Capsule Endoscopy in Obscure GI Bleeding

N/ACompletedNCT00203619

University of Calgary40 enrolled

Overview

The purpose of this study is to conduct a cost-effectiveness analysis of wireless capsule endoscopy in the investigation of patients with overt obscure gastrointestinal bleeding. To inform this analysis, a randomized controlled trial of capsule endoscopy compared with standard care will be conducted

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Obscure Gastrointestinal Bleeding

Interventions

Wireless capsule endoscopyDEVICE

wire less capsule endoscopy

standard careOTHER

standard diagnostic evaluation as decided by treating physician

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Age 18 or older 2. Obscure overt GI bleeding 3. No cause for bleeding found on Gastroscopy and colonoscopy within 1 week of bleeding Exclusion Criteria: 1. Known or suspected swallowing disorders 2. Known or suspected small bowel obstruction 3. Multiple comorbidities precluding surgery 4. Patients with implantable electromagnetic devices 5. Pregnant women

Locations (1)

University of Calgary

Calgary, Alberta, Canada

Outcomes

Primary Outcomes

sf36

Time frame: 48 weeks

giqli

Time frame: 48 weeks

eq50

Time frame: 48 weeks

diagnostic yield

Time frame: 48 weeks

Secondary Outcomes

transfusions

Time frame: 48 weeks

Data from ClinicalTrials.gov

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