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Completed

NCT Number: NCT02236507

Normal Values for 3D High Resolution Anorectal Manometry in Children

Anorectal 3D high resolution manometry (3D HRM) is the most advanced version of manometry equipment and has been recently introduced into clinical practice. It is the most precise method to assess the anal sphincter pressure function and may be crucial for planning and controlling surgical procedures of the anorectal area. Normal values in pediatric population have not been established.

The aim of this study is complex evaluation of anorectal function in children without symptoms from lower GI tract and establishment of normal values.

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Key information

Conditions

Children Anorectal Disorder Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases 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: Yes

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

Inclusion criteria

  • parental agreement
  • age: 1 to 18 yr

Exclusion criteria

  • parental disagreement
  • children younger than 1 yr
  • children after the surgery for anorectal malformations
  • children with constipation during the last 10 months
  • children with nonretentive fecal soiling
  • children with inflammatory bowel diseases or any other type of large bowel inflammation
  • children with anal fissure, anal varices, inflammation of the anorectal area or any other disease that may interfere with function of anorectum

Treatment and study plan

3D high resolution anorectal manometry

Device

Procedure will take about 15 min. During procedure resting, voluntary squeeze, bear down maneuver, cough reflex, ano-anal reflex and Rectoanal Inhibitory Reflex will be obtained, if possible.

Primary outcomes

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

    Time frame: up to 20 minutes

    Pressures during voluntary maneuvers will be obtained if cooperation with a child will be possible

Secondary outcomes

  1. Presence of Rectoanal Inhibitory Reflex

    Time frame: up to 5 minutes

    Amount of air in a balloon needed to elicit Rectoanal Inhibitory Reflex

  2. Presence of dyssynergic defecation

    Time frame: up to 1 minute

    Percent of children without constipation but with dyssynergic defecation pattern

  3. Presence of Cough Reflex

    Time frame: 10 seconds

  4. Presence of Ano-anal Reflex

    Time frame: 10 seconds

  5. Presence of discomfort during the procedure

    Time frame: up to 20 minutes

Sponsors and collaborators

Lead sponsor

Medical University of Warsaw

Other

Collaborators

  • Medtronic - MITG

Registry information

Official study title

Evaluation of Anorectal Area in Children Using 3D High Resolution Anorectal Manometry.

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Sep 10, 2014
Registry last updated
Dec 23, 2015

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.

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