Normal Values for 3D High Resolution Anorectal Manometry in Children

December 22, 2015 updated by: Marcin Banasiuk, Medical University of Warsaw

Evaluation of Anorectal Area in Children Using 3D High Resolution Anorectal Manometry.

Anorectal 3D high resolution manometry (3D HRM) is the most advanced version of manometry equipment and has been recently introduced into clinical practice. It is the most precise method to assess the anal sphincter pressure function and may be crucial for planning and controlling surgical procedures of the anorectal area. Normal values in pediatric population have not been established.

The aim of this study is complex evaluation of anorectal function in children without symptoms from lower GI tract and establishment of normal values.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 01-184
        • Department of Pediatric Gastroenterology and Nutrition

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • parental agreement
  • age: 1 to 18 yr

Exclusion Criteria:

  • parental disagreement
  • children younger than 1 yr
  • children after the surgery for anorectal malformations
  • children with constipation during the last 10 months
  • children with nonretentive fecal soiling
  • children with inflammatory bowel diseases or any other type of large bowel inflammation
  • children with anal fissure, anal varices, inflammation of the anorectal area or any other disease that may interfere with function of anorectum

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: children without anorectal disorders
All children will be investigated by 3D high resolution anorectal manometry procedure
Device: 3D high resolution anorectal manometry
Procedure will take about 15 min. During procedure resting, voluntary squeeze, bear down maneuver, cough reflex, ano-anal reflex and Rectoanal Inhibitory Reflex will be obtained, if possible.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and Asymmetry of the anal canal
Time Frame: up to 20 minutes
Pressures during voluntary maneuvers will be obtained if cooperation with a child will be possible
up to 20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of Rectoanal Inhibitory Reflex
Time Frame: up to 5 minutes
Amount of air in a balloon needed to elicit Rectoanal Inhibitory Reflex
up to 5 minutes
Presence of dyssynergic defecation
Time Frame: up to 1 minute
Percent of children without constipation but with dyssynergic defecation pattern
up to 1 minute
Presence of Cough Reflex
Time Frame: 10 seconds
10 seconds
Presence of Ano-anal Reflex
Time Frame: 10 seconds
10 seconds
Presence of discomfort during the procedure
Time Frame: up to 20 minutes
up to 20 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Collaborators

Medtronic - MITG

Investigators

  • Principal Investigator: Marcin Banasiuk, MD, Medical University of Warsaw

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2013

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

August 31, 2014

First Submitted That Met QC Criteria

September 7, 2014

First Posted (Estimate)

September 10, 2014

Study Record Updates

Last Update Posted (Estimate)

December 23, 2015

Last Update Submitted That Met QC Criteria

December 22, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Banasiuk2014 A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Children

Clinical Trials on 3D high resolution anorectal manometry

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Venezuela

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe