None listed
Conditions
Brief summary
To study the feasibility of capsule colonoscopy in patients with Crohn's Disease (CD). To compare the results of capsule colonoscopy with conventional colonoscopy in assessing mucosal healing. To correlate the level of faecal calprotectin with the results of capsule colonoscopy and conventional colonoscopy. To document changes in clinical practice attributable to the capsule colonoscopy findings a) concordant with and b) in addition to the parallel findings at colonoscopy and ileoscopy. Patients of the Royal Melbourne Hospital (RMH) and other associated speciality clinics with an established diagnosis of CD who need assessment of mucosal healing and have consented to be part of the study will undergo capsule colonoscopy and conventional colonoscopy after undergoing bowel preparation. The images of both the conventional and capsule colonoscopies will be recorded. In addition calprotectin (an inflammatory marker in faeces) will be measured in a sample of faeces collected by the patients prior to the colonoscopy day. Recorded images will be assessed once the images have been deidentified. Assessment will include the level of mucosal disease. To assess the level of mucosal disease they will use the Simple Endoscopic Score for CD (SESCD). The results of the assessment of mucosal healing obtained from conventional colonoscopy will be compared with those of capsule colonoscopy and levels of faecal calprotectin will then be correlated.
Interventions
The following investigations will be performed on participants: 1. capsule colonoscopy, 2. conventional colonoscopy and 3. faecal calprotectin (stool sample). The day before the procedure, patients will be asked to ingest bowel prep as per standard regime. Patients will be asked to come in early to clinic and have extra bowel prep before patient swallows a small capsule (pillcam colon) which will take photos of their colon. They will need to wear a small device around their hip for the duration
The following investigations will be performed on participants: 1. capsule colonoscopy, 2. conventional colonoscopy and 3. faecal calprotectin (stool sample). The day before the procedure, patients will be asked to ingest bowel prep as per standard regime. Patients will be asked to come in early to clinic and have extra bowel prep before patient swallows a small capsule (pillcam colon) which will take photos of their colon. They will need to wear a small device around their hip for the duration of the day which captures the photos. It is best to wear lose fitting clothing. The participants conventional colonoscopy will be booked for the same day, last on the list to make sure there is adequate time for the pillcam colon to take photos. The pill cam colon will be administered by a nurse. The conventional colonoscopy will be conducted by a Gastroenterologist and usually takes approximately 20 minutes. The stool sample will be need before the colonoscopy. The patient can complete one at home and bring it with them on the day of the procedure. The whole study takes around 24 hours.
Sponsors
Melbourne Health
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
Adults with established diagnosis of CD with ileal, colonic or ileo-colonic disease aged 18-75 years Gender: both male and female Patients of RMH IBD clinic and other specialty clinics where assessment of mucosal healing is clinically indicated this includes: a) Patients who have had Anti TNF induction therapy 6-12 months prior to commencement of this study. b) Patients referred for colonoscopy to assess mucosal disease status with a view to treatment escalation based on the findings.
Exclusion criteria
Patients must not: Have known/suspected gastrointestinal obstruction Have swallowing disorder Have a known oesophageal stricture Have severe gastroparesis Have dementia Have a cardiac pacemaker or other implanted medical device Have sever cardiac or renal insufficiency Have a previous allergy or contraindication to bowel preparation Be pregnant Prior major abdominal surgery Colonoscopy is contraindicated
Outcome results
None listed