Comparison of Anorectal Manometry and 3D Manometry in Diagnosis of Functional Disorders in Children
Comparison of High-resolution Anorectal Manometry and 3D High-definition Anorectal Manometry in Diagnosis of Functional Disorders in Children
1 other identifier
interventional
100
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2016
CompletedFirst Posted
Study publicly available on registry
June 24, 2016
CompletedStudy Start
First participant enrolled
March 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2019
CompletedNovember 14, 2018
November 1, 2018
1 year
June 22, 2016
November 12, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Difference in Resting pressure of the anorectal area
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.
20 seconds
Secondary Outcomes (4)
Maximum squeeze pressure
1 min
Bear down manoeuver
1 min
Thresholds of sensation
1 min
Recto anal inhibitory reflex
5 min
Study Arms (1)
High resolution anorectal manometry
OTHERAll 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.
Interventions
Recording of conventional manometric parameters after insertion of the catheters.
Eligibility Criteria
You may qualify if:
- Functional Constipation
- Fecal Incontinence
- Parental Agreement
You may not qualify if:
- After surgery on lower gastrointestinal tract
- Diagnosis of inflammatory bowel disorders
- Diagnosis of other disorders present in anorectal area, that may influence anorectal pressures
- Lack of parental agreement
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medical University of Warsawlead
- Medtroniccollaborator
Study Sites (1)
Department of Pediatric Gastroenterology and Nutrition
Warsaw, 02-091, Poland
Related Publications (1)
Banasiuk M, Dobrowolska ME, Skowronska B, Konys J, Banaszkiewicz A. Comparison of Anorectal Function as Measured with High-Resolution and High-Definition Anorectal Manometry. Dig Dis. 2022;40(4):448-457. doi: 10.1159/000518357. Epub 2021 Aug 10.
PMID: 34515101DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marcin Banasiuk, PhD
Medical University of Warsaw
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
June 22, 2016
First Posted
June 24, 2016
Study Start
March 1, 2018
Primary Completion
March 1, 2019
Study Completion
March 1, 2019
Last Updated
November 14, 2018
Record last verified: 2018-11
Data Sharing
- IPD Sharing
- Will not share