Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:16 PM
Ignite Modification Date:
2025-12-24 @ 9:16 PM
NCT ID:
NCT06116604
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
Study:
NCT06116604
Study Brief:
Protocol Section:
NCT06116604