NCT02624414

Capsule Colonoscopy in Crohn's Disease and Its Correlation With Conventional Colonoscopy and Faecal Calprotectin

A Prospective Study of the Feasibility of Capsule Colonoscopy in Crohn's Disease and Its Correlation With Conventional Colonoscopy and Faecal Calprotectin

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Melbourne Health · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Aims: * 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. 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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
DEVICE	PillCam® COLON 2 Capsule Endoscopy

Timeline

• Start date: 2015-02-06
• Primary completion: 2020-12-31
• Completion: 2022-05-05
• First posted: 2015-12-08
• Last updated: 2022-11-23

Locations

1 site across 1 country: Australia