Ignite Creation Date:
2024-05-06 @ 7:55 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02633592
Status:
COMPLETED
Last Update Posted:
2015-12-17
First Post:
2015-11-27
Brief Title:
Seated Evaluation of Anorectal funcTion by High Resolution Anorectal Manometry
Sponsor:
University of Zurich
Organization:
University of Zurich
Study Overview
Official Title:
Seated Evaluation of Anorectal funcTion by High Resolution Anorectal Manometry a Randomized Comparison of Measurements in the Seated and Left Lateral Positions
Status:
COMPLETED
Status Verified Date:
2015-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEAT
Brief 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
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 constipationHR-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 defecationThis 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 eg 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
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 defecationThis 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None