- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02782377
Evaluation of the Rectal Reflex Using Anal Acoustic Reflectometry
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.
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.
The Recto-anal Inhibitory Reflex (RAIR) is a normal response when the rectum fills with faeces, fluid or air, whereby there is a change in the pressures within the anal canal to determine the type of contents. This can be absent or altered in patients who have difficulty in opening their bowels. The RAIR is currently measured by anal manometry using a 4.9mm catheter, resulting in an anal canal which is already partially opened prior to the measurement, and potentially distorted.
AAR is considered a catheter free technique as the balloon has a cross-sectional area of only 0.4mm2 when collapsed. The investigators propose to measure the RAIR using a 1.7mm diameter catheter alongside the AAR balloon to determine the effect that its placement has on the recorded parameters of AAR. This aims to improve our understanding of the opening and closing of the anal canal in response to distension of the rectum.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Greater Manchester
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Manchester, Greater Manchester, Reino Unido, M23 9LT
- University Hospital of South Manchester
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
Inclusion Criteria:
- Adults over 18 years old
- Have capacity to consent to the study
- Patients with pelvic floor dysfunction.
Exclusion Criteria:
- Minors under the age of 18 years old
- Patients who lack capacity to consent
- Patients with known rectal tumours and proctitis
- Asymptomatic patients
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Pelvic Floor Dysfunction
Observational study where patients with pelvic floor dysfunction undergo three AAR measurements. One at baseline, one with the catheter alongside and a third with the rectal balloon inflated. No intervention is performed Note, that initial inclusion of Squeeze parameters was detailed in error, these were not compared in this study and were compared in previous study |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Opening Pressure
Periodo de tiempo: during single study visit- measurement taken prior to balloon inflation and post balloon inflation
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Measurements of differences in Opening pressure (Op - cm H2O) as measured by the AAR catheter. These measurements are taken at baseline with the rectal balloon collapsed (Pre-RAIR) and after inflation of 100mls air into rectal balloon (Post-RAIR). |
during single study visit- measurement taken prior to balloon inflation and post balloon inflation
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Opening Elastance
Periodo de tiempo: during single study visit- measurement taken prior to balloon inflation and post balloon inflation
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Measurements of differences in Opening Elastance (Oe - cm H2O/mm2) as measured by the AAR catheter.
These measurements are taken at baseline with the rectal balloon collapsed (Pre-RAIR) and after inflation of 100mls air into rectal balloon (Post-RAIR).
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during single study visit- measurement taken prior to balloon inflation and post balloon inflation
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Closing Pressure
Periodo de tiempo: during single study visit- measurement taken prior to balloon inflation and post balloon inflation
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Measurements of differences in Closing Pressure (Cp - cm H2O) as measured by the AAR catheter.
These measurements are taken at baseline with the rectal balloon collapsed (Pre-RAIR) and after inflation of 100mls air into rectal balloon (Post-RAIR).
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during single study visit- measurement taken prior to balloon inflation and post balloon inflation
|
Closing Elastance
Periodo de tiempo: during single study visit- measurement taken prior to balloon inflation and post balloon inflation
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Measurements of differences in Closing Elastance (Ce - cm H2O/mm2) as measured by the AAR catheter.
These measurements are taken at baseline with the rectal balloon collapsed (Pre-RAIR) and after inflation of 100mls air into rectal balloon (Post-RAIR).
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during single study visit- measurement taken prior to balloon inflation and post balloon inflation
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Hysteresis
Periodo de tiempo: during single study visit- measurement taken prior to balloon inflation and post balloon inflation
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Measurements of differences in Hysteresis (%) as measured by the AAR catheter. These measurements are taken at baseline with the rectal balloon collapsed (Pre-RAIR) and after inflation of 100mls air into rectal balloon (Post-RAIR). Hysteresis is the extent of energy expenditure during opening and closing of the anal canal and represents the difference between opening and closing pressure and is expressed as a percentage |
during single study visit- measurement taken prior to balloon inflation and post balloon inflation
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Karen J Telford, MBChBMDFRCS, University Hospital of South Manchester
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
- Cheeney G, Nguyen M, Valestin J, Rao SS. Topographic and manometric characterization of the recto-anal inhibitory reflex. Neurogastroenterol Motil. 2012 Mar;24(3):e147-54. doi: 10.1111/j.1365-2982.2011.01857.x. Epub 2012 Jan 11.
- Heywood NA, Sharma A, Kiff ES, Klarskov N, Telford KJ. Placement of a fine-bore rectal balloon catheter in the anal canal does not affect anal sphincter pressures: improving our understanding of physiological function with anal acoustic reflectometry. Colorectal Dis. 2020 Nov;22(11):1626-1631. doi: 10.1111/codi.15300. Epub 2020 Aug 30.
- Heywood NA, Sharma A, Kiff ES, Klarskov N, Telford KJ. A novel method for measurement of the recto-anal inhibitory reflex using anal acoustic reflectometry. Colorectal Dis. 2020 Nov;22(11):1632-1641. doi: 10.1111/codi.15110. Epub 2020 Sep 23.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- 2016GA002
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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