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

Nanfang Hospital, Southern Medical University

Status

Unknown

Conditions

Prospective Study

Ulcerative Colitis in Remission

Treatments

Combination Product: Colonoscope

Study type

Observational

Funder types

Other

Identifiers

NCT03698812

LC2016PY007

Details and patient eligibility

About

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.

Full description

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

Enrollment

9 estimated patients

Sex

All

Ages

14 to 75 years old

Volunteers

Accepts Healthy Volunteers

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