Bowel Urgency in Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Prevalence of bowel urgency in a cohort of patients with inflammatory bowel disease
研究概览
简要总结
Bowel urgency is commonly defined as the sudden need to rush to the bathroom to empty one's bowel. In the field of inflammatory bowel disease (IBD) (including Crohn's disease (CD) and ulcerative colitis (UC)), bowel urgency is part of the top five research priorities for future IBD nursing research, and it is a symptom that patients consider to be most important when prioritizing their disease control. Urgency is a patient-reported outcome associated with compromised quality of life and future risk of hospitalizations, corticosteroids, and colectomy in patients with UC.
A meta-analysis of 321 studies examining bowel urgency revealed that only one-third of these clinical studies clearly defined the concept of bowel urgency. Definition of bowel urgency was heterogeneous as 14 different definitions were identified. In most of these studies, non-validated questionnaires were used. They are based on subjective responses of the patients, and they could determine evaluation bias. These data emphasize the lack of standardization in bowel urgency assessment.
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
- •Male or female, aged at least 18 years old
- •Diagnosis of inflammatory bowel disease according to the European Crohn´s and Colitis Organisation criteria for at least 3 months
- •Person who has received full information about the organization of the research and who has not objected to his or her participation and to the use of his or her data
- •Person affiliated to or beneficiary of a social security plan
排除标准
- •Person unable to comply with study procedures
结局指标
主要结局
Prevalence of bowel urgency in a cohort of patients with inflammatory bowel disease
时间窗: Through study completion, an average of 12 months
Inability to defer defecation for more than 15 minutes in patients with inflammatory bowel disease
次要结局
- Prevalence of bowel urgency in a cohort of Crohn's disease patients(Through study completion, an average of 12 months)
- Prevalence of bowel urgency in a cohort of ulcerative colitis patients(Through study completion, an average of 12 months)
- Correlation between the URGENT index and the Urgency Numeric Rating Scale(Through study completion, an average of 12 months)
- Development of the URGENT index (i.e. inflammatory bowel disease-specific bowel urgency index)(Through study completion, an average of 12 months)
- To identify IBD-related risk factors associated with an increased risk of bowel urgency(Through study completion, an average of 12 months)
- Most appropriate definition of bowel urgency for patients with IBD(Through study completion, an average of 12 months)
- Correlation between the URGENT index and a Global Visual Evaluation(Through study completion, an average of 12 months)