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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:
Information provided by:
University of Southern California
ClinicalTrials.gov Identifier:
NCT01031342
First received: November 2, 2009
Last updated: January 24, 2011
Last verified: January 2011
History of Changes
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Early Versus Elective Colonoscopy in the Management of Lower Gastrointestinal Bleeding

Resource links provided by NLM:

U.S. FDA Resources

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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Diagnostic yield [ Time Frame: Duration of hospitalization (randomization to date of discharge from hospital) ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Loren Laine, University of Southern California
ClinicalTrials.gov Identifier: NCT01031342     History of Changes
Other Study ID Numbers: HS-025014
Study First Received: November 2, 2009
Last Updated: January 24, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Southern California:
Colonoscopy
Gastrointestinal bleeding

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

ClinicalTrials.gov processed this record on May 16, 2013