- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01031342
Early Colonoscopy for Lower Gastrointestinal (GI) Bleeding
Early Versus Elective Colonoscopy in the Management of Lower Gastrointestinal Bleeding
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The aim of this study is to determine if 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 clinical evidence of a significant bleeding episode (elevated heart rate, low blood pressure, or need for blood transfusion) have immediate upper endoscopy (examination of the stomach with a flexible rubber tube with a light and video camera on the end). If this shows no source of bleeding, the patients are randomized (like flipping a coin) to receive a colonsoscopy (examination of the large intestine with a flexible rubber tube with a light and video camera on the end) either as a 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90033
- L.A. County + U.S.C. Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
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
Exclusion Criteria:
- Inability to give informed consent
- Peritoneal signs
- Severe co-morbidities that would preclude the use of colonoscopy in standard clinical practice
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Early colonoscopy
Colonoscopy performed within 12 hours of presentation
|
Colonoscopy within 12 hours of presentation
|
Active Comparator: Elective colonoscopy
Colonoscopy 36-60 hours after presentation
|
Colonoscopy 36-60 hours after presentation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Further bleeding
Time Frame: Duration of hospitalization (randomization to date of discharge from hospital)
|
Duration of hospitalization (randomization to date of discharge from hospital)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Diagnostic yield
Time Frame: Duration of hospitalization (randomization to date of discharge from hospital)
|
Duration of hospitalization (randomization to date of discharge from hospital)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS-025014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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