TARGET

• Research type

  Research Study

• Full title

  TrAnexamic acid to pRevent anastomotic leak after rectal cancer surGEry: a feasibility sTudy (TARGET)

• IRAS ID

  1009682

• Contact name

  David Jayne

• Contact email

  D.G.Jayne@leeds.ac.uk

• Sponsor organisation

  University of Leeds

• ISRCTN Number

  ISRCTN13727659

• Research summary

  Background:
  Anastomotic leak is a life-threatening surgical complication that occurs when the two ends of bowel at the anastomosis fail to heal, causing spillage of bowel contents into the abdomen. Certain bacteria present within stool (the microbiome) have been shown to increase the risk of anastomotic leak by causing the join in the bowel to break down. This study will test a new treatment called tranexamic acid which may prevent this from happening.

  Aims:
  This study aims to provide important information about tranexamic acid and whether it can be used to prevent anastomotic leak. Before this new treatment can be tested on a larger scale, it is important to do a small feasibility study to be sure the treatment is acceptable to patients and healthcare workers.

  Methods:
  Patients undergoing rectal cancer surgery will be invited to participate. Patients will be divided into two groups at random. One group will receive a solution of tranexamic acid into the back passage. This will be done using a small flexible tube (rectal catheter) which is placed into the anus during the operation. The catheter will remain in place for 3 days after surgery. This allows tranexamic acid to be delivered close to the join in the bowel, where it may modify bacteria that cause anastomotic leak. Participants allocated to the other group will receive sterile water through a rectal catheter without tranexamic acid. This will give an indication of whether tranexamic acid can influence bacteria at the anastomosis.

  During the study, swabs will be used to take samples of bacteria from the back passage. This will be done before surgery, on the day of surgery, and after the final treatment. This is so that we can do further tests to see if the treatment is working against harmful bacteria. At the end of the study, we will invite patients/healthcare workers to talk to us about their experiences. This will help us to design a larger study to test if treatment with tranexamic acid works.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  24/NW/0254

• Date of REC Opinion

  30 Oct 2024

• REC opinion

  Further Information Favourable Opinion