Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease
Recruitment status was Recruiting
To show that prevalence of inflammation of the small bowel in patients with anorectal disease is under-diagnosed based on colonoscopy ileoscopy alone.
|Study Design:||Allocation: Non-Randomized
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 ]
|Study Start Date:||August 2008|
|Estimated Study Completion Date:||December 2009|
|Estimated Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
Patients presently suffering from anorectal abscess of anorectal fistula
Device: PillCam SB2 Capsule
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.
|Contact: Samuel Prof Adler, Profemail@example.com|
|Contact: Samuel Adler, Proffirstname.lastname@example.org|
|Assaf Harofeh Medical Center||Not yet recruiting|
|Tel Aviv, Zrifin, Israel, 70300|
|Contact: Eitan Skapa, Prof 97289779722 email@example.com|
|Contact: Tali Gura 97289779722 firstname.lastname@example.org|
|Principal Investigator: Eitan Skapa, Prf|
|Rambam Medical Center||Recruiting|
|Haifa, Israel, 31096|
|Contact: Rami Eliakim, Prof 9724854 2887 email@example.com|
|Contact: Dalia Katz, Mrs 9724854 2887 firstname.lastname@example.org|
|Principal Investigator: Rami Eliakim, Prof|
|Bikur Cholim Hospital||Recruiting|
|Jerusalem, Israel, 91004|
|Contact: Samuel Adler, Prof 97226464206 email@example.com|
|Contact: Pnina Rosental 97226464206 firstname.lastname@example.org|
|Principal Investigator: Samuel Adler, prof|
|Principal Investigator:||Samuel Adler, Prof.||Bikur Cholim Hospital, Jerusalem|