Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease

Not Applicable

Completed

• Conditions: Inflammatory Bowel Disease; Perianal Fistula; Perianal Abscess
• Interventions: Device: capsule endoscopy

• Registration Number: NCT00972088
• Lead Sponsor: Bikkur Holim Hospital

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.

Study Timeline

• Study Start: 2008-08
• Study First Submitted: 2009-09-02
• Study First Submitted QC: 2009-09-03
• Study First Posted: 2009-09-04
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2012-02-04
• Status Verified: 2013-05
• Results First Submitted QC: 2013-05-15
• Last Update Submitted: 2013-05-15
• Results First Posted: 2013-06-24
• Last Update Posted: 2013-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
capsule endoscopy	capsule endoscopy	patients eligible according to inclusion criteria who underwent a capsule endoscopy

Primary Outcome Measures

Name	Time	Method
Prevalence of Inflammation as Diagnosed by Capsule Endoscopy	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.

Trial Locations

Locations (3)

Bikur Cholim Hospital; 🇮🇱 Jerusalem, Israel

Rambam Medical Center; 🇮🇱 Haifa, Israel

Assaf Harofeh Medical Center; 🇮🇱 Tel Aviv, Zrifin, Israel