Normal Values for 3D High Resolution Anorectal Manometry in Children
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|ClinicalTrials.gov Identifier: NCT02236507|
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : December 23, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Children Anorectal Disorder||Device: 3D high resolution anorectal manometry||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||61 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Anorectal Area in Children Using 3D High Resolution Anorectal Manometry.|
|Study Start Date :||April 2013|
|Actual Primary Completion Date :||November 2015|
|Actual Study Completion Date :||November 2015|
children without anorectal disorders
All children will be investigated by 3D high resolution anorectal manometry procedure
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.
- Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and Asymmetry of the anal canal [ Time Frame: up to 20 minutes ]Pressures during voluntary maneuvers will be obtained if cooperation with a child will be possible
- Presence of Rectoanal Inhibitory Reflex [ Time Frame: up to 5 minutes ]Amount of air in a balloon needed to elicit Rectoanal Inhibitory Reflex
- Presence of dyssynergic defecation [ Time Frame: up to 1 minute ]Percent of children without constipation but with dyssynergic defecation pattern
- Presence of Cough Reflex [ Time Frame: 10 seconds ]
- Presence of Ano-anal Reflex [ Time Frame: 10 seconds ]
- Presence of discomfort during the procedure [ Time Frame: up to 20 minutes ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236507
|Department of Pediatric Gastroenterology and Nutrition|
|Warsaw, Poland, 01-184|
|Principal Investigator:||Marcin Banasiuk, MD||Medical University of Warsaw|