The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD

The ElectRx Study - A Neurotechnology Approach to the Treatment of IBD

The purpose of this study is to evaluate the safety of vagal nerve neuromodulation in a cohort of patients operated on for Crohn's disease, in a prospective, single centre, cohort study.

Inclusion Criteria:

• All patients aged 18 years or older with Crohn's disease who undergo resection with an endoscopically accessible primary anastomosis which results in macroscopic normality.
• Patients having a reversal of a temporary ileostomy created after previous surgery for Crohn's disease may be enrolled provided that the reversal of the ileostomy results in a primary anastomosis and macroscopic normality of the remaining bowel.
• Patients with co-existing perianal disease may be included provided the resection has led to a primary anastomosis and macroscopic normality of the intestine.
• Patients must have proven history of Crohn's disease based on (clinical, radiologic, endoscopic and histologic criteria).

Exclusion Criteria:

• Patients with anastomosis which is endoscopically inaccessible by standard colonoscopy.
• Patients in whom there is persisting macroscopic abnormality post-surgical resection.
• Patients with Crohn's disease who have an end stoma (ileostomy or colostomy).
• Patients for whom endoscopy is not suitable due to co-morbidities or unwell clinical state
• Inability to give informed consent.
• Inability to obtain access to the anastomosis at colonoscopy.
• Suspected perforation of the gastrointestinal tract.
• Patients who are pregnant or breastfeeding.