Incidence of venous thromboembolism following colorectal resectional surgery

Study type
Protocol
Date of Approval
Study reference ID
19_180
Lay Summary

Background: Blood clots in the legs and lungs following surgery represent a potentially life threatening complication but can be prevented. Several studies have shown that surgery to the organs in the abdomen carries a much higher risk of these clots forming. In patients for whom the surgery was performed for cancer, the risk may well be higher.

In 2010 the National institute for health and care excellence (NICE) made recommendations regarding assessment for clots, preventative measures and treatment. They recognised that age, cancer, surgery and immobility all contributed to risk of clots forming and made recommendations accordingly. Since then there have been no studies assessing the occurrence of blood clots after surgery.

Objective: To quantify the occurrence of blood clots following colorectal surgery before and after the NICE guidelines in 2010.

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 occurrence of blood clots in the legs and lungs after surgery and the factors that contribute to their occurrence. We will compare how frequently these clots occurred before and after 2010 to determine what change if any has occurred since these guidelines came into place.

Outcomes and patient benefit: Knowing whether or not these guidelines have made a difference may improve compliance with the current recommendations and provide much needed evidence in this field.

Technical Summary

Background: Venous thromboembolism is an important complication after surgery and is associated with an increased risk of morbidity and mortality. In 2010 the National institute for clinical excellence (NICE) made recommendations regarding VTE assessment, prevention and treatment and CQUIN (Commissioning for Quality and Innovation) targets were introduced to promote adherence to these guidelines. They also made recommendations regarding future research directions, having acknowledged the paucity of evidence in the form of population estimates of incidence of VTE after surgery.

Since then studies into VTE, some from our group have shown that gastrointestinal surgery and in particular gastrointestinal cancer surgery carries a much larger risk of VTE. What is still lacking is evidence of how the implementation of VTE assessment and risk prevention strategies have impacted incidence.

Objective: To quantify the risk of VTE following colorectal surgery, in the 9yrs before and 9yrs after the implementation of NICE guidelines on VTE, in order to assess the impact guidelines have had on both risk and rates of VTE.

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. The incidence of VTE following colorectal surgery will be calculated as rates per 100000 person years of follow up. 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 laparoscopically.

Outcomes: We will provide population based estimates of the incidence of VTE following colorectal surgery, comparing incidence rates pre and post 2010.

Health Outcomes to be Measured

·        Incidence of VTE

Collaborators

David Humes - Chief Investigator - University of Nottingham
David Humes - Corresponding Applicant - University of Nottingham
- Collaborator -
Colin Crooks - Collaborator - University of Nottingham

Linkages

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