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Evaluation of the Fast Fill Technique for Anal Acoustic Reflectometry (AAR) in the Incontinent Anal Sphincter

2021年1月4日 更新者:Manchester University NHS Foundation Trust

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:

  1. Stepwise then fast-fill
  2. Fast-fill then stepwise

研究概览

地位

完全的

条件

研究类型

观察性的

注册 (实际的)

36

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Greater Manchester
      • Manchester、Greater Manchester、英国、M23 9LT
        • University Hospital of South Manchester

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patients presenting to the pelvic floor clinic and neurogastroenterology with symptoms of faecal incontinence

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

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
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.
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.

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
Opening Pressure (Op - cm H2O) - the point at which the anal canal just begins to open
10 minutes
Opening Elastance
大体时间:10 minutes
Opening Elastance (Oe - cm H2O/mm2) - the resistance of the anal canal to stretch
10 minutes
Closing Pressure
大体时间:10 minutes
Closing Pressure (Cp - cm H2O) - the pressure at which the anal canal closes after a period of opening
10 minutes
Closing Elastance
大体时间:10 minutes
Closing Elastance (Ce - cm H2O/mm2) - the ability of the anal canal to close passively after a period of stretch
10 minutes
Hysteresis
大体时间:10 minutes
Hysteresis (%) - the energy dissipated during opeing and closing of the anal canal
10 minutes
Squeeze Opening Pressure
大体时间: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
10 minutes
Squeeze Opening Elastance
大体时间: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
10 minutes

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
anal manometry measured in cmH20
10 minutes

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

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

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年11月1日

初级完成 (实际的)

2016年10月1日

研究完成 (实际的)

2016年10月1日

研究注册日期

首次提交

2016年5月12日

首先提交符合 QC 标准的

2016年5月20日

首次发布 (估计)

2016年5月25日

研究记录更新

最后更新发布 (实际的)

2021年1月22日

上次提交的符合 QC 标准的更新

2021年1月4日

最后验证

2021年1月1日

更多信息

与本研究相关的术语

关键字

其他研究编号

  • 2015GA004

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

IPD 计划说明

individual patient data will not add any further information to the overall data

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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