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

Children Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02296008
• Other study ID #: Banasiuk2014 B
• Status: Completed
• Phase: N/A
• Start date: April 1, 2013
• Est. completion date: December 31, 2016

Study information

• Verified date: November 2018
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Anorectal Atresia
• Anorectal Disorder
• Anorectal Malformations
• Children
• Disease
• Hirschsprung Disease
• Rectal Diseases

Intervention

Device:
• 3D high resolution anorectal manometry
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.

Locations

Country	Name	City	State
Poland	Department of Pediatric Gastroenterology and Nutrition	Warsaw

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of Warsaw	Medtronic - MITG

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Presence of rectoanal inhibitory reflex	Amount of air inside the balloon needed to elicit rectoanal inhibitory reflex	5 minutes
Secondary	Presence of sphincteric lesion in 3D picture of anal canal		30 seconds
Secondary	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
Secondary	Presence of cough reflex	an increase in pressure during cough will be recorded by the sensors	10 seconds
Secondary	Presence of discomfort during procedure		20 minutes
Secondary	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