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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.
Assess the health condition of patients for 1year, 2year,3year and analyze outcomes and complications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CTL group | control group |
| |
| EXP group | Colonoscope |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colonoscope | Combination Product | take off specimen |
|
| Measure | Description | Time Frame |
|---|---|---|
| relapse rate | CAI ≥5 or necessity for additional treatment | 1year |
| Measure | Description | Time Frame |
|---|---|---|
| surgery rate | disease progress requiring surgery | 1year,2year,3year |
| Rehospitalization rate | observation | 1year,2year,3year |
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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.
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:
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The project includes 320 cases from 4 Hospital. The EG and CG
has 160 cases. Nanfang Hospital of southern medical university:230 cases(EG115,CG115) Zhujiang Hospital of southern medical university:30 cases(EG15,CG15) Third affiliated hospital of southern medical university: 30 cases(EG15,CG15) First Hospital Affiliated to Shantou University:30 cases(EG15,CG15)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinying Wang, MD | Contact | 13726754880 | sunwingwxy@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xinying Wang | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | sunwingwxy@163.com | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17258735 | Result | D'Haens G, Sandborn WJ, Feagan BG, Geboes K, Hanauer SB, Irvine EJ, Lemann M, Marteau P, Rutgeerts P, Scholmerich J, Sutherland LR. A review of activity indices and efficacy end points for clinical trials of medical therapy in adults with ulcerative colitis. Gastroenterology. 2007 Feb;132(2):763-86. doi: 10.1053/j.gastro.2006.12.038. Epub 2006 Dec 20. No abstract available. |
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1year,2year,3year
patients with ulcerative colitis in histological remission.
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D020685 | Colonoscopes |
| ID | Term |
|---|---|
| D020776 | Endoscopes, Gastrointestinal |
| D019723 | Endoscopes |
| D019719 | Diagnostic Equipment |
| D004864 | Equipment and Supplies |
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Biospecimen retention will be kept as evidence to evaluate the condition of health.
| requirement for escalation of drugs | observation | 1year,2year,3year |
| complication rate | toxic megacolon,perforation,carcinogenesis | 1year,2year,3year |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D013523 |
| Surgical Equipment |