TerminatedNot Applicable

Early Colonoscopy for Lower Gastrointestinal (GI) Bleeding

Stopped: Change in ER rules (no longer allowed endoscopies in ER) prevented ability to perform study according to protocol

United States72 participantsStarted 2002-08

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. Inability to give informed consent
✕. Peritoneal signs
✕. Severe co-morbidities that would preclude the use of colonoscopy in standard clinical practice

What they're measuring

Further bleeding

Timeframe: Duration of hospitalization (randomization to date of discharge from hospital)

Trial details

NCT IDNCT01031342

SponsorUniversity of Southern California

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-11

View on ClinicalTrials.gov More Gastrointestinal Hemorrhage trials