Evaluation of the Fast Fill Technique for Anal Acoustic Reflectometry (AAR) in the Incontinent Anal Sphincter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Closing Pressure
研究概览
简要总结
Anal Acoustic Reflectometry (AAR) is a technique that has been studied in our department over the last 6 years. Sound waves pass into a balloon placed in the anal canal and are used to measure the cross-sectional area. By gradually increasing and decreasing the pressure in the balloon the investigators can measure the pressure at which the cross-sectional area starts to increase and decrease, and the anal canal starts to open and close. This assessment mimics the natural opening and closing of the anal canal and the effect of squeezing the muscles.
The gold standard investigation of the anal sphincter muscles has been manometry which measures anal canal pressure at rest and during squeeze. However, it has limitations. Despite the two measurements being within the normal range, some patients can have significant faecal incontinence. This has prompted clinicians to search for a better investigation to guide the management of this condition.
AAR is a reproducible and repeatable technique that has been used as a research technique in the assessment of faecal incontinence. It has been shown to correlate with symptom severity and, unlike manometry, is able to distinguish between different symptomatic subgroups with faceal incontinence. In our studies so far the investigators have increased the bag inflation pressure a step at a time which means that each study takes about 20 minutes to perform. The limitation of this method is that during the measurement of squeeze pressure the sphincter muscle is subject to fatigue. A recent study using the acoustic technique in the urethra has demonstrated a faster method of recording measurements over an 8 minute period. The investigators propose to study the fatiguability effects of this faster technique and validate the method against the existing step-wise technique and standard anal manometry.
Patients will be randomised into two groups:
- Stepwise then fast-fill
- Fast-fill then stepwise
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
- •adults over 18 years
- •have capacity to consent to the study
- •patients with symptoms of faecal incontinence
排除标准
- •minors under age of 18 years old
- •patients who lack capacity to consent
结局指标
主要结局
Closing Pressure
时间窗: 10 minutes
Closing Pressure (Cp - cm H2O) - the pressure at which the anal canal closes after a period of opening
Squeeze Opening Elastance
时间窗: 10 minutes
Squeeze opening elastance (Sq)e - cm H20/mm2) - the resistance of the anal canal to stretch whilst the patient is voluntarily trying to keep the anal canal closed
Opening Pressure
时间窗: 10 minutes
Opening Pressure (Op - cm H2O) - the point at which the anal canal just begins to open
Closing Elastance
时间窗: 10 minutes
Closing Elastance (Ce - cm H2O/mm2) - the ability of the anal canal to close passively after a period of stretch
Hysteresis
时间窗: 10 minutes
Hysteresis (%) - the energy dissipated during opeing and closing of the anal canal
Opening Elastance
时间窗: 10 minutes
Opening Elastance (Oe - cm H2O/mm2) - the resistance of the anal canal to stretch
Squeeze Opening Pressure
时间窗: 10 minutes
Squeeze opening pressure (SqOp - cm H20) - the pressure at which the anal canal just starts to open whilst the patient is voluntarily trying to keep the anal canal closed
次要结局
- Manometry - Resting Pressure(10 minutes)