Early Colonoscopy for Lower Gastrointestinal (GI) Bleeding

Study Overview
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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.

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.

Official Title
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Early Versus Elective Colonoscopy in the Management of Lower Gastrointestinal Bleeding

Conditions
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Gastrointestinal Hemorrhage

Intervention / Treatment
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* Procedure: Early colonoscopy
* Procedure: Elective colonoscopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who are admitted with rectal bleeding and one of the following high-risk features: HR > 100/min Systolic blood pressure <100 mmHg 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 Need for blood transfusion Drop in hemoglobin > 1.5 g/dl or in hematocrit of > 6% in 6 hours Exclusion Criteria: Inability to give informed consent Peritoneal signs Severe co-morbidities that would preclude the use of colonoscopy in standard clinical practice

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early colonoscopy<br>Colonoscopy performed within 12 hours of presentation | Procedure: Early colonoscopy<br>* Colonoscopy within 12 hours of presentation<br>|
| Active Comparator: Elective colonoscopy<br>Colonoscopy 36-60 hours after presentation | Procedure: Elective colonoscopy<br>* Colonoscopy 36-60 hours after presentation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Further bleeding |  | Duration of hospitalization (randomization to date of discharge from hospital) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic yield |  | Duration of hospitalization (randomization to date of discharge from hospital) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colonoscopy, Gastrointestinal bleeding