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

Pelvic Floor Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02774798
• Other study ID #: 2016GA004
• Status: Completed
• Start date: April 2016
• Est. completion date: November 2016

Study information

• Verified date: March 2020
• Source: Manchester University NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Intussusception
• Pelvic Floor Disorders
• Prolapse

Locations

Country	Name	City	State
United Kingdom	University Hospital of South Manchester	Manchester	Greater Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Manchester University NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (5)

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. — View 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. Erratum in: Br J Surg. 2013 Jan;100(2):301. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Opening Elastance	in cmH20/mm2 - the resistance of the anal canal to stretch	at specific time point of measurement up to 1 hour
Secondary	Closing Pressure	The pressure (cmH20) at whihc the anal canal just closes	at specific time point of measurement up to 1 hour
Secondary	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
Secondary	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
Secondary	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
Secondary	Squeeze Opening Elastance	the resistance of the anal canal to stretch during voluntary contraction	at specific time point of measurement up to 1 hour