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Although the incidence of inflammatory bowel disease is stable in North American and European countries, the incidence of inflammatory bowel disease is increasing in newly industrialized countries, especially in China. The treatment drugs for ulcerative colitis include 5-aminosalicylic acid (5-ASA), glucocorticoids, immunosuppressants, and biological agents. The aim of this clinical trial is to evaluate the long-term safety and efficacy of sacral nerve stimulation in patients with ulcerative colitis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sacral nerve stimulation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sacral nerve stimulation | Device | Device: G132 system, Beijing PINS Medical Co., China Neuromodulation was performed according to the usual protocol |
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| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the Mayo score | The range of Mayo score is 0-12, and higher scores mean worse outcome | From baseline to 8 years |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical remission | overall mayo score ≤2 [and no individual subscore >1] | From baseline to 8 years |
| Clinical response | defined as the reduction of baseline scores by ≥3 points |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Wan | Contact | 15529202305 | 408127528@qq.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xijing Hospital | Recruiting | Xi'an | Shaanxi | 710032 | China |
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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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| From baseline to 8 years |
| Change from baseline in the Truelove and Witts Severity Index | Truelove and Witts Severity Index | From baseline to 8 years |
| Endoscopic remission | defined as Mayo endoscopic score ≤ 1 | From baseline to 8 years |
| Fecal calprotectin levels | fecal sample | From baseline to 8 years |
| erythrocyte sedimentation rate levels | blood sample | From baseline to 8 years |
| C reactive protein levels | blood sample | From baseline to 8 years |
| Inflammatory Bowel Disease Questionnaire Score | The range of Inflammatory Bowel Disease Questionnaire Score is 32-224, and higher scores mean worse outcome | From baseline to 8 years |
| Hospital Anxiety and Depression scale score | The range of Hospital Anxiety and Depression scale score is 0-21, and higher scores mean worse outcome | From baseline to 8 years |
| Gut microbiota profile | fecal sample | From baseline to 8 years |
| The Pittsburgh Sleep Quality Index | higher scores mean worse outcome | From baseline to 8 years |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |