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Modelling risk of early post-operative complications for patients undergoing major lower limb amputation

Modelling risk of in-hospital mortality and other early post-operative complications for patients undergoing major lower limb amputation entered into the United Kingdom National Vascular Registry

Status
Completed
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12618000356268
Enrollment
9549
Registered
2018-03-09
Start date
2018-03-30
Completion date
2018-05-30
Last updated
2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The appropriate counselling of patients about peri- and post-operative risks is an essential part of the process of consent to surgery. Patients undergoing major lower limb amputation (MLLA) are a high risk group, with 30-day mortality rates of around 10%, making MLLA the highest risk common Vascular Surgery operation other than ruptured abdominal aortic aneurysm (AAA) repair: higher than elective open AAA repair (3.0%) or lower limb bypass (3.0%). Recent UK court rulings about patient consent have brought this issue to the fore for both patients and surgeons alike. This is an evolving area, but current advice is now that ‘surgeons are required to engage in a consenting process tailored to the individual patient with detailed, accurate and realistic explanations of the pros and cons of surgery.’ In procedures such as MLLA, where individual risk clearly varies widely between patients, it is important therefore to be able to quantify risks as accurately as possible. The issue of risk prediction for high-risk surgical procedures is also important in light of the advent of surgeon-specific outcome publication in the United Kingdom. In order to reduce the likelihood that high risk patients are denied procedures which they might otherwise have chosen to undergo as a result of a surgeon’s unwillingness to run the risk of poor outcomes publication, it is essential to be able to appropriately risk adjust these national audits. Using existing, prospectively collected data from the United Kingdom National Vascular Registry, we will develop models to predict the chances of complications after surgery including death in hospital, prolonged stay in hospital, need to go back to the operating theatre for another operation, post-operative chest infection and post-operative heart problems.

Interventions

Patients undergoing major lower limb amputation who are entered into the United Kingdom National Vascular Registry Duration of observation: from time of surgery until discharge from hospital.

Sponsors

Aneurin Bevan University Health Board
Lead SponsorGovernment body

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Patients undergoing major lower limb amputation entered into the United Kingdom National Vascular Registry between January 1st 2014 and December 31st 2016

Exclusion criteria

Patients not entered into the database, or not undergoing major lower limb amputation during the study period.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026