Capsule Endoscopy in Obscure GI Bleeding

Not Applicable

Completed

• Conditions: Obscure Gastrointestinal Bleeding
• Interventions: Other: standard care; Device: Wireless capsule endoscopy

• Registration Number: NCT00203619
• Lead Sponsor: University of Calgary

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.

Study Timeline

• Study Start: 2005-05
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2015-09
• Study Completion: 2016-09
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-01
• Last Update Posted: 2017-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	standard care	Standard care
1	Wireless capsule endoscopy	Wireless capsule endoscopy

Primary Outcome Measures

Name	Time	Method
eq50	48 weeks
sf36	48 weeks
diagnostic yield	48 weeks
giqli	48 weeks

Secondary Outcome Measures

Name	Time	Method
transfusions	48 weeks

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada