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Normal Values for 3D High Resolution Anorectal Manometry in Children

NCT02236507 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2015-12-23

No results posted yet for this study

Summary

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.

Conditions

  • Children
  • Anorectal Disorder

Interventions

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.

Sponsors & Collaborators

  • Medtronic - MITG

    collaborator INDUSTRY

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Marcin Banasiuk, MD · Medical University of Warsaw

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02236507 on ClinicalTrials.gov