Sierra High Definition Ano-Rectal Manometry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To assess the feasibility of HDM in three groups of human subjects; healthy humans, patients with fecal incontinence and patients with chronic constipation
研究概览
简要总结
Hypotheses: High definition manometry (HDM) is safe and feasible in humans; HDM accurately characterizes anorectal anatomy and function in healthy humans; HDM provides comparable information regarding the structure and function of the anorectal region, to that obtained from ano-rectal manometry and anal ultrasonography (AUS), in patients with fecal incontinence or constipation.
Methods: 20 healthy volunteers, 20 patients with fecal incontinence, 20 patients with constipation will be recruited. Because anorectal disorders are more common in women, the investigators will recruit approximately 8 men and 12 women in each group. Each subject will undergo anorectal manometry, anal ultrasound and high definition manometry.
Data Analysis: Spearman correlational analysis will be performed to compare the parameters listed above. Also, the diagnostic yield of anal ultrasonography vs HDM in identifying anatomic sphincter defects will be assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •For patients:
- •Either fecal incontinence (the occurrence of at least one episode of involuntary discharge of stool matter per week) or constipation (Rome III criteria) (16,17)
- •Adults between the ages of 18-80 yrs.
- •For healthy volunteers:
- •Adults between the ages of 18-80 yrs
- •No gastrointestinal symptoms
排除标准
- •Rectal prolapse or anal fissure on physical examination
- •Recent pelvic or recto-anal surgery (< 6 months ago)
- •History of pelvic irradiation.
结局指标
主要结局
To assess the feasibility of HDM in three groups of human subjects; healthy humans, patients with fecal incontinence and patients with chronic constipation
时间窗: One visit
次要结局
未报告次要终点