Clinical trial NCT01031342: Early Colonoscopy for Lower Gastrointestinal (GI) Bleeding
Official title: Early Versus Elective Colonoscopy in the Management of Lower Gastrointestinal Bleeding
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gastrointestinal Hemorrhage
Keywords: Colonoscopy
Gastrointestinal bleeding
Lead sponsor: University of Southern California
Sponsor class: OTHER
First posted: 2009-12-14
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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

Primary outcomes:
measure: Further bleeding
timeFrame: Duration of hospitalization (randomization to date of discharge from hospital)
Secondary outcomes:
measure: Diagnostic yield
timeFrame: Duration of hospitalization (randomization to date of discharge from hospital)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: L.A. County + U.S.C. Medical Center
state: California
Study officials:
affiliation: University of Southern California
name: Loren Laine, M.D.
role: PRINCIPAL_INVESTIGATOR
References: