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A Prospective Evaluation of Same Day Bidirectional Endoscopy for Occult Bleeding

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ClinicalTrials.gov Identifier: NCT00636597
Recruitment Status : Terminated (Not able to find enough eligible patients (200) in last 4 years.)
First Posted : March 14, 2008
Last Update Posted : October 20, 2011
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development ( US Department of Veterans Affairs )

Brief Summary:
This study is a prospective evaluation of patients with occult (hidden) GI bleeding without iron deficiency. Such patients usually undergo a diagnostic colonoscopy as a standard of care. The study is aimed to determine any UGI-source of occult bleeding and to correlate UGI symptoms with findings. Therefore, EGD is being offered to such patients as part of research. We proposed to enroll 200 consecutive patients referred to our GI-unit for expedited diagnostic colonoscopy for positive FOBT.

Condition or disease
Occult GI Bleeding

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of Same Day Bidirectional Endoscopy for Occult Bleeding
Study Start Date : April 2007
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Endoscopy

Group/Cohort
1



Primary Outcome Measures :
  1. to determine if anemia or upper gi symptoms can accurately predict the presence of significant upper gi findings in patients with fobt positivity and a non-diagnostic colonoscopy. [ Time Frame: Baseline ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Outpatients referred for GI consult due to occult bleeding (iron deficiency or FOBT positivity)
Criteria

Inclusion Criteria:

  • Outpatients referred for occult bleeding (iron deficiency or FOBT positivity)

Exclusion Criteria:

  • Overt bleeding (melena, hematochezia)
  • Abnormal luminal imaging
  • Prior EGD or colonoscopy within 1 year

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00636597


Locations
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United States, New York
VA Western New York Healthcare System at Buffalo
Buffalo, New York, United States, 14215
Sponsors and Collaborators
US Department of Veterans Affairs
Investigators
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Principal Investigator: Shahid Mehboob, MD VA Western New York Healthcare System at Buffalo

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Responsible Party: US Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00636597     History of Changes
Other Study ID Numbers: Buff VAMC 001
00556 ( Other Identifier: VA Western NY Healthcare System, Buffalo )
First Posted: March 14, 2008    Key Record Dates
Last Update Posted: October 20, 2011
Last Verified: October 2011
Additional relevant MeSH terms:
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Hemorrhage
Pathologic Processes