Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease

NCT ID: NCT00972088

Last Updated: 2013-06-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2011-06-30

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.

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.

Conditions

Inflammatory Bowel Disease; Perianal Fistula; Perianal Abscess

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

capsule endoscopy

patients eligible according to inclusion criteria who underwent a capsule endoscopy

Group Type: OTHER

capsule endoscopy

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bikkur Holim Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sam Adler

Prof. Samuel N. Adler, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Samuel Adler, Prof.

Role: PRINCIPAL_INVESTIGATOR

Bikur Cholim Hospital, Jerusalem

Locations

Assaf Harofeh Medical Center

Tel Aviv, Zrifin, Israel

Rambam Medical Center

Haifa, , Israel

Bikur Cholim Hospital

Jerusalem, , Israel

Countries

Israel

Other Identifiers

Peri Anal Study

Identifier Type: -

Identifier Source: org_study_id