AnismusSEATNCT02633592
Seated Evaluation of Anorectal funcTion by High Resolution Anorectal Manometry
A study testing HRARM and MRI Defecography in people with Anismus and Incontinence, run by University of Zurich at 1 site in Switzerland.
Trial summary
To assess whether HR-ARM (High resolution Anorectal Manometry) performed in the more naturalistic / physiological upright, seated position on a commode provides a more valid assessment of anorectal function and simulated defecation than the same test performed in the standard, left lateral position Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Anismus, Incontinence
- What is being tested?
- HRARM and MRI Defecography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Male or female, age 18 - 75 years
- Females eligible to participate either if physiologically incapable of becoming pregnant or with a negative urine pregnancy test at screening
- HS: Absence of symptoms of constipation or incontinence
- Patients with fecal incontinence
- Passive or Urge Incontinence
Show all 9Show fewer
- Wexner Score of 5-20 ("more than mild severity of incontinence")
- Patients with obstructive defecation
- Cleveland Clinic Constipation Scoring System: 10-30 ("more than mild severity of constipation)
Who cannot join
- • Participation in any other clinical trial with investigational or approved drugs within the last month before the study
- Significant medical, surgical or psychiatric disease requiring on-going active management
- Previous gastrointestinal or gynaecological disease (exception: non symptomatic ovarian cysts, occasional reflux, appendectomy, hysterectomy, cholecystectomy)
- Regular use of opiates or other constipating agents
- Presence of fecal impaction on clinical per rectal exam
- Abnormal findings on proctoscopy / endoscopy (e.g. Inflammatory Bowel Disease, neoplasm, acute or chronic anal fissure, large haemorrhoids (grade 3-4) intussusception, prolapse or gross perineal descent (>5cm) on straining
- Insufficient understanding of German language to comply with instructions
- Contraindication for MRI: Presence of non-MR-compatible metallic implants, devices or metallic foreign bodies
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Department for Gastroenterology and Hepatology
Zurich, Canton of Zurich, 8091
About this study
Official title: Seated Evaluation of Anorectal funcTion by High Resolution Anorectal Manometry: a Randomized Comparison of Measurements in the Seated and Left Lateral Positions
To assess whether HR-ARM (High resolution Anorectal Manometry) performed in the more naturalistic / physiological upright, seated position on a commode provides a more valid assessment of anorectal function and simulated defecation than the same test performed in the standard, left lateral position
Read the detailed description
High Resolution Anorectal Manometry (HR-ARM) with data presented as pressure topography is a recent addition to the tests available for diagnosis of defecatory disorders including fecal incontinence and constipation.HR-ARM represents an advance on conventional manometry because closely spaced sensors across the anal sphincter remove the need for a pull-through procedure and facilitate data acquisition and interpretation. In particular measurements are not confounded by changes in position of the catheter relative to anal sphincter that occur during voluntary contraction and, especially, simulated defecation.
Notwithstanding these technological improvements, important concerns remain about the validity of manometry measurements during simulated defecation. These concerns are based on the observation in both conventional and HR-ARM that a large proportion of healthy individuals appear to have abnormal anorectal function ("dyssynergia") during simulated defecation.This limitation led to the recommendation that the finding of dyssynergia on manometry should be confirmed by defecography. This is unsatisfactory as diagnostic tests should not have a high rate of "false positives" and also because this increases the time and costs needed to complete diagnostic investigation in patients with defecatory disorders.
The high rate of abnormal findings in healthy individuals may be because current manometry procedures and other anorectal tests (e.g. rectal balloon expulsion) are usually performed, not in the upright, seated position (USP) usually adopted for defecation, but in the un-physiological left lateral position (LLP). Several factors may contribute. First, defecation in the LLP is not aided by gravity as it is in the sitting position. Second, anorectal anatomy may be altered and less conducive to the passage of stool in the LLP. Third, simulating defecation in the LLP does not reflect normal behavior and, despite optimal interaction and explanation by the investigator, changes in patient behavior may result in apparent "dyssynergia" Finally, social stress, related to proximity of the investigator observing defecation, makes individuals feel unable to strain at stool or attempt defecation.
A simple probe holder device that, by adhering to the skin is positioned at the natal cleft to support the ManoScan HR ARM catheter can be used to assess anorectal pressures in the sitting position (both produced by Given Imaging, Yoqeam, Israel). This simple device stabilizes the catheter position when the patient is in USP on a commode and allows the investigator to withdraw behind the curtains of the examination cubicle.
