Prospective Study, Ulcerative Colitis in Remission
Conditions
Keywords
Ulcerative Colitis, Mucosal Healing, Histological Remission, Prospective Study
Brief summary
Mucosal healing or histological remission is an important target for the treatment of inflammatory bowel disease. In this study, patients with mucosal healing are defined as a control group, observing their clinical outcomes for 3 years, and describing the recurrence rate. The secondary objective is to study the operative rate, glucocorticoid utilization rate, treatment escalation rate, hospitalization rate and incidence of related complications.
Detailed description
Assess the health condition of patients for 1year, 2year,3year and analyze outcomes and complications.
Interventions
COMBINATION_PRODUCTColonoscope
take off specimen
Sponsors
Nanfang Hospital, Southern Medical University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* sign informed consent before proceeding with any specific procedure. * ages:14-75 * subjects were diagnosed with ulcerative colitis in written form. (written diagnosis should include at least one histopathological change). * mucosal healing or histological remission has been achieved after medical treatment. 1. histological assessment is performed by 2 pathologists independently, and endoscopy have been independently evaluated by two endoscopic doctors. 2. prospective cohort study (3) definition of endoscopic mucosal healing: Baron score\<=1 and Mayo score\<=1 (4) definition of histological remission: Truelove/ Richards=1 and Geboes score\<3.0 (5) sampling methods: the terminal ileum, the ascending colon, the transverse colon, the descending colon, the sigmoid colon, and the rectum, the six parts were randomly taken specimen (at least 2 tissues each). * data integrity: the research data include: 1) enteroscopy; 2) laboratory examination indicators: blood routine, erythrocyte sedimentation rate, C reaction protein, liver function, renal function, fecal calprotectin, 3) serum concentration of infliximab, antibody to infliximab. * subjects were treated with the following treatment Mesalazine, glucocorticoid, immunosuppressive agent (azathioprine or thalidomide), biologics (infliximab) 7. subjects have the ability to answer the questionnaire
Exclusion criteria
* The diagnosis is unclear * Subjects with history of colectomy * Subjects with history of cancerogenesis * Subjects with severe liver disease, defined as child-pugh Grade B or Grade C * Subjects with severe renal disease, defined as Estimated glomerular filtration rate\<30 * major cardiovascular events, such as stroke, myocardial infarction, or unstable angina, occurred within 3 months before enrollment. * Subjects during pregnancy. * alcohol or drug abuse * poor compliance 10 Planners and investors
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| relapse rate | 1year | CAI ≥5 or necessity for additional treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| surgery rate | 1year，2year，3year | disease progress requiring surgery |
| Rehospitalization rate | 1year，2year，3year | observation |
| requirement for escalation of drugs | 1year，2year，3year | observation |
| complication rate | 1year，2year，3year | toxic megacolon，perforation，carcinogenesis |
Countries
China
Contacts
Primary ContactXinying Wang, MD
Outcome results
None listed