DRKS00013220进行中（未招募）不适用
Role of bowel ultrasonography to guide treatment with vedolizumab in patients with Crohn's disease and ulcerative colitis - VedoSono
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 65
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 Years 至 70 Years（—）
- 性别
- All
入选标准
- •Inclusion criteria for patients with active disease (study part 1):
- •1. Reliable diagnosis of Crohn's disease (active disease):
- •a. HBI = 7 and
- •b. Sonographic signs of active inflammation: intestinal wall thickness> 3.0 mm (colon) or> 2.0 mm (terminal ileum)
- •Reliable diagnosis of ulcerative colitis (active disease):
- •a. SCCAI = 5 and
- •b. Sonographic signs of active inflammation:
- •Intestinal wall thickness> 3.0 mm (Colon)
- •2. Study-independent therapy with vedolizumab
- •according to medical practice
- •3. Age 18 to 70 years
- •4. Sufficient communication skills in the German language
- •5. Patient must be able to recognize the nature, significance and scope of this study and to orientate its will accordingly
- •Inclusion criteria for patients in remission (study part 2):
- •1. Reliable diagnosis of Crohn's disease (remission): HBI = 4
- •Reliable diagnosis of ulcerative colitis (remission):
- •2. Study-independent therapy with vedolizumab
- •according to medical practice
- •3. Age 18 to 70 years
- •4. Sufficient communication skills in the German language
- •5. Patient must be able to recognize the nature, significance and scope of this study and to orientate its will accordingly
排除标准
- •1. Pregnancy or breastfeeding
- •2. Therapy with vedolizumab out of authorization
- •3. Contraindication to treatment with vedolizumab (sec.reg. FI)
- •4. Severe symptomatic strictures without signs of blood flow
- •5. Ileostoma or ileoanal pouch
- •6. Infectious colitis (e.g., Clostridium difficile colitis,
- •Cytomegalovirus colitis)
- •7. Obesity = grade I (BMI> 30) (insufficient, sonographic bowel wall imaging)
- •8. Ulcerative colitis: proctitis Crohn's disease: infestation of the upper GI tract (esophagus, stomach)
- •9. Participation in an intervention study within the last 30 days prior to initiation of therapy
- •10. Other medical reasons
研究者
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