A Randomized Controlled Trial Evaluating the Efficacy of Early Videocapsule Endoscopy Following Negative Gastroscopy in Patients Presenting With Suspected Upper Gastrointestinal Bleeding

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The objective of this study is to determine whether early video capsule endoscopy (VCE) immediately after a negative gastroscopy in the setting of suspected upper gastrointestinal bleeding (UGIB) improves patient outcomes as compared to the standard approach which typically involves performing colonoscopy prior to small bowel investigations. We aim to examine the differences in diagnostic yield, total number of procedures, length of hospitalization, mortality rates, and healthcare cost between the two groups.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• Age ≥ 18 years

• New onset of acute gastrointestinal bleeding defined as:

‣ The presence of melena/maroon stool on physical exam OR history of melena/maroon stool within 48 hours of emergency room presentation PLUS

⁃ Hemoglobin drop of ≥ 20 g/L from patient's baseline

• Have capacity to consent

• Hemodynamically stable (i.e. blood pressure \>100/60 or pulse \<110 at the time of consent)

• Initial gastroscopy negative for active bleeding or potential bleeding source

Locations
Other Locations
Canada
University of Alberta Hospital
RECRUITING
Edmonton
Contact Information
Primary
Sergio Zepeda-Gomez, MD
zepedago@ualberta.ca
780-248-1578
Backup
David Yang, MD
dyyang@ualberta.ca
647-502-7658
Time Frame
Start Date: 2021-09-01
Estimated Completion Date: 2025-10-30
Participants
Target number of participants: 70
Treatments
Experimental: Early small bowel investigation
Patients in the early small bowel investigation group will undergo VCE immediately after their initial negative gastroscopy
Active_comparator: Colonoscopy
Participants with negative gastroscopy will undergo bowel preparation and colonoscopy the next day
Sponsors
Leads: University of Alberta

This content was sourced from clinicaltrials.gov