An interventional study of 3D high resolution anorectal manometry in Children and Anorectal Disorder, sponsored by Medical University of Warsaw. Completed at 1 site in Poland. Open to participants aged 12 Months to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-23.
Sponsored by Medical University of Warsaw · Not applicable, Interventional, and Diagnostic
Anorectal 3D high resolution manometry (3D HRM) is the most advanced version of manometry equipment and has been recently introduced into clinical practice. It is the most precise method to assess the anal sphincter pressure function and may be crucial for planning and controlling surgical procedures of the anorectal area. Normal values in pediatric population have not been established.
The aim of this study is complex evaluation of anorectal function in children without symptoms from lower GI tract and establishment of normal values.
64 studies on the registry are indexed under Rectal Diseases; 14 are open to participants now.
This study's enrollment of 61 is below the median of 124 across 43 interventional studies indexed under Rectal Diseases.
Browse Rectal Diseases studies →Medical University of Warsaw is the lead sponsor of 316 studies on the registry; 87 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
All children will be investigated by 3D high resolution anorectal manometry procedure
Device: 3D high resolution anorectal manometry
Procedure will take about 15 min. During procedure resting, voluntary squeeze, bear down maneuver, cough reflex, ano-anal reflex and Rectoanal Inhibitory Reflex will be obtained, if possible.
Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and Asymmetry of the anal canal
Pressures during voluntary maneuvers will be obtained if cooperation with a child will be possible
Time frame: up to 20 minutes
Presence of Rectoanal Inhibitory Reflex
Amount of air in a balloon needed to elicit Rectoanal Inhibitory Reflex
Time frame: up to 5 minutes
Presence of dyssynergic defecation
Percent of children without constipation but with dyssynergic defecation pattern
Time frame: up to 1 minute
Presence of Cough Reflex
Time frame: 10 seconds
Presence of Ano-anal Reflex
Time frame: 10 seconds
Presence of discomfort during the procedure
Time frame: up to 20 minutes
This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.
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Medical University of Warsaw