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A Prospective Evaluation of Same Day Bidirectional Endoscopy for Occult Bleeding

This study has been terminated.
(Not able to find enough eligible patients (200) in last 4 years.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00636597
First Posted: March 14, 2008
Last Update Posted: October 20, 2011
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):
VA Office of Research and Development
  Purpose
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
Occult GI Bleeding

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Evaluation of Same Day Bidirectional Endoscopy for Occult Bleeding

Resource links provided by NLM:


Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 200
Study Start Date: April 2007
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
  Contacts and Locations
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
United States, New York
VA Western New York Healthcare System at Buffalo
Buffalo, New York, United States, 14215
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: Shahid Mehboob, MD VA Western New York Healthcare System at Buffalo
  More Information

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00636597     History of Changes
Other Study ID Numbers: Buff VAMC 001
00556 ( Other Identifier: VA Western NY Healthcare System, Buffalo )
First Submitted: March 7, 2008
First Posted: March 14, 2008
Last Update Posted: October 20, 2011
Last Verified: October 2011

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes