A Multicenter Prospective Cohort Study on the Clinical Prognosis of Ulcerative Colitis

Study Overview
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Brief Summary
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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
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Assess the health condition of patients for 1year, 2year,3year and analyze outcomes and complications.

Official Title
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A Multicenter Prospective Follow-up Study on the Effect of Histological Remission on the Clinical Prognosis of Ulcerative Colitis

Conditions
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Prospective Study, Ulcerative Colitis in Remission

Intervention / Treatment
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* Combination Product: Colonoscope


Participation Criteria
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Eligibility Criteria
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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. histological assessment is performed by 2 pathologists independently, and endoscopy have been independently evaluated by two endoscopic doctors. 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

Ages Eligible for Study
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Minimum Age: 14 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CTL group<br>control group | Combination Product: Colonoscope<br>* take off specimen<br>|
| EXP group<br>Colonoscope | Combination Product: Colonoscope<br>* take off specimen<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relapse rate | CAI ≥5 or necessity for additional treatment | 1year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgery rate | disease progress requiring surgery | 1year，2year，3year | 
| Rehospitalization rate | observation | 1year，2year，3year | 
| requirement for escalation of drugs | observation | 1year，2year，3year | 
| complication rate | toxic megacolon，perforation，carcinogenesis | 1year，2year，3year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ulcerative Colitis, Mucosal Healing, Histological Remission, Prospective Study