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Normal Values for 3D High Resolution Anorectal Manometry in Children

NCT ID: NCT02236507

Last Updated: 2015-12-23

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2015-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Children Anorectal Disorder

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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children without anorectal disorders

All children will be investigated by 3D high resolution anorectal manometry procedure

Group Type OTHER

3D high resolution anorectal manometry

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

12 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Medtronic - MITG

INDUSTRY

Sponsor Role collaborator

Medical University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Marcin Banasiuk

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcin Banasiuk, MD

Role: PRINCIPAL_INVESTIGATOR

Medical University of Warsaw

Locations

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Department of Pediatric Gastroenterology and Nutrition

Warsaw, , Poland

Site Status

Countries

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Poland

References

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Banasiuk M, Banaszkiewicz A, Dziekiewicz M, Zaleski A, Albrecht P. Values From Three-dimensional High-resolution Anorectal Manometry Analysis of Children Without Lower Gastrointestinal Symptoms. Clin Gastroenterol Hepatol. 2016 Jul;14(7):993-1000.e3. doi: 10.1016/j.cgh.2016.01.008. Epub 2016 Jan 25.

Reference Type DERIVED
PMID: 26820403 (View on PubMed)

Other Identifiers

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Banasiuk2014 A

Identifier Type: -

Identifier Source: org_study_id