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
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Condition or disease | Intervention/treatment | Phase |
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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) |
Primary Purpose: | Diagnostic |
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 |

Arm | Intervention/treatment |
---|---|
capsule endoscopy
patients eligible according to inclusion criteria who underwent a capsule endoscopy
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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.
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- 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.

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Ages Eligible for Study: | 10 Years to 80 Years (Child, Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients between the ages of 10 - 80
- Patients with anorectal abscess of anorectal fistula
- Patient is male or female
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Within three months prior to enrollment, patient has normal test results for at least one of the following tests:
- Colonoscopy with Ileoscopy, and/or
- Colonoscopy with small bowel series, and/or
- Colonoscopy with CT enterography
- Within three months prior to enrollment patient has the following lab tests: Blood count, sedimentation rate, CRP. IBD serology is optional.
- Sign informed consent
Exclusion Criteria:
- Can not sign informed consent
- Contraindications to colonoscopy ileoscopy or capsule endoscopy
- History of established IBD

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
Israel | |
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 |
Responsible Party: | Sam Adler, Prof. Samuel N. Adler, MD, Bikkur Holim Hospital |
ClinicalTrials.gov Identifier: | NCT00972088 History of Changes |
Other Study ID Numbers: |
Peri Anal Study |
First Posted: | September 4, 2009 Key Record Dates |
Results First Posted: | June 24, 2013 |
Last Update Posted: | June 24, 2013 |
Last Verified: | May 2013 |
Keywords provided by Sam Adler, Bikkur Holim Hospital:
inflammation of the small bowel |
Additional relevant MeSH terms:
Intestinal Diseases Inflammatory Bowel Diseases Fistula Gastrointestinal Diseases |
Digestive System Diseases Gastroenteritis Pathological Conditions, Anatomical |