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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-01

Study Completion Date

2019-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Normal Values for 3D High Resolution Anorectal Manometry in Children

NCT02236507

Children Anorectal Disorder

COMPLETED NA

3D High Resolution Manometry and Balloon Expulsion Test in Diagnosis of Dyssynergic Defecation in Children

NCT02812836

Children Constipation

UNKNOWN NA

ROLE OF PELVIC ULTRASOUND IN THE TREATMENT MONITORING OF CHILDREN WITH CHRONIC Idiopathic Constipation

NCT05787093

Pediatric Functional Constipation

UNKNOWN

Ureteropelvic Junction Obstruction in Early Childhood: Comparison of Surgical Therapy and Surveillance. A Prospective, Randomized, Controlled Multi-Center Study

NCT00444431

Unilateral Ureteropelvic Junction Obstruction

UNKNOWN NA

Enema Device for Children With Spina Bifida

NCT05253196

Spina Bifida Fecal Incontinence

NOT_YET_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Constipation Children Fecal Incontinence

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type OTHER

High-resolution anorectal manometry

Intervention Type DEVICE

Recording of conventional manometric parameters after insertion of the catheters.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High-resolution anorectal manometry

Recording of conventional manometric parameters after insertion of the catheters.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

4 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes