Crohn DiseaseE-BRICNCT06116604
Early Bowel Resection for Terminal Ileal Crohn's Disease
An observational study of Crohn Disease, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- How many people
- 496 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Sep 2023to 30 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with terminal ileal Crohn's disease (current or previous) Healthcare professionals with an interest or expertise in inflammatory bowel disease
Who may be able to join
- 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.
- 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.
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- Age 18 years and above
- Resection with primary anastomosis or with a stoma
- Elective, emergency and semi-elective operations.
Who cannot join
- 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
- Discrete choice experiment Inclusion and exclusion criteria for patient participants are as above in 1.
- Eligibility criteria for healthcare professionals are as follows:
- Consultant colorectal surgeon with an interest or expertise in IBD, or
- Consultant gastroenterologist with an interest or expertise in IBD, or
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- IBD clinical nurse specialist (IBD CNS), or
- 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
- 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)
- Incidental diagnosis of Crohn's disease as a result of resection performed for an alternative pathology
- Resection in the three months preceding the launch of the survey
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, S5 7AU
Nilofer Husnoo, +44114 2267052, nilofer.husnoo@nhs.net
Steven R Brown, steven.brown13@nhs.net
About this study
Official title: Early Bowel Resection for Terminal Ileal Crohn's Disease - Exploring Patients' and Clinicians' Perspectives and Barriers to Implementation
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?
Read more
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:
- an interview about their treatment choices
- 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
- a survey, for patients with a previous ileocaecal resection, assessing their experience of the operation
Read the 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:
- 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
- at what point in the treatment pathway surgery is seen as an acceptable option
- the facilitators and barriers to implementing early surgery
- 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:
- 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
- Interviews with patients with terminal ileal Crohn's disease to explore their views on treatment options including surgery for terminal ileal Crohn's disease
- Survey of patients with previous terminal ileal Crohn's disease to assess their decision-regret
- 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
- Conditions
- Crohn Disease
- Keywords
- Crohn's disease, terminal ileitis, ileocaecal Crohn's, ileocaecal resection, bowel resection, shared decision-making, qualitative interviews, discrete choice experiment
- Medical subject headings
- Crohn Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
Themes
Themes generated from analysis of patient interviews
Measured: Within 10 years of diagnosis
Trade off preferences for treatments
Relative importance of attributes from the analysis of the discrete choice experiment
Measured: Within 10 years of diagnosis
Patient preference for timing of resection
Primary outcome for survey of patients with a previous ileocaecal resection
Measured: Within 7 years of operation
Decision-regret
Primary outcome for survey of patients with a previous ileocaecal resection
Measured: Within 7 years of operation
Secondary outcomes (1)
Correlation of decision-regret score with pre-operative treatment experiences, Shared-decision making, body image score, selected post-operative outcomes
Secondary outcome for survey of patients with a previous ileocaecal resection
Measured: Within 7 years of operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2023
- Study start7 Sep 2023
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 496 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Centre for Health and Related Research, University of Sheffield, Crohn's & Colitis UK
- Responsible party
- Sponsor
- Investigators
- Steven Brown, Study chair, Sheffield Teaching Hospitals NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06116604
- Sponsor's protocol ID
- STH21927
- Acronym
- E-BRIC
- Status last verified
- Oct 2023
- First submitted
- 30 Oct 2023
- Last updated
- 3 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Bowel Resection for Terminal Ileal Crohn's Disease - Exploring Patients' and Clinicians' Perspectives and Barriers to Implementation
- ClinicalTrials.gov ID
- NCT06116604
- Acronym / sponsor ID
- E-BRIC / STH21927
- Conditions
- Crohn Disease
- Keywords
- Crohn's disease, terminal ileitis, ileocaecal Crohn's, ileocaecal resection, bowel resection, shared decision-making, qualitative interviews, discrete choice experiment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 496 participants (estimated)
- Lead sponsor
- Sheffield Teaching Hospitals NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Sheffield Centre for Health and Related Research, University of Sheffield, Crohn's & Colitis UK
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Nov 2025 (estimated)
- First posted
- 3 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- an interview about their treatment choices
- 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
- 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:
- 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
- at what point in the treatment pathway surgery is seen as an acceptable option
- the facilitators and barriers to implementing early surgery
- 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:
- 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
- Interviews with patients with terminal ileal Crohn's disease to explore their views on treatment options including surgery for terminal ileal Crohn's disease
- Survey of patients with previous terminal ileal Crohn's disease to assess their decision-regret
- 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with terminal ileal Crohn's disease (current or previous) Healthcare professionals with an interest or expertise in inflammatory bowel disease
Key inclusion criteria (9 listed)
- 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.
- 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.
Key exclusion criteria (12 listed)
- Discrete choice experiment Inclusion and exclusion criteria for patient participants are as above in 1.
- Consultant colorectal surgeon with an interest or expertise in IBD, or
- Consultant gastroenterologist with an interest or expertise in IBD, or
- IBD clinical nurse specialist (IBD CNS), or
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Themes
Time frame: Within 10 years of diagnosis
Themes generated from analysis of patient interviews
Trade off preferences for treatments
Time frame: Within 10 years of diagnosis
Relative importance of attributes from the analysis of the discrete choice experiment
Patient preference for timing of resection
Time frame: Within 7 years of operation
Primary outcome for survey of patients with a previous ileocaecal resection
Decision-regret
Time frame: Within 7 years of operation
Primary outcome for survey of patients with a previous ileocaecal resection
1 secondary outcome
Correlation of decision-regret score with pre-operative treatment experiences, Shared-decision making, body image score, selected post-operative outcomes
Time frame: Within 7 years of operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Steven Brown study chair
Sheffield Teaching Hospitals NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Sheffield Teaching Hospitals NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Debby Dr Hawkins (+44114 2267052, debby.hawkins@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Themes (time frame: Within 10 years of diagnosis). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2023.