Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease

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

Detailed Description
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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.

Official Title
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Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease

Conditions
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Inflammatory Bowel Disease, Perianal Fistula, Perianal Abscess

Intervention / Treatment
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* Device: capsule endoscopy


Participation Criteria
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Eligibility Criteria
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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: 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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: capsule endoscopy<br>patients eligible according to inclusion criteria who underwent a capsule endoscopy | Device: capsule endoscopy<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Inflammation as Diagnosed by Capsule Endoscopy | 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. | up to 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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inflammation of the small bowel