Evaluation of the Fast Fill Technique for Anal Acoustic Reflectometry (AAR) in the Incontinent Anal Sphincter
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
研究概览
地位
条件
研究类型
注册 (实际的)
联系人和位置
学习地点
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Greater Manchester
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Manchester、Greater Manchester、英国、M23 9LT
- University Hospital of South Manchester
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- adults over 18 years
- have capacity to consent to the study
- patients with symptoms of faecal incontinence
Exclusion Criteria:
- minors under age of 18 years old
- patients who lack capacity to consent
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
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Faecal Incontinence: fast-fill measurement first
Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique.
A further standard manometry measurement will be taken.
18 patients will undergo fast-fill measurement first.
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Faecal Incontinence: step-wise measurement first.
Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique.
A further standard manometry measurement will be taken.
18 patients will have step-wise measurement first.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Opening Pressure
大体时间:10 minutes
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Opening Pressure (Op - cm H2O) - the point at which the anal canal just begins to open
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10 minutes
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Opening Elastance
大体时间:10 minutes
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Opening Elastance (Oe - cm H2O/mm2) - the resistance of the anal canal to stretch
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10 minutes
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Closing Pressure
大体时间:10 minutes
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Closing Pressure (Cp - cm H2O) - the pressure at which the anal canal closes after a period of opening
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10 minutes
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Closing Elastance
大体时间:10 minutes
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Closing Elastance (Ce - cm H2O/mm2) - the ability of the anal canal to close passively after a period of stretch
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10 minutes
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Hysteresis
大体时间:10 minutes
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Hysteresis (%) - the energy dissipated during opeing and closing of the anal canal
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10 minutes
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Squeeze Opening Pressure
大体时间:10 minutes
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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
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10 minutes
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Squeeze Opening Elastance
大体时间:10 minutes
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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
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10 minutes
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Manometry - Resting Pressure
大体时间:10 minutes
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anal manometry measured in cmH20
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10 minutes
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合作者和调查者
调查人员
- 学习椅:Karen J Telford, MBChBMDFRCS、University Hospital of South Manchester
出版物和有用的链接
一般刊物
- Klarskov N, Saaby ML, Lose G. A faster urethral pressure reflectometry technique for evaluating the squeezing function. Scand J Urol. 2013 Dec;47(6):529-33. doi: 10.3109/21681805.2013.776629. Epub 2013 Mar 19.
- Hornung BR, Mitchell PJ, Carlson GL, Klarskov N, Lose G, Kiff ES. Comparative study of anal acoustic reflectometry and anal manometry in the assessment of faecal incontinence. Br J Surg. 2012 Dec;99(12):1718-24. doi: 10.1002/bjs.8943. Erratum In: Br J Surg. 2013 Jan;100(2):301.
- Mitchell PJ, Klarskov N, Telford KJ, Hosker GL, Lose G, Kiff ES. Viscoelastic assessment of anal canal function using acoustic reflectometry: a clinically useful technique. Dis Colon Rectum. 2012 Feb;55(2):211-7. doi: 10.1097/DCR.0b013e31823b2499.
- Mitchell PJ, Klarskov N, Telford KJ, Hosker GL, Lose G, Kiff ES. Anal acoustic reflectometry: a new reproducible technique providing physiological assessment of anal sphincter function. Dis Colon Rectum. 2011 Sep;54(9):1122-8. doi: 10.1097/DCR.0b013e318223fbcb.
- Klarskov N. Urethral pressure reflectometry. A method for simultaneous measurements of pressure and cross-sectional area in the female urethra. Dan Med J. 2012 Mar;59(3):B4412.
- Saaby ML, Klarskov N, Lose G. Urethral pressure reflectometry before and after tension-free vaginal tape. Neurourol Urodyn. 2012 Nov;31(8):1231-5. doi: 10.1002/nau.22239. Epub 2012 Mar 27.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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