Early Bowel Resection for Terminal Ileal Crohn's Disease

NCT06116604 | Unknown

• 1 other identifier: STH21927
• Study Type: observational
• Target: 496
• Locations: 1 country
• Sites: 1

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:
• 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

Conditions

Crohn Disease

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Themes

  Themes generated from analysis of patient interviews

  Within 10 years of diagnosis

• Trade off preferences for treatments

  Relative importance of attributes from the analysis of the discrete choice experiment

  Within 10 years of diagnosis

• Patient preference for timing of resection

  Primary outcome for survey of patients with a previous ileocaecal resection

  Within 7 years of operation

• Decision-regret

  Primary outcome for survey of patients with a previous ileocaecal resection

  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

  Within 7 years of operation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with terminal ileal Crohn's disease (current or previous) Healthcare professionals with an interest or expertise in inflammatory bowel disease

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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
• 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.
• \. Survey of patients with previous ileocaecal resection for 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.
• Age 18 years and above
• Resection with primary anastomosis or with a stoma
• Elective, emergency and semi-elective operations.
• 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

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead
• Sheffield Centre for Health and Related Research: collaborator
• University of Sheffield: collaborator
• Crohn's & Colitis UK: collaborator

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S5 7AU, United Kingdom

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Steven Brown

  Sheffield Teaching Hospitals NHS Foundation Trust

  STUDY CHAIR

Central Study Contacts

Debby Dr Hawkins

CONTACT

+44114 2267052; debby.hawkins@nhs.net

Nilofer Husnoo

CONTACT

+44114 2267052; nilofer.husnoo@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2023
• First Posted: November 3, 2023
• Study Start: September 7, 2023
• Primary Completion: March 31, 2025
• Study Completion: November 30, 2025
• Last Updated: November 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)