3D High Resolution Anorectal Manometry in Children After Surgery for Anorectal Disorders
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 43
- Locations
- 2
- Primary Endpoint
- Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and asymmetry of the anal canal
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 12 Months to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
surgery for Hirschsprung's disease
children after surgery for Hirschsprung's disease will undergo 3D high resolution anorectal manometry procedure
Intervention: 3D high resolution anorectal manometry (Device)
surgery for anorectal malformation
children after surgery for anorectal malformation will undergo 3D high resolution anorectal manometry procedure
Intervention: 3D high resolution anorectal manometry (Device)
surgery for other disorders
children after surgery for other disorders will undergo 3D high resolution anorectal manometry procedure
Intervention: 3D high resolution anorectal manometry (Device)
Outcomes
Primary Outcomes
Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and asymmetry of the anal canal
Time Frame: 20 minutes
pressures will be recorded in mmHg
Secondary Outcomes
- Presence of ano-anal reflex(10 seconds)
- Presence of cough reflex(10 seconds)
- Presence of sphincteric lesion in 3D picture of anal canal(30 seconds)
- Presence of rectoanal inhibitory reflex(5 minutes)
- Presence of discomfort during procedure(20 minutes)
- Presence of dyssynergic defecation(2 minutes)
Investigators
Marcin Banasiuk
M.D.
Medical University of Warsaw