Normal Values for 3D High Resolution Anorectal Manometry in Children

Not Applicable

Completed

• Conditions: Anorectal Disorder; Children
• Interventions: Device: 3D high resolution anorectal manometry

• Registration Number: NCT02236507
• Lead Sponsor: Medical University of Warsaw

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2014-08-31
• Study First Submitted QC: 2014-09-07
• Study First Posted: 2014-09-10
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-22
• Last Update Posted: 2015-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
children without anorectal disorders	3D high resolution anorectal manometry	All children will be investigated by 3D high resolution anorectal manometry procedure

Primary Outcome Measures

Name	Time	Method
Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and Asymmetry of the anal canal	up to 20 minutes	Pressures during voluntary maneuvers will be obtained if cooperation with a child will be possible

Secondary Outcome Measures

Name	Time	Method
Presence of Cough Reflex	10 seconds
Presence of Ano-anal Reflex	10 seconds
Presence of Rectoanal Inhibitory Reflex	up to 5 minutes	Amount of air in a balloon needed to elicit Rectoanal Inhibitory Reflex
Presence of dyssynergic defecation	up to 1 minute	Percent of children without constipation but with dyssynergic defecation pattern
Presence of discomfort during the procedure	up to 20 minutes

Trial Locations

Locations (1)

Department of Pediatric Gastroenterology and Nutrition; 🇵🇱 Warsaw, Poland