Atrial Fibrillation After Surgery for Colorectal Cancer

  • STATUS
    Recruiting
  • End date
    Mar 31, 2024
  • participants needed
    720
  • sponsor
    Sheffield Teaching Hospitals NHS Foundation Trust
Updated on 15 October 2021

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.

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.

Details
Condition colorectal neoplasm, colorectal cancers, cancer, colorectal, Colon cancer; rectal cancer, colorectal tumor, Rectal Disorders, Atrial Fibrillation New Onset, Colorectal Cancer, tumors, colorectal, Colon Cancer Screening, Rectal disorder
Treatment 24 hour holter monitor
Clinical Study IdentifierNCT04037319
SponsorSheffield Teaching Hospitals NHS Foundation Trust
Last Modified on15 October 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note