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

Sponsor:

Information provided by (Responsible Party):

Sam Adler, Bikkur Holim Hospital

Study Description

Brief Summary:

To show that prevalence of inflammation of the small bowel in patients with anorectal disease is under-diagnosed based on colonoscopy ileoscopy alone.

Condition or disease	Intervention/treatment	Phase
Inflammatory Bowel Disease Perianal Fistula Perianal Abscess	Device: capsule endoscopy	Not Applicable

Detailed Description:

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 Design


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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
capsule endoscopy 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.

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	10 Years to 80 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients between the ages of 10 - 80
Patients with anorectal abscess of anorectal fistula
Patient is male or female
Within three months prior to enrollment, patient has normal test results for at least one of the following tests:
1. Colonoscopy with Ileoscopy, and/or
2. Colonoscopy with small bowel series, and/or
3. 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

Contacts and Locations

Information from the National Library of Medicine

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

Locations


Israel
Assaf Harofeh Medical Center
Tel Aviv, Zrifin, Israel, 70300
Rambam Medical Center
Haifa, Israel, 31096
Bikur Cholim Hospital
Jerusalem, Israel, 91004

Sponsors and Collaborators

Bikkur Holim Hospital

Investigators


Principal Investigator:	Samuel Adler, Prof.	Bikur Cholim Hospital, Jerusalem

More Information


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

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