Anastomotic Leak Prediction After Colorectal Anastomosis (ALPACA)

• Research type

  Research Study

• Full title

  A prospective, cross-sectional, mixed-methods study to validate diagnostic accuracy of anastomotic leak prediction model with qualitative sub-study to assess acceptability and identify barriers to implementation

• IRAS ID

  331934

• Contact name

  Matthias Eberl

• Contact email

  EberlM@Cardiff.ac.uk

• Sponsor organisation

  Cardiff University

• Duration of Study in the UK

  0 years, 11 months, 30 days

• Research summary

  This is a mixed-methods study that aims to validate a biomarker-based diagnostic test for Anastamotic leaks and identify barriers to its implementation.
  An anastamotic leak is a relatively common complication that occurs during bowel surgery. It occurs when two pieces of bowel are connected together- this is called an anastomosis. For reasons that are unclear, the join can leak and release bowel contents into the abdomen. Detecting anastamotic leaks can be difficult and often only present themselves when patients get very ill. Emergency surgery is required to fix the anastomotic leak and if it is not caught soon enough, patients can become critically unwell and, in severe cases, die.

  We have previously developed a test that can detect anastomotic leaks based on the fluid that naturally occurs around the site of the operation. This fluid is usually removed from the site of the operation using a 'drain' or 'surgical drain' and is collected in a bag that attaches to patients. By looking at this 'drain fluid' we have found that a specific combination of proteins are present in patients that have anastamotic leaks. Now, in this study, we will confirm this test works in patients having bowel surgery, who may or may not go on to get an 'anastamotic leak'. We will collect drain fluid samples from patients, which will be analysed in Cardiff University laboratories. We will also collect blood samples to see if we can detect any differences in the blood of people that get anastamotic leaks, compared to those who don’t.
  We will also interview a selection of patients and clinicians and ask how they feel about the test, and see if there are any problems that might stop the test being used.
  

• REC name

  London - Queen Square Research Ethics Committee

• REC reference

  24/PR/0808

• Date of REC Opinion

  30 Jul 2024

• REC opinion

  Further Information Favourable Opinion