NCT03955328Unknown不适用
Progression of Damage in Ulcerative Colitis
David Garcia Cinca4 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年6月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 4
- 主要终点
- Relationship of structural changes in colon morphology and functional changes assessed by MRI with disease duration in UC patients in clinical remission
研究概览
简要总结
The hypothesis of the study is that in ulcerative colitis repeated flares of inflammatory activity, as well as mechanisms involved in resolution of the inflammatory response, may contribute to accumulation of damage in the colon leading to functional disturbances and symptoms that affect patient's functioning. The primary objective is to determine whether ulcerative colitis induces permanent anatomical damage, by means of magnetic resonance imaging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes aged >18 years and <72 years.
- •Ulcerative colitis diagnosed according to European Crohn's and Colitis Organization guidelines .
- •Ulcerative colitis in endoscopic remission as demonstrated by a recto-sigmoidoscopy/colonoscopy (defined as: Mayo Endoscopic Score 0-1; Ulcerative Colitis Endoscopic Index of Severity : bleeding 0, vascular 0-1, erosion/ulcers 0).
- •Normal C-reactive protein according local laboratory values.
- •Informed consent for participation.
- •Understands the language of the provided patient questionnaires.
排除标准
- •Pregnant women (or pregnancy suspected).
- •Previous colonic surgery.
- •Patients receiving corticosteroids or antidiarrheal medications.
- •Patients with suspected or confirmed active gastrointestinal infection.
- •Patients with a diagnosis of other gastrointestinal disorders that may result in symptoms including, but not limited to, celiac disease, intolerance to disaccharides and pancreatic disorders.
- •Diabetes.
- •Thyroid disorders.
- •Liver disease.
- •Any other systemic disease that, according to the investigator's criteria, might influence the variables investigated.
- •Patients with history of colonic dysplasia.
研究组 & 干预措施
Magnetic Resonance Imaging
Experimental
A magnetic resonance imaging is perform to detect permanent anatomical damage.
干预措施: Magnetic Resonance Imaging (Diagnostic Test)
结局指标
主要结局
Relationship of structural changes in colon morphology and functional changes assessed by MRI with disease duration in UC patients in clinical remission
时间窗: Baseline
Explorative structural changes
次要结局
- To identify disease characteristics associated with permanent/accumulated damage with the disease extension at diagnosis and maximal extension of the disease at any time extensive colitis(Baseline)
- Patient reported outcomes on EQ-5D-5L questionnaire(Baseline)
- Patient reported outcomes on Disability Index questionnaire(Baseline)
- To identify disease characteristics associated with permanent/accumulated damage disease severity with number of f the hospital admissions(Baseline)
- Patient reported outcomes on IBDQ-32 questionnaire(Baseline)
- Patient reported outcomes on Work Productivity and Activity questionnaire(Baseline)
- To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of corticoesteroids(Baseline)
- To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of immunosuppressants(Baseline)
- To identify disease characteristics associated with permanent/accumulated damage disease severity with dose of biologics drugs(Baseline)
- To identify disease characteristics associated with permanent/accumulated damage with the disease extension at diagnosis and maximal extension of the disease at any time proctitis(Baseline)
- To identify disease characteristics associated with permanent/accumulated damage with the disease extension at diagnosis and maximal extension of the disease at any time left colitis(Baseline)
- To identify disease characteristics associated with permanent/accumulated damage with the time since the disease diagnosis(Baseline)
- To identify disease characteristics associated with permanent/accumulated damage related to anorectal function using Cleveland Clinic Incontinence Score(Baseline)
研究者
David Garcia Cinca
Fundació Clínic per la Recerca Biomèdica
Hospital Clinic of Barcelona
研究点 (4)
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