Early Colonoscopy for Lower Gastrointestinal (GI) Bleeding

Gastrointestinal Hemorrhage Clinical Trial

Official title:

Early Versus Elective Colonoscopy in the Management of Lower Gastrointestinal Bleeding

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01031342
• Other study ID #: HS-025014
• Status: Terminated
• Phase: N/A
• First received: November 2, 2009
• Last updated: January 24, 2011
• Start date: August 2002
• Est. completion date: November 2009

Study information

• Verified date: January 2011
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 72
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Gastrointestinal Hemorrhage

Intervention

Procedure:
• Early colonoscopy
Colonoscopy within 12 hours of presentation
• Elective colonoscopy
Colonoscopy 36-60 hours after presentation

Locations

Country	Name	City	State
United States	L.A. County + U.S.C. Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Further bleeding		Duration of hospitalization (randomization to date of discharge from hospital)	No
Secondary	Diagnostic yield		Duration of hospitalization (randomization to date of discharge from hospital)	No