Evaluation of the Fast Fill Technique for Anal Acoustic Reflectometry (AAR) in the Incontinent Anal Sphincter
NCT ID: NCT02782364
Last Updated: 2021-01-22
Study Results
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View full resultsBasic Information
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COMPLETED
36 participants
OBSERVATIONAL
2015-11-30
2016-10-31
Brief Summary
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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. Despite the two measurements being within the normal range, some patients can have significant faecal incontinence. This has prompted clinicians to search for a better investigation to guide the management of this condition.
AAR is a reproducible and repeatable technique that has been used as a research technique in the assessment of faecal incontinence. It has been shown to correlate with symptom severity and, unlike manometry, is able to distinguish between different symptomatic subgroups with faceal incontinence. In our studies so far the investigators have increased the bag inflation pressure a step at a time which means that each study takes about 20 minutes to perform. The limitation of this method is that during the measurement of squeeze pressure the sphincter muscle is subject to fatigue. A recent study using the acoustic technique in the urethra has demonstrated a faster method of recording measurements over an 8 minute period. The investigators propose to study the fatiguability effects of this faster technique and validate the method against the existing step-wise technique and standard anal manometry.
Patients will be randomised into two groups:
1. Stepwise then fast-fill
2. Fast-fill then stepwise
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Faecal Incontinence: fast-fill measurement first
Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique. A further standard manometry measurement will be taken. 18 patients will undergo fast-fill measurement first.
No interventions assigned to this group
Faecal Incontinence: step-wise measurement first.
Observational study where patients with faecal incontinence undergo two AAR measurements; one with the original step-wise technique and the second with the newer fast-fill technique. A further standard manometry measurement will be taken. 18 patients will have step-wise measurement first.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* have capacity to consent to the study
* patients with symptoms of faecal incontinence
Exclusion Criteria
* patients who lack capacity to consent
18 Years
ALL
No
Sponsors
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Manchester University NHS Foundation Trust
OTHER_GOV
Responsible Party
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Principal Investigators
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Karen J Telford, MBChBMDFRCS
Role: STUDY_CHAIR
University Hospital of South Manchester
Locations
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University Hospital of South Manchester
Manchester, Greater Manchester, United Kingdom
Countries
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References
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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.
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.
Klarskov N. Urethral pressure reflectometry. A method for simultaneous measurements of pressure and cross-sectional area in the female urethra. Dan Med J. 2012 Mar;59(3):B4412.
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.
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.
Saaby ML, Klarskov N, Lose G. Urethral pressure reflectometry before and after tension-free vaginal tape. Neurourol Urodyn. 2012 Nov;31(8):1231-5. doi: 10.1002/nau.22239. Epub 2012 Mar 27.
Other Identifiers
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2015GA004
Identifier Type: -
Identifier Source: org_study_id
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