Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease

• Sponsor: Bikkur Holim Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00972088
• Collaborator: (none)
• Enrollment: 26
• Locations: 3
• Arm: 1
• Duration (Months): 34
• Patients Per Site: 8.7
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Inflammatory Bowel Disease; Perianal Fistula; Perianal Abscess	Device: capsule endoscopy	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease
• Study Start Date: Aug 1, 2008
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 10 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Assaf Harofeh Medical Center	Tel Aviv	Zrifin	Israel	70300
2	Rambam Medical Center	Haifa		Israel	31096
3	Bikur Cholim Hospital	Jerusalem		Israel	91004

Sponsors and Collaborators

• Bikkur Holim Hospital

Investigators

• Principal Investigator: Samuel Adler, Prof., Bikur Cholim Hospital, Jerusalem

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sam Adler, Prof. Samuel N. Adler, MD, Bikkur Holim Hospital
• ClinicalTrials.gov Identifier: NCT00972088
• Other Study ID Numbers: Peri Anal Study
• First Posted: Sep 4, 2009
• Last Update Posted: Jun 24, 2013
• Last Verified: May 1, 2013

• Keywords provided by Sam Adler, Prof. Samuel N. Adler, MD, Bikkur Holim Hospital: inflammation of the small bowel
• Additional relevant MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases; Fistula

Study Results

Participant Flow

Recruitment Details	from 2009 until june 2011 26 patients were enrolled from gastroenterology clinics
Pre-assignment Detail	patients were enrolled to undergo capsule endoscopy of the small bowel if they had perianal disease and a negative colonoscopy with ileoscopy or a negative colonoscopy with a negative small bowel series or negative ct enterography

Arm/Group Title	a Single Arm Group, Patients With Ano Rectal Disease
Arm/Group Description	patients suffering from anorectal disease with a negative standard work up to rule out crohn's disease
Period Title: Overall Study
STARTED	26
COMPLETED	26
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Anorectal Disease, Negative Work up for Crohns Disease
Arm/Group Description	Patients presently suffering from anorectal abscess or anorectal fistula
Overall Participants	26
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	26 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	34.3 (12.6)
Sex: Female, Male (Count of Participants)
Female	9 34.6%
Male	17 65.4%
Region of Enrollment (participants) [Number]
Israel	26 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

per protocol

Arm/Group Title	Anorectal Disease, Negative Work up for Crohns Disease
Arm/Group Description	Patients presently suffering from anorectal abscess or anorectal fistula
Measure Participants	26
Number [participants]	6 23.1%

Adverse Events

Arm/Group Title	Anorectal Disease, Negative Work up for Crohns Disease
Arm/Group Description	Patients presently suffering from anorectal abscess or anorectal fistula
All Cause Mortality
	Anorectal Disease, Negative Work up for Crohns Disease
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Anorectal Disease, Negative Work up for Crohns Disease
	Affected / at Risk (%)	# Events
Total	0/26 (0%)
Other (Not Including Serious) Adverse Events
	Anorectal Disease, Negative Work up for Crohns Disease
	Affected / at Risk (%)	# Events
Total	0/26 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.