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

Medical University of Warsaw

Status: Completed

Conditions: Hirschsprung Disease; Anorectal Atresia; Anorectal Disorder; Children

Treatments: Device: 3D high resolution anorectal manometry

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02296008

Banasiuk2014 B

Details and patient eligibility

About

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.

Enrollment: 43 patients

Sex: All

Ages: 12 months to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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43 participants in 3 patient groups

surgery for Hirschsprung's disease

Other group

Description:

children after surgery for Hirschsprung's disease will undergo 3D high resolution anorectal manometry procedure

Treatment:

Device: 3D high resolution anorectal manometry

surgery for anorectal malformation

Other group

Description:

children after surgery for anorectal malformation will undergo 3D high resolution anorectal manometry procedure

Treatment:

Device: 3D high resolution anorectal manometry

surgery for other disorders

Other group

Description:

children after surgery for other disorders will undergo 3D high resolution anorectal manometry procedure

Treatment:

Device: 3D high resolution anorectal manometry