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

November 12, 2018 updated by: Marcin Banasiuk, Medical University of Warsaw

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

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, 02-091
        • Recruiting
        • Department of Pediatric Gastroenterology and Nutrition
        • Contact:
        • Principal Investigator:
          • Marcin Banasiuk, PhD

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

4 months to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in Resting pressure of the anorectal area
Time Frame: 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.
20 seconds

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum squeeze pressure
Time Frame: 1 min
Pressure is recorded after the patient is asked to squeeze anorectum for 20 s (repeated 3 times).
1 min
Bear down manoeuver
Time Frame: 1 min
Pressures are recorded after the patient is asked to bear down for 20 s (repeated 2 times)
1 min
Thresholds of sensation
Time Frame: 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.
1 min
Recto anal inhibitory reflex
Time Frame: 5 min
The balloon at the top of the catheter is being filled with air until the relaxation of anal sphincter is observed.
5 min

Collaborators and Investigators

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

Sponsor

Medical University of Warsaw

Collaborators

Medtronic

Investigators

  • Principal Investigator: Marcin Banasiuk, PhD, 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 (Actual)

March 1, 2018

Primary Completion (Anticipated)

March 1, 2019

Study Completion (Anticipated)

March 1, 2019

Study Registration Dates

First Submitted

June 22, 2016

First Submitted That Met QC Criteria

June 23, 2016

First Posted (Estimate)

June 24, 2016

Study Record Updates

Last Update Posted (Actual)

November 14, 2018

Last Update Submitted That Met QC Criteria

November 12, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Banasiuk 2016A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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