Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease
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|ClinicalTrials.gov Identifier: NCT00972088|
Recruitment Status : Completed
First Posted : September 4, 2009
Results First Posted : June 24, 2013
Last Update Posted : June 24, 2013
|Condition or disease||Intervention/treatment||Phase|
|Inflammatory Bowel Disease Perianal Fistula Perianal Abscess||Device: capsule endoscopy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||26 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease|
|Study Start Date :||August 2008|
|Actual Primary Completion Date :||June 2011|
|Actual Study Completion Date :||June 2011|
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.
- Prevalence of Inflammation as Diagnosed by Capsule Endoscopy [ Time Frame: up to 7 days ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|