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Normal Values for 3D High Resolution Anorectal Manometry in Children

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ClinicalTrials.gov Identifier: NCT02236507
Recruitment Status : Completed
First Posted : September 10, 2014
Last Update Posted : December 23, 2015
Sponsor:
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
Marcin Banasiuk, Medical University of Warsaw

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Children Anorectal Disorder Device: 3D high resolution anorectal manometry Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Anorectal Area in Children Using 3D High Resolution Anorectal Manometry.
Study Start Date : April 2013
Actual Primary Completion Date : November 2015
Actual Study Completion Date : November 2015

Arm Intervention/treatment
children without anorectal disorders
All children will be investigated by 3D high resolution anorectal manometry procedure
Device: 3D high resolution anorectal manometry
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 Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   12 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02236507


Locations
Poland
Department of Pediatric Gastroenterology and Nutrition
Warsaw, Poland, 01-184
Sponsors and Collaborators
Medical University of Warsaw
Medtronic - MITG
Investigators
Principal Investigator: Marcin Banasiuk, MD Medical University of Warsaw

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Marcin Banasiuk, MD, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02236507     History of Changes
Other Study ID Numbers: Banasiuk2014 A
First Posted: September 10, 2014    Key Record Dates
Last Update Posted: December 23, 2015
Last Verified: December 2015

Additional relevant MeSH terms:
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases