Atrial Fibrillation After Surgery for Colorectal Cancer

• Conditions: Atrial Fibrillation New Onset; Colorectal Cancer
• Interventions: Diagnostic Test: 24 Hour Holter Monitor

• Registration Number: NCT04037319
• Lead Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary

This study will report the incidence of atrial fibrillation after elective colorectal cancer resection in the over 65 age group. This will be used to validate a risk model for the development of post-operative atrial fibrillation.

Eligible patients will undergo electrocardiogram based screening for atrial fibrillation, as well as brain natriuretic peptide tests prior to surgery. They will undergo 24 hour holter monitor prior to surgery, and at 30 and 90 days following surgery.

The primary outcome will be occurrence of atrial fibrillation within 90 days of surgery. Secondary outcomes include quality of life change, use of hospital services for atrial fibrillation, and complications of atrial fibrillation. This will be used to validate the pre-existing model for prediction of atrial fibrillation.

Detailed Description

Background Atrial fibrillation is an irregularly irregular heartbeat and occurs in around 1.5% of the population. It is associated with negative clinical outcomes such as cardiac failure and mortality. It is strongly implicated in the evolution of stroke, which carries significant burden and cost to patients and the National Health Service (NHS). Atrial fibrillation can be triggered by major physiological stresses such as surgery. The literature suggests that symptomatic atrial fibrillation occurs in 10% of patients within 90 days of surgery. This means that a proportion of patients may have undetected atrial fibrillation, and require treatment to reduce their risk of complications. As the investigators move towards stratified and personalised medicine, it is important to identify the characteristics of the patients at risk of developing atrial fibrillation after surgery in order to mitigate the effects of the condition. This research group has proposed a basic model to stratify patients into high risk groups for post-operative atrial fibrillation, although this requires testing and refinement in a prospective study.

Aims To estimate the rate of atrial fibrillation following colorectal cancer surgery and to characterise patients at highest risk of atrial fibrillation following surgery for colorectal cancer.

Method A prospective study of patients over the age of 65 undergoing colorectal cancer resection will be conducted across 15 colorectal units in the United Kingdom. It will recruit 720 patients over an 18 month period. The study has been designed with regard to public and patient involvement. Patients over the age of 65 undergoing surgery for colorectal cancer with curative intent and no prior diagnosis of atrial fibrillation will be eligible for inclusion. Participants will be screened prior to entry with an electrocardiogram (ECG). Following consent, routine demographic data, EQ-5D-5L (five dimension), and blood sample for Brain Natriuretic Peptide (BNP) will be collected. A 24-hour cardiac rhythm recording will be undertaken prior to surgery to confirm the absences of atrial fibrillation. ECG will be repeated on the day of discharge and 24 hour rhythm recordings repeated at 30 and 90 days post surgery. EQ-5D-5L x will be recorded at 90 days along with any use of health services for cardiac symptoms. Participants diagnosed with atrial fibrillation during the study will be directed to local inpatient or primary care services as appropriate. Demographic characteristics, ECG parameters and BNP will be combined with a previously derived model and tested for ability to predict atrial fibrillation.

Study Timeline

• Study First Submitted: 2019-06-26
• Study First Submitted QC: 2019-07-29
• Study First Posted: 2019-07-30
• Study Start: 2020-01-16
• Status Verified: 2021-01
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-08
• Primary Completion: 2023-12-31
• Study Completion: 2024-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 720

Inclusion Criteria

• Patients aged ≥65 years old
• Undergoing elective surgery for colorectal cancer with curative intent
• No prior diagnosis of atrial fibrillation.
• Willing to consent

Exclusion Criteria

• Patients aged less than 65 years old
• Pre-existing atrial fibrillation (persistent or paroxysmal)
• Unable to provide informed consent
• Life expectancy <12 months
• Prisoners
• Known pregnancy
• Lack mental capacity
• Patients with limited English language as there is no funding to cover costs of translation of materials

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Main cohort	24 Hour Holter Monitor	Will undergo surgery for colorectal cancer with curative intent as planned by local cancer multidisciplinary team.

Primary Outcome Measures

Name	Time	Method
Incidence of atrial fibrillation within 90 days of colorectal cancer surgery, defined as ≥30 seconds of atrial fibrillation identified on a 24-hour cardiac monitor OR absence of p waves and irregularly irregular rhythm on an electrocardiogram	Within 90 days of colorectal cancer surgery	24-hour recordings will be undertaken at 30 \& 90 days post surgery, and electrocardiogram on the day of discharge from hospital.

Secondary Outcome Measures

Name	Time	Method
Quality of life change (EQ-5D-5L (Euroqol-five dimension-five level)	Within 90 days of colorectal cancer surgery	Quality of life change as measured using EQ-5D-5L from baseline to 90 days post-surgery calculated as population adjusted health index based on total score. In the UK population this can range from -0.594 to 1.0. Higher values are associated with better quality of life scores. A positive change in quality of life index means improved quality of life.
Occurrence of complications of atrial fibrillation	Within 90 days of colorectal cancer surgery	Includes stroke and embolic events
Number of events of use of health services for atrial fibrillation or sequelae of atrial fibrillation	Within 90 days of colorectal cancer surgery	Number of events where health services accessed (e.g. primary care, hospital) including for treatment of atrial fibrillation or consequences such as cardiac failure, thromboembolism, or stroke.

Trial Locations

Locations (1)

Sheffield Teaching Hospitals NHS Foundation Trust; 🇬🇧 Sheffield, South Yorkshire, United Kingdom