Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease

Inflammatory Bowel Disease Clinical Trial

Official title:

Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00972088
• Other study ID #: Peri Anal Study
• Status: Completed
• Phase: N/A
• First received: September 2, 2009
• Last updated: May 15, 2013
• Start date: August 2008
• Est. completion date: June 2011

Study information

• Verified date: May 2013
• Source: Bikkur Holim Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Israeli Health Ministry Pharmaceutical Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 80 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Inflammatory Bowel Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Perianal Abscess
• Perianal Fistula

Intervention

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.

Locations

Country	Name	City	State
Israel	Rambam Medical Center	Haifa
Israel	Bikur Cholim Hospital	Jerusalem
Israel	Assaf Harofeh Medical Center	Tel Aviv	Zrifin

Sponsors (1)

Lead Sponsor	Collaborator
Bikkur Holim Hospital

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No