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Early Bowel Resection for Terminal Ileal Crohn's Disease

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06116604
Acronym
E-BRIC
Enrollment
496
Registered
2023-11-03
Start date
2023-09-07
Completion date
2025-11-30
Last updated
2023-11-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease

Keywords

Crohn's disease, terminal ileitis, ileocaecal Crohn's, ileocaecal resection, bowel resection, shared decision-making, qualitative interviews, discrete choice experiment

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 small bowel). The main questions it aims to answer are: * What factors influence patients' and clinicians' preferences with regards to the timing of the first bowel resection for isolated Crohn's disease of the terminal ileum? * What are patients' and clinicians' views on 'early' bowel resection (as an alternative to medical therapy) in this context? * What are the facilitators and barriers to implementation of early surgery in practice? Participants will be patients with Crohn's disease of the terminal ileum and healthcare professionals involved in treating inflammatory bowel disease. Healthcare professionals have previously been asked to participate in an interview to understand their views on the role of surgery for Crohn's disease of the terminal ileum. They will now be invited to participate in a choice exercise to understand how much weight they attribute to various factors and outcomes when choosing between surgery and medication for Crohn's disease of the terminal ileum. Patients will be asked to participate in: 1. an interview about their treatment choices 2. a choice exercise to understand how much weight they attribute to various factors and outcomes when choosing between surgery and medication for Crohn's disease of the terminal ileum 3. a survey, for patients with a previous ileocaecal resection, assessing their experience of the operation

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 immunosuppression and/or of biological therapies for refractory disease to maintain remission. Surgery may be considered late in this treatment pathway, when medical therapies have been exhausted or when complications of the disease process arise. There is a growing body of evidence supporting surgery as a valid option earlier in the treatment pathway. Studies have shown that surgery and medical treatment produce equivalent short term quality of life scores, and that earlier bowel resection is more cost effective. There is also a reduced need for medical therapy and subsequent surgery in patients having an earlier operation compared to those on conventional medical therapy. Despite the evidence, the concept of early surgery has not universally translated into clinical practice. The purpose of this study is to understand why through a mixed-methods study with clinicians and patients. The patient components will be multi-centre (involving up to 10 NHS sites across England and Wales). The aims will be to establish: 1. the views of clinicians and patients on early primary bowel resection as an alternative to escalation of medical therapy in the context of terminal ileal Crohn's disease 2. at what point in the treatment pathway surgery is seen as an acceptable option 3. the facilitators and barriers to implementing early surgery 4. patient and clinician treatment preferences for terminal ileal Crohn's disease and factors influencing their decision-making This study consists of the following work packages: 1. Interviews with healthcare professionals with an interest in inflammatory bowel disease to explore their views on the role of surgery for terminal ileal Crohn's disease - this has already been completed 2. Interviews with patients with terminal ileal Crohn's disease to explore their views on treatment options including surgery for terminal ileal Crohn's disease 3. Survey of patients with previous terminal ileal Crohn's disease to assess their decision-regret 4. Discrete choice experiment with clinicians and patients to understand the weight attributed to different factors and outcomes when choosing between medical treatment and surgery for terminal ileal Crohn's disease

Interventions

None listed

Sponsors

Sheffield Centre for Health and Related Research
CollaboratorUNKNOWN
University of Sheffield
CollaboratorOTHER
Crohn's & Colitis UK
CollaboratorUNKNOWN
Sheffield Teaching Hospitals NHS Foundation Trust
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
ThemesWithin 10 years of diagnosisThemes generated from analysis of patient interviews
Trade off preferences for treatmentsWithin 10 years of diagnosisRelative importance of attributes from the analysis of the discrete choice experiment
Patient preference for timing of resectionWithin 7 years of operationPrimary outcome for survey of patients with a previous ileocaecal resection
Decision-regretWithin 7 years of operationPrimary outcome for survey of patients with a previous ileocaecal resection

Secondary

MeasureTime frameDescription
Correlation of decision-regret score with pre-operative treatment experiences, Shared-decision making, body image score, selected post-operative outcomesWithin 7 years of operationSecondary outcome for survey of patients with a previous ileocaecal resection

Countries

United Kingdom

Contacts

Primary ContactDebby Dr Hawkins
debby.hawkins@nhs.net+44114 2267052
Backup ContactNilofer Husnoo
nilofer.husnoo@nhs.net+44114 2267052

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026