3D High Resolution Manometry and Balloon Expulsion Test in Diagnosis of Dyssynergic Defecation in Children
NCT ID: NCT02812836
Last Updated: 2018-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2018-03-01
2019-03-01
Brief Summary
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Our aim is to compare this two methods of diagnosis of dyssynergic defecation and to find the correlation between this diagnostic equipment.
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Detailed Description
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During anorectal manometry conventional manometric parameters will be recorded, such as resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and threshold of recto anal inhibitory reflex. 3D picture of anal canal will be recorded.
After the manometry standard BET will be performed. The balloon will be inserted into the rectum and patient will be asked to expel it in private during 1 min.
Data from manometry will be correlated with the success rate of BET.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Manometry
All patients will be investigated by anorectal manometry and after the procedure with balloon expulsion test as previously described.
Manometry
Each patient will be investigated first by anorectal manometry, standard protocol of conventional parameters will be recorded such as: resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and threshold of recto anal inhibitory reflex. 3D picture of anal canal will be recorded. After that balloon with 50 ml of water will be inserted into the rectum and patient will be asked to expel the device within 1 min in privacy.
Interventions
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Manometry
Each patient will be investigated first by anorectal manometry, standard protocol of conventional parameters will be recorded such as: resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and threshold of recto anal inhibitory reflex. 3D picture of anal canal will be recorded. After that balloon with 50 ml of water will be inserted into the rectum and patient will be asked to expel the device within 1 min in privacy.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Parental agreement
Exclusion Criteria
* diagnosis of inflammatory bowel disease
* diagnosis of other disorder that may affect anorectum function
* parental disagreement
5 Years
18 Years
ALL
No
Sponsors
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Medtronic
INDUSTRY
Medical University of Warsaw
OTHER
Responsible Party
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Marcin Banasiuk
PhD
Principal Investigators
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Marcin Banasiuk, PhD
Role: PRINCIPAL_INVESTIGATOR
Medical University of Warsaw
Locations
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Department of Pediatric Gastroenterology and Nutrition
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Banasiuk 2016B
Identifier Type: -
Identifier Source: org_study_id
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