Obscure Gastrointestinal Bleeding
Conditions
Brief summary
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
Detailed description
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. Patients randomized 1:1.
Interventions
wire less capsule endoscopy
OTHERstandard care
standard diagnostic evaluation as decided by treating physician
Sponsors
Alberta Heritage Foundation for Medical Research
Calgary Health Region
University of Calgary
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| sf36 | 48 weeks |
| giqli | 48 weeks |
| eq50 | 48 weeks |
| diagnostic yield | 48 weeks |
Secondary
| Measure | Time frame |
|---|---|
| transfusions | 48 weeks |
Countries
Canada
Outcome results
None listed