By InvitationNot Applicable

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

Poland120 participantsStarted 2020-01-10

Plain-language 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.

Who can participate

Age range4 Years – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria - the study group: * age from 5 to 18 years old * functional constipation diagnosed on the basis of Rome IV criteria * parental or guardian written consent to the participation of the child in the study; in the case of a child ≥16 years old also the child's written consent Inclusion criteria - the control group: * age from 5 to 18 years old * no lower gastrointestinal symptoms * parental or guardian written consent to the participation of the child in the study; in the case of a child ≥16 years old also the child's written consent Exclusion criteria - the study group and the control group: * undergone surgeries due to congenital anomalies in the lower gastrointestinal tract * inflammatory bowel diseases or inflammation of the large intestine with a different aetiology * anal fissure, inflammation of the anal area or other conditions which, in the opinion of the researcher, could affect the functioning of the distal gastrointestinal tract

What they're measuring

DD frequency

Timeframe: 1 day

Trial details

NCT IDNCT06924957

SponsorMedical University of Warsaw

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12