Clinical trial NCT02774798: Correlation of Anal Acoustic Reflectometry Parameters With Degree of Rectal Intussusception and Prolapse
Official title: Correlation of Anal Acoustic Reflectometry Parameters With Degree of Rectal Intussusception and Prolapse
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pelvic Floor Disorders
Keywords: Rectal Prolapse
Rectal Intussuception
Lead sponsor: Manchester University NHS Foundation Trust
Sponsor class: OTHER_GOV
First posted: 2016-05-17
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients presenting to the pelvic floor clinic and neurogastroenterology with symptoms of rectal 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Opening Pressure
timeFrame: at specific time point of measurement up to 1 hour
Secondary outcomes:
measure: Opening Elastance
timeFrame: at specific time point of measurement up to 1 hour
measure: Closing Pressure
timeFrame: at specific time point of measurement up to 1 hour
measure: Closing Elastance
timeFrame: at specific time point of measurement up to 1 hour
measure: Hysteresis
timeFrame: at specific time point of measurement up to 1 hour
measure: Squeeze Opening Pressure
timeFrame: at specific time point of measurement up to 1 hour
measure: Squeeze Opening Elastance
timeFrame: at specific time point of measurement up to 1 hour
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: University Hospital of South Manchester
state: Greater Manchester
Study officials:
affiliation: University Hospital of South Manchester
name: Karen J Telford
role: STUDY_CHAIR
References:
citation: Klarskov N, Saaby ML, Lose G. A faster urethral pressure reflectometry technique for evaluating the squeezing function. Scand J Urol. 2013 Dec;47(6):529-33. doi: 10.3109/21681805.2013.776629. Epub 2013 Mar 19.
citation: Hornung BR, Mitchell PJ, Carlson GL, Klarskov N, Lose G, Kiff ES. Comparative study of anal acoustic reflectometry and anal manometry in the assessment of faecal incontinence. Br J Surg. 2012 Dec;99(12):1718-24. doi: 10.1002/bjs.8943.
citation: Mitchell PJ, Klarskov N, Telford KJ, Hosker GL, Lose G, Kiff ES. Viscoelastic assessment of anal canal function using acoustic reflectometry: a clinically useful technique. Dis Colon Rectum. 2012 Feb;55(2):211-7. doi: 10.1097/DCR.0b013e31823b2499.
citation: Mitchell PJ, Klarskov N, Telford KJ, Hosker GL, Lose G, Kiff ES. Anal acoustic reflectometry: a new reproducible technique providing physiological assessment of anal sphincter function. Dis Colon Rectum. 2011 Sep;54(9):1122-8. doi: 10.1097/DCR.0b013e318223fbcb.
citation: Collinson R, Cunningham C, D'Costa H, Lindsey I. Rectal intussusception and unexplained faecal incontinence: findings of a proctographic study. Colorectal Dis. 2009 Jan;11(1):77-83. doi: 10.1111/j.1463-1318.2008.01539.x. Epub 2008 Apr 28.