Anorectal Disorder, Children, Constipation
Conditions
Keywords
anorectal manometry, HRAM, constipasion, position
Brief 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.
Interventions
OTHER3D 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.
Sponsors
Medical University of Warsaw
Medtronic
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| DD frequency | 1 day | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Values of pressures obtained during anorectal manometry | 1 day | 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). |
| Values of mean anal canal length | 1 day | The mean anal canal length will be assessed in sitting and lying position in the two groups. |
| Percentage of anal relaxation rate | 1 day | 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 |
Countries
Poland
Contacts
PRINCIPAL_INVESTIGATORBarbara Skowrońska, MD
Department of Pediatric Gastroenterology Medical University of Warsaw
Outcome results
None listed