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Early Colonoscopy for Lower Gastrointestinal (GI) Bleeding

This study has been terminated.
(Change in ER rules (no longer allowed endoscopies in ER) prevented ability to perform study according to protocol)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01031342
First Posted: December 14, 2009
Last Update Posted: January 25, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University of Southern California
  Purpose

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 Intervention
Gastrointestinal Hemorrhage Procedure: Early colonoscopy Procedure: Elective colonoscopy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Early Versus Elective Colonoscopy in the Management of Lower Gastrointestinal Bleeding

Resource links provided by NLM:


Further study details as provided by University of Southern California:

Primary Outcome Measures:
  • Further bleeding [ Time Frame: Duration of hospitalization (randomization to date of discharge from hospital) ]

Secondary Outcome Measures:
  • Diagnostic yield [ Time Frame: Duration of hospitalization (randomization to date of discharge from hospital) ]

Enrollment: 72
Study Start Date: August 2002
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients who are admitted with rectal bleeding and one of the following high-risk features:

  1. HR > 100/min
  2. Systolic blood pressure <100 mmHg
  3. 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
  4. Need for blood transfusion
  5. Drop in hemoglobin > 1.5 g/dl or in hematocrit of > 6% in 6 hours

Exclusion Criteria:

  1. Inability to give informed consent
  2. Peritoneal signs
  3. Severe co-morbidities that would preclude the use of colonoscopy in standard clinical practice
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01031342


Locations
United States, California
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
  More Information

Responsible Party: Loren Laine, University of Southern California
ClinicalTrials.gov Identifier: NCT01031342     History of Changes
Other Study ID Numbers: HS-025014
First Submitted: November 2, 2009
First Posted: December 14, 2009
Last Update Posted: January 25, 2011
Last Verified: January 2011

Keywords provided by University of Southern California:
Colonoscopy
Gastrointestinal bleeding

Additional relevant MeSH terms:
Hemorrhage
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases