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Completed

NCT Number: NCT02782364

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:

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of South Manchester

Manchester, Greater Manchester, M23 9LT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Opening Pressure

    Time frame: 10 minutes

    Opening Pressure (Op - cm H2O) - the point at which the anal canal just begins to open

  2. Opening Elastance

    Time frame: 10 minutes

    Opening Elastance (Oe - cm H2O/mm2) - the resistance of the anal canal to stretch

  3. Closing Pressure

    Time frame: 10 minutes

    Closing Pressure (Cp - cm H2O) - the pressure at which the anal canal closes after a period of opening

  4. Closing Elastance

    Time frame: 10 minutes

    Closing Elastance (Ce - cm H2O/mm2) - the ability of the anal canal to close passively after a period of stretch

  5. Hysteresis

    Time frame: 10 minutes

    Hysteresis (%) - the energy dissipated during opeing and closing of the anal canal

  6. Squeeze Opening Pressure

    Time frame: 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

  7. Squeeze Opening Elastance

    Time frame: 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

Secondary outcomes

  1. Manometry - Resting Pressure

    Time frame: 10 minutes

    anal manometry measured in cmH20

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
May 25, 2016
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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