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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary:
Sponsor: University Hospital of South Manchester NHS Foundation Trust

Current Primary Outcome: AAR parameters and their correlation with grade of rectal prolapse [ Time Frame: 3 years ]

AAR parameters may differ depending of grade of rectal intussusception. The outcome will only be able to be established upon full recruitment of patients and target number of patients in each group. Once fully recruited grouped analysis can be performed to establish any difference in AAR parameters depending on the grade of rectal prolapse


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University Hospital of South Manchester NHS Foundation Trust

Dates:
Date Received: May 10, 2016
Date Started: April 2016
Date Completion: April 2019
Last Updated: May 12, 2016
Last Verified: April 2016