Evaluation of the Rectal Reflex Using Anal Acoustic Reflectometry

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.

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.

The Recto-anal Inhibitory Reflex (RAIR) is a normal response when the rectum fills with faeces, fluid or air, whereby there is a change in the pressures within the anal canal to determine the type of contents. This can be absent or altered in patients who have difficulty in opening their bowels. The RAIR is currently measured by anal manometry using a 4.9mm catheter, resulting in an anal canal which is already partially opened prior to the measurement, and potentially distorted.

AAR is considered a catheter free technique as the balloon has a cross-sectional area of only 0.4mm2 when collapsed. The investigators propose to measure the RAIR using a 1.7mm diameter catheter alongside the AAR balloon to determine the effect that its placement has on the recorded parameters of AAR. This aims to improve our understanding of the opening and closing of the anal canal in response to distension of the rectum.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pelvic Floor Dysfunction Behavior Behavioral Symptoms Digestive System Diseases Elimination Disorders Encopresis Gastrointestinal Diseases Intestinal Diseases Mental Disorders Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Organ Prolapse Prolapse Rectal Diseases Rectal Prolapse Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of South Manchester

Manchester, Greater Manchester, M23 9LT, United Kingdom

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults over 18 years old
Have capacity to consent to the study
Patients with pelvic floor dysfunction.

Exclusion criteria

Minors under the age of 18 years old
Patients who lack capacity to consent
Patients with known rectal tumours and proctitis
Asymptomatic patients

Treatment and study plan

Primary outcomes

Opening Pressure

Time frame: during single study visit- measurement taken prior to balloon inflation and post balloon inflation

Measurements of differences in Opening pressure (Op - cm H2O) as measured by the AAR catheter.

These measurements are taken at baseline with the rectal balloon collapsed (Pre-RAIR) and after inflation of 100mls air into rectal balloon (Post-RAIR).
Opening Elastance

Time frame: during single study visit- measurement taken prior to balloon inflation and post balloon inflation

Measurements of differences in Opening Elastance (Oe - cm H2O/mm2) as measured by the AAR catheter. These measurements are taken at baseline with the rectal balloon collapsed (Pre-RAIR) and after inflation of 100mls air into rectal balloon (Post-RAIR).
Closing Pressure

Time frame: during single study visit- measurement taken prior to balloon inflation and post balloon inflation

Measurements of differences in Closing Pressure (Cp - cm H2O) as measured by the AAR catheter. These measurements are taken at baseline with the rectal balloon collapsed (Pre-RAIR) and after inflation of 100mls air into rectal balloon (Post-RAIR).
Closing Elastance

Time frame: during single study visit- measurement taken prior to balloon inflation and post balloon inflation

Measurements of differences in Closing Elastance (Ce - cm H2O/mm2) as measured by the AAR catheter. These measurements are taken at baseline with the rectal balloon collapsed (Pre-RAIR) and after inflation of 100mls air into rectal balloon (Post-RAIR).
Hysteresis

Time frame: during single study visit- measurement taken prior to balloon inflation and post balloon inflation

Measurements of differences in Hysteresis (%) as measured by the AAR catheter. These measurements are taken at baseline with the rectal balloon collapsed (Pre-RAIR) and after inflation of 100mls air into rectal balloon (Post-RAIR).

Hysteresis is the extent of energy expenditure during opening and closing of the anal canal and represents the difference between opening and closing pressure and is expressed as a percentage

Sponsors and collaborators

Lead sponsor

Manchester University NHS Foundation Trust

Other Gov

Registry information

Important dates

Study start: 2016
Primary completion: 2016
Study completion: 2017
First posted: May 25, 2016
Registry last updated: Dec 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed