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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pelvic Floor Disorders

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Rectal Intussusception and Prolapse<br>AAR measurements will be taken from patients with suspected intra-rectal intussusception or rectal prolapse. Subgroup analysis will be performed after grading of rectal prolapse according to the Oxford Grading system. The subgroups will be: Oxford Grades 1 & 2 - intra-rectal intussusception Oxford Grades 3 & 4 - intra-anal intussusception Oxford grade 5 - Overt Rectal Prolapse | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opening Pressure | The pressure (in cmH20) at which the anal canl just begins to open | at specific time point of measurement up to 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opening Elastance | in cmH20/mm2 - the resistance of the anal canal to stretch | at specific time point of measurement up to 1 hour | 
| Closing Pressure | The pressure (cmH20) at whihc the anal canal just closes | at specific time point of measurement up to 1 hour | 
| Closing Elastance | In cmH20/mm2 - the ability of the anal canal to close after a period of stretch | at specific time point of measurement up to 1 hour | 
| Hysteresis | measured as % - the percentage energy dissipated during opening and closing of the anal canal at rest | at specific time point of measurement up to 1 hour | 
| Squeeze Opening Pressure | the pressure (cmH2O) at whihc the anal canal opens during volunatry anal contraction | at specific time point of measurement up to 1 hour | 
| Squeeze Opening Elastance | the resistance of the anal canal to stretch during voluntary contraction | at specific time point of measurement up to 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rectal Prolapse, Rectal Intussuception