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

NCT02296008 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2018-11-14

No results posted yet for this study

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.

Conditions

  • Children
  • Anorectal Disorder
  • Anorectal Atresia
  • Hirschsprung Disease

Interventions

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.

Sponsors & Collaborators

  • Medtronic - MITG

    collaborator INDUSTRY

  • Medical University of Warsaw

    lead OTHER

Principal Investigators

  • Marcin Banasiuk, MD · Department of Pediatric Gastroenterology and Nutrition Medical University of Warsaw, Poland

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-04-01
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Poland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02296008 on ClinicalTrials.gov