Early Colonoscopy for Lower Gastrointestinal (GI) Bleeding

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-08-31

Study Completion Date

2009-11-30

Brief Summary

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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.

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Detailed Description

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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

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Gastrointestinal Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Early colonoscopy

Colonoscopy performed within 12 hours of presentation

Group Type EXPERIMENTAL

Early colonoscopy

Intervention Type PROCEDURE

Colonoscopy within 12 hours of presentation

Elective colonoscopy

Colonoscopy 36-60 hours after presentation

Group Type ACTIVE_COMPARATOR

Elective colonoscopy

Intervention Type PROCEDURE

Colonoscopy 36-60 hours after presentation

Interventions

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Early colonoscopy

Colonoscopy within 12 hours of presentation

Intervention Type PROCEDURE

Elective colonoscopy

Colonoscopy 36-60 hours after presentation

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No