An observational study in Constipation, Children and Anorectal Disorder, sponsored by Medical University of Warsaw. Terminated at 1 site in Poland. Open to participants aged 4 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-19.
Sponsored by Medical University of Warsaw · Observational
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. Resent studies suggest that the position in which 3D HRAM is performed should be changed. So far, no scientific research has been performed in children that directly compares both positions. The reference values of registered pressures during 3D HRAM in people without complaints were not specified, which would allow for a more precise diagnosis of patients with an incorrect defecation model and precise selection of patients who could benefit from biofeedback therapy.
Patients with the diagnosis of constipation will be enrolled in the study. Each patient will be investigated by anorectal manometry in both- sitted and lying position.
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.
1,046 studies on the registry are indexed under Constipation; 161 are open to participants now.
This study's enrollment of 84 is below the median of 120 across 126 observational studies indexed under Constipation.
Browse Constipation studies →Medical University of Warsaw is the lead sponsor of 326 studies on the registry; 87 are open to participants now.
Counted across the registry records on this site, refreshed daily.
The sample size was calculated to detect a 45% difference in the percentage of patients with a negative rectoanal gradient, assuming equal groups, alpha = 0.05, beta = 0.1, and a 30% drop out percentage. There should be 30 people in the constipation group and 30 healthy volunteers.
Due to possible differences depending on age, it was decided to conduct the study in two separate age groups (I. younger, i.e. 5-10 years old and II. older, 11-18 years old). The total number of patients in the study will therefore be 120 people.
Inclusion criteria - the study group:
Inclusion criteria - the control group:
Exclusion criteria - the study group and the control group:
Children that meet Rome IV criteria to diagnose functional constipation.
Other: 3D HRAM
Children without IBD, without chronic diseases of GI tract nor history of anorectal surgery
Other: 3D HRAM
The test will be performed both in supine and sitting position successively, using 3D HR-ARM. Resting, squeeze pressures, and bear down manoeuvre variables will be obtained. Diagnosis of dyssynergic defecation requires \< 20% relaxation of anal sphincter and/or intrarectal pressure\>40 mmHg during bear down manoeuvre.
Also known as: Three-dimensional high-resolution anorectal manometry
DD frequency
The difference in the number of patients with DD (defined as \<20% relaxation of anal sphincter and/or intrarectal pressure \>40 mmHg during bear down manoeuvre) in sitting and lying position.
Time frame: 1 day
Values of pressures obtained during anorectal manometry
Values of manometric parameters obtained in the lying and sitting position: mean resting pressure of the anal sphincter (mmHg), maximum squeeze pressure (mmHg), residual anal pressure (mmHg).
Time frame: 1 day
Values of mean anal canal length
The mean anal canal length will be assessed in sitting and lying position in the two groups.
Time frame: 1 day
Percentage of anal relaxation rate
the assessment of parameters of defecation dynamics during HR-ARM: rectoanal pressure gradient. All secondary end points will be assessed in sitting and lying position in the two groups. the assessment of parameters of defecation dynamics during HR-ARM: percentage of anal relaxation rate, rectoanal pressure gradient. All secondary
Time frame: 1 day
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2020 to primary completion in Aug 2026, 79 months.
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This study is terminated, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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