3D High Resolution Anorectal Manometry in Children After Surgery for Anorectal Disorders
NCT ID: NCT02296008
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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COMPLETED
NA
43 participants
INTERVENTIONAL
2013-04-01
2016-12-31
Brief Summary
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Until now, it has been used only in adult population to evaluate defecatory disorders.
Congenital anorectal disorders are severe conditions and may present wide spectrum of symptoms from gastrointestinal tract.
The usefulness of the 3DHRAM hasn't been evaluated in children after surgery for anorectal disorders such as Hirschsprung's disease and anorectal malformations.
It may help for better understanding of pathophysiology of anorectal area and allow for planning improved procedures in these patients.
Moreover, the investigators study may elucidate the real usefulness of the procedure in management of disorders of gastrointestinal tract in pediatric population.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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surgery for Hirschsprung's disease
children after surgery for Hirschsprung's disease will undergo 3D high resolution anorectal manometry procedure
3D high resolution anorectal manometry
Procedure will take about 15 minutes. During procedure resting, squeeze, bear down maneuver, cough, ano-anal and rectoanal inhibitory reflex will be obtained, if possible.
3D picture of pressures of anorectal will be recorded.
surgery for anorectal malformation
children after surgery for anorectal malformation will undergo 3D high resolution anorectal manometry procedure
3D high resolution anorectal manometry
Procedure will take about 15 minutes. During procedure resting, squeeze, bear down maneuver, cough, ano-anal and rectoanal inhibitory reflex will be obtained, if possible.
3D picture of pressures of anorectal will be recorded.
surgery for other disorders
children after surgery for other disorders will undergo 3D high resolution anorectal manometry procedure
3D high resolution anorectal manometry
Procedure will take about 15 minutes. During procedure resting, squeeze, bear down maneuver, cough, ano-anal and rectoanal inhibitory reflex will be obtained, if possible.
3D picture of pressures of anorectal will be recorded.
Interventions
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3D high resolution anorectal manometry
Procedure will take about 15 minutes. During procedure resting, squeeze, bear down maneuver, cough, ano-anal and rectoanal inhibitory reflex will be obtained, if possible.
3D picture of pressures of anorectal will be recorded.
Eligibility Criteria
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Inclusion Criteria
* after surgery for Hirschsprung's disease,
* after surgery for Anorectal malformations,
* after total procto/colectomy
* with parental agreement for the procedure
Exclusion Criteria
* children \<12 months of age and \>18 years
12 Months
18 Years
ALL
No
Sponsors
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Medtronic - MITG
INDUSTRY
Medical University of Warsaw
OTHER
Responsible Party
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Marcin Banasiuk
M.D.
Principal Investigators
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Marcin Banasiuk, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Pediatric Gastroenterology and Nutrition Medical University of Warsaw, Poland
Locations
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Department of Pediatric Gastroenterology and Nutrition
Warsaw, , Poland
Countries
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References
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Banasiuk M, Dziekiewicz M, Dembinski L, Piotrowski D, Kaminski A, Banaszkiewicz A. Three-dimensional high-resolution anorectal manometry in children after surgery for anorectal disorders. Eur Rev Med Pharmacol Sci. 2021 Apr;25(7):2981-2993. doi: 10.26355/eurrev_202104_25551.
Other Identifiers
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Banasiuk2014 B
Identifier Type: -
Identifier Source: org_study_id
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