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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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Aims:
Project design: Cross sectional, prospective, comparative study
Methodology: 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 on the same day 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.
Professor Macrae and the scholarly selective student researcher will assess the recorded images obtained from capsule colonoscopies once the images have been deidentified.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti TNF induction therapy 6-12 months | Other | All subjects will be identified through The Royal Melbourne Hospital's IBD clinic, associated specialty clinics and the colonoscopy waiting list of The Royal Melbourne Hospital. The potential participants who have been commenced on Anti TNF induction therapy 6-12 months prior to commencement of the study will be identified. The potential participants identified in this way will be informed of the project at the time of contact and assessment; in some instances the potential participant will be informed of the project via telephone where subjects are remote. The potential participants will be provided an Ethically-approved information sheet at this time. Consent will be gained at the time of assessment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PillCam® COLON 2 Capsule Endoscopy | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assess bowel cleanness based on the % of mucosal surface visualized by the Capsule colonoscopy | The quality of bowel preparation will be assessed using a new grading system proposed by Segal, et al, University of Melbourne Honours thesis in preparation, 2014. The investigator will assess five colonic segments (cecum, ascending, transverse and descending colon and the rectum). The investigator will assess bowel cleanness based on the % of mucosal surface visualized by the capsule for the presence of: Faecal residue, Turbid Fluid, Bubbles , Faecal residue on Dome, Rapid movement , Poor lighting, Light reflection. Each segment will be given a number out of 4: 0 =not present and 4=significantly prevented mucosal visualization. SES-CD= sum of the above 4 variables for 5 bowel segments (rectum, sigmoid and ascending colon, transverse colon, descending colon and ileum. The images taken during this procedure will be recorded and analysed at a later date. | 24 months |
| Simple Endoscopic Score for Crohn's Disease from Conventional colonoscopy | 24 months | |
| Levels of Faecal calprotectin | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
Patients must not:
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| Name | Affiliation | Role |
|---|---|---|
| Finlay Macrae | Melbourne Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Melbourne Hospital | Parkville | Victoria | 3050 | Australia |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D004724 | Endoscopy |
| ID | Term |
|---|---|
| D003949 | Diagnostic Techniques, Surgical |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D019060 | Minimally Invasive Surgical Procedures |
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| D007410 | Intestinal Diseases |
| D013514 | Surgical Procedures, Operative |