SOnographic evaLuation for Inflammatory bowel disease in Daily practice (SOLID) Study
Not Applicable
- Conditions
- lcerative colitis
- Registration Number
- JPRN-UMIN000050970
- Lead Sponsor
- Kyorin University School of Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
- Subjects who had total or partial colectomy or plan to take such surgery when providing written consent. - Subjects diagnosed with proctitis or an undetermined disease type. - Subjects with suspected concomitant colitis, e.g. infections enteritis, diverticulitis, and ischemic colitis (taking colonoscopy for examining other etiologies). - Subjects with an emergent, critical condition of UC.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Estimation accuracy of a scoring system based on IUS findings developed in this study (SOLID-UC index) for endoscopic remission at 6 months after starting the remission induction therapy.
- Secondary Outcome Measures
Name Time Method - Intra-/inter-observer agreement rates of each sonographic parameter in each segment of the colon and in the most severely affected part of the colon - Minimal important change of SOLID-UC index - Correlation between changes in SOLID-UC index, in its parameters, and in endoscopic scores - Assessment of reliability and measurement error of SOLID-UC index - Comparison of the predictive accuracy of SOLID-UC index, partial Mayo score, Lichtiger index, and biomarkers for endoscopic remission at 6 months after remission induction treatment