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

Completed

Conditions: Pelvic Floor Disorders

Registration Number: NCT02774798

Lead Sponsor: Manchester University NHS Foundation Trust

Brief Summary: 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: 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 31

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

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Opening Pressure	at specific time point of measurement up to 1 hour	The pressure (in cmH20) at which the anal canl just begins to open

Secondary Outcome Measures

Name	Time	Method
Opening Elastance	at specific time point of measurement up to 1 hour	in cmH20/mm2 - the resistance of the anal canal to stretch
Hysteresis	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
Closing Elastance	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
Squeeze Opening Elastance	at specific time point of measurement up to 1 hour	the resistance of the anal canal to stretch during voluntary contraction
Closing Pressure	at specific time point of measurement up to 1 hour	The pressure (cmH20) at whihc the anal canal just closes
Squeeze Opening Pressure	at specific time point of measurement up to 1 hour	the pressure (cmH2O) at whihc the anal canal opens during volunatry anal contraction