The Characterization of Small Bowel and Colonic Involvement in Patients With Seronegative Spondyloarthritides
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Number of patients with bowel lesions
研究概览
简要总结
Up to 60% of patients with Seronegative Spondyloarthritides have inflammation in the colon or ileum. This is usually asymptomatic, but in 5 to 10% of patients with SA, Frank IBD will develop. Lesions of the bowel could also be present in the SA patients because of the potential injury posed by the NSAIDS, a common used medication in this setting.
It is the bowel involvement in patients with SA that we propose to characterize, partly because there are scant communicated data in the medical literature, especially regarding small bowel lesions.
详细描述
The Seronegative Spondyloarthritides (SA) are a group of disorders that share certain clinical features and an association with the hla-b27 allele, having also overlapping features with inflammatory bowel disease (IBD).
Up to 60% of patients have inflammation in the colon or ileum. This is usually asymptomatic, but in 5 to 10% of patients with SA, Frank IBD will develop.
Lesions of the bowel could also be present in the SA patients because of the potential injury posed by the NSAIDS, a common used medication in this setting.
On the other hand, biologics used to treat patients with SA are believed to favorably influence the small bowel lesions that are concomitantly present.
It is the bowel involvement in patients with SA that we propose to characterize, partly because there are scant communicated data in the medical literature.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •signing of the inform consent
- •subjects 18 years old or more
- •patients with spondyloarthropathy as defined by the Amor criteria
排除标准
- •presumed intestinal obstruction
- •impaired deglutition
- •cardiac pace-makers present
- •pregnancy
- •pelvic or abdominal radiotherapy anytime in the past
- •major abdominal surgery anytime in the past
- •major comorbidities which could represent a contraindication to a surgical abdominal intervention
结局指标
主要结局
Number of patients with bowel lesions
时间窗: July 2012
次要结局
- Correlation of the bowel lesions with patient status(July 2012)
研究者
Prof. Dr. Mihail Radu Voiosu
University Professor
Carol Davila University of Medicine and Pharmacy