Electro-Entero-Graphy (EEnG) for Non-invasive Diagnosis of Motility Disorders of the Bowel
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Power Percent Difference
研究概览
简要总结
The current diagnostic process of colonic motility disorders often takes a long time and involves multiple invasive, painful and/or unnecessary diagnostic procedures. To improve this diagnostic process, the potential of Electro-Entero-Graphy (EEnG) is investigated.
During the EEnG procedure, several surface electrodes are positioned (under ultrasound guidance) on the abdomen so that electrical activity originating in the colon can be measured. Measurements will be performed after a period of fasting (when the colon is 'silent') and just after a meal (when the colon is moving) in both participants suffering from colonic motility disorders and healthy controls.
It is hypothesized that these measurements are an indication of colonic motility and can be used as a diagnostic tool for colonic motility disorders. It is also hypothesized that this EEnG procedure is not more burdensome than the Gold Standard procedures for diagnosing colonic motility disorders. This will be assessed using questionnaires.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All participants:
- •Age ≤ 11 years for babies and children
- •Age ≥ 18 years for adults.
- •For babies/children:
- •suffering from surgically untreated HSCR as determined by a rectal biopsy, or
- •suspected of HSCR, for which a rectal biopsy is planned
- •For adults: Suffering from a (suspected,) surgically untreated functional colonic motility disorder (such as slow-transit constipation, idiopathic/therapy resistant constipation of the colon), as diagnosed previously or will be diagnosed in the near future using the gold standard method.
- •Exclusion criteria:
- •All participants:
- •For adults: BMI > 27 kg/m2
- •For babies/children: weight for length > 2.5 standard deviations of WHO Child Growth Standard
- •Pregnancy
- •Any food intolerance
- •Presence of an intestinal stoma
- •Use of continuous tube feeding
- •Healthy controls:
- •The presence of any known gastro-intestinal conditions
- •Use of laxatives in the past two years
- •Participants with (suspected) motility disorder:
- •(Part of) colon removed
- •Inflammatory bowel disease
排除标准
- 未提供
结局指标
主要结局
Power Percent Difference
时间窗: During EEnG procedure
Relative power change when comparing pre-prandial EEnG measurements to post-prandial measurements. Power will be calculated as the mean amplitude (mV\^2/Hz) in a bandwidth of 2 cycles per minute around the dominant frequency related to colonic movements (between 2-10 cycles per minute).
次要结局
- EEnG questionnaire score(Directly after EEnG procedure, which is a one time procedure the subjects in this study will undergo)
- Gold Standard questionnaire score(Directly after EEnG procedure, which is a one time procedure the subjects in this study will undergo, or directly after the gold standard procedure, which some subjects will undergo in the near future at time of inclusion)