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

Not Applicable

Completed

• Conditions: Anorectal Disorder; Hirschsprung Disease; Children; Anorectal Atresia
• Interventions: Device: 3D high resolution anorectal manometry

• Registration Number: NCT02296008
• Lead Sponsor: Medical University of Warsaw

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-01
• Study First Submitted: 2014-11-12
• Study First Submitted QC: 2014-11-17
• Study First Posted: 2014-11-20
• Primary Completion: 2016-12-31
• Study Completion: 2016-12-31
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-12
• Last Update Posted: 2018-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
surgery for other disorders	3D high resolution anorectal manometry	children after surgery for other disorders will undergo 3D high resolution anorectal manometry procedure
surgery for anorectal malformation	3D high resolution anorectal manometry	children after surgery for anorectal malformation will undergo 3D high resolution anorectal manometry procedure
surgery for Hirschsprung's disease	3D high resolution anorectal manometry	children after surgery for Hirschsprung's disease will undergo 3D high resolution anorectal manometry procedure

Primary Outcome Measures

Name	Time	Method
Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and asymmetry of the anal canal	20 minutes	pressures will be recorded in mmHg

Secondary Outcome Measures

Name	Time	Method
Presence of ano-anal reflex	10 seconds	an increase in pressure during small movement of catheter inside and outside of the anal canal will be recorded by the sensors
Presence of rectoanal inhibitory reflex	5 minutes	Amount of air inside the balloon needed to elicit rectoanal inhibitory reflex
Presence of sphincteric lesion in 3D picture of anal canal	30 seconds
Presence of cough reflex	10 seconds	an increase in pressure during cough will be recorded by the sensors
Presence of discomfort during procedure	20 minutes
Presence of dyssynergic defecation	2 minutes	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

Trial Locations

Locations (1)

Department of Pediatric Gastroenterology and Nutrition; 🇵🇱 Warsaw, Poland