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Normal Values for 3D High Resolution Anorectal Manometry in Children

M

Medical University of Warsaw

Status

Completed

Conditions

Anorectal Disorder
Children

Treatments

Device: 3D high resolution anorectal manometry

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT02236507
Banasiuk2014 A

Details and patient eligibility

About

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.

Enrollment

61 patients

Sex

All

Ages

12 months to 18 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

61 participants in 1 patient group

children without anorectal disorders
Other group
Description:
All children will be investigated by 3D high resolution anorectal manometry procedure
Treatment:
Device: 3D high resolution anorectal manometry

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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