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Comparison of Anorectal Manometry and 3D Manometry in Diagnosis of Functional Disorders in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02812823
Recruitment Status : Recruiting
First Posted : June 24, 2016
Last Update Posted : November 14, 2018
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
Marcin Banasiuk, Medical University of Warsaw

Brief Summary:

Pressures measured by manometric solid-state catheters may differ according to the type of the catheter and specific anatomy and physiology of anorectum.

The aim of the study is to establish the difference in recordings between 2 types of anorectal catheters used in pediatric patients and to validate the most appropriate way to diagnose of functional disorders.


Condition or disease Intervention/treatment Phase
Constipation Children Fecal Incontinence Device: High-resolution anorectal manometry Not Applicable

Detailed Description:
Patients enrolled in study will be investigated by both types of anorectal catheters, first by anorectal high resolution flexible, thinner, solid-state catheter and after that with rigid, thicker, solid-state catheter. Both procedures will be undertaken during one session. There will be used standard protocol of the procedure that measures conventional manometric parameters (resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and recto anal inhibitory reflex threshold.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of High-resolution Anorectal Manometry and 3D High-definition Anorectal Manometry in Diagnosis of Functional Disorders in Children
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Arm Intervention/treatment
High resolution anorectal manometry
All subjects will be investigated by high-resolution anorectal manometry. At the beginning the anorectal cather will be used to record conventional parameters and after that 3D high-definition anorectal manometric catheter will be inserted in order to measure conventional parameters and 3D picture of anorectum.
Device: High-resolution anorectal manometry
Recording of conventional manometric parameters after insertion of the catheters.




Primary Outcome Measures :
  1. Difference in Resting pressure of the anorectal area [ Time Frame: 20 seconds ]

    Resting pressure will be measured after insertion catheter into anorectum. The software automatically record pressure while patient is lying on the bed.

    The parameter is recorded with 2 different types of anorectal catheters and the difference is evaluated.



Secondary Outcome Measures :
  1. Maximum squeeze pressure [ Time Frame: 1 min ]
    Pressure is recorded after the patient is asked to squeeze anorectum for 20 s (repeated 3 times).

  2. Bear down manoeuver [ Time Frame: 1 min ]
    Pressures are recorded after the patient is asked to bear down for 20 s (repeated 2 times)

  3. Thresholds of sensation [ Time Frame: 1 min ]
    The balloon at the top of the catheter is being filled with air until a patient is able to report sensation, urge and discomfort.

  4. Recto anal inhibitory reflex [ Time Frame: 5 min ]
    The balloon at the top of the catheter is being filled with air until the relaxation of anal sphincter is observed.



Information from the National Library of Medicine

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Ages Eligible for Study:   4 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Functional Constipation
  • Fecal Incontinence
  • Parental Agreement

Exclusion Criteria:

  • After surgery on lower gastrointestinal tract
  • Diagnosis of inflammatory bowel disorders
  • Diagnosis of other disorders present in anorectal area, that may influence anorectal pressures
  • Lack of parental agreement

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): NCT02812823


Contacts
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Contact: Marcin Banasiuk, PhD +48223179463 mbanasiu@tlen.pl

Locations
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Poland
Department of Pediatric Gastroenterology and Nutrition Recruiting
Warsaw, Poland, 02-091
Contact: Marcin Banasiuk, PhD    +48223179463    mbanasiu@tlen.pl   
Principal Investigator: Marcin Banasiuk, PhD         
Sponsors and Collaborators
Medical University of Warsaw
Medtronic
Investigators
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Principal Investigator: Marcin Banasiuk, PhD Medical University of Warsaw
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Responsible Party: Marcin Banasiuk, PhD, Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT02812823    
Other Study ID Numbers: Banasiuk 2016A
First Posted: June 24, 2016    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marcin Banasiuk, Medical University of Warsaw:
manometry
children
constipation
functional disorders
Additional relevant MeSH terms:
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Fecal Incontinence
Constipation
Signs and Symptoms, Digestive
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases