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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Page 1 of 1 (3 locations)

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