Using Second-Generation Colon Capsule Endoscopy to Locate and Diagnose Bleeding in Adults With Severe Rectal Bleeding

What this Trial Is About

Researchers are evaluating the use of a second-generation colon capsule endoscopy system to detect bleeding sources in patients with severe hematochezia, which involves bright red blood per rectum. This study compares this capsule endoscopy with standard diagnostic tests like tagged red blood cell scans and angiography to see if it improves the accuracy and speed of locating bleeding lesions. The study aims to provide a new approach that could change current guidelines and management for patients with this condition. Participants will undergo bowel preparation and then swallow the colon capsule, which records images of the entire gastrointestinal tract for up to 10 hours. Alongside this, patients will receive standard tests such as tagged RBC scans, CT or MRI angiography, and urgent colonoscopy within 48 hours to identify bleeding sources. The study also includes further diagnostic procedures if needed, and specialists will review all results while blinded to the capsule endoscopy findings initially to avoid bias. During the study, researchers will collect medical history, physical exams, lab tests, and details about bleeding and treatments. Safety monitoring will track adverse events daily during hospitalization and weekly for 30 days after discharge. The main outcome measured is the ability of each diagnostic method to locate the bleeding site within 30 days. Follow-up includes monitoring treatments, complications, transfusions, hospital stay, and survival, with data kept confidential and securely managed throughout the study.

Capsule Endoscopy for Severe Hematochezia