Vagus Nerve Stimulator: The device consists of implantable (inside the body) and external (outside the body) components. Implantable components consist of a stimulating/recording electrode assembly that is placed around the vagus nerve in the abdomen, between the diaphragm and the stomach, a cable connecting the electrode assembly to an implantable pulse generator (IPG) that generates the stimulus and records nerve responses. The external components include a Clinical Control/Review Tool (used by the study team after implantation to adjust and periodically review the stimulation settings) and a Patient Control Unit and Charger (to turn on/off the system and perform limited adjustment of the stimulation strategy).
Study summary
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Safety and efficacy based on endoscopic recurrence — 6 months post-operation Recurrence defined as the presence of any aphthous ulcers, and severe recurrence defined as an endoscopic Rutgeerts score ≥ 2 (5 aphthous ulcers or larger ulcers confined to the anastomosis)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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