Pelvic Floor DisordersNCT02774798
Correlation of Anal Acoustic Reflectometry Parameters With Degree of Rectal Intussusception and Prolapse
An observational study of Pelvic Floor Disorders, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvic Floor Disorders
- How many people
- 31 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Apr 2016to Nov 2016
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presenting to the pelvic floor clinic and neurogastroenterology with symptoms of rectal prolapse
Who may be able to join
- Adults over 18 years old
- Have capacity to consent to the study
- Patients with pelvic floor dysfunction and symptoms of rectal intussusception and rectal prolapse
Who cannot join
- Minors under the age of 18 years old
- Patients who lack capacity to consent
- Patients without pelvic floor dysfunction or symptoms of rectal intussusception or rectal prolapse
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospital of South Manchester
Manchester, Greater Manchester, M23 9LT
About this study
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.
Read the detailed description
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.
- Conditions
- Pelvic Floor Disorders
- Keywords
- Rectal Prolapse, Rectal Intussuception
- Medical subject headings
- Pelvic Floor Disorders, Rectal Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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: 1. Oxford Grades 1 \& 2 - intra-rectal intussusception 2. Oxford Grades 3 \& 4 - intra-anal intussusception 3. Oxford grade 5 - Overt Rectal Prolapse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opening Pressure
The pressure (in cmH20) at which the anal canl just begins to open
Measured: at specific time point of measurement up to 1 hour
Secondary outcomes (6)
Opening Elastance
in cmH20/mm2 - the resistance of the anal canal to stretch
Measured: at specific time point of measurement up to 1 hour
Closing Pressure
The pressure (cmH20) at whihc the anal canal just closes
Measured: 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
Measured: 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
Measured: 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
Measured: at specific time point of measurement up to 1 hour
Squeeze Opening Elastance
the resistance of the anal canal to stretch during voluntary contraction
Measured: at specific time point of measurement up to 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2016 (estimated)
- Study startApr 2016
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pelvic Floor DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Karen J Telford, Study chair, University Hospital of South Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774798
- Sponsor's protocol ID
- 2016GA004
- Status last verified
- Mar 2020
- First submitted
- 10 May 2016
- Last updated
- 30 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Individual data will not be shared. The correlations will be made with grade of oxford prolapse and then be grouped
Publications
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.
PubMed 23506115Hornung 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.
PubMed 23132420Mitchell 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.
PubMed 22228166Mitchell 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.
PubMed 21825892Collinson 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.
PubMed 18462221
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation of Anal Acoustic Reflectometry Parameters With Degree of Rectal Intussusception and Prolapse
- ClinicalTrials.gov ID
- NCT02774798
- Acronym / sponsor ID
- 2016GA004
- Conditions
- Pelvic Floor Disorders
- Keywords
- Rectal Prolapse, Rectal Intussuception
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- Apr 2016 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 17 May 2016 (estimated)
- Results
- Posted 30 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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: 1. Oxford Grades 1 \& 2 - intra-rectal intussusception 2. Oxford Grades 3 \& 4 - intra-anal intussusception 3. Oxford grade 5 - Overt Rectal Prolapse |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the pelvic floor clinic and neurogastroenterology with symptoms of rectal prolapse
Key inclusion criteria (3 listed)
- Adults over 18 years old
- Have capacity to consent to the study
- Patients with pelvic floor dysfunction and symptoms of rectal intussusception and rectal prolapse
Key exclusion criteria (3 listed)
- Minors under the age of 18 years old
- Patients who lack capacity to consent
- Patients without pelvic floor dysfunction or symptoms of rectal intussusception or rectal prolapse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Opening Pressure
Time frame: at specific time point of measurement up to 1 hour
The pressure (in cmH20) at which the anal canl just begins to open
6 secondary outcomes
Opening Elastance
Time frame: at specific time point of measurement up to 1 hour
Closing Pressure
Time frame: at specific time point of measurement up to 1 hour
Closing Elastance
Time frame: at specific time point of measurement up to 1 hour
Hysteresis
Time frame: at specific time point of measurement up to 1 hour
Squeeze Opening Pressure
Time frame: at specific time point of measurement up to 1 hour
Squeeze Opening Elastance
Time frame: at specific time point of measurement up to 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23506115Klarskov 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.
- Background: PubMed 23132420Hornung 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.
- Background: PubMed 22228166Mitchell 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.
- Background: PubMed 21825892Mitchell 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.
- Background: PubMed 18462221Collinson 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.
- Individual participant dataSharing planned: No. Individual data will not be shared. The correlations will be made with grade of oxford prolapse and then be grouped
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karen J Telford study chair
University Hospital of South Manchester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Floor Disorders, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Opening Pressure (time frame: at specific time point of measurement up to 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02774798, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2020.