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

Medical University of Warsaw

Status

Invitation-only

Conditions

Anorectal Disorder

Children

Constipation

Treatments

Other: 3D HRAM

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT06924957

Banasiuk2021B

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 estimated patients

Sex

All

Ages

4 to 18 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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