Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease
1 other identifier
interventional
26
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2008
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
September 2, 2009
CompletedFirst Posted
Study publicly available on registry
September 4, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedResults Posted
Study results publicly available
June 24, 2013
CompletedJune 24, 2013
May 1, 2013
2.8 years
September 2, 2009
February 4, 2012
May 15, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
up to 7 days
Study Arms (1)
capsule endoscopy
OTHERpatients eligible according to inclusion criteria who underwent a capsule endoscopy
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Can not sign informed consent
- Contraindications to colonoscopy ileoscopy or capsule endoscopy
- History of established IBD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Assaf Harofeh Medical Center
Tel Aviv, Zrifin, 70300, Israel
Rambam Medical Center
Haifa, 31096, Israel
Bikur Cholim Hospital
Jerusalem, 91004, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- samuel n adler md, director of clinical trial
- Organization
- bikur holim hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Samuel Adler, Prof.
Bikur Cholim Hospital, Jerusalem
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Prof. Samuel N. Adler, MD
Study Record Dates
First Submitted
September 2, 2009
First Posted
September 4, 2009
Study Start
August 1, 2008
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
June 24, 2013
Results First Posted
June 24, 2013
Record last verified: 2013-05