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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02236507
Other study ID # Banasiuk2014 A
Secondary ID
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


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
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