VERDDICT

• Research type

  Research Study

• Full title

  VolatilE biomarkeR Detection of anastomotic Dehiscence In ColorecTal surgery - A feasibility study

• IRAS ID

  162903

• Contact name

  Nader Francis

• Contact email

  nader.francis@ydh.nhs.uk

• Sponsor organisation

  Yeovil District Hospital NHS Foundation Trust

• Duration of Study in the UK

  0 years, 6 months, 2 days

• Research summary

  BACKGROUND:
  Major bowel operations require a section of bowel to be removed, with the two ends of bowel then re-joined. If this join leaks (average 10%), it can result in significant delay in recovery, cancer recurrence, or even death. One of the frequent signs of leak is the bowel stops working, this is called 'ileus'. Early detection of this is crucial but it is difficult as conventional tests such as x-rays or scans are frequently inconclusive.
  Detection of chemical markers from testing of exhaled breath has been successfully used for diagnosing a range of infectious diseases. We propose trialling a simple breath test to detect gas build up from bowel bacteria as an indication for early onset of bowel leak and ileus.

  METHODS:
  Patients undergoing bowel surgery with joining, will be recruited from three NHS hospitals (Yeovil District Hospital NHS Foundation Trust, North Bristol NHS Trust, and University Hospitals Leeds NHS Foundation Trust). Samples of breath will be collected on the morning before surgery and in the morning daily after surgery for 3 days. These will be sent to a laboratory at the University of the West of England (Bristol, UK) for analysis. Clinical data related to recovery and any complications will also be collected.

  OBJECTIVE:
  The primary objective of this feasibility study is to establish whether the breath tests can be successfully collected from patients and transferred for analysis after major bowel surgery. If successful, the next stage will be to expand the study to a larger population of patients to generate “norm” values and inform about the suitability of this test for early detection.

  POTENTIAL BENEFITS:
  If this test works, it could be used as a quick and convenient bed side test to predict those patients with a leak/ileus early and allow clinicians to act immediately to improve patient outcomes.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  14/EM/1170

• Date of REC Opinion

  24 Sep 2014

• REC opinion

  Favourable Opinion