Early Colonoscopy for Lower Gastrointestinal (GI) Bleeding
Stopped early · Not applicable
Conditions studied: Gastrointestinal Hemorrhage
In brief
Study hypothesis is that performing early colonoscopy in patients who present to the hospital with lower GI bleeding improves their outcome. Patients who are admitted with bleeding from their rectum and a negative endoscopic exam of the stomach and upper intestine are randomized (like flipping a coin) to receive a colonsoscopy either as an emergency (within 12 hours) or as a routine procedure (36 hours after admission). Patients are followed during their hospitalization to see if they have further bleeding, if they require blood transfusions, if they need other diagnostic tests, if they need surgery or other treatments, and how long they stay in the hospital.
Key facts
- Study ID
- NCT01031342
- Run by
- University of Southern California
- People needed
- 72
- Starts
- 2002-08-01
- Expected to finish
- 2009-11-01
- Last updated by the study team
- 2011-01-25
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients who are admitted with rectal bleeding and one of the following high-risk features:
- HR > 100/min
- Systolic blood pressure <100 mmHg
- Orthostasis -considered as increase in HR by> 20/min on assuming erect position as well as by decrease by 20 mmHg in systolic blood pressure
- Need for blood transfusion
- Drop in hemoglobin > 1.5 g/dl or in hematocrit of > 6% in 6 hours
You may not qualify if…
- Inability to give informed consent
- Peritoneal signs
- Severe co-morbidities that would preclude the use of colonoscopy in standard clinical practice
Where it is running
- L.A. County + U.S.C. Medical Center — Los Angeles, California, United States
Full record on ClinicalTrials.gov
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