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

Medical University of Warsaw43 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Children Anorectal Disorder Anorectal Atresia Hirschsprung Disease

Interventions

3D high resolution anorectal manometryDEVICE

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

Sex: ALLMin age: 12 MonthsMax age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Department of Pediatric Gastroenterology and Nutrition

Warsaw, Poland

Outcomes

Primary Outcomes

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

Time frame: 20 minutes

Secondary Outcomes

Presence of rectoanal inhibitory reflex

Amount of air inside the balloon needed to elicit rectoanal inhibitory reflex

Time frame: 5 minutes

Presence of sphincteric lesion in 3D picture of anal canal

Time frame: 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

Time frame: 10 seconds

Presence of cough reflex

an increase in pressure during cough will be recorded by the sensors

Time frame: 10 seconds

Presence of discomfort during procedure

Time frame: 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

Time frame: 2 minutes

Data from ClinicalTrials.gov

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