Clinical Trials Directory

Trials / Terminated

TerminatedNCT01031342

Early Colonoscopy for Lower Gastrointestinal (GI) Bleeding

Early Versus Elective Colonoscopy in the Management of Lower Gastrointestinal Bleeding

Status
Terminated
Phase
N/A
Study type
Interventional
Enrollment
72 (actual)
Sponsor
University of Southern California · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREEarly colonoscopyColonoscopy within 12 hours of presentation
PROCEDUREElective colonoscopyColonoscopy 36-60 hours after presentation

Timeline

Start date
2002-08-01
Primary completion
2009-11-01
Completion
2009-11-01
First posted
2009-12-14
Last updated
2011-01-25

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT01031342. Inclusion in this directory is not an endorsement.