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3D High Resolution Manometry and Balloon Expulsion Test in Diagnosis of Dyssynergic Defecation in Children

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ClinicalTrials.gov Identifier: NCT02812836
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:

Anorectal 3D manometry (3D HRAM) is the most advanced version of manometric equipment that measures pressures along the anal canal in a very detailed manner. It provides complete data about pressure profile of anorectum and may indicate impaired defecation dynamics. Balloon expulsion test (BET) is a cheap, easy way to diagnose constipation as the result of outlet obstruction.

Our aim is to compare this two methods of diagnosis of dyssynergic defecation and to find the correlation between this diagnostic equipment.


Condition or disease Intervention/treatment Phase
Children Constipation Device: Manometry Not Applicable

Detailed Description:

Patients with the diagnosis of constipation will be enrolled in the study. Each patient will be investigated by anorectal manometry and after the procedure BET will be performed at the same day.

During anorectal manometry conventional manometric parameters will be recorded, such as resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and threshold of recto anal inhibitory reflex. 3D picture of anal canal will be recorded.

After the manometry standard BET will be performed. The balloon will be inserted into the rectum and patient will be asked to expel it in private during 1 min.

Data from manometry will be correlated with the success rate of BET.

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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: 3D High Resolution Manometry and Balloon Expulsion Test in Diagnosis of Dyssynergic Defecation in Children
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : March 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Manometry
All patients will be investigated by anorectal manometry and after the procedure with balloon expulsion test as previously described.
Device: Manometry
Each patient will be investigated first by anorectal manometry, standard protocol of conventional parameters will be recorded such as: resting pressure, squeeze pressure, bear down manoeuver, thresholds of sensation and threshold of recto anal inhibitory reflex. 3D picture of anal canal will be recorded. After that balloon with 50 ml of water will be inserted into the rectum and patient will be asked to expel the device within 1 min in privacy.
Other Name: Balloon




Primary Outcome Measures :
  1. Correlation between percent of dyssynergic defecation diagnosed by the manometry and BET. [ Time Frame: 30 min ]
    Percent of patients with the diagnosis of dyssynergic defecation made by BET and according to manometric equipment.


Secondary Outcome Measures :
  1. Bear down manoeuver pressure differential [ Time Frame: 1 min ]
    Pressures of rectum and anal canal during bear down manoeuver will be recorded 3 times. Patients will be classified as dyssynergic defecation type. Correlation between the type and the result of BET will be evaluated.

  2. puborectalis muscle pressure [ Time Frame: 1 min ]
    3D picture of anal canal will be recorded and pressure of puborectalis muscle will be recorded during rest and squeeze. The level of pressure will be correlated with the result of BET



Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Constipation
  • Parental agreement

Exclusion Criteria:

  • after surgery on lower gastrointestinal tract
  • diagnosis of inflammatory bowel disease
  • diagnosis of other disorder that may affect anorectum function
  • parental disagreement

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): NCT02812836


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: NCT02812836    
Other Study ID Numbers: Banasiuk 2016B
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:
anorectal manometry
children
constipation
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive