An interventional study of 3D high resolution anorectal manometry in Children, Anorectal Disorder and Anorectal Atresia, sponsored by Medical University of Warsaw. Completed at 1 site in Poland. Open to participants aged 12 Months to 18 Years. Per ClinicalTrials.gov, last updated 2018-11-14.
Sponsored by Medical University of Warsaw · Not applicable, Interventional, and Diagnostic
3D high resolution anorectal manometry (3DHRAM) is the most precise tool to assess function and 3D topographic picture of pressures along the anal canal.
Until now, it has been used only in adult population to evaluate defecatory disorders.
Congenital anorectal disorders are severe conditions and may present wide spectrum of symptoms from gastrointestinal tract.
The usefulness of the 3DHRAM hasn't been evaluated in children after surgery for anorectal disorders such as Hirschsprung's disease and anorectal malformations.
It may help for better understanding of pathophysiology of anorectal area and allow for planning improved procedures in these patients.
Moreover, the investigators study may elucidate the real usefulness of the procedure in management of disorders of gastrointestinal tract in pediatric population.
87 studies on the registry are indexed under Rectal Diseases; 14 are open to participants now.
This study's enrollment of 43 is below the median of 114 across 59 interventional studies indexed under Rectal Diseases.
Browse Rectal Diseases studies →Medical University of Warsaw is the lead sponsor of 326 studies on the registry; 87 are open to participants now.
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Exclusion Criteria:
children after surgery for Hirschsprung's disease will undergo 3D high resolution anorectal manometry procedure
Device: 3D high resolution anorectal manometry
children after surgery for anorectal malformation will undergo 3D high resolution anorectal manometry procedure
Device: 3D high resolution anorectal manometry
children after surgery for other disorders will undergo 3D high resolution anorectal manometry procedure
Device: 3D high resolution anorectal manometry
Procedure will take about 15 minutes. During procedure resting, squeeze, bear down maneuver, cough, ano-anal and rectoanal inhibitory reflex will be obtained, if possible. 3D picture of pressures of anorectal will be recorded.
Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and asymmetry of the anal canal
pressures will be recorded in mmHg
Time frame: 20 minutes
Presence of rectoanal inhibitory reflex
Amount of air inside the balloon needed to elicit rectoanal inhibitory reflex
Time frame: 5 minutes
Presence of sphincteric lesion in 3D picture of anal canal
Time frame: 30 seconds
Presence of ano-anal reflex
an increase in pressure during small movement of catheter inside and outside of the anal canal will be recorded by the sensors
Time frame: 10 seconds
Presence of cough reflex
an increase in pressure during cough will be recorded by the sensors
Time frame: 10 seconds
Presence of discomfort during procedure
Time frame: 20 minutes
Presence of dyssynergic defecation
during bear down maneuver lasting 20 second and repeated 2 times with the resting period of 1 minute the configuration of pressures inside the rectum and anal canal will be recorded and analyzed according to the criteria of dyssynergic defecation
Time frame: 2 minutes
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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