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

• Conditions: Prospective Study; Ulcerative Colitis in Remission
• Interventions: Combination Product: Colonoscope

• Registration Number: NCT03698812
• Lead Sponsor: Nanfang Hospital, Southern Medical University

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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2018-09-30
• Status Verified: 2018-10
• Study First Submitted QC: 2018-10-04
• Study First Posted: 2018-10-09
• Last Update Submitted: 2018-10-16
• Last Update Posted: 2018-10-17
• Primary Completion: 2020-09-30
• Study Completion: 2021-09-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CTL group	Colonoscope	control group
EXP group	Colonoscope	Colonoscope

Primary Outcome Measures

Name	Time	Method
relapse rate	1year	CAI ≥5 or necessity for additional treatment

Secondary Outcome Measures

Name	Time	Method
complication rate	1year，2year，3year	toxic megacolon，perforation，carcinogenesis
Rehospitalization rate	1year，2year，3year	observation
surgery rate	1year，2year，3year	disease progress requiring surgery
requirement for escalation of drugs	1year，2year，3year	observation

Trial Locations

Locations (1)

Nanfang Hospital, Southern Medical University; 🇨🇳 Guangzhou, Guangdong, China