Early Colonoscopy for Lower Gastrointestinal (GI) Bleeding
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Early colonoscopy Colonoscopy performed within 12 hours of presentation |
Procedure: Early colonoscopy
Colonoscopy within 12 hours of presentation
|
| Active Comparator: Elective colonoscopy Colonoscopy 36-60 hours after presentation |
Procedure: Elective colonoscopy
Colonoscopy 36-60 hours after presentation
|
Outcome Measures
Primary Outcome Measures
- Further bleeding [Duration of hospitalization (randomization to date of discharge from hospital)]
Secondary Outcome Measures
- Diagnostic yield [Duration of hospitalization (randomization to date of discharge from hospital)]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | L.A. County + U.S.C. Medical Center | Los Angeles | California | United States | 90033 |
Sponsors and Collaborators
- University of Southern California
Investigators
- Principal Investigator: Loren Laine, M.D., University of Southern California
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HS-025014