Using neurotechnology to treat Crohn's disease after surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety of vagal nerve neuromodulation in patients who have undergone surgical resection for Crohn's disease. It is a prospective, single-center cohort study that aims to assess the effectiveness of a vagus nerve stimulator in preventing the recurrence of Crohn's disease post-operatively. Participants will be monitored for safety and outcomes related to their condition following the intervention. The study focuses on patients with macroscopic normality after surgery, ensuring a targeted approach to treatment.

Why it matters

Who can join: the full rules

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.

Where it's running

• Austin Health
  Melbourne, Victoria, Australia Recruiting

Study contacts

• Principal investigator: Peter De Cruz, MBBS PhD FRACP — Austin Health, Melbourne
• Study coordinator: Peter De Cruz, MBBS PhD FRACP
• Email: Peter.DeCruz@austin.org.au
• Phone: +61 3 9496 6233

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.