Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease
To show that prevalence of inflammation of the small bowel in patients with anorectal disease is under-diagnosed based on colonoscopy ileoscopy alone.
Inflammatory Bowel Disease
Device: capsule endoscopy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease|
- Prevalence of Inflammation as Diagnosed by Capsule Endoscopy [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]The capsule endoscopy findings were carefully examined by specialists in the field. findings such as erosions, edema, erythema and ulceration in significant areas of the intestine led to the clinical diagnosis of crohn's disease. all together 6 patients were diagnosed as suffering from crohn's disease.
|Study Start Date:||August 2008|
|Study Completion Date:||June 2011|
|Primary Completion Date:||June 2011 (Final data collection date for primary outcome measure)|
patients eligible according to inclusion criteria who underwent a capsule endoscopy
Device: capsule endoscopy
The disposable, ingestible PillCam® SB2 Capsule acquires the video images during natural propulsion through the digestive system. The Capsule transmits the acquired images via digital radio frequency communication channel to the Given® Data Recorder unit located outside the body.
IBD of the small bowel is associated with perianal disease such as ano-rectal abscesses and fistulas. Colonoscopy with ileoscopy and small bowel series are relied upon to document the presence of Crohn's disease of the small bowel. We suspect that the prevalence of inflammatory small bowel disease is underestimated.
In my practice I have cases that had negative colonoscopy ileoscopy and positive findings at capsule endoscopy. These patients are receiving therapy for Crohn's disease. It is important to prove that the prevalence is higher.
Capsule Endoscopy (CE) is the "first line tool" diagnostic procedure for the examination of the small bowel. It is performed today in more than 2,900 GI clinics in hospitals, outpatient departments and physicians' offices all over the world using the PillCam® Platform. Over 500,000 CE procedures with the Given PillCam SB have been completed to date.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00972088
|Assaf Harofeh Medical Center|
|Tel Aviv, Zrifin, Israel, 70300|
|Rambam Medical Center|
|Haifa, Israel, 31096|
|Bikur Cholim Hospital|
|Jerusalem, Israel, 91004|
|Principal Investigator:||Samuel Adler, Prof.||Bikur Cholim Hospital, Jerusalem|