The patient and clinician perspective on 'early' bowel resection for terminal ileal Crohn's disease (EBRIC): protocol for a multicentre mixed-methods study.

AIM: Emerging evidence supports the consideration of surgery earlier in the treatment pathway for isolated luminal terminal ileal (TI) Crohn's disease (CD), as an alternative to medical therapy. Surgery is still considered late in the treatment pathway; recruiting participants into trials comparing medical therapy and surgery is difficult. This will be the first study to explore patients' and clinicians' views on bowel resection as an alternative to medical therapy for surgery-naïve luminal TI CD. An understanding of the facilitators and barriers to this approach will provide insight into the gap between the evidence base and practice; these should be considered when designing future trials.

METHODS

A multicentre mixed-methods study (NCT06116604) will be conducted. This will include semi-structured interviews with 25-35 patients with TI CD exploring their views of treatment options, a survey of patients who have undergone a bowel resection for TI CD measuring their decision-regret relating to the timing of their first resection (n = 271), and discrete choice experiments with healthcare professionals treating inflammatory bowel disease (surgeons, nurses and gastroenterologists) and with patients with TI CD (n = 100-300 for each participant group) to understand the importance given to different factors when making treatment choices. Patients will be recruited from 10 English and Welsh hospitals and healthcare professionals will be recruited from across the UK.

ETHICS AND DISSEMINATION: This study has been approved by the London-Brent NHS Research Ethics Committee (reference 23/PR/0568). Dissemination will be through international and national colorectal and gastroenterology meetings and through the study patient panel.