- Conditions
- Anismus, Incontinence
- Being tested
- HRARM, MRI Defecography
- Keywords
- High Resolution Anorectal Manometry, Magnetic Resonance Imaging, Balloon Expulsion, Position
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRARMOther
Patients and healthy volunteers are investigated in the seated and lying position during HRAM
MRI DefecographyOther
Also called MRD
Patients and healthy volunteers are investigated in the supine and left lateral position in the MRI
| Study group | Role | What they receive |
|---|---|---|
| HRARM | Active comparator | Patients and healthy volunteers are subjected to position change ( LLP to SP) during pressure measurements with HR-ARM. Receives: Other: HRARM |
| MRI Defecography | Active comparator | Patients and healthy volunteers are subjected to position change during MRI Defecography Receives: Other: MRI Defecography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recto-anal pressure gradient (RAPG)
RAPG change in the LLP and sitting position (mmHg)
Measured: 1 hour
Secondary outcomes (4)
Presence of dyssynergia on HR-ARM
RAPG of -40mmHg or lower
Measured: 1 hour
Presence of dyssynergic defecation on MRI in healthy controls
paradox contraction or no opening of the anal canal
Measured: 1 hour
Agreement of MR findings in different body positions with HR-ARM findings
diagnostic concordance of the two investigations
Measured: 1 hour
Patient positional preference
Categorical (forced choice) LLP vs. SEAT
Measured: 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 Dec 2015 (estimated)
- Study startNov 2014
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnismusStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henriette Heinrich, Study director, Department for Gastroenterology and Hepatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02633592
- Sponsor's protocol ID
- KEK-ZH-Nr. 2014-0058
- Acronym
- SEAT
- Status last verified
- Dec 2015
- First submitted
- 27 Nov 2015
- Last updated
- 17 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bharucha AE, Pemberton JH, Locke GR 3rd. American Gastroenterological Association technical review on constipation. Gastroenterology. 2013 Jan;144(1):218-38. doi: 10.1053/j.gastro.2012.10.028. No abstract available.
PubMed 23261065Ratuapli SK, Bharucha AE, Noelting J, Harvey DM, Zinsmeister AR. Phenotypic identification and classification of functional defecatory disorders using high-resolution anorectal manometry. Gastroenterology. 2013 Feb;144(2):314-322.e2. doi: 10.1053/j.gastro.2012.10.049. Epub 2012 Nov 7.
PubMed 23142135Noelting J, Ratuapli SK, Bharucha AE, Harvey DM, Ravi K, Zinsmeister AR. Normal values for high-resolution anorectal manometry in healthy women: effects of age and significance of rectoanal gradient. Am J Gastroenterol. 2012 Oct;107(10):1530-6. doi: 10.1038/ajg.2012.221. Epub 2012 Sep 18.
PubMed 22986439Heinrich H, Fruehauf H, Sauter M, Steingotter A, Fried M, Schwizer W, Fox M. The effect of standard compared to enhanced instruction and verbal feedback on anorectal manometry measurements. Neurogastroenterol Motil. 2013 Mar;25(3):230-7, e163. doi: 10.1111/nmo.12038. Epub 2012 Nov 6.
PubMed 23130678
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seated Evaluation of Anorectal funcTion by High Resolution Anorectal Manometry: a Randomized Comparison of Measurements in the Seated and Left Lateral Positions
- ClinicalTrials.gov ID
- NCT02633592
- Acronym / sponsor ID
- SEAT / KEK-ZH-Nr. 2014-0058
- Conditions
- Anismus, Incontinence
- Keywords
- High Resolution Anorectal Manometry, Magnetic Resonance Imaging, Balloon Expulsion, Position
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 17 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess whether HR-ARM (High resolution Anorectal Manometry) performed in the more naturalistic / physiological upright, seated position on a commode provides a more valid assessment of anorectal function and simulated defecation than the same test performed in the standard, left lateral position
Detailed description
High Resolution Anorectal Manometry (HR-ARM) with data presented as pressure topography is a recent addition to the tests available for diagnosis of defecatory disorders including fecal incontinence and constipation.HR-ARM represents an advance on conventional manometry because closely spaced sensors across the anal sphincter remove the need for a pull-through procedure and facilitate data acquisition and interpretation. In particular measurements are not confounded by changes in position of the catheter relative to anal sphincter that occur during voluntary contraction and, especially, simulated defecation.
