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

Medical University of Warsaw

Status: Unknown

Conditions: Fecal Incontinence; Children; Constipation

Treatments: Device: High-resolution anorectal manometry

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02812823

Banasiuk 2016A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 4 months to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

High resolution anorectal manometry

Other group

Description:

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.

Treatment:

Device: High-resolution anorectal manometry