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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

November 2, 2009
January 24, 2011
August 2002
November 2009   (final data collection date for primary outcome measure)
Further bleeding [ Time Frame: Duration of hospitalization (randomization to date of discharge from hospital) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01031342 on ClinicalTrials.gov Archive Site
Diagnostic yield [ Time Frame: Duration of hospitalization (randomization to date of discharge from hospital) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Gastrointestinal Hemorrhage
  • Procedure: Early colonoscopy
    Colonoscopy within 12 hours of presentation
  • Procedure: Elective colonoscopy
    Colonoscopy 36-60 hours after presentation
  • Experimental: Early colonoscopy
    Colonoscopy performed within 12 hours of presentation
    Intervention: Procedure: Early colonoscopy
  • Active Comparator: Elective colonoscopy
    Colonoscopy 36-60 hours after presentation
    Intervention: Procedure: Elective colonoscopy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
72
November 2009
November 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01031342
HS-025014
No
Loren Laine, University of Southern California
University of Southern California
Not Provided
Principal Investigator: Loren Laine, M.D. University of Southern California
University of Southern California
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP