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

Primary Purpose

Constipation, Children, Fecal Incontinence

Status

Unknown status

Phase

Not Applicable

Locations

Poland

Study Type

Interventional

Intervention

High-resolution anorectal manometry

About this trial

This is an interventional diagnostic trial for Constipation focused on measuring manometry, children, constipation, functional disorders

Eligibility Criteria

4 Months - 18 Years (Child, Adult)All SexesAccepts 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

Sites / Locations

Department of Pediatric Gastroenterology and NutritionRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

High resolution anorectal manometry

Arm 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.

Outcomes

Primary Outcome Measures

Difference in Resting pressure of the anorectal area

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

Maximum squeeze pressure

Pressure is recorded after the patient is asked to squeeze anorectum for 20 s (repeated 3 times).

Bear down manoeuver

Pressures are recorded after the patient is asked to bear down for 20 s (repeated 2 times)

Thresholds of sensation

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

The balloon at the top of the catheter is being filled with air until the relaxation of anal sphincter is observed.

Full Information

NCT ID

NCT02812823

First Posted

June 22, 2016

Last Updated

November 12, 2018

Sponsor

Medical University of Warsaw

Collaborators

Medtronic

1. Study Identification

Unique Protocol Identification Number

NCT02812823

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2018

Overall Recruitment Status

Unknown status

Study Start Date

March 1, 2018 (Actual)

Primary Completion Date

March 2019 (Anticipated)

Study Completion Date

March 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Medical University of Warsaw

Collaborators

Medtronic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Constipation, Children, Fecal Incontinence

Keywords

manometry, children, constipation, functional disorders

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

High resolution anorectal manometry

Arm Type

Other

Arm Description

Intervention Type

Device

Intervention Name(s)

High-resolution anorectal manometry

Intervention Description

Recording of conventional manometric parameters after insertion of the catheters.

Primary Outcome Measure Information:

Title

Difference in Resting pressure of the anorectal area

Description

Time Frame

20 seconds

Secondary Outcome Measure Information:

Title

Maximum squeeze pressure

Description

Pressure is recorded after the patient is asked to squeeze anorectum for 20 s (repeated 3 times).

Time Frame

1 min

Title

Bear down manoeuver

Description

Pressures are recorded after the patient is asked to bear down for 20 s (repeated 2 times)

Time Frame

1 min

Title

Thresholds of sensation

Description

The balloon at the top of the catheter is being filled with air until a patient is able to report sensation, urge and discomfort.

Time Frame

1 min

Title

Recto anal inhibitory reflex

Description

The balloon at the top of the catheter is being filled with air until the relaxation of anal sphincter is observed.

Time Frame

5 min

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Months

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marcin Banasiuk, PhD

Phone

+48223179463

mbanasiu@tlen.pl

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marcin Banasiuk, PhD

Organizational Affiliation

Medical University of Warsaw

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Pediatric Gastroenterology and Nutrition

City

Warsaw

ZIP/Postal Code

02-091

Country

Poland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marcin Banasiuk, PhD

Phone

+48223179463

mbanasiu@tlen.pl

First Name & Middle Initial & Last Name & Degree

Marcin Banasiuk, PhD

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34515101

Citation

Banasiuk M, Dobrowolska ME, Skowronska B, Konys J, Banaszkiewicz A. Comparison of Anorectal Function as Measured with High-Resolution and High-Definition Anorectal Manometry. Dig Dis. 2022;40(4):448-457. doi: 10.1159/000518357. Epub 2021 Aug 10.

Results Reference

derived

Learn more about this trial

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

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