Inflammatory Bowel Disease, Perianal Abscess, Perianal Fistula
Conditions
Keywords
inflammation of the small bowel
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.
Interventions
DEVICEcapsule 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.
Sponsors
Bikkur Holim Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 80 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Israel
Participant flow
Recruitment details
from 2009 until june 2011 26 patients were enrolled from gastroenterology clinics
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| Anorectal Disease, Negative Work up for Crohns Disease Patients presently suffering from anorectal abscess or anorectal fistula | 26 |
| Total | 26 |
Baseline characteristics
| Characteristic | Anorectal Disease, Negative Work up for Crohns Disease |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Age Continuous | 34.3 years STANDARD_DEVIATION 12.6 |
| Region of Enrollment Israel | 26 participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
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.
Time frame: up to 7 days
Population: per protocol
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Anorectal Disease, Negative Work up for Crohns Disease | Prevalence of Inflammation as Diagnosed by Capsule Endoscopy | 6 participants |