Notwithstanding these technological improvements, important concerns remain about the validity of manometry measurements during simulated defecation. These concerns are based on the observation in both conventional and HR-ARM that a large proportion of healthy individuals appear to have abnormal anorectal function ("dyssynergia") during simulated defecation.This limitation led to the recommendation that the finding of dyssynergia on manometry should be confirmed by defecography. This is unsatisfactory as diagnostic tests should not have a high rate of "false positives" and also because this increases the time and costs needed to complete diagnostic investigation in patients with defecatory disorders.
The high rate of abnormal findings in healthy individuals may be because current manometry procedures and other anorectal tests (e.g. rectal balloon expulsion) are usually performed, not in the upright, seated position (USP) usually adopted for defecation, but in the un-physiological left lateral position (LLP). Several factors may contribute. First, defecation in the LLP is not aided by gravity as it is in the sitting position. Second, anorectal anatomy may be altered and less conducive to the passage of stool in the LLP. Third, simulating defecation in the LLP does not reflect normal behavior and, despite optimal interaction and explanation by the investigator, changes in patient behavior may result in apparent "dyssynergia" Finally, social stress, related to proximity of the investigator observing defecation, makes individuals feel unable to strain at stool or attempt defecation.
A simple probe holder device that, by adhering to the skin is positioned at the natal cleft to support the ManoScan HR ARM catheter can be used to assess anorectal pressures in the sitting position (both produced by Given Imaging, Yoqeam, Israel). This simple device stabilizes the catheter position when the patient is in USP on a commode and allows the investigator to withdraw behind the curtains of the examination cubicle.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HRARM | Active comparator | Other: HRARMPatients and healthy volunteers are subjected to position change ( LLP to SP) during pressure measurements with HR-ARM. |
| MRI Defecography | Active comparator | Other: MRI DefecographyPatients and healthy volunteers are subjected to position change during MRI Defecography |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed informed consent
- Male or female, age 18 - 75 years
- Females eligible to participate either if physiologically incapable of becoming pregnant or with a negative urine pregnancy test at screening
- HS: Absence of symptoms of constipation or incontinence
- Patients with fecal incontinence
Key exclusion criteria (8 listed)
- • Participation in any other clinical trial with investigational or approved drugs within the last month before the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRARMPatients and healthy volunteers are investigated in the seated and lying position during HRAM | Other | HRARM |
| MRI DefecographyAlso: MRDPatients and healthy volunteers are investigated in the supine and left lateral position in the MRI | Other | MRI Defecography |
Primary outcome
Recto-anal pressure gradient (RAPG)
Time frame: 1 hour
RAPG change in the LLP and sitting position (mmHg)
4 secondary outcomes
Presence of dyssynergia on HR-ARM
Time frame: 1 hour
Presence of dyssynergic defecation on MRI in healthy controls
Time frame: 1 hour
Agreement of MR findings in different body positions with HR-ARM findings
Time frame: 1 hour
Patient positional preference
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2015.
- Background: PubMed 23261065Bharucha AE, Pemberton JH, Locke GR 3rd. American Gastroenterological Association technical review on constipation. Gastroenterology. 2013 Jan;144(1):218-38. doi: 10.1053/j.gastro.2012.10.028. No abstract available.
- Background: PubMed 23142135Ratuapli SK, Bharucha AE, Noelting J, Harvey DM, Zinsmeister AR. Phenotypic identification and classification of functional defecatory disorders using high-resolution anorectal manometry. Gastroenterology. 2013 Feb;144(2):314-322.e2. doi: 10.1053/j.gastro.2012.10.049. Epub 2012 Nov 7.
- Background: PubMed 22986439Noelting J, Ratuapli SK, Bharucha AE, Harvey DM, Ravi K, Zinsmeister AR. Normal values for high-resolution anorectal manometry in healthy women: effects of age and significance of rectoanal gradient. Am J Gastroenterol. 2012 Oct;107(10):1530-6. doi: 10.1038/ajg.2012.221. Epub 2012 Sep 18.
- Background: PubMed 23130678Heinrich H, Fruehauf H, Sauter M, Steingotter A, Fried M, Schwizer W, Fox M. The effect of standard compared to enhanced instruction and verbal feedback on anorectal manometry measurements. Neurogastroenterol Motil. 2013 Mar;25(3):230-7, e163. doi: 10.1111/nmo.12038. Epub 2012 Nov 6.
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.
Henriette Heinrich study director
Department for Gastroenterology and Hepatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HRARM and MRI Defecography in people with Anismus and Incontinence, run by University of Zurich at 1 site in Switzerland.
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 9 inclusion and 8 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 17 Dec 2015. 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 Switzerland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Recto-anal pressure gradient (RAPG) (time frame: 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 NCT02633592, which also lists 4 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 17 Dec 2015.