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Evaluation of the Rectal Reflex Using Anal Acoustic Reflectometry

NCT ID: NCT02782377

Last Updated: 2020-12-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2017-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Pelvic Floor Dysfunction

Keywords

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Faecal Incontinence Obstructive Defaecation Rectal Prolapse

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Adults over 18 years old
2. Have capacity to consent to the study
3. Patients with pelvic floor dysfunction.

Exclusion Criteria

1. Minors under the age of 18 years old
2. Patients who lack capacity to consent
3. Patients with known rectal tumours and proctitis
4. Asymptomatic patients
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United Kingdom

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.

Reference Type BACKGROUND
PMID: 23506115 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23132420 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22457059 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22381095 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22228166 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21825892 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22235880 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32770704 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32367609 (View on PubMed)

Other Identifiers

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2016GA002

Identifier Type: -

Identifier Source: org_study_id