Comparison of Anorectal Manometry and 3D Manometry in Diagnosis of Functional Disorders in Children

Sponsor

Medical University of Warsaw (Other)

Overall Status

Unknown status

CT.gov ID

NCT02812823

Collaborator

Medtronic (Industry)

100

Enrollment

Location

Arm

Anticipated Duration (Months)

8.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Constipation Children Fecal Incontinence	Device: High-resolution anorectal manometry	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Comparison of High-resolution Anorectal Manometry and 3D High-definition Anorectal Manometry in Diagnosis of Functional Disorders in Children

Actual Study Start Date :

Mar 1, 2018

Anticipated Primary Completion Date :

Mar 1, 2019

Anticipated Study Completion Date :

Mar 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Other: High resolution anorectal manometry All subjects will be investigated by high-resolution anorectal manometry. At the beginning the anorectal cather will be used to record conventional parameters and after that 3D high-definition anorectal manometric catheter will be inserted in order to measure conventional parameters and 3D picture of anorectum.	Device: High-resolution anorectal manometry Recording of conventional manometric parameters after insertion of the catheters.

Arm

Intervention/Treatment

Other: High resolution anorectal manometry

All subjects will be investigated by high-resolution anorectal manometry. At the beginning the anorectal cather will be used to record conventional parameters and after that 3D high-definition anorectal manometric catheter will be inserted in order to measure conventional parameters and 3D picture of anorectum.

Device: High-resolution anorectal manometry

Recording of conventional manometric parameters after insertion of the catheters.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

4 Months to 18 Years

Sexes Eligible for Study:

All

Accepts 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