Back to results3D High Resolution Anorectal Manometry in Children After Surgery for Anorectal Disorders
Primary Purpose
Children, Anorectal Disorder, Anorectal Atresia
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
3D high resolution anorectal manometry
Sponsored by
About this trial
This is an interventional diagnostic trial for Children focused on measuring high resolution manometry, children, congenital anorectal disorder, surgery
Eligibility Criteria
Inclusion Criteria:
- age:1-18 yr
- after surgery for Hirschsprung's disease,
- after surgery for Anorectal malformations,
- after total procto/colectomy
- with parental agreement for the procedure
Exclusion Criteria:
- parental disagreement
- children <12 months of age and >18 years
Sites / Locations
- Department of Pediatric Gastroenterology and Nutrition
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
surgery for Hirschsprung's disease
surgery for anorectal malformation
surgery for other disorders
Arm Description
children after surgery for Hirschsprung's disease will undergo 3D high resolution anorectal manometry procedure
children after surgery for anorectal malformation will undergo 3D high resolution anorectal manometry procedure
children after surgery for other disorders will undergo 3D high resolution anorectal manometry procedure
Outcomes
Primary Outcome Measures
Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and asymmetry of the anal canal
pressures will be recorded in mmHg
Secondary Outcome Measures
Presence of rectoanal inhibitory reflex
Amount of air inside the balloon needed to elicit rectoanal inhibitory reflex
Presence of sphincteric lesion in 3D picture of anal canal
Presence of ano-anal reflex
an increase in pressure during small movement of catheter inside and outside of the anal canal will be recorded by the sensors
Presence of cough reflex
an increase in pressure during cough will be recorded by the sensors
Presence of discomfort during procedure
Presence of dyssynergic defecation
during bear down maneuver lasting 20 second and repeated 2 times with the resting period of 1 minute the configuration of pressures inside the rectum and anal canal will be recorded and analyzed according to the criteria of dyssynergic defecation
Full Information
NCT ID
NCT02296008
First Posted
November 12, 2014
Last Updated
November 12, 2018
Sponsor
Medical University of Warsaw
Collaborators
Medtronic - MITG
1. Study Identification
Unique Protocol Identification Number
NCT02296008
Brief Title
3D High Resolution Anorectal Manometry in Children After Surgery for Anorectal Disorders
Official Title
3D High Resolution Anorectal Manometry in Children After Surgery for Anorectal Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
April 1, 2013 (Actual)
Primary Completion Date
December 31, 2016 (Actual)
Study Completion Date
December 31, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical University of Warsaw
Collaborators
Medtronic - MITG
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
3D high resolution anorectal manometry (3DHRAM) is the most precise tool to assess function and 3D topographic picture of pressures along the anal canal.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children, Anorectal Disorder, Anorectal Atresia, Hirschsprung Disease
Keywords
high resolution manometry, children, congenital anorectal disorder, surgery
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
surgery for Hirschsprung's disease
Arm Type
Other
Arm Description
children after surgery for Hirschsprung's disease will undergo 3D high resolution anorectal manometry procedure
Arm Title
surgery for anorectal malformation
Arm Type
Other
Arm Description
children after surgery for anorectal malformation will undergo 3D high resolution anorectal manometry procedure
Arm Title
surgery for other disorders
Arm Type
Other
Arm Description
children after surgery for other disorders will undergo 3D high resolution anorectal manometry procedure
Intervention Type
Device
Intervention Name(s)
3D high resolution anorectal manometry
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and asymmetry of the anal canal
Description
pressures will be recorded in mmHg
Time Frame
20 minutes
Secondary Outcome Measure Information:
Title
Presence of rectoanal inhibitory reflex
Description
Amount of air inside the balloon needed to elicit rectoanal inhibitory reflex
Time Frame
5 minutes
Title
Presence of sphincteric lesion in 3D picture of anal canal
Time Frame
30 seconds
Title
Presence of ano-anal reflex
Description
an increase in pressure during small movement of catheter inside and outside of the anal canal will be recorded by the sensors
Time Frame
10 seconds
Title
Presence of cough reflex
Description
an increase in pressure during cough will be recorded by the sensors
Time Frame
10 seconds
Title
Presence of discomfort during procedure
Time Frame
20 minutes
Title
Presence of dyssynergic defecation
Description
during bear down maneuver lasting 20 second and repeated 2 times with the resting period of 1 minute the configuration of pressures inside the rectum and anal canal will be recorded and analyzed according to the criteria of dyssynergic defecation
Time Frame
2 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
age:1-18 yr
after surgery for Hirschsprung's disease,
after surgery for Anorectal malformations,
after total procto/colectomy
with parental agreement for the procedure
Exclusion Criteria:
parental disagreement
children <12 months of age and >18 years
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marcin Banasiuk, MD
Organizational Affiliation
Department of Pediatric Gastroenterology and Nutrition Medical University of Warsaw, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatric Gastroenterology and Nutrition
City
Warsaw
ZIP/Postal Code
01-184
Country
Poland
12. IPD Sharing Statement
Citations:
PubMed Identifier
33877661
Citation
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.
Results Reference
derived
Learn more about this trial
3D High Resolution Anorectal Manometry in Children After Surgery for Anorectal Disorders
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