An interventional study of Manometry in Children and Constipation, sponsored by Medical University of Warsaw. Status unknown at 1 site in Poland. Open to participants aged 5 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-11-14.
Sponsored by Medical University of Warsaw · Not applicable, Interventional, and Diagnostic
Anorectal 3D manometry (3D HRAM) is the most advanced version of manometric equipment that measures pressures along the anal canal in a very detailed manner. It provides complete data about pressure profile of anorectum and may indicate impaired defecation dynamics. Balloon expulsion test (BET) is a cheap, easy way to diagnose constipation as the result of outlet obstruction.
Our aim is to compare this two methods of diagnosis of dyssynergic defecation and to find the correlation between this diagnostic equipment.
Patients with the diagnosis of constipation will be enrolled in the study. Each patient will be investigated by anorectal manometry and after the procedure BET will be performed at the same day.
During anorectal manometry conventional manometric parameters will be recorded, such as resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and threshold of recto anal inhibitory reflex. 3D picture of anal canal will be recorded.
After the manometry standard BET will be performed. The balloon will be inserted into the rectum and patient will be asked to expel it in private during 1 min.
Data from manometry will be correlated with the success rate of BET.
1,018 studies on the registry are indexed under Constipation; 139 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 850 interventional studies indexed under Constipation.
Browse Constipation 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 patients will be investigated by anorectal manometry and after the procedure with balloon expulsion test as previously described.
Device: Manometry
Each patient will be investigated first by anorectal manometry, standard protocol of conventional parameters will be recorded such as: resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and threshold of recto anal inhibitory reflex. 3D picture of anal canal will be recorded. After that balloon with 50 ml of water will be inserted into the rectum and patient will be asked to expel the device within 1 min in privacy.
Also known as: Balloon
Correlation between percent of dyssynergic defecation diagnosed by the manometry and BET.
Percent of patients with the diagnosis of dyssynergic defecation made by BET and according to manometric equipment.
Time frame: 30 min
Bear down manoeuver pressure differential
Pressures of rectum and anal canal during bear down manoeuver will be recorded 3 times. Patients will be classified as dyssynergic defecation type. Correlation between the type and the result of BET will be evaluated.
Time frame: 1 min
puborectalis muscle pressure
3D picture of anal canal will be recorded and pressure of puborectalis muscle will be recorded during rest and squeeze. The level of pressure will be correlated with the result of BET
Time frame: 1 min
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Medical University of Warsaw