Children, Constipation, Fecal Incontinence
Conditions
Keywords
manometry, children, constipation, functional disorders
Brief summary
Pressures measured by manometric solid-state catheters may differ according to the type of the catheter and specific anatomy and physiology of anorectum. The aim of the study is to establish the difference in recordings between 2 types of anorectal catheters used in pediatric patients and to validate the most appropriate way to diagnose of functional disorders.
Detailed description
Patients enrolled in study will be investigated by both types of anorectal catheters, first by anorectal high resolution flexible, thinner, solid-state catheter and after that with rigid, thicker, solid-state catheter. Both procedures will be undertaken during one session. There will be used standard protocol of the procedure that measures conventional manometric parameters (resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and recto anal inhibitory reflex threshold.
Interventions
Recording of conventional manometric parameters after insertion of the catheters.
Sponsors
Medtronic
Medical University of Warsaw
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Months to 18 Years
Healthy volunteers
Yes
Inclusion criteria
* Functional Constipation * Fecal Incontinence * Parental Agreement
Exclusion criteria
* After surgery on lower gastrointestinal tract * Diagnosis of inflammatory bowel disorders * Diagnosis of other disorders present in anorectal area, that may influence anorectal pressures * Lack of parental agreement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in Resting pressure of the anorectal area | 20 seconds | Resting pressure will be measured after insertion catheter into anorectum. The software automatically record pressure while patient is lying on the bed. The parameter is recorded with 2 different types of anorectal catheters and the difference is evaluated. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maximum squeeze pressure | 1 min | Pressure is recorded after the patient is asked to squeeze anorectum for 20 s (repeated 3 times). |
| Bear down manoeuver | 1 min | Pressures are recorded after the patient is asked to bear down for 20 s (repeated 2 times) |
| Thresholds of sensation | 1 min | The balloon at the top of the catheter is being filled with air until a patient is able to report sensation, urge and discomfort. |
| Recto anal inhibitory reflex | 5 min | The balloon at the top of the catheter is being filled with air until the relaxation of anal sphincter is observed. |
Countries
Poland
Contacts
Primary ContactMarcin Banasiuk, PhD
Outcome results
None listed