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Prevalence of Inflammatory Bowel Disease in Patients With Perianal Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00972088
First Posted: September 4, 2009
Last Update Posted: June 24, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sam Adler, Bikkur Holim Hospital
Results First Submitted: February 4, 2012  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions: Inflammatory Bowel Disease
Perianal Fistula
Perianal Abscess
Intervention: Device: capsule endoscopy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
from 2009 until june 2011 26 patients were enrolled from gastroenterology clinics

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    a Single Arm Group, Patients With Ano Rectal Disease
STARTED   26 
COMPLETED   26 
NOT COMPLETED   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Anorectal Disease, Negative Work up for Crohns Disease Patients presently suffering from anorectal abscess or anorectal fistula

Baseline Measures
   Anorectal Disease, Negative Work up for Crohns Disease 
Overall Participants Analyzed 
[Units: Participants]
 26 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   26 
>=65 years   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.3  (12.6) 
Gender 
[Units: Participants]
 
Female   9 
Male   17 
Region of Enrollment 
[Units: Participants]
 
Israel   26 


  Outcome Measures

1.  Primary:   Prevalence of Inflammation as Diagnosed by Capsule Endoscopy   [ Time Frame: up to 7 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: samuel n adler md, director of clinical trial
Organization: bikur holim hospital
phone: 972 2 6464206
e-mail: nasnadler@gmail.com



Responsible Party: Sam Adler, Bikkur Holim Hospital
ClinicalTrials.gov Identifier: NCT00972088     History of Changes
Other Study ID Numbers: Peri Anal Study
First Submitted: September 2, 2009
First Posted: September 4, 2009
Results First Submitted: February 4, 2012
Results First Posted: June 24, 2013
Last Update Posted: June 24, 2013