Understanding the timing of surgery for Crohn's disease of the terminal ileum

Early Bowel Resection for Terminal Ileal Crohn's Disease - Exploring Patients' and Clinicians' Perspectives and Barriers to Implementation

This study is trying to understand what patients and doctors think about when the best time is to have surgery for Crohn's disease in the last part of the small intestine.

Quick facts

• Study type: Observational
• Enrollment: 496 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Sheffield Teaching Hospitals NHS Foundation Trust (Academic / other)
• Locations: 1 site (Sheffield)
• Trial ID: NCT06116604 on ClinicalTrials.gov

What this trial studies

This multicentre mixed-methods study aims to explore the perspectives of patients and clinicians regarding the timing of bowel resection for Crohn's disease affecting the terminal ileum. It seeks to identify factors influencing preferences for early surgery versus medical therapy, as well as barriers and facilitators to implementing early surgical options in clinical practice. The study will involve qualitative interviews with patients who have terminal ileal Crohn's disease and healthcare professionals treating inflammatory bowel disease across multiple NHS sites in England and Wales.

Who should consider this trial

Good fit: Ideal candidates for this study are patients aged 18 and older with a diagnosis of terminal ileal Crohn's disease within the last ten years.

Not a fit: Patients who have never received treatment for their terminal ileal Crohn's disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for Crohn's disease, potentially allowing for earlier surgical interventions that enhance patient outcomes.

How similar studies have performed: There is a growing body of evidence supporting early surgery for Crohn's disease, suggesting that this approach may be effective, although it has not been universally adopted in clinical practice.

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

Where this trial is running

Sheffield

• Sheffield Teaching Hospitals NHS Foundation Trust — Sheffield, United Kingdom (Recruiting)

Study contacts

• Study coordinator: Debby Dr Hawkins

Conditions Crohn Disease; Crohn's disease; terminal ileitis; ileocaecal Crohn's; ileocaecal resection; bowel resection; shared decision-making; qualitative interviews