跳至主要内容
临床试验/NCT05955963
NCT05955963已完成不适用

Bowel Sounds Analysis in Paediatric Inflammatory Bowel Disease: Relationship With wPCDAI

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2021年6月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
49
试验地点
2
主要终点
evaluation of wPCDAI

研究概览

简要总结

The precise and noninvasive evaluation of disease activity among patients with Crohn's disease is not easy, especially for children. It deals with clinical, biological, histological and radiological parameters.

Bowel sounds (BS) when evaluated by a stethoscope are modified by several factors including surgery, infection, drugs or intestinal inflammation. These factors can interact on intestinal motricity. There is a direct relationship between gastrointestinal motility and characteristics of BW. The study of BS using a stethoscope is a simple method, although operator dependent and subjective,with a wide inter and intraindividual variability. Some studies among adults showed interest in the spectral analysis of BS to assess gastrointestinal motility. This more precise and reproducible method is not operator dependent.

To date, no such study has evaluated the correlation between disease activity and the spectral pattern of BS.

of this project is to assess the correlation between disease activity and the spectral pattern of BS in pediatric Crohn's disease.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
4 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Crohn's Disease
  • Age between 4 and 17 years
  • Follow-up at CHU Amiens-Picardie

排除标准

  • Other diseases than Crohn's or treatments affecting the gastrointestinal tract, recent (< 3 months) surgery or refusal to participate (parents or children)

研究组 & 干预措施

paediatric inflammatory bowel disease

Experimental

干预措施: Abdominal auscultation (Other)

结局指标

主要结局

evaluation of wPCDAI

时间窗: one day

wPCDAI is WEIGHTED PAEDIATRIC CROHN'S DISEASE ACTIVITY INDEX

evaluation of frequency of bowel sounds

时间窗: one day

correlation between wPCDAI and frequency of bowel sounds

时间窗: one day

wPCDAI is WEIGHTED PAEDIATRIC CROHN'S DISEASE ACTIVITY INDEX

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验