Anorectal Disorder, Children
Conditions
Brief summary
Anorectal 3D high resolution manometry (3D HRM) is the most advanced version of manometry equipment and has been recently introduced into clinical practice. It is the most precise method to assess the anal sphincter pressure function and may be crucial for planning and controlling surgical procedures of the anorectal area. Normal values in pediatric population have not been established. The aim of this study is complex evaluation of anorectal function in children without symptoms from lower GI tract and establishment of normal values.
Interventions
Procedure will take about 15 min. During procedure resting, voluntary squeeze, bear down maneuver, cough reflex, ano-anal reflex and Rectoanal Inhibitory Reflex will be obtained, if possible.
Sponsors
Medtronic - MITG
Medical University of Warsaw
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* parental agreement * age: 1 to 18 yr
Exclusion criteria
* parental disagreement * children younger than 1 yr * children after the surgery for anorectal malformations * children with constipation during the last 10 months * children with nonretentive fecal soiling * children with inflammatory bowel diseases or any other type of large bowel inflammation * children with anal fissure, anal varices, inflammation of the anorectal area or any other disease that may interfere with function of anorectum
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and Asymmetry of the anal canal | up to 20 minutes | Pressures during voluntary maneuvers will be obtained if cooperation with a child will be possible |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence of Rectoanal Inhibitory Reflex | up to 5 minutes | Amount of air in a balloon needed to elicit Rectoanal Inhibitory Reflex |
| Presence of dyssynergic defecation | up to 1 minute | Percent of children without constipation but with dyssynergic defecation pattern |
| Presence of Cough Reflex | 10 seconds | — |
| Presence of Ano-anal Reflex | 10 seconds | — |
| Presence of discomfort during the procedure | up to 20 minutes | — |
Countries
Poland
Outcome results
None listed