Study Stopped
Change in ER rules (no longer allowed endoscopies in ER) prevented ability to perform study according to protocol
Early Colonoscopy for Lower Gastrointestinal (GI) Bleeding
Early Versus Elective Colonoscopy in the Management of Lower Gastrointestinal Bleeding
1 other identifier
interventional
72
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2002
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2002
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 2, 2009
CompletedFirst Posted
Study publicly available on registry
December 14, 2009
CompletedJanuary 25, 2011
January 1, 2011
7.3 years
November 2, 2009
January 24, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Further bleeding
Duration of hospitalization (randomization to date of discharge from hospital)
Secondary Outcomes (1)
Diagnostic yield
Duration of hospitalization (randomization to date of discharge from hospital)
Study Arms (2)
Early colonoscopy
EXPERIMENTALColonoscopy performed within 12 hours of presentation
Elective colonoscopy
ACTIVE COMPARATORColonoscopy 36-60 hours after presentation
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
L.A. County + U.S.C. Medical Center
Los Angeles, California, 90033, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Loren Laine, M.D.
University of Southern California
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 2, 2009
First Posted
December 14, 2009
Study Start
August 1, 2002
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
January 25, 2011
Record last verified: 2011-01