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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.
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.
This an observational study based on not intervention. Patients are grouped depending on grade of prolapse, and all undergo the routine AAR investigation. Patients are grouped solely on differences in pathology already present and not on any intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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:
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Opening Elastance | in cmH20/mm2 - the resistance of the anal canal to stretch | at specific time point of measurement up to 1 hour |
| Closing Pressure | The pressure (cmH20) at whihc the anal canal just closes |
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Inclusion Criteria:
Exclusion Criteria:
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Patients presenting to the pelvic floor clinic and neurogastroenterology with symptoms of rectal prolapse
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| Name | Affiliation | Role |
|---|---|---|
| Karen J Telford | University Hospital of South Manchester | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of South Manchester | Manchester | Greater Manchester | M23 9LT | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23506115 | Background | 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. | |
| 23132420 | 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. |
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Individual data will not be shared. The correlations will be made with grade of oxford prolapse and then be grouped
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| ID | Title | Description |
|---|---|---|
| FG000 | Intra-rectal Intussusception (Oxford Groups 1 &2) | Patients grade of rectal prolapse depending on Oxford grading criteria |
| FG001 | Intra-anal Intussusception (Oxford Grades 3 & 4) | Patients grade of rectal prolapse depending on Oxford grading criteria |
| FG002 | Overt Rectal Prolapse (Oxford Grade 5) | Patients grade of rectal prolapse depending on Oxford grading criteria |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intra-rectal Intussusception (Oxford Groups 1 &2) | Patients grade of rectal prolapse depending on Oxford grading criteria |
| BG001 | Intra-anal Intussusception (Oxford Grades 3 & 4) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Opening Pressure | The pressure (in cmH20) at which the anal canl just begins to open | Posted | Mean | Standard Deviation | cmH20 | at specific time point of measurement up to 1 hour |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intra-rectal Intussusception (Oxford Groups 1 &2) | Patients grade of rectal prolapse depending on Oxford grading criteria |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nick Heywood | University Hospital of South Manchester | +447739002473 | nheywood@doctors.org.uk |
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| ID | Term |
|---|---|
| D059952 | Pelvic Floor Disorders |
| D012005 | Rectal Prolapse |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D011248 | Pregnancy Complications |
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| at specific time point of measurement up to 1 hour |
| Closing Elastance | In cmH20/mm2 - the ability of the anal canal to close after a period of stretch | at specific time point of measurement up to 1 hour |
| Hysteresis | measured as "%" - the percentage energy dissipated during opening and closing of the anal canal at rest | at specific time point of measurement up to 1 hour |
| Squeeze Opening Pressure | the pressure (cmH2O) at whihc the anal canal opens during volunatry anal contraction | at specific time point of measurement up to 1 hour |
| Squeeze Opening Elastance | the resistance of the anal canal to stretch during voluntary contraction | at specific time point of measurement up to 1 hour |
| 22228166 | 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. |
| 21825892 | 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. |
| 18462221 | 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. |
Patients grade of rectal prolapse depending on Oxford grading criteria
| BG002 | Overt Rectal Prolapse (Oxford Garde 5) | Patients grade of rectal prolapse depending on Oxford grading criteriaProlapse |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Patients grade of rectal prolapse depending on Oxford grading criteria |
|
|
| Secondary | Opening Elastance | in cmH20/mm2 - the resistance of the anal canal to stretch | Posted | Mean | Standard Deviation | cmH20/mm2 | at specific time point of measurement up to 1 hour |
|
|
|
| Secondary | Closing Pressure | The pressure (cmH20) at whihc the anal canal just closes | Posted | Mean | Standard Deviation | cmH20 | at specific time point of measurement up to 1 hour |
|
|
|
| Secondary | Closing Elastance | In cmH20/mm2 - the ability of the anal canal to close after a period of stretch | Posted | Mean | Standard Deviation | cmH20/mm2 | at specific time point of measurement up to 1 hour |
|
|
|
| Secondary | Hysteresis | measured as "%" - the percentage energy dissipated during opening and closing of the anal canal at rest | Posted | Mean | Standard Deviation | percent | at specific time point of measurement up to 1 hour |
|
|
|
| Secondary | Squeeze Opening Pressure | the pressure (cmH2O) at whihc the anal canal opens during volunatry anal contraction | Posted | Mean | Standard Deviation | cmH2O | at specific time point of measurement up to 1 hour |
|
|
|
| Secondary | Squeeze Opening Elastance | the resistance of the anal canal to stretch during voluntary contraction | Posted | Mean | Standard Deviation | cmH20/mm2 | at specific time point of measurement up to 1 hour |
|
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 0 |
| 7 |
| EG001 | Intra-anal Intussusception (Oxford Grades 3 & 4) | Patients grade of rectal prolapse depending on Oxford grading criteria | 0 | 17 | 0 | 17 | 0 | 17 |
| EG002 | Overt Rectal Prolapse (Oxford Garde 5) | Patients grade of rectal prolapse depending on Oxford grading criteriaProlapse | 0 | 7 | 0 | 7 | 0 | 7 |
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| D052801 | Male Urogenital Diseases |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D056887 | Pelvic Organ Prolapse |
| D011391 | Prolapse |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Male |
|