Status:
UNKNOWN
MR Assessment of Perianal Crohn's Disease
Lead Sponsor:
University of Nottingham
Conditions:
Perianal Fistula
Eligibility:
All Genders
16-75 years
Brief Summary
Perianal Crohn's disease (pCD) is the commonest form of fistulising Crohn's disease, with up to 38% of patients affected and with 30% of them experiencing recurring disease symptoms. Presence of fistu...
Detailed Description
Background: Inflammatory Bowel Disease has the United Kingdom prevalence of \~620,000 patients. PCD is the commonest form of fistulising Crohn's disease with 20% of patients affected and with 30% of ...
Eligibility Criteria
Inclusion
- Active perianal Crohn's disease as defined by clinical assessment and a PDAI score of \>4.
- A clinical decision has been taken to start biological therapy
- Ages of 16-75
- No immediate plan for surgery in the near future
- Ability to consent
- No obvious contraindication to the use of MR
- A clear intention by the recruited participant to adhere to the study protocol.
Exclusion
- Immediate surgery planned on the perianal Crohn's disease in the following 12 weeks.
- 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
- Abnormal blood results other than those explained by CD
- Participants currently (or in the last three months) participating in another research project
- pregnancy or breastfeeding
- If MRI is contraindicated (e.g. pacemaker
Key Trial Info
Start Date :
April 21 2017
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 1 2019
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03325582
Start Date
April 21 2017
End Date
February 1 2019
Last Update
October 11 2018
Active Locations (3)
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1
St Mark's Hospital and London North West Healthcare NHS Trust
London, United Kingdom
2
University of Manchester Institute of Inflammation and Repair Clinical Sciences Building, Salford Royal NHS Trust, Salford
Manchester, United Kingdom, M6 8HD
3
Nottingham Digestive Diseases Centre, QMC Campus, Nottingham University Hospitals
Nottingham, United Kingdom, NG7 2UH