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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02774798

Enrollment

Registered

2016-05-17

Start date

2016-04-30

Completion date

2016-11-30

Last updated

2020-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pelvic Floor Disorders

Keywords

Rectal Prolapse, Rectal Intussuception

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Opening Pressure	at specific time point of measurement up to 1 hour	The pressure (in cmH20) at which the anal canl just begins to open

Secondary

Measure	Time frame	Description
Closing Pressure	at specific time point of measurement up to 1 hour	The pressure (cmH20) at whihc the anal canal just closes
Closing Elastance	at specific time point of measurement up to 1 hour	In cmH20/mm2 - the ability of the anal canal to close after a period of stretch
Opening Elastance	at specific time point of measurement up to 1 hour	in cmH20/mm2 - the resistance of the anal canal to stretch
Squeeze Opening Pressure	at specific time point of measurement up to 1 hour	the pressure (cmH2O) at whihc the anal canal opens during volunatry anal contraction
Squeeze Opening Elastance	at specific time point of measurement up to 1 hour	the resistance of the anal canal to stretch during voluntary contraction
Hysteresis	at specific time point of measurement up to 1 hour	measured as % - the percentage energy dissipated during opening and closing of the anal canal at rest

Countries

United Kingdom

Participant flow

Participants by arm

Arm	Count
Intra-rectal Intussusception (Oxford Groups 1 &2) Patients grade of rectal prolapse depending on Oxford grading criteria	7
Intra-anal Intussusception (Oxford Grades 3 & 4) Patients grade of rectal prolapse depending on Oxford grading criteria	17
Overt Rectal Prolapse (Oxford Garde 5) Patients grade of rectal prolapse depending on Oxford grading criteriaProlapse	7
Total	31

Baseline characteristics

Characteristic	Intra-anal Intussusception (Oxford Grades 3 & 4)	Overt Rectal Prolapse (Oxford Garde 5)	Total	Intra-rectal Intussusception (Oxford Groups 1 &2)
Age, Continuous	64 years	68 years	61 years	53 years
Race and Ethnicity Not Collected	—	—	0 Participants	—
Region of Enrollment United Kingdom	17 participants	7 participants	31 participants	7 participants
Sex: Female, Male Female	13 Participants	6 Participants	26 Participants	7 Participants
Sex: Female, Male Male	4 Participants	1 Participants	5 Participants	0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	0 / 7	0 / 17	0 / 7
other Total, other adverse events	0 / 7	0 / 17	0 / 7
serious Total, serious adverse events	0 / 7	0 / 17	0 / 7