Inflammatory Bowel DiseaseNCT00972088
Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease
A study testing capsule endoscopy in people with Inflammatory Bowel Disease and Perianal Fistula, run by Bikkur Holim Hospital at 3 sites in Israel.
Trial summary
To show that prevalence of inflammation of the small bowel in patients with anorectal disease is under-diagnosed based on colonoscopy ileoscopy alone. Read more about this study
- Who is it for?
- Ages 10 to 80 years
- Conditions the study is for
- Inflammatory Bowel Disease, Perianal Fistula, Perianal Abscess
- What is being tested?
- capsule endoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 3 sitesIsrael
- Study dates
- Aug 2008to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- Can not sign informed consent
- Contraindications to colonoscopy ileoscopy or capsule endoscopy
- History of established IBD
Trial locations and contacts
3 sites in 1 country.
Israel3 sites
Rambam Medical Center
Haifa, 31096
Bikur Cholim Hospital
Jerusalem, 91004
Assaf Harofeh Medical Center
Tel Aviv, Zrifin, 70300
About this study
To show that prevalence of inflammation of the small bowel in patients with anorectal disease is under-diagnosed based on colonoscopy ileoscopy alone.
Read the 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.
- Being tested
- capsule endoscopy
- Keywords
- inflammation of the small bowel
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capsule endoscopyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| capsule endoscopy | Other | patients eligible according to inclusion criteria who underwent a capsule endoscopy Receives: Device: capsule endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2009 (estimated)
- Study startAug 2008
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bikkur Holim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sam Adler, Bikkur Holim Hospital
- Investigators
- Samuel Adler, Prof., Principal investigator, Bikur Cholim Hospital, Jerusalem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00972088
- Sponsor's protocol ID
- Peri Anal Study
- Status last verified
- May 2013
- First submitted
- 2 Sep 2009
- Last updated
- 24 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease
- ClinicalTrials.gov ID
- NCT00972088
- Acronym / sponsor ID
- Peri Anal Study
- Keywords
- inflammation of the small bowel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Bikkur Holim HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 4 Sep 2009 (estimated)
- Results
- Posted 24 Jun 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| capsule endoscopy | Other | Device: capsule endoscopypatients eligible according to inclusion criteria who underwent a capsule endoscopy |
Who may qualify
- Ages
- 10 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- Can not sign informed consent
- Contraindications to colonoscopy ileoscopy or capsule endoscopy
- History of established IBD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| capsule endoscopyThe 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. | Device | capsule endoscopy |
Primary outcome
Prevalence of Inflammation as Diagnosed by Capsule Endoscopy
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Adler, Prof. principal investigator
Bikur Cholim Hospital, Jerusalem
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing capsule endoscopy in people with Inflammatory Bowel Disease and Perianal Fistula, run by Bikkur Holim Hospital at 3 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Inflammation as Diagnosed by Capsule Endoscopy (time frame: up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2013.