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Trans-abdominal ultrasound as a point-of-care test for the assessment of disease activity in patients with ulcerative colitis

Completed
Conditions
inflammatory bowel disease
ulcerative colitis
10017969
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
NameTimeMethod
<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
NameTimeMethod
<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>
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