Vagus nerve stimulation to improve bowel function after surgery

• Research type

  Research Study

• Full title

  Transcutaneous vagal nerve stimulation to reduce Ileus: A feasibility study (TRANSIT)

• IRAS ID

  262904

• Contact name

  David G Jayne

• Contact email

  D.G.Jayne@leeds.ac.uk

• Sponsor organisation

  University of Leeds

• Duration of Study in the UK

  2 years, 5 months, 1 days

• Research summary

  Ileus is a common complication after colorectal surgery (surgery of the large bowel and rectum). It is characterised by a slow return of normal bowel function, giving rise to symptoms such as bloating, constipation, and vomiting. This increases the risk of other serious complications, reduces patient satisfaction, and increases healthcare costs.

  We aim to test a new treatment to reduce Ileus in patients having colorectal surgery. Patients will self-administer a non-invasive nerve stimulator device (GammaCore) for five days before and after surgery. This will be a randomised study with some patients receiving "active" devices, and others receiving "placebo" (sham) devices.

  For all patients, bowel function will be assessed via short, clinical consultations during their hospital admission. Participants will also be invited to participate in a series of optional sub-studies:

  1) Assessment of inflammation after surgery - this will include a series of blood tests and abdominal fluid samples
  2) Assessment of bowel motility - this will include a short MRI scan performed before and after surgery
  3) Assessment of patient opinions of the treatment - this will include a short interview after hospital discharge

• REC name

  North East - Tyne & Wear South Research Ethics Committee

• REC reference

  19/NE/0217

• Date of REC Opinion

  17 Jul 2019

• REC opinion

  Favourable Opinion