Early Colonoscopy for Lower Gastrointestinal (GI) Bleeding
Primary Purpose
Gastrointestinal Hemorrhage
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Early colonoscopy
Elective colonoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for Gastrointestinal Hemorrhage focused on measuring Colonoscopy, Gastrointestinal bleeding
Eligibility Criteria
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
Sites / Locations
- L.A. County + U.S.C. Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Early colonoscopy
Elective colonoscopy
Arm Description
Colonoscopy performed within 12 hours of presentation
Colonoscopy 36-60 hours after presentation
Outcomes
Primary Outcome Measures
Further bleeding
Secondary Outcome Measures
Diagnostic yield
Full Information
NCT ID
NCT01031342
First Posted
November 2, 2009
Last Updated
January 24, 2011
Sponsor
University of Southern California
1. Study Identification
Unique Protocol Identification Number
NCT01031342
Brief Title
Early Colonoscopy for Lower Gastrointestinal (GI) Bleeding
Official Title
Early Versus Elective Colonoscopy in the Management of Lower Gastrointestinal Bleeding
Study Type
Interventional
2. Study Status
Record Verification Date
January 2011
Overall Recruitment Status
Terminated
Why Stopped
Change in ER rules (no longer allowed endoscopies in ER) prevented ability to perform study according to protocol
Study Start Date
August 2002 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Southern California
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Hemorrhage
Keywords
Colonoscopy, Gastrointestinal bleeding
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early colonoscopy
Arm Type
Experimental
Arm Description
Colonoscopy performed within 12 hours of presentation
Arm Title
Elective colonoscopy
Arm Type
Active Comparator
Arm Description
Colonoscopy 36-60 hours after presentation
Intervention Type
Procedure
Intervention Name(s)
Early colonoscopy
Intervention Description
Colonoscopy within 12 hours of presentation
Intervention Type
Procedure
Intervention Name(s)
Elective colonoscopy
Intervention Description
Colonoscopy 36-60 hours after presentation
Primary Outcome Measure Information:
Title
Further bleeding
Time Frame
Duration of hospitalization (randomization to date of discharge from hospital)
Secondary Outcome Measure Information:
Title
Diagnostic yield
Time Frame
Duration of hospitalization (randomization to date of discharge from hospital)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Loren Laine, M.D.
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
L.A. County + U.S.C. Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
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Early Colonoscopy for Lower Gastrointestinal (GI) Bleeding
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