Capsule Endoscopy in Obscure GI Bleeding

University of Calgary

Status: Completed

Conditions: Obscure Gastrointestinal Bleeding

Treatments: Device: Wireless capsule endoscopy; Other: standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT00203619

1

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

1

Experimental group

Description:

Wireless capsule endoscopy

Treatment:

Device: Wireless capsule endoscopy

2

Active Comparator group

Description:

Standard care

Treatment:

Other: standard care