Early Colonoscopy for Lower Gastrointestinal (GI) Bleeding

Not Applicable

Terminated

• Conditions: Gastrointestinal Hemorrhage

• Registration Number: NCT01031342
• Lead Sponsor: University of Southern California

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.

Study Timeline

• Study Start: 2002-08
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Study First Submitted: 2009-11-02
• Study First Submitted QC: 2009-12-11
• Study First Posted: 2009-12-14
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-24
• Last Update Posted: 2011-01-25

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Further bleeding	Duration of hospitalization (randomization to date of discharge from hospital)

Secondary Outcome Measures

Name	Time	Method
Diagnostic yield	Duration of hospitalization (randomization to date of discharge from hospital)

Trial Locations

Locations (1)

L.A. County + U.S.C. Medical Center; 🇺🇸 Los Angeles, California, United States