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Enrolling By InvitationNCT06924957

Influence of Body Position on the Defecation Model During Anorectal Manometry.

Influence of Body Position on the Defecation Model Measured During High Resolution Anorectal Manometry in Children- a Control Study.

Status
Enrolling By Invitation
Phase
Study type
Observational
Enrollment
120 (estimated)
Sponsor
Medical University of Warsaw · Academic / Other
Sex
All
Age
4 Years – 18 Years
Healthy volunteers
Accepted

Summary

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.

Detailed description

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.

Conditions

Interventions

TypeNameDescription
OTHER3D HRAMThe 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.

Timeline

Start date
2020-01-10
Primary completion
2025-12-01
Completion
2025-12-01
First posted
2025-04-13
Last updated
2025-09-18

Locations

1 site across 1 country: Poland

Source: ClinicalTrials.gov record NCT06924957. Inclusion in this directory is not an endorsement.