Comparison of Anorectal Manometry and 3D Manometry in Diagnosis of Functional Disorders in Children
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|ClinicalTrials.gov Identifier: NCT02812823|
Recruitment Status : Recruiting
First Posted : June 24, 2016
Last Update Posted : November 14, 2018
Pressures measured by manometric solid-state catheters may differ according to the type of the catheter and specific anatomy and physiology of anorectum.
The aim of the study is to establish the difference in recordings between 2 types of anorectal catheters used in pediatric patients and to validate the most appropriate way to diagnose of functional disorders.
|Condition or disease||Intervention/treatment||Phase|
|Constipation Children Fecal Incontinence||Device: High-resolution anorectal manometry||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparison of High-resolution Anorectal Manometry and 3D High-definition Anorectal Manometry in Diagnosis of Functional Disorders in Children|
|Actual Study Start Date :||March 1, 2018|
|Estimated Primary Completion Date :||March 2019|
|Estimated Study Completion Date :||March 2019|
High resolution anorectal manometry
All subjects will be investigated by high-resolution anorectal manometry. At the beginning the anorectal cather will be used to record conventional parameters and after that 3D high-definition anorectal manometric catheter will be inserted in order to measure conventional parameters and 3D picture of anorectum.
Device: High-resolution anorectal manometry
Recording of conventional manometric parameters after insertion of the catheters.
- Difference in Resting pressure of the anorectal area [ Time Frame: 20 seconds ]
Resting pressure will be measured after insertion catheter into anorectum. The software automatically record pressure while patient is lying on the bed.
The parameter is recorded with 2 different types of anorectal catheters and the difference is evaluated.
- Maximum squeeze pressure [ Time Frame: 1 min ]Pressure is recorded after the patient is asked to squeeze anorectum for 20 s (repeated 3 times).
- Bear down manoeuver [ Time Frame: 1 min ]Pressures are recorded after the patient is asked to bear down for 20 s (repeated 2 times)
- Thresholds of sensation [ Time Frame: 1 min ]The balloon at the top of the catheter is being filled with air until a patient is able to report sensation, urge and discomfort.
- Recto anal inhibitory reflex [ Time Frame: 5 min ]The balloon at the top of the catheter is being filled with air until the relaxation of anal sphincter is observed.
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): NCT02812823
|Contact: Marcin Banasiuk, PhDfirstname.lastname@example.org|
|Department of Pediatric Gastroenterology and Nutrition||Recruiting|
|Warsaw, Poland, 02-091|
|Contact: Marcin Banasiuk, PhD +48223179463 email@example.com|
|Principal Investigator: Marcin Banasiuk, PhD|
|Principal Investigator:||Marcin Banasiuk, PhD||Medical University of Warsaw|