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

NCT02774798 | Completed Results

• 1 other identifier: 2016GA004
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Floor Disorders

Keywords

Rectal Prolapse; Rectal Intussuception

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Opening Elastance

  at specific time point of measurement up to 1 hour

• Closing Pressure

  at specific time point of measurement up to 1 hour

• Closing Elastance

  at specific time point of measurement up to 1 hour

• Hysteresis

  at specific time point of measurement up to 1 hour

• Squeeze Opening Pressure

  at specific time point of measurement up to 1 hour

Study Arms (1)

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: 1. Oxford Grades 1 \& 2 - intra-rectal intussusception 2. Oxford Grades 3 \& 4 - intra-anal intussusception 3. Oxford grade 5 - Overt Rectal Prolapse

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Manchester University NHS Foundation Trust: lead

Study Sites (1)

University Hospital of South Manchester

Manchester, Greater Manchester, M23 9LT, United Kingdom

Location

Related Publications (5)

• 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.

  PMID: 23506115 BACKGROUND

• 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.

  PMID: 23132420 BACKGROUND

• 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.

  PMID: 22228166 BACKGROUND

• 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.

  PMID: 21825892 BACKGROUND

• 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.

  PMID: 18462221 BACKGROUND

MeSH Terms

Conditions

Pelvic Floor Disorders; Rectal Prolapse

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pregnancy Complications; Male Urogenital Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Nick Heywood
• Organization: University Hospital of South Manchester

nheywood@doctors.org.uk

+447739002473

Study Officials

• Karen J Telford

  University Hospital of South Manchester

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2016
• First Posted: May 17, 2016
• Study Start: April 1, 2016
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: March 30, 2020
• Results First Posted: March 30, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)