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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:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00636597
First received: March 7, 2008
Last updated: October 19, 2011
Last verified: October 2011
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00636597

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

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00636597     History of Changes
Other Study ID Numbers: Buff VAMC 001, 00556
Study First Received: March 7, 2008
Last Updated: October 19, 2011
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Hemorrhage
Gastrointestinal Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013