The Utility of Second Generation Colon Capsule Endoscopy in Ulcerative Colitis

Chinese University of Hong Kong150 enrolled

Overview

The purpose of this study is to investigate the accuracy of second generation colon capsule (C2) in evaluating colonic mucosal inflammation of ulcerative colitis patients, using conventional endoscopy as the gold standard.

Consecutive patients with ulcerative colitis will be recruited. Second generation colon capsule endoscopy (C2) and conventional colonoscopy will be performed one after another on the same day. Colonic mucosal inflammation will be scaled by physicians who review C2 videos and those who perform conventional colonosocpies independently. Physicians who review C2 videos and colonoscopists will be blinded to the findings of colonoscopies and C2 videos, respectively.The accuracy of C2 in evaluating mucosal inflammation will be evaluated, using conventional endoscopy as the gold standard.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

150

Conditions

Colitis, Ulcerative

Interventions

C2DEVICE

C2 and colonoscopy will be performed one after another on the same day

colonoscopyPROCEDURE

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age 18-80 years * suspected or known UC * written informed consent Exclusion Criteria: * patients with severe UC according to Truelove and Witts' criteria * current pregnancy/lactating * patients with a pacemaker or other implanted electromedical device * the presence of dysphagia * patients at higher risk of capsule retention (including Crohn's disease, small bowel tumor, radiation enteropathy, previous intestinal surgery, acute abdominal pain without regular defecation) * patients with a contraindication to bowel preparation (congestive heart failure, renal insufficiency, a life-threatening condition) * patients with an allergy to polyethylene glycol, sodium phosphate solution, metoclopramide or bisacodyl suppository

Locations (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

Outcomes

Primary Outcomes

Number of participants with extent and severity of colonic inflammation

extent and severity of mucosal inflammation will be assessed by each investigation

Time frame: 1 day

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.