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N/A N=31

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

Pelvic Floor Disorders

Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: Opening Pressure — 56.35; 39.01; 23.42 cmH20

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Manchester University NHS Foundation Trust
Primary completion
Nov 2016

Outcome Measures

OutcomeResultp-value
PRIMARY
Opening Pressure
56.35; 39.01; 23.42
SECONDARY
Opening Elastance
1.72; 1.19; 0.93
SECONDARY
Closing Pressure
33.31; 22.78; 13.58
SECONDARY
Closing Elastance
1.52; 1.05; 0.85
SECONDARY
Hysteresis
37.54; 39.05; 40.57
SECONDARY
Squeeze Opening Pressure
81.21; 82.91; 52.51
SECONDARY
Squeeze Opening Elastance
1.46; 1.08; 1.29

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02774798). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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