Skip to main content
OpenTrials
Completed

NCT Number: NCT02296008

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Children Anorectal Atresia Anorectal Disorder Anorectal Malformations Colonic Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Abnormalities Digestive System Diseases Gastrointestinal Diseases Hirschsprung Disease Intestinal Diseases Megacolon Rectal Diseases

Age range

12 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Pediatric Gastroenterology and Nutrition

Warsaw, 01-184, Poland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D high resolution anorectal manometry

Device

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.

Primary outcomes

  1. Mean and maximum sphincters pressures during rest, voluntary squeeze and bear down maneuvers and asymmetry of the anal canal

    Time frame: 20 minutes

    pressures will be recorded in mmHg

Secondary outcomes

  1. Presence of rectoanal inhibitory reflex

    Time frame: 5 minutes

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

  2. Presence of sphincteric lesion in 3D picture of anal canal

    Time frame: 30 seconds

  3. Presence of ano-anal reflex

    Time frame: 10 seconds

    an increase in pressure during small movement of catheter inside and outside of the anal canal will be recorded by the sensors

  4. Presence of cough reflex

    Time frame: 10 seconds

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

  5. Presence of discomfort during procedure

    Time frame: 20 minutes

  6. Presence of dyssynergic defecation

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Collaborators

  • Medtronic - MITG

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Nov 20, 2014
Registry last updated
Nov 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.