The added value of frequent intestinal ultrasonography in the close monitoring of moderate-severe ulcerative colitis
Recruiting
- Conditions
- lcerative colitis, inflammatory bowel diseases
- Registration Number
- NL-OMON22303
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 54
Inclusion Criteria
•Ulcerative colitis, histologically and endoscopically confirmed
•Endoscopically moderate to severe disease with a eMayo score =2
•Start of medical treatment
•>18 years of age
Exclusion Criteria
A potential subject who meets any of the following criteria will be excluded from participation in this study:
•Proctitis only
•Colonic stricture at baseline endoscopy
•Imminent need of surgery
•Sigmoidoscopy/colonoscopy older than eight weeks
•Ongoing gastroenteritis
•Cytomegalovirus (CMV) associated colitis
•Obesity (BMI >35 kg/m²)
•A normal bowel wall < 2mm at baseline ultrasonography
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main endpoint of this study will be change in bowel wall width in millimetres within 0 to 26 weeks against the reference standard of endoscopy where response on endoscopy is defined as a decrease of at least 1 point in eMayo-score at follow-up endoscopy after 8 to 26 weeks.
- Secondary Outcome Measures
Name Time Method