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

Not Applicable

• Conditions: Fecal Incontinence; Constipation; Children
• Interventions: Device: High-resolution anorectal manometry

• Registration Number: NCT02812823
• Lead Sponsor: Medical University of Warsaw

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.

Study Timeline

• Study First Submitted: 2016-06-22
• Study First Submitted QC: 2016-06-23
• Study First Posted: 2016-06-24
• Study Start: 2018-03-01
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-12
• Last Update Posted: 2018-11-14
• Primary Completion: 2019-03
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
High resolution anorectal manometry	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
Maximum squeeze pressure	1 min	Pressure is recorded after the patient is asked to squeeze anorectum for 20 s (repeated 3 times).

Trial Locations

Locations (1)

Department of Pediatric Gastroenterology and Nutrition; 🇵🇱 Warsaw, Poland