An observational study in Pelvic Floor Disorders, sponsored by Manchester University NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-30.
Sponsored by Manchester University NHS Foundation Trust · Observational
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.
212 studies on the registry are indexed under Pelvic Floor Disorders; 46 are open to participants now.
This study's enrollment of 31 is below the median of 161 across 60 observational studies indexed under Pelvic Floor Disorders.
Browse Pelvic Floor Disorders studies →Manchester University NHS Foundation Trust is the lead sponsor of 140 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients presenting to the pelvic floor clinic and neurogastroenterology with symptoms of rectal prolapse
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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: 1. Oxford Grades 1 \& 2 - intra-rectal intussusception 2. Oxford Grades 3 \& 4 - intra-anal intussusception 3. Oxford grade 5 - Overt Rectal Prolapse
Opening Pressure
The pressure (in cmH20) at which the anal canl just begins to open
Time frame: at specific time point of measurement up to 1 hour
Opening Elastance
in cmH20/mm2 - the resistance of the anal canal to stretch
Time frame: at specific time point of measurement up to 1 hour
Closing Pressure
The pressure (cmH20) at whihc the anal canal just closes
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: at specific time point of measurement up to 1 hour
Squeeze Opening Elastance
the resistance of the anal canal to stretch during voluntary contraction
Time frame: at specific time point of measurement up to 1 hour
| Milestone | Intra-rectal Intussusception (Oxford Groups 1 &2) | Intra-anal Intussusception (Oxford Grades 3 & 4) | Overt Rectal Prolapse (Oxford Grade 5) |
|---|---|---|---|
| Started | 7 | 17 | 7 |
| Completed | 7 | 17 | 7 |
| Not completed | 0 | 0 | 0 |
The pressure (in cmH20) at which the anal canl just begins to open
| cmH20 | Intra-rectal Intussusception (Oxford Groups 1 &2) | Intra-anal Intussusception (Oxford Grades 3 & 4) | Overt Rectal Prolapse (Oxford Grade 5) |
|---|---|---|---|
| Opening Pressure | 56.35 ± 16.64 | 39.01 ± 18.02 | 23.42 ± 14.52 |
in cmH20/mm2 - the resistance of the anal canal to stretch
| cmH20/mm2 | Intra-rectal Intussusception (Oxford Groups 1 &2) | Intra-anal Intussusception (Oxford Grades 3 & 4) | Overt Rectal Prolapse (Oxford Grade 5) |
|---|---|---|---|
| Opening Elastance | 1.72 ± 7.82 | 1.19 ± 0.40 | 0.93 ± 0.34 |
The pressure (cmH20) at whihc the anal canal just closes
| cmH20 | Intra-rectal Intussusception (Oxford Groups 1 &2) | Intra-anal Intussusception (Oxford Grades 3 & 4) | Overt Rectal Prolapse (Oxford Grade 5) |
|---|---|---|---|
| Closing Pressure | 33.31 ± 10.84 | 22.78 ± 12.53 | 13.58 ± 9.80 |
In cmH20/mm2 - the ability of the anal canal to close after a period of stretch
| cmH20/mm2 | Intra-rectal Intussusception (Oxford Groups 1 &2) | Intra-anal Intussusception (Oxford Grades 3 & 4) | Overt Rectal Prolapse (Oxford Grade 5) |
|---|---|---|---|
| Closing Elastance | 1.52 ± 0.63 | 1.05 ± 0.46 | 0.85 ± 0.41 |
measured as "%" - the percentage energy dissipated during opening and closing of the anal canal at rest
| percent | Intra-rectal Intussusception (Oxford Groups 1 &2) | Intra-anal Intussusception (Oxford Grades 3 & 4) | Overt Rectal Prolapse (Oxford Grade 5) |
|---|---|---|---|
| Hysteresis | 37.54 ± 6.32 | 39.05 ± 7.32 | 40.57 ± 11.16 |
the pressure (cmH2O) at whihc the anal canal opens during volunatry anal contraction
| cmH2O | Intra-rectal Intussusception (Oxford Groups 1 &2) | Intra-anal Intussusception (Oxford Grades 3 & 4) | Overt Rectal Prolapse (Oxford Grade 5) |
|---|---|---|---|
| Squeeze Opening Pressure | 81.21 ± 41.46 | 82.91 ± 43.57 | 52.51 ± 33.58 |
the resistance of the anal canal to stretch during voluntary contraction
| cmH20/mm2 | Intra-rectal Intussusception (Oxford Groups 1 &2) | Intra-anal Intussusception (Oxford Grades 3 & 4) | Overt Rectal Prolapse (Oxford Grade 5) |
|---|---|---|---|
| Squeeze Opening Elastance | 1.46 ± 0.31 | 1.08 ± 0.28 | 1.29 ± 0.49 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intra-rectal Intussusception (Oxford Groups 1 &2) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Intra-anal Intussusception (Oxford Grades 3 & 4) | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Overt Rectal Prolapse (Oxford Garde 5) | 0/7 (0%) | 0/7 (0%) | 0/7 (0%) |
| Age, Continuous(years) | Intra-rectal Intussusception (Oxford Groups 1 &2) | Intra-anal Intussusception (Oxford Grades 3 & 4) | Overt Rectal Prolapse (Oxford Garde 5) | Total |
|---|---|---|---|---|
| Median | 53 (35 to 95) | 64 (35 to 70) | 68 (41 to 95) | 61 (35 to 95) |
| Sex: Female, Male(Participants) | Intra-rectal Intussusception (Oxford Groups 1 &2) | Intra-anal Intussusception (Oxford Grades 3 & 4) | Overt Rectal Prolapse (Oxford Garde 5) | Total |
|---|---|---|---|---|
| Female | 7 | 13 | 6 | 26 |
| Male | 0 | 4 | 1 | 5 |
| Race and Ethnicity Not Collected(Participants) | Intra-rectal Intussusception (Oxford Groups 1 &2) | Intra-anal Intussusception (Oxford Grades 3 & 4) | Overt Rectal Prolapse (Oxford Garde 5) | Total |
|---|---|---|---|---|
| Count of participants | — | — | — | 0 |
| Region of Enrollment(participants) | Intra-rectal Intussusception (Oxford Groups 1 &2) | Intra-anal Intussusception (Oxford Grades 3 & 4) | Overt Rectal Prolapse (Oxford Garde 5) | Total |
|---|---|---|---|---|
| United Kingdom | 7 | 17 | 7 | 31 |
Plan to share: No — Individual data will not be shared. The correlations will be made with grade of oxford prolapse and then be grouped
Ran from Apr 2016 to primary completion in Nov 2016, 7 months.
Results were first posted in Mar 2020, 3 years 4 months after primary completion.
Of 26 observational studies under Pelvic Floor Disorders, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 45. This study's 7 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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