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To show that prevalence of inflammation of the small bowel in patients with anorectal disease is under-diagnosed based on colonoscopy ileoscopy alone.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| capsule endoscopy | Other | patients eligible according to inclusion criteria who underwent a capsule endoscopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| capsule endoscopy | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Samuel Adler, Prof. | Bikur Cholim Hospital, Jerusalem | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assaf Harofeh Medical Center | Tel Aviv | Zrifin | 70300 | Israel | ||
| Rambam Medical Center |
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
from 2009 until june 2011 26 patients were enrolled from gastroenterology clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | a Single Arm Group, Patients With Ano Rectal Disease | patients suffering from anorectal disease with a negative standard work up to rule out crohn's disease |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Anorectal Disease, Negative Work up for Crohns Disease | Patients presently suffering from anorectal abscess or anorectal fistula |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | per protocol | Posted | Number | participants | up to 7 days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Anorectal Disease, Negative Work up for Crohns Disease | Patients presently suffering from anorectal abscess or anorectal fistula |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| samuel n adler md, director of clinical trial | bikur holim hospital | 972 2 6464206 | nasnadler@gmail.com |
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| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D053704 | Capsule Endoscopy |
| ID | Term |
|---|---|
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
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|
| Haifa |
| 31096 |
| Israel |
| Bikur Cholim Hospital | Jerusalem | 91004 | Israel |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
| 0 |
| 26 |
| 0 |
| 26 |
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| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |