Trans-abdominal ultrasound as a point-of-care test for the assessment of disease activity in patients with ulcerative colitis
Completed
- Conditions
- inflammatory bowel diseaseulcerative colitis10017969
- Registration Number
- NL-OMON42820
- Lead Sponsor
- Academisch Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
- Histo-pathologically confirmed diagnosis of UC
- Quiescent disease, mild to moderate active disease or moderate to severe active disease according to the Montreal classification
- Needing a endoscopy with biopsies for evaluation of the disease
Exclusion Criteria
- Pregnancy
- Age < 18years
- Chronic obstructive lung disease
- Acute coronary heart disease
- Ongoing gastroenteritis
- Previous colorectal surgery
- Obesity (BMI >30 kg/m²)
- Coagulation disorders
- Use of warfarins
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Candidate parameters for the ultrasound index:<br /><br>colon wall thickness, colon wall layer stratification, mucosa thickness,<br /><br>submucosa thickness, muscularis propria thickness, colon wall perfusion,<br /><br>superior mesenteric artery (SMA) blood flow, inferior mesenteric artery (IMA)<br /><br>blood flow, colon visibility, colon contents, disease extent (affected area),<br /><br>haustra coli visibility, mesenteric lymphnodes, </p><br>
- Secondary Outcome Measures
Name Time Method <p>other parameters:<br /><br>endoscopic disease activity (UCEIS, Mayo), clinical disease activity (SCCAI,<br /><br>Mayo), biochemical disease activity (inflammatory parameters), patient<br /><br>satisfaction, examination costs.</p><br>