Status:
UNKNOWN
Early Bowel Resection for Terminal Ileal Crohn's Disease
Lead Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Collaborating Sponsors:
Sheffield Centre for Health and Related Research
University of Sheffield
Conditions:
Crohn Disease
Eligibility:
All Genders
18+ years
Brief Summary
The goal of this multicentre mixed -methods study is to understand the patient and clinician perspective on the ideal timing of an operation for Crohn's disease of the terminal ileum (last part of the...
Detailed Description
Crohn's disease is localised to the terminal ileum/ileocaecum in a third of patients. Typical medical therapy for ileocaecal Crohn's involves steroids to induce remission, followed by escalation to im...
Eligibility Criteria
Inclusion
- Qualitative interviews with patients with terminal ileal (TI) Crohn's disease (CD)
- Any patient ≥18 years of age, with CD currently or previously affecting the terminal ileum or ileocaecum (with or without involvement of the ascending colon). Where the patient also has concomitant CD affecting other sites, this should be L1-dominant disease (i.e. where treatment is predominantly being required for, or symptoms are predominantly being caused by, disease of the terminal ileum).
- AND
- The diagnosis of TI CD should have been made in the ten years preceding the start of the study.
- AND
- The patient should either currently be on steroid-sparing treatment for TI CD, or should have previously been on such treatment (to include enteral nutrition, immunomodulator therapy or biologics), or should have had an ileocolic resection or right hemicolectomy for TI CD.
Exclusion
- Patients who have never been on any treatment for their TI CD or who have only ever had steroids as treatment (i.e. no other medical or surgical treatment)
- Unable to communicate in English
- Discrete choice experiment Inclusion and exclusion criteria for patient participants are as above in 1.
- Eligibility criteria for healthcare professionals are as follows:
- Consultant colorectal surgeon with an interest or expertise in IBD, or
- Consultant gastroenterologist with an interest or expertise in IBD, or
- IBD clinical nurse specialist (IBD CNS), or
- any doctor (medical or surgical) undertaking a fellowship in IBD following achievement of their Certificate of Completion of Training, working in an NHS trust in any part of the UK.
- 3\. Survey of patients with previous ileocaecal resection for CD
- Inclusion criteria:
- Any patient who had their first ileocaecal or ileocolic resection for Crohn's disease of the TI (confirmed using the pathology report for the resected specimen) within 7 years of the launch of the study. Patients who subsequently require a redo ileocolic resection (such as for recurrence in the neo-terminal ileum) during the 7 year study time frame chosen can still be included, as long as their first resection was within the study period.
- Age 18 years and above
- Resection with primary anastomosis or with a stoma
- Elective, emergency and semi-elective operations.
- Exclusion criteria:
- Ileocaecal or ileocolic resection performed as an emergency operation for the first presentation of Crohn's disease (i.e. in someone not previously diagnosed with Crohn's)
- Incidental diagnosis of Crohn's disease as a result of resection performed for an alternative pathology
- Resection in the three months preceding the launch of the survey
Key Trial Info
Start Date :
September 7 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
November 30 2025
Estimated Enrollment :
496 Patients enrolled
Trial Details
Trial ID
NCT06116604
Start Date
September 7 2023
End Date
November 30 2025
Last Update
November 3 2023
Active Locations (1)
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1
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom, S5 7AU