An interventional study of capsule endoscopy in Inflammatory Bowel Disease, Perianal Fistula and Perianal Abscess, sponsored by Bikkur Holim Hospital. Completed at 3 sites in Israel. Open to participants aged 10 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-06-24.
Sponsored by Bikkur Holim Hospital · Not applicable, Interventional, and Diagnostic
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.
963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.
This study's enrollment of 26 is below the median of 70 across 552 interventional studies indexed under Intestinal Diseases.
Browse Intestinal Diseases studies →Bikkur Holim Hospital is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Within three months prior to enrollment, patient has normal test results for at least one of the following tests:
Exclusion Criteria:
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.
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
from 2009 until june 2011 26 patients were enrolled from gastroenterology clinics
| Milestone | a Single Arm Group, Patients With Ano Rectal Disease |
|---|---|
| Started | 26 |
| Completed | 26 |
| Not completed | 0 |
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.
| participants | Anorectal Disease, Negative Work up for Crohns Disease |
|---|---|
| Prevalence of Inflammation as Diagnosed by Capsule Endoscopy | 6 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Anorectal Disease, Negative Work up for Crohns Disease | — | 0/26 (0%) | 0/26 (0%) |
| Age, Categorical(Participants) | Anorectal Disease, Negative Work up for Crohns Disease |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 26 |
| >=65 years | 0 |
| Age Continuous(years) | Anorectal Disease, Negative Work up for Crohns Disease |
|---|---|
| Mean | 34.3 ± 12.6 |
| Sex: Female, Male(Participants) | Anorectal Disease, Negative Work up for Crohns Disease |
|---|---|
| Female | 9 |
| Male | 17 |
| Region of Enrollment(participants) | Anorectal Disease, Negative Work up for Crohns Disease |
|---|---|
| Israel | 26 |
This study is completed, as verified in May 2013. You cannot join it, but the record below documents what was studied.
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Bikkur Holim Hospital