Normal Values for 3D High Resolution Anorectal Manometry in Children

Children Clinical Trial

Official title:

Evaluation of Anorectal Area in Children Using 3D High Resolution Anorectal Manometry.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02236507
• Other study ID #: Banasiuk2014 A
• Status: Completed
• Phase: N/A
• First received: August 31, 2014
• Last updated: December 22, 2015
• Start date: April 2013
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Months to 18 Years

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Anorectal Disorder
• Children

Intervention

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.

Locations

Country	Name	City	State
Poland	Department of Pediatric Gastroenterology and Nutrition	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Warsaw	Medtronic - MITG

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and Asymmetry of the anal canal	Pressures during voluntary maneuvers will be obtained if cooperation with a child will be possible	up to 20 minutes	No
Secondary	Presence of Rectoanal Inhibitory Reflex	Amount of air in a balloon needed to elicit Rectoanal Inhibitory Reflex	up to 5 minutes	No
Secondary	Presence of dyssynergic defecation	Percent of children without constipation but with dyssynergic defecation pattern	up to 1 minute	No
Secondary	Presence of Cough Reflex		10 seconds	No
Secondary	Presence of Ano-anal Reflex		10 seconds	No
Secondary	Presence of discomfort during the procedure		up to 20 minutes	No