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Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00972088
Recruitment Status : Completed
First Posted : September 4, 2009
Results First Posted : June 24, 2013
Last Update Posted : June 24, 2013
Information provided by (Responsible Party):
Sam Adler, Bikkur Holim Hospital

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: N/A
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

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.

Primary Outcome Measures :
  1. 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.

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

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

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 identifier (NCT number): NCT00972088

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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
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Principal Investigator: Samuel Adler, Prof. Bikur Cholim Hospital, Jerusalem
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Responsible Party: Sam Adler, Prof. Samuel N. Adler, MD, Bikkur Holim Hospital Identifier: NCT00972088    
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:
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Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical