The effect of diabetes mellitus on perioperative outcomes following colorectal resectional surgery

Study type
Protocol
Date of Approval
Study reference ID
21_000404
Lay Summary

Background:
Diabetes mellitus is a widespread medical condition that is rapidly becoming more common in the UK where there is an abnormally high level of sugar in the blood because the body cannot regulate its sugar levels. Many patients with diabetes undergo surgery. Several studies have shown that patients with diabetes undergoing surgery are more likely to die or have complications than the general population.

There are national guidelines in place for the management of patients with diabetes undergoing surgery. However, no study so far, examining the UK population, has assessed the risk of death following surgery in diabetic patients by type of diabetes or by treatment type.

Objective:
To quantify the risk of death following colorectal surgery in patients with diabetes compared with those without diabetes and assess if there are any differences between type of diabetes, prior sugar levels and treatment type for patients with diabetes.

Design:
We will use data from three large electronic health records, the Clinical Practice Research Datalink, Hospital Episode Statistics and Office of National Statistics to determine the risk of death after surgery for patients with diabetes and the factors that contribute to their death. We will compare how frequently deaths occurred by type of diabetes and by medication treatment type.

Outcomes and patient benefit:
Knowing the risk of death for patients with diabetes and specifically how this relates to type of and treatment for diabetes will help surgeons counsel patients with diabetes who require surgery more effectively.

Technical Summary

Background:
Diabetes mellitus (DM) is a common condition with a UK prevalence of 3.9 million (1 in 17) people diagnosed with the condition that is expected to increase significantly. The disease impacts the morbidity and mortality outcomes following surgery with specific national guidance detailing its peri-operative management. DM affects more than 10% of patients undergoing surgery with a peri-operative mortality as high as 50% greater than those without the condition.

There have been several population-based cohort studies from Australia, the USA, the Netherlands and Denmark showing conflicting results regarding the post-operative outcomes of patient with DM following colorectal resection and specifically there is a lack of evidence from large primary and secondary care linked UK population data.

Objective:
To quantify the risk and therefore assess the impact DM confers following colorectal surgery compared to the general population and assess whether there are differences in outcomes between the types of DM including differences in treatment regimen. This will aid future guidance with respect to the peri-operative management of DM in the UK.

Design:
The linked primary and secondary care databases (Clinical Practice Research Datalink, Hospital Episode Statistics) together with mortality data from the Office of National Statistics will be used to establish a cohort of patients undergoing colorectal resectional surgery. 90-day mortality will be compared between those with DM and those without undergoing colorectal resectional surgery. We will control for the confounders of age, gender, BMI, smoking, malignant and benign disease, along with emergency and elective admission and whether the procedure was performed in a minimally invasive way (robotic or laparoscopic).

Outcomes:
We will provide stratified population-based estimates of the length of stay and mortality rates up to 1-year following colorectal surgery in diabetic patients.

Health Outcomes to be Measured

• 90-day mortality
• Length of hospital stay

Collaborators

David Humes - Chief Investigator - University of Nottingham
Christopher Lewis-Lloyd - Corresponding Applicant - University of Nottingham
Colin Crooks - Collaborator - University of Nottingham
Dileep Lobo - Collaborator - University of Nottingham

Linkages

HES Admitted Patient Care;ONS Death Registration Data;Patient Level Index of Multiple Deprivation