Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT06116604
Eligibility Criteria:
1. Qualitative interviews with patients with terminal ileal (TI) Crohn's disease (CD)
Inclusion Criteria:
* 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 Criteria:
* 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
2. Discrete choice experiment Inclusion and exclusion criteria for patient participants are as above in 1.
Eligibility criteria for healthcare professionals are as follows:
1. Consultant colorectal surgeon with an interest or expertise in IBD, or
2. Consultant gastroenterologist with an interest or expertise in IBD, or
3. IBD clinical nurse specialist (IBD CNS), or
4. 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:
1. 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)
2. Incidental diagnosis of Crohn's disease as a result of resection performed for an alternative pathology
3. Resection in the three months preceding the launch of the survey
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06116604
Study Brief:
Protocol Section:
NCT06116604