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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
Information provided by (Responsible Party):

September 2, 2009
September 4, 2009
February 4, 2012
June 24, 2013
June 24, 2013
August 2008
June 2011   (Final data collection date for primary outcome measure)
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.
Prevalence of Inflammation as Diagnosed by Capsule Endoscopy [ Time Frame: up to 7 days ]
Complete list of historical versions of study NCT00972088 on ClinicalTrials.gov Archive Site
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Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease
Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease
To show that prevalence of inflammation of the small bowel in patients with anorectal disease is under-diagnosed based on colonoscopy ileoscopy alone.

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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Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
  • Inflammatory Bowel Disease
  • Perianal Fistula
  • Perianal Abscess
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.
capsule endoscopy
patients eligible according to inclusion criteria who underwent a capsule endoscopy
Intervention: Device: capsule endoscopy
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2011
June 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
10 Years to 80 Years   (Child, Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Peri Anal Study
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Sam Adler, Bikkur Holim Hospital
Bikkur Holim Hospital
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Principal Investigator: Samuel Adler, Prof. Bikur Cholim Hospital, Jerusalem
Bikkur Holim Hospital
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP