CompletedPhase IIInterventional

Tranexamic acid to prevent anastomotic leak after rectal cancer surgery

When surgeons remove bowel cancer from the rectum or lower bowel, they join the healthy ends back together. Sometimes, natural gut bacteria can cause this new join to break down and leak, which is a serious surgical complication. Researchers at the University of Leeds want to find out if a well-known medicine called tranexamic acid can protect the healing bowel. In this study, patients having bowel cancer surgery are split into two groups by chance. One group receives tranexamic acid liquid through a small, soft tube placed in the back passage during surgery. The other group receives sterile water. The tube stays in place for three days. Researchers will also take gentle swabs to check bowel bacteria. This small trial aims to make sure the treatment is safe, comfortable, and practical before testing it in a larger UK-wide study.

At a glance

Status

Completed

Phase

Phase II

Sponsor

University of Leeds

Enrolment target

Start

10 Dec 2024

Estimated completion

01 Oct 2026

Anastomotic leak; rectal cancer surgery

What is this study about?

When doctors operate to treat cancer in the lower bowel or rectum, they remove the tumour and carefully join the healthy ends of the bowel back together. Most of the time, this join heals smoothly. However, in some patients, the join fails to seal properly. This problem, known as a leak, can allow bowel contents to escape into the tummy, causing severe illness and requiring urgent care.

Doctors have found that certain bacteria naturally living inside the stool can attack the healing tissue and weaken the new join. Researchers believe that a medicine called tranexamic acid might help stop these bacteria from causing damage. While this medicine is normally used to help blood clot and stop bleeding, laboratory tests suggest it could also protect delicate bowel tissue as it mends.

This trial, called the TARGET study, is run by the University of Leeds and funded by the National Institute for Health and Care Research (NIHR). Before launching a massive nationwide study, doctors need to know whether giving this medicine through a temporary tube is safe, practical, and acceptable to patients and nursing staff. The results will help surgeons design better, safer recovery plans for bowel cancer patients in the future.

Key takeaways

The TARGET study tests if tranexamic acid can prevent bowel joins from leaking after rectal cancer surgery.
Half of the participants receive the medicine through a soft tube for three days, while the other half receive sterile water.
Researchers will take quick swabs from the back passage before and after surgery to monitor gut bacteria.
This is a feasibility study funded by the NIHR to ensure the treatment is practical and comfortable for patients.
Taking part is entirely voluntary and will not change your planned surgical dates or cancer care.

Who may be eligible?

You may be able to join this study if you are 18 or older and are due to have planned surgery to remove cancer or pre-cancerous cells in your rectum or lower bowel (sigmoid colon). Your surgeon must be planning to join your bowel back together during the operation, whether using keyhole, robotic, or traditional open surgery. You will also need to be well enough overall to undergo major surgery.

This study will not be suitable for people having operations where the bowel is not reconnected, such as operations where the back passage is permanently removed or where a permanent stoma is formed without a join. You will also not be able to take part if you have an inflammatory bowel condition like Crohn's disease or ulcerative colitis, if you are allergic to tranexamic acid, or if you have a history of serious blood clots in your veins or arteries.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years of age or older?
Have you been diagnosed with cancer or pre-cancer in your rectum or lower bowel?
Is your surgeon planning to reconnect your bowel ends during your operation?
Are you free from inflammatory bowel conditions like Crohn's disease or ulcerative colitis?
Do you have no previous history of serious blood clots and no known allergy to tranexamic acid?

Answer every question to see your result.

What does participation involve?

If you choose to take part, you will be placed into one of two treatment groups by chance (similar to flipping a coin). During your cancer operation, while you are asleep under general anaesthetic, your surgeon will place a small, soft tube into your back passage. For three days after surgery, you will receive either the tranexamic acid liquid or plain sterile water through this tube.

To see how the treatment affects gut bacteria, the research team will take gentle swabs from your back passage at three points: before surgery, on the day of surgery, and after your final treatment on day three. The tube will then be removed. After you have recovered, you may also be invited to complete a short interview to share your thoughts about what the experience was like. Your participation mainly happens during your normal hospital stay, and you will continue with your standard NHS follow-up appointments afterwards.

Potential risks and benefits

Taking part may not directly benefit your own recovery, but your help will provide vital answers that could protect future cancer patients from dangerous surgical leaks. Having a small tube in your back passage for three days is safe, but it may cause slight fullness or mild discomfort. Tranexamic acid is an established medicine, but like all drugs, it can sometimes cause mild side effects such as nausea, vomiting, loose stools, or a rash. Your medical team will monitor you closely while you are in hospital. Taking part is completely your choice, and you can withdraw at any time without it affecting your standard NHS care.

Locations (1)

St James's University Hospital
Approximate
Leeds, England

Common questions

Why is sterile water used for one of the groups?

Sterile water acts as a comparison treatment (a control). It allows researchers to see whether any changes in bacteria or healing are truly caused by the tranexamic acid or would have happened anyway.

Will having the tube placed in my back passage hurt?

The tube is placed while you are asleep during your operation, so you will feel nothing at the time. While it is in place for three days, you might feel minor discomfort or a sensation of fullness, but it should not be painful.

Will taking part delay my cancer surgery?

No. The study is built directly into your planned operation and hospital recovery, so your surgery will go ahead on its planned schedule.

Can I choose whether I receive tranexamic acid or sterile water?

No. A computer assigns you to a group at random. This ensures the study results are fair, balanced, and completely unbiased.

What happens if I change my mind later?

You are free to leave the study at any point. You do not have to give a reason, and your medical team will continue to provide you with the best possible NHS cancer care.

How to find out more

Jack Helliwell

J.A.Helliwell@leeds.ac.uk +44 7827448588 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.