Evaluation of Digestive Damage and Associated Predictive Factors in Crohn's Disease 5 to 10 Years After Diagnosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 9
- 主要终点
- Digestive damage
研究概览
简要总结
The primary objective is to evaluate digestive damage in CD 5 to 10 years after diagnosis in the GETAID centers included in the RAPID study. Secondary objective is to identify predictive factors of the evolution digestive damage.
详细描述
Background: Crohn's disease (CD) is a chronic inflammatory disorder of the bowel that is characterized by periods of clinical remission alternating with periods of recurrence. Persistent inflammation is believed to lead to progressive bowel damage that, over time, will manifest in the development of strictures, fistulae, and abscesses. The recent development of the Lemann index allows us to precisely assess digestive damage in CD. The aim of the present study is to evaluate digestive damage and associated predictive factors in CD 5 to 10 years after diagnosis.
Methods: Prospective, multicenter, international, transversal, observational study. Patients who completed the RAPID trial (evaluating the benefits on the course of CD of an early prescription of azathioprine compared with conventional step-care therapy) will be eligible. Digestive damage will be assessed using methods described in the Lemann index protocol, dependent on CD location (abdominal MRI obligatory). The total duration of study participation for 1patient will be ≤4 months.
Aims: The primary objective is to evaluate digestive damage in CD 5 to 10 years after diagnosis in the GETAID centers included in the RAPID study. Secondary objective is to identify predictive factors of the evolution digestive damage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients over 18 years old
- •Active or Inactive Crohn's Disease
- •Previously enrolled in RAPID clinical trial
排除标准
- •Pregnant or nursing woman
- •Patient with a contraindication or who decline to have study exams (MRI and endoscopy)
- •Other medical or psychiatric or serious chronic conditions or according to the physician's discretion that could affect the patient's cooperation or the capacity to follow study procedures.
研究组 & 干预措施
Evaluation group
Digestive damage will be assessed on patients by using the methods described in the Lemann index protocol, dependant of Crohn's disease locations.
All patients will have clinical examination and abdominal magnetic resonance imaging analyses. Upper endoscopy, colonoscopy, and pelvic magnetic resonance imaging analyses will be performed according to disease locations :
- Upper tract location : upper endoscopy
- Colorectal location : colonoscopy
- Perianal location : pelvic MRI
- All patients : abdominal MRI
干预措施: Abdominal MRI (Procedure)
Evaluation group
Digestive damage will be assessed on patients by using the methods described in the Lemann index protocol, dependant of Crohn's disease locations.
All patients will have clinical examination and abdominal magnetic resonance imaging analyses. Upper endoscopy, colonoscopy, and pelvic magnetic resonance imaging analyses will be performed according to disease locations :
- Upper tract location : upper endoscopy
- Colorectal location : colonoscopy
- Perianal location : pelvic MRI
- All patients : abdominal MRI
干预措施: Upper endoscopy (Procedure)
Evaluation group
Digestive damage will be assessed on patients by using the methods described in the Lemann index protocol, dependant of Crohn's disease locations.
All patients will have clinical examination and abdominal magnetic resonance imaging analyses. Upper endoscopy, colonoscopy, and pelvic magnetic resonance imaging analyses will be performed according to disease locations :
- Upper tract location : upper endoscopy
- Colorectal location : colonoscopy
- Perianal location : pelvic MRI
- All patients : abdominal MRI
干预措施: Colonoscopy (Procedure)
Evaluation group
Digestive damage will be assessed on patients by using the methods described in the Lemann index protocol, dependant of Crohn's disease locations.
All patients will have clinical examination and abdominal magnetic resonance imaging analyses. Upper endoscopy, colonoscopy, and pelvic magnetic resonance imaging analyses will be performed according to disease locations :
- Upper tract location : upper endoscopy
- Colorectal location : colonoscopy
- Perianal location : pelvic MRI
- All patients : abdominal MRI
干预措施: Pelvic MRI (Procedure)
结局指标
主要结局
Digestive damage
时间窗: 5 to 10 years after diagnosis
Evaluate digestive damage in Crohn's Disease by using Lemann Index
次要结局
- Predictive factors of the digestive damage evolution(5 to 10 years after diagnosis)
- Variation of Lemann Index(5 to 10 years after diagnosis)