Evaluation of the Fast Fill Technique for Anal Acoustic Reflectometry (AAR) in the Incontinent Anal Sphincter
Anal Acoustic Reflectometry (AAR) is a 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. 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:
- Stepwise then fast-fill
- Fast-fill then stepwise
Обзор исследования
Статус
Условия
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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Greater Manchester
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Manchester, Greater Manchester, Соединенное Королевство, M23 9LT
- University Hospital of South Manchester
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
Inclusion Criteria:
- adults over 18 years
- have capacity to consent to the study
- patients with symptoms of faecal incontinence
Exclusion Criteria:
- minors under age of 18 years old
- patients who lack capacity to consent
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
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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.
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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.
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Opening Pressure
Временное ограничение: 10 minutes
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Opening Pressure (Op - cm H2O) - the point at which the anal canal just begins to open
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10 minutes
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Opening Elastance
Временное ограничение: 10 minutes
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Opening Elastance (Oe - cm H2O/mm2) - the resistance of the anal canal to stretch
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10 minutes
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Closing Pressure
Временное ограничение: 10 minutes
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Closing Pressure (Cp - cm H2O) - the pressure at which the anal canal closes after a period of opening
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10 minutes
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Closing Elastance
Временное ограничение: 10 minutes
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Closing Elastance (Ce - cm H2O/mm2) - the ability of the anal canal to close passively after a period of stretch
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10 minutes
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Hysteresis
Временное ограничение: 10 minutes
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Hysteresis (%) - the energy dissipated during opeing and closing of the anal canal
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10 minutes
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Squeeze Opening Pressure
Временное ограничение: 10 minutes
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Squeeze opening pressure (SqOp - cm H20) - the pressure at which the anal canal just starts to open whilst the patient is voluntarily trying to keep the anal canal closed
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10 minutes
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Squeeze Opening Elastance
Временное ограничение: 10 minutes
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Squeeze opening elastance (Sq)e - cm H20/mm2) - the resistance of the anal canal to stretch whilst the patient is voluntarily trying to keep the anal canal closed
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10 minutes
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
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Manometry - Resting Pressure
Временное ограничение: 10 minutes
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anal manometry measured in cmH20
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10 minutes
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Соавторы и исследователи
Следователи
- Учебный стул: Karen J Telford, MBChBMDFRCS, University Hospital of South Manchester
Публикации и полезные ссылки
Общие публикации
- 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. Erratum In: Br J Surg. 2013 Jan;100(2):301.
- 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.
- 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.
- 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.
Даты записи исследования
Изучение основных дат
Начало исследования
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Оценивать)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- 2015GA004
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Описание плана IPD
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