Using virtual technology to improve treatment for perianal Crohn's disease
A Feasibility Study to Assess a "Virtual" (vEUA) Technology to Improve the Management of Perianal Crohn's Disease
This study is testing a new virtual tool that helps doctors better plan surgery for fistulas in people with perianal Crohn's disease to see if it leads to quicker healing and fewer complications than regular methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Nottingham University Hospitals NHS Trust Academic / other |
| Locations | 1 site (Nottingham) |
| Trial ID | NCT06587646 on ClinicalTrials.gov |
What this trial studies
This study focuses on the management of perianal Crohn's disease, particularly the treatment of fistulas that can develop in patients. It utilizes a virtual examination under anesthesia (vEUA) tool that provides 3D imaging to enhance surgical planning and reduce complications associated with traditional methods. By accurately visualizing the fistula anatomy, surgeons can minimize invasiveness and improve post-operative care, potentially leading to faster healing and fewer follow-up surgeries. The study aims to assess the effectiveness of this innovative approach compared to standard care.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with active perianal Crohn's disease requiring surgical intervention.
Not a fit: Patients with conditions such as rectovaginal fistulas, significant comorbidities, or those who cannot undergo MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve surgical outcomes and reduce complications for patients with perianal Crohn's disease.
How similar studies have performed: While the use of advanced imaging techniques in surgical planning is gaining traction, this specific application of 3D imaging for perianal Crohn's disease is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Ability to give informed consent * Active perianal Crohn's disease as defined by clinical assessment with fistula or abscess formation * A clinical decision has been taken that surgery is required for perianal disease * Ages of 18-75 Exclusion Criteria: * Inability to consent * history of Proctectomy, * absence of a diagnosis of Crohn's disease, * perianal fistulising disease not secondary to Crohn's disease, * Rectovaginal fistulas * Malignant disease * Significant cardiovascular or respiratory disease * Neurological or cognitive impairment * Significant physical disability * Significant hepatic disease or renal failure * Subjects currently (or in the last three months) participating in another research project * Pregnancy or breastfeeding * If MRI is contraindicated (e.g. pacemaker). * under 18 years old or over 75 years old
Where this trial is running
Nottingham
- Nottingham University Hospital NHS Trust — Nottingham, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Jonathan Paul Evans, MBChB PhD FRCS
- Email: nuhnt.researchsponsor@nhs.net
- Phone: +44115 924 9924
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.