3D High Resolution Anorectal Manometry in Children After Surgery for Anorectal Disorders

Study Overview
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Brief Summary
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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.

Official Title
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3D High Resolution Anorectal Manometry in Children After Surgery for Anorectal Disorders

Conditions
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Hirschsprung Disease, Children, Anorectal Disorder, Anorectal Atresia

Intervention / Treatment
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* Device: 3D high resolution anorectal manometry


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: surgery for Hirschsprung's disease<br>children after surgery for Hirschsprung's disease will undergo 3D high resolution anorectal manometry procedure | Device: 3D high resolution anorectal manometry<br>* 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.<br>|
| Other: surgery for anorectal malformation<br>children after surgery for anorectal malformation will undergo 3D high resolution anorectal manometry procedure | Device: 3D high resolution anorectal manometry<br>* 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.<br>|
| Other: surgery for other disorders<br>children after surgery for other disorders will undergo 3D high resolution anorectal manometry procedure | Device: 3D high resolution anorectal manometry<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of rectoanal inhibitory reflex | Amount of air inside the balloon needed to elicit rectoanal inhibitory reflex | 5 minutes | 
| Presence of sphincteric lesion in 3D picture of anal canal |  | 30 seconds | 
| 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 | 10 seconds | 
| Presence of cough reflex | an increase in pressure during cough will be recorded by the sensors | 10 seconds | 
| Presence of discomfort during procedure |  | 20 minutes | 
| 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 | 2 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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high resolution manometry, children, congenital anorectal disorder, surgery