analysis of ISOS was to follow up patients by linking to national datasets via patient identifiable information to determine the long-term survival.
ISOS completed patient recruitment, and closed, in 2014 and patient consent for linkage to national datasets to enable long term follow up of those recruited within England was obtained. NHS Digital has subsequently informed us that our consent does not meet contemporary standard of consent and we are therefore unable to obtain data. To perform these studies, we are applying to REC for an ethical opinion on our plan to access these data without patient consent but section 251 (NHS Act 2006) support from the Confidentiality Advisory Group (CAG).
REC name
Yorkshire & The Humber - South Yorkshire Research Ethics Committee
REC reference
18/YH/0310
Date of REC Opinion
6 Sep 2018
REC opinion
Favourable Opinion