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.

Study Overview

• Status: Completed
• Conditions: Pelvic Floor Disorders

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.

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• United Kingdom
  • Greater Manchester
    • Manchester, Greater Manchester, United Kingdom, M23 9LT
      • University Hospital of South Manchester

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients presenting to the pelvic floor clinic and neurogastroenterology with symptoms of rectal prolapse

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Rectal Intussusception and Prolapse; 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?

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

Collaborators and Investigators

• Sponsor: Manchester University NHS Foundation Trust
• Investigators: Study Chair: Karen J Telford, University Hospital of South Manchester

Publications and helpful links

General Publications

• 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.
• 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. Erratum In: Br J Surg. 2013 Jan;100(2):301.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: May 10, 2016
• First Submitted That Met QC Criteria: May 12, 2016
• First Posted (Estimate): May 17, 2016

Study Record Updates

• Last Update Posted (Actual): March 30, 2020
• Last Update Submitted That Met QC Criteria: March 16, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Rectal Prolapse; Rectal Intussuception
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Pregnancy Complications; Intestinal Obstruction; Prolapse; Pelvic Floor Disorders; Intussusception
• Other Study ID Numbers: 2016GA004

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual data will not be shared. The correlations will be made with grade of oxford prolapse and then be grouped