A Multicenter Prospective Cohort Study of Surgically Resected Crohn's Disease Patients Aiming to Identify Prognostic Factors for Re-operation: a New Score
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- Re-operation rate in CD patients who underwent surgery for the first time - Re-operation rate
研究概览
简要总结
The project will consist of a multicentre, prospective, observational study with a total duration of 24 months. Clinical, endoscopic and ultrasound data will be collected in a dedicated database (on IG-IBD Register), which will be used to identify potential clinical, endoscopic and ultrasound risk factors of re-operation. These data could be merged into a shared score, to stratify patients according to the risk of post-surgical re- operation and to define an optimal therapeutic management in the post- operative period. Approximately 220 adult patients, with a defined diagnosis of CD, who underwent a surgery for CD in the previous 6 months will be enrolled.
详细描述
Patients will be consecutively enrolled in this prospective cross-sectional study, during the first 12 months, and then followed for 12 (minimum) up to 24(maximum) months, depending on date of patients' enrolment (total study length: 2 years). Patients will be stratified according to risk factors and type of treatment carried out in that year
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged 18 to 65 years, inclusive
- •Diagnosis of Crohn's Disease (CD) for at least 6 months prior to enrolment, by clinical, endoscopic and histopathologic evidence
- •First surgery for CD performed less than 6 months before enrolment (no second surgery allowed)
- •Ability to provide written informed consent and to be compliant with the schedule of protocol assessments
排除标准
- •Diagnosis of ulcerative colitis or indeterminate colitis
- •Crohn's disease isolated at stomach, duodenum, jejunum, or perianal region, without ileo-colonic involvement
- •More than one surgery for luminal CD
- •Current stoma or need for ileostomy or colostomy
- •Clinically relevant diseases making interpretation of the trial difficult or that would put the patient at risk of severe complications, in the opinion of the investigator
- •Inability to provide written informed consent and poor compliance with the schedule of protocol assessments
结局指标
主要结局
Re-operation rate in CD patients who underwent surgery for the first time - Re-operation rate
时间窗: 12 months
re-operation rate
次要结局
- Ideation of a new score for the risk of re-operation in CD patients(12 months)