Disease Course in an IBD Cohort in the Era of Biological Treatment
Risk of Surgery Among Patients Wih Ulcerative Colitis and Croh'ns Disease After Seven Years of Follow-up in the Era of Biological Treatment.
The aim of the study is to do a 7-year follow-up of a consecutive inception cohort of 562 adults and children diagnosed and registered with inflammatory bowel disease in 2003-04 in order to evaluate the consequences of biological therapy in the treatment of IBD. The cohort is established after the implementation of biological agents in the treatment of IBD and the investigators hypothesis is that a) Severe disease course in IBD can be predicted by phenotypic presentation by serological, genetic, clinical and endoscopic characteristics to be used as guidance in the selection of treatment strategy and b) Introduction of biological treatment changes the course of disease in IBD and reduces the need of surgical procedures.
Methods: Medical records will be reviewed to register the use of medication, flare ups (medical and surgical) and hospital admissions. Diagnosis, disease localization and behavior will be evaluated. At outpatient visits patients will get a clinical examination, blood and faeces will be collected to biobank and patients will be offered an endoscopical examination. The Montreal classification, The Harvey & Bradshaw's activity index (CD) and the SCAAI score (UC) will be used to describe disease localization, extent, behavior and severity. An electronic database will be established in use of processing data.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
-
Hvidovre、丹麦、2650
- Hvidovre Hospital
-
Hvidovre、丹麦、2650
- Hvidovre Hospital, Gastroenheden 360
-
-
参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- All patients wil be followed up and diagnosis will be reassessed.
Exclusion Criteria:
- Non-IBD (after reassessing diagnosis)
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
|---|
|
Disease course
562 patients diagnosed with Crohn's disease (209), ulcerative colitis (326) or indeterminant colitis (27) in the period of 1st of January 2003 to 31st of December 2004 in Copenhagen City and County (an area covering 23% of the Danish population).
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Surgical rate
大体时间:7 years from inception (2003-04)
|
The risk of intestinal surgery from inception (2003-04) until 7 years of follow-up in Crohn's disease and ulcerative colitis
|
7 years from inception (2003-04)
|
合作者和调查者
调查人员
- 首席研究员:Marianne Vester-Andersen, MD、Dep. of Gastroenterology 360, Hvidovre Hospital
- 学习椅:Pia Munkholm, MD, DMsc、Dep. of Gastroenterology, Herlev Hospital
- 学习椅:Ida Vind, MD, PhD、Dep. of gastroenterology, Amager Hospital
- 研究主任:Flemming Bendtsen, prof. DMsci、Gastroenheden 360 Hvidovre University Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.