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Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Bikkur Holim Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Bikkur Holim Hospital
ClinicalTrials.gov Identifier:
NCT00972088
First received: September 2, 2009
Last updated: September 3, 2009
Last verified: September 2009
History of Changes
  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 Disease
 Device: PillCam SB2 Capsule

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:

MedlinePlus related topics: Colonoscopy
U.S. FDA Resources

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 ]

Estimated Enrollment: 30
Study Start Date: August 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Patients presently suffering from anorectal abscess of anorectal fistula
 Device: PillCam SB2 Capsule
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00972088

Contacts
Contact: Samuel Prof Adler, Prof 97226464206 nasnadler@gmail.com
Contact: Samuel Adler, Prof 97226464206 nasnadler@gmail.com

Locations
Israel
Assaf Harofeh Medical Center Not yet recruiting
Tel Aviv, Zrifin, Israel, 70300
Contact: Eitan Skapa, Prof     97289779722     eitans@asaf.health.gov.il    
Contact: Tali Gura     97289779722     talig@asaf.health.gov.il    
Principal Investigator: Eitan Skapa, Prf            
Rambam Medical Center Recruiting
Haifa, Israel, 31096
Contact: Rami Eliakim, Prof     9724854 2887     r_eliakim@rambam.health.gov.il    
Contact: Dalia Katz, Mrs     9724854 2887     dl_katz@rambam.health.gov.il    
Principal Investigator: Rami Eliakim, Prof            
Bikur Cholim Hospital Recruiting
Jerusalem, Israel, 91004
Contact: Samuel Adler, Prof     97226464206     nasnadler@gmail.com    
Contact: Pnina Rosental     97226464206     secadler@gmail.com    
Principal Investigator: Samuel Adler, prof            
Sponsors and Collaborators
Bikkur Holim Hospital
Investigators
Principal Investigator: Samuel Adler, Prof. Bikur Cholim Hospital, Jerusalem
  More Information

No publications provided

Responsible Party: Prof. Samuel Adler, Bikur Cholim Hospital
ClinicalTrials.gov Identifier: NCT00972088     History of Changes
Other Study ID Numbers: Peri Anal Study
Study First Received: September 2, 2009
Last Updated: September 3, 2009
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Bikkur Holim Hospital:
inflammation of the small bowel
inflammation of the small bowel in patients with anorectal disease is under-diagnosed based on colonoscopy ileoscopy alone

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

ClinicalTrials.gov processed this record on May 23, 2013