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Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease

Primary Purpose

Inflammatory Bowel Disease, Perianal Fistula, Perianal Abscess

Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
capsule endoscopy
Sponsored by
Bikkur Holim Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Inflammatory Bowel Disease focused on measuring inflammation of the small bowel

Eligibility Criteria

10 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Assaf Harofeh Medical Center
  • Rambam Medical Center
  • Bikur Cholim Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

capsule endoscopy

Arm Description

patients eligible according to inclusion criteria who underwent a capsule endoscopy

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 2, 2009
Last Updated
May 15, 2013
Sponsor
Bikkur Holim Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00972088
Brief Title
Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease
Official Title
Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bikkur Holim Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammatory Bowel Disease, Perianal Fistula, Perianal Abscess
Keywords
inflammation of the small bowel

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
capsule endoscopy
Arm Type
Other
Arm Description
patients eligible according to inclusion criteria who underwent a capsule endoscopy
Intervention Type
Device
Intervention Name(s)
capsule endoscopy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prevalence of Inflammation as Diagnosed by Capsule Endoscopy
Description
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.
Time Frame
up to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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: Colonoscopy with Ileoscopy, and/or Colonoscopy with small bowel series, and/or 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samuel Adler, Prof.
Organizational Affiliation
Bikur Cholim Hospital, Jerusalem
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assaf Harofeh Medical Center
City
Tel Aviv
State/Province
Zrifin
ZIP/Postal Code
70300
Country
Israel
Facility Name
Rambam Medical Center
City
Haifa
ZIP/Postal Code
31096
Country
Israel
Facility Name
Bikur Cholim Hospital
City
Jerusalem
ZIP/Postal Code
91004
Country
Israel

12. IPD Sharing Statement

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Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease

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