Trials / Enrolling By Invitation
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
| Type | Name | Description |
|---|---|---|
| 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. |
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.