Early Colonoscopy for Lower Gastrointestinal (GI) Bleeding

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University of Southern California

Status

Terminated

Conditions

Gastrointestinal Hemorrhage

Treatments

Procedure: Elective colonoscopy
Procedure: Early colonoscopy

Study type

Interventional

Funder types

Other

Identifiers

NCT01031342
HS-025014

Details and patient eligibility

About

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.

Full 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.

Enrollment

72 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

72 participants in 2 patient groups

Early colonoscopy
Experimental group
Description:
Colonoscopy performed within 12 hours of presentation
Treatment:
Procedure: Early colonoscopy
Elective colonoscopy
Active Comparator group
Description:
Colonoscopy 36-60 hours after presentation
Treatment:
Procedure: Elective colonoscopy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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