Back to resultsNormal Values for 3D High Resolution Anorectal Manometry in Children
Primary Purpose
Children, Anorectal Disorder
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
3D high resolution anorectal manometry
Sponsored by
About this trial
This is an interventional diagnostic trial for Children
Eligibility Criteria
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
Sites / Locations
- Department of Pediatric Gastroenterology and Nutrition
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
children without anorectal disorders
Arm Description
All children will be investigated by 3D high resolution anorectal manometry procedure
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Presence of Rectoanal Inhibitory Reflex
Amount of air in a balloon needed to elicit Rectoanal Inhibitory Reflex
Presence of dyssynergic defecation
Percent of children without constipation but with dyssynergic defecation pattern
Presence of Cough Reflex
Presence of Ano-anal Reflex
Presence of discomfort during the procedure
Full Information
NCT ID
NCT02236507
First Posted
August 31, 2014
Last Updated
December 22, 2015
Sponsor
Medical University of Warsaw
Collaborators
Medtronic - MITG
1. Study Identification
Unique Protocol Identification Number
NCT02236507
Brief Title
Normal Values for 3D High Resolution Anorectal Manometry in Children
Official Title
Evaluation of Anorectal Area in Children Using 3D High Resolution Anorectal Manometry.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
April 2013 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw
Collaborators
Medtronic - MITG
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children, Anorectal Disorder
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
61 (Actual)
8. Arms, Groups, and Interventions
Arm Title
children without anorectal disorders
Arm Type
Other
Arm Description
All children will be investigated by 3D high resolution anorectal manometry procedure
Intervention Type
Device
Intervention Name(s)
3D high resolution anorectal manometry
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and Asymmetry of the anal canal
Description
Pressures during voluntary maneuvers will be obtained if cooperation with a child will be possible
Time Frame
up to 20 minutes
Secondary Outcome Measure Information:
Title
Presence of Rectoanal Inhibitory Reflex
Description
Amount of air in a balloon needed to elicit Rectoanal Inhibitory Reflex
Time Frame
up to 5 minutes
Title
Presence of dyssynergic defecation
Description
Percent of children without constipation but with dyssynergic defecation pattern
Time Frame
up to 1 minute
Title
Presence of Cough Reflex
Time Frame
10 seconds
Title
Presence of Ano-anal Reflex
Time Frame
10 seconds
Title
Presence of discomfort during the procedure
Time Frame
up to 20 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcin Banasiuk, MD
Organizational Affiliation
Medical University of Warsaw
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatric Gastroenterology and Nutrition
City
Warsaw
ZIP/Postal Code
01-184
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
26820403
Citation
Banasiuk M, Banaszkiewicz A, Dziekiewicz M, Zaleski A, Albrecht P. Values From Three-dimensional High-resolution Anorectal Manometry Analysis of Children Without Lower Gastrointestinal Symptoms. Clin Gastroenterol Hepatol. 2016 Jul;14(7):993-1000.e3. doi: 10.1016/j.cgh.2016.01.008. Epub 2016 Jan 25.
Results Reference
derived
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Normal Values for 3D High Resolution Anorectal Manometry in Children
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