Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sam Adler, Bikkur Holim Hospital
ClinicalTrials.gov Identifier:
NCT00972088
First received: September 2, 2009
Last updated: May 15, 2013
Last verified: May 2013
  Purpose

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


Condition Intervention
Inflammatory Bowel Disease
Perianal Fistula
Perianal Abscess
Device: capsule endoscopy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease

Resource links provided by NLM:


Further study details as provided by Bikkur Holim Hospital:

Primary Outcome Measures:
  • Prevalence of Inflammation as Diagnosed by Capsule Endoscopy [ Time Frame: up to 7 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 26
Study Start Date: August 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
capsule endoscopy
patients eligible according to inclusion criteria who underwent a capsule endoscopy
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.

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.

  Eligibility

Ages Eligible for Study:   10 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00972088

Locations
Israel
Assaf Harofeh Medical Center
Tel Aviv, Zrifin, Israel, 70300
Rambam Medical Center
Haifa, Israel, 31096
Bikur Cholim Hospital
Jerusalem, Israel, 91004
Sponsors and Collaborators
Bikkur Holim Hospital
Investigators
Principal Investigator: Samuel Adler, Prof. Bikur Cholim Hospital, Jerusalem
  More Information

No publications provided

Responsible Party: Sam Adler, Prof. Samuel N. Adler, MD, Bikkur Holim Hospital
ClinicalTrials.gov Identifier: NCT00972088     History of Changes
Other Study ID Numbers: Peri Anal Study
Study First Received: September 2, 2009
Results First Received: February 4, 2012
Last Updated: May 15, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Bikkur Holim Hospital:
inflammation of the small bowel

Additional relevant MeSH terms:
Intestinal Diseases
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Gastroenteritis

ClinicalTrials.gov processed this record on September 30, 2014