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Completed

NCT Number: NCT02774798

Correlation of Anal Acoustic Reflectometry Parameters With Degree of Rectal Intussusception and Prolapse

Anal Acoustic Reflectometry (AAR) is a reliable and reproducible 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.

Rectal intussusception occurs when the rectal wall telescopes into itself distally and is termed prolapse when it protrudes through the anal canal. Not all patients will require surgery and, for some, it can lead to debilitating symptoms of constipation, pain and faecal incontinence. Currently, the Oxford grading system through radiological testing is used for classifying severity of rectal intussusception and prolapse; however this does not give us sufficient information about the anal sphincter 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. In previous studies AAR has shown promise in the assessment of faecal incontinence and, that unlike manometry, it has been able to distinguish between different types of incontinence. Thus far, it has not been studied in patients with rectal intussusception and it is hoped that AAR parameters may provide an indication of when rectal intussusception becomes overt rectal prolapse. This can inform the clinician to guide further management of a group of patients with a condition that can have significant impact on quality of life.

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Key information

About this study

This an observational study based on not intervention. Patients are grouped depending on grade of prolapse, and all undergo the routine AAR investigation. Patients are grouped solely on differences in pathology already present and not on any intervention.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adults over 18 years old
  • Have capacity to consent to the study
  • Patients with pelvic floor dysfunction and symptoms of rectal intussusception and rectal prolapse

Exclusion criteria

  • Minors under the age of 18 years old
  • Patients who lack capacity to consent
  • Patients without pelvic floor dysfunction or symptoms of rectal intussusception or rectal prolapse

Treatment and study plan

Primary outcomes

  1. Opening Pressure

    Time frame: at specific time point of measurement up to 1 hour

    The pressure (in cmH20) at which the anal canl just begins to open

Secondary outcomes

  1. Opening Elastance

    Time frame: at specific time point of measurement up to 1 hour

    in cmH20/mm2 - the resistance of the anal canal to stretch

  2. Closing Pressure

    Time frame: at specific time point of measurement up to 1 hour

    The pressure (cmH20) at whihc the anal canal just closes

  3. Closing Elastance

    Time frame: at specific time point of measurement up to 1 hour

    In cmH20/mm2 - the ability of the anal canal to close after a period of stretch

  4. Hysteresis

    Time frame: at specific time point of measurement up to 1 hour

    measured as "%" - the percentage energy dissipated during opening and closing of the anal canal at rest

  5. Squeeze Opening Pressure

    Time frame: at specific time point of measurement up to 1 hour

    the pressure (cmH2O) at whihc the anal canal opens during volunatry anal contraction

  6. Squeeze Opening Elastance

    Time frame: at specific time point of measurement up to 1 hour

    the resistance of the anal canal to stretch during voluntary contraction

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Registry information

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 17, 2016
Registry last updated
Mar 30, 2020

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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