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The management of stricturing Crohn's disease (CD) remains challenging. Although surgical resection may be the final way to solve it, the efficacy of biologics for symptomatic CD associated strictures was acceptable. In clinical practice, the chioce of treatment is particularly difficult. Therefore, a clinical trial of biologics versus surgery is needed to assess which one is prefered.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biologic group | Other | If biologic(s) fails to provide relief, surgical intervention is considered. Following surgery, a prophylactic medication is offered based on the risk factors for recurrence |
|
| Surgery group | Other | treat paticipants with surgery and prophylactic medication according to the guidelines |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Group A | Drug | treat participants with biologics |
| |
| Group B |
| Measure | Description | Time Frame |
|---|---|---|
| clinical remmision rate within 1 year | Crohn's disease activity index < 150 | within 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| inflammatory bowel disease score | 32-224ï¼›the higher the better | within 1 and 5 year |
| Crohn's disease obstructive score | 0-6ï¼› the higher the worse |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weinming Zhu, Ph.D. | Contact | +86025-80860036 | juwiming@nju.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of General Surgery, Jinling hosptal,Medical School of Nanjing University | Recruiting | Nanjing | Jiangsu | 210002 | China |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Procedure |
treat participants with surgery |
|
| within 1 and 5 year |
| endoscopic recurrence | Rutgeert score >i2b (i0-i4); the higher the worse | within 1 and 5 year |
| medical cost | cost for hospitalization | within 1 and 5 year |
| sugical recurrence | disease recurrence that needs surgical resection | within 1 and 5 year |
| clinical remmision rate within 5 year | CDAI>150 | within 5 year |
| D007410 | Intestinal Diseases |