Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease

N/ACompletedNCT00972088

Bikkur Holim Hospital26 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Inflammatory Bowel Disease Perianal Fistula Perianal Abscess

Interventions

capsule endoscopyDEVICE

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.

Eligibility

Sex: ALLMin age: 10 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (3)

Assaf Harofeh Medical Center

Tel Aviv, Zrifin, Israel

Rambam Medical Center

Haifa, Israel

Bikur Cholim Hospital

Jerusalem, Israel

Outcomes

Primary Outcomes

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.

Time frame: up to 7 days

Data from ClinicalTrials.gov

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